(12) United States Patent
`Lebel et al.
`
`111111
`
`1111111111111111111111111111111111111111111111111111111111111
`US006811533B2
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 6,811,533 B2
`Nov. 2, 2004
`
`(54) AMBULATORY MEDICAL APPARATUS AND
`METHOD USING A ROBUST
`COMMUNICATION PROTOCOL
`
`(75)
`
`Inventors: Ronald J. Lebel, Sherman Oaks, CA
`(US); Varaz Shahmirian, Northridge,
`CA (US); Sam W. Bowman, IV,
`Valencia, CA (US); Timothy J.
`Starkweather, Simi Valley, CA (US);
`Philip T. Weiss, Pasadena, CA (US);
`Robert C. Dennard, Lancaster, CA
`(US); John T. Armstrong, Pasadena,
`CA (US); John D. Richert, La Habra
`Heights, CA (US)
`
`(73) Assignee: Medtronic Minimed, Inc., Northridge,
`CA(US)
`
`( *) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 482 days.
`
`(21) Appl. No.: 09/768,035
`
`(22) Filed:
`
`Jan.22,2001
`
`(65)
`
`Prior Publication Data
`
`US 2002/0173702 A1 Nov. 21, 2002
`
`Related U.S. Application Data
`(60) Provisional application No. 60/177,414, filed on Jan. 21,
`2000.
`
`Int. Cl? ............................ A61B 5/00; GOSB 23/00
`(51)
`(52) U.S. Cl. ..................................... 600/300; 340/573.1
`(58) Field of Search ....................... 600/300; 340/573.1,
`340/573.2, 573.3, 573.4; 434/258; 604/131,
`132
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`3,910,257 A * 10/1975 Fletcher et a!. ............. 600/483
`
`4,399,821 A *
`4,854,328 A *
`5,127,404 A
`5,191,326 A
`
`8/1983 Bowers ...................... 600/301
`8/1989 Pollack ....................... 600/549
`7/1992 Wyborny eta!.
`3/1993 Montgomery
`
`(List continued on next page.)
`
`FOREIGN PATENT DOCUMENTS
`
`EP
`wo
`wo
`wo
`
`0 346 783
`wo 95/02426
`wo 96/03168
`wo 97/18639
`
`6/1989
`1!1995
`2/1996
`5/1997
`
`OTHER PUBLICATIONS
`
`PCT International Search Report as issued in International
`Application No. PCT/USOl/23003, Mailing Date Jul. 3,
`2002.
`
`(List continued on next page.)
`
`Primary Examiner-Daniel Robinson
`(74) Attorney, Agent, or Firm-Foley & Lardner LLP
`
`(57)
`
`ABSTRACT
`
`An implanted medical device (e.g. infusion pump) and
`external device communicate with one another via telemetry
`wherein messages are transmitted under a robust communi(cid:173)
`cation protocol. The communication protocol gives
`enhanced assurance concerning the integrity of messages
`that impact medical operations of the implantable device.
`Messages are transmitted using a multipart format that
`includes a preamble, a frame sync, a telemetry ID, data, and
`a validation code. The data portion of the message includes
`an op-code that dictates various other elements that form
`part of the message. The data portion may also include
`additional elements such as sequence numbers, bolus
`numbers, and duplicate data elements. A telemetry ID for the
`transmitting device may be implicitly embedded in the
`message as part of the validation code that is sent with the
`message and that must be pre-known by the receiver to
`confirm the integrity of the received message.
`
`38 Claims, 3 Drawing Sheets
`
`31
`I
`EXTERNALSUBSYSTEM 34
`SUBSYSTEM
`
`1
`I
`IMPLANTABLE
`IMPLANT UNIT
`
`l---94
`IRCOMMUNICATION
`SIGNALS ~
`
`1·2
`
`001
`
`

`
`US 6,811,533 B2
`Page 2
`
`U.S. PATENT DOCUMENTS
`
`5,368,562 A
`11/1994 Blomquist et a!.
`5,416,695 A
`5/1995 Stutman et a!.
`5,438,621 A
`8/1995 Hornak eta!.
`5,456,692 A
`10/1995 Smith eta!.
`5,630,710 A
`5/1997 Tune eta!.
`5,647,854 A
`7/1997 Olsen eta!.
