`
`1111111111111101111111111111111911,1101!!!!!1111111111111111111111110111111
`
`(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2006/0084848 Al
`Apr. 20, 2006
`Mitchnick
`(43) Pub. Date:
`
`(54) APPARATUS AND METHODS FOR
`MONITORING SUBJECTS
`
`(52) U.S. Cl.
`
`600/301; 600/549; 128/903;
`600/595; 600/591; 600/573
`
`(76)
`
`Inventor: Mark Mitchnick, East Hampton, NY
`(US)
`
`(57)
`
`ABSTRACT
`
`Correspondence Address:
`Dwight H. Renfrew, Esq.
`Ohlandt, Greeley, Ruggiero & Perle, L.L.P.
`10th Floor
`One Landmark Square
`Stamford, CT 06901-2682 (US)
`
`(21) Appl. No.:
`
`10/965,010
`
`(22) Filed:
`
`Oct. 14, 2004
`
`Publication Classification
`
`(51) Int. Cl.
`A61B 5/00
`A61B 5/103
`
`(2006.01)
`(2006.01)
`
`This invention provides a device, and method and system for
`its use, for monitoring participants in clinical trials so that
`participant self-reporting, which is known to be notoriously
`inaccurate, can be minimized or eliminated. In preferred
`embodiments, the device is self-contained and self-powered,
`resides on or in a body cavity of the participant, collects data
`monitoring medically relevant aspects of the participant's
`behavior and of the local device environment, and stores
`data in a memory on-board the device. An accompanying
`external station reads stored data and prepares it for use.
`Devices may include electrically-active sensors and non-
`electrical active sampling sensors. A preferred embodiment
`of the device is in clinical trials of microbicides inhibiting
`transmission of the HIV virus.
`
`110
`
`128
`
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`114—,
`
`130
`
`124
`
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`

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`OTHER SENSORS
`OTHER SENSORS
`(AND "ANTENNA") 9
`(AND "ANTENNA＇”）气 9
`
`1 (HOUSING)
`1 (HOUSING)
`
`5 (HOUSING
`13 (BATTERIES) DIAMETER)
`\
`
`\
`
`\
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`/ ,
`3 (INSIDE
`3 (INSIDE
`DIAMETER)
`DIAMETER)
`
`CAVITY - 23
`
`23 ( ICs)
`
`25 (PASSIVE
`COMPONENTS)
`
`/
`
`11 (FLEXIBLE PCB)
`
`21 (SENSOR
`21 (SENS。R
`PORTS/PORES)
`PORTS/PORES)
`
`19 (SAMPLING
`19 (SAMPLING
`SENSOR)
`SENSOR)
`
`7
`7
`(ACCELEROMETER)
`(ACCELEROMETER)
`
`/
`
`17 (EXTERNAL
`17 (EXTERNAL
`CONTACTS)
`CONTACTS)
`
`se
`
`) 15 (FLEXIBLE
`
`15 (FLEXIBLE
`CONNECTOR)
`CONNECTOR)
`
`FIG. 1
`FIG.
