WO2010107608A1 - Rf activated aimd telemetry transceiver - Google Patents

Rf activated aimd telemetry transceiver Download PDF

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Publication number
WO2010107608A1
WO2010107608A1 PCT/US2010/026548 US2010026548W WO2010107608A1 WO 2010107608 A1 WO2010107608 A1 WO 2010107608A1 US 2010026548 W US2010026548 W US 2010026548W WO 2010107608 A1 WO2010107608 A1 WO 2010107608A1
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WO
WIPO (PCT)
Prior art keywords
aimd
telemetry
telemetry transceiver
activated
transceiver
Prior art date
Application number
PCT/US2010/026548
Other languages
French (fr)
Inventor
Robert A. Stevenson
Christine A. Frysz Frysz
Original Assignee
Greatbatch Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US12/407,402 external-priority patent/US8195295B2/en
Priority claimed from US12/566,223 external-priority patent/US8253555B2/en
Application filed by Greatbatch Ltd. filed Critical Greatbatch Ltd.
Publication of WO2010107608A1 publication Critical patent/WO2010107608A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators
    • A61N1/37252Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
    • A61N1/37276Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data characterised by means for reducing power consumption during telemetry
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0031Implanted circuitry
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90Identification means for patients or instruments, e.g. tags
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90Identification means for patients or instruments, e.g. tags
    • A61B90/98Identification means for patients or instruments, e.g. tags using electromagnetic means, e.g. transponders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36082Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • A61N1/37Monitoring; Protecting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators
    • A61N1/37217Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile
    • A61N1/37223Circuits for electromagnetic coupling
    • A61N1/37229Shape or location of the implanted or external antenna
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06KGRAPHICAL DATA READING; PRESENTATION OF DATA; RECORD CARRIERS; HANDLING RECORD CARRIERS
    • G06K19/00Record carriers for use with machines and with at least a part designed to carry digital markings
    • G06K19/06Record carriers for use with machines and with at least a part designed to carry digital markings characterised by the kind of the digital marking, e.g. shape, nature, code
    • G06K19/067Record carriers with conductive marks, printed circuits or semiconductor circuit elements, e.g. credit or identity cards also with resonating or responding marks without active components
    • G06K19/07Record carriers with conductive marks, printed circuits or semiconductor circuit elements, e.g. credit or identity cards also with resonating or responding marks without active components with integrated circuit chips
    • G06K19/077Constructional details, e.g. mounting of circuits in the carrier
    • G06K19/07749Constructional details, e.g. mounting of circuits in the carrier the record carrier being capable of non-contact communication, e.g. constructional details of the antenna of a non-contact smart card
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/08Sensors provided with means for identification, e.g. barcodes or memory chips
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • A61N1/37Monitoring; Protecting
    • A61N1/3718Monitoring of or protection against external electromagnetic fields or currents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators
    • A61N1/37217Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile
    • A61N1/37223Circuits for electromagnetic coupling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/375Constructional arrangements, e.g. casings
    • A61N1/3752Details of casing-lead connections
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/375Constructional arrangements, e.g. casings
    • A61N1/3758Packaging of the components within the casing

Definitions

  • the present invention relates generally telemetry transceivers associated with active implantable medical devices (AIMDs) and related components. More particularly, the present invention relates AIMD RF telemetry circuits having radio frequency identification (RFID) controllable wake-up features.
  • AIMDs active implantable medical devices
  • RFID radio frequency identification
  • FIG. 1 is a wire formed diagram of a generic human body showing a number of implanted medical devices.
  • 10OA represents a family of hearing devices which can include the group of cochlear implants, piezoelectric sound bridge transducers and the like.
  • 10OB represents a variety of neurostimulators and brain stimulators. Neurostimulators are used to stimulate the Vagus nerve, for example, to treat epilepsy, obesity and depression. Brain stimulators are pacemaker-like devices and include electrodes implanted deep into the brain for sensing the onset of the seizure and also providing electrical stimulation to brain tissue to prevent the seizure from actually occurring.
  • 1 0OC shows a cardiac pacemaker which is well-known in the art.
  • 10OD includes the family of left ventricular assist devices (LVAD's) and artificial hearts.
  • 1 0OE includes an entire family of drug pumps which can be used for dispensing of insulin, chemotherapy drugs, pain medications and the like.
  • Insulin pumps are evolving from passive devices to ones that have sensors and closed loop systems. That is, real time monitoring of blood sugar levels will occur. These devices tend to be more sensitive to EMI than passive pumps that have no sense circuitry or externally implanted lead wires.
  • 1 0OF includes a variety of bone growth stimulators for rapid healing of fractures.
  • 1 0OG includes urinary incontinence devices.
  • 1 0OH includes the family of pain relief spinal cord stimulators and anti-tremor stimulators. 10OH also includes an entire family of other types of neurostimulators used to block pain.
  • 1 001 includes a family of implantable cardioverter defibrillators (ICD) devices and also includes the family of congestive heart failure devices (CHF). This is also known in the art as cardio resynchronization therapy devices, otherwise known as CRT devices.
  • 10OJ illustrates an externally worn pack. This pack could be an external insulin pump, an external drug pump, an external neurostimulator or even a ventricular assist device.
  • FIGURE 2 is a prior art cardiac pacemaker 10OC.
  • a cardiac pacemaker typically has an electromagnetically shielded and hermetically sealed housing 102 which is generally constructed from titanium, stainless steel or the like. It also has a plastic or Techothane header block 1 04 which houses ISO standard IS-I type connectors 106, 1 08.
  • AIMDs in particular pacemakers, ICDs and neurostimulators, embodied close-coupled telemetry circuits. The purpose of telemetry is so that the AIMD could be interrogated or even reprogrammed after implantation. For example, it is common to monitor battery status, patient biologic conditions and the like, through telemetry.
  • an external telemetry programmer can be used to re-program the AIMD, for example, and put it into different modes of operation.
  • the telemetry was inductive (low frequency magnetic) and close coupled.
  • the AIMD would have a multiple turn wire antenna within its titanium housing.
  • the physician or other medical practitioners would bring a wand, with a similar antenna embedded in it, very close to the AIMD.
  • the telemetry wand would be placed directly over the implant. The wand is/was connected with wiring to the external programmer.
  • the medical practitioner would move the wand around until the "sweet-spot" was located. Once the wand is located in the "sweet-spot," a communication link is established between the multiple turn wire antenna implanted in the AIMD and a similar multiple turn wire antenna located inside the telemetry wand. The external programmer would then become active and electrograms and other important information would be displayed. Typically the telemetry wand would be placed either against or very close to the patient's skin surface or at most a few centimeters away. [Para 4] In the last few years, distance RF telemetry has become increasingly common.
  • a high frequency antenna that would be located outside of the AIMD shielded titanium housing 1 02. This could, for example, be placed in or adjacent to the AIMD plastic header block 1 04.
  • the external antenna would communicate with an external programmer that would have its own RF transceiver.
  • a typical band for such communication is in the 402 to 405 MHz frequency range (known as the MICS band).
  • MICS band 402 to 405 MHz frequency range
  • a problem with such prior art RF distance telemetry circuits is that energy consumption is high because the receiver circuitry must be on all the time.
