EP3518750A1 - Système pour la détection précoce d'hémorragies postopératoires - Google Patents

Système pour la détection précoce d'hémorragies postopératoires

Info

Publication number
EP3518750A1
EP3518750A1 EP17771398.9A EP17771398A EP3518750A1 EP 3518750 A1 EP3518750 A1 EP 3518750A1 EP 17771398 A EP17771398 A EP 17771398A EP 3518750 A1 EP3518750 A1 EP 3518750A1
Authority
EP
European Patent Office
Prior art keywords
parameter
monitored
person
evaluation
pressure
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
EP17771398.9A
Other languages
German (de)
English (en)
Inventor
Anne Schardey
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.)
Isar-M GmbH
Original Assignee
Isar-M 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 Isar-M GmbH filed Critical Isar-M GmbH
Publication of EP3518750A1 publication Critical patent/EP3518750A1/fr
Pending legal-status Critical Current

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 pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/02042—Determining blood loss or bleeding, e.g. during a surgical procedure
    • 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 pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/03—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs
    • A61B5/036—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs by means introduced into body tracts
    • 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
    • A61B5/1073—Measuring volume, e.g. of limbs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14542—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring blood gases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7235—Details of waveform analysis
    • A61B5/7264—Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems
    • A61B5/7267—Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems involving training the classification device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7271—Specific aspects of physiological measurement analysis
    • A61B5/7275—Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
    • 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
    • A61B5/7425—Displaying combinations of multiple images regardless of image source, e.g. displaying a reference anatomical image with a live image
    • 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
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06N—COMPUTING ARRANGEMENTS BASED ON SPECIFIC COMPUTATIONAL MODELS
    • G06N3/00—Computing arrangements based on biological models
    • G06N3/02—Neural networks
    • G06N3/08—Learning methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0223—Operational features of calibration, e.g. protocols for calibrating sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0247—Pressure sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0261—Strain gauges
    • 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 pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
    • 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 pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/024—Detecting, measuring or recording pulse rate or heart rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/0816—Measuring devices for examining respiratory frequency

