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    Ppt For Esteck Complex For New Broucher Diagnosis Ppt For Esteck Complex For New Broucher Diagnosis Presentation Transcript

    • LD TECHNOLOGY SYMPOSIUM CANCUN 2008
    • Welcome to LD TECHNOLOGY
      We are listening the body signals
      <
      <
      <
    • Medical devices Positioning Diagnosis /Monitoring
      GENERAL INFORMATION’S
      ACCURACY
    • DIAGNOSIS DEFINITION*
      Diagnosis is the identification, by process of elimination, of the nature of anything.
      *Wikipedia
    • Process of elimination in medical diagnosis
      Clinical context : signs, symptoms, history, current treatments………………..
      Specific Examinations : Medical devices
      • Imaging
      • In vitro Laboratory tests
      • In vivo Physiological measurements
      .Physician’s Knowledge and interpretation
    • Medical devices
      • features : Provide Indicators necessary for the process of elimination for diagnosis
      • A medical device do not make a diagnosis, only a Physician can make a diagnosis.
      • According to the investigation site, each medical device is providing specific indicators in same or different direction.
      • The cross analysis of all indicators are necessary in the process of elimination for diagnosis and interpretation and knowledge of the physician
    • Accuracy of the Medical devices
      Depend of the Specificity and Sensitivity of the Indicators provided.
    • Specificity and sensitivity
    • Diagnosis are hypothesis
      After the process of elimination , the cross analysis of the clinical context and supplementary examinations , the physician make a hypothesis of diagnosis: because the human body is a complex of balance and all the dysfunctions or diseases have implications in all the body systems
    • Treatment choice
      Hypothesis of diagnostic
      Adapted Treatment of the diagnosed diseases issues from the clinical investigations
      Improvement of the results of the supplementary examinations
      No Improvement of the results of the supplementary examinations
      MONITORING
      Improvement of the clinical context
      Or Improvement or no improvement of the clinical context
      Side effect over the benefits of the treatment
      No validation , misdiagnosis or no responses dues to inter individual difference
      Validation of the diagnosis hypothesis
    • EIS SYSTEM TECHNOLOGY
      FEATURES
      BACKGROUND
    • EIS Measurement
    • EIS SYSTEM Features : Impedance plethysmography
      1.Measurement of the conductivity in DC* of 22 segments of the human body.
      *The conductivity in DC ( way from anode (+) to cathode (-) ) is proportional with the :
      • I.S.F volume
      • I.S.F Ionic concentration and in particular the Na+ concentration
      • Blood flow
      Conductivity measurement accuracy +/-3.5%
      2. Modeling** of the Human body according to the conductivity of the 22 segments by mathematical application of the Venn diagram and the normal positioning extrapolation of the body systems.
      **Accuracy of the modeling ( p<0.001) for the cerebral frontal lobes, digestive system Prostate and thyroid.
    • EIS Features
      Sequence of the measurement of the 22 body segments
      ESG graphic: conductivity of the 22 segments
      ESG normal range values
    • EIS Features (2)
      Min
      C
      O
      N
      D
      U
      C
      T
      I
      V
      I
      T
      Y
      Venn diagram calculation
      Max
      Modeling
      Maxwell equation’ s calculation
    • EIS / EFFECT OF THE DC CURRENT IN INTERSTITIAL FLUID
      Na+
      The current is carrier by the ions . The Current is sending from the Anode (+) to Cathode (-) , and therefore the Na+ ( most significant concentration of positive ions in the IF) are moving to the negative pole .
      The conductivity is proportionally increased with the Na+ concentration and the volume of the interstitial fluid
      Na+
      Na+
      Na+
      Na+
      1.28 V
    • Na+/K+ pump Na+/H+ anti porterNa+/ATP Production
      Na+
      Na+
      Na+
      Na+
      Na+
      H+
      Na+
      Na+
      Na+
      Na+
      Na+
      ATP
    • Interstitial fluid volume and Oxygen delivery
      Effect of inter capillary distance on relation between oxygen delivery BMJ. 1998 November 14; 317(7169): 1370–1373. Copyright © 1998, British Medical Journal
    • EIS MODELING PARAMETERS
      • I.SF volume
      Related with the Oxygen delivery and osmotic/ hydrostatic pressure
      • I.SF [Na+]
      Related with [K+] (2/3), [H+] and ATP production.