  • the Zarlink chip has provided one solution to this problem.
  • the Zarlink chip uses higher frequencies (in the gigahertz range) to wake-up the lower frequency RF telemetry circuit which is generally in the MICS band.
  • the higher frequency GHz receiver of the Zarlink chip is very energy efficient, however the device or chip still consumes an amount of idling energy from the AIMD battery to always be alert for its wake-up call.
  • this current draw link is in the order of 250 picoamperes (250,000 nanoamperes). This is still a significant amount of idling current over the life of the pacemaker and generally shortens the pacemaker life by at least one month.
  • an RF activated AIMD telemetry transceiver that includes means responsive to a signal from an RF transmitter to place an AIMD telemetry transceiver into its active telemetry mode.
  • the system should draw a minimal amount of power from the AIMD, on the order of 25,000 nanoamperes or less, and preferably 500 nanoamperes or less.
  • a circuit connection is provided which would be responsive to a signal from the RF tag to place the telemetry transceiver into its active telemetry mode.
  • the entire wake- up feature would be externally powered by, for example, the energy coupled from an external/remote RF reader.
  • the AIMD telemetry transceiver Once the AIMD telemetry transceiver is placed into its active mode, a feature is needed wherein the AIMD telemetry circuit can go back into its quiescent sleep mode. Accordingly, there is need for circuits and/or programmer commands to place the AIMD telemetry receiver back into a sleep mode after a set amount of time or after a receipt of a signal from the external programmer.
  • the present invention fulfills these needs and provides other related advantages.
  • the present invention relates to an RF (radio frequency) activated AIMD (active implantable medical device) telemetry transceiver, generally comprising: (1 ) a telemetry transceiver associated with the AIMD, (2) a passive RF tag associated with the telemetry transceiver, and (3) a telemetry wake-up circuit electrically disposed between the telemetry transceiver and the RF tag.
  • the telemetry transceiver has an active telemetry mode wherein the telemetry transceiver is powered by the AIMD, and a sleep mode.
  • the telemetry wake-up circuit is responsive to a signal from the RF tag to place the telemetry transceiver into the active telemetry mode.
  • the RF tag comprises a passive RF or RFID chip and an antenna.
  • the RF chip typically includes at least four terminals, and the antenna preferably comprises a biocompatible antenna.
  • the RF chip is disposed within a hermetic package to prevent contact between the RF chip and body tissue or body fluids.
  • the RF chip may be disposed within a housing for the AIMD which, thus, serves as the hermetic package.
  • the RF tag may be disposed within its own hermetic package and disposed within the header block for the AIMD.
  • the RF chip is activated by a remote source, such as an RF transmitter such as an RFID reader/interrogator, which may be a wireless unit, or integrated into or tethered to an AIMD programmer.
  • a remote source such as an RF transmitter such as an RFID reader/interrogator, which may be a wireless unit, or integrated into or tethered to an AIMD programmer.
  • the signal from the RF tag to place the telemetry transceiver into the active telemetry mode is generated in response to activation of the RF chip.
  • the telemetry wake-up circuit typically comprises a microelectronic switch.
  • the microelectronic switch may comprise a bipolar junction transistor (BJT) switch, a field effect transistor (FET) switch, a MOSFET switch, a MEMS switch, a unijunction transistor switch, a silicon-controlled rectifier (SCR) switch, a PIN diode switch, a P-N junction transistor switch, a P-N-P transistor switch, or an N-P-N junction switch.
  • the telemetry transceiver In its sleep mode, the telemetry transceiver draws less than 25,000 nanoamperes from the AIMD, and preferably less than 500 nanoamperes.
  • a timing circuit is provided for switching the telemetry transceiver from the active telemetry mode to the sleep mode. The timing circuit is re-set responsive to the signal from the RF tag to place the telemetry transceiver into the active telemetry mode.
  • the telemetry transceiver includes a sleep mode circuit responsive to a signal from the RF tag or a remote RF or inductive low frequency magnetic coupling source, for switching the telemetry transceiver from the active telemetry mode to the sleep mode.
  • the telemetry transceiver communicates with the remote RF or inductive low frequency magnetic coupling source.
  • This remote source may comprise an AIMD programmer.
  • FIGURE 1 is a wire formed diagram of a generic human body showing a number of implanted medical devices.
  • FIGURE 2 is a prior art cardiac pacemaker.
  • FIGURE 3 is an enlarged cross-sectional view of the cardiac pacemaker taken generally along the line 3-3 from FIG. 2.
  • FIGURE 4 is a perspective view of a typical cardiac pacemaker embodying the present invention, wherein the RF tag is disposed within the header block.
  • FIGURE 5 is an enlarged perspective view of the RF tag taken generally about the line 5-5 from FIG. 4.
  • FIGURE 6 is a diagrammatic view illustrating the component parts of the RF activated AIMD telemetry transceiver of the present invention.
  • FIGURE 7 is an electrical schematic of the circuitry illustrated in FIG.
  • FIGURE 8 is a system diagram illustrating operation of the present invention.
  • FIGURE 9 is a system illustration similar to FIG. 8, except that an older style of external program is shown including a wand which is placed over the patient's AIMD.
  • FIGURES 10 and 1 1 are similar to FIGS. 8 and 9, illustrating that the
  • RFID reader/interrogator can be incorporated either within or connected to the
  • AIMD external programmer.
  • the present invention in a broad sense, relates to an RF activated AIMD telemetry transceiver which includes (1 ) a telemetry transceiver associated with an AIMD, having an active telemetry mode wherein the telemetry transceiver is powered by the AIMD, and a sleep mode; (2) a passive RF tag associated with the telemetry transceiver; and (3) a telemetry wake-up circuit electrically disposed between the telemetry transceiver and the passive RF tag.
  • the telemetry wake-up circuit is responsive to a signal from the RF tag to place the telemetry transceiver in the active telemetry mode.
  • the AIMD transceiver has a timer wherein it returns to its sleep mode after a predetermined amount of time.
  • a remote AIMD programmer may send a signal to the AIMD telemetry antenna and associated transceiver telling it to turn off and return to its sleep mode.
  • the remote AIMD programmer can incorporate a low frequency (LF) RF transmitter or RFID reader/interrogator operating in the 50 to 1 35 KHz frequency range which would transmit a signal sufficient to penetrate right through the titanium housing of an AIMD and activate an embedded passive RF chip.
  • the circuitry of the RF chip would be connected to telemetry circuits contained within the AIMD.
  • the remote pacemaker programmer would send the RF signal as a wake-up call to turn on the AIMD telemetry receiving circuits so that the pacemaker could communicate with the remote AIMD programmer.
  • the RF chip is a four terminal RFID chip. RFID is widely used for inventory and article tracking.
  • RFID operational protocols and frequencies have evolved worldwide.
  • EPC and ISO standards and also ANSI standards that cover the frequency band, forms of modulation, etc.
  • the ISO 1 8,000 standards are particularly applicable to the present invention.
  • low frequency RFID systems operating below 1 35 kHz are governed by ISO 1 8,000-2.
  • EPC Global which defines various UHF and HF RFID protocols.
  • EPC HF Class 1 covers 1 3.56 MHz. 1 3.56 MHz is also known as the RFID HF band and is covered by ISO 1 8,000-3.
