EP3478184A1 - Système de mesure non invasive de la pression artérielle. - Google Patents

Système de mesure non invasive de la pression artérielle.

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Publication number
EP3478184A1
EP3478184A1 EP17749436.6A EP17749436A EP3478184A1 EP 3478184 A1 EP3478184 A1 EP 3478184A1 EP 17749436 A EP17749436 A EP 17749436A EP 3478184 A1 EP3478184 A1 EP 3478184A1
Authority
EP
European Patent Office
Prior art keywords
pressure
ultrasound
reflector
passive
natural
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.)
Withdrawn
Application number
EP17749436.6A
Other languages
German (de)
English (en)
Inventor
Alexander Brenner
Yuri Brodsky
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.)
PI-Harvest Holding AG
PI HARVEST HOLDING AG
Original Assignee
PI-Harvest Holding AG
PI HARVEST HOLDING AG
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
Priority claimed from EP16182619.3A external-priority patent/EP3278735A1/fr
Priority claimed from US15/227,905 external-priority patent/US20180035971A1/en
Application filed by PI-Harvest Holding AG, PI HARVEST HOLDING AG filed Critical PI-Harvest Holding AG
Publication of EP3478184A1 publication Critical patent/EP3478184A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/04—Measuring blood pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0891—Detecting organic movements or changes, e.g. tumours, cysts, swellings for diagnosis of blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/13—Tomography
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/48—Diagnostic techniques
    • A61B8/486—Diagnostic techniques involving arbitrary m-mode
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/48—Diagnostic techniques
    • A61B8/488—Diagnostic techniques involving Doppler signals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0883—Detecting organic movements or changes, e.g. tumours, cysts, swellings for diagnosis of the heart

Definitions

  • a system and method for non-invasive measurement of pressure inside a body including intravascular blood pressure
  • the present invention pertains to the field of implantable medical devices and systems as well as related methods. More particularly it relates to a medical imaging modality for the noninvasive determination of a pressure inside of a body from outside the body.
  • the medical imaging modality may include a non-invasive medical imaging system, such as ultrasound; artificially implanted, or natural signal reflectors, such as ultrasound wave reflectors; a set of processes for pressure measurements, e.g. for measuring intravascular blood pressure; and to medical imaging transducers and receivers.
  • CHF congestive heart failure
  • AAA abdominal aortic aneurysm
  • PAH pulmonary artery hypertension
  • implantable sensors are that implanted via endovascular techniques.
  • Invasive measurement of intra cardiac pressure by pressure sensors introduced on catheters is desi ed to be minimized due to complexity of the procedure and related patient risk.
  • passive implantable sensors which are typically electromagnetic, providing an electromagnetic signal when irradiated from the external to the human body source of
  • RF radio frequencies
  • These sensors have electronics incorporated and have thus related disadvantages, such as size or reliabil ity of the implanted sensor, over time.
  • parts of the RF energy are absorbed by the body which may cause potential problems in an the l iving organisms.
  • Energy transmitted from outside the body may be converted in these implants to power the electronics, make measurements and transmit measurement results to the outside of the body again.
  • a detecting system external to the human body regi ters the
  • electromagnetic field irradiated in its turn by the ci rcuit of the implanted sensor is detected by the detecting system.
  • An example of electromagnetic sensors is described in the United States patent number US 7245117 B l with the title "Communicating with implanted wireless sensor", the resonant frequency of a sensor is determined for energizing the system to burst the RF energy at predetermined frequencies and amplitudes.
  • a similar technology is described in the United States patent number US 8894582 B2.
  • Intravascular ultrasound measurements are known, but restricted to either catheter based ultrasound transceivers introduced into the body, mainly for imaging and Doppler ultrasound measurements. Blood pressure in peripheral vessels may be measured non-invasively from the outside of the body using ultrasound.
  • non-invasive techniques include methods to examine dimensions of blood vessels, or methods based on examining blood flow and are based on Doppler ultrasound or other ultrasound imaging methods, as disclosed in, for instance, US 5411028, US 5477858 A, US 5544656, US 6814702 B2, US 5724973 A, US 20140081144 Al, EP 1421905 Al , US 7128713 B2, WO 2007087522 A2, US 20080119741 Al, US 7736314 B2, US 20130197367 Al, or US 20130006112.
  • the Doppler frequency spectra display the blood flow information from a certain area at a given depth, (control volume), and do not provide information about blood flow in other parts of the vessel which are visible on the ultrasound image. Therefore, in case choosing an inadequate control volume (ex., when cos ⁇ ⁇ 0) all diagnostic information will be incorrect.
  • the frequency analysis of the resultant signal permits allocate the frequencies of the maximal attenuation of the intensity and the value of the specific physical parameter is determined on the basis of the correlation relationships between the values of the parameters and the frequencies of the maximum attenuation of the resultant signal.
  • the method is dependent of the frequencies of both the direct and reflected signals, It is desired to provide a more simple method and system that is independent of the frequencies of both the direct and reflected signals which are also present in the following patent: US 20070208293 Al "Methods and devices for non-invasive pressure measurement in ventricular shunts". This disclosure relates to a ventricular shunt including a pressure-sensitive body that changes its dimensions in response to the pressure of the cerebrospinal fluid within the shunt.