`5,658,133 A
`8/1997 Anderson et a!.
`5,658,250 A
`8/1997 Blomquist et a!.
`5,659,299 A
`8/1997 Williamson et a!.
`5,669,877 A
`9/1997 Blomquist
`5,695,473 A
`12/1997 Olsen
`5,718,234 A
`2/1998 Warden eta!.
`5,752,976 A * 5/1998 Duffin eta!. ................. 607/32
`5,788,669 A
`8/1998 Peterson
`5,791,344 A * 8/1998 Schulman et a!.
`5,810,771 A
`9/1998 Blomquist
`
`.......... 600/347
`
`5,876,370 A
`5,935,099 A
`5,935,106 A
`6,024,539 A
`6,026,124 A
`6,123,686 A
`6,208,894 B1 *
`6,364,834 B1 *
`6,554,798 B1 *
`6,577,893 B1 *
`
`3/1999 Blomquist
`8/1999 Peterson et a!.
`8/1999 Olsen
`2/2000 Blomquist
`2/2000 Lee et a!.
`9/2000 Olsen et a!.
`. . . . . . . . . . . . . 607/2
`3/2001 Schulman et a!.
`4/2002 Reuss et a!. . . . . . . . . . . . . . . . . 600/300
`4/2003 Mann et a!.
`................ 604/131
`6/2003 Besson et a!.
`.............. 600!509
`
`OTHER PUBLICATIONS
`
`PCT International Search Report as issued in International
`Application No. PCT/USOl/22926, Mailing Date Jul. 8,
`2002.
`
`* cited by examiner
`
`002
`
`

`
`U.s. Patent
`
`Nov. 2, 2004
`
`Sheet 1 of 3
`
`US 6,811,533 B2
`
`2 I
`
`12
`
`8
`
`FIG. lA
`
`16
`
`2 I
`
`FIG. lB
`
`14
`
`003
`
`

`
`U.S. Patent
`
`Nov. 2, 2004
`
`Sheet 2 of 3
`
`US 6,811,533 B2
`
`32
`
`36
`
`12:03 1m <1£ ® 'R" n 2
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`PPC
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`38
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`38b 38c 38d 38e
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`F\G. 2
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`
`

`
`U.S. Patent
`
`Nov. 2, 2004
`
`Sheet 3 of 3
`
`US 6,811,533 B2
`
`~ 38
`
`KEYPAD
`
`ALARM
`
`32
`I
`EXTERNAL SUBSYSTEM 34
`SUBSYSTEM
`I
`l PROCESSING ELECTRONICS ~
`r- 42
`. 4 LCD DISPLAY ~
`~ 36
`y
`r-
`y
`r- 44
`~
`RF
`METRY ,./B2
`~ VIBRATOR
`TELE
`SYST
`EM
`./ 12
`r- 52
`1'.:"
`: MAIN BATIERY ~
`~-54 ..... (
`
`2
`I
`IMPLANTABLE
`IMPLANT UNIT
`
`6
`
`BATIERY
`
`TELEMETRY
`SYSTEM
`
`ALARM
`
`86
`
`14
`
`16
`
`2-2
`
`BACKUP
`
`92 84
`
`BATTERY w
`
`TELEMETRY
`SYSTEM
`
`) .-56
`
`I
`I
`
`IRDA 1!0 r ..-58
`
`f\
`r~
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`.......l
`IR COMMUNICATION ~ 94
`SIGNALS
`~
`
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`FIG. 3
`
`005
`
`

`
`US 6,811,533 B2
`
`1
`AMBULATORY MEDICAL APPARATUS AND
`METHOD USING A ROBUST
`COMMUNICATION PROTOCOL
`
`RELATED APPLICATIONS
`
`This application claims the benefit of prior filed U.S.
`Provisional Patent Application No. 60/177,414; filed Jan.
`21, 2000, by Ronald J. Lebel, et al., and entitled "Medical
`Apparatus and Method Including an Implantable Device and
`an External Communication Device". The entirety of this
`provisional application is hereby incorporated herein by this
`reference, including appendices filed therewith and any
`references incorporated therein by reference, as if set forth
`in full herein.
