WO2016138541A1 - Essai de distensibilité œsophagienne utilisant l'impédance électrique - Google Patents

Essai de distensibilité œsophagienne utilisant l'impédance électrique Download PDF

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Publication number
WO2016138541A1
WO2016138541A1 PCT/US2016/020138 US2016020138W WO2016138541A1 WO 2016138541 A1 WO2016138541 A1 WO 2016138541A1 US 2016020138 W US2016020138 W US 2016020138W WO 2016138541 A1 WO2016138541 A1 WO 2016138541A1
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csa
impedance
measurements
volume
saline
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PCT/US2016/020138
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English (en)
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Ravinder MITTAL
Ali ZIFAN
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The Regents Of The University Of California
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Publication of WO2016138541A1 publication Critical patent/WO2016138541A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/687—Oesophagus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0538—Measuring electrical impedance or conductance of a portion of the body invasively, e.g. using a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/107—Measuring physical dimensions, e.g. size of the entire body or parts thereof
    • A61B5/1076—Measuring physical dimensions, e.g. size of the entire body or parts thereof for measuring dimensions inside body cavities, e.g. using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/42—Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems
    • A61B5/4205—Evaluating swallowing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0048—Detecting, measuring or recording by applying mechanical forces or stimuli
    • A61B5/0053—Detecting, measuring or recording by applying mechanical forces or stimuli by applying pressure, e.g. compression, indentation, palpation, grasping, gauging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient ; user input means
    • A61B5/742—Details of notification to user or communication with user or patient ; user input means using visual displays
    • A61B5/7445—Display arrangements, e.g. multiple display units

