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USRE39863E1 - Combined flow, pressure and temperature sensor - Google Patents

Combined flow, pressure and temperature sensor Download PDF

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Publication number
USRE39863E1
USRE39863E1 US10/224,346 US22434697A USRE39863E US RE39863 E1 USRE39863 E1 US RE39863E1 US 22434697 A US22434697 A US 22434697A US RE39863 E USRE39863 E US RE39863E
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United States
Prior art keywords
temperature
pressure
resistor
sensor
sensitive element
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US10/224,346
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English (en)
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Leif Smith
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St Jude Medical Coordination Center BVBA
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Radi Medical Systems AB
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Assigned to ST. JUDE MEDICAL COORDINATION CENTER BVBA reassignment ST. JUDE MEDICAL COORDINATION CENTER BVBA ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ST. JUDE MEDICAL SYSTEMS AB
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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01L—MEASURING FORCE, STRESS, TORQUE, WORK, MECHANICAL POWER, MECHANICAL EFFICIENCY, OR FLUID PRESSURE
    • G01L19/00—Details of, or accessories for, apparatus for measuring steady or quasi-steady pressure of a fluent medium insofar as such details or accessories are not special to particular types of pressure gauges
    • G01L19/0092—Pressure sensor associated with other sensors, e.g. for measuring acceleration or temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/026—Measuring blood flow
    • A61B5/0275—Measuring blood flow using tracers, e.g. dye dilution
    • A61B5/028—Measuring blood flow using tracers, e.g. dye dilution by thermo-dilution
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01F—MEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
    • G01F1/00—Measuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow
    • G01F1/68—Measuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow by using thermal effects
    • G01F1/684—Structural arrangements; Mounting of elements, e.g. in relation to fluid flow
    • G01F1/6845—Micromachined devices
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01K—MEASURING TEMPERATURE; MEASURING QUANTITY OF HEAT; THERMALLY-SENSITIVE ELEMENTS NOT OTHERWISE PROVIDED FOR
    • G01K1/00—Details of thermometers not specially adapted for particular types of thermometer
    • G01K1/02—Means for indicating or recording specially adapted for thermometers
    • G01K1/04—Scales
    • G01K1/045—Scales temperature indication combined with the indication of another variable
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01L—MEASURING FORCE, STRESS, TORQUE, WORK, MECHANICAL POWER, MECHANICAL EFFICIENCY, OR FLUID PRESSURE
    • G01L19/00—Details of, or accessories for, apparatus for measuring steady or quasi-steady pressure of a fluent medium insofar as such details or accessories are not special to particular types of pressure gauges
    • G01L19/14—Housings
    • G01L19/148—Details about the circuit board integration, e.g. integrated with the diaphragm surface or encapsulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0001—Catheters; Hollow probes for pressure measurement
    • A61M2025/0002—Catheters; Hollow probes for pressure measurement with a pressure sensor at the distal end

