US20080140163A1 - Telemetry device for a medical device programmer - Google Patents

Telemetry device for a medical device programmer Download PDF

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Publication number
US20080140163A1
US20080140163A1 US11/940,734 US94073407A US2008140163A1 US 20080140163 A1 US20080140163 A1 US 20080140163A1 US 94073407 A US94073407 A US 94073407A US 2008140163 A1 US2008140163 A1 US 2008140163A1
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device
telemetry
consumer electronic
medical device
implantable medical
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US11/940,734
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Jeffrey T. Keacher
Donald R. Johnson
Andrew H. Houchins
Theodore J. Stone
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Medtronic Inc
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Medtronic Inc
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Priority to US87319006P priority
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Priority to US11/940,734 priority patent/US20080140163A1/en
Assigned to MEDTRONIC, INC. reassignment MEDTRONIC, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: HOUCHINS, ANDREW H., JOHNSON, DONALD R., STONE, THEODORE J., KEACHER, JEFFREY T.
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Application status is Abandoned legal-status Critical

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    • GPHYSICS
    • G06COMPUTING; CALCULATING; COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F19/00Digital computing or data processing equipment or methods, specially adapted for specific applications
    • G06F19/30Medical informatics, i.e. computer-based analysis or dissemination of patient or disease data
    • G06F19/34Computer-assisted medical diagnosis or treatment, e.g. computerised prescription or delivery of medication or diets, computerised local control of medical devices, medical expert systems or telemedicine
    • G06F19/3481Computer-assisted prescription or delivery of treatment by physical action, e.g. surgery or physical exercise
    • GPHYSICS
    • G06COMPUTING; CALCULATING; COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F19/00Digital computing or data processing equipment or methods, specially adapted for specific applications
    • G06F19/30Medical informatics, i.e. computer-based analysis or dissemination of patient or disease data
    • G06F19/34Computer-assisted medical diagnosis or treatment, e.g. computerised prescription or delivery of medication or diets, computerised local control of medical devices, medical expert systems or telemedicine
    • G06F19/3418Telemedicine, e.g. remote diagnosis, remote control of instruments or remote monitoring of patient carried devices

Abstract

In general, the disclosure is directed towards a small telemetry device with a limited user interface that allows a patient to program an implantable medical device. The user interface may comprise a safe mode button. In some embodiments, a consumer electronic device with a more complex user interface may communicate with the implantable medical device via the telemetry device.

Description

  • This application claims the benefit of U.S. Provisional Application No. 60/873,264 to Keacher et al. entitled “TELEMETRY MODULE FOR A MEDICAL DEVICE PROGRAMMER,” and filed on Dec. 6, 2006, and U.S. Provisional Application No. 60/873,190 to Goetz et al. entitled “MEDICAL DEVICE PROGRAMMING SAFETY,” and filed on Dec. 6, 2006. The entire content of each of these provisional applications is incorporated herein by reference.
  • TECHNICAL FIELD
  • The invention relates to medical devices, and more particularly, to a medical device programming system.
  • BACKGROUND
  • Clinicians and patients typically communicate with an implantable medial device (IMD) using a clinician programmer (CP) and patient programmer, i.e., patient therapy manager (PTM), respectively. For example, a clinician may use a CP to perform advanced IMD setup and diagnostics, while the PTM may be configured to provide a less feature-rich interface for the patient to interact with the IMD. For example, while both the CP and PTM may be used to program an IMD and receive diagnostic information from the IMD, the PTM is generally only able to make limited programming modifications, and receive limited diagnostic information that is relevant to the patient, e.g., battery status. Both the CP and the PTM have traditionally communicated directly with the IMD for programming the IMD.
  • CPs and PTMs are computing devices. Traditionally, these computing devices have been special-purpose devices, i.e., dedicated to tasks associated with programming or otherwise communicating with IMDs. For example, these computing devices generally run custom operating systems, with only software supporting CP or PTM functionality loaded thereon. Further, these computing devices are typically limited in their input/output capabilities, e.g., to communicate with IMDs and, in some cases, each other.
  • SUMMARY
  • In general, the invention is directed towards a small telemetry device with a limited user interface for programming an implantable medical device (IMD). In one embodiment, the user interface comprises a safe mode button. In some embodiments, another programming device with a more complex user interface, such as a consumer electronic device including the appropriate programming application or a clinician programmer (CP), may communicate with the IMD via the telemetry device.
  • In some embodiments, the telemetry device includes a relatively limited number of programming functions. Thus, it may be desirable to have access to another, more complex programming device with richer programming features, such as a dedicated medical device programmer, a consumer electronic device, or another computing device. The telemetry device may be useful for situations in which the dedicated medical device programmer, consumer electronic device or other computing device does not have the capability to communicate directly with the IMD. The telemetry device may be configured to communicate according to a plurality of protocols. For example, the telemetry device may be configured to communicate according to a first protocol, which may be the same as the communication protocol used by the IMD, as well as a second protocol, which may be the same as the communication protocol used by the dedicated medical device programmer, a consumer electronic device, or another computing device. In this way, the telemetry device may be an intermediate telemetry link between the IMD and another computing device.
  • In other embodiments, the telemetry device may also be configured to communicate according to a third protocol, which may be the same protocol used by another IMD or another programming device (e.g., another consumer electronic device or dedicated medical device programmer). The telemetry device may be configured to support any suitable number of communication protocols for any suitable number of devices.
  • In one embodiment, the relatively small telemetry device is sized to fit in a pocket in a patient's clothing. For example, the telemetry device may be the approximate size of a key fob for an automobile keyless entry system. In this way, the telemetry device may provide a discreet way to communicate with an implanted medical device.
  • In one embodiment, the invention is directed toward a system comprising an IMD configured to transmit and receive information according to a first communication protocol, a telemetry device configured to program the IMD, and a consumer electronic device configured to program the IMD. The telemetry device comprises a first housing, a first transceiver disposed within the first housing and configured to transmit and receive information according to the first communication protocol, and a second transceiver disposed within the first housing and configured to transmit and receive information according to a second communication protocol. The consumer electronic device comprises a second housing separate from the first housing and is configured to transmit and receive information according to the second communication protocol. The consumer electronic device is configured to communicate with the IMD via the telemetry device, and the telemetry device includes fewer programming features than the consumer electronic device.
  • In another embodiment, the invention is directed toward a method comprising receiving an input from a user via a user interface on a consumer electronic device, the user input indicating a desired programming change to be implemented into an IMD, generating a programming signal based on the user input, and transmitting the programming signal to a telemetry device via a first transmission signal according to a first communication protocol. The telemetry device comprises a first transceiver configured to receive the programming signal from the consumer electronic device and a second transceiver configured to transmit the programming signal to the IMD according to a second communication protocol. The telemetry device is configured to program the IMD independently of the consumer electronic device.
  • In yet another embodiment, the invention is directed toward a method comprising positioning a telemetry device within an operative distance of a consumer electronic device and positioning the telemetry device within an operative distance of an implantable medical device implanted within a patient, the telemetry device comprising a first transceiver configured to transmit and receive information from a medical device programmer according to a first communication protocol, a second transceiver configured to communicate with the implantable medical device according to a second communication protocol, and a user interface to receive an input from a user. The method further comprising inputting a desired programming change for the implantable medical device into the consumer electronic device, wherein the telemetry device delivers a programming signal to implement the desired programming change to the implantable medical device.
  • The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.
  • BRIEF DESCRIPTION OF DRAWINGS
  • FIG. 1 is a schematic perspective view of a therapy system including an implantable medical device (IMD).
  • FIG. 2 is a schematic block diagram illustrating various components of an electrical stimulator and an implantable lead.
  • FIG. 3 illustrates a system in which a telemetry device may be used to communicate with an IMD.
  • FIG. 4 is a conceptual diagram of an embodiment of a telemetry device, which is shown to be a key fob.
  • FIG. 5 is a conceptual diagram of another embodiment of a telemetry device, which is shown to be aligned for connection to a docking station.
