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WO2025191048A1 - Système et procédé de détermination et de surveillance de paramètres cardiologiques - Google Patents

Système et procédé de détermination et de surveillance de paramètres cardiologiques

Info

Publication number
WO2025191048A1
WO2025191048A1 PCT/EP2025/056822 EP2025056822W WO2025191048A1 WO 2025191048 A1 WO2025191048 A1 WO 2025191048A1 EP 2025056822 W EP2025056822 W EP 2025056822W WO 2025191048 A1 WO2025191048 A1 WO 2025191048A1
Authority
WO
WIPO (PCT)
Prior art keywords
pressure
evaluation circuit
determination
pressure transducer
probe
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.)
Pending
Application number
PCT/EP2025/056822
Other languages
German (de)
English (en)
Inventor
Felix GLOCKER
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.)
Emka Medical GmbH
Original Assignee
Emka Medical GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Emka Medical GmbH filed Critical Emka Medical GmbH
Publication of WO2025191048A1 publication Critical patent/WO2025191048A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/02028—Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/02108—Measuring pressure in heart or blood vessels from analysis of pulse wave characteristics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/02141—Details of apparatus construction, e.g. pump units or housings therefor, cuff pressurising systems, arrangements of fluid conduits or circuits
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
    • A61B5/02156—Calibration means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0031—Implanted circuitry

