(12) United States Patent
`US 6,790,178 B1
`(10) Patent N0.:
`Mault et al.
`(45) Date of Patent:
`Sep. 14, 2004
`
`USOO6790178B1
`
`(54)
`
`(75)
`
`(73)
`
`( * )
`
`PHYSIOLOGICAL MONITOR AND
`ASSOCIATED COMPUTATION, DISPLAY
`AND COMMUNICATION UNIT
`
`Inventors: James R. Mault, Evergreen, CO (US);
`Noel Johnson, Saratoga, CA (US);
`John Sanderson, Bainbridge Island,
`WA (US)
`
`Assignee: Healthetech, Inc., Golden, CO (US)
`
`Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C, 154(b) by 278 days.
`
`(21)
`(22)
`
`Appl. N0.: 09/669,125
`Filed:
`Sep. 25, 2000
`
`(60)
`
`Related U.S. Application Data
`Provisional application No. 60/155,851, filed on Sep. 24,
`1999, provisional application No, 60/158,553, filed on Oct.
`8, 1999, provisional application No. 60/158,556, filed on
`Oct. 8, 1999, provisional application No. 60/158,554, filed
`on Oct. 8, 1999, provisional application No. 60/159,285,
`filed on Oct. 13, 1999, provisional application No. 60/165,
`166, filed on Nov. 12, 1999, provisional application No.
`60/165,988, filed on Nov. 17, 1999, provisional application
`No. 60/167,276, filed on Nov. 24, 1999, provisional appli—
`cation No. 60/177,011, filed on Jan. 19, 2000, provisional
`application No. 60/177,016, filed on Jan. 19, 2000, provi—
`sional application No. 60/177,009, filed on Jan. 19, 2000,
`provisional application No. 60/178,979, filed on Jan. 28,
`2000, provisional application No. 60/179,882, filed on Feb.
`2, 2000, provisional application No. 60/194,126, filed on
`Apr. 3, 2000, provisional application No. 60/201,902, filed
`on May 4, 2000, provisional application No. 60/195,779,
`filed on Apr. 10, 2000, provisional application No. 60/205,
`709, filed on May 19, 2000, provisional application No.
`60/206,905, filed on May 25, 2000, provisional application
`No. 60/207,089, filed on May 25, 2000, provisional appli
`cation No. 60/207,051, filed on May 25, 2000, provisional
`application No. 60/209,921, filed on Jun. 7, 2000, provie
`sional application No. 60/212,319, filed on Jun. 16, 2000,
`provisional application No. (30/219,069, filed on Jul. 18,
`2000, provisional application No. (50/219,070, filed on Jul.
`18, 2000, provisional application No. 60/224,651, filed on
`Aug. 11, 2000, provisional application No. (30/225,101, filed
`on Aug. 14, 2000, provisional application No. (30/225,454,
`filed on Aug. 15, 2000, provisional application No. 60/228,
`388, filed on Aug. 28, 2000, provisional application No.
`60/234,866, filed on Sep. 22, 2000, and provisional appli—
`cation No. 6U/234,154, filed on Sep. 21, 2000.
`
`Int. CI.7 .......................................... A61B 5/00
`(51)
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`....................... 600/300; 128/903; 128/920;
`(52) US. Cl.
`600/508
`(58) Field of Search ................................. 600/300—301,
`600/500—509, 549, 587—595, 128/903, 904,
`120; 374/100
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`(56)
`
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`DE
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`OTHER PUBLICATIONS
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`Medical Progress Through Technology, vol. 9, No. 1, 1982
`Berlin (D), pp. 27—32, R. Salminen et al., “Computerized
`Breath—By—Breath Analysis of Respiratory Variables During
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`
`(List continued on next page.)
`Primary Examiner—Max F. Hindenburg
`Assistant Examiner—Michael Astorino
`
`(74) Attorney, Agent, or Firm—Cooley Godward LIP
`(57)
`ABSTRACT
`
`Various physiological monitor modules are provided for use
`with computing devices such as personal digital assistants
`(PDAs). In some embodiments, the personal digital assistant
`provides the controls, display, and processing circuitry for
`the physiological monitor module. The personal digital
`assistant stores data from the physiological monitors so that
`the data may be used in various software applications. In
`other embodiments, the physiological monitor and the per—
`sonal digital assistant include accessory slots sized to accept
`memory modules Which may be used to transfer data ther—
`ebetween.
`In yet other embodiments,
`the physiological
`monitors include data storage but do not include onboard
`processing capability, and data is transferred to a personal
`digital assistant either during or after use of the physiologi-
`cal monitor.