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`EXTERNAL
`INTERFACE/CONTACTS
`
`31
`
`-.0
`-.0
`-.0
`
`POWER CONTROL 45
`
`47
`
`39
`
`41
`
`43
`
`OWE
`
`55
`
`53
`
`49
`
`OPTIONAL
`PROXIMITY/
`MATERIAL
`SENSOR
`
`THERMISTOR &
`OTHER
`OPTIONAL
`SENSORS
`
`ACCELERO-
`METER
`
`37
`
`0
`
`MICRO-
`CONTROLLER
`
`33
`
`35
`
`MEMORY
`
`51
`
`IV 817817800/900Z SR
`
`RC "CLOCK"
`
`65
`
`FIG. 2
`
`57
`
`"ANTENNA"
`
`59
`
`69
`
`APPLICATOR
`
`61
`
`67"
`
`•
`
`•
`
`• 0
`•
`
`•
`•
`
`67'
`
`

`

`Patent Application Publication Apr. 20, 2006 Sheet 3 of 6
`
`US 2006/0084848 Al
`
`WAITING STATE
`(SLEEP)
`
`71
`
`•
`
`OPERATIONAL
`STATE (SLEEP)
`
`73
`
`NO
`
`75
`
`77
`
`CHECK FOR
`SEX
`
`YES
`+
`ADAPTIVELY
`SAMPLE SENSOR
`DATA
`
`V
`STORE DATA IN
`MEMORY
`
`79
`
`81
`
`SPECIAL STATES
`
`FIG. 3
`
`

`

`Patent Application Publication Apr. 20, 2006 Sheet 4 of 6
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`US 2006/0084848 Al
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`101
`
`99
`
`105
`
`cm
`
`103
`
`FIG. 4A
`
`91
`
`READ OUT DATA
`
`I'
`
`93
`
`EXTRACT SENSOR
`DATA
`
`94
`
`CORRECT SENSOR
`DATA
`
`95
`
`REFORMAT
`SENSOR DATA
`
`97
`
`STORE/TRANSMIT
`DATA
`
`FIG. 4B
`
`

`

`Patent Application Publication Apr. 20, 2006 Sheet 5 of 6
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`US 2006/0084848 Al
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`FIG. 5A
`
`FIG. 5B
`
`

`

`Patent Application Publication Apr. 20, 2006 Sheet 6 of 6
`Patent Application Publication Apr. 20, 2006 Sheet 6 of 6
`
`US 2006/0084848 Al
`US 2006/0084848 Al
`
`110
`\ ‘
`
`128
`
`112'
`
`130
`
`13p_
`
`/- 126
`
`124
`
`114—,
`
`116
`
`118
`
`— 120
`
`-122
`
`FIG. 5C
`FIG. 5C
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`US 2006/0084848 Al
`US 2006/0084848 Al
`
`Apr. 20, 2006
`Apr. 20, 2006
`
`1
`
`APPARATUS AND METHODS FOR MONITORING
`APPARATUS AND METHODS FOR MONITORING
`SUBJECTS
`SUBJE℃TS
`
`1. FIELD OF THE INVENTION
`1. FIELD OF THE INVENTION
`
`[0001] The present invention, in a preferr巳d embodiment,
`[0001] The present invention, in a preferred embodiment,
`relates to monitoring participants in clinical trials of phar(cid:173)
`relates to monitoring participants in clinical trials of phar-
`maceuticals relating to sexual activity, especially those for
`maceuticals relating to sexual activity, especially those for
`limiting or preventing transmission of sexually transmitted
`limiting or preventing transmission of sexually transmitted
`diseases (STD时， and provides a device for participant
`diseases (STDs), and provides a device for participant
`monitoring with accompanying systems and methods that
`monitoring with accompanying systems and methods that
`automatically collects monitoring data with little or no
`automatically collects monitoring data with little or no
`participant attention.
`participant attention.
`
`2. BACKGROUND OF THE INVENTION
`2. BACKGROUND OF THE INVENTION
`
`[0002] Women now account for the majority of people
`[0002] Women now account for the majority of people
`with human immunodeficiency virus (HIV) infections, and
`with human immunodeficiency virus (HIV) infections, and
`young women bear the brunt of new infections in many parts
`young women bear the brunt of new infections in many parts
`of the world. See Copan et al., 2004, Science 304:1911 (and
`of the world. See Copan et al., 2004, Science 304:1911 (and
`the references contained therein). Advances in understand(cid:173)
`the references contained therein). Advances in understand-
`ing the molecular mechanisms of HIV sexual transmission
`ing the molecular mechanisms of HIV sexual transmission
`are focusing new interest and resources on development of
`are focusing new interest and resources on development of
`topical intra-vaginal agents that block HIV infection. Even
`topical intra-vaginal agents that block HIV infection. Even
`if these agents, known as microbicides, are only partially
`if these agents, known as microbicides, are only partially
`effective at preventing infection, they will hugely comple(cid:173)
`effective at preventing infection, they will hugely comple-
`ment existing prevention and treatment methods. Math(cid:173)
`ment existing prevention and treatment methods. Math-
`ematical modeling studies estimate that a partially effective
`ematical modeling studies estimate that a partially effective
`microbicide used in half of coital acts by 20% of women at
`microbicide used in half of coital acts by 20% of women at
`risk could prevent 2.5 million infections in 3 years.
