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CN-116600703-B - Measuring device for noninvasively detecting intracranial pressure of patient and corresponding method

CN116600703BCN 116600703 BCN116600703 BCN 116600703BCN-116600703-B

Abstract

A measuring device for noninvasively detecting intracranial pressure pulsation of a patient includes a holder detachably attached to an outside of the skull bone of the patient in a force-fit and/or form-fit manner, at least one double-laminate bending sensor arranged in or on the holder, an analog signal amplifier for amplifying measurement data provided by the double-laminate bending sensor, an A/D converter for converting the analog measurement data into digital data, a calculation unit for preprocessing the data and calculating vital parameters such as intracranial pressure based on the digital data. The invention also discloses a related method for noninvasively detecting intracranial pressure pulsation.

Inventors

  • Renault Petrichevich
  • Clemens Launa

Assignees

  • 尹迪泰特有限责任公司

Dates

Publication Date
20260512
Application Date
20211216
Priority Date
20201216

Claims (20)

  1. 1. A measurement device for noninvasively detecting intracranial pressure pulsations in a patient, comprising: A holder (2) removably attached to the outside of the patient's skull in a force-fit and/or form-fit manner; At least one bi-laminate bending sensor (3, 14, 15) having two bending sensor layers of anti-parallel polarity symmetrically arranged around a neutral fiber and arranged in or on the holder (2), wherein after bending in one direction one of the bending sensor layers stretches while the other bending sensor layer compresses equally, the bending sensor layers being signal superposed upon reverse loading; -an analog signal amplifier (5) for amplifying the measurement data provided by the dual-stack bending sensor (3, 14, 15); an A/D converter (6) for converting analog measurement data into digital data; A calculation unit for preprocessing the data and calculating parameters related to life state variables in the intracranial pressure pulsation curve based on the digital data.
  2. 2. Measuring device according to claim 1, wherein the holder (2) is formed as a headband or a headband and/or has a display (11) for displaying a measurement curve, calculated parameters and associated time course.
  3. 3. The measurement device according to claim 1, wherein the dual-stack bending sensor (3, 14, 15) is a dual-stack piezoelectric bending sensor.
  4. 4. The measurement device according to claim 1, wherein the dual-stack bending sensor (3, 14, 15) is arranged in a rocker-like manner on a bracket attachable to the outside of the patient's skull and movable about a pivot point.
  5. 5. The measurement device according to claim 1, wherein the double-stack bending sensor (3, 14, 15) is arranged at a middle section of the C-shaped support (30) between two end sections.
  6. 6. The measurement device according to claim 2, wherein the holder (2) is configured as a headband with a pretension generator (13) for generating and adjusting a pretension against the skull of the patient.
  7. 7. The measuring device according to claim 6, wherein the pretension generator (13) has a force sensor or a strain sensor.
  8. 8. The measurement device according to claim 6, wherein the pretension generator (13) comprises an indicator for pretension or its associated voltage.
  9. 9. The measurement device according to claim 6, wherein the pretension generator (13) is configured to automatically set a predetermined pretension.
  10. 10. The measurement device according to claim 9, wherein the pretension generator (13) comprises an electromechanical or pneumatic mechanism.
  11. 11. The measurement device according to claim 2, wherein the holder (2) is configured as a headband with a spacer (17, 40) at least over part of its length.
  12. 12. The measurement device according to any one of claims 1 to 11, wherein the measurement device comprises one or more of a structural acoustic sensor (12), an acceleration sensor, a position sensor, an external pulsation sensor, an external blood pressure sensor and a temperature sensor, wherein the calculation unit is configured to detect external disturbance influences or conditions detected by at least one of the sensors and to correct disturbance influences if necessary.
  13. 13. The measurement device according to claim 2, wherein the holder (2) is formed as a headband from which the dual stack bending sensor (3, 14, 15) can be removed and replaced.
  14. 14. The measurement device according to any one of claims 1 to 11, wherein the measurement device comprises a data recorder connected to the a/D converter (6) or the computing unit.
  15. 15. The measurement device according to claim 2, wherein the holder (2) comprises an accumulator (4) when configured as a headband.
  16. 16. The measurement device according to claim 15, wherein the accumulator (4) comprises a battery.
  17. 17. The measurement device according to claim 16, wherein the accumulator (4) comprises a rechargeable battery.
  18. 18. The measurement device according to any one of claims 15 to 17, wherein the dual stack bending sensor (3, 14, 15) and/or the analog signal amplifier (5) and/or the a/D converter (6) are connected to a transmitter.
  19. 19. The measurement device according to claim 18, wherein the dual stack bending sensor (3, 14, 15) and/or the analog signal amplifier (5) and/or the a/D converter (6) are connected to a wireless data transmission transceiver.
  20. 20. The measurement device according to claim 18, wherein the dual stack bending sensor (3, 14, 15), the analog signal amplifier (5), the a/D converter (6) and/or the transmitter if present and/or the accumulator if present are integrated into a single component.

