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`PROVISIONAL APPLICATION FOR PA TENT COVER SHEET
`This is a request for filing a PROVISIONAL APPLICATION FOR PATENT under 37 CFR 1.53 (c).
`INVENTOR S
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`A
`Given Name (first and middle III 3WD
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`.
`Famlly Name or Surname
`
`
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`
`Reeldenoe
`(Clty and elther State or Forelgn Country)
`Ypsilanti,M|
`Ann Arbor, MI
`Plymouth, MI
`All A H U
`
`
`
`
`is #5'E a
`
`lllliilll
`”98634 l'lll
`/27 ll!
`Ill/
`ll
`jcs79
`a
`60
`iiIIillI
`
` El Addltlonal Inventors are being named on the
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`MEMS Transducers Ill
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`Integrated Sensing Systems (ISSYS), Inc.
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`USE ONLY FOR FILING A PROVISIONAL APPLICATION FOR PA TENT
`This collection of information is re uired by 37 CFR 1.51. The information is used by the public to file (and by the PTO to
`process) a prowSIonal application
`onfidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated
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`Abbott
`Exhibit 1004
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`Page 001
`
`Abbott
`Exhibit 1004
`Page 001
`
`

`

`(c
`
`MEMS Transducers Ill
`
`Field of the Invention
`
`This invention relates generally to the design and implementation of micromachined transducers for biomedical
`and other applications;
`in particular,
`to (i) packaging schemes for biomedical applications; (ii) lead and signal
`transfer techniques for biomedical and other applications; (iii) wireless telemetry schemes; (iv) location of system
`components for biomedical transducers; (v) various means to ensure biocompatibility for biologic applications; and
`(vi) various applications of the aforementioned technology.
`
`Background of the Invention
`
`Although micromachined piezoresistive pressure and force sensing technologies are well established and
`commonplace to those familiar with the an, piezoresistive technologies have many limitations for biomedical
`applications,
`including high power consumption, the risk of leakage currents, uncertain biocompatibility,
`low
`sensitivity, and the like. Furthermore, the vast majority of piezoresistive sensors require some hybrid assembly,
`compromising ruggedness and making them of dubious use for chronic implant applications. Capacitive diaphragm
`sensors, however, are conducive to low-power applications and are easily integrated into monolithic devices.
`Additionally,
`such sensors are well-suited to longer-term and implanted biomedical applications where
`biocompatibility is an issue. Among the following Descriptions are enumerated some features for envisioned
`transducer technology based on capacitive sensing techniques.
`Furthermore, a number of the design innovations listed here are applicable to other transducers beyond
`caiiicitive sensors, both in biomedical and more general applications of MEMS transducer technology. As such, the
`Made
`innovations shall be widely interpreted or construed to include non-medical and/or non—pressure-sensing
`' es wherever applicable.
`
`
`
`Definitions
`
`The following definitions will be used for the sake of clarity in subsequent discussion.
`
`
`, Sensor (or Pressure Sensor or Force Sensor): a micromachined capacitive diaphragm pressure or force sensor,
`
`n versions capable of differential and/or absolute measurement, and which may or may not include an integral
`eference electrode for temperature compensation.
`
`Transducer:
`a micromachined sensor, actuator, or other device used to interface between the physical world
`and an electrical circuit.
`
`Micromachined: using batch—microfabrication techniques understood by those familiar with the art that are
`
`ypically common to integrated—circuit and/or MicroElectroMechanical Systems (MEMS) fabrication processes.
`
`Readout:
`the process of determining the state of a sensor and converting that data into a form useful for
`subsequent
`transmission, processing, recording, or display. Readout may be an interactive process (ie,
`influenced by other input or control variables,
`including, but not limited to, sampling rates, correction, and
`scaling factors).
`5. Readout unit:
`the circuit, case, coil (for a wireless transducer), and/or other components needed to perform
`readout function for a sensor.
`6. Bioactz've: conducive to or encouraging the growth of tissue or tissue-related substances on a surface
`7. Bioinert: not conducive (neutral or discouraging to) the growth of tissue or tissue-related substances on a
`surface.
`8. Disposable: for one-time use over 24h or less
`9.
`Short-term:
`for use up to 3 days
`10. Medium-term: for use up to 29 days
`i 1. Long-term: for use beyond one month
`12. Monolithic: constructed of one relatively rigid, substantially batch-fabricated package, without a flexible joint
`or flexible lead set interconnecting separately-fabricated sections (e.g. an anodically-bonded, glass-and-silicon
`package)
`13. Wireless: employing a transmission means other than electrical signals along a wire or wires, at some point
`along the signal transmission/readout path from the sensor site to an external monitoring unit.
`14. Battery/less: a wireless transducer that does not ever require an electrochemical power source be connected to
`the transducer or internal circuitry for sensing and/or readout of the sensed signal.
`
`Abbott
`Exhibit 1004
`
`Page 002
`
`Abbott
`Exhibit 1004
`Page 002
`
`