      • Blood flow
      Related with the Blood viscosity and the Blood velocity.
    • EIS –BF SYSTEM
      CLINICAL INVESTIGATIONS
      UPDATE VERSION 10
    • EIS- BF Clinical Investigations
      Accuracy for Monitoring of the following treatment (p< 0.001) : Sp 94% No sensitivity
      Thyroid substitute treatment
      Hypo tensors ( Beta blockers and CEI)
      Anticoagulants
      Antidepressants SSRI
      Accuracy in Adjunct in conventional diagnosis of the ADHD children: (p< 0.0001) :
      Sp 95% / Se 78%
    • Visit 1 : No treatment
      Visit 2: Dosage 100 µg
      Visit 3: Dosage 120 µg
      Visit 4: Dosage 150 µg
      Visit 5: Dosage 100 µg
      Thyroid value in EIS Modeling
      Visit 1 :-40 Visit 2: -10
      Visit 3: 0
      Visit 4: +20
      Visit 5: -5
      N=52
      (r=0.79, P<0.001, and r=0.80, P<0.001, respectively).
      TSH measured in lab tests
      Visit 1
      Visit 2: 6
      Visit 3: 3
      Visit 4: 0
      Visit 5: 2
      N=52
      (r=0.81, P<0.001, and r=0.73, P<0.001, respectively).
    • N=52
      (r=0.79, P<0.001, and r=0.80, P<0.001,).
      N=52
      (r=0.79, P<0.001, and r=0.80, P<0.001,).
    • N=52
      (r=0.79, P<0.001, and r=0.80, P<0.001,).
      N=52
      (r=0.79, P<0.001, and r=0.80, P<0.001,).
    • N=52
      (r=0.79, P<0.001, and r=0.80, P<0.001,).
      N=52
      (r=0.79, P<0.001, and r=0.80, P<0.001,).
    • ADHD Children Profile
    • EIS BF Results Version 10
    • Digestive system Indicators
    • Brain Indicators
    • Cardiovascular Indicators
    • HORMONAL INDICATORS
    • RESPIRATORY INDICATORS
    • General metabolic indicators
    • Uro genital and renal indicators
    • Follow up of all the indicators
    • Medications monitoring indicators
    • Antidepressant (SSRI) Follow up
      Before treatment
      Response
      No response
    • Follow up of the Cerebral neurotransmitters
    • Medications monitoring indicators
    • Follow up of thyroid treatment
      Monitoring and results
      Before treatment
      Over doses
      Under doses
    • Medications monitoring indicators
    • Anti agregants and anticoagulants follow up
      Before treatment
      Effective treatment
      No effective
    • Medications monitoring indicators
    • Beta blockers follow up
      Before treatment
      No effective treatment
      Overdosis and side effects
      Good treatment
    • CEI Follow up
      Before treatment
      Good treatment
      Overdose and side effect
      No effective
    • ADHD Children profile and diagnosis in adjunct with the clinical context
    • Indicator of ADHD Children
      Lack Dopamine and Serotonin and signs and symptoms from clinical context children less 17 y.o
    • EIS POSITIONING
      QUALITY SYSTEM IN MEDECINE
    • EIS System: May be a possibility for help the quality system requirements in medicine
    • Positioning of the EIS in the Quality System Requirements
      EIS SYSTEM
      ADHD
    • Why a quality system with the EIS System
      • No invasive, quick, usability, Low cost
      • For the patient : Understanding of the treatment and goal of the treatment
      • For the practitioner Early visualization of the therapies and early possibility of corrective action
      • Because a disease treatment requires drug, sometime surgery and always lifestyle change
      • Because , the major diseases cannot be treated by lifestyle change or alternative medicine.