`
`1 Claim, 15 Drawing Sheets
`
`
`
`UA-1007.001
`
`UA-1007.001
`
`

`

`US 6,790,178 B1
`Page 2
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`US, PATENT DOCUMENTS
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`3/’ 987 Raemer
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`UA-1007.002
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`UA-1007.002
`
`

`

`US 6,790,178 B1
`Page 3
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`
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`pp. 575—587, J. A, Bushman et al. “Closed Circuit Anaes-
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`:Kgrgtzd b} B7 A. Weissman et al, Plenum Press, Nevs York,
`PP~ ,
`~
`
`* cited by examiner
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`1
`PHYSIOLOGICAL MONITOR AND
`ASSOCIATED COMPUTATION, DISPLAY
`AND COMMUNICATION UNIT
`
`REFERENCE TO RELATED APPLICATIONS
`
`This application claims priority from US. provisional
`application Serial Nos. 60/155,851, filed Sep. 24, 1999;
`60/158,553, filed Oct. 8, 1999; 60/158,556, filed Oct. 8,
`1999; 60/158,554, filed Oct. 8, 1999; 60/159,285, filed Oct.
`13 1999; 60/165,166, filed Nov. 12, 1999; 60/165,988, filed
`Nov. 17, 1999; 60/167,276, filed Nov. 24, 1999; 60/177,011,
`filed Jan. 19, 2000; 60/177,016, filed Jan. 19, 2000; 60/177,
`009, filed Jan. 19, 2000; 60/178,979, filed Jan. 28, 2000;
`60/179,882, filed Feb. 2, 2000; 60/194,126, filed Apr. 3,
`2000; 60/201,902, filed May 4, 2000; 60/195,779, filed Apr.
`10, 2000; 60/205,709, filed May 19, 2000; 60/206,905, filed
`May 25, 2000; 60/207,089, filed May 25 , 2000; 60/207,051,
`filed May 25, 2000; 60/209,921, filed Jun. 7, 2000; 60/212,
`319, filed Jun. 16, 2000; 60/219,069, filed Jill. 18, 2000;
`60/219,070, filed Jul. 18, 2000; 60/224,651, filed Aug. 11,
`2000; 60/225,101, filed Aug. 14, 2000; 60/225,454, filed
`Aug. 15, 2000; 60/228,388, filed Aug. 28, 2000; 60/234,154;
`filed Sept. 21, 2000; and 60/234,866, filed Sep. 22, 2000, the
`entire contents of all of which are incorporated herein by
`reference.
`
`FIEI D OF THE INVENTION
`
`The present invention relates generally to physiological
`monitors and, more specifically, to physiological monitors
`that connect with and/or communicate with a hand-held
`computing device such as a personal digital assistant (PDA).
`
`BACKGROUND OF THE INVENTION
`
`Portable electronic computing devices have become
`increasingly common. These devices include personal digi-
`tal assistants (PDAs) such as organizers using the PALM®
`operating system and organizers using Windows® CE based
`operating systems. These devices also include other portable
`electronic devices that include a computing capability such
`as mobile telephones, electronic books, laptop and hand-
`held computers, some types of pagers, hand-held game
`platforms such as the Nintendo® Gameboy® and other
`devices.
`
`The prevalence of PDAs, and their broad acceptance by
`many of types of users, provides an opportunity to offer
`accessories to PDAs which may be used by this large
`installed base. Also, the PDAs can act as a general purpose
`computing device. In this capacity, the PDA may be inter-
`connected with a variety of accessories and provide the
`necessary computing, control and display functions for the
`accessory, thereby reducing the cost of the accessory as
`compared to a stand along device. As an example, digital
`camera modules are available which interconnect with the
`PDAs of several types. When the camera module is inter-
`connected with PDA, the PDA’s buttons and display serve
`to control and communicate the camera functions, thereby
`eliminating the need for controls or a display on the camera
`module itself. Also, the PDA’s internal computing capability
`is used, thereby avoiding the necessity of on—board comput—
`ing capability in the camera module. Consequently,
`the
`camera module is both smaller and less expensive than a
`stand-alone camera of similar capability.
`Physiological monitors of various types are used in the
`health and medical fields to monitor various physiological
`parameters of human patients. These physiological monitors
`
`2
`allow health and medical professionals, as well as individual
`users, to accurately determine the current status of particular
`physiological parameters and monitor those parameters over
`a period of time. This information is extremely helpful in
`health and fitness management and medical
`treatment.
`Traditionally, physiological monitors have been very
`expensive, and their use has therefore been primarily limited
`to medical facilities. As the cost of electronic equipment has
`fallen, lower cost physiological monitors have been used in
`the home.