  • the use of a passive four terminal RFID tag for the present invention is preferred because the frequency allocations and other protocols have been worked out over the last couple of decades and have resolved themselves into these international standards.
  • the passive RFID tag draws no current at all from the AIMD battery.
  • a passive RFID tag is entirely powered from the external reader/interrogator. This is what makes it possible to achieve such very low levels of current drop when the telemetry circuit is in its sleep mode.
  • the only part of the AIMD transceiver or receiver that would be active at all is the electronic switch that is coupled to the RFID chip. In the case where this is a field effect transistor (FET) switch, the current draw would be exceedingly low. It is only when the RFID tag itself receives energy from an external source such as an RFID reader/interrogator, that it sends a pulse to activate the transceiver electronic switch, thereby waking up the entire AIMD telemetry transceiver circuitry.
  • the prior art Zarlink chip shortens a pacemaker battery life by over one month. The present invention would, in contrast, shorten a pacemaker battery life by only a portion of a single day.
  • the RFID tag can be multifunctional. That is, when it receives a wake-up encoded pulse from an external reader/interrogator, it can act as the described telemetry wake-up trigger. However, by sending it an interrogation pulse, it can also be used to identify the make, model number, and/or identify MRI compatible features of the AIMD.
  • FIGURE 3 is a cross-sectional view taken generally along section 3-3 from FIG. 2. Shown is a circuit board or substrate 1 10 which contains many electronic components and microelectronic chips which enable the AIMD I OOC to function. Also shown is an RF or RFID tag 1 1 2 which includes an antenna 1 1 4 and a four terminal RF or RFID chip 1 1 6. Two of the leadwires that are routed to the RFID chip 1 16 are connected to the antenna 1 1 4. There are also leadwires 1 1 8, 1 20 that are connected from the RFID chip 1 1 6 to AIMD telemetry transceiver circuitry 1 22 as shown. In a typical application, energy is received from a remote RFID reader/interrogator 1 24 (FIG.
  • the RFID chip 1 1 6 receives the proper encoded signal from the reader/interrogator 1 24 (Fig. 7), it is activated and transmits a wake-up signal via leadwires 1 1 8, 1 20 to the AIMD telemetry transceiver 1 22. This wake-up pulse puts the telemetry transceiver 1 22 into its active mode so that it may communicate with its external/remote programmer 1 28 (FIG. 6).
  • the remote programmer 1 28 may be the older style close-wanded telemetry low frequency magnetic coupling-type (FIG. 9) or it may be the newer RF distance telemetry-type (FIG. 8).
  • FIG. 3 the RFID tag 1 1 2 and its associated component antenna 1 1 4 and RFID chip 1 16 need not be biocompatible or hermetic. This is because they are disposed inside the overall electromagnetically shielded and hermetically sealed housing 1 02 of the AIMD
  • FIGURE 4 illustrates a cardiac pacemaker 1 0OC having an RFID tag
  • the RFID antenna 1 14 would be more efficient because it is outside of the generally electromagnetically shielded housing 1 02 of the AIMD. Since the antenna 1 1 4 that is associated with the RFID tag 1 1 2 is now displaced within the plastic header block 1 04, it can more effectively pick up signals from the RFID reader/interrogator 1 24. In this case, the RFID frequency could still be in the low frequency range (LF) generally from 50 to 1 35 kHz, but it could also be in the HF (1 3.56 MHz) frequency range or even the UHF frequency bands. When the RFID tag 1 1 2 and its associated chip 1 1 6 and antenna 1 14 are placed in the header block 1 04, it is important that these components be resistant to body fluids.
  • LF low frequency range
  • HF HF
  • the antenna 1 1 4 of the RFID tag 1 1 2 must be made of biocompatible material, such as platinum, palladium, niobium and the like.
  • the RFID chip 1 1 6 itself must be either biocompatible or placed within a hermetic package so it is also resistant to body fluids. See U.S. Patent Application No. 1 2/566,233, which is incorporated herein by reference. Leadwires 1 1 8 and 1 20 should also be biocompatible up to the point where they are connected to the hermetic seal 1 30.
  • hermetic seal 1 30 for the RFID tag 1 1 2 could be incorporated within the overall hermetic seal 1 32 which is coupled to the IS-I connectors 1 06, 108 and internal electronic circuits.
  • Leadwires 1 1 8 and 1 20 are routed to leadwires 1 1 8' and 1 20' within the AIMD housing 102 and are connected to the telemetry transceiver 1 22 which is disposed on a circuit board 1 10.
  • FIGURE 5 shows that the RFID tag 1 1 2 of FIG. 4 consists of antenna structure 1 14 and a hermetically sealed package 1 32 in which the RFID chip 1 16 is disposed. Terminals 1 34 and 1 36 are connected to the RFID tag's antenna 1 14. Leadwires 1 1 8 and 1 20 are routed to the telemetry transceiver 1 22 which is located inside of the electromagnetically shielded and hermetically sealed AIMD housing 102. [Para 34] Referring once again to FIG. 4, one can see that the antenna 1 14 of the RFID tag 1 1 2 is disposed outside of the hermetic and electromagnetically sealed housing 1 02 of the AIMD 10OC.
  • the RFID chip 1 1 6 could be disposed inside of the housing 102 of the AIMD, for example, placed on the circuit board 1 10 adjacent to transceiver chip 1 22.
  • the antenna 1 14 of the RFID tag 1 1 2 would still be disposed outside of the AIMD shielded housing 1 02 wherein its associated RFID chip and energy storage capacitor 1 26 are disposed inside the hermetically sealed housing 1 02.
  • FIGURE 6 is a diagrammatic view illustrating how the RFID activated AIMD telemetry transceiver of the present invention would operate. Shown is an RFID reader/interrogator 1 24. It may be a standalone unit, such as a hand-held RFID reader (FIGS. 8-1 0) or it could be incorporated within or adjacent to the AIMD remote programmer 1 28 (FIG. 1 1 ). A signal or pulse 1 38 is produced when the RFID reader/interrogator 1 24 is activated which couples energy to tuned antenna 1 14 of the RFID tag 1 1 2. This couples energy to terminals 1 34 and 1 36 of the RFID chip 1 16 which activates the RFID chip.
  • an RFID reader/interrogator 1 24 may be a standalone unit, such as a hand-held RFID reader (FIGS. 8-1 0) or it could be incorporated within or adjacent to the AIMD remote programmer 1 28 (FIG. 1 1 ).
  • a signal or pulse 1 38 is produced when the RFID reader/interrogator 1 24 is activated which couples energy to tuned antenna 1 14 of the RFID tag
  • the RFID chip 1 16 stores this energy in a capacitor (not shown) which then transmits a wake-up pulse via terminals 1 40 and 1 42 to the telemetry wake-up circuit 144.
  • the telemetry wake-up circuit 1 44 then turns power to the AIMD telemetry transceiverl 22 placing it into an active telemetry mode.
  • an optional timer 146 which will turn off the telemetry transceiver 1 22 and put it back into its sleep mode after a predetermined amount of time.
  • An alternative to the timer 1 46 is that a second activation of the RFID reader/interrogator 1 24 would cause the RFID chip 1 1 6 to once again be activated so that it sent a toggle pulse back to the telemetry wake-up circuit 144.