  • FIG. 6 is a schematic block diagram illustrating various components of a telemetry device.
  • FIG. 7 illustrates one embodiment of a system in which a telemetry device includes a watchdog module to provide an intermediate security link between a consumer electronic device and IMD 12.
  • DETAILED DESCRIPTION
  • FIG. 1 is a schematic perspective view of therapy system 10, which includes implantable medical device (IMD) 12. In the illustrated embodiment, IMD 12 is an electrical stimulator. However, in other embodiments, IMD 12 may be any type of IMD or an external medical device. For example, IMD 12 may be an implantable or external fluid delivery device, a pacemaker, a defibrillator, a trial stimulator or any other type of medical device. Examples of fluid delivery devices that may be used include fluid delivery pumps or reservoirs configured to deliver pharmaceutical agents, insulin, pain relieving agents, gene therapy agents or the like to a tissue site within patient 16. Accordingly, although therapy system 10 and IMD 12 are referenced throughout the remainder of the disclosure for purposes of illustration, therapy system 10 and IMD 12, in accordance with the invention, may be adapted for use in a variety of applications.
  • IMD 12 is coupled to stimulation lead 14 and provides a programmable stimulation signal (e.g., in the form of electrical pulses or substantially continuous-time signals) to target stimulation site 18 via stimulation lead 14. More particularly, the programmable stimulation signal is delivered to target stimulation site 18 via one or more stimulation electrodes carried by lead 14. In some embodiments, lead 14 may also carry one or more sense electrodes to permit IMD 12 to sense electrical signals from target stimulation site 18. Stimulation delivery and sensing may occur via the same electrodes, in some embodiments. Proximal end 14A of lead 14 may be both electrically and mechanically coupled to connector 13 of IMD 12 either directly or indirectly (e.g., via a lead extension). In particular, conductors disposed in the lead body of lead 14 may electrically connect stimulation electrodes (and sense electrodes, if present) adjacent to distal end 14B of lead 14 to IMD 12.
  • IMD 12 may be subcutaneously implanted in the body of a patient 16 (e.g., in a chest cavity, lower back, lower abdomen, or buttocks of patient 16). In the example of FIG. 1, IMD 12 is a neurostimulator that is implanted in patient 16 proximate to target stimulation site 18. IMD 12 may also be referred to as a signal generator, and in the embodiment shown in FIG. 1, IMD 12 may also be referred to as a neurostimulator. The configuration of IMD 12 and lead 14 shown in FIG. 1 is merely exemplary. For example, in some embodiments, IMD 12 may be coupled to two or more leads, e.g., for bilateral or multi-lateral stimulation.
  • In the embodiment of therapy system 10 shown in FIG. 1, target stimulation site 18 is proximate to the S3 sacral nerve, and lead 14 has been introduced into the S3 sacral foramen 22 of sacrum 24 to access the S3 sacral nerve. Stimulation of the S3 sacral nerve may help treat pelvic floor disorders, urinary control disorders, fecal control disorders, interstitial cystitis, sexual dysfunction, and pelvic pain.
  • Therapy system 10 may additionally or alternatively be used to provide stimulation therapy to other nerves or tissue sites of a patient. In other embodiments, target stimulation site 18 may be a location proximate to any of the other sacral nerves in patient 16 or any other suitable nerve, organ, muscle, muscle group or another suitable tissue site in patient 16, which may be selected based on, for example, the symptoms or medical condition of a particular patient. For example, therapy system 10 may be used to deliver neurostimulation therapy to a pudendal nerve, a perineal nerve or other areas of the nervous system, in which cases, lead 14 would be implanted and substantially fixed proximate to the respective nerve. As further examples, lead 14 may be positioned for temporary or chronic spinal cord stimulation for the treatment of pain, for peripheral neuropathy or post-operative pain mitigation, ilioinguinal nerve stimulation, intercostal nerve stimulation, gastric stimulation for the treatment of gastric mobility disorders and obesity, muscle stimulation (e.g., functional electrical stimulation (FES) of muscles), for mitigation of other peripheral and localized pain (e.g., leg pain or back pain), or for deep brain stimulation to treat movement disorders and other neurological disorders. Therapy system 10 may also be used in cardiac applications.
  • FIG. 2 is a block diagram illustrating various components of IMD 12 and implantable lead 14. IMD 12 includes therapy delivery module 40, processor 42, memory 44, telemetry module 46, and power source 47. In some embodiments, IMD 12 may also include a sensing circuit (not shown in FIG. 2) to sense a physiological parameter (e.g., electrical activity, blood pressure or temperature) of patient 16. Implantable lead 14 includes elongated lead body 48 extending between proximal end 48A and distal end 48B. Lead body 48 may be a cylindrical or may be a paddle-shaped (i.e., a “paddle” lead). Electrodes 50A, 50B, 50C, and 50D (collectively “electrodes 50”) are disposed on lead body 48 adjacent to distal end 48B of lead body 48.
  • In some embodiments, electrodes 50 may be ring electrodes. In other embodiments, electrodes 50 may be segmented or partial ring electrodes, each of which extends along an arc less than 360 degrees (e.g., 90-120 degrees) around the periphery of lead body 48. In embodiments in which lead 14 is a paddle lead, electrodes 50 may extend along one side of lead body 48. The configuration, type, and number of electrodes 50 illustrated in FIG. 2 are merely exemplary.
  • Electrodes 50 extending around a portion of the circumference of lead body 48 or along one side of a paddle lead may be useful for providing an electrical stimulation field in a particular direction/targeting a particular therapy deliver site. For example, in applications involving electrical stimulation of a nerve proximate to patient 16's scalp (e.g., an occipital nerve), electrodes 50 may be disposed along lead body 48 such that the electrodes face toward the target nerve, or otherwise away from the skin of patient 16. This may be an efficient use of stimulation because electrical stimulation of the skin of patient 16 may not provide any or may provide minimal therapy to patient 16. In addition, the use of segmented or partial ring electrodes 50 may also reduce the overall power delivered to electrodes 50 by IMD 12 because of the efficient delivery of stimulation to target stimulation site 18 by eliminating or minimizing the delivery of stimulation to unwanted or unnecessary regions within patient 16.
  • In embodiments in which electrodes 50 extend around a portion of the circumference of lead body 48 or along one side of a paddle lead, lead 14 may include one or more orientation markers 45 proximate to proximal end 48A of lead body 48 that indicate the relative location of electrodes 50. Orientation marker 45 may be a printed marking on lead body 48, an indentation in lead body 48, a radiographic marker, or another type of marker that is visible or otherwise detectable (e.g., detectable by a radiographic device) by a clinician. Orientation marker 45 may help a clinician properly orient lead 14 such that electrodes 50 face the desired direction within patient 16. For example, orientation marker 45 may also extend around the same portion of the circumference of lead body 48 or along the side of the paddle lead as electrodes 50. In this way, orientation marker 45 faces the same direction as electrodes, thus indicating the orientation of electrodes 50 to the clinician. When the clinician implants lead 14 in patient 16, orientation marker 45 may remain visible to the clinician.
  • IMD 12 delivers stimulation therapy via electrodes 50 of lead 14. In particular, electrodes 50 are electrically coupled to a therapy delivery module 40 of IMD 12 via conductors within lead body 48. In one embodiment, an implantable signal generator or other stimulation circuitry within therapy delivery module 40 delivers electrical signals (e.g., pulses or substantially continuous-time signals, such as sinusoidal signals) to target stimulation site 18 (FIG. 1) via at least some of electrodes 50 under the control of a processor 42. The electrical signals may be delivered from therapy delivery module 40 to selected electrodes 50 via a switch matrix controlled by processor 42. The stimulation energy generated by therapy delivery module 40 may be formulated as neurostimulation energy, e.g., for treatment of any of a variety of neurological disorders, or disorders influenced by patient neurological response. As described above, in other embodiments, therapy delivery module 40 may deliver therapy to other tissue sites within the body of patient 16.