`risk could prevent 2.5 million infections in 3 years.
`
`[0003] Many new microbicides are now under develop(cid:173)
`[0003] Many new microbicides are now under develop-
`ment. More than 40 new compounds are being tested in the
`ment. More than 40 new compounds are being tested in the
`laboratory; many new compounds are in clinical testing; and
`laboratory; many new compounds are in clinical testing; and
`six cand dates are currently in or about to enter phase III
`six cand dates are currently in or about to enter phase III
`studies. Further, new microbicide preparations containing
`studies. Further, new microbicide preparations containing
`two or more active ingredients, which are likely to be more
`two or more active ingredients, which are likely to be more
`effective than single active agent preparations, will require
`effective than single active agent preparations, will require
`independent laboratory and clinical testing.
`independent laboratory and clinical testing.
`
`[0004] Yet there are significant and unique obstacles to
`[0004] Yet there are significant and unique obstacles to
`microbicide testing and licensing. Chronic use of topical
`microbicide testing and licensing. Chronic use of topical
`intravaginal drugs to prevent infection is a new concept with
`intravaginal drugs to prevent infection is a new concept with
`which regulators have little previous experience. There is no
`which regulators have little previous experience. There is no
`surrogate marker or animal model known to reliably predict
`surrogate marker or animal model known to reliably predict
`microbicide efficacy in humans. Since microbicides are
`microbicide efficacy in humans. Since microbicides are
`expect巳d to be effi巳ctive only on average, trials require larger
`expected to be effective only on average, trials require larger
`numbers of participants. All these factors suggest that large
`numbers of participants. All these factors suggest that large
`clinical trials are, if an严hing, even more necessary to
`clinical trials are, if anything, even more necessary to
`demonstrate the safety and efficacy of microbicides.
`demonstrate the safety and efficacy of microbicides.
`
`[0005] But the logistics and costs of these studies are
`[0005] But the logistics and costs of these studies are
`formidable. Intrinsic characteristics of microbicides require
`formidable. Intrinsic characteristics of microbicides require
`that trials have up to tens of thousands of HIV-free, but
`that trials have up to tens of thousands of HIV-free, but
`high-risk women participants and that the participants be
`high-risk women participants and that the participants be
`follow巳d for up to several years. During licensing delays
`followed for up to several years. During licensing delays
`required by this testing, large numbers of new infections will
`required by this testing, large numbers of new infections will
`unnecessarily occur if new drugs prove efficacious. Further,
`unnecessarily occur if new drugs prove efficacious. Further,
`many trials will necessarily involve participants in devel(cid:173)
`many trials will necessarily involve participants in devel-
`oping countries subject to economic, environmental and
`oping countries subject to economic, environmental and
`social stresses. Finally, against this complex background,
`social stresses. Finally, against this complex background,
`trial data must currently rely essentially on self-reporting of
`trial data must currently rely essentially on self-reporting of
`sexual habits, which is known to be notoriously inaccurate
`sexual habits, which is known to be notoriously inaccurate
`even in the best conditions.
`even in the best conditions.