  • FIGURE 7 is an electrical schematic diagram of the system of FIG. 6, illustrating the components of the telemetry wake-up circuit 1 44. Shown, in this case, is a bipolar junction transistor (BJT) which is also known as a N-P-N transceiver switch 1 50.
  • BJT bipolar junction transistor
  • the transistor 1 50 base 1 52 receives a signal from the RFID chip 1 1 6 from terminals 140 andl 42 through leadwires 1 1 8 and 1 20. This results in a very low voltage drop between the transistor 1 50 collector C and the emitter E. This effectively connects the telemetry transceiver 1 22 to voltage source Vs and to the ground reference voltage OV. This activates the telemetry transceiver 1 22 which is shown connected to its antenna 148 so that it can receive and transmit information from the AIMD remote programmer 1 28 (FIG. 6).
  • the voltage source Vs is normally supplied from the AIMD internal battery 1 54 (FIG. 3).
  • the N-P-N transceiver switch 1 50 is illustrative of any type of microelectronic switch.
  • the RFID chip 1 16 of the present invention contains at least four terminals. Two of these terminals 1 34, 1 36 are reserved for connection to the antenna 1 14 and its associated resonating capacitor 1 26.
  • FIGURE 8 illustrates the operation of the present invention. Shown is a human patient 1 56 who has an AIMD 100. In its normal operating mode, the AIMD's telemetry transceiver circuits would be in a sleep or quiescent low battery drain mode. A signal 1 38 is transmitted by an RFID reader/interrogator 1 24. This pulse 1 38 is coupled to the RFID tag 1 1 2 that is associated with the AIMD 1 00. The RFID signal 1 38 then wakes up the AIMD's telemetry transceiver 1 22.
  • the remote programmer 1 28 can form a two-way communication link between the AIMD 100 and the programmer 1 28.
  • the remote programmer 1 28 has an antenna 1 58, which is an RF antenna. This forms a so-called distance telemetry link between the remote programmer 1 28 and the AIMD 1 00. This typically operates at high frequency.
  • One popular set of frequencies is the MICS band operating in the 402 to 405 MHz frequency range.
  • the telemetry transceiver of the AIMD 1 00 can be put back into its wake-up mode in a number of ways, including an internal timer circuit 1 46, receipt of a second type of RFID pulse 1 38' which will instruct the RFID chip 1 1 6 to unlatch the telemetry wake-up circuit thereby putting the telemetry transceiver back into its sleep mode, or even by transmission of a special pulse sequence 1 60 from the remote programmer 1 28 which instructs the transceiver 1 22 to go back into its sleep mode.
  • FIGURE 9 is very similar to FIG. 8, except that an older style of remote programmer 1 28 is shown which includes a wand 162 which is placed over the patient's AIMD 100.
  • the wand 162 is generally connected through leads 1 64 to the remote programmer 1 28.
  • This type of wanded telemetry involves a close coupled low frequency magnetic link between an antenna in the wand 162 and an associated multi-turn loop antenna associated with the AIMD 1 00.
  • the wand 162 would be placed either very close to or directly on the patient's chest directly over the AIMD 100. This is the case for a cardiac pacemaker 1 0OC.
  • the AIMD 1 00 could be located anywhere within the human body in which case the wand 162 would have to be placed over it.
  • the system of FIG. 9 operates in all ways as previously described in connection with FIG. 8.
  • FIGURES 10 and 1 1 are similar to FIGS. 8 and 9, however in this case, the RFID reader 1 24, which is illustrated in FIG. 1 0, can be incorporated either within or connected to the AIMD remote programmer 1 28. This eliminates the need to have an external portable RFID reader 1 24, which would be about the size of a garage door opener. The problem with a small reader around a hospital or operating theater is it is easily misplaced or lost. Accordingly, it is a feature of the present invention that the RFID reader 1 24 that activates the RFID tag 1 1 2 may be built inside of or connected to via leads 166 of the AIMD remote programmer 1 28.
  • an RF-activated AIMD telemetry transceiver which includes a telemetry transceiver associated with the AIMD, an RF tag associated with the telemetry transceiver, and a telemetry wake-up circuit electrically disposed between the telemetry transceiver and the RF tag.
  • the RF tag comprises a passive RF chip and an antenna.
  • the antenna is biocompatible and the RF chip is disposed within a hermetic package.
  • the telemetry transceiver has an active telemetry mode wherein a telemetry transceiver is powered by the AIMD, and a sleep mode.
  • the telemetry wake-up circuit is responsive to a signal from the RF tag to place the telemetry transceiver into the active telemetry mode.

Abstract

A telemetry wake-up circuit is electrically disposed between a telemetry transceiver associated with an AIMD, and an RF tag. The RF tag may be remotely interrogated to generate a signal to which the telemetry wake-up circuit is responsive to switch the telemetry transceiver from a sleep mode to an active telemetry mode. In the sleep mode, the telemetry transceiver draws less than 25,000 nanoamperes from the AIMD, and preferably less than 500 nanoamperes.

Description

RF ACTIVATED AIMD TELEMETRY TRANSCEIVER
DESCRIPTION
BACKGROUND OF THE INVENTION
[Para 1 ] The present invention relates generally telemetry transceivers associated with active implantable medical devices (AIMDs) and related components. More particularly, the present invention relates AIMD RF telemetry circuits having radio frequency identification (RFID) controllable wake-up features.
[Para 2] FIGURES 1 and 2 provide a background for better understanding of the present invention. FIG. 1 is a wire formed diagram of a generic human body showing a number of implanted medical devices. 10OA represents a family of hearing devices which can include the group of cochlear implants, piezoelectric sound bridge transducers and the like. 10OB represents a variety of neurostimulators and brain stimulators. Neurostimulators are used to stimulate the Vagus nerve, for example, to treat epilepsy, obesity and depression. Brain stimulators are pacemaker-like devices and include electrodes implanted deep into the brain for sensing the onset of the seizure and also providing electrical stimulation to brain tissue to prevent the seizure from actually occurring. The lead wires associated with a deep brain stimulator are often placed using real time MRI imaging. 1 0OC shows a cardiac pacemaker which is well-known in the art. 10OD includes the family of left ventricular assist devices (LVAD's) and artificial hearts. 1 0OE includes an entire family of drug pumps which can be used for dispensing of insulin, chemotherapy drugs, pain medications and the like. Insulin pumps are evolving from passive devices to ones that have sensors and closed loop systems. That is, real time monitoring of blood sugar levels will occur. These devices tend to be more sensitive to EMI than passive pumps that have no sense circuitry or externally implanted lead wires. 1 0OF includes a variety of bone growth stimulators for rapid healing of fractures. 1 0OG includes urinary incontinence devices. 1 0OH includes the family of pain relief spinal cord stimulators and anti-tremor stimulators. 10OH also includes an entire family of other types of neurostimulators used to block pain. 1 001 includes a family of implantable cardioverter defibrillators (ICD) devices and also includes the family of congestive heart failure devices (CHF). This is also known in the art as cardio resynchronization therapy devices, otherwise known as CRT devices. 10OJ illustrates an externally worn pack. This pack could be an external insulin pump, an external drug pump, an external neurostimulator or even a ventricular assist device.