  • The therapy delivery module 40 and processor 42 may be coupled to power source 47. Power source 47 may take the form of a small, rechargeable or non-rechargeable battery, or an inductive power interface that transcutaneously receives inductively coupled energy. In the case of a rechargeable battery, power source 47 similarly may include an inductive power interface for transcutaneous transfer of recharge power.
  • Processor 42 may include a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), discrete logic circuitry, or the like. Processor 42 controls the implantable signal generator within therapy delivery module 40 to deliver neurostimulation therapy according to selected stimulation parameters. Specifically, processor 42 controls therapy delivery module 40 to deliver electrical signals with selected amplitudes, pulse widths (if applicable), and rates specified by the programs. In addition, processor 42 may also control therapy delivery module 40 to deliver the neurostimulation signals via selected subsets of electrodes 50 with selected polarities. For example, electrodes 50 may be combined in various bipolar or multi-polar combinations to deliver stimulation energy to selected sites, such as nerve sites adjacent the spinal column, pelvic floor nerve sites, or cranial nerve sites.
  • Processor 42 may also control therapy delivery module 40 to deliver each signal according to a different program, thereby interleaving programs to simultaneously treat different symptoms or provide a combined therapeutic effect. For example, in addition to treatment of one symptom such as sexual dysfunction, IMD 12 may be configured to deliver neurostimulation therapy to treat other symptoms such as pain or incontinence.
  • Memory 44 of IMD 12 may include any volatile or non-volatile media, such as a random access memory (RAM), read only memory (ROM), non-volatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), flash memory, and the like. In some embodiments, memory 44 of IMD 12 may store multiple sets of stimulation parameters that are available to be selected for delivery of neurostimulation therapy. For example, memory 44 may store stimulation parameters transmitted by telemetry device 62, consumer electronic device 64, and/or clinician programmer (CP) 66 (FIG. 3). Memory 44 also stores program instructions that, when executed by processor 42, cause IMD 12 to deliver neurostimulation therapy. Accordingly, computer-readable media storing instructions may be provided to cause processor 42 to provide functionality as described herein.
  • As discussed below, the program instruction that dictates the stimulation therapy parameters of IMD 12 may be changed via an external programming device, such as a telemetry device 62 (FIG. 3), a programmer 66 (e.g., CP 26 or patient programmer 28 of FIG. 1) or a consumer electronic device 64 (FIG. 3) running an application that provides IMD 12 programming capabilities. Stimulation parameters include, but are not limited to, a voltage or current amplitude of the electrical signals, pulse widths (if applicable) of the electrical signals, the rate of delivery of the electrical signals or a particular program, which may include particular electrode configuration (e.g., a pattern and/or locations of anodes and cathodes of the electrodes 50). Programs that control delivery of other therapies by IMD 12 may include other therapy parameters. For example, a program that controls delivery of a drug or other therapeutic agent may include a titration rate or information controlling the timing (e.g., frequency) of bolus deliveries.
  • Processor 42 controls telemetry module 46 of IMD 12 to exchange information with an external programmer, such as telemetry device 62 (which is external to and separate from IMD 12), consumer electronic device 64 via telemetry module 46 and/or programmer 66 (FIG. 3), by wireless telemetry. In addition, in some embodiments, telemetry module 46 of IMD 12 supports wireless communication with one or more wireless sensors that sense physiological signals or a patient condition (e.g., a patient activity level or posture) and transmit the signals to IMD 12. The wireless sensors may be implanted within patient 16 or external to patient 16.
  • FIG. 3 illustrates system 60 in which telemetry device 62 may be used to communicate with IMD 12. As will be described in further detail below, telemetry device 62 is configured to communicate directly with IMD 12, and may directly program or otherwise modify therapy parameters of IMD 12 and/or provide a telemetry bridge for another programming device, such as consumer electronic device 64 or medical device programmer 66. Programmer 66 may be a CP, patient programmer or another programmer suitable for programming IMD 12. Thus, while a CP 66 is primarily referred to throughout the description of FIG. 3, in other embodiments, programmer 66 may be any other programming device. CP 66 may be a dedicated hardware device with dedicated software for programming of IMD 12. Alternatively, CP 66 may be an off-the-shelf computing device running an application that enables CP 66 to program IMD 12. In another embodiment, telemetry device 62 may also be configured to provide a telemetry bridge for another programming device, such as a patient therapy manager (PTM), in addition to CP 66.
  • To help better meet the needs of patients, telemetry device 62 may be a relatively small device used to program the therapy delivered by IMD 12 via direct and/or indirect manipulation of telemetry device 62. Telemetry device 62 is in a separate housing from IMD 12, consumer electronic device 64, and CP 66. Thus, telemetry device 62 is a self-contained telemetry device that is separate from IMD 12, consumer electronic device 64 and CP 66.
  • Telemetry device 62 provides many roles within system 60. In each aspect, however, telemetry device 62 is configured to communicate directly with IMD 12, and particularly, telemetry module 46 within IMD 12. Telemetry device 62 is configured to bridge IMD 12 with a programming application on a separate device, whether the device is consumer electronic device 64, CP 66, or another computing device. In this way, telemetry device 62 may provide an intermediary telemetry interface for IMD 12 and another device.
  • Telemetry device 62 is configured to transmit and receive information according to at least two different telemetry protocols (i.e., communication protocols), and typically includes two or more transceivers configured to support each of the telemetry protocols. One telemetry protocol is configured to transmit and receive information from IMD 12, while at least one other telemetry protocol is configured to transmit and receive information from at least one other device, such as consumer electronic device 64 or CP 66. Examples of communication protocols include, but are not limited to, radio frequency (RF) communication protocols, such as RF communication according to the 802.11 or Bluetooth specification sets, infrared (Ir) communication, e.g., according to the IrDA standard, or other standard or proprietary telemetry protocols.
  • Telemetry device 62 may also include a signal processor to translate one telemetry protocol into another telemetry protocol in order to translate communication signals from IMD 12 to a protocol understood by consumer electronic device 64 and/or CP 66. For example, telemetry device 62 may include a general purpose processor with signal processing software capable of translating communication signals from one protocol to another.
  • In one embodiment, telemetry device 62 is configured to interact with more than one IMD. For example, telemetry device 62 may be configured to communicate via one telemetry protocol for interacting with an electrical stimulator and another telemetry protocol for interacting with a fluid delivery device, such as a drug pump.
  • In some embodiments, telemetry device 62 does not include any direct programming functionality, but rather only serves to link a programming device (e.g., consumer electronic device 64 or CP 66) with IMD 12. In other embodiments, telemetry device 62 includes a minimal set of programming features, but is configured to interface with a separate “feature-rich” programming device with substantially more programming features than telemetry device 62. Such a feature-rich device may be, for example, consumer electronic device 64, CP 66, a PTM, and/or a custom hardware device. For example, telemetry device 62 may interface with a PTM to allow patient 16 to control more advanced functions typically included on a traditional PTM.
  • As previously discussed, telemetry device 62 may include functionality that enables telemetry device 62 to directly program IMD 12. That is, in some embodiments, telemetry device 62 includes a user interface that enables a user to input a desired programming change or otherwise indicate program parameters for IMD 12. Telemetry device 62 may then deliver the desired programming change to IMD 12. The programming functionality of telemetry device 62 enables patient 16 to use telemetry device 62 as a PTM for IMD 12 in addition to or instead of another PTM. The user interface may include one or more buttons that may be activated to change one or more parameters of the therapy delivered by IMD 12. As described above, the therapy parameters may include, but are not limited to, amplitudes of the electrical signals, pulse widths (if applicable) of the electrical signals, the rate of delivery of the electrical signals or a particular program in the case of electrical stimulation therapy, and drug dosage or frequency of drug delivery in the case of a drug delivery therapy.