  • 20070208293 Al is tracking the distance changes between the transducer and a ultrasonic beam reflecting gas-filled capsule, while in the current description the pressure is dete m i ned/esti mated as the function of volumes of oscillating traceable regions in a series of the images, not necessarily produced by ultrasound.
  • the methods of some aspects of the disclosure comprise set of processes for pressure
  • a system or modality is for instance provided for determining a pressure inside a body.
  • the system includes a control unit.
  • the control unit is configured to estimate at least a volume of an oscillating traceable region inside said body.
  • the volume may be estimated from at least a series of images generated by an ultrasound or other medical imaging unit.
  • the control unit is configured to correlate said volume with a pressure at said region for said determining of said pressure.
  • the system preferably includes at least one medical implant previously implanted at said body for tracing said oscillating region in said series of images.
  • the implant optionally and preferably has at least one reflective surface and said surface is preferably an integral part of the implant or is attached to the implant.
  • said implant is part of the group of impmants known to people skilled in the art as "passive implants” or "passive sensor”.
  • the medical implant is preferably implantable in the cardiovascular system, in regions including the heart, veins or arteries.
  • said implant is implantable in the atria and most preferably said implant is implanted in the inter-atrial wall of the heart.
  • the medical implant is implanted in major vessels of the cardiovascular system.
  • said implant is implantable in the pulmonary arteries.
  • a plurality of such implants described herein may advantageously used for pressure determination, e.g. with improved precision of the pressure determination result and/or for multiple pressure values at different anatomical positions that may be interrelated to each other.
  • Said implant may include devices from the group including devices used for the repair or occlusion cardiovascular structures.
  • said implant includes devices known to people skilled in the art as occluders, plugs, coils, stents, or shunt devices.
  • Said implants may include devices such as ASD, PFO, LAA, or paravalvular leak occluders; stenting devices intended to maintain the patency of vessels, openings (natural or induced), or cavities in cardiovascular structures; or plug devices to close, seal or obstruct cardiovascular structures.
  • medical images of said implant are used to determine pressure.
  • medical images of a naturally occurring implant are used to determine pressure.
  • cardiovascular structures are used to determine pressure.
  • medical images are taken from oscillating traceable region in a non-invasive manner and from the exterior of the body.
  • said images are taken from at least one atrium or one pulmonary artery.
  • a method of determining a pressure inside a body includes estimating at least a volume of an oscillating traceable region inside said body from at least a series of images generated by an ultrasound or other medical imaging unit, and correlating said volume with a pressure at said region for said determining of said pressure.
  • a software comprising an algorithm for performing such pressure determination method is provided. Said software is preferably stored on a computer readable medium. The present dislcosure provides systems, methods, devices, software and uses of implants that permit to directly measure pressure and its dynamic changes inside a body from the outside of the body without the need o an actively driven implanted device.
  • a passive sensor may be implanted into the cardiovascular system, such as into an artery or the heart itself.
  • the sensor is preferably implanted minimally invasively via a catheter based technique.
  • the passive sensor optionally has ultrasonic beam reflectors which reflect ultrasound waves generated by ultrasound transducers to be captured by ultrasound receivers.
  • the intra-cardiac structures such as heart chambers can play the role of the passive sensors in particular if the intra body pressure is initially calibrated by alternative means as micro-manometer catheters. In the absence of the calibration only the pressure relative dynamic changes can be calculated / determined.
  • the present document provides herein the means for pressure measurement inside the body, such as inside the cardiovascular system, measured e.g. by ultrasound or any other medical imaging system. Calculation or determination of pressure is based on medical image time series. Said Calculation or determination includes the processing of measurements of the dynamics of a movably reflective surface portion of a passive artificial or natural (ultrasound) reflector, optionally implanted inside a body. Said reflector may be optionally implanted in the
  • cardiovascular system preferably in the heart or in blood vessels.
  • High accuracy and stability of intra-body pressure measurements are preferably based on synchronised and simultaneous measurements using catheter-based pressure sensors and imaging devices followed by compiling a mathematical model to calculate the pressure function and calibrated to the measured, real-time absolute pressure values.
  • the imaging (preferably ultrasound) device connected to the current system.
  • the essence of a preferred example of the current disclosure lies in the development of a direct method of ultrasonic measurement of the blood pressure in the heart or a blood vessel and an apparatus for its practical implementation.
  • said reflecting surfaces may be composed of the same or differing materials and/or may have the same or different shapes: a) A first surface or surface portion at a constant position, i.e. said first surface is independent of intravascular blood pressure changes, by virtue of it being fixed on, onto, to, or by tit being in relation to a cardiovascular wall, such as an vessel or heart chamber wall;
  • a second surface or surface portion configured so as to oscillate relative to the first surface and in relation to intravascular blood pressure changes.
  • Both first and second surfaces are placed into a cardiovascular structure subject to changes as result of pressure changes in or around said cardiovascular structure.
  • Said surfaces are placed such that the first surface, or surface portion of it, and the second surface, or surface portion of it, are in fluid communication.
  • Said fluid communications is provided by preferably a liquid such as blood.
  • Said pressure changes preferably are blood pressure changes inside the cardiovascular system, such as inside of a blood vessel or the heart.
  • the present disclosure further provides an example of a system for subsequent calibration, measurements and calculations of pressure based on the volume of cardiovascular structures including but not limited to the left atrium (LA), right atrium (RA), left ventricle (LV), right ventricle (RA), or the pulmonary artery (PA).
