WO2026032502A1 - Système médical, procédé de fonctionnement d'un système médical et produit-programme informatique - Google Patents

Système médical, procédé de fonctionnement d'un système médical et produit-programme informatique

Info

Publication number
WO2026032502A1
WO2026032502A1 PCT/EP2024/072431 EP2024072431W WO2026032502A1 WO 2026032502 A1 WO2026032502 A1 WO 2026032502A1 EP 2024072431 W EP2024072431 W EP 2024072431W WO 2026032502 A1 WO2026032502 A1 WO 2026032502A1
Authority
WO
WIPO (PCT)
Prior art keywords
magnetic field
biological tissue
medical system
sensor
instrument
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/EP2024/072431
Other languages
German (de)
English (en)
Inventor
Alexander Neugebauer
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.)
Erbe Elecktromedizin GmbH
Original Assignee
Erbe Elecktromedizin 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 Erbe Elecktromedizin GmbH filed Critical Erbe Elecktromedizin GmbH
Priority to PCT/EP2024/072431 priority Critical patent/WO2026032502A1/fr
Publication of WO2026032502A1 publication Critical patent/WO2026032502A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

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    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/0017—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system transmitting optical signals
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Definitions

  • the invention relates to a medical system.
  • the medical system comprises a medical instrument with a tool part configured to influence biological tissue.
  • a high-frequency current can be introduced into the biological tissue.
  • the influence can be effected by contact through direct contact of the tool part with the biological tissue.
  • the influence can be effected without contact, for example, by means of a spark discharge between the tool part and the biological tissue or by means of a plasma generated and ignited in the area of the tool part, which then acts on the biological tissue.
  • the medical instrument can be configured for open surgical, laparoscopic, or endoscopic use. It can be a monopolar or bipolar electromedical or electrosurgical instrument.
  • the medical system can include a power supply unit to provide the medical instrument with electrical energy and optionally at least one other operating medium, in particular a fluid (for example, a gas for plasma generation).
  • Such medical systems or medical instruments can be used for different applications.
  • the medical system or medical instrument can be configured to perform the Tool component used to coagulate, cut, ablate, devitalize, or fuse biological tissue.
  • fenbart EP 3 831 291 Al an instrument for the electrosurgical treatment of biological tissue, which has a color marking at a distal end.
  • the color marking can be compared with the color of the treated tissue.
  • EP 0 813 387 A of fenbart discloses an electrosurgical system in which a measuring voltage can be applied between electrodes of an electrosurgical instrument to perform an impedance measurement for tissue identification.
  • a similar system is also known from EP 1 511 534 B1.
  • Electrosurgical systems also use magnetic field sensors.
  • US 11,207,092 B2 describes the use of magnetic field sensors in the form of Hall sensors. The relative position of an instrument part equipped with a magnet relative to an instrument part equipped with the Hall sensor is detected. It is also proposed to equip interchangeable probes with different magnets, so that an associated Hall sensor can measure the different magnetic field strengths and thus identify which probe is being used.
  • the medical system comprises a medical instrument with a tool part.
  • the tool part is configured to influence biological tissue, for example by direct contact of the tool part or at least a section thereof with the biological tissue, or indirectly by generating a spark between the tool part and the biological tissue, or by generating a plasma that is emitted onto the biological tissue.
  • the medical instrument can be an electromedical instrument and in particular an electrosurgical instrument
  • the instrument may be an electrosurgical instrument. It can be designed for open surgical, laparoscopic, or endoscopic use.
  • the medical instrument may have one or more electrodes, such as at least one cutting electrode, at least one coagulation electrode, and/or at least one electrode for plasma ignition.
  • the electrosurgical instrument (especially an electrosurgical instrument) may be monopolar or bipolar.
  • the tool part can have movable components, for example, two jaws that are movable or pivotable relative to each other, between which biological tissue can be grasped.
  • the tool part can optionally include a movable blade for cutting tissue.
  • the medical system and in particular the medical instrument can be configured to perform at least one type of tissue treatment, for example, coagulation and/or dissection (cutting) and/or thermofusion and/or ablation (devitalization) of biological tissue.
  • tissue treatment for example, coagulation and/or dissection (cutting) and/or thermofusion and/or ablation (devitalization) of biological tissue.