`
`FIELD OF THE DISCLOSURE
`
`This invention relates generally to ambulatory medical
`systems that include a medical device and a control device
`that communicate via telemetry and more particularly to
`devices that exchange messages using a robust telemetry
`protocol. Preferred embodiments relate to implantable infu(cid:173)
`sian pumps and external devices for communicating there(cid:173)
`with.
`
`BACKGROUND
`
`2
`For example, implantable infusion pumps are generally
`configured to accept infusion commands from an external
`communication device via an RF telemetry system, or the
`like. These commands may be used, inter alia, to set program
`5 variables that are in turn used in defining the quantity and/or
`timing that is used in supplying a drug to the patient. As the
`dispensing of appropriate amounts of the drug may be
`critical to the patient's well being, it is desirable that a
`reliable and trustworthy communication channel exist
`between the external communication device and the
`10 implantable device so that messages from the external
`communication device requesting drug delivery are received
`with integrity, confirmation of accurate reception acknowl(cid:173)
`edged in a rapid manner, and minimal electric power con(cid:173)
`sumption occurring in the entire process of listening for a
`15 message, receiving the message, and transmitting a response
`to the message that is appropriately received by the external
`communication device.
`Implantable medical devices typically operate by battery
`power. The batteries may or may not be rechargeable.
`20 Higher consumption of power from an implantable medical
`device containing non-rechargeable batteries leads to a
`shortening of the usable life of the device and an associated
`increased frequency of surgery, potential pain, recovery, and
`inconvenience. Higher consumption of power from an
`25 implantable medical device containing rechargeable batter(cid:173)
`ies leads to more frequent charging periods for the batteries
`and associated inconvenience and may lead to an overall
`shortening of the usable life of the device. As such, whether
`or not an implantable medical device contains rechargeable
`30 batteries or non-rechargeable batteries, it is desirable to
`lower the power consumption of the device. As telemetry
`reception and transmission are highly energy consumptive,
`it is desirable to minimize the operation time of telemetry
`reception and transmission modules. As such it is desirable
`to ensure that message length is kept to a minimum and that
`repeated transmissions and attempted receptions of pre vi-
`ously sent but unsuccessfully received messages be kept to
`a m1mmum.
`A need exists in the field for improved telemetry features/
`elements that tend to optimize each of the above noted
`attributes individually, with out consideration of the impact
`on other attributes, or tend to simultaneously optimize
`groups of selected attributes, or tend to provide a balance
`between various ones of the attributes.
`
`Various ambulatory medical devices have been proposed
`and a number of such devices are commercially available.
`These devices include, for example, implantable infusion
`pumps, externally carried infusion pumps, implantable
`pacemakers, implantable defibrillators, implantable neural
`stimulators, implantable physiological sensors, externally
`carried physiologic sensors, and the like.
`Numerous electronic devices exist that communicate with 35
`one another using electromagnetic radiation of various
`wavelengths and of various formats. These electronic
`devices can act as sources of interference that can negatively
`impact other devices that also need to communicate via
`telemetry. This is particularly true when other devices 40
`attempt to communicate using small signal strengths that are
`typically associated with the limited power that is available
`to ambulatory medical devices and most particular to ambu(cid:173)
`latory devices that are implanted within the body of a
`patient.
`As appropriate operation of medical devices may be
`critical to those patients being treated using those devices,
`and as telemetry communications between medical devices
`and external controllers can greatly enhance the convenience
`of using such devices, or even be an enabling necessity to the 50
`use of such devices (e.g. implantable devices with sophis(cid:173)
`ticated functionality), the operation of such medical devices
`can benefit significantly by use of telemetry systems and
`protocols that have features/elements that lead to optimiza(cid:173)
`tion of various attributes. Attributes of interest may vary 55
`with circumstance but some attributes of general interest
`include (1) flexibility in communicating the wide variety
`signals that may be useful to controlling and retrieving
`information from a sophisticated medical device, (2) robust(cid:173)
`ness in distinguishing actual signals from noise, (3) robust- 60
`ness in distinguishing valid signals from corrupt signals, ( 4)
`robustness in ascertaining when appropriate communication
`has occurred and when additional communication must be
`attempted, (5) a reasonable efficiency in communication
`time, and/or ( 6) a reasonable efficiency in electrical power 65
`consumption associated with conveying information over
`the telemetry system.
`
`45
`
`SUMMARY OF THE INVENTION
`It is a first object of certain aspects of the invention to
`enhance the ability to communicate a wide variety signals
`that are useful in controlling and retrieving information from
`an ambulatory medical device.