  • LA left atrium
  • RA right atrium
  • LV left ventricle
  • RA right ventricle
  • PA pulmonary artery
  • the values P £ at time moments t t are measures by direct pressure meters, such as catheter based blood pressure sensors.
  • the imaging (preferably ultra-sound) measurements are provided simultaneously by an imaging modality (preferably an ultrasound device).
  • Both intra body pressure meter measurement data and images series over time is synchronously recorded into the system (1100) and optimally regressed to a function F of a given shape in the way that « F ⁇ Ln, L 2 i
  • L l£ is the brightness line of the first artificial or natural stationary surface (one of 140, 230, 330, 430, 640) in the image, which is preferably ultrasound image of said passive reflector
  • L 2 t is the brightness line of the said second moving artificial or natural surface (one of 130, 210, 310, 410, 630, 720) in the image , which is preferably ultrasound image of said passive reflector respectively, measured at said time moment t ⁇ .
  • the further substitution into the formula P F(L lt L 2 ) gives the real time pressure and pressure changes while the series of ultrasound images is recorded. If the system was not previously calibrated, no absolute pressure measurements are provided, but only dynamic pressure changes are calculated / determined from the image series obtained over time.
  • the system for the non-invasive ultrasound measurement of the intravascular blood pressure comprises a plurality of passive moving artificial or natural ultrasound beam reflectors optionally implantable or implanted into the cardiovascular system, such as blood vessels or one or both of the heart chambers.
  • Said passive reflectors contain surface elements or surface portions that are stationary or respectively moving under blood pressure changes and adapted to receive and reflect ultrasound beams (or thei position in the body be capturable by other image modalities).
  • the ultrasound beam reflectors may be natural or artificial, the last being integrated or attached to a medical implantable device adapted for delivery and implantation in the body.
  • medical implants include for instance stents including self-expandable stents, or occluders such as atrial septal occluders, ventricular septal occluders, (left) atrial appendage occluders, PDA occluders, vascular occluders, vascular plugs, flow regulators, Atrial Flow Regulators (AFR), Aorto- Pulmonary Flow Regulators (APFR), pacemakers, etc.
  • AFR Atrial Flow Regulators
  • APFR Aorto- Pulmonary Flow Regulators
  • the system further comprises in an example an ultrasound apparatus adapted to send ultrasound signals to the natural or artificial implanted ultrasound beam reflectors and to receive reflected signals in return, for performing the intravascular pressure measurements.
  • the system comprises one or more of the following units: a) A calibration unit containing
  • At least one catheter based blood pressure sensor preferably with digital output, permitting to stream the output data into the information system with a processing and/or control unit estimating the volumes of oscillating traceable regions for pressure calculation as the function of the respective volumes, preferably a computer b. at least one ultrasound probe (or alternatively or in addition a different image
  • At least one ultrasound probe with at least one transducer configured to convert an electromagnetic input or control signal into a mechanical ultrasound signal to be transmitted towards a surface, and configured for the reverse conversion of reflected or echoed, incoming mechanical ultrasound signals into electro -magnetic measurement signals, wherein said transducer transmits the direct output ultrasound signal and receives the reflected ultrasound signals;
  • At least one beam former unit configured to provide a desired shape of the electro-magnetic signal in the transmission mode
  • At least one control unit configured for estimating the volumes of oscillating traceable regions.
  • the unit for the information processing includes preferably a software, and alternatively or in addition a hardware which is for instance comprised of: a. an ultrasound apparatus, such as disclosed above, and preferably with a
  • a client device such as a smartphone/tablet/personal computer with a user interface and a client application installed; optionally integral part of the ultrasound apparatus (a) and/or in communication thereto;
  • d. optionally a cloud information storage unit.
  • the software system includes code segments for performing an intra body pressure determination or estimation based on at least an image series over time of a region of interest where the pressure is to be determined or estimated in the body from images obtained remote from the region of interest.
  • the software and/or system is in use operating as follows: e. Connect the ultrasound apparatus (a) to a client device (b) via suitable communication interface, such as WiFi/Bluetooth/USB, cable;
  • the transducer into operation; the user interface, such as a graphical user interface (GUI) including an on-screen image is displayed on a display, preferably of the ultrasound apparatus or a display connected thereto, such as the client display.
  • GUI graphical user interface
  • the ultrasound apparatus is in a first operation mode run in B-mode. For instance the client (b) starts the apparatus to operate in B-mode. A picture formed by the signal is displayed.
  • the transducer is pointed to the region where the reflector for pressure measurement is located inside the body, such as the heart, and hold.
  • the signal direction is adjusted according to the displayed image until the reflective implanted membrane is visible on the image.
  • the ultrasound apparatus is switched to a second mode of operation, the M-mode, or the generalized M-mode, being the set of M-modes corresponding to all formed beams.
  • the client application (b) provides for the identification.
  • the membrane may be automatically recognized by suitable image processing steps, and switched to
  • the transducer is then retrieving the signal changes for a certain time length, preferably for a number of seconds. Pressure inside the body is then calculated by the control unit based on the analysis of the accumulated M-modes.
  • the results may be displayed and/or further processed. This may be done by the client application (b).
  • the ultrasound apparatus may be returned to first operational mode, the B-mode.