  • the medical system is configured to determine at least one operating parameter during operation.
  • the operating parameter describes the biological tissue on which the medical instrument acts and/or the effect or action achieved on the biological tissue through the use of the medical instrument.
  • the at least one operating parameter allows for monitoring of the effect or treatment of the biological tissue. become .
  • At least one magnetic field sensor is arranged on the tool part of the medical instrument.
  • This magnetic field sensor is configured to detect a magnetic field emanating from the biological tissue and to generate a sensor signal that describes the detected magnetic field.
  • the sensor signal can, for example, describe the magnitude of a magnetic field strength and/or the direction of magnetic field lines.
  • the at least one sensor signal from the at least one magnetic field sensor can be used to measure or determine a location-dependent magnetic field strength and/or a spatial change in the magnetic field strength and/or a temporal change in the magnetic field strength.
  • the magnetic field is generated by the flow of an electric current in the biological tissue.
  • the current through the biological tissue can be introduced into the biological tissue by the medical instrument, and in particular by the tool part, or it can flow through the patient's bodily functions in the biological tissue.
  • action potentials APs
  • nerve fibers axons
  • Such a magnetic field can be detected by means of the at least one magnetic field sensor on the tool part.
  • the medical system has an evaluation unit which is connected to the at least one magnetic field sensor by means of a transmission link.
  • the transmission link is preferably an optical transmission link, in particular an exclusively optical one. Transmission link.
  • the optical transmission link is insensitive to interference, particularly from interference caused by the high-frequency currents and voltages in an electromedical instrument.
  • Such an optical transmission link can be implemented, for example, using at least one optical fiber. It is advantageous if the at least one magnetic field sensor is configured to provide an optical sensor signal as the sensor signal, thus eliminating the need for an additional converter unit coupled to the magnetic field sensor in the instrument for generating an optical sensor signal.
  • the at least one sensor signal (in particular, the at least one optical sensor signal) can be provided to the evaluation unit via the transmission connection.
  • the evaluation unit determines the at least one operating parameter based on the at least one sensor signal.
  • Information can be output to an operator via a user interface based on the at least one operating parameter.
  • the output of the information can in all cases be optical and/or acoustic and/or haptic (e.g., display and/or loudspeaker and/or haptic feedback on the instrument).
  • Signals describing at least one operating parameter allow one or more settings (parameters, modes, etc.) of the medical system and, in particular, the supply device to be checked and, if necessary, adjusted.
  • two or more magnetic field sensors are arranged on the tool part. This allows additional information about the magnetic field to be obtained, for example, a spatially changing magnetic field strength.
  • the magnetic field sensors can be positioned in a suitable spatial arrangement relative to each other.
  • each existing electrode can be assigned a separate magnetic field sensor.
  • at least one magnetic field sensor can be provided on each of the components of the tool part that are movable relative to each other.
  • one or more magnetic field sensors can be arranged on each of the branches that are movable or pivotable relative to each other.
  • the magnetic field sensors on the branches can be opposite each other when the branches are completely closed. If several magnetic field sensors are provided on each branch, they can be arranged at a distance from each other in at least one spatial direction.
  • the sensor signal is not an electrical sensor signal, but in particular an optical sensor signal.
  • the wavelength of the optical sensor signal can be in the visible light range and/or in the infrared range.
  • the The wavelength of the optical sensor signal must be at least 560 nm or at least 600 nm.
  • the wavelength can additionally or alternatively be a maximum of 830 nm.
  • the transmission link between the evaluation device and the at least one magnetic field sensor is designed as an optical transmission link, as already described above.
  • the evaluation unit can be configured to provide an electrical signal.
  • This electrical signal can be an electrical sensor signal generated by converting the optical sensor signal and/or a result or evaluation signal generated by evaluating the at least one sensor signal, which indicates the at least one operating parameter.
  • the result or evaluation signal can be provided to a user interface and used there—as explained—to output acoustic and/or optical and/or haptic information to an operator.
  • the evaluation device may include a photodetector by which the optical sensor signal is converted into an electrical sensor signal.
  • the electrical sensor signal at the output of the photodetector may be provided to a processing unit connected to the photodetector.
  • the evaluation device may include a spectrometer, for example a slit spectrometer, to which the at least one optical sensor signal is provided for evaluation.