Definitions

  • the subject application relates to esophageal distensibility testing.
  • Prior methods for testing esophageal distensibility include using esophageal ultrasound imaging (US) or using a functional luminal imaging probe (FLIP) which estimates distention using a balloon at one site in the gastrointestinal tract.
  • US esophageal ultrasound imaging
  • FLIP functional luminal imaging probe
  • one methodology involves measuring volume change across the entire esophagus as a surrogate of cross-sectional area (CSA) change, by combining the volume of the bolus taken by the patient during a swallow with an impedance measurement taken at multiple electrode pair sites to solve a system of linear equations, to get the individual volume changes at each electrode pair site.
  • CSA cross-sectional area
  • the posture of the patient can also affect the measurement, as air swallowed along with salinecan create inaccurate measurements. Particularly in the supine position, there is a mixture of air and saline with each swallow.
  • air in the bolus can result in an exaggeration of the impedance values.
  • Systems and methods according to present principles solve one or more of the problems above, and relate to measuring intraluminal esophageal distention/luminal cross sectional area (CSA) during bolus transport using multichannel intraluminal impedance (Mil) measurements.
  • CSA intraluminal esophageal distention/luminal cross sectional area
  • Mo multichannel intraluminal impedance
  • the invention is directed towards a method for estimating intraluminal esophageal distension/luminal cross sectional area (CSA) during peristalsis using multichannel intraluminal impedance (Mil) measurements in real-time, the measurements performed by a Mil catheter having a plurality of electrode pairs, including: taking a first set of impedance measurements while a subject swallows a bolus having a first volume and a first concentration of saline solution, the first set corresponding to measurements taken at different electrode pairs of the Mil catheter; taking a second set of impedance measurements while a subject swallows a bolus having a second volume and a second concentration of saline solution, the second set corresponding to measurements taken at different electrode pairs of the Mil catheter, where the second concentration of saline solution is different than the first concentration; repeating the taking a first set and the taking a second set for respective third and fourth volumes of saline solution; and estimating a CSA at one or more points of the es
  • Implementations of the invention may include one or more of the following.
  • the first volume may be equal to the second volume, and the third volume equal to the fourth, and the first and second volumes may be unequal to the third and fourth.
  • the estimating a CSA may include solving two algebraic equations in two unknowns, the two algebraic equations expressing Ohm's law, the two algebraic equations resulting from the first and second sets of measurements taken at different concentrations of saline solution.
  • the method may further include refining the estimates of CSA using a correction factor.
  • the correction factor may be calculated in vitro in glass test tubes of known CSA.
  • the method may further include providing a visualization of the estimated CSA.
  • the visualization may include distention of the esophagus in real-time as a bolus is ingested.
  • the first volume, second volume, third volume, and fourth volume may all be different.
  • the first and second concentrations of saline may be chosen to reduce or eliminate an effect of parallel impedances.
  • the first and second concentrations of saline may be chosen to cause the impedance measurements to have a net effect of only measuring esophageal impedance.
  • the estimated CSA may be directly proportional to the distance between electrode pairs.
  • the estimated CSA may be inversely proportional to the difference between the first and second concentration of saline.
  • the estimated CSA may be based on nadir impedance values.
  • the method may further include displaying an indication on a user interface that the subject being measured should adopt the Trendlenburg position.
  • the method may further include measuring a pressure in the esophagus, and calculating a value of esophageal compliance based on the estimated CSA and the measured pressure.
  • the invention is directed towards a non-transitory computer readable medium, including instructions for causing a computing environment to perform the above method.
  • the invention is directed towards a system for estimating intraluminal esophageal distension/luminal cross sectional area (CSA) during peristalsis using multichannel intraluminal impedance (Mil) measurements in real-time, including: a catheter configured to perform Mil measurements and having a plurality of electrode pairs; a monitoring system, the monitoring system configured to perform a method, the method including steps of: taking a first set of impedance measurements using the catheter while a subject swallows a bolus having a first volume and a first concentration of saline solution while in a Trendelenburg position, the first set corresponding to measurements taken at different electrode pairs of the Mil catheter; taking a second set of impedance measurements using the catheter while a subject swallows a bolus having a second volume and a second concentration of saline solution while in the Trendelenburg position, the second set corresponding to measurements taken at different electrode pairs of the catheter, and where the second concentration of saline solution is different than the first concentration; repeat
  • Advantages of the invention may include, in certain embodiments, one or more of the following.
  • Implementations can expand use of current technology, e.g., esophageal manometry along with Mil is routinely performed in the diagnosis of difficulty swallowing (dysphagia) and esophageal motility disorders, and systems and methods according to present principles can greatly expand Mil, currently used in GI function labs, to measure luminal distension during bolus transport, which is not currently nor measured in an optimized way.
  • the disclosed method can potentially revolutionize esophageal motility testing by adding another powerful tool alongside manometry, in diagnosing various motility disorders.
  • FIG. 1 shows the effect of posture on the separation of liquid and air in the swallowed bolus.
  • the subject In Fig. 1(A), the subject is in the supine position where air and liquid surround the electrodes.