`

`I. Transducer packaging for biomedical applications.
`
`Descriptions of the Technology
`
`transducer and associated electronics attached to the same,
`integrated package (i.e.
`1. The use of a hybrid,
`monolithic substrate, but with the substrate being distinct from at least one of them) for biomedical applications.
`(See Figure l.)
`2. The use of an entirely monolithic device (transducer and associated electronics fabricated infon the same
`semiconductor substrate) for biomedical applications. (See Figure 2.)
`3. Radiation-hard transducer and/or electronics design for use in medical applications subject
`electromagnetic radiation that would otherwise be detrimental to device operation.
`
`to incident
`
`II. Lead transfer/signal transfer techniques.
`
`4. The use of an integral, monolithic, microfabricated semiconductor “ribbon cable” originating in/on the
`transducer die for interconnection with other system components or leads in biomedical applications.
`(See
`Figure 3.)
`
`5. Wirebonding from a transducer to bus lead(s) embedded in an extruded material, including catheter material.
`(See Figure 4.)
`
`
`
`6. The use of lead/bus wire with at least one side that has a flat or substantially flat surface (including, but not
`limited to, square, rectangular, oval, and “sliced-circular” cross—sections) to facilitate direct wirebonding from a
`ansducer onto the lead wire without use of an intermediate bonding pad, for biomedical and other applications.
`
`u(See Figure 5.)
`e use of stud-bumping for lead transfer from a transducer to lead/bus wire within a catheter. (See Figure 6.)
`
`e use of a compression bond or “clamped” intimate-contact—style lead transfer from a transducer to catheter
`us/leads. (See Figure 7.)
`se of electromagnetically shielded cable in a catheter to improve signal SNR.
`se of a (uni- or bi-directional) communication scheme in catheters that includes encoding of multiple pressure,
`rce, temperature, actuation, and/or other signals onto a common signal bus.
`11 =The use of a small, flexible or rigid substrate (such as, but not
`limited to, ceramic or flex-tape) as an
`intermediate electrical/mechanical buffer between a transducer and/or circuit chip and catheter leads/body. (See
`
`;
`igure 8 and Figure 9.)
`
`flush, or recessed region in/on the substrate to
`' he use of a transducer (or circuit) with an elevated,
`commodate one or more circuits (or transducers), such that
`the substrate serves as an intermediate
`
`
`
`
`
`intermediate buffer of (11) above in such a way that the top surface of the buffer is lower (with respect to the
`top of the sensor) than it would otherwise have been with a flat substrate. (See Figure 1 1,)
`
`III. Wireless telemetry schemes.
`
`into a capacitive sensor structure to achieve a capacitance—to-resonant-
`14. Integration of an inductor or coil
`frequency conversion for the purpose of transducer communication, including RF telemetry. (See Figure 12.)
`15. Placement of an inductor coil in/on the glass cap (for the case in which a transducer package consists of a glass-
`and-silicon (and/or quartz, and/or other semiconductor» structure in order to improve inductor Q-factor.
`(See
`Figure l3.)
`16. Use of the structure of (14) or (15) in a wireless, batteryless readout scheme for implanted and/or temporary
`medical devices, as well as non—medical applications, particularly, but not
`limited to, when no other
`strucmral/electrical components are included in the transducer package. (See Figure 14.)
`17. Use of the structure of (14) or ( 15) for battery-powered readout.
`18. The use of an inductor-based resonant circuit as described in (14) through (17), along with another coil placed
`intimately close to the transducer package, to achieve wireless lead transfer from the transducer to other system
`components or leads, both for remote powering and communication. (See Figure 15.)
`19. An implementation of the system of (18) using separate excitation and sensing coils in the readout unit.
`
`Abbott
`Exhibit 1004
`
`Page 003
`
`Abbott
`Exhibit 1004
`Page 003
`
`

