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`PROVISIONAL APPLICATION
`
`Attorney Docket No.: 3524-000004 AJpvY
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`!'1 This is a request for the filing of a PROVISIONAL APPLICATION pursuant to 37 CFRtr--
`..., 1.53 for the novel and useful invention entitled:
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`COVER SHEET AND TRANSMITTAL
`
`MEMS Transducers
`
`and invented by:
`
`Rich A. Collin
`3530 Cloverlawn Ave., Ypsilanti, Ml 48197
`a United States citizen
`
`and
`
`Nader Najafi
`1240 Severn Ct., Ann Arbor, Ml 48105
`an Iranian citizen
`
`and
`
`Yafan Zhang
`11352 Maple Valley Dr., Plymouth, Ml 48170
`an Iranian citizen
`
`The PROVISIONAL APPLICATION included the following: specification on five (5)
`pages and eight (8) sheets of drawings containing 15 figures.
`
`A check in the amount of $75.00 is enclosed to cover the SMALL ENTITY provisional
`filing fee. Small Entity status is hereby asserted. If the inappropriate fee is being
`the Commissioner is hereby authorized to charge the amount of
`provided,
`underpayment, the full fee or to credit any overpayment (which ever is appropriate) to
`Deposit Account No. 08-0750.
`
`The invention was not made by or under contract with an agency of the United States
`Government.
`
`An Express Mailing Certificate is enclosed.
`
`Please address all correspondence to the undersigned at the following address:
`
`Eric J. Sosenko
`Harness, Dickey & Pierce, P.L.C.
`P.O. Box 828
`Bloomfield Hills, Michigan 48303
`
`Dated: ~w. dd- 1 J.-O(J (
`
`Eric J. Sos
`Reg. 34,440
`(734) 662-8000
`
`Abbott
`Exhibit 1003
`Page 001
`
`

`

`HARNESS, DICKEY & PIERCE, P.L.C.
`
`ATTORNEYS AND COUNSELORS
`
`P.O. BOX 828
`BLOOMFIELD HILLS, MICHIGAN 48303
`U.S.A
`
`FOR COURIER DELIVERY ONLY
`
`5445 CORPORATE DRIVE
`TROY. MICHIGAN 48098
`(248) 641-1600
`
`CABLE
`PATENTS TROYMICHIGAN
`
`TELEX NO & REPLY
`287637 HARNES UR
`
`TELEFACSIMILE
`(248) 641-0270
`
`Commissioner of Patents
`and Trademarks
`Washington, D.C. 20231
`
`Sir:
`
`EXPRESS MAILING CERTIFICATE
`
`Applicant(s):
`
`Collin et al.
`
`Serial No. (if any):
`
`Title:
`
`MEMS Transducers
`
`Attorney Docket:
`
`3524-000004
`
`Attorney:
`
`Eric J. Sosenko
`
`"Express Mail" Mailing Label Number ...................................... EL623518789US
`
`Date of Deposit .......................................................................... January 22, 2001
`
`I hereby certify and verify that the accompanying Cover Sheet and Transmittal,
`
`a check in the amount of $75.00, Provisional Patent Application, 8 sheets of
`drawings, and a postcard are being deposited with the United States Postal
`
`Service "Express Mail Post Office To Addressee" service under 37 C.F.R. 1.1 O on
`
`the date indicated above and are addressed to the Commissioner of Patents and
`
`Trademarks, Washington, D.C. 20231.
`
`Abbott
`Exhibit 1003
`Page 002
`
`

`

`MEMS Transducers
`
`Field of the Invention
`
`3524-000004
`
`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 micrornachined piezoresistive pressure and force sensing technologies are well established and
`
`commonplace to those familiar with the art, 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 ofpiezoresistive 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
`
`capacitive sensors, both in biomedical and more general applications of MEMS transducer technology. As such,
`
`the listed innovations shall be widely interpreted or construed to include non-medical and/or non-pressure(cid:173)
`
`sensing devices wherever applicable.
`
`The following definitions will be used for the sake of clarity in subsequent discussion.
`
`Definitions
`
`I. Sensor (or Pressure Sensor or Force Sensor): a micromachined capacitive diaphragm pressure or force
`
`sensor, in versions capable of differential and/or absolute measurement, and which may or may not include
`
`an integral reference electrode for temperature compensation.
`
`2. Transducer: a micromachined sensor, actuator, or other device used to interface between the physical
`
`world and an electrical circuit.
`
`3.
`
`lvficromachined: usmg batch-microfabrication techniques understood by those familiar with the art that are
`
`typically common to integrated-circuit and/or MicroElectroMechanical Systems (MEMS) fabrication
`
`processes.
`
`4. 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 (i.e.
`
`Abbott
`Exhibit 1003
`Page 003
`
`