`
`[0006] Thus, it is a worldwide priority to expand capacity
`[0006] Thus, it is a worldwide priority to expand capacity
`for rapidly, cheaply, and easily performing efficacy trials of
`for rapidly, cheaply, and easily performing efficacy trials of
`
`microbicides and other preventions. Targeted efforts and
`microbicides and other preventions. Targeted efforts and
`significant financial investment by several organizations
`significant financial investment by several organizations
`have established clinical sites capable of conducting these
`have established clinical sites capable of conducting these
`microbicide trials according to international guidelines.
`microbicide trials according to international guidelines.
`However, these sites are overburdened already with the
`However, these sites are overburdened already with the
`current candidates for phase III trials.
`current candidates for phase III trials.
`
`[0007] Therefore, systems and methods that help make
`[0007] Therefore, systems and methods that help make
`such trials simpler and more economical are urgently needed
`such trials simpler and more economical are urgently needed
`and will have great benefit. For example, systems and
`and will have great benefit. For example, systems and
`methods providing more accurate and up-to-date trial data
`methods providing more accurate and up-to-date trial data
`can reduce the number of participants required and shorten
`can reduce the number of participants required and shorten
`the time to demonstrate (or not) the efficacy of candidate
`the time to demonstrate (or not) the efficacy of candidate
`drugs. Such systems and methods are not currently avail(cid:173)
`drugs. Such systems and methods are not currently avail-
`able.
`able.
`
`[0008] A number of references are cited herein, the entire
`[0008] A number of references are cited herein, the entire
`disclosures of which are incorporated herein, in their
`disclosures of which are incorporated herein, in their
`entirety, by reference for all purposes. Further, none of these
`entirety, by reference for all purposes. Further, none of these
`references, regardless of how characteriz巳d above, is admit(cid:173)
`references, regardless of how characterized above, is admit-
`ted as prior to the invention of the subject matter claimed
`ted as prior to the invention of the subject matter claimed
`herein.
`herein.
`
`3. SU肌f鸟也气RY OF THE INVENTION
`3. SUMMARY OF THE INVENTION
`
`[0009] The objects of the present invention are to provide
`[0009] The objects of the present invention are to provide
`unobtrusive devices for automatically monitoring partici(cid:173)
`unobtrusive devices for automatically monitoring partici-
`pants in clinical trials of topical pharmaceutical agents for
`pants in clinical trials of topical pharmaceutical agents for
`limiting or preventing STD transmission, and also in trials of
`limiting or preventing STD transmission, and also in trials of
`other types of pharmaceutical agents, especially pharmaceu(cid:173)
`other types of pharmaceutical agents, especially pharmaceu-
`tical agents relating to sexual activity. For example, because
`tical agents relating to sexual activity. For example, because
`anti-depressants and similar psychoactive agents are known
`anti-depressants and similar psychoactive agents are known
`to affect patient-reported libido, it may be advantageous to
`to affect patient-reported libido, it may be advantageous to
`objectively monitor patients taking such agents. These
`objectively monitor patients taking such agents. These
`objects also include providing systems and methods for use
`objects also include providing systems and methods for use
`of such monitoring devices in clinical trials.
`of such monitoring devices in clinical trials.
`
`[0010] Further objects of the present invention include
`[0010] Further objects of the present invention include
`monitoring subjects whether or not engaged in clinical trials.
`monitoring subjects whether or not engaged in clinical trials.
`Preferred devices reside in a body cavity and can provide
`Preferred devices reside in a body cavity and can provide
`access to body-core values for, for example, temperature,
`access to body-core values for, for example, temperature,
`glucose, p02, and the like. Also, the present invention can
`glucose, p02, and the like. Also, the present invention can
`monitor menstrual cycles and their characteristics. Addition(cid:173)
`monitor menstrual cycles and their characteristics. Addition-
`ally, the present invention can be combined with drug
`ally, the present invention can be combined with drug
`delivery devices similarly configured to reside in a body
`delivery devices similarly configured to reside in a body
`cavity, and thereby provide passive or actively-triggered
`cavity, and thereby provide passive or actively-triggered
`drug delivery.