  • Fig. 1(B) the subject is in the Trendelenburg position where air, being lighter than liquid, is located in the caudal and liquid in the cranial part of the bolus. Lines around the electrodes represent where the electrical field is present, which includes the bolus, the
  • Fig. 2 illustrates (a) the relationship between saline concentration and conductance values measured in test tubes of different cross sectional area, and (b) estimation error between actual CSA of the tube and values estimated from the impedance method.
  • Fig. 3 illustrates (a) US B-mode delineations for swallowed bolus volumes of 5, 10 and 15cc's, (b) a boxplot showing the distribution of CSA across the three volumes, (c) the identity relation for two US duplicates measurements, (d) Bland-Altman plots for the pair-wise comparisons of two US CSA measurements, including mean differences (solid line) and 2SD limits (dashed lines).
  • Fig. 4 illustrates (a) impedance topographs of a sample lOcc swallow: (a) 0.1N, (b) 0.5N, (c) impedance tracing with swallows of 0.1N and 0.5N saline swallows, where lines represent mean value and the shaded area around them represents one standard deviation, and (d) zoomed version of (c) between the 6 th and 10 th second time period.
  • the impedance value represents passage of air over the electrode followed by a drop in impedance which reflects passage of the saline bolus over the electrodes. Nadir impedance values are lower with 0.5N compared to 0.1N saline.
  • Fig. 5 illustrates (a) a boxplot of nadir impedance values with swallowed boluses of two saline concentration swallows with (a) 5cc, (b) lOcc, and (c) 15cc in each of the five subjects (A denoting 0.1N and B denoting 0.5N saline concentrations).
  • Fig. 6 illustrates (a) a boxplot showing the distribution of CSA across the three volumes using the two injection method protocol and equation described below, (b) the identity relation of the proposed impedance method versus an intraluminal US method, (c) Bland-Altman plots for the pair-wise comparisons of US and estimated CSA using Ohm's law with two solutions, mean differences (solid line) and 2SD limits (dashed lines).
  • Fig. 7(A) illustrates an exemplary user interface of the GulletXTM visualization tool
  • Fig. 7(B) illustrates a sequence of bolus transport visualizations during peristalsis in the supine position of a pairwise 5cc saline compound swallow. Pressure is overlaid on the mesh with different shades ranging from low to high pressure values.
  • the impedance drop between a pair of electrodes located in the esophagus during peristalsis occurs in a two-step process: an initial large drop in impedance that occurs with the arrival of bolus on the two electrodes (onset of esophageal distension), and a small drop in impedance that correlates with the increase in the esophageal luminal CSA thereafter.
  • the peak CSA coincides with the nadir impedance.
  • Kassab et al. proposed a strategy to estimate CSA of the blood vessels from impedance measurements, in which both of the above problems were addressed. They injected saline in the blood vessels to transiently replace blood to make the electrical field around the electrodes more uniform. Second, by the injection of two different saline concentrations, they used a revised Ohm's law equation to estimate the luminal CSA of the blood vessel. The two saline injection method eliminated the parallel impedance issue.
  • the impedance when an electric current passes through the length of the esophagus, the current experiences an opposition or impedance (Z) to its flow, which results in a loss of energy.
  • Z impedance
  • This impedance is not only due to the segment of the esophagus lying in between the electrode pairs, but also due to the tissue/organs in proximity of the electric field, because of leakage of the current into the surrounding body.
  • R Lx p/CSA where p denotes the resistivity ( ⁇ -m) of the conductor material, L the length of the conductor (m), and CSA the cross sectional area (m 2 ). Therefore, one can use Eq. (1) to calculate CSA provided all the other parameters in the former equation are known.
  • Esophageal electrical impedance (or equivalently resistance) can be obtained from
  • the total resistance will be a weighted sum of all the tissue/organs present in the electric field between the electrode pair, rather than solely the esophagus, causing inter-patient impedance value variability, especially differences in baseline.
  • the technique introduced by Kassab et al. for coronary arteries removes the above restriction, by using two bolus injections of saline solutions with known electrical conductivities to transiently displace blood and to effectively minimize the hemodynamics- induced blood conductance alterations for analytical determination of vessel cross-sectional area (CSA) and the electric current leakage through the vessel wall and surrounding tissue (parallel conductance).
  • CSA vessel cross-sectional area
  • Equation (5) the use of Equation (5) combined with the correction factor, estimated in-vitro, produces the final CSA at any electrode pair site.
  • the GIVEN system of impedance measurement can accurately resolve impedance values of greater than 90 Ohms; therefore higher concentrations of saline, i.e., > IN were not tested because they yielded impedance values ⁇ 90 Ohms.
  • Tubes were filled with different concentrations of saline that was heated to body temperature (37 ° C). At least one pair of impedance electrodes was submersed in the saline solution to measure the impedance value for each saline concentration and for each tube size. Conductivity of all the saline concentrations solutions at body
  • FIFIUS catheter probe 15 MHz, Boston Scientific instruments, Boston, MA, USA
  • Concurrent HRM/MII and FIFIUS imaging was recorded by placing the probe via the nose into the esophagus and positioning the same at 7cm above the lower esophageal sphincter (LES).
  • the saline solutions of 0.1N and 0.5N were warmed in a water bath set at body temperature (37°C) and their conductivities measured using a
  • the HRMZ catheter and the FIFIUS catheter were taped together in such a manner that the US transducer was positioned in the middle of two adjacent pressure transducers and the corresponding two impedance electrodes of the HRMZ catheter.
  • the nasal cavity and oropharynx were anesthetized using 1 % lidocaine gel and 1 % bezocaine spray and the catheter assembly was introduced via the nose into the esophagus and positioned with the US transducer located 7 cm above the LES.
  • ManoView ESO 3.0 when used in conjunction with a ManoScan V A400 (set to capture a maximum frame rate of 30Hz), provided the tools to acquire and visualize video data using a DVI-VGA connection.