Definitions

  • the present invention relates generally to pressure, temperature and flow measurements, in particular in the medical field, and especially to in situ measurements of the intracoronary pressure, distally of a stricture, using a guide wire having a pressure sensor mounted at its distal end.
  • FFR myo Fractional Flow Reserve
  • Circulation Vol. 92, No. 11, Dec. 1, 1995, by Nico H. j. Pijls et al.
  • FFR myo P dist /P prox .
  • the distal pressure is measured in the vessel using a micro-pressure transducer, and the proximal pressure is the arterial pressure.
  • a vessel having a significant stricture would not yield any pressure drop if the myocardium is defective and has no ability to receive blood. The diagnosis will incorrectly show that the coronary vessel is healthy, when instead the conclusion should have been that the myocardium and possibly the coronary vessel are ill.
  • a diagnosis method for diagnosing small vessel disease is performed as follows:
  • Fractional Flow Reserve is determined. If the FFR is ⁇ 0.75 the coronary vessel should be treated.
  • CFR Coronary Flow Reserve
  • CVR Coronary Velocity Reserve
  • the object of the invention is therefor to make available means and methods for carrying out such combined pressure and flow measurements with a single unit, thus facilitating investigations of the outlined type, and making diagnosing more reliable.
  • the object outlined above is achieved according to the invention with the sensor as defined in claim 1 , whereby the problems of the prior art have been overcome.
  • the key is to use the temperature sensitive element for obtaining a flow parameter.
  • a single sensor having the ability to measure both the pressure and to determine the velocity of flow or the volume flow.
  • a great advantage with such a solution is that only one electrical circuit needs to be provided in a guide wire.
  • the senor is an electrical sensor of a piezoresistive type.
  • other pressure sensitive devices e.g. capacitive devices, or mechanically resonating sensors.
  • FIGS. 1a and 1b show a microphone for recording extremely small eddies in turbulent gas flows
  • FIG. 2 shows a sensor/guide assembly to be used together with the invention
  • FIG. 3 shows a top view of a pressure sensor chip and the electric circuitry schematically illustrated
  • FIG. 4 shows schematically the circuit of a “double” Wheatstone bridge for use in the invention
  • FIG. 5 is an illustration of a Wheatstone bridge used in a second embodiment of the invention.
  • FIG. 6 shows temperature profiles obtained in a thermodilution type measurement
  • FIG. 7 is a schematic illustration showing how transit time is used to obtain the desired parameter.
  • FIGS. 1a and 1b there is shown a prior art device disclosed in a publication entitled “A Small-Size Microphone for Measurements in Turbulent Gas Flows” in Sensors and Actuators A, 1994. It comprises a microphone for recording extremely small eddies in turbulent gas flows. It is based on piezoresistive techniques for transducing pressure fluctuations into electrical signals.
  • the microphone comprises a silicon substrate 100 , and a cavity 102 in said substrate.
  • a diaphragm of polysilicon 104 covers the cavity 102 .
  • a polysilicon piezoresistor 106 is attached on the diaphragm.
  • Etch holes 108 and etch channels 110 are provided for manufacturing purposes. Vent channels 112 are also provided.
  • metal conductors 114 and bond pads 116 for connecting cabling to external devices.
  • FIG. 2 there is shown a sensor/guide device comprising a solid wire 1 which is machined by so called centering grinding, and inserted into a proximal tube portion 2 .
  • the wire 1 forms the distal portion of the guide, and extends beyond the distal end of the proximal tube portion 2 where said tube is connected to or integrally formed with a spiral portion 3 .
  • On the distal end of the wire 1 there is mounted a pressure sensor 6 . Between the wire 1 and the spiral portion 3 , electrical leads 4 from the electronic circuitry run parallel with said wire 1 .
  • the sensor 6 is protected by a short section of a tube 7 having an aperture 8 through which surrounding media act on the pressure sensor.
  • a radio opaque coil 9 e.g. made of Pt, and used for location purposes, and a safety wire 10 for securing the distal part of the spiral 9 .
  • the wire or tube may be used as one of the electrical leads.
  • the proximal tubing 2 and the spiral 3 may be coupled such as to be utilized as an electrical shield, in which case it of course cannot be used as an electrical lead.
  • the sensor is based on the small size silicon microphone mentioned above, which is designed for detecting extremely small eddies in turbulent gas flows. It has been fully described for that application in said publication “Sensors and Actuators A”, 1994 (incorporated herein in its entirety by reference). However, it has been modified in accordance with the present invention in the way described below.
  • the external dimensions for accommodating the lead pattern on the sensor should be no more than 0.18 mm ⁇ 1.3 mm ⁇ 0.18 mm, preferably no more than 0.14 mm ⁇ 1.3 mm ⁇ 0.1 mm.
  • the sensor (see FIG. 3 ) comprises a sensor support body in the form of a silicon chip 13 in which there is a cavity 14 made e.g. by etching. Across the cavity there is formed a polysilicon diaphragm 15 having a thickness of e.g. 0.4-1.5 ⁇ m or possibly up to 5 ⁇ m, and a side length of 100 ⁇ m. Within the cavity a vacuum of less than 1000 Pa, preferably less than 30 Pa prevails. In contact with said diaphragm there is mounted a piezoresistive element 41 . A pressure acting on the diaphragm 15 will cause a deflection thereof and of the piezoresistive element 41 , which yields a signal that may be detected.
  • bond pads 19 are required. These bond pads must have a certain dimension (e.g. 100 ⁇ 75 ⁇ m), and must be spaced apart a certain distance, respect distance approximately 125 ⁇ m. Since the dimensional adaptation entails narrowing the chip, the consequence is that in order to be able to meet the mentioned requirements, the bond pads have to be located in a row, one after the other, as shown in FIG. 3 .
  • This reference resistor 42 may be located on different points on the sensor chip.
  • the diaphragm 15 it is placed on the diaphragm 15 .
  • the active element i.e. the piezoresistive element 41
  • the reference resistor 42 is preferably mounted perpendicularly with respect to the active element 41 and along the border of the diaphragm 15 , i.e. at the periphery of the cavity 14 present underneath the diaphragm 15 .
  • Another possibility is to locate the reference resistor on a “dummy” diaphragm adjacent the real diaphragm 15 , in order to provide the same mechanical and thermal environment for the active element 41 and the reference resistor 42 .
  • one embodiment of the sensor circuit comprises six resistors 41 . . . 46 , two of which 41 , 42 are mounted on the diaphragm, as previously mentioned (resistor 41 corresponds to resistor 41 in FIG. 3 , and resistor 42 corresponds to resistor 42 in FIG. 3 ).
  • Resistor 41 is a piezoresistive element, and resistor 42 is only temperature sensitive.
  • the remaining resistors 43 , 44 , 45 , 46 are located externally of the entire sensor/guide assembly, and do not form part of the sensor element.
  • the resistors are coupled as a “double” Wheatstone bridge, i.e. with resistors 42 , 43 , 44 , 46 forming one bridge (for temperature compensation and flow calculation), resistors 41 , 42 , 42 , 46 forming the second bridge for pressure measurement.