`

`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. Bioactive: 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
`
`IO. Medium-term: for use up to 29 days
`
`11. 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(cid:173)
`
`and-silicon package)
`
`13. Wireless: employing a transmission means other than electrical signals along a wire or wires, at some point
`
`along the signal transmissionireadout path from the sensor site to an external monitoring unit.
`
`14. Batteryless: 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.
`
`Descriptions of the Technology
`
`I. Transducer packaging for biomedical applications.
`
`1. The use of a hybrid, integrated package (i.e. transducer and associated electronics attached to the sarne,
`
`monolithic substrate, but with the substrate being distinct from at least one of them) for biomedical
`
`applications. (See Figure 1.)
`
`2. The use of an entirely monolithic device (transducer and associated electronics fabricated inion the same
`
`semiconductor substrate) for biomedical applications. (See Figure 2.)
`
`3. Radiation-hard transducer and/or electronics design for use in medical applications subject to incident
`
`electromagnetic radiation that would otherwise be detrimental to device operation.
`
`JI. Lead transfer/signal transfer techniques.
`
`1. The use of an integral, monolithic, microfabricated semiconductor "ribbon cable" originating inion the
`
`transducer die for interconnection with other system components or leads in biomedical applications. (See
`
`Figure 3.)
`
`2. Wirebonding from a transducer to bus lead(s) embedded m an extruded material, including catheter
`
`material. (See Figure 4.)
`
`3. 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 wire bonding
`
`2
`
`Abbott
`Exhibit 1003
`Page 004
`
`

`

`from a transducer onto the lead wire without use of an intermediate bonding pad, for biomedical and other
`
`applications. (See Figure 5.)
`
`4. The use of stud-bumping for lead transfer from a transducer to lead/bus wire within a catheter. (See Figure
`
`6.)
`
`5. The use of a compression bond or "clamped" intimate-contact-style lead transfer from a transducer to
`
`catheter bus/leads. (See Figure 7.)
`
`6. Use of electromagnetically shielded cable in a catheter to improve signal Sl'l"'R.
`
`7. Use of a (uni- or bi-directional) communication scheme in catheters that includes encoding of multiple
`
`pressure, force, temperature, actuation, and/or other signals onto a common signal bus.
`
`8. 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 Figure 8 and Figure 9.)
`
`9. The use of a transducer ( or circuit) with an elevated, flush, or recessed region in/on the substrate to
`
`accommodate one or more circuits ( or transducers), such that the substrate serves as an intermediate
`
`electrical/mechanical buffer between one or more devices and the catheter leads/body. (See Figure 8 and
`
`Figure 10.)
`
`III. Wireless telemetry schemes.
`
`1.
`
`Integration of an inductor or coil into a capacitive sensor structure to achieve a capacitance-to-resonant(cid:173)
`
`frequency conversion for the purpose of transducer communication, including RF telemetry. (See Figure
`
`11.)
`
`2. 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(cid:173)
`
`factor. (See Figure 12.)
`
`3. Use of the structure of(l) or (2) 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
`
`structural/electrical components are included in the transducer package. (See Figure 13.)
`
`4. Use of the structure of(l) or (2) for battery-powered readout.
`
`5. The use of an inductor-based resonant circuit as described in (1) through ( 4), 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 14.)
`
`6. An implementation of the system of (5) using separate excitation and sensing coils in the readout unit.
`
`7. 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.
`
`8. The readout scheme of (1) through (5) with data-logging capability in the readout unit.
`
`3
`
`Abbott
`Exhibit 1003
`Page 005
`
`