Definitions

  • the invention relates to a system for the early detection of disabling states of persons, e.g. for the early detection of post-operative bleeding, especially rebleeding in organ harvesting, e.g. a thyroid surgery.
  • monitoring systems known in various designs, which are preferably used in hospitals for patient monitoring. Often, only relevant vital parameters such as, for example, heart rate, heart rate, etc. are monitored, whereby when the respective static limit values are exceeded
  • Parameter constellation is closed to certain states of the patient.
  • Thyroid surgery is extremely dangerous, as it can lead to sudden respiratory arrest.
  • a generic system is known, for example, from the document EP 2 377 460 B1, whose disclosure content with regard to the parameter evaluation is to be fully included in this application - known. With this system, it is very reliable to distinguish insignificant hematomas from internal bleeding in order to recognize the risk of bleeding or compression of vital organs as early as possible.
  • Vital parameters and a suitable classification of the measured parameters in the states to be queried readily succeed in determining a probability on the state of the person to be monitored, with a clear demarcation between life-threatening conditions on the one hand and rather uncritical states on the other hand is possible.
  • Object of the present invention is to further improve the system in such a way that it is able to protect the patient safely and reliably from the consequences of postoperative bleeding with a simplified structure.
  • the decisive parameter for detecting and predicting a postoperative bleeding is the pressure in the body in the operating area.
  • Threshold has risen, a complete loss of voluntary breathing has occurred.
  • Thyroid surgery protected, for which already the continuous monitoring of a parameter is sufficient.
  • the second parameter then fulfills an additional control function.
  • the operation of the system can not only continue to refine arbitrarily, but also adapt to the individual reaction patterns of the persons to be monitored.
  • the display device with which the evaluation is displayed is advantageous because it can be used on the one hand to signal the person to be monitored a state that is critical for them, and they can be used simultaneously, the result of the evaluation communicate in such a way as, for example, to a hospital or to a treating physician, so that life-saving measures can start as quickly as possible.
  • the detector unit can be any unit capable of detecting the selected parameters. Because the detector unit has measuring probes, a computing unit and an interface, the system is designed to function as a
  • the arithmetic unit converts the input signal of the measuring probes so that it becomes visible, for example, on an external device via an interface.
  • the advantage of the interface is that on the one hand in an emergency, the vital parameters of the person to be monitored for a professional, such as a doctor, can be quickly made visible, and on the other hand, the system at
  • the evaluation logic has a neural network, with the aid of which previously trained parameter patterns are recognized.
  • the early detection system with the help of the evaluation logic is additionally able, on the basis of the detected vital parameters and
  • Parameter states in particular taking into account their time course, to generate an instruction of the content, how to deal with the person to be monitored. It therefore corresponds to an individual, adapted to the circumstances
  • the instruction of the system corresponds to that which a family doctor who is familiar with medical history would order.
  • Special equipment is necessary for the treatment of the person to be monitored which may not be one of the emergency medical devices supplied by default may be obtained by an instruction giving an indication of this circumstance, again precious time.
  • the system can be used particularly energy-efficient, whereby a long operating time is achieved.
  • the system can gain particular attractiveness if variable time intervals (dt) are used to record the parameters.
  • This feature allows the system to vary the distances between two measurement points, depending on the circumstances, so that the time intervals during use of the system can be adapted to the current health status of the patient. For example, they become shorter as the condition worsens, and longer as the condition improves.
  • the time intervals (dt) can thus be longer in uncritical phases, such as when sleeping, in turn, an energy-saving
  • the critical thresholds for organ log pressure are higher in young patients than in older patients.
  • the system can more accurately distinguish between a critical health condition and noncritical conditions such as a resting phase or short stress phase, especially if the measured parameters differ significantly from person to person.
  • Distinction means that significantly fewer false alarms are displayed or
  • the fuzzy logic module of the evaluation logic can be calibrated in advance individually according to the health of the person to be monitored. This eliminates any adjustment runs at the beginning of the operation and the patient is monitored from the beginning in the best possible way.
  • the evaluation logic can be designed to be adaptive. This has the advantage that the system during the
  • Result of the evaluation and / or an instruction on how to deal with the current state of the person to be monitored are transmitted by a transmitting unit to a central office.
  • a transmitting unit For example, a bluetooth or a WLAN module can be used for the transmission. In this way, appropriate experts can analyze the result of the evaluation immediately and, if necessary, act.
  • the transmitting unit can be designed such that it transmits the determined spatial or geographical position of the person to be monitored to a central office.
  • the person to be monitored can be found immediately if a life-threatening condition has occurred, even if that person can not independently draw attention to himself.
  • valuable time can be gained both in locating the space of a stationary patient and in non-stationary patients.
  • 1A is a block diagram of the evaluation logic
  • FIG. 1B shows a detailed representation of the sensor for detecting the parameter depicting the skin stretch near the surgical area
  • FIG. 2 and 3 is a schematic front view and a side view of a
  • FIG. 4 shows a perspective view of a pressure transducer with connection signal cable to a signal node
  • FIG. 4A is a perspective view of a connector, with a
  • Pressure signal hose can be connected to the pressure transducer
  • FIG. 5 is a perspective view of a signal node with signal connection cable to a base unit.
  • Fig. 6 is a perspective view of the base unit; 7 shows a schematic perspective representation of the neck area of a patient to clarify the position of a thyroid lobe with inserted pressure sensor;
  • Figure 8 shows the condition prior to surgery
  • Figures 9 and 10 show the conditions after partial and total organ removal
