WO2003098177A2 - Minimally invasive calibration of implanted pressure transducers - Google Patents

Minimally invasive calibration of implanted pressure transducers Download PDF

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Publication number
WO2003098177A2
WO2003098177A2 PCT/US2003/015174 US0315174W WO03098177A2 WO 2003098177 A2 WO2003098177 A2 WO 2003098177A2 US 0315174 W US0315174 W US 0315174W WO 03098177 A2 WO03098177 A2 WO 03098177A2
Authority
WO
WIPO (PCT)
Prior art keywords
pressure
location
patient
perturbation
measuring
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2003/015174
Other languages
English (en)
French (fr)
Other versions
WO2003098177A3 (en
Inventor
Neal L. Eigler
James S. Whiting
Brian M. Mann
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Savacor Inc
Original Assignee
Savacor Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Savacor Inc filed Critical Savacor Inc
Priority to EP03753033A priority Critical patent/EP1503662A4/en
Priority to AU2003232133A priority patent/AU2003232133A1/en
Priority to JP2004505655A priority patent/JP2005525572A/ja
Publication of WO2003098177A2 publication Critical patent/WO2003098177A2/en
Publication of WO2003098177A3 publication Critical patent/WO2003098177A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/03—Measuring fluid pressure within the body other than blood pressure, e.g. cerebral pressure ; Measuring pressure in body tissues or organs
    • 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
    • A61B5/48—Other medical applications
    • A61B5/4884—Other medical applications inducing physiological or psychological stress, e.g. applications for stress testing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0223—Operational features of calibration, e.g. protocols for calibrating sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0242—Operational features adapted to measure environmental factors, e.g. temperature, pollution
    • A61B2560/0247—Operational features adapted to measure environmental factors, e.g. temperature, pollution for compensation or correction of the measured physiological value
    • A61B2560/0252—Operational features adapted to measure environmental factors, e.g. temperature, pollution for compensation or correction of the measured physiological value using ambient temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0242—Operational features adapted to measure environmental factors, e.g. temperature, pollution
    • A61B2560/0247—Operational features adapted to measure environmental factors, e.g. temperature, pollution for compensation or correction of the measured physiological value
    • A61B2560/0257—Operational features adapted to measure environmental factors, e.g. temperature, pollution for compensation or correction of the measured physiological value using atmospheric pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/07—Endoradiosondes
    • A61B5/076—Permanent implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Measuring devices for evaluating the respiratory organs
    • A61B5/087—Measuring breath flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/41—Detecting, measuring or recording for evaluating the immune or lymphatic systems
    • A61B5/414—Evaluating particular organs or parts of the immune or lymphatic systems
    • A61B5/418—Evaluating particular organs or parts of the immune or lymphatic systems lymph vessels, ducts or nodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/45—For evaluating or diagnosing the musculoskeletal system or teeth
    • A61B5/4528—Joints