`

`20. The use in the readout unit of a narrowband filter matched to the nominal resonant frequency range of the
`implant to increase the maximum allowable separation between implant and readout unit by improving the
`signal-to-noise ratio of the sensed signal.
`2 l. The readout scheme of (14) through (20) with data-logging capability in the readout unit.
`
`IV. Location of system components for biomedical transducers.
`
`22. The use of a reference sensor external to the main sensor environment (e.g. a reference outside of the body for a
`catheter or implanted sensor), particularly in catheter applications, to allow adjustment of the measured pressure
`or force from an absolute value to one relative to atmospheric, ambient, or other arbitrary reference pressure or
`force.
`
`23. Placement of a signal-conditioning circuit or control electronics for a capacitive sensor or other transducers
`in/on a catheter tip, catheter body, or catheter connector.
`24. Placement of a signal—conditioning circuit or control electronics for a capacitive sensor or other transducers in
`an interface box separate from the catheter.
`25. Inclusion in the catheter body of an electronically stored calibration table, coefficients, and/or identification
`numbers for a capacitive sensor and/or other transducers, such that they can be read by an external circuit.
`26. Inclusion of the stored data of (25) in an external and/or separate electronic or non-electronic (e.g. bar-code)
`device that can be read by an external interface.
`
`V. Methods to ensure biocompatibility for biomedical devices.
`
`
`
`27. The use of p++ (highly p-doped) silicon as a structural material and/or exterior coating to achieve or enhance
`device biocompatibility.
`Dating a p++ device with Ti, Ir, parylene, and/or other thick or thin films to yield a device with primary,
`
`econdary, and/or subsequent barriers to ensure biocompatibility.
`se of the technique of (28) with one or more layers to ensure biocompatibility even when using films that may
`ontain pinholes, cracks, and/or other discontinuities.
`iThe use of bioactive and/or bioinert surface treatments on disposable, and short-, medium-, and long—terrn
`
`implantable, micromachined pressure transducers and/or other devices.
`Surface treatments include both
`3 oatings and direct modification of the semiconductor surface (e.g. porous silicon).
`
`,
`se of a transducer with an exterior at ground potential relative to the surrounding environment in order to
`
`minimize the risk of exposing a patient to stray currents/voltages, and to reduce undesirable electrochemical
`tching effects in a biological (or other harsh) environment.
`
`
`pplications for the technology of Section I through Section V.
`
`
`
`se of a wired, implanted, capacitive or other pressure sensor or transducer, with a biocompatible structure as
`escribed, for chronically monitoring blood pressure in patients to control hypo- or hypertension.
`In the
`
`referred embodiment for such applications, the sensor (with or without associated signal-conditioning ASIC),
`in biocompatible form as described in Section V would be attached to a set of biocompatible leads (from a
`monitoring unit) and surgically implanted in the anatomical region of interest. The sensors are then monitored
`intermittently or continuously by the monitoring unit. The sensors may be located internal or external to a
`blood vessel.
`
`33. Use of the wireless sensor technology described herein for monitoring blood pressure in patients as an
`alternative to external blood pressure cuffs or other devices.
`In the preferred application, one or more wireless
`sensors are placed subcutaneously through surgical implantation, injection by needle, or by other means. The
`sensors are then monitored intermittently or continuously by the external readout unit. Multiple sensors may be
`distinguished by tuning each sensor to a different frequency range, altering the output waveform (in the case of
`an active sensor), or by other means that render distinct signals for each sensing location. The sensors may be
`located internal or external to a blood vessel.
`34. Use of the wired or wireless sensor technology described herein in conjunction with drug administration or
`other therapies for controlling hypo- or hypertension.
`In the preferred embodiment, pressure data from the
`sensor, alone or in conjunction with other real-time or preexisting data, is used to adjust drug or other therapy
`for a hypo- or hypertensive patient. Therapy is provided by means of a control module worn by, or implanted
`within, the patient (similar to e.g., an insulin pump for diabetics). The module may alert the user to take action,
`directly administer a drug intravenously, and/or initiate other invasive or non-invasive action. The system may
`operate in open-loop or closed-loop fashion.
`
`Abbott
`Exhibit 1004
`
`Page 004
`
`Abbott
`Exhibit 1004
`Page 004
`
`