  • the magnetic field sensor is a quantum magnetometer or quantum gradiometer based on an NVCD sensor.
  • the abbreviation NVCD stands for "Nitrogen Vacancy Centers in Diamonds".
  • the magnetic field sensor has a diamond with nitrogen vacancy centers (NV centers). Such a magnetic field sensor is advantageous for detecting magnetic fields with low magnetic field strength and can be miniaturized very well for integration into the tool part of a medical instrument.
  • Magnetic field sensors or magnetometers used previously in medical instruments have disadvantages:
  • Hall sensors can be implemented cost-effectively, but are less sensitive than, for example, NVCD sensors.
  • NVCD sensors thin-film sensors
  • XMR sensors thin-film sensors
  • a fluxgate magnetometer also known as a Förster probe
  • the magnetic fields must have a magnetic strength of at least 0.1 nT to 1 mT in order to be detected.
  • Superconducting quantum interference sensors (“SQUIDs”) detect a magnetic flux through a superconducting ring. Creating superconductivity is very complex because extremely low temperatures are required.
  • Proton magnetometers are used for medical instruments unsuitable due to their size.
  • the evaluation unit is provided with a magnetic field characteristic that describes a relationship between the at least one input parameter and the at least one sensor signal of the at least one magnetic field sensor.
  • the magnetic field characteristic can also describe one or more relationships between the at least one input parameter and at least one further input parameter.
  • the at least one input parameter can, for example, be a current electrical operating parameter of the medical system and/or an environmental parameter and/or a tissue parameter.
  • the at least one input parameter can be measured by means of a suitable sensor and/or can be known or predetermined based on the settings of the medical system and/or can be calculated or estimated or determined in another way. For example, such an additional input parameter can be determined empirically or based on a simulation or an observer or in another suitable way.
  • the conductivity or impedance of the biological tissue can be considered as an input parameter.
  • electrical parameters that characterize or influence an electric current flowing through the biological tissue can be considered as input parameters, such as a frequency and/or an amplitude and/or a waveform and/or a crest factor of an electric voltage and/or an electric current for at least one electrode of a medical instrument.
  • at least one operating parameter can be determined in the evaluation unit. In all embodiments, one of the following operating parameters or several of the following operating parameters in any combination can be determined in the evaluation unit:
  • a distance parameter that describes the distance of the magnetic field sensor or of at least one of the existing magnetic field sensors to a peripheral nerve - and thus, for example, indirectly also the distance of the tool part to the peripheral nerve;
  • a temperature parameter that describes a temperature in the area of the detected magnetic field and/or the medical instrument and/or the tool part, and/or in the area of biological tissue when in contact with biological tissue;
  • tissue type parameter that describes a tissue type of the biological tissue from which the detected magnetic field originates
  • - at least one length parameter that describes a dimension in a respective assigned spatial direction of an area of the biological tissue influenced by the medical instrument, whereby several length parameters can also be determined in different spatial directions
  • - at least one contact parameter that describes contact between the tool parts and the biological tissue, for example a penetration depth of the tool part into the biological tissue and/or a contact pressure between the at least one tool part and the biological tissue
  • tissue state and/or the change in tissue state can be determined depending on location or time.
  • Treatment progress can be detected using one or more of the aforementioned operating parameters. For example, it can be detected whether the temperature in the biological tissue in the zone affected by the instrument is sufficiently high for tissue ablation (devitalization). Based on a change in the magnetic field over time, and in particular the magnetic field strength, it can be detected, for example, whether sufficient dosage, i.e., sufficient energy input into the affected or treated tissue, has occurred. It is thus possible to determine whether the dosage and/or depth of penetration required for the desired treatment has been achieved, for example, to monitor whether complete coagulation and/or complete ablation has been achieved in a desired area of the biological tissue. Additionally or alternatively, it is also possible to The spatial size of the area of biological tissue influenced by the instrument will be determined.
  • the invention also relates to a method for operating a medical system, in particular any embodiment of a medical system described above.
  • a magnetic field emanating from biological tissue is detected by means of at least one magnetic field sensor arranged on a tool part of a medical instrument.
  • the at least one magnetic field sensor provides a sensor signal to an evaluation unit, which then determines the at least one operating parameter.