`drug delivery.
`
`[0011] The inventive principles to be described herein
`[0011] The inventive principles to be described herein
`provide for monitoring devices that are designed to be
`provide for monitoring devices that are designed to be
`affixed to, or to reside in a cavity of, a participant in a clinical
`affixed to, or to reside in a cavity of, a participant in a clinical
`trial (or otherwise the subject of a study) with little or no
`trial (or otherwise the subject of a study) with little or no
`discomfort or risk for extend巳d periods, e.g., weeks, a
`discomfort or risk for extended periods, e.g., weeks, a
`month, or several months, or up to a year or more. These
`month, or several months, or up to a year or more. These
`devices incorporate sensors and supporting components for
`devices incorporate sensors and supporting components for
`sensing and recording data relevant to the clinical trial or
`sensing and recording data relevant to the clinical trial or
`study. This data advantageously includes participant behav(cid:173)
`study. This data advantageously includes participant behav-
`ioral data that would otherwise require participant self(cid:173)
`ioral data that would otherwise require participant self-
`reporting or invasive devices. Sensors usually detect the
`reporting or invasive devices. Sensors usually detect the
`local environment where a topical pharmaceutical is to be
`local environment where a topical pharmaceutical is to be
`appli巳d, whether or not the topical pharmaceutical has been
`applied, whether or not the topical pharmaceutical has been
`appli巳d, and the like. This data is stored, at least temporarily,
`applied, and the like. This data is stored, at least temporarily,
`in the device, and later off loaded and processed to provide
`in the device, and later off loaded and processed to provide
`useful participant monitoring data. The preferred practical
`useful participant monitoring data. The preferred practical
`application of these principles, and the preferred but not
`application of these principles, and the preferred but not
`limiting embodiments of the device, is as an intra-vaginal
`limiting embodiments of the device, is as an intra-vaginal
`device used during trials of pharmaceuticals, especially
`device used during trials of pharmaceuticals, especially
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`US 2006/0084848 Al
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`Apr. 20, 2006
`
`2
`2
`
`microbicides, for preventing or limiting STD (e.g., HIV)
`microbicides, for preventing or limiting STD (e.g., HIV)
`transmission. The following description is directed and
`transmission. The following description is directed and
`exemplified largely in terms of these preferred but non(cid:173)
`exemplified largely in terms of these preferred but non-
`limiting embodiments.
`limiting embodiments.
`
`[0012] Accordingly, a preferred intra-vaginal device of
`[0012] Accordingly, a preferred intra-vaginal device of
`this invention includes sensors for, at least, det巳:cting and
`this invention includes sensors for, at least, detecting and
`storing the occurrences of sexual activity (primarily, inter(cid:173)
`storing the occurrences of sexual activity (primarily, inter-
`course). Sexual activity is preferably detected by observing
`course). Sexual activity is preferably detected by observing
`characteristic patterns of participant motion as sensed by an
`characteristic patterns of participant motion as sensed by an
`acceleration. Preferably, devices also include sensors for
`acceleration. Preferably, devices also include sensors for
`other aspects of the vaginal environment and for detecting
`other aspects of the vaginal environment and for detecting
`the application or presence of topical pharmaceuticals. Addi(cid:173)
`the application or presence of topical pharmaceuticals. Addi-
`tional sensors that can be part of a device include tempera(cid:173)
`tional sensors that can be part of a device include tempera-
`ture sensors, pH sensors, heart rate sensors, p02 sensors
`ture sensors, pH sensors, heart rate sensors, p02 sensors
`(based on pulse oximeter electror让cs), and the like. If
`(based on pulse oximeter electronics), and the like. If
`available, sensors for specific chemicals can be included,
`available, sensors for specific chemicals can be included,
`such as sensors for selected pharmaceuticals, microbicides,
`such as sensors for selected pharmaceuticals, microbicides,
`spermicides, and the like. Further, chemical or physical
`spermicides, and the like. Further, chemical or physical
`labels can be added to pharmaceuticals, pharmaceutical
`labels can be added to pharmaceuticals, pharmaceutical
`applicators, and the like, to simplify their detection. One
`applicators, and the like, to simplify their detection. One
`preferred physical label is magnetic micro-beads or other
`preferred physical label is magnetic micro-beads or other
`magnetic materials in combination with a compact magnetic
`magnetic materials in combination with a compact magnetic
`自己ld sensor in a device.