  • Given the relatively small size of telemetry device 62 as compared to many CPs 66 or existing PTMs, the user interface of telemetry device 62 may only allow a small subset of programming options because telemetry device 62 may only be able to support a small subset of programming options. In addition, the user interface of telemetry device 62 may provide fewer features (e.g., buttons or displays) than consumer electronic device 64 or programmer 66. For example, as discussed below in reference to FIG. 4, telemetry device 62 may include an “on/off” button to turn stimulation therapy on or off (which, as discussed in further detail below, is typically a safe mode, rather than turning therapy 100% off) and/or “increment/decrement” buttons in order to increase or decrease a stimulation frequency or amplitude.
  • Telemetry device 62 may interact with IMD 12 using telemetry protocols known in the art, such as a RF telemetry protocol. Some telemetry protocols may be optimized if telemetry device 62 is placed within a certain distance of IMD 12. For example, when using a RF telemetry protocol to communicate with IMD 12, telemetry device 62 may be placed within about 2 centimeters (cm) to about 125 cm, such as about 13 cm, of IMD 12 during programming activities. Telemetry device 62 may be easily placed at an appropriate location during programming of IMD 12 because of its relatively small size.
  • FIG. 4 is a schematic plan view of one embodiment of telemetry device 62, in which telemetry device 62 is a key fob including a key ring 100 that is configured to receive one or more keys 102. In other embodiments, telemetry device 62 may be attached to the clothing of patient 16, attached to a strap secured to patient 16 (e.g., telemetry device 62 may be a pendent on a necklace), or placed in a pocket of patient 16 during programming activities. In the embodiment shown in FIG. 4, telemetry device 62 has limited functionality for programming IMD 12. In particular, telemetry device 62 includes on button 104, off button 106, increment button 108, decrement button 110, and light emitting diode (LED) 112. Each button 104, 106, 108, and 110 includes a visual indication of a function. For example, the increment button 108 has a printed graphic (+) indicating the increment functionality of button 108. Buttons 104, 106, 108, and 110 and LED 112 are electrically coupled to circuitry within telemetry device housing 114, which also defines openings for buttons 104, 106, 108, and 110 and LED 112 to extend to an outer surface. Telemetry device housing 114 may be formed of any suitable material, such as a relatively hard plastic or polymer.
  • Buttons 104, 106, 108, and 110 may be push buttons, soft-keys, voice activated commands, activated by physical interactions, magnetically triggered, activated upon password authentication push buttons, contacts defined by a touch screen, or any other suitable user interface. In some embodiments, buttons of telemetry device 62 may be reprogrammable. That is, using buttons 104, 106, 108, and 110 as an example, buttons 104, 106, 108, and 110 may be reprogrammed to provide different programming functionalities as the needs of patient 16 changes or if IMD 12 changes. Buttons 104, 106, 108, and 110 may be reprogrammed, for example, by CP 66 (FIG. 3) or another computing device.
  • Buttons 104, 106, 108, and 110, as well as any other buttons provided on telemetry device 62 may be designed to help reduce accidental activation of a programming function. For example, the buttons 104, 106, 108, and 110 may be recessed from an outermost surface of the housing 114. Alternatively or additionally, patient 16 may be required to hold a button for a predetermined amount of time in order to activate the button, and/or there may be a hold function that prevents the buttons from being activated unless the hold function is deactivated. For example, the hold function may be activated and deactivated via manipulation of a slider bar (not shown) or manipulation of a specified combination of buttons.
  • Activation of the “off” button 106 may not turn the therapy delivered by IMD 12 completely off and, instead, may change the therapy delivered by IMD 12 to a safe mode setting. The safe mode setting may or may not be equivalent to turning the therapy delivered by IMD 12 off. For some therapies and patients, turning off the therapy delivered by IMD 12 may not be safe or comfortable. A safe mode setting that defines a set of parameters that is known to provide a safe and comfortable therapy to patient 16 from IMD 12 may provide a better alternative than completely turning the therapy delivered by IMD 12 off. The safe mode setting may define a minimal amount of therapy that provides comfortable and safe therapy to patient 16.
  • In the example of an implanted neurostimulator, the safe mode for patient 16 may be a specific combination of therapy parameters that yield a safe and comfortable therapy setting. In some embodiments, the safe mode is a preconfigured setting or a rollback to a last or last-known safe and comfortable therapy state. In one embodiment, the safe mode for an implanted neurostimulator may be to set the stimulation amplitude to zero volts. This would effectively turn off the stimulation and remove any undesirable side effects of the therapy. In some cases, eliminating the stimulation may provide discomfort to patient 16 if, for example, IMD 12 is used to treat pain. In such a case, the safe mode may set forth a therapy program including a relatively low current or voltage amplitude in order to provide a minimal degree of pain relief to patient 16. For an implantable drug delivery device, the safe mode setting may involve a user-predefined rate (e.g., set by a clinician) which takes into account the possibilities of drug concentration change, tube-set, and/or other variables.
  • In some embodiments, the safe mode may be defined by allowing patient 16, a clinician, a caregiver, or another qualified individual to save one or more safe therapy configurations that provide patient 16 with safe and comfortable therapy. Patient 16, a clinician, a caregiver, or another qualified individual may have the ability to rollback to any of the safe mode configurations for IMD 12 as desired. In one embodiment, the user interface provided on telemetry device 62 may only include means for programming IMD 12 to enter a defined safe mode. The safe mode settings may be saved within telemetry device 62, which may include any volatile or non-volatile media, such as a RAM, ROM, NVRAM, EEPROM, flash memory, and the like to store the safe mode settings for IMD 12. Alternatively, the settings for the safe mode of IMD 12 may be stored in IMD 12, and telemetry device 62 may provide instructions to IMD 12 to access and implement the stored safe mode setting, rather than sending the actual safe mode settings themselves.
  • The increment/decrement function activated by buttons 108 and 110, respectively, are optionally included on telemetry device 62 and may increment or decrement the amplitude of the therapy that is currently being delivered from IMD 12 to patient 16. In the example of neurostimulation, the increment/decrement function may modify the amplitude of the electrical signal delivered from IMD 12. In the example of drug delivery, the increment/decrement function may modify the dosage delivered during a bolus. Additionally, telemetry device 62 may include a button to administer a bolus of a drug by IMD 12 (if IMD 12 is a fluid delivery device). The increment/decrement function may be limited to patient-specific adjustment ranges defined by a clinician (e.g., via CP 66 of FIG. 3) in order to ensure that the therapy delivered by IMD 12 stays within a safe, clinician-approved range.
  • Telemetry device 62 may include an alert LED 112 or other suitable alert feature. In some embodiments, IMD 12 may send an alert signal to telemetry device 62 to activate LED 112 in order to indicate to a user that a problem may be present. The alert signal may, for example, signify a low battery, a sensed physiological event, or another problem. For example, in the embodiment of a drug delivery device, IMD 12 may active the alert feature on telemetry device 62 in response to detecting a low level of drug remaining. Activation of the alert feature on telemetry device 62 may alert patient 16 to contact a clinician or take other precautions. In one embodiment, a more detailed description of the issue causing the activation of the alert feature is forwarded to another external programming device (e.g., consumer electronic device 64). The external programming device may then forward the alert to a remote device in a remote location, such as a clinician office.
  • LED 112 (or another LED) may also provide confirmation to a user that an operation has been carried out or that an input via buttons 104, 106, 108, and 110 or another user interface has been received. For example, when button 108 is depressed by patient 16, and a programming signal is sent to IMD 12 to increment a therapy parameter, LED 112 may be activated in order to provide positive feedback to the patient regarding the successfully sent programming signal. Telemetry device 62 may include more than one LED 112.
  • Regardless of whether telemetry device 62 is configured to directly program IMD 12, telemetry device 62 may be configured to communicate with other programming devices, such as consumer electronic device 64 and CP 66 to provide a telemetry link between IMD 12 and the other programming devices.