`It is a second object of certain aspects of the invention to
`enhance the robustness of distinguishing actual signals from
`when receiving telemetry communications in an ambulatory
`medical system.
`It is a third object of certain aspects of the invention to
`enhance the robustness of distinguishing valid signals cor(cid:173)
`rupt signals when receiving telemetry communications in an
`ambulatory medical system.
`It is a fourth object of certain aspects of the invention to
`enhance the robustness of ascertaining when appropriate
`communication has occurred and when additional commu(cid:173)
`nication must be attempted in an ambulatory medical sys(cid:173)
`tem.
`It is a fifth object of certain aspects of the invention to
`decrease the time that is spent in transmitting and receiving
`messages using a telemetry system in an ambulatory medical
`system.
`
`006
`
`

`
`US 6,811,533 B2
`
`3
`It is a sixth object of certain aspects of the invention to
`decrease the electrical power consumption associated with
`conveying a given amount of information via telemetry in an
`ambulatory medical system.
`Other objects and advantages of various aspects of the 5
`invention will be apparent to those of skill in the art upon
`review of the teachings herein. The various aspects of the
`invention set forth below as well as other aspects of the
`invention not specifically set forth below but ascertained
`from the teachings found herein, may address the above
`noted objects or other objects ascertained from the teachings
`herein individually or in various combinations. As such, it is
`intended that each aspect of the invention address at least
`one of the above noted objects or address some other object
`that will be apparent to one of skill in the art from a review
`of the teachings herein. It is not intended that all, or even a
`portion of these objects, necessarily be addressed by any
`single aspect of the invention even though that may be the
`case with regard to some aspects.
`A first aspect of the invention provides a medical system
`that includes (a) an ambulatory medical device (MD) that
`includes MD electronic control circuitry that further
`includes at least one MD telemetry system and at least one
`MD processor that controls, at least in part, operation of the
`MD telemetry system and operation of the medical device,
`wherein the medical device is configured to provide a
`treatment to a body of a patient or to monitor a selected state
`of the body; and (b) a communication device (CD) that
`includes CD electronic control circuitry that further includes
`at least one CD telemetry system and at least one CD
`processor that controls, at least in part, operation of the CD
`telemetry system and operation of the communication
`device, wherein the CD telemetry system sends messages to
`or receives messages from the MD telemetry system,
`wherein at least a portion of the messages transmitted
`between the communication device and the medical device
`are transmitted using a message structure that includes a
`preamble, a telemetry identifier, and data.
`In a specific variation of the first aspect of the invention, 40
`the CD telemetry system sends messages to the MD telem(cid:173)
`etry system using a message structure that comprises: (1) an
`MD preamble, (2) an MD telemetry identifier, (3) MD data
`including an op-code, and ( 4) an MD validation code.
`In another specific variation of the first aspect of the
`invention, the MD telemetry system sends messages to the
`CD telemetry system using a message structure that com(cid:173)
`prises: (1) a CD preamble, (2) a CD telemetry identifier, (3)
`CD data including a CD op-code, and (4) a CD validation
`code.
`A second aspect of the invention provides a medical
`system that includes (a) an ambulatory medical device (MD)
`that includes MD electronic control circuitry that further
`includes at least one MD telemetry system and at least one
`MD processor that controls, at least in part, operation of the
`MD telemetry system and operation of the medical device,
`wherein the medical device is configured to provide a
`treatment to a body of a patient or to monitor a selected state
`of the body; and (b) a communication device (CD) that
`includes CD electronic control circuitry that further includes
`at least one CD telemetry system and at least one CD
`processor that controls, at least in part, operation of the CD
`telemetry system and operation of the communication
`device, wherein the CD telemetry system sends messages to
`or receives messages from the MD telemetry system,
`wherein at least a portion of the messages sent between the
`communication device and the medical device are directed
`
`4
`to specific medical device, or a specific communication
`device, by inclusion of an MD identifier that identifies the
`medical device or a CD identifier that identifies the com(cid:173)
`munication device.