`

`n
`
`35.
`
`37.
`
`Use of the technology described in (32) — (34) above in a therapeutic system with local feedback for the
`treatment of other medical conditions which require or benefit from regular, subcutaneous monitoring of
`pressures or other parameters.
`For blood pressure measurement applications, placement of the wired or wireless sensors as described above
`such that blood pressure is measured externally through a vessel wall. The sensor is placed in intimate contact
`with the wall (by adhesive, clips, tissue growth, or other means) such that the sensing surface measures pressure
`transduced through the vessel wall. (See Figure 16.) A calibration factor may be used to adjust the measured
`value to account for the effects of transmission through the vessel wall.
`The implementation of therapeutic systems for hypo-, hypertension, or other medical conditions, as described
`above, such that relevant information (including, but not limited to, measured physiologic parameters, treatment
`regimens, data histories, drug reservoir levels) is transmitted from the control module to other locations via
`cellular phone, wireless infrared communication protocols, or other means.
`
`
`
`Abbott
`Exhibit 1004
`
`Page 005
`
`Abbott
`Exhibit 1004
`Page 005
`
`

`

`,-
`
`
`
`n
`
`
`
`
`
`Recess in
`glass
`
`
`
`p++ single-crystal Si substrate
`
`Figure 1
`
`
`
`
`Recess in
`glass
`
`
`
`p++ single—crystal Si substrate
`
`Figure 2
`
`
`shallow
`p++lay‘
`
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`
`
`(monolithic with
`bstrate)
`”pad
`.
`\
`Deposued trace(s)
`(top and/or bottom)
`
`/
`
`
`
`Glass cap
`
`Figure 3
`
`Optional bond~
`strengthening
`comptuund
`
`Bond wire
`
`
`
`Abbott
`Exhibit 1004
`
`Page 006
`
`Abbott
`Exhibit 1004
`Page 006
`
`

`

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`
`
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`
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`
`
`
`
`
`Abbott
`Exhibit 1004
`
`Page 007
`
`Abbott
`Exhibit 1004
`Page 007
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Encapsulant
`/
`
`Continuous
`catheter body
`
`
`
`
`
`
`
`
`
`Vcc ((0 catheter bus)
`
`
`
`Figure 9
`
`
`
`
`
`
`
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`‘- ‘ ‘ 9
`
`
`
`m.
`‘2.
`‘ 0
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`B fagj VCC (on catheter bus)
`
`Figure 10
`Leads on glass
`Electrical bond
`
`Sensor die
`
`
`
`
`l \ Flex-tape
`-
`.-_. .
`Bond to
`
`cath leads
`
`Recess to accommodate flex—tape
`
`Figure l 1
`
`Abbott
`Exhibit 1004
`
`Page 008
`
`Abbott
`Exhibit 1004
`Page 008
`
`

`

`i
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`
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`
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`2 "> \
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`
`(b)
`
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`
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` Insulator
`Upper electrode]
`
`otte-erin material
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`
`lower electrode
`
`
`
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`
`Figure 12
`
`Abbott
`Exhibit 1004
`
`Page 009
`
`Abbott
`Exhibit 1004
`Page 009
`
`