`field sensor in a device.
`
`[0013] A preferred device also includes supporting com(cid:173)
`[0013] A preferred device also includes supporting com-
`ponents for making use of these electrically-active types of
`ponents for making use of these electrically-active types of
`sensors. Preferably, a device includes a micro-controller
`sensors. Preferably, a device includes a micro-controller
`(MC), or the equivale凶， for retrie飞ring data 企om sensors, for
`(MC), or the equivalent, for retrieving data from sensors, for
`storing retrieved data in an on-board memory, and for
`storing retrieved data in an on-board memory, and for
`controlling overall device operation, especially by managing
`controlling overall device operation, especially by managing
`power use for longer battery life. A device 臼rther advanta(cid:173)
`power use for longer battery life. A device further advanta-
`geously includes data memory, power management cir(cid:173)
`geously includes data memory, power management cir-
`cuitry, and other components known in the art. Data com(cid:173)
`cuitry, and other components known in the art. Data com-
`pression is preferably used to conserve memory. All
`pression is preferably used to conserve memory. All
`components are selected to have compact form factors and
`components are selected to have compact form factors and
`low and/or controllable power consumption.
`low and/or controllable power consumption.
`
`In one preferred embodiment, these sensors and
`[0014]
`In one preferred embodiment, these sensors and
`[0014]
`supporting components are packaged into a single unit sized
`supporting components are packaged into a single unit sized
`and shaped for residing intra-vaginally in a monitored
`and shaped for residing intra-vaginally in a monitored
`participant. It is paramount that a device be safe, convenient,
`participant. It is paramount that a device be safe, convenient,
`comfortable, and acceptable to participants, and that it
`comfortable, and acceptable to participants, and that it
`interfere only minimally, or not at all, with the participants
`interfere only minimally, or not at all, with the participants
`normal sexual activities. A preferred configuration is ring(cid:173)
`normal sexual activities. A preferred configuration is ring-
`shaped and sized to reliably reside in the back of the vagina
`shaped and sized to reliably reside in the back of the vagina
`adjacent to the cervix much like a diaphragm or cervical cap.
`adjacent to the cervix much like a diaphragm or cervical cap.
`Ring-shaped intra-vaginal devices have been used for drug
`Ring-shaped intra-vaginal devices have been used for drug
`delivery and other applications, and patients have found
`delivery and other applications, and patients have found
`them comfortable and acceptable. S巳毡， for example, U.S.
`them comfortable and acceptable. See, for example, U.S.
`Pat. No. 4,827,946, U.S. Pat. No. 5,928,195, and Rathbone
`Pat. No. 4,827,946, U.S. Pat. No. 5,928,195, and Rathbone
`et al. eds., 2003, Modified-Release Drug Delivery T巳chnol­
`et al. eds., 2003, Modified-Release Drug Delivery Technol-
`ogy, C.H.I.P.S., Weimar, Tex. (all presenting further details
`ogy, C.H.I.P.S., Weimar, Tex. (all presenting further details
`of intra-vaginal ring technology; and all incorporated by
`of intra-vaginal ring technology; and all incorporated by
`reference herein in their entireties for all purposes). Alter(cid:173)
`reference herein in their entireties for all purposes). Alter-
`nate physical con且gurations, such a cylindrical shape, are
`nate physical configurations, such a cylindrical shape, are
`also within the scope of this invention. Devices are prefer(cid:173)
`also within the scope of this invention. Devices are prefer-
`ably constructed from m巳dical-grade silicone elastomers, as
`ably constructed from medical-grade silicone elastomers, as
`these materials have already been proven suitable in intra(cid:173)
`these materials have already been proven suitable in intra-
`vaginal drug-delivery rings.