  • the invention also relates to a computer program product comprising a program code which, when executed on a computing device, causes the medical system to operate as described above or to execute the method according to the invention.
  • Figure 1 shows a schematic, block diagram-like representation of an embodiment of a medical system with a medical instrument comprising a tool part and a magnetic field sensor arranged on the tool part,
  • Figure 2 shows a schematic, block diagram-like representation of a further embodiment of a medical system with a medical instrument, which has a tool part and a magnetic field sensor arranged on the tool part,
  • Figure 3 shows an embodiment of a medical instrument in a schematic partial view, which can be used in a medical system according to Figures 1 or 2,
  • Figures 4 and 5 each show a schematic, block diagram-like representation of a further embodiment of a medical system with a medical instrument comprising a tool part and a magnetic field sensor arranged on the tool part,
  • Figure 6 shows a block diagram of an embodiment for realizing an evaluation unit, an excitation unit and an associated magnetic field sensor for any embodiment of a medical system
  • Figure 7 shows a schematic view of a spatial arrangement of several magnetic field sensors on the tool part of a medical instrument, in particular on a branch of a medical instrument,
  • Figure 8 shows a schematic cross-sectional view of an embodiment of a tool part with an exemplary arrangement of several magnetic field sensors on the sides of the tool part
  • Figures 9 and 10 each show a schematic representation of a preferred embodiment of a magnetic field sensor
  • Figure 11 shows a schematic representation of the time course of an electrical voltage at at least one Electrode of a medical instrument and of a sensor signal generated by an evaluation unit
  • Figure 12 shows a schematic representation of the determination of at least one input parameter as a function of at least one sensor signal and optionally at least one further input parameter using a magnetic field characteristic.
  • FIG. 1 shows a schematic representation of an embodiment of a medical system 15 in a block diagram.
  • the medical system 15 includes a medical instrument 16, which in the embodiment is designed as an electromedical instrument 17 and, in particular, as an electrosurgical instrument 18. Where reference is subsequently made to an electromedical instrument 17, it can refer to an electrosurgical instrument 18 in all embodiments.
  • the medical instrument 16 has a tool part 19 which serves to influence biological tissue 20.
  • at least one electrode 21 can be provided on the tool part 19. Schematic representations of tool parts 19 with at least one electrode 21 are shown in Figures 4, 5, 7 and 8. The number of electrodes 21 can vary.
  • An electric current can be introduced into the biological tissue 20 via the at least one electrode 21 in order to influence or treat the biological tissue 20. This influence or effect on the biological tissue 20 can be effected by contact of the at least one electrode 21 with the biological tissue 20 or alternatively without contact by generating a A spark is generated between the electrode 21 or one of the electrodes 21 and the biological tissue 20.
  • a plasma can be generated by means of the at least one electrode 21 using a supplied gas and directed onto the biological tissue 20.
  • biological tissue can be coagulated and/or cut and/or ablated.
  • the medical system 15 includes a power supply unit 25.
  • the power supply unit 25 has a high-frequency generator 26 for generating a high-frequency voltage U ⁇ sub> G ⁇ /sub> or a high-frequency current I ⁇ sub> G ⁇ /sub> for the electromedical instrument 17 or electrosurgical instrument 18.
  • the frequency of the high-frequency voltage U ⁇ sub>G ⁇ /sub> or of a high-frequency current I ⁇ sub> G ⁇ /sub> is in particular in a range of 100 kHz to 10 MHz.
  • the electromedical instrument 17 can be configured as a monopolar instrument or as a bipolar instrument.
  • Figure 1 shows an example of a monopolar electromedical instrument 17, in which a treatment circuit originates from the high-frequency generator.
  • the treatment circuit leads from the high-frequency generator 26 via the electrode 21 or one of the electrodes 21, the biological tissue 20, and a neutral electrode 27 attached to the biological tissue 20, back to the high-frequency generator 26.
  • the electromedical instrument 17 is designed as a bipolar instrument (as shown, for example, in Figures 2, 4, and 5), at least two electrodes 21 are present, which may have different electrical voltage potentials.
  • the treatment circuit then leads from the high-frequency generator 26 via one of the electrodes 21, the biological tissue 20, to another electrode 21, and from there back to the high-frequency generator 26 of the power supply unit 25.