    • Benefits of the quality system in medicine
      • For the patient:
      Visualization / motivation/ compliance
      • For the practitioner:
      • Organization , save time
      • Better understanding of the intended use and side effects of the treatments used
      • Corrective actions that the patient can understand
      • Referrals
      • Income increased
    • NEW PRODUCTS
      WHY?
    • New products
      EIS
      BWS: Wellness and lifestyle
      ES Teck: Estimated of the ANS activity and of cardiovascular indicators. 510k in progress
      Nr K083229
      ES Teck Complex : Combination EIS /ES Teck
      ITM Breast imaging by electro impedance.
    • EIS New application : BSW (Body Scan Wellness)
      Why BSW?
      Because
      There is not good or bad diet for every people, there is good or bad diet for each person
      The change of nutrition need to be monitoring and the good nutrition for each person is not available all his life.
      Based on the EIS and BC device measurement
    • Why the E S Teck
      Because
      HRV ( ANS activity estimation)
      Photoelectrical Plethysmograph ( Vascular estimation)
      body composition and the phase Angle measurement
      Can give new indicators in the process of elimination of the physician’s diagnosis
    • Why the ES Teck Complex
      Combination of the EIS and the ES Teck:
      Because :
      The cross analysis of the indicators issue from 4 different technologies will increase the sensitivity and therefore the accuracy of a medical device
    • Why the ITM
      • Because
      • The positive predictive value of mammography for breast cancer ranges from 20% in women under age 50.
      • The tissue conductivity has a high sensitivity (> 80%) for the cancer.
      • The ITM as an adjunct to mammography in patients who have equivocal mammographic findings within ACR BI-RADSTM categories 3 or 4 provides the radiologist with additional information to guide a biopsy recommendation and increase the sensitivity of the examination from 20 % to 80 % in women under age 50.
    • BODY SCAN WELLNESS
      New application
      of the EIS Technology
    • BWS Measurement
    • BSW Results
    • Body Composition
    • Nutritional and micro nutrional program Analysis
    • Nutritional Analysis ReportAll results should be considered in the clinical context of the patient's case history, symptoms, known diagnosis, current medications, treatment plan and therapies. This diet analysis does not replace the advice of your practitioner.The estimated body composition is made according to the James equation and the formulas from the peer reviews.
    • Nutritional Analysis Report (2)
    • Body Composition Follow up
    • ES TECK SYSTEM
      GENERAL INFORMATION’S
    • ES Teck System (Cardiology)
      HRV Photoelectrical Plethysmograph
    • HRV ( short time)
      HRV Reference:
      Task Force of The European Society of Cardiology and The North American Society of Pacing and Electrophysiology (1996)
    • SpO2 and Photoelectrical Plethysmograph
      References:
      • Nichols WW, O’Rourke MF. McDonald’s : Blood Flow in Arteries:Theoretical, Experimental and Clinical Principles. London: Arnold, 1998.
      • Takazawa, Kenji; Tanaka, Nobuhiro; Fujita, Masami; Matsuoka, Osamu; Saiki, Tokuyu; Aikawa, Masaru; Tamura, Sinobu; Ibukiyama, Chiharu :Assessment of Vasoactive Agents and Vascular Aging by the Second Derivative of Photoplethysmogram Waveform Hypertension: Volume 32(2)August 1998pp 365-370
      • IToshiaki OTSUKA , Tomoyuki KAWADA , Masao KATSUMATA , Chikao IBUKI , and Yoshiki KUSAMA ndependent Determinants of Second Derivative of the Finger Photoplethysmogram among Various Cardiovascular Risk Factors in Middle-Aged Men Hypertens Res Vol. 30, No. 12 (2007)
      • Toshiaki Otsuka, , Tomoyuki Kawada, Masao Katsumata,ChikaoIbuki, :Utility of Second Derivative of the Finger Photoplethysmogram for the Estimation of the Risk of Coronary Heart Disease in the General Population Circ J 2006; 70: 304 – 310
      • Alberto Avolio: The finger volume pulse and assessment of arterial properties .Journal of Hypertension 2002, 20:2341–2343
      • Oximeter Guidelines 1998
    • ES Teck Measurements
    •  Heart Rate and sinus node depolarization
    • Autonomic Nervous System and Heart rate variability
    • SpO2 AND Photoelectrical Plethysmography
      SpO2 Probe
      Infra red/ Red
      660/905 nm
      Photo diode
      SpO2%
      PR
      Vascular waves
    • SpO2 ANALYSIS
      Oxygen - hemoglobin Affinity Changes.