`A third aspect of the invention provides a medical system
`that includes (a) an ambulatory medical device (MD) that
`includes MD electronic control circuitry that further
`includes at least one MD telemetry system and at least one
`MD processor that controls, at least in part, operation of the
`10 MD telemetry system and operation of the medical device,
`wherein the medical device is configured to provide a
`treatment to a body of a patient or to monitor a selected state
`of the body; and (b) a communication device (CD) that
`includes CD electronic control circuitry that further includes
`15 at least one CD telemetry system and at least one CD
`processor that controls, at least in part, operation of the CD
`telemetry system and operation of the communication
`device, wherein the CD telemetry system sends messages to
`or receives messages from the MD telemetry system,
`20 wherein the integrity of at least a portion of a message
`passed between the communication device and medical
`device is confirmed by analysis of a predefined interrelation
`between at least two portions of the message.
`A fourth aspect of the invention provides a medical
`25 system that includes (a) an ambulatory medical device (MD)
`that includes MD electronic control circuitry that further
`includes at least one MD telemetry system and at least one
`MD processor that controls, at least in part, operation of the
`MD telemetry system and operation of the medical device,
`30 wherein the medical device is configured to provide a
`treatment to a body of a patient or to monitor a selected state
`of the body; and (b) a communication device (CD) that
`includes CD electronic control circuitry that further includes
`at least one CD telemetry system and at least one CD
`35 processor that controls, at least in part, operation of the CD
`telemetry system and operation of the communication
`device, wherein the CD telemetry system sends messages to
`or receives messages from the MD telemetry system,
`wherein at least one of the medical device or the commu(cid:173)
`nication device acts as a sender to transmit a message to the
`other of the communication device or the medical device,
`which is the intended receiver of the message, wherein the
`message is sent with a validation code that is derived in part
`from the content of the message and in part from other
`45 information not explicitly transmitted in the message, and
`wherein the other information is known in advance by the
`receiver and is used by the receiver in determining that the
`message was received without error.
`A fifth aspect of the invention provides a medical system
`50 that includes (a) an ambulatory medical device (MD) that
`includes MD electronic control circuitry that further
`includes at least one MD telemetry system and at least one
`MD processor that controls, at least in part, operation of the
`MD telemetry system and operation of the medical device,
`55 wherein the medical device is configured to provide a
`treatment to a body of a patient or to monitor a selected state
`of the body; and (b) a communication device (CD) that
`includes CD electronic control circuitry that further includes
`at least one CD telemetry system and at least one CD
`60 processor that controls, at least in part, operation of the CD
`telemetry system and operation of the communication
`device, wherein the CD telemetry system sends messages to
`or receives messages from the MD telemetry system,
`wherein a message is sent using one of a predefined plurality
`65 of preambles.
`A sixth aspect of the invention provides a medical system
`that includes (a) an ambulatory medical device (MD) that
`
`007
`
`

`
`US 6,811,533 B2
`
`5
`includes MD electronic control circuitry that further
`includes at least one MD telemetry system and at least one
`MD processor that controls, at least in part, operation of the
`MD telemetry system and operation of the medical device,
`wherein the medical device is configured to provide a
`treatment to a body of a patient or to monitor a selected state
`of the body; and (b) a communication device (CD) that
`includes CD electronic control circuitry that further includes
`at least one CD telemetry system and at least one CD
`processor that controls, at least in part, operation of the CD 10
`telemetry system and operation of the communication
`device, wherein the CD telemetry system sends messages to
`or receives messages from the MD telemetry system,
`wherein the communication device has a CD telemetry
`identifier and the medical device has a MD telemetry
`identifier wherein the length of the CD telemetry and MD
`telemetry identifiers are different.
`A seventh aspect of the invention provides a medical
`system that includes (a) an ambulatory medical device (MD)
`that includes MD electronic control circuitry that further
`includes at least one MD telemetry system and at least one
`MD processor that controls, at least in part, operation of the
`MD telemetry system and operation of the medical device,
`wherein the medical device is configured to provide a
`treatment to a body of a patient or to monitor a selected state
`of the body; and (b) a communication device (CD) that
`includes CD electronic control circuitry that further includes
`at least one CD telemetry system and at least one CD
`processor that controls, at least in part, operation of the CD
`telemetry system and operation of the communication 30
`device, wherein the CD telemetry system sends messages to
`or receives messages from the MD telemetry system,
`wherein the MD telemetry system is configured to perform
`a bit pattern recognition that allows a selected level of fault
`tolerance in concluding that a selected portion of a message 35
`matches an expected pattern to be received.