  • Additionally, as illustrated in FIG. 5, telemetry device 62 may configured to communicate with display 120. Display 120 may be capable of connecting to telemetry device 62 via a USB link 121, which is aligned to be received in USB port 123 of display 120, or other suitable means. In this manner, display 120 is a docking station for telemetry device 62. In embodiments in which telemetry device 62 has a display, and embodiments in which telemetry device does not have a display, display 120 may provide a larger user interface for interacting with telemetry device 62 or may merely be a passive display for telemetry device 62. A larger display 120 may be beneficial to patients with visual and/or tactile impairments.
  • In embodiments in which display 120 is more than a passive display for telemetry device 62, display 120 may optionally include a user interface, such as a touch screen and/or additional buttons, as well as processing capabilities. In embodiments in which display 120 provides a larger user interface for interacting with telemetry device 62, display 120 may give patient 16, a clinician or other medical professional access to advanced features that are not available via direct manipulation of telemetry device 62. Thus, display 120 may be a feature-rich programming interface for telemetry device 62. Patient 16 may have the option of leaving display 120 at home or carrying it with him or her. In some embodiments in which telemetry device 62 includes a rechargeable battery, display 120 may recharge power source 80 (FIG. 6).
  • Returning now to FIG. 2, in embodiments in which telemetry device 62 communicates with consumer electronic device 64, consumer electronic device 64 may function as a PTM that includes richer features than telemetry device 62. In one embodiment, consumer electronic device 64 is a mobile phone. In other embodiments, consumer electronic device 64 may be another type of consumer electronic device, which typically serves another purpose besides that of a medical device programmer. For example, consumer electronic device 64 may be a personal digital assistant, a portable digital music player, a laptop computer, and the like.
  • Consumer electronic device 64 may not be configured to transmit and receive information according to the same telemetry protocol as IMD 12, and thus, may not be configured to communicate directly with IMD 12. In addition, because consumer electronic device 64 is typically a readily available, off-the-shelf device, consumer electronic device 64 may be relatively difficult to modify to include the telemetry circuitry necessary to communicate with IMD 12. Telemetry device 62 includes a transceiver, such as a Blue Tooth transceiver, that is configured to communicate with a broad range of consumer electronic devices 64 and CPs 66, as well as a transceiver that is configured to communicate directly with IMD 12. Thus, consumer electronic device 64 or CP 66 may link to IMD 12 via telemetry device 62 in order to program IMD 12 or to upload or download information from and to IMD 12. Information may be transmitted from IMD 12 to telemetry device 62, which may then transmit the information to consumer electronic device 64 or CP 66. As another example, information may be transmitted from consumer electronic device 64 or CP 66 to telemetry device 62, which may then transmit the information to IMD 12.
  • Patient 16, a clinician, caregiver, and/or other qualified individuals may use telemetry device 62 in order to communicate with IMD 12. For example, patient 16 may have mobile phone that includes software for programming IMD 12. Patient 16 may then use telemetry device 62 to link the mobile phone with IMD 12 because the mobile phone may not include the appropriate telemetry module for communicating with IMD 12.
  • Consumer electronic device 64 may allow patient 16 to program IMD 12 in a subtle, non-obvious manner that may allow patient 16 more privacy than a traditional programmer. In some embodiments, consumer electronic device 64 may run a Java applet or other appropriate application that allows consumer electronic device 64 to perform programming functions. Consumer electronic device 64 may perform the same or similar functions as a PTM with a more traditional appearance. For example, patient 16 may use consumer electronic device 64 to start, stop, or adjust therapy and/or select a program from a library of stored therapy programs. In embodiments in which IMD 12 is an electrical stimulator, consumer electronic device 64 may permit patient 16 to adjust stimulation parameters such as duration, amplitude, pulse width, and pulse rate within an adjustment range specified by a clinician (e.g., via a CP).
  • Using consumer electronic device 64 programmed by a Java applet or other appropriate application may better allow PTMs to use cutting-edge technology. Consumer electronic devices 64 such as mobile phones are typically redesigned and updated faster than traditional PTMs. Accordingly, implementing an IMD programming application into a consumer electronic device, such as a mobile phone, enables a PTM to operate according to the latest hardware, innovative processing capabilities, ornamental product designs, and so forth. Once established, the Java applet may be easily modified to keep up with current technology. It may be easier to modify a Java applet than an entire PTM. Furthermore, use of a telemetry device 62 may simplify development of PTMs because of the ability to use off-the-shelf devices that are running a particular programming application.
  • Consumer electronic device 64 may provide patient 16 with an interface for control of the therapy delivered by IMD 12. More specifically, consumer electronic device 64 may interface with telemetry device 62 to program IMD 12. Consumer electronic device 64 may be programmed, using a Java applet or other appropriate means, to communicate with telemetry device 62 according to one communication protocol, while telemetry device 62 is configured to communicate with IMD 12 according to another communication protocol in order to transmit the information from consumer electronic device 64 to IMD 12. In this manner, telemetry device 62 acts as an intermediate telemetry link between consumer electronic device 64 and IMD 12.
  • Consumer electronic device 64 may include a display and input keys that allow patient 16 to interact with telemetry device 62 and IMD 12. The Java applet or other appropriate application running on consumer electronic device 64 may temporarily borrow a display and input keys of consumer electronic device 64 for use in programming applications. The user interface of consumer electronic device 64 may provide patient 16 with a user interface similar to that of traditional PTMs. For example, like traditional therapy managers, the user interface on consumer electronic device 64 used for programming IMD 12 may include one or more menus and soft keys. In one embodiment, changes to the therapy delivered by IMD 12 made via the user interface of telemetry device 62 may be visible on the display of consumer electronic device 64.
  • Alternatively, in embodiments in which telemetry device 62 also includes some functionality (e.g., as shown and described with reference to FIG. 4), telemetry device 62 may borrow the display from consumer electronic device 64 to provide a more sophisticated user interface for the patient. For example, the patient may view the display of the consumer electronic device 64 to, for example, see the available therapy programs that may be programmed into IMD 12 via telemetry device 62, but the patient may still interact with buttons on telemetry device 62 to select the specific programs. The buttons on telemetry device 62 may correspond to the visual interface provided on the display of consumer electronic device 64, and as the patient engages a button on telemetry device 62, the display of consumer electronic device 64 may reflect the action taken by the patient.
  • In some embodiments, consumer electronic device 64 may also include applications and a user interface to access more sophisticated programming options stored within telemetry device 62, but otherwise not accessible by telemetry device 62.
  • Consumer electronic device 64 may communicate with telemetry device 62 via a wired or wireless connection. In one embodiment, telemetry device 62 plugs into a USB port of consumer electronic device 64. In other embodiments, consumer electronic device 64 and telemetry device 62 may communicate with each other using any of a variety of local wireless communication techniques, such as RF communication according to the 802.11 or Bluetooth specification sets, infrared communication, e.g., according to the IrDA standard, or other standard or proprietary telemetry protocols.
  • Using a wireless connection between telemetry device 62 and consumer electronic device 64 may allow consumer electronic device 64 to be located at a distance away from telemetry device 62 when programming IMD 12. For example, a Bluetooth connection may allow signals to be transferred between telemetry device 62 and consumer electronic device 64 as long as the devices are located within approximately 500 centimeters (cm) of each other. This may allow patient 16 to place telemetry device 62 on or near his or her body and hold consumer electronic device 64 in his or her hand without the need to hold consumer electronic device 64 proximate to telemetry device 62. This may allow patient 16 to use consumer electronic device 64 to program IMD 12 more discreetly. For example, telemetry device 62 may be located in a clothing pocket of patient 16 or around a neck of patient 16 (e.g., as a necklace) during programming of IMD 12 via consumer electronic device 64. If consumer electronic device 64 is a mobile telephone, the discreetly located telemetry device 62 may give the impression that patient 16 is making a telephone call via consumer electronic device 64 or using other consumer electronic features of consumer electronic device 64 rather than programming IMD 12. Additionally, this may allow a parent, caregiver, or other qualified individual located near patient 16 to use consumer electronic device 64 to program IMD 12 without the need to place consumer electronic device 64 proximate to telemetry device 62 or IMD 12.