      The functions of hemoglobin are oxygen pickup and delivery. The hemoglobin has an affinity (the strength of bond between oxygen and hemoglobin) that can be increased or decreased due to various situations. If hemoglobin has an increased affinity, it is highly saturated; but oxygen is less available for release to the tissues due to the strong bond. The reverse is also true.
    • Vascular Wave Analysis
    • Analysis by Acceleration and Second derivative
    • Analysis of the Second derivative with age
    • Analysis of the second derivative and diseases : b/a
    • Analysis of the second derivative and diseases : d/a
    • Specificity and sensitivity of the b/a and d/a indicators
    • Specificity and sensitivity of the b/a and d/a indicators
      Ref. Toshiaki OTSUKA , Tomoyuki KAWADA , Masao KATSUMATA , Chikao IBUKI , and Yoshiki KUSAMA Independent Determinants of Second Derivative of the Finger Photoplethysmogram among Various Cardiovascular Risk Factors in Middle-Aged Men Hypertens Res Vol. 30, No. 12 (2007)
    • Results of ES Teck
    • HRV STATISTICAL RESULTS
    • SpO2 and Photoelectrical Plethysmograph results
    • E.S TECK COMPLEX
      GENERAL INFORMATION’S
    • ES TECK COMPLEX THE NATURAL EIS UPDATE
    • ES Teck Complex Measurements
    • CROSS ANALYSIS
    • E.S TECK COMPLEX INTENDED USES
      • HRV module: To analyze the basic rhythms of the NN or RR intervals in electrocardiograms, both in the time domain and in the frequency domain (short time 5 minutes)
      • It only provides numerical analyses of the input electrocardiogram.
      • Estimate of the parasympathetic and sympathetic system stimulation.
      • PP module: Analyze the pulse waveform by photoelectric plethysmography and Pulse rate.
      • Evaluation of Large and small artery
      • EIS module:
      • Monitoring of diseases, functional and lifestyle ‘ treatments
      • Adjunct to conventional diagnosis of ADHD children
      • BIA module :
      • Calculation and Historical Tracking of body composition
    • Body Impedance Analysis (BIA)
      Measurement of the Resistance and Reactance in Tetra polar mode with a frequency of 50 KHz
    • Resistance and Reactance measurements
      Resistance is a measure of how difficult it is for electricity to flow through an object.
      Reactance
      Most objects have some capacitance, which is a measure of ability to store an electrical charge. The more capacitance the object has, or the faster the current changes direction, the less the object will “react” to the current.
       
    • EIS B I A
      Peer reviews formula
      • Total Body Water :TWB
      5-19 y.o Davies et al 1988
      20-80 y.o Lukaski and Bolonchuk 1988
      Adult obese subjects: Segal et al 1988
      • Fat free fat mass:
      7-15 y.o Deurenberg et al 1991
      16-83 y.o Deurenberg et al 1991
      • Extra cellular water volume : EWC
      Sergi G, et al 1994
    • Phase Angle
    • Impedance Components
      Phase Angle
      Xc = 1 / (2 * PI * F * C), C – Capacity [Farad]
      Phase Angle = Arctan (Xc / R)
    • Clinical application in survival in colorectal cancer
      The survival curves for the 2 categories of phase angle areshown. Patients with a phase angle < 5.57 had a mediansurvival of 8.6 mo (95% CI: 4.8, 12.4; n = 26), and those witha phase angle > 5.57 had a median survival of 40.4 mo (95%CI: 21.9, 58.8; n = 26); this difference was significant (P= 0.0001).