  • the measurement results including intra-body pressure values may then be manually or automatically uploaded to a local medical centre server (c), a cloud information storage (d), and/or stored otherwise, e.g. in a memory of the client device.
  • the current approach is based on a combination of both B-mode and the generalized M-mode imaging.
  • B-Mode or 2D mode or brightness mode in ultrasound scanning is a cross -sectional image representing body components through the simultaneous scanning by a linear array of transducers and represented as a two-dimensional image on a screen.
  • M-mode or TM-mode is or motion mode in ultrasound scanning, permits to fix a specific scan line in B-Mode and simultaneously generate its real time evolution as a vector time series.
  • Current approach is based on the simultaneous analysis of the set of M-modes corresponding to all formed beams (generalized M-mode imaging).
  • D-mode or Doppler mode in ultrasound scanning makes use of the Doppler effect in measuring and visualizing blood flow or tissue movements in a given sample volume.
  • M-mode we call herein the generalized M-mode. It is defined a set of M-modes corresponding to all ultrasound channels at a certain time moment .
  • the B-mode is got from this mode by passing to polar coordinates and respective interpolations.
  • our analysis is based on the initially acquired data which permits to get the better analysis of all ultrasound channels without B-mode smoothings and interpolations.
  • An example of an implantation medical procedure for deployment of a passive ultrasound beam reflector inside the body such as inside the cardiovascular system e.g. an appropriate heart region, left and/or right atrium of the heart, or pulmonary artery, comprises
  • a carrier unit including a passive ultrasound beam reflector and catheter based blood pressure sensors inside a catheter sheath, such as being releasably attached, preferably at a proximal end, to a connector, such as a capturing unit, such as a claw, being arranged at a distal end of a delivery unit, such as a guide wire or pusher wire of interventional cardiology, configured for releasable attaching said passive ultrasound beam reflector to said connector;
  • tissue anchoring unit such as at least one screw, hook, spring, flange, or the like, at the carrier unit or passive ultrasound beam reflector, or alternatively or in addition based on shape memory material and characteristics thereof to allow fixation;
  • the carrier unit may be a medical implantable device as mentioned above.
  • Releasable attachment may be made in any suitable form, such as threaded screw attachment, gripper, forceps, thermal release attachment, etc.
  • the system, method, software and use of the present dislcosure permits to directly measure a blood pressure through a passive sensor implanted into an artery or heart itsel .
  • Pressure values such determined may provide valuable diagnostic information for potential therapeutical treatment of a patient.
  • Fig.l depicts a schematic illustration of two versions of a standalone passive ultrasound beam reflector (ball tipped narrow reflector and membrane type reflector) with the ultrasound beam reflecting surfaces deployed in a blood vessel;
  • Fig.2 depicts a schematic illustration of a medical implantable device, in an example of an Atrial Flow Regulator (AFR) or APFR (Aorto-Pulmonary Flow Regulator), see Patent Application WO 2016 038115, which is incorporated herein by reference in its entirety for all purposes, namely a passive ultrasound beam reflector, here in form of a membrane with the ultrasound beam reflecting surfaces based measuring the blood pressure in the Right Atrium (the capturing unit resides in the right blood circle); APFR does not significantly differ from AFR device in its geometry, though differs significantly in the method of implantation see Guo K, Langleben D, Afilalo J, Shimony A, Leask R, Marelli A, Martucci G, Therrien J. Anatomical considerations for the development of a new transcatheter aortopulmonary shunt device in patients with severe pulmonary arterial hypertension. Pulm Circ. 2013 Sep;3(3):639-46. doi:
  • Fig.3 depicts a schematic illustration of the Atrial Flow Regulator (AFR) or APFR (Aorto-Pulmonary Flow Regulator) based passive ultrasound beam reflector with the ultrasound beam reflecting surfaces, deployed in the Left Atrium (the capturing unit resides in the right blood circle);
  • AFR Atrial Flow Regulator
  • APFR Anato-Pulmonary Flow Regulator
  • Fig.4 depicts a schematic illustration of an Atrial Flow Regulator (AFR) based passive ultrasound beam reflector with the ultrasound beam reflecting surfaces deployed both in the Left and Right Atrium (the capturing unit resides in the right blood circle);
  • AFR Atrial Flow Regulator
  • Fig.5 depicts a schematic illustration of a blood pressure measuring, registration and reporting medical information system
  • Fig.6 depicts a schematic illustration of Ultrasound Transducer interaction with the passive membrane inside the blood vessel or the heart;
  • Fig.7 depicts a schematic illustration of another 3d visible via Ultrasound Transducer example of both the standalone passive ultrasound beam reflector being attached to a Atrial Flow Regulator (AFR) or APFR (Aorto-Pulmonary Flow Regulator);
  • AFR Atrial Flow Regulator
  • APFR Access-Pulmonary Flow Regulator
  • Fig.8 depicts a flow chart illustrating an implantation medical procedure
  • Fig.9 depicts a schematic illustration of a passive ultrasound beam reflector being attached as positioned at a distal end of a self-expandable stent, incorporated into an Atrial Flow Regulator (AFR) or APFR (Aorto-Pulmonary Flow Regulator).
  • AFR Atrial Flow Regulator
  • APFR Adorto-Pulmonary Flow Regulator
  • Fig.10 depicts a schematic illustration of a passive ultrasound beam ball tipped narrow reflector being attached as positioned at a distal end of a self-expandable stent, incorporated into an Atrial Flow Regulator (AFR) or APFR (Aorto-Pulmonary Flow Regulator).