  • Figures 1 1 to 13 exemplary signal diagrams that are recorded with a system according to the invention.
  • person a person who has undergone thyroid surgery, so that the schematically indicated operation area 12 is located in the neck area.
  • the sensor 14 is formed by a voltage sensor, with which the strain of the skin of the patient on a skin portion is detectable, which is located in the vicinity of the organ box not shown in detail, i. near the operating area 12.
  • a sensor could be used to measure the neck circumference. Both parameters have in common that they are a measure of the swelling of a
  • the strain sensor can optimally absorb the forces
  • the sensor is cast in a silicone rubber with a defined Shore hardness A, different material materials and a certain material thickness.
  • the sensor is - as shown in Figure 1 - fixed sufficiently fixed at the neck of the patient by means of known methods and optionally additional aids, so that the
  • the meandered wire meander structures 142 are located in the central area, which have a compensating effect for larger forces and can absorb lateral forces to a lesser extent.
  • the measurement result can be further increased by a layer model, in which case the curvature of the strain sensor affects the longitudinal strain.
  • the strain sensor thus measures the resistance change of the
  • FIG. 4A shows a connection piece 50 with which the signal tube 30 can be connected to the pressure sensor 16.
  • the fitting 50 has a central body 52 in which a pressure transmitting space with a
  • Pressure transfer diaphragm 54 is in the mounted state of the fitting 50 with the pressure sensor diaphragm 17 (see Figure 4) of the pressure transducer in solid
  • the reference numeral 70 denotes a terminating cap of the signal tube 30.
  • the end cap 70 is preferably of a thin-walled
  • a distal end portion 72 of the signal tube 30 is sewn into the organ box. So that the pressure detection can take place, the signal hose with liquid - preferably a NaCI solution - must be filled bubble-free. The filling takes place if necessary, but not necessarily so that in the signal tube a certain, preferably low pre-pressure is reached.
  • one sets the connector 50 on the pressure transducer 16 opens the check valve 64 and fills the signal tube 30 by means of a syringe on the
  • the signals of the sensors are guided in the embodiment shown via signal lines 22, 24 and 26 to a signal node 28, which is separately fixed to the patient near the operating area 12.
  • the interface mainly has two functions. On the one hand, it serves as a kind of internal interface of the detector unit for the vital parameters detected by the measuring probes 14, 16 and 18. On the other hand, it can serve as an external interface to connect external devices such as a computer or monitor.
  • the ECU / CPU may be equipped to access a memory in which all relevant instructions are stored, as in
  • the memory can be both an internal, as well as an external memory.
  • the ECU / CPU can both store the instructions so that they can be read out as needed, as well as store the progressions of the course of parameters over longer periods of time. These can be read out and analyzed via the interface during routine checks, for example.
  • the distal end of the signal tube 30 is positioned in the resulting thyroid lodge 80 with the closing off the pressure chamber chamber 70 cap. This portion of the signal tube 30 is sewn into the patient, for example, or elsewhere in the body of the patient in the case of a minimally invasive surgical procedure
  • each box 80R and 80L are related, in the latter case it is advantageous if each box is equipped with a pressure sensor.
  • the signal tubes 30 are then preferably together via a Y-fitting to the
  • the detected parameters are evaluated by the ECU / CPU, with the
  • instructions can be output on the display device which, depending on the display device, can be read partially, continuously or by means of symbols.
  • the instructions can only be partially displayed, whereas a larger display device also allows for the display of detailed instructions.
  • the base unit 30 displays the rating in the top line with a symbol similar to a traffic light.
  • the values of the monitored parameters are displayed.
  • the log pressure is displayed in mmHg
  • another line of the parameters of the skin stretch for example the neck circumference in mm (as shown)
  • the respiratory rate in 1 / min.
  • a percentage increase in skin stretch near the surgical site such as the percent increase in neck circumference, may also be indicated. It can also be a one- or multi-dimensional measurement of postoperative swelling of the
  • the breathing is additionally monitored. It can be seen that this parameter reflects a resting state of the patient. By recording this parameter, however, it is possible to include the state of agitation of the patient (wakefulness, relaxation, panic, sleep) in the evaluation.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pathology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Physiology (AREA)
  • Cardiology (AREA)
  • Artificial Intelligence (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Theoretical Computer Science (AREA)
  • Signal Processing (AREA)
  • Evolutionary Computation (AREA)
  • Psychiatry (AREA)
  • Computer Vision & Pattern Recognition (AREA)
  • Pulmonology (AREA)
  • Mathematical Physics (AREA)
  • Data Mining & Analysis (AREA)
  • Radiology & Medical Imaging (AREA)
  • General Physics & Mathematics (AREA)
  • Software Systems (AREA)
  • Optics & Photonics (AREA)
  • General Engineering & Computer Science (AREA)
  • Computing Systems (AREA)
  • Computational Linguistics (AREA)
  • Fuzzy Systems (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Dentistry (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne un système pour la détection précoce d'états invalidants de personnes, comme par exemple une hémorragie postopératoire d'un patient, en particulier une hémorragie consécutive à une opération d'un organe, présentant une unité de détection (30) pour la détection continue de plusieurs paramètres sélectionnés. L'unité de détection présente des capteurs (14, 16, 18), une unité de calcul, une interface et une logique d'évaluation, qui réalise, en fonction des états existants des paramètres, une évaluation de la probabilité de l'existence d'une anomalie de la santé, comme par exemple une probabilité d'hémorragie postopératoire. Le système comprend en outre un dispositif d'affichage (40) qui permet d'afficher l'évaluation. Les paramètres choisis sont la pression dans le compartiment de l'organe postopératoire et/ou un paramètre représentant la dilatation de la section de peau adjacente au compartiment de l'organe.
EP17771398.9A 2016-09-30 2017-09-15 Système pour la détection précoce d'hémorragies postopératoires Pending EP3518750A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102016118673.2A DE102016118673A1 (de) 2016-09-30 2016-09-30 System zur Früherkennung von post-operativen Blutungen
PCT/EP2017/073366 WO2018059975A1 (fr) 2016-09-30 2017-09-15 Système pour la détection précoce d'hémorragies postopératoires