[Para 3] FIGURE 2 is a prior art cardiac pacemaker 10OC. A cardiac pacemaker typically has an electromagnetically shielded and hermetically sealed housing 102 which is generally constructed from titanium, stainless steel or the like. It also has a plastic or Techothane header block 1 04 which houses ISO standard IS-I type connectors 106, 1 08. In the past, AIMDs, in particular pacemakers, ICDs and neurostimulators, embodied close-coupled telemetry circuits. The purpose of telemetry is so that the AIMD could be interrogated or even reprogrammed after implantation. For example, it is common to monitor battery status, patient biologic conditions and the like, through telemetry. In addition, an external telemetry programmer can be used to re-program the AIMD, for example, and put it into different modes of operation. In the past, for pacemakers and ICDs the telemetry was inductive (low frequency magnetic) and close coupled. In this older art it was typical that the AIMD would have a multiple turn wire antenna within its titanium housing. There were even AIMDs that used an external loop antenna of this type. To interrogate or re-program the AIMD, the physician or other medical practitioners would bring a wand, with a similar antenna embedded in it, very close to the AIMD. For example, for a typical pacemaker application the telemetry wand would be placed directly over the implant. The wand is/was connected with wiring to the external programmer. The medical practitioner would move the wand around until the "sweet-spot" was located. Once the wand is located in the "sweet-spot," a communication link is established between the multiple turn wire antenna implanted in the AIMD and a similar multiple turn wire antenna located inside the telemetry wand. The external programmer would then become active and electrograms and other important information would be displayed. Typically the telemetry wand would be placed either against or very close to the patient's skin surface or at most a few centimeters away. [Para 4] In the last few years, distance RF telemetry has become increasingly common. For distance telemetry, for example for a cardiac pacemaker 10OC, there would be a high frequency antenna that would be located outside of the AIMD shielded titanium housing 1 02. This could, for example, be placed in or adjacent to the AIMD plastic header block 1 04. The external antenna would communicate with an external programmer that would have its own RF transceiver. A typical band for such communication is in the 402 to 405 MHz frequency range (known as the MICS band). There are other bands that may be used for RF telemetry including gigahertz frequencies. A problem with such prior art RF distance telemetry circuits is that energy consumption is high because the receiver circuitry must be on all the time.
[Para 5] The Zarlink chip has provided one solution to this problem. The Zarlink chip uses higher frequencies (in the gigahertz range) to wake-up the lower frequency RF telemetry circuit which is generally in the MICS band. The higher frequency GHz receiver of the Zarlink chip is very energy efficient, however the device or chip still consumes an amount of idling energy from the AIMD battery to always be alert for its wake-up call. In general, this current draw link is in the order of 250 picoamperes (250,000 nanoamperes). This is still a significant amount of idling current over the life of the pacemaker and generally shortens the pacemaker life by at least one month.
[Para 6] Accordingly, there is a need for an RF activated AIMD telemetry transceiver that includes means responsive to a signal from an RF transmitter to place an AIMD telemetry transceiver into its active telemetry mode. During a sleep mode for the AIMD telemetry transceiver, the system should draw a minimal amount of power from the AIMD, on the order of 25,000 nanoamperes or less, and preferably 500 nanoamperes or less. A circuit connection is provided which would be responsive to a signal from the RF tag to place the telemetry transceiver into its active telemetry mode. Preferably, the entire wake- up feature would be externally powered by, for example, the energy coupled from an external/remote RF reader. Once the AIMD telemetry transceiver is placed into its active mode, a feature is needed wherein the AIMD telemetry circuit can go back into its quiescent sleep mode. Accordingly, there is need for circuits and/or programmer commands to place the AIMD telemetry receiver back into a sleep mode after a set amount of time or after a receipt of a signal from the external programmer. The present invention fulfills these needs and provides other related advantages.
SUMMARY OF THE INVENTION
[Para 7] The present invention relates to an RF (radio frequency) activated AIMD (active implantable medical device) telemetry transceiver, generally comprising: (1 ) a telemetry transceiver associated with the AIMD, (2) a passive RF tag associated with the telemetry transceiver, and (3) a telemetry wake-up circuit electrically disposed between the telemetry transceiver and the RF tag. The telemetry transceiver has an active telemetry mode wherein the telemetry transceiver is powered by the AIMD, and a sleep mode. The telemetry wake-up circuit is responsive to a signal from the RF tag to place the telemetry transceiver into the active telemetry mode.
[Para 8] In a preferred embodiment, the RF tag comprises a passive RF or RFID chip and an antenna. The RF chip typically includes at least four terminals, and the antenna preferably comprises a biocompatible antenna. As shown, the RF chip is disposed within a hermetic package to prevent contact between the RF chip and body tissue or body fluids. The RF chip may be disposed within a housing for the AIMD which, thus, serves as the hermetic package. Alternatively, the RF tag may be disposed within its own hermetic package and disposed within the header block for the AIMD. The RF chip is activated by a remote source, such as an RF transmitter such as an RFID reader/interrogator, which may be a wireless unit, or integrated into or tethered to an AIMD programmer. The signal from the RF tag to place the telemetry transceiver into the active telemetry mode is generated in response to activation of the RF chip.
[Para 9] The telemetry wake-up circuit typically comprises a microelectronic switch. The microelectronic switch may comprise a bipolar junction transistor (BJT) switch, a field effect transistor (FET) switch, a MOSFET switch, a MEMS switch, a unijunction transistor switch, a silicon-controlled rectifier (SCR) switch, a PIN diode switch, a P-N junction transistor switch, a P-N-P transistor switch, or an N-P-N junction switch.
[Para 10] In its sleep mode, the telemetry transceiver draws less than 25,000 nanoamperes from the AIMD, and preferably less than 500 nanoamperes. In one embodiment, a timing circuit is provided for switching the telemetry transceiver from the active telemetry mode to the sleep mode. The timing circuit is re-set responsive to the signal from the RF tag to place the telemetry transceiver into the active telemetry mode. In another embodiment, the telemetry transceiver includes a sleep mode circuit responsive to a signal from the RF tag or a remote RF or inductive low frequency magnetic coupling source, for switching the telemetry transceiver from the active telemetry mode to the sleep mode. [Para 1 1 ] In the active telemetry mode, the telemetry transceiver communicates with the remote RF or inductive low frequency magnetic coupling source. This remote source may comprise an AIMD programmer. [Para 12] Other features and advantages of the present invention will become apparent from the following more detailed description, taken in conjunction with the accompanying drawings which illustrate, by way of example, the principles of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[Para 13] The accompanying drawings illustrate the invention. In such drawings:
[Para 14] FIGURE 1 is a wire formed diagram of a generic human body showing a number of implanted medical devices.
[Para 1 5] FIGURE 2 is a prior art cardiac pacemaker.
[Para 16] FIGURE 3 is an enlarged cross-sectional view of the cardiac pacemaker taken generally along the line 3-3 from FIG. 2. [Para 17] FIGURE 4 is a perspective view of a typical cardiac pacemaker embodying the present invention, wherein the RF tag is disposed within the header block.
[Para 18] FIGURE 5 is an enlarged perspective view of the RF tag taken generally about the line 5-5 from FIG. 4.