  • AFR Atrial Flow Regulator
  • APFR Ado-Pulmonary Flow Regulator
  • Fig.l 1 depicts a schematic illustration of a passive ultrasound beam ball tipped narrow reflector being attached as positioned at a proximal end of a self -expandable stent, incorporated into an Atrial Flow Regulator (AFR) or APFR (Aorto-Pulmonary Flow Regulator).
  • AFR Atrial Flow Regulator
  • APFR Adorto-Pulmonary Flow Regulator
  • Fig.12 depicts a schematic illustration of a blood pressure calibration and measuring system (1100), where the pressure sensors (1200) are connected with the pressure monitor (1400) which in case of analogue output is connected through an oscilloscope (1300) with a computer.
  • Fig.13 depicts the generalised M-Mode of ultrasound image as received in polar coordinates (2000) with the selected region of interest image (2100) compression to the mean value (2200) resulting in the depth brightness column (2300);
  • Fig.14 depicts the correspondence of the objects in the region of interest to the anatomical objects as ultrasound signature of the top of the image (2500), chamber wall (2600), membrane ball position (2700), AFR/inter- atrial septum (2800);
  • Fig.15 depicts the images sequence (3000) compressed into the union of the depth brightness lines (3100) forming a new compressed image showing the brightness changes over the time (photometry);
  • Fig.16 compares the result of the photometry (compressed images over the time) with the micro-manometer catheter based pressure meter synchronized results
  • Fig.17 depicts the new compressed image (from Fig.15) interior structure as the surface in 3D space, which is rotated in the lower image;
  • Fig.18 depicts the search regions for the model parameters L lt L 2 , ... in the compressed image (from Fig.15), such as the chamber wall (3200), membrane ball position (3300), AFR/ inter -atrial septum (3400);
  • Fig.19 depicts the found model parameters L lt L 2 , ... in the compressed image (from Fig.15), such as local ridges (3500) of the chamber wall/upper path (3200) and AFR /lower path (3400);
  • Fig.20 depicts the found model parameters L lt , h t , in example, corresponding to chamber wall/upper path (3200) and AFR /lower path (3400) fitting the regression model (3600) in the compressed image (from Fig.15);
  • Fig.21 depicts the calculation results of the fitted regression model (red graph) and the micro-manometer catheter based pressure (blue graph) with 2 parameter model corresponding to upper and lower paths from Fig. 20;
  • Fig.22 depicts the basis for the model improvement using the brightness changes (3700) in the surface of Fig.17;
  • Fig.23 depicts the brightness accounting 3 parameter model (red graph) calculations against the simple 2 parameter model (blue graph);
  • Fig.24 depicts the overall system testing results where the upper graph shows the calibration results of the ultrasound image processing algorithm to the micro -manometer catheter based pressure data and the second shows the model calculation reproducing the other series of the micro -manometer catheter based pressure data. It is clearly seen that the most correlated normalized brightness line has considerably improved the very small details of the micro- manometer catheter based pressure (blue graph) and the pressure movements (yellow graph) comparing to 2 parameter model (red graph);
  • Fig. 25 is a schematic illustration of a PFO Occluder Example (Occlutech Funnel Occluder, single distal disc layer (5000), central channel (5100), one clamp (5200))
  • Fig. 26 is a schematic illustration of ASD Occluder Examples (Occlutech double disc occluder, WO07110195 left), (WO 1997/042878 right);
  • Fig. 27 is a schematic illustration of LAA Occluder Examples (WO2007054116A1 left) (WO2013060855A1 right);
  • Fig. 28 is a schematic illustration of a Mitral valve replacement and/or annuloplasty structure Example WO2012127309(Al);
  • Fig. 29 is a schematic illustration of a Para valvular Leakage Device Example
  • Fig. 30 is a schematic illustration of an example of a medical implant (6000) when implanted at the inter- atrial region (6100);
  • Fig. 31 is a schematic illustration of medical implants for occlusion of PFO and/or ASD (WO2010104493(Al) left and WO2010151510(Al) right.
  • the present description of the current invention is given with reference to a blood vessel or a heart chamber as an example only. It should be born in mind however that the present invention is not limited strictly to a blood vessel or a heart chamber, but can be easily adapted to any medium transparent for ultrasound or other waves with the need to measure pressure changes of the liquid flow. Examples include one or more passive ultrasound beam reflectors positioned in the lymphatic system, bile ducts, urinary ducts, subarachnoid space around the brain and spinal cord (Cerebrospinal fluid), inside or exterior of the lung in the chest wall, etc. for measuring pressures and dynamic progress thereof. Correspondingly, implants adapted for implantation in such a location in the body having optionally at least one attached passive ultrasound beam reflectors are provided.
  • Echo Doppler Magnetic Resonance Imaging
  • MRI Magnetic Resonance Imaging
  • Roentgen X-Ray, Computer tomographic Imaging [CT]
  • CT Computer tomographic Imaging
  • the reflectors comprise two kinds of surface elements arranged relative each other. Firstly, a stationary natural, or implanted (substantially not moving under blood pressure, i.e. a reference reflector surface) surface element adapted to receive and reflect ultrasound beams. Secondly a natural, or implanted surface element configured to move under (blood when implanted in the cardiovascular system) pressure changes and adapted to receive and reflect ultrasound or other beams.