`A eighth aspect of the invention provides a medical
`system that includes (a) an ambulatory medical device (MD)
`that includes MD electronic control circuitry that further
`includes at least one MD telemetry system and at least one 40
`MD processor that controls, at least in part, operation of the
`MD telemetry system and operation of the medical device,
`wherein the medical device is configured to provide a
`treatment to a body of a patient or to monitor a selected state
`of the body; and (b) a communication device (CD) that 45
`includes CD electronic control circuitry that further includes
`at least one CD telemetry system and at least one CD
`processor that controls, at least in part, operation of the CD
`telemetry system and operation of the communication
`device, wherein the CD telemetry system sends messages to 50
`or receives messages from the MD telemetry system,
`wherein at least one of the MD telemetry system or the CD
`telemetry system is configured to establish bit synchroniza(cid:173)
`tion using bit information transmitted in a preamble portion
`of a message and uses a different pattern to establish 55
`synchronization for groups of bits.
`An ninth aspect of the invention provides a medical
`system that includes (a) an ambulatory medical device (MD)
`that includes MD electronic control circuitry that further
`includes at least one MD telemetry system and at least one 60
`MD processor that controls, at least in part, operation of the
`MD telemetry system and operation of the medical device,
`wherein the medical device is configured to provide a
`treatment to a body of a patient or to monitor a selected state
`of the body; and (b) a communication device (CD) that 65
`includes CD electronic control circuitry that further includes
`at least one CD telemetry system and at least one CD
`
`6
`processor that controls, at least in part, operation of the CD
`telemetry system and operation of the communication
`device, wherein the CD telemetry system sends messages to
`or receives messages from the MD telemetry system,
`5 wherein at least one of the MD telemetry system or the CD
`telemetry system is configured to establish frame synchro(cid:173)
`nization and to confirm that a message is intended specifi(cid:173)
`cally for the medical device or the communication device,
`respectively, by confirming receipt of a predefined identifier.
`An tenth aspect of the invention provides a medical
`system that includes (a) an ambulatory medical device (MD)
`that includes MD electronic control circuitry that further
`includes at least one MD telemetry system and at least one
`MD processor that controls, at least in part, operation of the
`15 MD telemetry system and operation of the medical device,
`wherein the medical device is configured to provide a
`treatment to a body of a patient or to monitor a selected state
`of the body; and (b) a communication device (CD) that
`includes CD electronic control circuitry that further includes
`20 at least one CD telemetry system and at least one CD
`processor that controls, at least in part, operation of the CD
`telemetry system and operation of the communication
`device, wherein the CD telemetry system sends messages to
`or receives messages from the MD telemetry system,
`25 wherein selected messages sent between the MD telemetry
`system and the CD telemetry system comprise character
`patterns that are incremented in relationship to correspond(cid:173)
`ing character patterns included in one or more previous
`messages.
`In a specific variation of the tenth aspect of the invention,
`the character patterns are sequence numbers that are varied
`between first and second messages that are varied within a
`receiver when they are successfully received and varied
`within a transmitter when the transmitter receives confirma-
`tion that the message was successfully received.
`A eleventh aspect of the invention provides a medical
`system that includes (a) an ambulatory medical device (MD)
`that includes MD electronic control circuitry that further
`includes at least one MD telemetry system and at least one
`MD processor that controls, at least in part, operation of the
`MD telemetry system and operation of the medical device,
`wherein the medical device is configured to provide a
`treatment to a body of a patient or to monitor a selected state
`of the body; and (b) a communication device (CD) that
`includes CD electronic control circuitry that further includes
`at least one CD telemetry system and at least one CD
`processor that controls, at least in part, operation of the CD
`telemetry system and operation of the communication
`device, wherein the CD telemetry system sends messages to
`or receives messages from the MD telemetry system,
`wherein the communication device requires pre-knowledge
`of a telemetry identifier for the medical device prior to
`sending any messages to the medical device that can be used
`by the medical device to significantly modify the medical
`functioning of the medical device, or wherein the medical
`device requires pre-knowledge of a telemetry identifier for
`the communication device prior to the medical device
`accepting any messages from the communication device that
`can be used by the medical device to significantly modify the
`medical functioning of the medical device.