    • Impact of phase angle in liver cirrhosis
    • NEW INTERFACE
    • E.S TECK RESULTS
    • EIS ANALYSIS
    • HRV STATISTICAL RESULTS
    • HRV RECORDS
    • HRV GEOMETRICAL ANALYSIS
    • SpO2 RESULTS AND MANAGEMENT OF THE PHOTOELECTRICAL WAVE
    • PHOTOELECTRICAL PLETHYSMOGRAPH ANALYSIS AND RESULTS
    • Vascular Indicators
      PH : Relation with blood flow of small artery
      EEI : Relation with LV ejection and elasticity of large artery - LV Ejection Insufficiency
      DDI : Relation with contraction and tension of small artery - Hypertension & Arteriosclerosis
      DEI : Relation with blood flow to vein system.
      Etc (Estimated Cardiac Ejection time) : 260~380  Function of left ventricle
    • BODY COMPOSITION RESULTS
    • Body Composition follow up
    • E.S TECK COMPLEX
      • CROSS ANALYSIS
      • MODELING AND BODY SYSTEMS’ INDICATORS
    • DIGESTIVE SYSTEM INDICATORS
    • BRAIN INDICATORS
    • CARDIOVASCULAR INDICATORS
    • HORMONAL INDICATORS
    • RESPIRATORY SYSTEM INDICATORS
    • GENERAL METABOLIC INDICATORS
    • UROGENITAL AND RENAL INDICATORS
    • Follow up of all the indicators
    • Follow up of the Cerebral neurotransmitters
    • Medications monitoring indicators
    • Medications monitoring indicators
    • Medications monitoring indicators
    • Medications monitoring indicators
    • ADHD Children profile and diagnosis in adjunct with the clinical context
    • Chiropractor Indicators and monitoring treatment
    • Advices for Lifestyle and exercises and monitoring
    • Advices for Lifestyle and exercises and monitoring
    • Advices for Lifestyle and exercises and monitoring
    • Exercises
    • Sport men condition Evaluation and improvement
    • Statistical risk analysis
      No access before 5 measurements. The accuracy increased with the number of measurements.
      Statistical analysis of the indicators of each body systems and metabolic general indicators
      It is not a diagnosis , but help for the physician in the process of elimination
    • I.T.M Impedance Tomography Mammography
      GENERAL INFORMATION’S
    • ITM ADJUNCT TO THE MAMMOGRAPHY
      BI-RADS
    • MAMOGRAPHY IMAGES AND MRI IMAGES
    • MAMMOGRAPHY AND ITM IMAGES
    • Mammography accuracy
      • specificity from 90% to 95%
      • The positive predictive value of mammography for breast cancer ranges from 20% in women under age 50 to 60% to 80% in women age 50-69. Randomized clinical trials (RCTs) have demonstrated a 30% reduction in breast cancer mortality in women 50-69 years who are screened annually or biennially with mammograms. (4) The data on women under age 50 are less clear.
    • Breast Cancer tissue and conductivity
      The studies of T-Scan and ITM devices are demonstrated the evidence between the breast cancer tissue and the increased of conductivity. The sensitivity is > at 80 %
    • MRI and Ultrasound
      The specificity of these techniques are inferior to the mammography and do not increased the sensitivity of the screening
    • ITM in adjunct to the Mammography
      Increase the sensitivity of the breast cancer diagnosis from 20% to 80% for the women under 50 y.o and therefore reduce the number of no necessary biopsies
    • Intended Uses
      In Gynecology:
      The ITM is intended for use as:
      Early detection of mastopathy and monitoring of the mastopathy treatment.
      Estimated the lactation function for the pregnant women
      In Oncology:
      The ITM is intended for use as an adjunct to mammography in patients who have equivocal mammographic findings within ACR BI-RADSTM categories 3 or 4.
      This device provides the radiologist with additional information to guide a biopsy recommendation.
      The device is intended for use on women age > 20 years old and increase the sensitivity of the diagnosis of breast cancer in particular for the women under 50 y.o
      The system will be use by licensed practitioner and the interpretation will be made by radiologists who have satisfactorily completed the training phase of the ITM system.