  • the beam reflectors hence include a first fixed surface at a constant position independent from the (intravascular blood) pressure changes at its implantation location.
  • a second moving surface is included in the ultrasound reflector, the second surface adapted to oscillate under (blood) or in line with (blood) pressure changes at the implantation site, such as inside a blood vessel or a location of the heart.
  • the passive ultrasound beam reflector(s) are provided arranged at a medical implant to be implanted at a location inside the body where pressure changes may occur, as for instance described above.
  • the implanted passive ultrasound beam reflector (or the medical implant with attached passive ultrasound beam reflector(s)) is at least partly endothelialized (overgrown with tissue) after a certain implantation time.
  • a thin tissue layer will not hinder the movable membrane from oscillation with the pressure of the adjacent fluid (blood) across the tissue layer.
  • the surfaces in blood contact can be suitable coated (e.g. heparin coated or with another pharmaceutical substance as desired) and/or being made of a material compatible with blood.
  • the implanted passive ultrasound beam reflectors beams have suitable shape and sizes for being collapsible into a catheter for delivery, for being attachable to a carrier, and/or for fitting with reliable anchoring at the implantation size. Sizes can be as small as a few mm.
  • the beams can be foldable and be of a resilient material returning to their expanded, substantially planar relaxed shape as shown in the Figs. Shapes include rectangular, square, circular, semi-circular, oval, open oval, generally elongate, or the like.
  • the open ring shaped reflector of Fig. 2 could be in the form of a standalone reflector device, or attached to other medical implants than an AFR.
  • rectangular membranes, or a ball tipped narrow reflectors (920) as shown in Fig. 1 could be attached to medical implants, like the AFR in Fig. 2, Fig. 9- 11 but also alternatively or in addition to other exemplary medical implants, such as those are shown in Figs. 25 to Fig. 31.
  • Fig. 25 a schematic illustration of a PFO Occluder Example (Occlutech Funnel Occluder, single distal disc layer, central channel, one clamp).
  • the device is disclosed without the present improvements described herein in WO2005020822A1, which is incorporated herein by reference in its entirety for all purposes. Particular reference is taken to the device shown in the Figure and the related description therein.
  • FIG. 26 a schematic illustration is provided of ASD Occluder Examples (Occlutech double disc occluder, WO07110195 left) , (WO 1997/042878 right) without the present improvements described herein; Both WO07110195 and 042878 are incorporated herein by reference in its entirety for all purposes.
  • Fig. 27 a schematic illustration of LAA Occluder Examples is provided
  • Fig. 28 a schematic illustration of a Mitral valve replacement and/or annuloplasty structrure Example is provided (WO2012127309(Al)) without the present improvements described herein; WO2012127309(Al) is incorporated herein by reference in its entirety for all purposes.
  • Fig. 29 a schematic illustration of a Paravalvular Leakage Device Example is provided. (WO2013041721A1) without the present improvements described herein. WO2013041721A1 incorporated herein by reference in its entirety for all purposes.
  • Fig. 30 is a schematic illustration of an example of a medical implant when implanted at the atrial region.
  • Fig. 31 is a schematic illustration of medical implants for occlusion of PFO and/or ASD (WO2010104493 (Al) left and WO2010151510(Al) right; which are incorporated herein by reference in its entirety for all purposes).
  • the medical implants are merely examples of such implant, but all facilitate an advantageous pressure determination of a pressure at the implantation region, wherein the pressure is determined from images of a medical imaging modality in accordance with systems, methods, software as described herein.
  • an oscillation (such as with cyclic blood pressure as actuated by the cardiac pumping cycle) at the region of implant is advantageously determinable from a medical image series over time.
  • the oscillation is preferably relatable to a volume change at the implantation region.
  • the (cyclic) change is determinable from the medical image series.
  • the volume change is in turn correlatable to a pressure change at the implantation region, e.g.
  • a passive ultrasound beam reflector 150 (Fig.
  • the device 150 is provided in the exemplary form of a plate or contoured membrane which is deformed under the (blood) pressure changes at its location.
  • the device 150 is shown deployed inside a blood vessel, such as the pulmonary artery.
  • the device is a standalone device, i.e. not attached to a carrier medical implant. In similar examples, it may be attached to a medical implant carrier, such as a stent.
  • the reflector 150 includes both stationary 140 and movable 130 surface elements, wherein the movable surface element 130 is moving under (blood) pressure changes when implanted.
  • the moveable surface element is attached at its beam ends to a carrier and/or the stationary surface element 140.
  • an oscillatable beam with a free apex is provided that is deflectable by the pressure at its implantation location.
  • the reflector is shown inside the delivery sheath 120 inside the vessel, here the pulmonary artery 110 during transvascular deployment and before release and anchoring in the vessel.
  • Anchoring of the device 150 may be done in many suitable anchoring means implementing ways, such as with hooks, bows, screws, tissue adhesives, etc.
  • the apex is preferably also present in other examples described herein.
  • the stationary surface element may be arranged in parallel, above or below the oscillatable beam for reflection in substantially the same direction as the oscillatable beam. Alternatively, or in addition, such a stationary surface may be provided adjacent the oscillatable beam as e.g. shown in Fig.
  • the passive ultrasound beam reflector 210 in the form of a plate or contour membrane has an open ring shape.