  • resistors 45 and 46 are shared by the bridges. Thereby it is possible to measure the temperature (across B-C) and pressure (across A-C) independently of each other. From the measured temperature values the flow velocity or volume flow may be calculated.
  • resistors 51 , 52 , 53 , 54 there are four resistors ( 51 , 52 , 53 , 54 ) connected as shown in FIG. 5 , i.e. as a simple “single” Wheatstone bridge. If at least one of the four resistors, say 51 , has a temperature coefficient ⁇ 0, then temperature changes may be measured as follows:
  • the current I through the circuit may be measured and is a measure of the temperature, since the total impedance (resistance) of the circuit will change with temperature.
  • the current I may be maintained constant, and in this case the voltage over the bridge will be temperature dependent.
  • the CFR can be determined by registering the temperature drop due to a passing liquid having a lower temperature than the body temperature, as will be discussed in detail below.
  • thermo-dilution may be employed in which case the volume flow may be obtained.
  • Hot-wire anemometers commonly are made in two basic forms: the constant current type and the constant temperature type. Both utilize the same physical principle but in different ways.
  • the constant current type a fine resistance wire carrying a fixed current is exposed to the fluid flowing at a certain velocity.
  • the wire attains an equilibrium temperature when the i 2 R heat is essentially constant; thus the wire temperature must adjust itself to change the convective loss until equilibrium is reached. Since the convection film coefficient is a function of flow velocity, the equilibrium wire temperature is a measure of velocity.
  • the wire temperature can be measured in terms of its electrical resistance.
  • the current through the wire is adjusted to keep the wire temperature (as measured by its resistance) constant. The current required to do this then becomes a measure of flow velocity.
  • V is the flow velocity
  • C 0 and C 1 are constants.
  • the resistors in the circuit are supplied with 1-10 V (AC or DC), and the potential difference between A and B is registered as a signal representing the pressure.
  • this potential difference will be temperature dependent, i.e. one has to know a quantity representative of the temperature at which the measurement takes place in order to obtain a correct pressure value, and therefore the bridge has to be calibrated. This is achieved by recording the potential difference between A and B (see FIG. 4 ) as a function of the potential difference between A and C at different temperatures, e.g. in a controlled temperature oven or in a water bath.
  • an “off set” vs temperature dependence curve is obtained, that is used to compensate the pressure signal (A-B) for a given temperature. Namely, at a given temperature it is known from the calibration curve how much should be subtracted from or added to the actual registered signal in order to obtain a correct pressure. It would be advantageous if resistors 41 and 42 have identical or at least a very similar temperature dependence. This is in fact also the case, since they are made in practice at the same time during manufacture of the chip itself. Thus, material composition and properties are in practice identical. Nevertheless the above outlined compensation is necessary in most cases.
  • the inventors have now realized that it is possible to make use of the temperature dependent resistor in a pressure bridge as described above, for flow measurements, using the principle of the hot-wire anemometer.
  • the temperature sensitive resistor 42 ( FIG. 4 ) having a known temperature behavior as a function of the current supplied to it, is fed with a current that in a static situation (i.e. no flowing fluid surrounding it) would yield a certain temperature, as reflected in its resistance. If there is a difference in the measured resistance compared to what would have been expected in the static situation (i.e. no flow), it can be concluded that a cooling of the resistor is taking place, and thus that there is a flow of fluid. The measurement is made over B-C in the figure. On the basis of this information, the theory indicated above for anemometers may be applied, and a flow velocity calculated.
  • the CFR value may be obtained in the following way using the anemometer principle:
  • the FFR Fractional Flow Reserve
  • thermodilution utilizing the principle of thermodilution
  • thermo-dilution involves injecting a known amount of cooled liquid, e.g. physiological saline in a blood vessel. After injection the temperature is continuously recorded with a temperature sensor attached to the tip of a guide wire that is inserted in the vessel. A temperature change due to the cold liquid passing the measurement site, i.e. the location of the sensor, will be a function of the flow (see FIG. 5 ).
  • cooled liquid e.g. physiological saline
  • the latter is the simpler way, and may be carried out by measuring the width at half height of the temperature change profile in the two situations indicated, and forming a ratio between these quantities (see FIG. 6 ).
  • Another way of obtaining a ratio would be to measure the transit time from injection and until the cold liquid passes the sensor, in rest condition and in work condition respectively. The relevant points of measurement are shown in FIG. 7 .
  • the former method i.e. the utilization of the volume flow parameter as such, requires integration of the temperature profile over time (see FIG. 6 ) in accordance with the equations given below
  • Q rest V / ⁇ t 0 t 1 ⁇ ( T r , m / T r , l ) ⁇ ⁇ d t ⁇ V / ⁇ t 0 t 1 ⁇ ( T r , 0 - T r , m ) ⁇ ⁇ d t ( 1 )
  • Q work V / ⁇ t0 t 1 ⁇ ( T w , m / T w , l ) ⁇ ⁇ d t ⁇ V / ⁇ t 0 t 1 ⁇ ( T w , 0 - T w , m ) ⁇ ⁇ d t ( 1 )
  • a method of diagnosing small vessel disease comprises performing measurements at a site in a vessel distally of a suspected stricture.
  • a pressure sensitive element and a resistor on a sensor element is provided at a measurement site, by inserting through a catheter.
  • the pressure sensitive element and said resistor are part of an electric circuit yielding a pressure indicative output and a temperature indicative output, and have known temperature dependencies.
  • the resistor is used as a reference for the pressure sensitive element.
  • the sensor element will be subjected to flowing fluid, i.e. blood, and the temperature of said fluid is monitored by continuously recording said temperature indicative output from said electric circuit. Then said resistor is subjected to a changed thermal environment.
  • the change in said temperature indicative output resulting from said changed thermal environment is registered.
  • This change in temperature indicative output is used to calculate a flow parameter (Q rest ).
  • a vaso dilating drug is injected in said vessel to simulate a work condition, and the distal pressure (P work,dist ) and temperature of said fluid is monitored by continuously recording said pressure indicative output and said temperature indicative output from said electric circuit.
  • the resistor is exposed to a changed thermal environment, and the change in said temperature indicative output resulting from said changed thermal environment is registered.
  • a flow parameter (Q work ) is calculated from said change in said temperature indicative output.