[Para 19] FIGURE 6 is a diagrammatic view illustrating the component parts of the RF activated AIMD telemetry transceiver of the present invention.
[Para 20] FIGURE 7 is an electrical schematic of the circuitry illustrated in FIG.
6.
[Para 21 ] FIGURE 8 is a system diagram illustrating operation of the present invention.
[Para 22] FIGURE 9 is a system illustration similar to FIG. 8, except that an older style of external program is shown including a wand which is placed over the patient's AIMD.
[Para 23] FIGURES 10 and 1 1 are similar to FIGS. 8 and 9, illustrating that the
RFID reader/interrogator can be incorporated either within or connected to the
AIMD external programmer.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [Para 24] The present invention, in a broad sense, relates to an RF activated AIMD telemetry transceiver which includes (1 ) a telemetry transceiver associated with an AIMD, having an active telemetry mode wherein the telemetry transceiver is powered by the AIMD, and a sleep mode; (2) a passive RF tag associated with the telemetry transceiver; and (3) a telemetry wake-up circuit electrically disposed between the telemetry transceiver and the passive RF tag. The telemetry wake-up circuit is responsive to a signal from the RF tag to place the telemetry transceiver in the active telemetry mode. In a preferred embodiment, the AIMD transceiver has a timer wherein it returns to its sleep mode after a predetermined amount of time. As an alternative, a remote AIMD programmer may send a signal to the AIMD telemetry antenna and associated transceiver telling it to turn off and return to its sleep mode.
[Para 25] In a preferred embodiment, the remote AIMD programmer can incorporate a low frequency (LF) RF transmitter or RFID reader/interrogator operating in the 50 to 1 35 KHz frequency range which would transmit a signal sufficient to penetrate right through the titanium housing of an AIMD and activate an embedded passive RF chip. The circuitry of the RF chip would be connected to telemetry circuits contained within the AIMD. For example, in the case of a pacemaker, the remote pacemaker programmer would send the RF signal as a wake-up call to turn on the AIMD telemetry receiving circuits so that the pacemaker could communicate with the remote AIMD programmer. [Para 26] In a preferred embodiment, the RF chip is a four terminal RFID chip. RFID is widely used for inventory and article tracking. RFID operational protocols and frequencies have evolved worldwide. There are EPC and ISO standards, and also ANSI standards that cover the frequency band, forms of modulation, etc. In particular, the ISO 1 8,000 standards are particularly applicable to the present invention. For example, low frequency RFID systems operating below 1 35 kHz are governed by ISO 1 8,000-2. There are also standards governed by the standard body known as EPC Global which defines various UHF and HF RFID protocols. For example, EPC HF Class 1 covers 1 3.56 MHz. 1 3.56 MHz is also known as the RFID HF band and is covered by ISO 1 8,000-3. The use of a passive four terminal RFID tag for the present invention is preferred because the frequency allocations and other protocols have been worked out over the last couple of decades and have resolved themselves into these international standards.
[Para 27] The passive RFID tag draws no current at all from the AIMD battery. A passive RFID tag is entirely powered from the external reader/interrogator. This is what makes it possible to achieve such very low levels of current drop when the telemetry circuit is in its sleep mode. The only part of the AIMD transceiver or receiver that would be active at all is the electronic switch that is coupled to the RFID chip. In the case where this is a field effect transistor (FET) switch, the current draw would be exceedingly low. It is only when the RFID tag itself receives energy from an external source such as an RFID reader/interrogator, that it sends a pulse to activate the transceiver electronic switch, thereby waking up the entire AIMD telemetry transceiver circuitry. [Para 28] The prior art Zarlink chip shortens a pacemaker battery life by over one month. The present invention would, in contrast, shorten a pacemaker battery life by only a portion of a single day.
[Para 29] There is another significant advantage to using a passive RFID tag to wake up the AIMD telemetry circuit. The RFID tag can be multifunctional. That is, when it receives a wake-up encoded pulse from an external reader/interrogator, it can act as the described telemetry wake-up trigger. However, by sending it an interrogation pulse, it can also be used to identify the make, model number, and/or identify MRI compatible features of the AIMD.
[Para 30] FIGURE 3 is a cross-sectional view taken generally along section 3-3 from FIG. 2. Shown is a circuit board or substrate 1 10 which contains many electronic components and microelectronic chips which enable the AIMD I OOC to function. Also shown is an RF or RFID tag 1 1 2 which includes an antenna 1 1 4 and a four terminal RF or RFID chip 1 1 6. Two of the leadwires that are routed to the RFID chip 1 16 are connected to the antenna 1 1 4. There are also leadwires 1 1 8, 1 20 that are connected from the RFID chip 1 1 6 to AIMD telemetry transceiver circuitry 1 22 as shown. In a typical application, energy is received from a remote RFID reader/interrogator 1 24 (FIG. 6) and coupled to the RFID tag 1 1 2 antenna 1 1 4. A resonant circuit is formed between this antenna 1 14 and the RFID chip 1 1 6. Normally, a capacitor 1 26 (FIG. 7) would be placed in parallel with the antenna 1 14 to store energy. Once the RFID chip 1 1 6 receives the proper encoded signal from the reader/interrogator 1 24 (Fig. 7), it is activated and transmits a wake-up signal via leadwires 1 1 8, 1 20 to the AIMD telemetry transceiver 1 22. This wake-up pulse puts the telemetry transceiver 1 22 into its active mode so that it may communicate with its external/remote programmer 1 28 (FIG. 6). The remote programmer 1 28 may be the older style close-wanded telemetry low frequency magnetic coupling-type (FIG. 9) or it may be the newer RF distance telemetry-type (FIG. 8). [Para 31 ] Referring once again to FIG. 3, the RFID tag 1 1 2 and its associated component antenna 1 1 4 and RFID chip 1 16 need not be biocompatible or hermetic. This is because they are disposed inside the overall electromagnetically shielded and hermetically sealed housing 1 02 of the AIMD
I 0OC. There are advantages and disadvantages to this placement. The obvious advantage is the RFID tag 1 1 2 and all its associated components are in an environmentally inert environment and are never exposed to body tissue or body fluids. A disadvantage is the fact that the antenna 1 1 4 is disposed inside of the electromagnetically shielded housing 1 02 of the AIMD. This means, the antenna 1 14 can only effectively pick up low frequency RFID signals. These signals would typically be in the 50 to 1 35 kHz frequency range. The antenna 1 1 4 would be completely ineffective in picking up signals from an external RFID reader/interrogator 1 24 at HF (1 3.56 MHz) or higher frequencies. This is because the housing 102 of the AIMD would effectively shield such signals. [Para 32] FIGURE 4 illustrates a cardiac pacemaker 1 0OC having an RFID tag
I 1 2 which is mounted in the AIMD plastic header block 104. In this application, the RFID antenna 1 14 would be more efficient because it is outside of the generally electromagnetically shielded housing 1 02 of the AIMD. Since the antenna 1 1 4 that is associated with the RFID tag 1 1 2 is now displaced within the plastic header block 1 04, it can more effectively pick up signals from the RFID reader/interrogator 1 24. In this case, the RFID frequency could still be in the low frequency range (LF) generally from 50 to 1 35 kHz, but it could also be in the HF (1 3.56 MHz) frequency range or even the UHF frequency bands. When the RFID tag 1 1 2 and its associated chip 1 1 6 and antenna 1 14 are placed in the header block 1 04, it is important that these components be resistant to body fluids. Over time, body fluids can penetrate through bulk permeability through the header block 1 04 plastic material. Accordingly, the antenna 1 1 4 of the RFID tag 1 1 2 must be made of biocompatible material, such as platinum, palladium, niobium and the like. In addition, the RFID chip 1 1 6 itself must be either biocompatible or placed within a hermetic package so it is also resistant to body fluids. See U.S. Patent Application No. 1 2/566,233, which is incorporated herein by reference. Leadwires 1 1 8 and 1 20 should also be biocompatible up to the point where they are connected to the hermetic seal 1 30. It will be apparent to those skilled in the art that the hermetic seal 1 30 for the RFID tag 1 1 2 could be incorporated within the overall hermetic seal 1 32 which is coupled to the IS-I connectors 1 06, 108 and internal electronic circuits. Leadwires 1 1 8 and 1 20 are routed to leadwires 1 1 8' and 1 20' within the AIMD housing 102 and are connected to the telemetry transceiver 1 22 which is disposed on a circuit board 1 10.