Definitions

  • the invention relates to a system for determining and monitoring cardiological parameters and a method.
  • Determining blood pressure is one of the most common and widespread methods for recording vital signs in medical diagnosis, therapy, and care. Methodologically, a distinction is made between direct blood pressure measurement and indirect blood pressure measurement.
  • IBP direct blood pressure measurement
  • a sensor is inserted directly into an artery via an arterial access.
  • access is created to an artery and connected extracorporeally to a sensor.
  • NIBP non-invasive blood pressure measurement
  • NIBP uses an electronic blood pressure monitor or a blood pressure cuff and a stethoscope. The values obtained with this method are somewhat less accurate than those obtained with direct blood pressure measurement.
  • Indirect blood pressure measurement is used much more frequently on wards and in doctor's offices and can also be performed by the patient themselves outside of medical facilities.
  • US 2011/0209553 A1 proposes equipping a piezoresistive pressure sensor with two measuring chambers, one of which is hermetically sealed and has a predetermined reference pressure set in it. Drift is to be minimized by comparative measurements.
  • Jiachou Wang and Xinxin Li propose a similar approach in "A dual-unit pressure sensor for on-chip self-compensation of zero-point temperature drift," Journal of Micromechanics and Microengineering, 24 (2014) 085010 (doi:10.1088/0960-1317/24/8/085010).
  • US 2011/0040206 A1 proposes an arrangement with two membranes, in which one of the membranes is to be electrically deformable for offset compensation.
  • DE 19 19 246 B2 discloses an electrode arrangement for electrically stimulating the right ventricle of the heart, comprising a connecting line consisting of an insulating strand and running to a pacemaker, through which an electrical conductor leads to the electrode arranged on the outside of the insulating strand.
  • the insulating strand is intended to be so flexible that its insertion is possible solely through entrainment by the heart's bloodstream. This is said to have the disadvantage that electrical conductors which are embedded in the plastic strand so that they cannot be displaced longitudinally are subjected to severe stretching stress when the insulating strand is bent, causing them to tear. This is said to occur particularly easily when the electrode arrangement is retracted slightly in order to change its position.
  • a tensile-resistant core running through the insulating strand.
  • the core When using two electrical conductors that are not intended to run close together in a central channel in a tubular strand to avoid parasitic capacitance, the core must be positioned centrally between the conductors for maximum protection.
  • the core is designed to absorb the tensile forces occurring in the insulating strand.
  • the arrangement between the electrical conductors is intended to achieve different bending capabilities of the insulating strand in different bending directions.
  • a device for measuring body pressures or physiological pressures is known, which is said to be particularly useful for a continuous measurement of pressures.
  • a pressure transmitter catheter device for transmitting the physiological pressure to a pressure transducer device, which comprises: a hollow, flexible tube with a first end for placement at a location where the physiological pressure is to be measured and a second end connected to the pressure transducer device, and a liquid filling the tube and forming a connection with the pressure transducer device, wherein a Plug is positioned at the first end in the hose, the plug comprising a material capable of transmitting pressure to the fluid, which in turn transmits this pressure to the pressure transducer device.
  • the pressure sensor device described therein has an arrangement that makes it possible to monitor a patient's blood pressure and, in particular, pressure profiles using the implantable probe, without the need for electronic components such as pressure transducers to also be implanted. This significantly reduces the bureaucratic effort involved in manufacturing and using a pressure sensor device according to the invention compared to known implantable pressure measuring devices. Furthermore, the pressure sensor device also makes it possible to monitor the pressure and pressure profiles in a patient while they are being treated with devices that cause strong electrical interference, e.g., an ablation catheter.
  • the catheter section of the probe with the measuring tip can be implanted into a human or animal body, e.g., into a blood vessel, via a port with only a slightly larger inner diameter.
  • the part of the pressure sensor device containing the pressure transducer with associated electronics can be located outside the Such an arrangement allows the advantages of direct blood pressure measurement to be combined with the lower regulatory requirements of a passive implant in a cost-effective manner.
  • US 2015/0045644 A1 discloses a method and system for estimating arterial compliance and resistance based on medical image data and pressure measurements.
  • An estimate of arterial inflow over a plurality of time points is determined based on medical image data of a patient.
  • An arterial pressure measurement of the patient is received.
  • At least one cardiac cycle of the arterial pressure measurement is synchronized with at least one cardiac cycle of the arterial inflow measurement.
  • the patient's arterial compliance and resistance are estimated based on the arterial inflow estimate and the synchronized arterial pressure measurement.
  • PV loops The measurement of pressure-volume loops (PV loops) is the gold standard for determining the hemodynamic parameters Ees and Ea.
  • Conductance catheters are the gold standard for measuring PV loops. These are inserted invasively into the ventricle and can simultaneously measure pressure via a pressure sensor and volume via a conductance measurement.
  • PV loops can be performed by combining independently performed pressure and volume measurements. An example of this is the measurement of pressure via a right heart catheter and volume via 3D echocardiography or cardiac MRI.
  • the pressure and volume measurements can be performed simultaneously or with a time offset, although simultaneous measurement is ideal. We describe a method for the automated synchronization of arbitrary pressure and volume data based on the leads.
  • This method can be used, for example, to generate pressure-volume loops (PV loops) at the push of a button.
  • PV loops pressure-volume loops
  • An example of this is the use of CorLog data for the pressure signal and 3D echocardiography (3D echo) data for the volume signal.
  • CorLog continuously measures pressure values in the right ventricle.
  • the 3D echo can be used to record the volume curve at specific points.
  • an event marker is set in the system according to the invention. This is used to synchronize the data. If both systems are connected, for example, wirelessly, data transmission can occur automatically as soon as the volume curve has been recorded.
  • One or both of the sensor systems can combine the data into a PV loop. Continuous pressure and volume curves are roughly synchronized with each other using an event marker.
  • Either both signals have an event marker, or the event marker of one signal is set when the measurement of the other signal starts. Specific physiologically significant points are detected within the signals. This is done using the time derivatives of the signals. An example of this could be the opening of the tricuspid valve, characterized by the 7+ zero in the 1st derivative of the volume curve.
  • N beats are selected from the curves. The period of these beats must correspond to a predetermined period Ts. If one of the two sensors already outputs an averaged curve, the period of the averaged curve is used as Ts. Permissible deviations can be specified using an additional parameter dTs. If a suitable beat is found, the respective curve section is saved for later averaging. Once all beats have been found, the individual curve sections are averaged and then displayed as a PV loop.
  • This crossing point can be converted into Pmax, which in turn can be used to calculate variables such as ejection fraction, coupling, stroke volume as well as Ees and Ea.
  • the described method does not use regression but calculates CROSS or Piso directly using the first derivative of the pressure signal. This leads to a strict definition of CROSS that is independent of the person performing the measurement. Furthermore, this type of calculation increases the robustness of the algorithm.
  • the method can be applied to left and right ventricular curves. Using Pmax, the isovolumetric pressure curve (Pmax sine curve) can be determined. This can then be used to calculate the difference curve between the isovolumetric and the true pressure curve. The difference between the curves corresponds to the flow and can be used to generate partial flow curves or to determine stroke volume and cardiac output.
  • Fig. 1 shows the pressure and volume curve obtained from the evaluation circuit according to the present invention
  • Fig. 2 a PV loop from pressure and volume curve according to Fig. 1 ,
  • Fig. 3 shows a system according to the invention connected to a patient with a continuous pressure sensor in the right ventricle and simultaneous measurement of 3D echocardiography;
  • Fig. 4 an event mark for the rough synchronization of pressure and volume curves according to the method according to the invention
  • Fig. 5 Use of the time derivatives to determine physiologically significant points on the pressure and volume curve, here using the example of the opening of the tricuspid valve,
  • Fig. 6 shows the selection of N cycles from the pressure and volume curve. The cycle must correspond to the specified period Ts.
  • Fig. 7 the determination of the crossing point CROSS using the tangents on the rising and falling flanks of the ventricular pressure curve
  • Fig. 8 shows the determination of the differential pressure HMP(t)-RVP(t) from the right ventricular pressure curves.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physiology (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Physics & Mathematics (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Vascular Medicine (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)