  • Because of the relatively small size of telemetry device 62 and the ability of telemetry device 62 to be discreetly held relatively close to IMD 12, telemetry device 62 may also help reduce the power that is necessary for IMD 12 to communicate with an external programming device. Telemetry device 62 may be actively or passively held relatively close to IMD 12 in order to decrease the distance for telemetry between IMD 12 and telemetry device 62, thereby reducing the amount of power that is necessary to obtain telemetry transcription. Reducing the amount of power that is consumed by the power source within IMD 12 for transmitting and receiving information may help extend the useful life of IMD 12. Telemetry device 62 may support relatively long distance communication with a consumer electronic device 64 or CP 66 because there is less of a concern about power consumption with telemetry device 62 as compared to IMD 12, which is not as easily accessible. The power source within telemetry device 62 may more easily be renewed than that of IMD 12.
  • CP 66 is a device that a clinician or other medical professionals may use to communicate with IMD 12. CP 66 may perform advanced device setup and diagnostics in addition to performing the programming functions of consumer electronic device 64. In this manner, CP 66 may be more feature-rich than consumer electronic device 64 or telemetry device 62. CP 66 may communicate with IMD 12 directly and/or indirectly. For example, CP 66 may indirectly communicate with IMD 12 via telemetry device 62. Additionally or alternatively, CP 66 may indirectly communicate with IMD 12 by communicating with consumer electronic device 64 which in turn communicates with telemetry device 62. As yet another alternative, CP may include an internal telemetry module that is configured to directly transmit and receive information according to the telemetry protocol for IMD 12.
  • Telemetry device 62 may be useful for situations in which CP 66 may not include telemetry circuitry that is configured to interact and communicate directly with IMD 12. CP 66 may be a general purpose device, such as a computer, that does not include the specific transceiver necessary for communicating with IMD 12.
  • CP 66 may be a computing device that permits a clinician to program therapy for patient 16, e.g., using input keys and a display. For example, using CP 66, the clinician may specify parameters for use in delivery of therapy via IMD 12. Therapy parameters may be downloaded to IMD 12 from CP 66. Optionally, operational or physiological data stored by IMD 12 may be uploaded to CP 66. In this manner, a clinician or other medical professional may periodically interrogate IMD 12 to evaluate efficacy and, if necessary, modify the therapy parameters.
  • CP 66 may communicate directly with IMD 12 using telemetry techniques known in the art, such as, for example, RF telemetry techniques. CP 66 and telemetry device 62 may communicate via cables or a wireless communication link, as shown in FIG. 3. CP 66 and telemetry device 62 may, for example, communicate via wireless communication using RF telemetry techniques known in the art. CP 66 and telemetry device 62 also may communicate with each other using any of a variety of local wireless communication techniques, such as RF communication according to the 802.11 or Bluetooth specification sets, infrared communication, e.g., according to the IrDA standard, or other standard or proprietary telemetry protocols.
  • However, CP 66 and telemetry device 62 need not communicate wirelessly. For example, in other embodiments, CP 66 and telemetry device 62 may communicate via a wired connection, such as via a serial communication cable, or via exchange of removable media, such as magnetic or optical disks, or memory cards or sticks. Further, CP 66 may communicate with telemetry device 62 via remote telemetry techniques known in the art, communicating via a local area network (LAN), wide area network (WAN), public switched telephone network (PSTN), or cellular telephone network, for example. Additionally, CP 66 may communicate with consumer electronic device 64 using any of the wired or wireless techniques described with respect to communication between CP 66 and telemetry device 62.
  • Telemetry device 62 provides a relatively small and/or discreet programming device to a patient as compared to many existing PTMs. The relatively small size of telemetry device 62 may provide social advantages and may better serve patient needs as compared some existing, larger PTMs. Some patients with IMDs have indicated a desire for relatively small PTMs, such as PTMs that may be easily hidden from view. Additionally, due to social stigmas associated with medical devices and the PTMs that interface with them, some patients have indicated a desire for PTMs that may be used discreetly. Telemetry device 62 enables a PTM to be used discreetly because telemetry device 62 enables a consumer electronic device 64, such as a mobile phone or a PDA, to be used as a PTM. In embodiments in which telemetry device 62 includes some programming functionality, the relatively small size of telemetry device 62 enables telemetry device 62 to be used discreetly as a PTM. Additionally, small PTMs may be easier for patients to carry with them.
  • Additionally, many patients with IMDs use PTMs to access a small subset of the functions allowed by traditional PTMs. A simplified PTM that allows a patient to turn the therapy on, off, up, or down (e.g., adjust the stimulation amplitude) may meet the programming needs of many patients with IMDs, and provides a simpler programming interface for a patient than many existing PTMs. Telemetry device 62, which is typically smaller than a conventional patient programmer, may provide these patients with a small, simple programming device.
  • In some embodiments, telemetry device 62 may be a pocket-sized device that it is capable of being easily placed in a pocket of the patient's clothing. For example, telemetry device 62 may be approximately the same size as a key fob used to lock and unlock an automobile (e.g., as shown in FIG. 4). Telemetry device 62 may be less than approximately 12 centimeters (cm) long, less than approximately 8 cm wide, and less than approximately 3 cm high (i.e., thick). In one embodiment, telemetry device may be less than approximately 8 centimeters (cm) long, less than approximately 4 cm wide, and less than approximately 1 cm high (i.e., thick). In another embodiment, telemetry device may be approximately 2 centimeters (cm) long, approximately 2 cm wide, and approximately 1 cm high (i.e., thick). As will be described in further detail below, the minimum size of telemetry device 62 may be determined based on the size of the antenna and the telemetry techniques used.
  • In some embodiments, consumer electronic device 64 or CP 66 may also be linked to a remote device via a cabled or wireless network. For example, a consumer electronic device 64 may transmit information received from IMD 12 via telemetry device 62 to a remote server via a wireless telephone or internet communication network. The remote server may be, for example, a remote clinician computer, and may be located, for example, in another room or another remote location (e.g., in another city).
  • FIG. 6 is a schematic block diagram illustrating various components of telemetry device 62, which are disposed within housing 114 (also shown in FIG. 4). Telemetry device 62 may include telemetry transceiver 70 for communicating with IMD 12 and programmer transceiver 72 for communicating with consumer electronic device 64 and/or CP 66. Telemetry device 62 also includes antenna 74, processor 76, memory 78, and power source 80. In some embodiments, telemetry device 62 may not include memory 78.
  • As described previously, telemetry transceiver 70 may communicate with IMD 12 using telemetry protocols known in the art, such as RF telemetry techniques, and programmer transceiver 72 may communicate with consumer electronic device 64 and/or CP 66 using any appropriate wired or wireless means. Programmer transceiver 70 may also communicate with another device (e.g., consumer electronic device 64 or CP 66) using known communication protocols.
  • Antenna 74 may be used to receive signals from telemetry device 62 and/or CP 66 and may optionally receive signals from IMD 12. Alternatively, a second antenna may be used to receive signals from IMD 12. If telemetry device 62 includes two antennas, each antenna may operate at a different bandwidth or orientation in order to minimize interference between the antennas. The size of telemetry device 62 may be determined by the size of antenna 74 and the telemetry techniques used to communicate with IMD 12. The size of antenna 74 may be minimized to minimize the size of telemetry device 62 while maintaining telemetry function.
  • Processor 76 may include a microprocessor, a controller, a DSP, an ASIC, an FPGA, discrete logic circuitry, or the like. Processor 76 controls communication between telemetry device 62 and IMD 12 and may also control communication between telemetry device 62 and consumer electronic device 64 and/or CP 66. Processor 76 may also be used to “translate” signals received via telemetry protocol used by IMD 12 to a signal to the telemetry protocol used by consumer electronic device 64 and/or CP 66, or vice versa. Processor 76 is also configured to execute software that may be stored within memory 78 of telemetry device 62. The software may include, for example, IMD 12 programming applications. Additionally, processor 76 may transfer information to and from memory 78.