    • Contra Indications
      None known to date
      No Invasive and Safe
      No Compressive
    • The ITM Device
    • ITM Data acquisition sequence
      Connect first matrix electrode to voltmeter
      Connect first matrix electrode to current source
      Inject current and
      make measurement
      Last electrode
      for injecting?
      No
      Connect next matrix
      electrode to current source
      Yes
      Last electrode
      for measuring?
      Connect next matrix
      electrode to voltmeter
      No
      Result is 65536 pulses
      In 22 seconds
      Yes
      End of measurements
    • Reconstruction


      I
      L
      x
      y
      E
      z
      R
      Re
      P(x,y,z)
      - measured electric intensity
      - reference electric intensity
      Electrical impedance tomography with planar array enables imaging of three-dimensional distribution of electrical conductivity in subsurface areas (~ 5-cm depth) using flat matrix of 256 electrodes. For the convenience of viewing, the results are represented as the set of
    • ITM Calculation of the electric field intensity
      1. Finite-difference approximation on staggered grids:
      x1
      2. Two-dimensional linear interpolation of each component:
      y2
      : electrodes
      : grid, where Exis defined
      : grid, where Eyis defined
      position inside corresponding grid cell
    • The T-Scan 2000 First application
      of the Impedance Mammography
      The T-Scan™ 2000 is an electrical impedance scanning device that received approval for marketing from the U.S. Food and Drug Administration (FDA) in 1999, with the following labeled indication: "The T-Scan™ 2000 is intended for use as an adjunct to mammography in patients who have equivocal mammographic finding with ACR Bi-RADS™ categories 3 or 4…”
      Electrical impedance studies are used as an adjunct to mammography to improve patient selection for biopsy in patients with equivocal indications..
    • ITM Versus T-Scan 2000
      V
      V
      V
      V
      V
      A
      A
      A
      A
      A
      A
      T-Scan measurements
      ITM measurements
      V
      I
      ~
      ~
      Image quality is rigidly limited in T-Scan by the physics of the current flow. The collected data set is poor and no data processing is applicable.In ITM system there are no hard limitations of image quality. The number of electrodes, accuracy of measurements and complexity of reconstruction algorithm are limiting factors. The collected data set is full for given geometry of electrodes.
    • ITM Versus T-Scan 2000
      8 images for each breast and only 2 depth slides. 42 electrodes and 2 frequencies
      1 image for each breast and 7 depth slides . 256 electrodes and 7 frequencies
    • IMAGES’ PRESENTATION
    • BREAST NORMAL RANGE OF CONDUCTIVITY
    • ITM Clinical investigation protocol performed in accordance with trial protocol approved by the Western Institutional Review Board (WIRB) in Olympia, Washington
    • Specificity = Mammography + ITM diagnosis is malignant | Biopsy is malignant) = 13/14 = 0.926Specificity = only Radiology diagnosis is malignant | Biopsy is malignant) = 13/14 = 0.926Note that the specificity for malignant biopsy (cancer) is the same for both Mammography + ITM and diagnostic only radiology.Sensitivity Mammography + ITM diagnosis is benign | Biopsy is benign) = 17/26 = 0.654 Similarly, the conditional probability that defines specificity for diagnostic radiology is as follows: Sensitivity only Radiology diagnosis is benign | Biopsy is benign) = 3/26 = 0.115
    • CLINICAL CASES
    • FIBRO ADENOMA
    • FIBRO ADENOMA CONDUCTIVITY
    • Mastopathy : Multiple cysts of the left and the right breasts
    • Multiple cysts of the left and the rights breasts
    • Left Breast Cancer
    • Left Breast Cancer : Conductivity analysis
    • TECHNICAL SUPPORT
    • Remote Technical Support Assistance
    • Remote Technical Support Assistance
    • Installation problems
    • Software problems
    • Hardware problems
    • NETWORK
    • Contract of MaintenanceFree the first yearAnd then US$ 500 / Year If no maintenance contract : Update price : US$ 400Each technical support intervention: US$ 80
    • BILLING SYSTEM
    • BILLING SYSTEM NETWORK