Publications (1)

Publication Number Publication Date
EP3518750A1 true EP3518750A1 (fr) 2019-08-07

Family

ID=59923421

Family Applications (1)

Application Number Title Priority Date Filing Date
EP17771398.9A Pending EP3518750A1 (fr) 2016-09-30 2017-09-15 Système pour la détection précoce d'hémorragies postopératoires

Country Status (8)

Country Link
US (1) US11793409B2 (fr)
EP (1) EP3518750A1 (fr)
JP (1) JP7170646B2 (fr)
KR (2) KR20190057368A (fr)
CN (1) CN109788916A (fr)
CA (1) CA3038866A1 (fr)
DE (1) DE102016118673A1 (fr)
WO (1) WO2018059975A1 (fr)

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KR102386872B1 (ko) 2020-03-10 2022-04-13 부산대학교 산학협력단 실시간 영상을 이용한 대장 혈류속도 분석방법
DE102021114117A1 (de) 2021-06-01 2022-12-01 Isar-M Gmbh Drucküberwachungseinrichtung und Verfahren zur Inbetriebnahme einer solchen Einrichtung
KR20230041507A (ko) * 2021-09-17 2023-03-24 사회복지법인 삼성생명공익재단 신경병증의 자가 진단 방법, 컴퓨터 프로그램 및 시스템
CN117158919B (zh) * 2023-10-25 2024-03-15 深圳大学 出血点检测装置和计算机可读存储介质

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KR20190057368A (ko) 2019-05-28
CN109788916A (zh) 2019-05-21
KR102460836B1 (ko) 2022-10-28
CA3038866A1 (fr) 2018-04-05
DE102016118673A1 (de) 2018-04-05
KR20220122801A (ko) 2022-09-02
JP2019531171A (ja) 2019-10-31
US11793409B2 (en) 2023-10-24
US20200022593A1 (en) 2020-01-23
WO2018059975A1 (fr) 2018-04-05
JP7170646B2 (ja) 2022-11-14

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