`
`An example of a health related physiological monitor is
`the indirect calorimeter disclosed in co—pending US. patent
`application Ser. No. 09/630,398 to Mault et al,, which is
`incorporated herein in its entirety by reference. The indirect
`calorimeter allows a patient to determine their current meta-
`bolic rate by breathing through the calorimeter for a period
`of time. As explained in the application, this metabolic rate
`information is beneficial in weight and health management.
`Other types of physiological monitors include EKG
`monitors, electronic heart sound monitors, exercise monitors
`such as pedometers, body fat measurement devices, heart
`rate monitors, body temperature monitors, spirometers,
`blood pressure monitors, blood oxygenation monitors, and
`blood glucose monitors. Typically, physiological monitors
`are stand-alone devices including their own controls,
`displays, and,
`if necessary, computing capability.
`Consequently,
`these physiological monitors tend to be
`expensive and potentially bulky.
`Current physiological monitors typically do not commu-
`nicate with one another or with any type of central comput—
`ing device.
`If a health care professional or a patient
`measures, or monitors over time, numerous physiological
`parameters,
`it is typically necessary to record the output
`from each individual monitor and then to manually transfer
`the data to the patient’s medical record. This is laborious and
`introduces potential for error in recording and transferring
`the data. The process can be especially laborious where
`physiological parameters are monitored over long periods of
`time. For example, it is necessary for some diabetics to test
`their blood glucose level numerous times each day.
`Preferably,
`this data is recorded so that
`trends may be
`determined and shared with a physician or other health
`professional. However, a typical patient will get tired of
`constantly recording blood sugar levels and may therefore
`do a poor job.
`SUMMARY OF THE PRESENT INVENTION
`
`The present invention includes a variety of physiological
`monitor modules designed to interface with computing
`devices such as PDAs. In some embodiments, this combi-
`nation allows the PDA to take the place of some of the costly
`electronic controls, displays, and processing circuitry nor-
`mally embodied in a physiological monitor. Instead, the
`PDA provides these capabilities. Also, the PDA preferably
`stores testing data from one or more physiological monitor
`modules to allow the rise of data in health and fitness
`tracking as well as in a variety of software applications. In
`another embodiment of the present invention, the physi—
`ological monitor modules include storage means such as
`memory for storing data from one or more sensors. Either
`during or after the test, the data from the storage means is
`transferred to the PDA for processing, display, and storage.
`In another embodiment of the present invention, the PDA is
`of the type including an accessory slot for accepting mod-
`ules such as memory modules.
`In this embodiment,
`the
`physiological monitor module also includes an accessory
`slot for accepting a memory module. Memory modules are
`then used to transfer data between the physiological monitor
`and the PDA.
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`3
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1A is a perspective view of a calorimeter module
`according to the present invention (locked with a PDA;
`FIG. 1B is a perspective View of a calorimeter module and
`PDA of FIG. 1A with the PDA removed from the docking
`interface;
`FIG. 2 is a perspective view of a second embodiment of
`a calorimeter module wherein the docking interface is
`interconnected with the remainder of the module by a wire;
`FIG. 3 is a perspective view of a third embodiment of a
`calorimeter module along with a PDA wherein each utilize
`memory modules for transfer of data;
`FIG. 4 is a perspective view of the back side of a PDA
`sold under the brand Handspring Visor®;
`FIG. 5 is a perspective View of a PDA sold by Sony®;
`FIG. 6 is a side elevational view of a spirometer module
`and a PDA;
`FIG. 7 is a front view of a runner with a PDA strapped to
`his belt;
`FIG. 8 is a perspective view of a pedometer module
`according to the present invention along with a memory
`module;
`FIG. 9 is a front View of a portion of a runner with another
`embodiment of a pedometer module shown attached to the
`runner’s chest;
`FIG. 10 is a perspective view of a pedometer module
`supported in a support clip;
`FIG. 11 is a perspective view of a PDA docked with a
`EKG/heart sound module according to the present invention;
`FIG. 12 is a front view of a PDA showing an example of
`software used with the EKG/heart sound module;
`FIG. 13 is a perspective view of a PDA with a body fat
`measurement module interconnected therewith;
`FIG. 14 is an end view of the body fat measurement
`module of FIG. 13;
`FIG. 15 is a perspective view of another embodiment of
`a body fat measurement module docked with a PDA and
`shown grasped between the hands of a user;
`FIG. 16 is a front elevational view of the PDA and body
`fat measurement module of FIG. 15;
`FIG. 17 is a perspective view of a PDA with a pacifier-
`based body temperature module;
`FIG. 18 is a perspective view of a PDA with an ear canal
`body temperature measurement module according to the
`present invention;
`FIG. 19 is a perspective view of a PDA docked with a
`blood pressure measurement module according to the
`present invention;
`FIG. 20 is a perspective view of a PDA with a pulse
`oximeter module according to the present invention;
`FIG. 21 is a perspective view of a portion of a PDA with
`a blood glucose module docked therewith;
`FIG. 22 is a perspective View of an ultrasonic sensor
`module supported in an accessory clip;
`FIG. 23 is a perspective View of an ultrasonic sensor
`module;
`FIG. 24 is a cross—sectional View of a baby in a womb with
`a pair of ultrasonic sensors shown supported in support
`clips;
`FIG. 25 is a perspective view, partially exploded, showing
`a portion of a PDA, an adapter, and a physiological monitor
`module;
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`FIG. 26 is a perspective view of a PDA docked with a
`food scale module;
`FIG. 27 is a perspective view of the PDA and module of
`FIG. 26 in a use position;
`FIG. 28 is a perspective view of an alternative embodi-
`ment of a food scale module according to the present
`invention along with a PDA; and
`FIG. 29 is a perspective view of a body weight scale
`module according to the present invention.