  • the output from the ultrasound was fed into ManoView and synchronized video was recorded for the entire length of the recording.
  • US images were also recorded on a SVHS tape and subsequently digitized at video rates (30 images/s) using a video capture card (Pinnacle Express; Mountain View, CA, USA) interfaced to a personal computer using the Adobe Premiere 6.0 program (Adobe Systems; Mountain View, CA, USA) and captured in AVI format.
  • the corresponding B-mode US image was selected.
  • Esophageal mucosa and liquid interface was marked interactively using a custom built Matlab graphical user interface to calculate the esophageal luminal CSA.
  • Data were analyzed only for those events in which US image quality was adequate to define the luminal edges.
  • the CSA value was updated using the correction factor estimated from t ein-vitro study to calculate the final CSA estimate.
  • a Bland-Altman analysis was used to assess the level of agreement between the CSA measured by the proposed two-concentration impedance technique and the intraluminal ultrasound image technique. A range of agreement was defined as mean bias ⁇ 2SD. In a Bland- Altman diagram, the differences between the two measurements of CSA against their means are plotted.
  • the root mean square (RMS) error and squared sum of errors (SSE) was used to assess the reliability of the technique.
  • Fig.2(A) shows the relationship between different concentrations of saline and conductance for test tubes of different CSAs. Note that the relation between the conductance and the saline concentrations are nearly linear, especially for tube diameters smaller than the electrode spacing (20mm). Two concentrations of saline, 0.1N and 0.5N, were chosen for in-vivo human studies based on their least CSA approximation error using Eq. (5), and the fact that these provided the biggest difference (spread) in the impedance values for the same CSA. Fig.
  • FIG. 3(A) the B-mode US images with three different swallow volumes, 5cc, lOcc and 15cc, were marked and interactive software in Matlab used to measure the luminal CSA.
  • Fig. 3(B) shows the esophageal CSAs measured from the marked B-mode US images for the three volumes.
  • the US CSA measurements were carried out in duplicates to measure the repeatability of the markings.
  • Figs. 4(A)-4(D) shows sample impedance topographs of the two swallows with two different concentrations of saline for a lOcc volume. Each swallow resulted in an increase in impedance followed by drop in impedance and a resultant nadir impedance value. The latter was lower for the 0.5N swallow compared to the 0. IN saline swallow (See Figs. 4(B) and 4(C)).
  • Figs. 5(A)-5(C) show nadir impedance values with 0.5N and 0. IN saline with swallows of 5, 10 and 10 ml bolus volumes in each of the five subjects. Each data point represents the mean of 8-10 swallows in that subject. The impedance values were significantly lower for 0.5N compared to 0. IN for each bolus volume. An increase in bolus volumes resulted in lower nadir impedance values.
  • Fig. 6(A) shows the esophageal CSAs measured from the electrode pair on the catheter close to the US probe, which was calculated using nadir impedance values for the swallowed saline solutions of two concentrations and the equation discussed above.
  • the CSA measured from the US images and the one measured from the proposed impedance methodology were almost identical (Fig. 6(B)).
  • in-vitro (test tube) measurements show the expected relationship between impedance values and CSA. That is, using in-vitro measurements, it is possible to determine a correction factor to accurately calculate CSA of the tubes.
  • in- vivo measurements with US B-mode images show a linear increase in the luminal CSA with an increase in the swallowed bolus volume.
  • an in-vivo study also shows an expected linear relationship between the impedance values with two saline concentrations for different volumes of swallowed boluses.
  • the two saline concentration algorithm may be effectively employed to estimate the esophageal luminal CSA analytically.
  • the electrodes are placed inside a balloon and saline solution of known concentration is injected into the balloon to create a homogenous electrical field inside the balloon.
  • the balloon material in these studies is made of an electrically non-conducting material that prevents leakage of current outside of the balloon into the tissue, which eliminates the parallel impedance issue. Therefore, Ohm's law assumptions to measure luminal CSA are satisfied in the impedance planimetry and FLIP techniques.
  • Parallel impedance is another major problem in estimating luminal CSA of ventricles of the heart and blood vessels using impedance methodology.
  • Fig. 1 shows, with the Mil technique, the current flows through the saline bolus, the esophageal wall, as well as through structures surrounding the esophagus, and as noted such is termed parallel impedance.
  • the impedance methodology described above is used in which two impedance values are measured using two concentrations of saline.
  • the impedance-based CSA calculations are dependent only on two nadir impedance values with two concentrations of saline (and the conductivity of the two concentrations of saline).
  • the maximal CSA may be measured and the value from the impedance value is almost identical to the one measured from the B-mode US image analysis.
  • Electrodes Another important factor that is important in measuring accurate impedance value is the instrumentation used.
  • the above Example used the GIVEN system that has electrodes located every two centimeters.
  • electrode spacing determines the depth of current penetration and depth sensitivity, with most of the current density lying near the electrodes and exponentially decaying moving away from them. Therefore, the proposed method will perform best for esophageal dilations less than the 2cm (electrode spacing), and will underestimate any larger bolus dimensions.
  • a tetra-polar system using a different current injection/pickup protocol may be employed to remove this obstacle.
  • the GIVEN system can measure impedance values of > 90 Ohms with a possible margin of error of 3-5%.
  • different systems may have different fidelities and different distances between the electrodes that need to be taken into the consideration when using the proposed methodology.
  • the impedance measurement afforded by systems and methods according to present principles is relatively inexpensive and can be performed at closely-spaced intervals over the entire length of the esophagus at the same time. Data shows that Mil measurements can detect changes in the esophageal CSA accurately and thus provide useful information on the inhibitory phase of peristaltic reflex.