[Para 33] FIGURE 5 shows that the RFID tag 1 1 2 of FIG. 4 consists of antenna structure 1 14 and a hermetically sealed package 1 32 in which the RFID chip 1 16 is disposed. Terminals 1 34 and 1 36 are connected to the RFID tag's antenna 1 14. Leadwires 1 1 8 and 1 20 are routed to the telemetry transceiver 1 22 which is located inside of the electromagnetically shielded and hermetically sealed AIMD housing 102. [Para 34] Referring once again to FIG. 4, one can see that the antenna 1 14 of the RFID tag 1 1 2 is disposed outside of the hermetic and electromagnetically sealed housing 1 02 of the AIMD 10OC. In an alternative embodiment, the RFID chip 1 1 6 could be disposed inside of the housing 102 of the AIMD, for example, placed on the circuit board 1 10 adjacent to transceiver chip 1 22. In this embodiment, the antenna 1 14 of the RFID tag 1 1 2 would still be disposed outside of the AIMD shielded housing 1 02 wherein its associated RFID chip and energy storage capacitor 1 26 are disposed inside the hermetically sealed housing 1 02.
[Para 35] FIGURE 6 is a diagrammatic view illustrating how the RFID activated AIMD telemetry transceiver of the present invention would operate. Shown is an RFID reader/interrogator 1 24. It may be a standalone unit, such as a hand-held RFID reader (FIGS. 8-1 0) or it could be incorporated within or adjacent to the AIMD remote programmer 1 28 (FIG. 1 1 ). A signal or pulse 1 38 is produced when the RFID reader/interrogator 1 24 is activated which couples energy to tuned antenna 1 14 of the RFID tag 1 1 2. This couples energy to terminals 1 34 and 1 36 of the RFID chip 1 16 which activates the RFID chip. The RFID chip 1 16 stores this energy in a capacitor (not shown) which then transmits a wake-up pulse via terminals 1 40 and 1 42 to the telemetry wake-up circuit 144. The telemetry wake-up circuit 1 44 then turns power to the AIMD telemetry transceiverl 22 placing it into an active telemetry mode. Also shown is an optional timer 146 which will turn off the telemetry transceiver 1 22 and put it back into its sleep mode after a predetermined amount of time. An alternative to the timer 1 46 is that a second activation of the RFID reader/interrogator 1 24 would cause the RFID chip 1 1 6 to once again be activated so that it sent a toggle pulse back to the telemetry wake-up circuit 144. This would unlatch or turn off the telemetry transceiver 1 22 and put it back into its sleep mode. There is a third method of putting the telemetry transceiver 1 22 back into its sleep mode and that would be by sending a special pulse 1 48 from the remote programmer 1 28 which would instruct the telemetry transceiver 1 22 to go back into its sleep mode. [Para 36] FIGURE 7 is an electrical schematic diagram of the system of FIG. 6, illustrating the components of the telemetry wake-up circuit 1 44. Shown, in this case, is a bipolar junction transistor (BJT) which is also known as a N-P-N transceiver switch 1 50. The transistor 1 50 base 1 52 receives a signal from the RFID chip 1 1 6 from terminals 140 andl 42 through leadwires 1 1 8 and 1 20. This results in a very low voltage drop between the transistor 1 50 collector C and the emitter E. This effectively connects the telemetry transceiver 1 22 to voltage source Vs and to the ground reference voltage OV. This activates the telemetry transceiver 1 22 which is shown connected to its antenna 148 so that it can receive and transmit information from the AIMD remote programmer 1 28 (FIG. 6). The voltage source Vs is normally supplied from the AIMD internal battery 1 54 (FIG. 3). The N-P-N transceiver switch 1 50 is illustrative of any type of microelectronic switch. These can include a bipolar junction transistor (BJT), a field effect transistor (FET), a metal oxide substrate field effect transistor (MOSFET), a microelectronic mechanical switch (MEMS), a unijunction transistor switch, a silicon-controlled rectifier (SCR) switch, a PIN diode, a P-N junction transistor switch, a P-N-P transistor switch, or any type of N-P-N transistor switch. In general, the RFID chip 1 16 of the present invention contains at least four terminals. Two of these terminals 1 34, 1 36 are reserved for connection to the antenna 1 14 and its associated resonating capacitor 1 26. The other two or more terminals 1 40, 142 are for connection to AIMD telemetry transceiver circuits 1 1 8, 1 20 in order to provide both wake-up and go back to sleep pulses. [Para 37] FIGURE 8 illustrates the operation of the present invention. Shown is a human patient 1 56 who has an AIMD 100. In its normal operating mode, the AIMD's telemetry transceiver circuits would be in a sleep or quiescent low battery drain mode. A signal 1 38 is transmitted by an RFID reader/interrogator 1 24. This pulse 1 38 is coupled to the RFID tag 1 1 2 that is associated with the AIMD 1 00. The RFID signal 1 38 then wakes up the AIMD's telemetry transceiver 1 22. It is at this point that the remote programmer 1 28 can form a two-way communication link between the AIMD 100 and the programmer 1 28. In the case shown in FIG. 8, the remote programmer 1 28 has an antenna 1 58, which is an RF antenna. This forms a so-called distance telemetry link between the remote programmer 1 28 and the AIMD 1 00. This typically operates at high frequency. One popular set of frequencies is the MICS band operating in the 402 to 405 MHz frequency range. As previously described, the telemetry transceiver of the AIMD 1 00 can be put back into its wake-up mode in a number of ways, including an internal timer circuit 1 46, receipt of a second type of RFID pulse 1 38' which will instruct the RFID chip 1 1 6 to unlatch the telemetry wake-up circuit thereby putting the telemetry transceiver back into its sleep mode, or even by transmission of a special pulse sequence 1 60 from the remote programmer 1 28 which instructs the transceiver 1 22 to go back into its sleep mode. [Para 38] FIGURE 9 is very similar to FIG. 8, except that an older style of remote programmer 1 28 is shown which includes a wand 162 which is placed over the patient's AIMD 100. The wand 162 is generally connected through leads 1 64 to the remote programmer 1 28. This type of wanded telemetry involves a close coupled low frequency magnetic link between an antenna in the wand 162 and an associated multi-turn loop antenna associated with the AIMD 1 00. Generally, the wand 162 would be placed either very close to or directly on the patient's chest directly over the AIMD 100. This is the case for a cardiac pacemaker 1 0OC. Of course, the AIMD 1 00 could be located anywhere within the human body in which case the wand 162 would have to be placed over it. The system of FIG. 9 operates in all ways as previously described in connection with FIG. 8.