Definitions

  • the offset of a transducer incorporating a sealed chamber with an internal pressure that defines the baseline pressure will drift if the sealed chamber leaks so that its internal pressure changes.
  • the direction of drift is determined by the initial pressure differential between the internal and external pressure. If the external pressure is lower than the internal pressure, the leak will cause an upward drift in pressure readings. If the internal pressure is lower, the leak will cause a downward drift in pressure readings.
  • the rate of a leak is generally directly proportional to the pressure differential. In one aspect of the present invention, the rate of leak is used to maintain calibration over time.
  • the method described does provide a means for in vivo calibration of gain (and offset if the assumption holds true) without direct access to the transducer through the skin.
  • the method of using a chamber against the skin overlying the transducer would work only for those cases where access to the second side the transducer is located very superficially.
  • the step of measuring at least one second pressure includes measuring at least one second pressure wherein the at least one second pressure is indicative of an upper airway pressure.
  • the comparator comprises a digital computer.
  • a pressure measurement calibration system in another embodiment, includes: one or more first sensors for measuring a first measured pressure at a first location at least partially within a medical patient; one or more second sensors for measuring a second measured pressure at a second location with respect to the medical patent; and a perturbation operable to calibrate the one or more first sensors based upon the second measured pressure.
  • a pressure measurement calibration system is provided.
  • a pressure measurement calibration system in another embodiment, includes: a first means for measuring a first measured pressure at a first location inside of a medical patent; a second means for measuring a second measured pressure at a second location with respect to the medical patent; and a perturbation, where the perturbation is operable to calibrate the first means with respect to the second measured pressure.
  • inducing a perturbation comprises one or more of the following: performing a Mueller maneuver, applying positive pressure artificial ventilation, performing unassisted normal ventilation, applying assisted positive pressure artificial ventilation, performing forced rhythmic breathing, sneezing, humming, coughing, abdominal straining, applying insufflations of a body cavity, applying external mechanical pressure, applying external hydraulic pressure, applying external pneumatic pressure, applying an acceleration, applying a deceleration, applying a change in ambient air pressure, applying a change in ambient temperature.
  • the PCWP, LAP, PADP, LVEDP, RA, and RVEDP vary in a highly predictable and reproducible way with upper airway pressure during the Valsalva maneuver in patients with and without congestive heart failure.
  • patients with a history or other objective evidence of congestive heart failure are instrumented with a pulmonary artery balloon flotation catheter (Swan-Ganz®) to measure first transducer pressures RAP, RVEDP, PAD, or PCWP.
  • first transducer pressures are measured with a pigtail catheter placed in the left ventricle to measure LVEDP, or a trans-septal catheter is placed to measure LAP.
  • the fluid filled catheters are connected to external calibrated resistive strain gauge transducers that measure gauge pressure.
  • Si a- ⁇ LAP - Po
  • si the measured output value at a moment in time in the cardiac cycle
  • a and Po are the unknown gain and offset calibration parameters
  • LAP the unknown true left atrial pressure at the same moment in time in the cardiac cycle.
  • Calibration parameter shall be given its ordinary meaning and shall include calibration coefficient as well.
  • maneuvers can be used to manipulate intracardiac and intrathoracic pressures in a predictable way allowing non-invasive in vivo calibration of implanted pressure transducers.
  • Other examples of maneuvers that can be used in accordance with the current invention include the Mueller maneuver, which is the forced attempted inspiration through a restricted or blocked orifice, and forced rhythmic breathing through a restricting orifice.
  • the intrathoracic pressure is reduced and/or increased in known relation to the reduced upper airway pressure during inspiration and/or expiration.
  • the adjustment factor is compared to a predetermined adjustment factor tolerance range. If the adjustment factor falls within the tolerance range, the calibration of the system is left unchanged. In one aspect, if the adjustment factor falls outside the tolerance range, the pressure measurement system is calibrated as described, for examble, above.
  • the adjustment factor tolerance range is at least as wide as the error in determining the adjustment factor itself. In a further aspect, the tolerance range is specified such that changes of the adjustment factor within the tolerance range produce pressure measurement changes that are medically insignificant.
  • any site within the thoracic cavity is subject to transmitted perturbation in pressure associated with respiratory maneuvers.
  • other respiratory maneuvers are determined to create transient pressure changes at locations of the first and second transducers that are related one to the other, where an empirically validated algorithm can characterize that relationship. All such maneuvers and relationships can be empirically validated before being applied as a method of transducer calibration.
  • Other respiratory maneuvers include, but are not limited to, deep rapid breathing, breathing through a narrowed mouthpiece that restricts air flow, positive pressure ventilation, high frequency ventilation, coughing, sneezing, humming, etc.
  • Another example is the Mueller maneuver which is the opposite of the Valsalva.
  • the pressure measurement device provides a measurement of pressure.
  • the ambient pressure is compared to a valid ambient pressure range and the measured pressured is compared to a valid measured pressure range. If both values fall within their respective valid pressure ranges, the method proceeds to operational block 50, where the appropriate therapy is subsequently delivered. If either value does not fall within its respective valid pressure range, the method returns to operational block 40, whereby the pressure measurement device is calibrated once again.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Physics & Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Public Health (AREA)
  • Surgery (AREA)
  • Cardiology (AREA)
  • Physiology (AREA)
  • Psychiatry (AREA)
  • Child & Adolescent Psychology (AREA)
  • Developmental Disabilities (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychology (AREA)
  • Social Psychology (AREA)
  • Hematology (AREA)
  • Vascular Medicine (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)
  • Measuring Fluid Pressure (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)
PCT/US2003/015174 2002-05-14 2003-05-14 Minimally invasive calibration of implanted pressure transducers Ceased WO2003098177A2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP03753033A EP1503662A4 (en) 2002-05-14 2003-05-14 APPARATUS AND METHOD FOR MINIMAL INVASIVE CALIBRATION OF IMPLANT PRESSURE TRANSDUCERS
AU2003232133A AU2003232133A1 (en) 2002-05-14 2003-05-14 Minimally invasive calibration of implanted pressure transducers
JP2004505655A JP2005525572A (ja) 2002-05-14 2003-05-14 複数の埋め込まれた圧力変換器の低侵襲較正のための装置および方法

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US37816602P 2002-05-14 2002-05-14
US60/378,166 2002-05-14
US10/438,309 US7195594B2 (en) 2002-05-14 2003-05-13 Method for minimally invasive calibration of implanted pressure transducers
US10/438,300 US7862513B2 (en) 2002-05-14 2003-05-13 Apparatus for minimally invasive calibration of implanted pressure transducers
US10/438,309 2003-05-13
US10/438,300 2003-05-13

Publications (2)

Publication Number Publication Date
WO2003098177A2 true WO2003098177A2 (en) 2003-11-27
WO2003098177A3 WO2003098177A3 (en) 2004-06-24

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2003/015174 Ceased WO2003098177A2 (en) 2002-05-14 2003-05-14 Minimally invasive calibration of implanted pressure transducers

Country Status (5)

Country Link
US (2) US7195594B2 (enExample)
EP (1) EP1503662A4 (enExample)
JP (2) JP2005525572A (enExample)
AU (1) AU2003232133A1 (enExample)
WO (1) WO2003098177A2 (enExample)

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WO2017165761A1 (en) * 2016-03-24 2017-09-28 Eresearchtechnology, Inc. Methods and systems for collecting spirometry data
US10376694B2 (en) 2008-10-09 2019-08-13 Virender K. Sharma Method and apparatus for stimulating the vascular system
US10603489B2 (en) 2008-10-09 2020-03-31 Virender K. Sharma Methods and apparatuses for stimulating blood vessels in order to control, treat, and/or prevent a hemorrhage

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