`

`IV. Location of system components for biomedical transducers.
`
`1. 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.
`
`2. 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.
`
`3. Placement of a signal-conditioning circuit or control electronics for a capacitive sensor or other transducers
`
`in an interface box separate from the catheter.
`
`4.
`
`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.
`
`5.
`
`Inclusion of the stored data of (4) 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.
`
`1. The use of p++ (highly p-doped) silicon as a structural material and/or exterior coating to achieve or
`
`enhance device biocompatibility.
`
`2. Coating a p++ device with Ti, Ir, parylene, and/or other thick or thin films to yield a device with primary,
`
`secondary, and/or subsequent barriers to ensure biocompatibility.
`
`3. Use of the technique of (2) with one or more layers to ensure biocompatibility even when using films that
`
`may contain pinholes, cracks, and/or other discontinuities.
`
`4. The use of bioactive and/or bioinert surface treatments on disposable, and short-, medium-, and long-term
`
`implantable, micromachined pressure transducers and/or other devices. Surface treatments include both
`
`coatings and direct modification of the semiconductor surface (e.g. porous silicon).
`
`5. Use 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
`
`etching effects in a biological ( or other harsh) environment.
`
`VI. Applications for the technology of Section I through Section V.
`
`1. Use of an implanted pressure sensor or transducer, with a biocompatible structure as described, for
`
`chronically monitoring arterial, atrial, and left ventricle cardiac and/or blood pressures. In the preferred
`
`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
`
`pacemaker, defibrillator, or other diagnostic/interventional system) and surgically implanted in the
`
`anatomical region of interest.
`
`2. Use of a capacitive sensor for the above applications.
`
`4
`
`Abbott
`Exhibit 1003
`Page 006
`
`

`

`3. Use of a capacitive pressure sensor or other transducer in a disposable, short-, medium-, or long-term
`
`implantable application.
`
`4.
`
`Implementation of a monolithic or hybrid, wireless, implantable, MEMS-based biomedical transducer using
`
`the described technology.
`
`5. Use of a monolithic or hybrid, capacitive pressure sensor or transducer, or any other sensors, (such as
`
`temperature), or any other actuators, in a catheter. In the preferred embodiment, one or more sensors are
`
`embedded in a catheter at various positions (radially and/or laterally), using appropriate adhesive materials
`
`and/or sealing compounds, such that the transduction surface is exposed to the environment while lead
`
`transfers are kept isolated from the environment. The transduction surface may also be protected by a
`
`coating that allows force to be transmitted to the surface without direct media contact. Power and/or output
`
`signals are transmitted along one or more leads embedded in the catheter to an external monitoring unit.
`
`6. Use of one or more monolithic or hybrid pressure sensors or transducers, or other sensors, or other
`
`actuators, in a catheter for diagnostic and/or interventional cardiac catheterization procedures.
`
`7. Use of one or more monolithic or hybrid pressure sensors or transducers, or other sensors, or other actuators
`
`in a catheter for esophageal motility studies, diagnoses, and/or other diagnostic or interventional procedures
`
`related to gastrointestinal medicine.
`
`8. Construction of a catheter as in (7) with more than 6 sensors.
`
`9. The use of collected pressure data from a catheter as described in (7) or (8) in conjunction with contour(cid:173)
`
`plotting and/or pattern recognition software to generate medical diagnoses.
`
`10. Use of the technology described herein, and/or other suitable technologies, in a catheter or other
`
`applications, to determine flow path cross-section as well as mass and/or volumetric blood or other fluid
`
`flow rates, as shown in Figure 15. The sensors may be integrated into a catheter or they may be placed
`
`separately in a configuration with equivalent geometries as to allow the necessary flow calculations to be
`
`made.
`
`11. Construction and use of one or more capacitive-diaphragm, semiconductor-based, micromachined sensors
`
`for monitoring the pressures on either or both sides of, and/or the flow through (with technique similar to
`
`(10) above), an original or replacement (artificial or natural) heart or other biologic valve. In the preferred
`
`embodiment, the sensor may be: (a) surgically implanted, in the wireless form of Section III; (b) attached to
`
`a set ofleads similar to (1) and implanted; or (c) imbedded in a catheter similar to Section II and implanted.
`
`The sensor(s) may be an integral/imbedded part of the valve and/or implanted as a separate unit(s).
`
`12. Construction and use of one or more sensors in a manner similar to (10) for the monitoring of pressures or
`
`other parameters on either or both sides of, and/or the flow through, a vascular stent.
`
`13. Use of the wrreless, batteryless sensor technology described herein for other medical and non-medical
`
`applications including, but not limited to, the measurement of tire pressures. The sensor may be an
`
`embedded/integral part of the pressure chamber { e.g. in the rubber or rim of a tire), or it may be attached
`
`internally or externally as a separate unit, or it may be free-floating within the pressure chamber.
`
`5
`
`Abbott
`Exhibit 1003
`Page 007
`
`