`A twelfth aspect of the invention provides a medical
`system that includes (a) an ambulatory medical device (MD)
`that includes MD electronic control circuitry that further
`includes at least one MD telemetry system and at least one
`MD processor that controls, at least in part, operation of the
`MD telemetry system and operation of the medical device,
`wherein the medical device is configured to provide a
`
`008
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`

`
`US 6,811,533 B2
`
`7
`treatment to a body of a patient or to monitor a selected state
`of the body; (b) a communication device (CD) that includes
`CD electronic control circuitry that further includes at least
`one CD telemetry system and at least one CD processor that
`controls, at least in part, operation of the CD telemetry 5
`system and operation of the communication device, wherein
`the CD telemetry system sends messages to or receives
`messages from the MD telemetry system; and (c) a second
`device (SD) including at least one infrared SD communica(cid:173)
`tion system, wherein the and CD telemetry system and the 10
`MD telemetry system are RF telemetry systems, and
`wherein the communication device further comprises an
`infrared CD communication system for sending messages to
`or receiving messages from the SD communication system.
`A thirteenth aspect of the invention provides a medical 15
`system that includes (a) an ambulatory medical device (MD)
`that includes MD electronic control circuitry that further
`includes at least one MD telemetry system and at least one
`MD processor that controls, at least in part, operation of the
`MD telemetry system and operation of the medical device, 20
`wherein the medical device is configured to provide a
`treatment to a body of a patient or to monitor a selected state
`of the body; (b) a communication device (CD) that includes
`CD electronic control circuitry that further includes at least
`one CD telemetry system and at least one CD processor that 25
`controls, at least in part, operation of the CD telemetry
`system and operation of the communication device, wherein
`the CD telemetry system sends messages to or receives
`messages from the MD telemetry system, wherein a mes(cid:173)
`sage is sent by the communication device to the medical 30
`device using a first frame synchronization pattern and
`wherein a message sent by the medical device to the
`communication device is sent with a second frame synchro(cid:173)
`nization pattern which is different from the first pattern.
`Additional specific variations, provide the medical 35
`devices of each of the above aspects and above noted
`variations as implantable devices such as implantable infu(cid:173)
`sian pumps, implantable physiological sensors, implantable
`stimulators, and the like, or external devices such as sub(cid:173)
`cutaneous delivery infusion pumps or sensors that ascertain 40
`a physiological parameter or parameters from subcutaneous
`tissue or from the skin of the patient. Such infusion pumps
`may dispense insulin, analgesics, neurological drugs, drugs
`for treating AIDS, drugs for treating chronic ailments or
`acute ailments. Sensors may be used to detect various 45
`physiological parameters such as hormone levels, insulin,
`pH, oxygen, other blood chemical constituent levels, and the
`like. The sensor may be of the electrochemical type, optical
`type, and may or may not be enzymatic in operation.
`In even further variations of the above noted aspects, and 50
`above noted variations, one or more of the following is
`provided: (1) a first portion of the MD telemetry system is
`incorporated into the MD processor and a second portion of
`the MD telemetry system is external to the MD processor,
`(2) a first portion of the CD telemetry system is incorporated 55
`into the CD processor and a second portion of the CD
`telemetry system is external to the CD processor, (3) the MD
`processor includes an MD central processing unit and at
`least one other MD functional module, (4) the CD processor
`includes a CD central processing unit and at least one other 60
`CD functional module, (5) the MD electronic control cir(cid:173)
`cuitry includes at least one external MD functional module,
`other than a portion of the MD telemetry system, that is
`external to the MD processor, or ( 6) the CD electronic
`control circuitry includes at least one external CD functional 65
`module, other than a portion of the CD telemetry system,
`that is external to the CD processor.
`
`8
`Still additional aspects of the invention set forth method
`counterparts to the above system aspects as well as to other
`functional associations and relationships, and processes that
`have not been specifically set forth above but will be
`understood by those of skill in the art from a review of the
`teachings provided herein.
`Further aspects of the invention will be understood by
`those of skill in the art upon reviewing the teachings herein.
`These other aspects of the invention may provide various
`combinations of the aspects presented above as well as
`provide other configurations, structures, functional
`relationships, and processes that have not been specifically
`set forth above.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`The above referred to objects and aspects of the