`vaginal drug-delivery rings.
`
`In other preferred embodim已由， the device may be
`[0015]
`In other preferred embodiments, the device may be
`[0015]
`configured into 阳o (or more) separate units. In one such
`configured into two (or more) separate units. In one such
`configuration, the device includes an intra-vaginal unit and
`configuration, the device includes an intra-vaginal unit and
`a cooperating extra-vaginal unit, the extra-vaginal unit being
`a cooperating extra-vaginal unit, the extra-vaginal unit being
`on or near the participant, for example, being supported on
`on or near the participant, for example, being supported on
`
`the participant’ s clothing. These two units communicate
`the participant's clothing. These two units communicate
`wirelessly using one of the available very low power, short
`wirelessly using one of the available very low power, short
`range radio link protocols (e.g., Bluetooth) now available as
`range radio link protocols (e.g., Bluetooth) now available as
`single chip integrated circuit (IC) transceivers. For example,
`single chip integrated circuit (IC) transceivers. For example,
`the intra-vaginal unit can retrieve sensor data and transmit it
`the intra-vaginal unit can retrieve sensor data and transmit it
`to the extra-vaginal unit; the extra-vaginal unit can r巳：ceive
`to the extra-vaginal unit; the extra-vaginal unit can receive
`and store sensor data and perform overall management of
`and store sensor data and perform overall management of
`both units. The intra-vaginal can then use simpler, smaller,
`both units. The intra-vaginal can then use simpler, smaller,
`and more power efficient supporting components, while the
`and more power efficient supporting components, while the
`larger components requiring more power, such as the MC,
`larger components requiring more power, such as the MC,
`may reside externally where the physical constraints are less.
`may reside externally where the physical constraints are less.
`Alternatively, the extra-vaginal unit may be supplemented or
`Alternatively, the extra-vaginal unit may be supplemented or
`replaced by an external station to which data is be trans(cid:173)
`replaced by an external station to which data is be trans-
`mitted from time-to-time to free memory in the intra-vaginal
`mitted from time-to-time to free memory in the intra-vaginal
`unit. In a further alternative, the two units may include an
`unit. In a further alternative, the two units may include an
`inductive coupling (e.g., forming a transformer) so that the
`inductive coupling (e.g., forming a transformer) so that the
`extra-vaginal unit can recharge from time-to-time batteries
`extra-vaginal unit can recharge from time-to-time batteries
`in the intra-vaginal unit. It is then possible, for ex缸口ple, that
`in the intra-vaginal unit. It is then possible, for example, that
`the intra-vaginal unit be even more compact by dispensing
`the intra-vaginal unit be even more compact by dispensing
`with batteries and power control. The extra-vaginal unit then
`with batteries and power control. The extra-vaginal unit then
`provides power to the intra-vaginal unit only when n臼ded
`provides power to the intra-vaginal unit only when needed
`to retrieve and transmit sensor data; otherwise, the intra(cid:173)
`to retrieve and transmit sensor data; otherwise, the intra-
`vaginal unit is inactive. Finally, in other embodiments, the
`vaginal unit is inactive. Finally, in other embodiments, the
`intra-vaginal unit may be entirely dispens巳d with, and all
`intra-vaginal unit may be entirely dispensed with, and all
`data sensed from an external unit on or near the participant.
`data sensed from an external unit on or near the participant.