Description

Measuring device for noninvasively detecting intracranial pressure of patient and corresponding method Technical Field The present invention relates to a measuring device for the noninvasive detection of intracranial pressure in a patient. Background Many neurological conditions may be associated with life threatening elevation of intracranial pressure (ICP). The internal volume of the skull remains unchanged, so that expansion of the volume of one or more compartments results in an increase in ICP. Such compartments include brain tissue (e.g., due to bleeding, swelling, and inflammation), CSF space (e.g., due to hydrocephalus and bleeding), and vascular lacuna (e.g., changes due to hyperventilation or hypoventilation). The relationship between intracranial volume and intracranial pressure is called intracranial compliance. The initial rise in ICP may be compensated by so-called headspace (CSF space, vascular lacuna) (Monro-Kellie theory), but as the volume expands, ICP also rises exponentially. Conditions that may lead to elevated pressure include brain trauma, epidural/subdural hematomas, occupied ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, venous sinus/venous thrombosis, meningitis, encephalitis, global cerebral hypoxia, brain tumor, poisoning and metabolic disorders among other disease categories. In order to monitor ICP without interruption in critical situations such as severe brain trauma, a measurement catheter may be inserted invasively from the top of the cranium. However, invasive measurement procedures are burdensome to many patients and often the monitoring is abandoned. Non-invasive measurement methods based on measuring skull stretching have been proposed. The fluctuation in blood volume caused by the heartbeat can lead to stretching of the skull, particularly across the craniotomy where connective tissue is occluded. The resulting intra-cerebral pressure pulsatile fluctuations are about 3-4mmHg, which in turn results in minimally simultaneous expansion of intra-cranial pulsations. Patent document WO 2013/04973 A2 proposes a measuring device for non-invasive measurement of intracranial pressure, comprising a sensor configured to detect deformation of the skull. The sensor is connected with the amplifier, the A/D converter, the processor, the display and the memory. The measuring device may determine the intracranial pressure by evaluating the sensor signal, and determine the skull deformation based on the sensor signal. Patent document WO2019/087148A1 discloses a similar measuring device, wherein data acquired by a sensor is processed and transmitted wirelessly to a receiver. However, a disadvantage of such measuring devices is that the significant effect of external carotid artery pulsations cannot be excluded due to lack of decoupling. The skull pulsation caused by the pulsation internal pressure is obviously smaller than the arterial pulsation, and if the arterial pulsation is not distinguished, the skull pulsation is not significant. The strain gauge proposed in the above publication is arranged to operate at its measurement limit. This also means that the on-skull measurement device cannot be lined up, and thus, over time, can be quite uncomfortable for the patient. Disclosure of Invention The invention aims to provide a measuring device for noninvasively detecting intracranial pressure pulsation, which overcomes the defects and can simply and reliably measure static intracranial pressure and other life data. In order to achieve the above object, the invention proposes a measuring device having the features of claim 1. The measuring device according to the invention comprises a holder which can be detachably attached to the outside of the skull bone of a patient in a force-fitting and/or form-fitting manner, at least one double-laminate bending sensor arranged in or on the holder, an analog signal amplifier and/or an analog signal filter for amplifying and/or filtering the measurement data provided by the double-laminate bending sensor, an A/D converter for converting the analog measurement data into digital data, a calculation unit for preprocessing the digital data and calculating and/or deriving vital parameters such as intracranial pressure, etc. based on the digital data. The measuring device according to the invention is characterized in that the influence of arterial vessel pulsations, that is to say the intracranial pressure pulsations, is largely eliminated. In addition to adjusting the digital data, the calculation unit is also used to make corrections and calculate the characteristic curve parameters and values derivable therefrom, such as intracranial pressure (ICP). Furthermore, systolic or diastolic characteristic values or vital parameters may be derived from the digital data. Optionally, the measuring device according to the invention comprises a display, so that an amplitude curve, a measurement curve, a determined parameter or a derived value or