  • Memory 78 may include any volatile or non-volatile media, such as a RAM, ROM, NVRAM, EEPROM, flash memory, and the like. Memory 78 may store data received from IMD 12. For example, memory 78 may store data relating to the status and/or programming history of IMD 12 or physiological parameter values determined by sensors coupled to IMD 12. Data may be stored in memory 78 until consumer electronic device 64 or CP 66 requests to receive the data from telemetry device 62. In addition, processor 76 may extract information from the data received from IMD 12, such as to provide an alert function for IMD 12. For example, processor 76 may buffer data received from IMD 12 and upon finding, for example, that the power level of IMD 12 is below a certain threshold or a physiological parameter of patient 16 measured by IMD 12 is past a permissible threshold (i.e., whether an alert condition is present), telemetry device 62 may provide an alert (e.g., via LED 112 or by transmitting a signal to consumer electronic device 64 or CP 66).
  • Telemetry device 62 also includes power source 80, which may be a battery. In embodiments in which battery 80 is rechargeable, telemetry device 62 may include a recharge interface, such as a USB port, that may be connected to a power source for recharging of telemetry device 62.
  • As discussed above, telemetry device 62 may be configured to communicate with more than one type of IMD. While in some embodiments, a single telemetry device 62 may be used to communicate with multiple IMDs, in other embodiments multiple telemetry devices 62 may be used, where each of the multiple telemetry devices is configured to communicate with a different IMD. Each telemetry device may be configured to operate according to a different telemetry protocol, or may provide different programming features.
  • FIG. 7 illustrates one embodiment of a system in which telemetry device 62 includes watchdog module 132 to provide an intermediate security link between consumer electronic device 64 and IMD 12. Consumer electronic device 64 may run a common desktop operating system and thus may be prone to computer viruses or other security threats. Risks associated with use of consumer electronic device 64 include possible conflicts for resources (e.g., memory, processing capacity, and the like) with other programs within consumer electronic device 64, effects of computer viruses, other corruption of applications or other disruptions of the expected operation of consumer electronic device 64. For example, disruptions caused by a virus or other corruption could result in transmission of repeated, spurious or erroneous commands to IMD 12. Such commands may result in unintended, and possibly harmful, changes to the therapy delivered to patient 16. The use of a watchdog module may facilitate safer use of consumer electronic device 64 as a programmer. The watchdog module may also provide an added layer of security when telemetry device 62 is communicating with a dedicated programming device, such as programmer 66.
  • In the illustrated embodiment, the security system comprises watchdog module 132 of telemetry device 62 and watchdog increment module 138 of consumer electronic device 64. Telemetry device 62 and consumer electronic device 64 further comprise application modules 136 and 142 and operating system modules 134 and 140, respectively. Application modules 136 and 142 may contain software applications that may be run on telemetry device 62 and consumer electronic device 64 and operating system modules 134 and 140 may contain software defining the operation systems (e.g., Windows Vista or a custom operating system) which telemetry device 62 and consumer electronic device 64, respectively, use to run the software applications. Application modules 136 and 142, operating system modules 134 and 140, system watchdog module 132, and system watchdog increment module 138 may each comprise software that may be executed by a processor, which may be may include a microprocessor, a controller, a DSP, an ASIC, an FPGA, discrete logic circuitry, or the like. A separate processor may provide be associated with each of the each modules 132, 134, 136 of telemetry device 62 or two or more of the modules 132, 134, 136 may be implemented controlled by a common processor. The software may be stored within separate or common memory of the intermediate device. The memory may include any volatile or non-volatile media, such as a RAM, ROM, NVRAM, EEPROM, flash memory, and the like. Similarly, a separate processor may be associated with each of the modules 138, 140, 142 of consumer electronic device 64 or two or more of the modules may be controlled by a common processor.
  • System watchdog module 132 of telemetry device 62 may indirectly verify that information transmitted from consumer electronic device 64 to telemetry device 62, e.g., a programming command for IMD 12, is valid without analyzing the logical validity of the content of the information. For example, system watchdog module 132 may comprise a software task that runs on telemetry device 62 to monitor the behavior of consumer electronic device 64. More specifically, in one embodiment, system watchdog module 132 expects to periodically receive a defined signal, such as elements of a signature, or a particular programming command from consumer electronic device 64 at predetermined intervals. In this manner, telemetry device 62 (the more secure device) monitors consumer electronic device 64 (the less secure device). The signature or other signal transmitted from consumer electronic device 64 to telemetry device 62 may be, for example, a series of sequential numbers or a predefined pattern of numbers. Watchdog module 132 may monitor the behavior of consumer electronic device 64 during a programming session (e.g., while consumer electronic device 64 is sending commands to telemetry device 62) or during a down time, when no programming instructions are being sent from consumer electronic device 64 to IMD 12 via telemetry device 12.
  • As another example, in one embodiment, system watchdog module 132 may expect to receive a signature or other signal from consumer electronic device 64. If the signature or other signal is not received from consumer electronic device 64 within a predetermined time limit, watchdog module 132 may instruct IMD 12 to enter a safe mode. In this way, signals from consumer electronic device 64 to watchdog module 132 may be considered a “stay alive” signal that maintains telemetry device 62 in an active state to act as a link between consumer electronic device 64 and IMD 12.
  • Watchdog increment module 138 on consumer electronic device 64 may deliver the defined signature from consumer electronic device 64 to telemetry device 62 at predetermined time intervals. Described in further detail below, the watchdog increment module 138 may be reset by rebooting consumer electronic device 64 or by any other suitable means.
  • Watchdog module 132 may maintain a timer, and reset the timer in response to receiving each element of the signature. Expiration of the watchdog timer may involve either counting up to or down from a predetermined value related to the time intervals at which the consumer electronic device sends the signature. The signature may include a completion indicator that notifies telemetry device 62 when consumer electronic device 64 has successfully completed sending instructions to telemetry device 62. In other embodiments, the completion indicator may be sent separately from the signature to notify telemetry device 62 when consumer electronic device 64 has successfully completed sending instructions to telemetry device 62.
  • If for any reason, the transmission of the defined signature from consumer electronic device 64 to telemetry device 62 or from IMD 12 to telemetry device 62 is interrupted during a particular time period, e.g., during a programming session, as indicated by expiration of the timer maintained by watchdog module 132 (e.g., between the start of the transmission of the defined signature and the transmission of the completion indicator), telemetry device 62 may stop forwarding instructions from consumer electronic device 64 and change the therapy delivered by IMD 12 to the safe mode until the watchdog is reset. In one embodiment, the interruption in the transmission of the defined signature is indicated by expiration of the timer maintained by watchdog module 132 (e.g., between the start of the transmission of the defined signature and the transmission of the completion indicator). More specifically, if telemetry device 62 does not receive the next element in the sequence of the signature before the timer expires, telemetry device 62 may change the therapy delivered by IMD 12 to the safe mode.
  • For example, if telemetry device 62 does not receive any signals from watchdog increment module 138 of consumer electronic device 64 before the timer elapses, which may indicate that the consumer electronic device 64 has become central processing unit (CPU) bound (e.g., consumer electronic device 64 is prevented from successfully performing an operation), telemetry device 62 may change the therapy delivered by IMD 12 to the safe mode. As another example, telemetry device 62 may also change the therapy delivered by IMD 12 to the safe mode if an incorrect element in the sequence of the signature is received. For example, if telemetry device 62 receives an element of the signature multiple times, which may indicate that consumer electronic device 64 in stuck in an infinite loop, telemetry device 62 may change the therapy delivered by IMD 12 to the safe mode.
  • As described in further detail below, the watchdog may be reset by rebooting consumer electronic device 64 or by any other suitable means. Expiration of the watchdog timer may involve either counting up to or down from a predetermined value related to the period time intervals at which the clinician programmer sends the signature. Watchdog increment module 138 on consumer electronic device 64 may deliver the defined signature from consumer electronic device 64 to telemetry device 62 at predetermined time intervals.