`
`In the following, without limitation, the de叽ce of
`[0016]
`In the following, without limitation, the device of
`[0016]
`this invention is described largely in its single-unit embodi(cid:173)
`this invention is described largely in its single-unit embodi-
`ment. Constructing an embodiment with two (or more) units
`ment. Constructing an embodiment with two (or more) units
`simply requires, first, that the functions and components of
`simply requires, first, that the functions and components of
`the single unit be distribut巳d 缸nong the two units, and
`the single unit be distributed among the two units, and
`second, that a wireless link component and/or optional
`second, that a wireless link component and/or optional
`inductive coupling by added to both units. Wireless links and
`inductive coupling by added to both units. Wireless links and
`inductive coupling are already known and used in the art.
`inductive coupling are already known and used in the art.
`Therefore, in view of the following description of the
`Therefore, in view of the following description of the
`single-unit embodiments, it will be readily apparent to one
`single-unit embodiments, it will be readily apparent to one
`of ordinary skill in the art how other embodiments can be
`of ordinary skill in the art how other embodiments can be
`constructed.
`constructed.
`
`[0017] Finally, this invention includes also systems and
`[0017] Finally, this invention includes also systems and
`methods for making device monitoring data available for its
`methods for making device monitoring data available for its
`ultimate uses. Data is retrieved or read-out from the single
`ultimate uses. Data is retrieved or read-out from the single
`unit device usually when the device is removed from the
`unit device usually when the device is removed from the
`participant. Preferably, electrical contact pads provided on
`participant. Preferably, electrical contact pads provided on
`the device interface to an external data reader so that data
`the device interface to an external data reader so that data
`can non-destructively be moved from the on-board memory
`can non-destructively be moved from the on-board memory
`to an external station or system, such as a standard personal
`to an external station or system, such as a standard personal
`computer (PC). (In multi-unit embodiments, data can be
`computer (PC). (In multi-unit embodiments, data can be
`wirelessly retrieved from time-to-time without device
`wirelessly retrieved from time-to-time without device
`removal.) The external station performs basic processi吨，
`removal.) The external station performs basic processing,
`such as extracting data from the format in which it was
`such as extracting data from the format in which it was
`stored in device on-board memory and correcting apparent
`stored in device on-board memory and correcting apparent
`sensor errors (such as baseline drift). After such processing,
`sensor errors (such as baseline drift). After such processing,
`the data is transmitted or sent for its ultimate uses.
`the data is transmitted or sent for its ultimate uses.
`
`[0018] A device can also advantageously include electri(cid:173)
`[0018] A device can also advantageously include electri-
`cally-non-active sensors. Preferred el巳：ctrically-non-active
`cally-non-active sensors. Preferred electrically-non-active
`sensors include passive physical sensors designed to S缸口ple
`sensors include passive physical sensors designed to sample
`and retain components encountered in the device’ s (intra(cid:173)
`and retain components encountered in the device's (intra-
`vaginal) environment. Components sampled by such a sen(cid:173)
`vaginal) environment. Components sampled by such a sen-
`sor are detected upon device removal using known chemical
`sor are detected upon device removal using known chemical
`and biological techniques that are usually destructive of the
`and biological techniques that are usually destructive of the
`sensor. A preferred embodiment of a sampling sensor
`sensor. A preferred embodiment of a sampling sensor
`includes an absorbent material disposed in an enclosed
`includes an absorbent material disposed in an enclosed
`cavity in the device, the cavity communicating with the
`cavity in the device, the cavity communicating with the
`external device environment through pores and/or a mem-
`external device environment through pores and/or a mem-
`
`HTC v. Uniloc
`
`Page 9 of 22
`
`HTC Ex. 1007
`
`

`

`US 2006/0084848 Al
`US 2006/0084848 Al
`
`Apr. 20, 2006
`Apr. 20, 2006
`
`3
`3
`
`brane. Characteristics of the membrane and/or absorbent
`brane. Characteristics of the membrane and/or absorbent
`material can be selected to give such a sampling sensor a
`material can be selected to give such a sampling sensor a
`degree of selectivity and specificity. For example, correctly
`degree of selectivity and specificity. For example, correctly