[Para 39] FIGURES 10 and 1 1 are similar to FIGS. 8 and 9, however in this case, the RFID reader 1 24, which is illustrated in FIG. 1 0, can be incorporated either within or connected to the AIMD remote programmer 1 28. This eliminates the need to have an external portable RFID reader 1 24, which would be about the size of a garage door opener. The problem with a small reader around a hospital or operating theater is it is easily misplaced or lost. Accordingly, it is a feature of the present invention that the RFID reader 1 24 that activates the RFID tag 1 1 2 may be built inside of or connected to via leads 166 of the AIMD remote programmer 1 28. [Para 40] From the foregoing, it will be appreciated that the present invention relates to an RF-activated AIMD telemetry transceiver which includes a telemetry transceiver associated with the AIMD, an RF tag associated with the telemetry transceiver, and a telemetry wake-up circuit electrically disposed between the telemetry transceiver and the RF tag. The RF tag comprises a passive RF chip and an antenna. Preferably, the antenna is biocompatible and the RF chip is disposed within a hermetic package. The telemetry transceiver has an active telemetry mode wherein a telemetry transceiver is powered by the AIMD, and a sleep mode. The telemetry wake-up circuit is responsive to a signal from the RF tag to place the telemetry transceiver into the active telemetry mode.
[Para 41 ] Although several embodiments of the invention have been described in some detail for purposes of illustration, various modifications may be made without departing from the spirit and scope of the invention. Accordingly, the invention is not to be limited, except as by the appended claims.

Claims

What is clai med is :
[Claim 1 ] An RF activated AIMD telemetry transceiver, comprising: a telemetry transceiver associated with an AIMD, having an active telemetry mode wherein the telemetry transceiver is powered by the AIMD, and a sleep mode; a passive RF tag associated with the telemetry transceiver; and a telemetry wake-up circuit electrically disposed between the telemetry transceiver and the RF tag, the telemetry wake-up circuit responsive to a signal from the RF tag to place the telemetry transceiver into the active telemetry mode.
[Claim 2] The RF activated AIMD telemetry transceiver of claim 1 , wherein the RF tag comprises a passive RF chip and an antenna.
[Claim 3] The RF activated AIMD telemetry transceiver of claim 2, wherein the RF chip comprises a passive RFID chip.
[Claim 4] The RF activated AIMD telemetry transceiver of claim 2, wherein the RF chip is activated by a remote source.
[Claim 5] The RF activated AIMD telemetry transceiver of claim 4, wherein the remote source comprises an RF transmitter.
[Claim 6] The RF activated AIMD telemetry transceiver of claim 6, wherein the remote source comprises an RFID reader/interrogator.
[Claim 7] The RF activated AIMD telemetry transceiver of claim 4, wherein the signal from the RF tag to place the telemetry transceiver in the active telemetry mode is generated in response to activation of the RF chip.
[Claim 8] The RF activated AIMD telemetry transceiver of claim 7, wherein the telemetry transceiver draws less than 25,000 nanoamperes from the AIMD during the telemetry transceiver's sleep mode.
[Claim 9] The RF activated AIMD telemetry transceiver of claim 8, wherein the telemetry transceiver draws less than 500 nanoamperes from the AIMD during the telemetry transceiver's sleep mode.
[Claim 1 0] The RF activated AIMD telemetry transceiver of claims 1 or 9, wherein the telemetry wake-up circuit comprises a microelectronic switch.
[Claim 1 1 ] The RF activated AIMD telemetry transceiver of claim 1 0, wherein the microelectronic switch comprises: a bipolar junction transistor (BJT) switch, a field effect transistor (FET) switch, a metal oxide substrate field effect transistor (MOSFET) switch, a microelectronic mechanical switch (MEMS), a unijunction transistor switch, a silicon-controlled rectifier (SCR) switch, a PIN diode switch, a P-N junction transistor switch, a P-N-P transistor switch, or a N-P-N junction switch.
[Claim 1 2] The RF activated AIMD telemetry transceiver of claims 1 or 7, including a timing circuit for switching the telemetry transceiver from the active telemetry mode to the sleep mode.
[Claim 1 3] The RF activated AIMD telemetry transceiver of claim 1 0, wherein the timing circuit is re-set responsive to the signal from the RF tag to place the telemetry transceiver into the active telemetry mode.
[Claim 1 4] The RF activated AIMD telemetry transceiver of claims 1 or 7, wherein the telemetry transceiver includes a sleep mode circuit responsive to a signal from the RF tag or a remote RF or inductive low frequency magnetic coupling source, for switching the telemetry transceiver from the active telemetry mode to the sleep mode.
[Claim 1 5] The RF activated AIMD telemetry transceiver of claim 1 , wherein the telemetry transceiver, in the active telemetry mode, communicates with a remote RF or inductive low frequency magnetic coupling source.
[Claim 1 6] The RF activated AIMD telemetry transceiver of claim 1 5, wherein the remote RF or inductive low frequency magnetic coupling source comprises an AIMD programmer.
[Claim 1 7] The RF activated AIMD telemetry transceiver of claim 2, wherein the RF chip includes at least four terminals.
[Claim 1 8] The RF activated AIMD telemetry transceiver of claims 2 or 1 7, wherein the antenna comprises a biocompatible antenna.
[Claim 1 9] The RF activated AIMD telemetry transceiver of claim 1 8, wherein the RF chip is disposed within a hermetic package.
[Claim 20] The RF activated AIMD telemetry transceiver of claim 1 9, wherein the RFID tag is disposed within a header block of the AIMD.
[Claim 21 ] The RF activated AIMD telemetry transceiver of claim 1 8, wherein the hermetic package comprises a housing for the AIMD.
[Claim 22] The RF activated AIMD telemetry transceiver of claim 21 , wherein the antenna is disposed external of the hermetic package.
[Claim 23] The RF activated AIMD telemetry transceiver of claim 5, wherein the RF transmitter is associated with an AIMD programmer.
[Claim 24] The RF activated AIMD telemetry transceiver of claim 23, wherein the RF transmitter is disposed within or tethered to the AIMD programmer.
PCT/US2010/026548 2009-03-19 2010-03-08 Rf activated aimd telemetry transceiver WO2010107608A1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US12/407,402 2009-03-19
US12/407,402 US8195295B2 (en) 2008-03-20 2009-03-19 Shielded three-terminal flat-through EMI/energy dissipating filter
US12/566,223 2009-09-24
US12/566,223 US8253555B2 (en) 2006-01-25 2009-09-24 Miniature hermetically sealed RFID microelectronic chip connected to a biocompatible RFID antenna for use in conjunction with an AIMD

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