`

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`
`Abbott
`Exhibit 1004
`
`Page010
`
`
`
`Abbott
`Exhibit 1004
`Page 010
`
`

`

`Tra nsd ucer
`capsule
`
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`
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`
`Figure 16
`
`Abbott
`Exhibit 1004
`
`Page 011
`
`Abbott
`Exhibit 1004
`Page 011
`
`

`

`re
`
`II
`
`
`
`(1-99
`PTO/SB/10
`EPARTMENT OF COMMERCE
`Patent and Trademark Office: US.
`Approved for use througjh 09/30/2000. OMB 0551-003
`
`Under me Paperwork Reduction Act of 1995. no persons are required to respond to a collection of Information unless It displays a valid OMB control number
`STATEMENT CLAIMING SMALL ENTITY STATUS
`Docket Number (Optional)
`(37 CFR 1.9m & 1.27(c))--SMALL BUSINESS CONCERN
`IB—s
`
`Application or Patent No.:__
`Filedorlssued: 3/16/01
`T’rtle: MEMS Transducers lll
`
`
`
`___
`
`l hereby state that i am
`E]
`the owner of the small business concern identified below:
`[X]
`an official of the small business concern empowered to act on behalf of the concern identified below.
`
`NAMEOFSMALLBUSlNESSCONCERN integrated Sensing Systems, Inc.
`
`ADDRESSOFSMALLBUSINESSCONCERN 387 Airport Industrial Drive
`Ypsilanti, MI 48198
`
`I hereby state that the above identified small business concern qualifies as a small business concern as defined in
`13 CFR Part 121 for purposes of paying reduced fees to the United States Patent and Trademark Office. Questions related
`to size standards for a small business concem may be directed to: Small Business Administration. Size Standards Staff,
`409 Third Street. SW, Washington, DC 20416.
`
`I hereby state that rights under contract or law have been conveyed to and remain with the small business concern
`identified above with regard to the invention described in:
`
`the specification filed herewith with title as listed above.
`[El
`D the application identified above.
`El
`the patent identified above.
`
`If the rights held by the above identified small business concern are not exclusive, each individual, concern, or
`organization having rights in the invention must file separate statements as to their status as small entities, and no rights
`to the invention are held by any person, other than the inventor, who would not qualify as an independent inventor under
`37 CFR 1.9(c) if that person made the invention, or by any concern which would not qualify as a small business concern
`under 37 CFR 1.9(d), or a nonprofit organization under 37 CFR 1.9(e),
`
`Each person. concern, or organization having any rights in the invention is listed below:
`IX] no such person. concem, or organization exists.
`D each such person. concern, or organization is listed below.
`
`Separate statements are required from each named person, concern or organization having rights to the invention
`stating their status as small entities. (37 CFR 1.27)
`
`in this application or patent. notification of any change in status resulting in loss of
`I acknowledge the duty to file.
`entitlement to small entity status prior to paying, or at the time of paying, the earliest of the issue fee or any maintenance
`fee due after the date on which status as a small entity is no longer appropriate. (37 CFR 1.28(b))
`
` Applicant, Patentee,orldentifier:_QQan A B'ch
`
`NAME OF PERSON SIGNING ___9oliin A. Rich
`
`ADDRESS OF PERSON SIGNING §§Ifl§_a$ above
`SIGNATURE ________My;fl_:gtpj_\___m_m________ DATE gas/01
`
`
`comments on the amount of time
`Burden Hour Statement ThIs form 15 estimated to take 0.2 hours to com lete. TIme WI" vary depending upon the needs of the IndIVIduai case, Any
`on are re uired to com lets this form 5 ould be sent to the Chief information Officer, Patent and Trademark Office,
`WashIngtcn, DC 20231
`WashIngton, DC 20231. DO NgT SEND EES OR C MPLETED FORMS TO THIS ADDRESS. SEND TO' ASSIstant Commissmner for Patents.
`
`Abbott
`Exhibit 1004
`
`Page 012
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`Abbott
`Exhibit 1004
`Page 012
`
`