  • An apex as in the previous example may be provided.
  • a moveable membrane 210 is deformed under the blood pressure changes.
  • the reflector 210 is attached to an AFR device playing itself the role of the first fixed surface 230 and having two flanges to be positioned on two different sides of the heart across a septal shunt.
  • the AFR device allows a blood flow through its central passageway as shown.
  • the flanges (here disk formed) retain AFR device at the septal wall in its position.
  • the moveable reflector part is attached to the proximal end on the surface of the AFR where in the example a delivery connector or capturing unit 220 is positioned on the AFR (Atrial Flow Regulator) device
  • the aggregate of AFR and reflector 210 allows for a controlled shunt between left and right atria.
  • the reflector 210 provides for pressure measurement on the proximal side of the AFR. Being able to measure pressure at an AFR is a long felt need and provided in an advantageous way by these examples having an integrated pressure measuring reflector 210 with an AFR. Pressure is an important parameter to determine the effective implantation of an AFR as the shunt is created to treat a hypertonic condition by providing a desired shunt flow between the right and left heart.
  • the reflector 210 may be attached to or integrated with other medical implants than AFR devices, such as medical implants of the occlusion devices type including Atrial Septal Occluders, Ventricular Septal Occluders, stents, etc. c)
  • the passive ultrasound beam reflector 310 (Fig.3) is provided in the form of a plate or contoured membrane in the form of an open ring. The reflector 310 is deformed under the blood pressure changes and is attached to the distal end surface of an AFR, i.e. on the surface opposite to the delivery connector or capturing unit 320 of the AFR (Atrial Flow
  • two passive ultrasound beam reflectors 410 in the form of a plate or contoured membrane deformed under the blood pressure changes are attached to both the distal and proximal end of an AFR (Atrial Flow Regulator) device 430 deployed to create a shunt between left and right ventricles.
  • AFR Atrial Flow Regulator
  • the illustrated dimension of the protrusion may be smaller in order to not hinder endothelisation.
  • a ring may be closed as an alternative and attached at a perimeter only allowing a certain protrusion and movement of a ring portion.
  • a ring, open or closed as described herein is generally flat to allow for the desired reflectivity and movability/flexibility.
  • Having two reflectors on two sides of the shunt when implanted allows for differential pressure measurements across the shunt when the AFR is implanted.
  • the shunt is of defined diameter and length, given by the expanded dimension of the AFR, the blood flow across the shunt is determinable.
  • Each of the plurality of reflectors may be identified by position and direction of the ultrasound probe towards the reflector, respectively.
  • the size and/or shape of various reflectors may be different so that a particular reflector is identifiable for measurement at a particular location in the body, e.g. in the ultrasonic image taken in B-made by suitable image recognition software. Fiducial markers in various patterns may also assist in identifying a particular reflector.
  • the passive ultrasound beam reflectors 210, 310, 410 in the forms of a plate or contoured membrane that is deformed under the blood pressure changes are attached to the distal and/or proximal end of an APFR (Aorto-Pulmonary Flow Regulator) device similar to the AFRs 230, 330, 430, deployed to create a shunt between the left pulmonary artery and the descending aorta. Pressure measurements are thus provided at the left pulmonary artery side and/or the descending aorta side of the APFR when implanted.
  • the beam Aorto-Pulmonary Flow Regulator
  • a passive ultrasound 3 dimensional (in the sense that it has multiple reflective surfaces and is visible by an ultrasound device from any viewing angle) beam reflector 720 (Fig.7) in the form the contour membrane deformed under the blood pressure changes and shifted directly into the blood flow with the help of the shape memory alloy rods 710, can be attached both to AFR or APFR 230 playing the role of stationary ultrasound reflective surface or perform as stand-alone device in left pulmonary artery being fixed on the walls with the shape memory alloy rods playing the role of the stationary surface.
  • the 3 dimensional ultrasound device detectable body has for instance orthogonally and parallel arranged reflective surfaces, such as shown in the Fig. 7.
  • the reflector 720 or a ball tipped narrow reflector (920) is for instance attached to the stent 910 with the help of additional ball 220 acting as immobilizer of the stent relatively to the AFR/ APFR 250.
  • the self- expandable stent 910 can be substituted by a regular, e.g. balloon expandable, stent, but then the balloon catheterization is needed.
  • This option provides the freedom of using the same product to measure Right Atrium (RA) or Left Atrium (LA) pressure with no need to alter an AFR device.
  • the stent 910 is integrated with the AFR device upon expansion in its inner flow channel. With minor changes this example can be used alternatively to measure Pulmonary Artery (PA) pressure.
  • PA Pulmonary Artery
  • the passive ultrasound beam reflector 720 is arranged orthogonal to the interior surface of the the self-expandable stent 910 as on Fig. l.
  • the above described preferred examples of reflectors and/or medical implantable devices further may be comprised in a system an ultrasound apparatus 530 (Fig. 5) adapted to send ultrasound signals 520 to the one or more natural, or implanted ultrasound beam reflectors 5 10 and receive reflected signals in return, and performing the measurements / pressure determinations.