Abstract

L'invention concerne un système de détermination et de surveillance de paramètres cardiologiques, comprenant un dispositif capteur de pression pour une application médicale in vivo, ledit dispositif capteur de pression présentant au moins un transducteur de pression et une sonde implantable. Le système comprend un circuit d'évaluation qui est connecté au transducteur de pression et est de préférence placé conjointement avec le transducteur de pression dans un boîtier extracorporel commun, et le circuit d'évaluation est connecté à un module de communication pour transmettre sans fil des données du circuit d'évaluation à un dispositif pour visualiser les signaux émis par le circuit d'évaluation et/ou à un dispositif pour stocker les signaux émis par le circuit d'évaluation. L'invention concerne également un procédé pour faire fonctionner le système.
PCT/EP2025/056822 2024-03-12 2025-03-12 Système et procédé de détermination et de surveillance de paramètres cardiologiques Pending WO2025191048A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102024000814.4A DE102024000814A1 (de) 2024-03-12 2024-03-12 System zur Bestimmung und Überwachung von kardiologischen Parametern und Verfahren
DE102024000814.4 2024-03-12

Publications (1)

Publication Number Publication Date
WO2025191048A1 true WO2025191048A1 (fr) 2025-09-18

Family

ID=95211728

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2025/056822 Pending WO2025191048A1 (fr) 2024-03-12 2025-03-12 Système et procédé de détermination et de surveillance de paramètres cardiologiques

Country Status (2)

Country Link
DE (1) DE102024000814A1 (fr)
WO (1) WO2025191048A1 (fr)

Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE1919246B2 (de) 1968-07-27 1980-11-06 Harmjanz, Dietrich, Prof. Dr.Med., 3101 Gross Hehlen Elektrodenanordnung zur elektrischen Reizung der rechten Herzkammer
EP0417171B1 (fr) 1988-05-27 1995-08-02 Data Sciences International, Inc. Dispositif pour mesurer en continu la pression interne du corps
WO1999037983A2 (fr) 1998-01-24 1999-07-29 Manfred Adolfs Element de connexion permettant de connecter un transducteur a un systeme fluidique etanche
US20040073122A1 (en) 2002-10-15 2004-04-15 Data Sciences International, Inc. Barriers and methods for pressure measurement catheters
WO2009115223A1 (fr) 2008-03-20 2009-09-24 Mhm Harzbecher Medizintechnik Gmbh Élément de liaison pour relier un enregistreur de valeurs de mesure à un système fluidique étanché
US20110040206A1 (en) 2009-08-12 2011-02-17 Medos International Sarl In situ offset compensation for pressure sensors
US20110209553A1 (en) 2010-02-27 2011-09-01 Codman Neuro Sciences Sarl Apparatus and method for minimizing drift of a piezo-resistive pressure sensors due to progressive release of mechanical stress over time
US8142362B2 (en) 2008-04-24 2012-03-27 Pacesetter, Inc. Enhanced pressure sensing system and method
US8573062B2 (en) 2007-05-18 2013-11-05 Pacesetter, Inc. Implantable micro-electromechanical system sensor
US20150045644A1 (en) 2013-08-09 2015-02-12 Dorin Comaniciu System and Method for Estimating Artery Compliance and Resistance from 4D Cardiac Images and Pressure Measurements
DE102015116648A1 (de) 2015-10-01 2017-04-06 Biotronik Se & Co. Kg Implantierbare Drucksensorvorrichtung
DE102018005911A1 (de) 2018-07-27 2020-01-30 EMKA Medical GmbH Drucksensoreinrichtung für medizinische in vivo Anwendung