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US10/224,346 1996-01-30 1997-01-30 Combined flow, pressure and temperature sensor Expired - Lifetime USRE39863E1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE9600334A SE9600334D0 (sv) 1996-01-30 1996-01-30 Combined flow, pressure and temperature sensor
PCT/SE1997/000150 WO1997027802A1 (en) 1996-01-30 1997-01-30 Combined flow, pressure and temperature sensor

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US10/224,346 Expired - Lifetime USRE39863E1 (en) 1996-01-30 1997-01-30 Combined flow, pressure and temperature sensor
US09/117,416 Ceased US6343514B1 (en) 1996-01-30 1997-01-30 Combined flow, pressure and temperature sensor
US10/022,361 Expired - Lifetime US6615667B2 (en) 1996-01-30 2001-12-20 Combined flow, pressure and temperature sensor

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US10/022,361 Expired - Lifetime US6615667B2 (en) 1996-01-30 2001-12-20 Combined flow, pressure and temperature sensor

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EP (1) EP0877574B1 (sv)
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DE (1) DE69725703T2 (sv)
SE (1) SE9600334D0 (sv)
WO (1) WO1997027802A1 (sv)

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US20090281437A1 (en) * 2008-05-12 2009-11-12 Alexander Grinberg Application of Nanotechnology for Blood Flow Meters
EP2182340A1 (en) 2008-10-30 2010-05-05 Radi Medical Systems AB Pressure Sensor and Guide Wire Assembly
WO2011120565A1 (en) 2009-03-31 2011-10-06 St Jude Medical Systems Ab Sensor guide wire
WO2011135014A2 (en) 2010-04-30 2011-11-03 St Jude Medical Systems Ab A measurement system
WO2011157299A1 (en) 2010-06-18 2011-12-22 St. Jude Medical Ab Implantable sensor device and system
WO2012004107A1 (en) 2010-07-06 2012-01-12 St Jude Medical Systems Ab Sensor element with an insulation layer
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WO2012166216A1 (en) 2011-06-02 2012-12-06 St. Jude Medical, Atrial Fibrillation Division, Inc. Multi-rate fluid flow and variable power delivery for ablation electrode assemblies used in catheter ablation procedures
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US6615667B2 (en) 2003-09-09
DE69725703D1 (de) 2003-11-27
EP0877574B1 (en) 2003-10-22
DE69725703T2 (de) 2004-06-17
SE9600334D0 (sv) 1996-01-30
US20020059827A1 (en) 2002-05-23
WO1997027802A1 (en) 1997-08-07
US6343514B1 (en) 2002-02-05
JP2000504249A (ja) 2000-04-11
JP3830528B2 (ja) 2006-10-04
EP0877574A1 (en) 1998-11-18

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