  • the system preferably comprises one or more of the following units: a) The calibration unit (Fig.12) containing
  • an information processing unit synchronising input channels and calibrating the pressure calculating model b) at least one ultrasound probe 530 (Fig. 5), or probe 650 (Fig.6), with at least one
  • transducer providing the direct conversion of the electro-magnetic signal into mechanical ultrasound signal and the reverse conversion of the mechanical ultrasound signals into electro-magnetic signals, wherein said transducer transmits and receives the direct and reflected ultrasound signals;
  • At least one beam former unit (not shown) providing the necessary shape of the electromagnetic signal in the transmission mode
  • At least one transmitter unit (not sown) generating the electro -magnetic signals with their further transformation into ultrasound signals by the transducer 530, 650;
  • the system further provides the subsequent synchronous recordings of the pressure measurements from alternative pressure meters, such as catheter based blood pressure sensors and imaging , preferably ultrasound measurements with the said probes and the calculation method for the best fit of the measured pressure values P £ at the implantation areas of said reflector and at time moments t £ as a function P £ ⁇
  • alternative pressure meters such as catheter based blood pressure sensors and imaging , preferably ultrasound measurements with the said probes and the calculation method for the best fit of the measured pressure values P £ at the implantation areas of said reflector and at time moments t £ as a function P £ ⁇
  • L l£ is the brightness line of the first artificial or natural stationary surface (one of 140, 230, 330, 430, 640) in the image, which is preferably ultrasound image of said passive reflector
  • L 2£ is the brightness line of the said second moving artificial or natural surface (one of 130, 210, 310, 410, 630, 720) in the image , which is preferably ultrasound image of said passive reflector respectively, measured at said time moment t £ .
  • the calculation is based on the utilization of the best fitted through calibration function F such that P £ « F(L lit L 2i ) based on calibration measurements of said dependency P £ from the parameters L l£ and L 2£ at the varying pressure values in the predetermined range.
  • the method further includes calculation of a local pressure P at time moments t as a function P £ « F(Li, L 2 , . . . , L n ) of L lt L 2 , . . .
  • F can be a linear function of the brightnesses L 1 , L 2 , ... , L n with the coefficients
  • W lt W 2 , ... , W n optimally fitted for equations P £ « W L i -I h W n L ni + C to hold for the subsequent ultrasound recordings (Fig. 21).
  • Said coefficients W lt W 2 , ... , W n are proportional to the cut areas of the said target volume at given depths orthogonally to the transducer working plane, while the whole sum is approximating the pressure as the function of the target area volume. This follows from the assumption that
  • the procedure of the best fit to the measured data provides the accurate hypothesis for the weights W lt W 2 , ... , W n .
  • the ultrasound apparatus 530, 650 is configured to work in 2-Dimensional (2D- or B-) visualization mode, or simply B-mode, see for example, Fig. 5.
  • the ultrasound apparatus 530, 650 is configured to work in the generalized time motion mode (TM- or M- mode, see Fig. 5).
  • TM- or M- mode the generalized time motion mode
  • the system further provides the subsequent tracking of the brightness lines h xi , L 2i at the measurement time moments t t adjustable to 3-dimensional movements of the passive ultrasound beam reflector and/or AFR/APFR.
  • the software system processing the measurements from previous item 3) in its preferred example is composed of: i) ultrasound apparatus 530, 650 with wireless/USB port capability
  • the client 540 software application automatically recognizes the membrane 630 and switch to the generalized M-mode - being the set of M-modes corresponding to all formed beams, retrieving the signal changes for a number of seconds.
  • Results may be manually or automatically uploaded to local medical centre server 560 or cloud information storage 560 and stored on the client device 540.
  • the passive ultrasound beam reflector (one of 210, 310, 410, 640) according to the above examples is further deployed according to medical procedure described below 800 (Fig.8) inside the appropriate heart region that can be left and/or right atrium of the heart or inside pulmonary artery, said procedure comprising
  • the invention can be used with the presently available processes of deployment of the described system through a subclavian jugular or cephalic vein.
  • Nitinol nickel-titanium alloy
  • any Shape Memory Alloy with appropriate properties can be used.
  • super elastic or elastic material may be used.
  • the invention can be used for development of the system applicable to any medium transparent for ultrasound waves with the need to measure pressure changes of the liquid flow inside.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Physics & Mathematics (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Hematology (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)
  • Magnetic Resonance Imaging Apparatus (AREA)

Abstract

L'invention porte sur un système (140) d'échographie non invasive basé sur l'imagerie de la pression intravasculaire. La mesure de la pression artérielle est faite par le traitement chronologique d'images estimant le volume des régions oscillantes traçables. Le nouveau mode M généralisé est introduit comme l'ensemble des modes M correspondants aux canaux à ultrasons. L'invention s'applique aux supports transparents pour les ondes d'imageries pouvant être convertis en séries d'images étalonnées aux variations de pression du liquide.
EP17749436.6A 2016-08-03 2017-08-03 Système de mesure non invasive de la pression artérielle. Withdrawn EP3478184A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP16182619.3A EP3278735A1 (fr) 2016-08-03 2016-08-03 Système et procédé de mesure non invasive de la pression à l'intérieur d'un corps y compris la pression du sang intravasculaire
US15/227,905 US20180035971A1 (en) 2016-08-03 2016-08-03 System And Method For Non-Invasive Measurement Of Pressure Inside A Body Including Intravascular Blood Pressure
PCT/EP2017/069756 WO2018024868A1 (fr) 2016-08-03 2017-08-03 Système de mesure non invasive de la pression artérielle.

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