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Abstract

La présente invention concerne des systèmes et des procédés pour estimer la distension œsophagienne intraluminale/aire de section transversale luminale (CSA) pendant un péristaltisme au moyen de la mesure d'impédance intraluminal multicanal (MII) en temps réel. Des mesures d'impédance sont effectuées pendant que le sujet avale un bolus avec deux concentrations de solution saline de différents volumes (par exemple, 5 cm3, 10 cm3 et 15 cm3) tout en étant positionné dans la position de Trendelenburg. La CSA à chaque paire d'électrodes du cathéter MII est estimée par résolution de deux équations algébriques de loi d'Ohm résultant des deux solutions salines. Cette dernière estimation peut être affinée au moyen d'un facteur de correction précédemment calculé in vitro (en utilisant la même méthodologie) dans des tubes d'essai en verre de CSA connue. Une interface utilisateur graphique permet la visualisation et la quantification du bolus au fur et à mesure qu'il traverse la longueur de l'œsophage en temps réel.
PCT/US2016/020138 2015-02-27 2016-02-29 Essai de distensibilité œsophagienne utilisant l'impédance électrique WO2016138541A1 (fr)

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Cited By (1)

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WO2022093477A1 (fr) * 2020-10-30 2022-05-05 The Regents Of The University Of California Manométrie haute résolution à impédance intraluminale (hrmz) pour déterminer des paramètres du tractus digestif

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US20100094328A1 (en) * 2007-06-27 2010-04-15 Flip Technologies Limited System, device and a method for dilating a stricture in a lumen and for determining the transverse cross-sectional area of a lumen or cavity
US20110112429A1 (en) * 2003-09-05 2011-05-12 Sandhill Scientific, Inc. Impedance analysis for esophageal maladies
US20130296662A1 (en) * 2010-09-13 2013-11-07 Taher Imad Omari Methods for assessing swallowing motor function
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US20150038805A1 (en) * 2013-08-01 2015-02-05 The Regents Of The University Of California Quantitation and display of impedance data for estimating gastroenterology tract parameters

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Publication number Priority date Publication date Assignee Title
US20130338530A1 (en) * 2003-02-21 2013-12-19 Ghassan S. Kassab Body lumen junction localization
US20110112429A1 (en) * 2003-09-05 2011-05-12 Sandhill Scientific, Inc. Impedance analysis for esophageal maladies
US20060116564A1 (en) * 2004-10-14 2006-06-01 Mintchev Martin P Esophageal diagnostic sensor
US20090062684A1 (en) * 2005-03-31 2009-03-05 Globalreach Holding Aps Apparatus and method for a global model of hollow internal organs including the determination of cross-sectional areas and volume in internal hollow organs and wall properties
US20100094328A1 (en) * 2007-06-27 2010-04-15 Flip Technologies Limited System, device and a method for dilating a stricture in a lumen and for determining the transverse cross-sectional area of a lumen or cavity
US20130296662A1 (en) * 2010-09-13 2013-11-07 Taher Imad Omari Methods for assessing swallowing motor function
US20150038805A1 (en) * 2013-08-01 2015-02-05 The Regents Of The University Of California Quantitation and display of impedance data for estimating gastroenterology tract parameters

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022093477A1 (fr) * 2020-10-30 2022-05-05 The Regents Of The University Of California Manométrie haute résolution à impédance intraluminale (hrmz) pour déterminer des paramètres du tractus digestif
EP4251035A4 (fr) * 2020-10-30 2024-04-03 The Regents of The University of California Manométrie haute résolution à impédance intraluminale (hrmz) pour déterminer des paramètres du tractus digestif

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