`

`CLAIMS
`
`1.
`
`A micromachined device adapted for sensing one of pressure and of force, said device
`
`comprising:
`
`a substrate having at least one rnicromachined integrated electronic circuit formed thereon,
`
`said circuit generatmg a signal; and
`
`means, connected to said substrate, for transferring said signal to an external monitoring unit
`
`to process said signal.
`
`2.
`
`A rnicromachined device as described on pages 1 through 4 and in Figures 1 through 15.
`
`6
`
`Abbott
`Exhibit 1003
`Page 008
`
`

`

`Recess in
`glass
`
`Recess in
`glass
`
`Figures
`
`Glass cap
`
`---
`-
`
`Transducer
`
`p++ single-crystal Si substrate
`
`Figure 1
`
`Glass cap
`
`Transdi:Jcer
`
`p++ single-crystal Si substrate
`
`Figure 2
`
`/
`
`Glass cap
`
`Deposited trace(s)
`(top and/or bottom)
`Figure 3
`
`Abbott
`Exhibit 1003
`Page 009
`
`

`

`Optional bond(cid:173)
`strengthening
`compound
`
`/
`
`Bond wire
`
`Lumen
`
`Figure 4
`
`Figure 5
`
`Main bus wire
`cross-section
`
`Abbott
`Exhibit 1003
`Page 010
`
`

`

`Bonding.
`bump··
`
`Lumen
`
`Figure 6
`
`Spring compression
`clip
`
`Compression
`bond contact
`
`Lumen
`
`Figure 7
`
`Abbott
`Exhibit 1003
`Page 011
`
`

`

`Encapsulant
`
`/
`
`/
`,,/
`
`Continuous
`catheter body
`/
`
`/
`
`_·:_-.:::· 0 • = - Bus wires
`
`,, ...
`.-OJI
`
`-
`
`-- - - - -
`
`-
`
`•
`
`-
`
`Figure 8
`
`ASIC
`
`Figure 9
`
`fl:=~ Vcc{oncatheterbus)
`Figure 10
`
`Abbott
`Exhibit 1003
`Page 012
`
`

`

`Transducer package
`
`Magnetic flux
`
`- - --,,.
`
`Pressure
`sensor
`
`Integrated
`coil
`
`Coupling
`coil in
`external
`readout
`unit
`
`(a)
`
`Inductor
`
`Glass cap
`
`p++ single-crystal Si substrate
`Pressure sensor diaphragm
`(b)
`
`Glass
`
`Pressure sensor diaphragm/
`lower electrode
`(c)
`
`Figure 11
`
`Abbott
`Exhibit 1003
`Page 013
`
`

`

`Inductor
`
`Glass cap
`
`p++ single-crystal Si substrate
`Pressure sensor diaphragm
`(a)
`
`llr.:
`
`Ill!!::
`
`Insulator
`
`Glass
`
`Getter
`:;p++ ·sm&911 _ ~--=-------· _,..,.,, ,--,-----,----..
`Pressure sensor diaphragm/
`lower electrode
`(b)
`Figure 12
`
`Getter
`
`~ - - - .C . - - - - '
`
`Abbott
`Exhibit 1003
`Page 014
`
`

`

`Atmospheric
`reference
`
`(I)
`
`Micro(cid:173)
`controller
`
`User
`interface
`
`-v
`
`RF
`Generator
`
`Z(ro)
`Driver/
`Impedance
`Measurement
`
`Transducer
`capsule
`
`Figure 13
`
`Transducer
`capsule
`
`Figure 14
`
`Abbott
`Exhibit 1003
`Page 015
`
`

`

`L
`
`L
`
`Vessel wall
`
`Q = CM (mass flow= conductance x pressure)
`
`A
`C=k·(cid:173)
`L
`
`from above, Ar and Q (if k is known) can be found
`
`Figure 15
`
`Abbott
`Exhibit 1003
`Page 016
`
`