  • To ensure that the watchdog increment module 138 is not incremented unless all other critical tasks for sending valid information to telemetry device 62 have been run to completion, the task that increments the watchdog, i.e., the watchdog increment task, may be the lowest priority critical task running on consumer electronic device 64. In some embodiments, the watchdog increment task is the lowest priority task running on consumer electronic device 64 overall. The watchdog increment task may be set as a low priority task to help prevent the defined signature from continuing to be transmitted if consumer electronic device 64 has become CPU bound or encountered any other problem that may inhibit transmission of commands to telemetry device 62. Additionally, watchdog increment module 138 may monitor other operations of consumer electronic device 64 to help ensure that no process inadvertently permanently disables the watchdog increment task and/or enables the watchdog increment task under inappropriate conditions. This monitoring may be coupled to the watchdog increment task and performed as a low priority task.
  • For example, if an application task is stuck in an infinite loop that is mistakenly sending the same telemetry message to telemetry device 62, the watchdog increment task on consumer electronic device 64 would never run. After a predefined amount of time during which watchdog module 132 of telemetry device 62 does not receive an element of the defined signature from watchdog increment module 138 of consumer electronic device 64, watchdog module 132 may instruct telemetry device 62 to program IMD 12 to go into the safe mode and may refuse further commands from consumer electronic device 64 until watchdog increment module 138 is reset.
  • As mentioned previously, watchdog increment module 138 may be reset by rebooting consumer electronic device 64. Additionally, if consumer electronic device 64 recovers from a problem, it may automatically reset watchdog increment module 138 and send a reset indication message to telemetry device 62. Alternatively, after transmission of the defined signature has been interrupted, telemetry device 62 may send a reset command to consumer electronic device 64 to attempt to reset watchdog increment module 138. If successful, consumer electronic device 64 may send a reset indication message to telemetry device 62. As an additional alternative, consumer electronic device 64 and/or telemetry device 62 may include a button or other means that may be activated by a user to reset the watchdog function.
  • Various embodiments of the invention have been described. These and other embodiments are within the scope of the following claims.

Claims (24)

1. A system comprising:
an implantable medical device configured to transmit and receive information according to a first communication protocol;
a telemetry device configured to program the implantable medical device and comprising:
a first housing;
a first transceiver disposed within the first housing and configured to transmit and receive information according to the first communication protocol;
a second transceiver disposed within the first housing and configured to transmit and receive information according to a second communication protocol; and
a consumer electronic device configured to program the implantable medical device and comprising a second housing separate from the first housing, the consumer electronic device being configured to transmit and receive information according to the second communication protocol,
wherein the consumer electronic device is configured to communicate with the implantable medical device via the telemetry device, and
wherein the telemetry device includes fewer programming features than the consumer electronic device.
2. The system of claim 1, wherein the telemetry device comprises a user interface.
3. The system of claim 2, wherein the user interface comprises a safe mode button.
4. The system of claim 2, wherein the user interface comprises at least one of a button indicating an input relating to a programming change to the implantable medical device or a light emitting diode, and a function of the button is reprogrammable.
5. The system of claim 2, wherein the implantable medical device delivers electrical stimulation therapy to a patient, and the user interface comprises a therapy increment button that increases at least one of amplitude, frequency or pulse width of the electrical stimulation therapy and a therapy decrement button that decreases at least one of the amplitude, frequency or pulse width of the electrical stimulation therapy.
6. The system of claim 2, wherein the implantable medical device delivers fluid delivery therapy to a patient, and the user interface comprises a therapy increment button that increases at least one of frequency or bolus size of the fluid delivery therapy and a therapy decrement button that decreases at least one of the frequency or bolus size of the fluid delivery therapy.
7. The system of claim 1, wherein the telemetry device has a length of less than or equal to approximately 12 centimeters (cm), a width of less than or equal to approximately 8 cm, and a height of less than or equal to approximately 3 cm.
8. The system of claim 7, wherein the telemetry device has a length of less than or equal to approximately 8 cm, a width of less than or equal to approximately 4 cm, and a height of less than or equal to approximately 1 cm.
9. The system of claim 1, wherein the consumer electronic device comprises a first user interface comprising more features than a second user interface of the telemetry device.
10. The system of claim 1, further comprising a medical device programmer for programming the implantable medical device, wherein the medical device programmer is configured to communicate with the implantable medical device via the telemetry device.
11. The system of claim 10, wherein the telemetry device further comprises a third transceiver disposed within the first housing and configured to transmit and receive information according to a third communication protocol, wherein the medical device programmer is configured to transmit and receive information according to the third communication protocol.
12. The system of claim 10, wherein the medical device programmer is configured to transmit and receive information according to the second communication protocol.
13. The system of claim 1, further comprising a watchdog module, wherein the consumer electronic device to configured to periodically transmit a defined signal to the watchdog module, wherein the consumer electronic device is configured to transmit programming instructions to the telemetry device, and wherein the telemetry device to configured to transmit the programming instructions to the implantable medical device if the defined signal is uninterrupted and transmit alternative instructions to the implantable medical device instead of the programming instructions in response to an interruption in transmission of the defined signal.
14. A method comprising:
receiving an input from a user via a user interface on a consumer electronic device, the user input indicating a desired programming change to be implemented into an implantable medical device;
generating a programming signal based on the user input; and
transmitting the programming signal to a telemetry device via a first transmission signal according to a first communication protocol, the telemetry device comprising:
a first transceiver configured to receive the programming signal from the consumer electronic device; and
a second transceiver configured to transmit the programming signal to the implantable medical device according to a second communication protocol,
wherein the telemetry device is configured to program the implantable medical device independently of the consumer electronic device.
15. The method of claim 14, further comprising:
receiving data from the implantable medical device; and
processing the data to determine whether an alert condition is present.
16. The method of claim 15, further comprising communicating the alert condition to at least one of the consumer electronic device or the telemetry device.
17. The method of claim 15, further comprising communicating the alert condition to the user by activating a light emitting diode on the telemetry device.
18. The method of claim 14, further comprising delivering the programming signal to the implantable medical device according to the second communication protocol.
19. The method of claim 14, wherein the desired programming change comprises converting an operation of the implantable medical device to a safe mode.
20. The method of claim 14, wherein the desired programming change comprises adjusting a therapy parameter.
21. The method of claim 14, further comprising periodically transmitting a defined signal to the telemetry device according to the first communication protocol, wherein the second transceiver is configured to transmit the programming signal to the implantable medical device according to the second communication protocol if transmission of the defined signal is uninterrupted and transmit alternative instructions to the implantable medical device instead of the programming signal in response to an interruption in transmission of the defined signal.
22. The method of claim 21, wherein transmitting alternative instructions to the implantable medical device instead of the programming signal comprises transmitting alternative instructions to the implantable medical device to place the implantable medical device in a known safe mode.
23. A method comprising:
positioning a telemetry device within an operative distance of a consumer electronic device;
positioning the telemetry device within an operative distance of an implantable medical device implanted within a patient, the telemetry device comprising:
a first transceiver configured to transmit and receive information from a medical device programmer according to a first communication protocol;
a second transceiver configured to communicate with the implantable medical device according to a second communication protocol; and
a user interface to receive an input from a user;
inputting a desired programming change for the implantable medical device into the consumer electronic device, wherein the telemetry device delivers a programming signal to implement the desired programming change to the implantable medical device.
24. The method of claim 23, wherein the consumer electronic device comprises at least one of a mobile phone or a personal digital assistant.
US11/940,734 2006-12-06 2007-11-15 Telemetry device for a medical device programmer Abandoned US20080140163A1 (en)

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WO2008069896A3 (en) 2008-08-21
WO2008069913A2 (en) 2008-06-12
WO2008069913A3 (en) 2008-08-21
US7885712B2 (en) 2011-02-08
US7848819B2 (en) 2010-12-07
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EP2097845A2 (en) 2009-09-09
US20080140161A1 (en) 2008-06-12

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