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`
`General
`
`This invention relates to a physiological monitor for use
`in measuring a health characteristic of a user, such as
`metabolism, weight, body fat percentage, heart rate, EKG,
`blood pressure, blood oxygenation, body temperature or the
`like, and an associated computing device which acts to
`receive, record, process, compute, display and/or transmit
`signals from the monitor. The computing device may take
`any form, including portable computers such as personal
`digital assistances (PDAs) as well as non—portable comput—
`ers. The portable computer category includes all portable
`devices with onboard computing capability, such as cellular
`telephones, electronic books, pagers, watches, and organiz-
`ers. Also included are currently available, as well as yet to
`be developed, wearable computing devices such as may take
`the form of jewelry, buttons, and eyeglasses. The FDA need
`not be a unitary device, but instead the components could be
`distributed. As one example, the display could be incorpo—
`rated in eyeglasses while the remainder is incorporated into
`a wristwatch. For ease of reference, the present application
`will refer primarily to PDAs, though all other computing
`devices may be used as well. The term “general purpose
`personnel digital assistant” will also be used herein. This
`refers to a PDA capable of running a variety of software that
`may be loaded into memory. This category excludes dedi-
`cated devices and non-programmable devices,
`According to a first preferred embodiment of the present
`invention, the physiological monitor is a module designed to
`interconnect with a PDA, such as by docking with the PDA.
`The PDA is preferably of the type adapted to receive a
`variety of plug-in modules, each of which may provide the
`PDA with a particular application program. Alternatively,
`the application software may be stored in the memory of the
`PDA, or in other ways. The physiological monitor modules
`used with the present invention also incorporate connections
`to the sensors forming part of the physiological monitor, and
`may include electronics that act as an interface between the
`sensors of the physiological monitor and the PDA. In this
`embodiment, when the PDA and monitor module are
`docked, they form an integral unit. The module may insert
`into an accessory slot in the PDA, or grip its housing, or
`interconnect in any other way.
`Preferably, when the monitor module is docked with the
`PDA, the PDA recognizes the module and loads the software
`either from its own memory or from the module. As known
`to those of skill in the art, recognition of the module by the
`PDA may take several forms. The module may have a code
`either temporarily or permanently stored in its memory.
`Plugging the module into the PDA causes the code to be
`transferred to the PDA where the code may be interpreted to
`identify the module and/or the user. As another alternative,
`the PDA may include bar code scanning capability and the
`module may include a bar code that may be scanned prior to
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`inserting the module. When the monitor module is not in
`use,
`the PDA may be removed and used for alternative
`purposes, possibly with other modules.
`During use of the monitor module, the PDA may display
`instructions for use. If the PDA and module combination
`includes voice generation capability, either as part of the
`PDA itself, as part of the module itself, or as an additional
`accessory, voice commands may be generated to instruct the
`user on proper use of the monitor module and/or to provide
`feedback and results. If voice recording or recognition is
`available in the combination, this capability may be used to
`control the module and/0r annotate results. Voice recogni-
`tion and generation capability may be provided as an addi-
`tional accessory for the PDA or monitor module or the
`monitor module may include these capabilities. Voice rec-
`ognition modules are more completely described in
`co-pending provisional patent application Ser. No. 60/212,
`319, which is incorporated herein in its entirety.
`The physiological monitor module may dispense with
`controls, memory, processing, and/or a display,
`instead
`relying on the PDA to provide these functions. In this case,
`it may be necessary to first dock the PDA with the monitor
`module in order to use the monitor. Alternatively, the physi-
`ological monitor may be operational without being inter-
`connected or in communication with a PDA. Instead, the r,
`physiological monitor measures one or more physiological
`parameters and stores the resulting data to memory.
`Optionally, the monitor may have onboard data processing
`and/or display. At a later time, the physiological monitor
`may be interconnected with, or ot