Patent Citations (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE1919246B2 (de) 1968-07-27 1980-11-06 Harmjanz, Dietrich, Prof. Dr.Med., 3101 Gross Hehlen Elektrodenanordnung zur elektrischen Reizung der rechten Herzkammer
EP0417171B1 (fr) 1988-05-27 1995-08-02 Data Sciences International, Inc. Dispositif pour mesurer en continu la pression interne du corps
DE68923703T2 (de) 1988-05-27 1996-04-04 Data Sciences International In Anordnung zur fortwährenden messung des inneren körperdrucks.
WO1999037983A2 (fr) 1998-01-24 1999-07-29 Manfred Adolfs Element de connexion permettant de connecter un transducteur a un systeme fluidique etanche
US20040073122A1 (en) 2002-10-15 2004-04-15 Data Sciences International, Inc. Barriers and methods for pressure measurement catheters
US8573062B2 (en) 2007-05-18 2013-11-05 Pacesetter, Inc. Implantable micro-electromechanical system sensor
WO2009115223A1 (fr) 2008-03-20 2009-09-24 Mhm Harzbecher Medizintechnik Gmbh Élément de liaison pour relier un enregistreur de valeurs de mesure à un système fluidique étanché
US8142362B2 (en) 2008-04-24 2012-03-27 Pacesetter, Inc. Enhanced pressure sensing system and method
US20110040206A1 (en) 2009-08-12 2011-02-17 Medos International Sarl In situ offset compensation for pressure sensors
US20110209553A1 (en) 2010-02-27 2011-09-01 Codman Neuro Sciences Sarl Apparatus and method for minimizing drift of a piezo-resistive pressure sensors due to progressive release of mechanical stress over time
US20150045644A1 (en) 2013-08-09 2015-02-12 Dorin Comaniciu System and Method for Estimating Artery Compliance and Resistance from 4D Cardiac Images and Pressure Measurements
DE102015116648A1 (de) 2015-10-01 2017-04-06 Biotronik Se & Co. Kg Implantierbare Drucksensorvorrichtung
DE102018005911A1 (de) 2018-07-27 2020-01-30 EMKA Medical GmbH Drucksensoreinrichtung für medizinische in vivo Anwendung
WO2020020480A1 (fr) 2018-07-27 2020-01-30 EMKA Medical GmbH Dispositif de détection de pression pour application médicale in vivo
US20210290078A1 (en) 2018-07-27 2021-09-23 EMKA Medical GmbH Pressure-sensor device for medical in-vivo application

Non-Patent Citations (7)

* Cited by examiner, † Cited by third party
Title
GAERTNER MATTHIAS ET AL: "Continuous long-term wireless measurement of right ventricular pressures and estimated diastolic pulmonary artery pressure in patients with severe COVID-19 acute respiratory distress syndrome", ESC HEART FAILURE, vol. 8, no. 6, 6 September 2021 (2021-09-06), pages 5213 - 5221, XP093277630, ISSN: 2055-5822, Retrieved from the Internet <URL:https://onlinelibrary.wiley.com/doi/full-xml/10.1002/ehf2.13600> DOI: 10.1002/ehf2.13600 *
GAERTNER MATTHIAS ET AL: "Pressure-based beat-to-beat right ventricular ejection fraction and Tau from continuous measured ventricular pressures in COVID-19 ARDS patients", PULMONARY CIRCULATION 2012 APR-JUN, vol. 13, no. 1, 1 January 2023 (2023-01-01), XP093277746, ISSN: 2045-8940, Retrieved from the Internet <URL:https://onlinelibrary.wiley.com/doi/full-xml/10.1002/pul2.12179> DOI: 10.1002/pul2.12179 *
GAERTNER, M: "Continuous long-term wireless measurement of right ventricular pressures and estimated diastolic pulmonary artery pressurein patients with severe COVID-19 acute respiratory distress syndrome", ESC HEART FAILURE, vol. 178, 2021, pages 5213 - 5221
GAERTNER, M: "Pulmonary Circulation", vol. 13, 6 January 2023, JOHN WILEY & SONS LTD, article "Pressure-based beat-to-beat right ventricular ejection fraction and Tau fromcontinuous measured ventricular pressures in COVID-19 ARDS patients", pages: 12179
JIACHOU WANGXINXIN LI: "A dual-unit pressure sensor for on-chip self-compensation of zero-point temperature drift", JOURNAL OF MICROMECHANICS AND MICROENGINEERING, vol. 24, 2014, pages 085010
KREMER N. ET AL: "Monitoring of Right Ventricular Failure With Daily Pressure Volume Loops Obtained via an Application and 3-Dimensional Echocardiography", CIRCULATION. HEART FAILURE, vol. 16, no. 1, 1 January 2023 (2023-01-01), US, XP093277635, ISSN: 1941-3289, DOI: 10.1161/CIRCHEARTFAILURE.122.010097 *
ZURAB DARBAIDZE ET AL: "First in human implantation of the CorLog device for postoperative intravascular pressure sensing in left ventricular assist device patients", ARTIFICIAL ORGANS, BLACKWELL SCIENTIFIC PUBLICATIONS, INC., BOSTON, US, vol. 48, no. 5, 8 December 2023 (2023-12-08), pages 567 - 569, XP072621348, ISSN: 0160-564X, DOI: 10.1111/AOR.14690 *

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