  • the number of available electrodes 21 is not limited to one or two electrodes 21. If several electrodes 21 are present, an electrode group with two or more electrodes 21 can have the same electrical voltage potential.
  • the at least one electrode 21 available can be used for one or more applications.
  • an electromedical instrument 17 can have at least one coagulation electrode for coagulating biological tissue 20 and/or at least one cutting electrode for cutting biological tissue 20 and/or at least one ablation electrode for ablating biological tissue 20.
  • the medical instrument 16 or electromedical instrument 17 can have a handle 22 on which the tool part 19 is arranged directly or indirectly ( Figures 1 and 2). Such instruments can be used for open surgical or laparoscopic procedures.
  • the electromedical instrument 16 can be set up for use (e.g., Figures 1, 2, 4 and 5).
  • the electromedical instrument 16 can also be set up for endoscopic use and guided through a working channel of an endoscope 23, as shown schematically in Figure 3.
  • At least one magnetic field sensor 30 is arranged at 17.
  • the at least one magnetic field sensor 30 is preferably an NVCD sensor.
  • the at least one magnetic field sensor 30 has a diamond 32 doped with several nitrogen vacancy centers 31 ( Figures 4 to 6, 9 and 10).
  • the nitrogen vacancy centers 31 are realized by replacing a carbon atom in the diamond lattice of the diamond 32 in combination with an immediately adjacent vacancy.
  • the nitrogen vacancy center 31 has an excess of electrons and is therefore negative. It is also referred to below as the NV center 31, and the magnetic field sensor 30 can also be referred to as the NVCD sensor.
  • the abbreviation NVCD stands for "Nitrogen Vacancy Centers in Diamonds".
  • the diamond 32 of the magnetic field sensor 30 is connected to an evaluation unit 35 of the medical system 15 by means of a transmission link 33 and, for example, an optical transmission link 34.
  • the evaluation unit 35 can be part of the power supply unit 25 or alternatively be designed separately from it.
  • the evaluation unit 35 can be communicatively connected to a display unit 36.
  • the display unit 36 can, for example, be part of a user interface of the medical system 15 and can, for example, be part of the power supply unit 25.
  • the display device 36 can have optical and/or acoustic and/or haptic display means. It is also possible to use the handle 22 of the medical instrument 16 or electromedical instrument 17 as a haptic display means.
  • the optical transmission link 34 is designed such that only optical signals or light signals are transmitted. In particular, the optical transmission link 34 is not designed for the transmission of electrical signals.
  • the optical transmission link 34 between the magnetic field sensor 30 and the evaluation unit 35 has, in particular, one or more optical waveguides 37.
  • the at least one optical waveguide 37 is, for example, a glass fiber conductor. Single-mode fibers are preferably used as the optical waveguide 37.
  • the at least one magnetic field sensor 30 can transmit a sensor signal S and, for example, an optical sensor signal S ⁇ sub> opt ⁇ /sub> to the evaluation unit 35.
  • the sensor signal S or the optical sensor signal S ⁇ sub>opt ⁇ /sub> describes a magnetic field 38 detected by the respective magnetic field sensor 30, in particular the magnitude of the field strength B at the respective position of the magnetic field sensor 30.
  • the magnetic field 38 to be detected by the at least one magnetic field sensor 30 originates from the biological tissue 20 when a current I ⁇ sub> B ⁇ /sub> flows through the biological tissue 20 ( Figures 1, 3 and 5).
  • a magnetic field 38 is generated when a current I ⁇ sub>B ⁇ /sub> flows through one or more nerve fibers (axons) of a peripheral Nerve 30 spreads an action potential along the peripheral nerve 30 ( Figure 3).
  • the current through the biological tissue 20 can also be introduced into the tissue 20 by means of at least one electrode 21 or the treatment circuit and generate the magnetic field 38 there due to the current flow ( Figures 1 and 5).
  • At least one application parameter EP can be determined.
  • An application parameter EP is understood to be a parameter that specifies the biological tissue 20 and, in particular, the type of biological tissue 20 and/or that describes an effect or influence exerted on the biological tissue 20 by the medical instrument 16 or electromedical instrument 17. Depending on the application and the design of the medical instrument 16 or electromedical instrument 17 used, one or more application parameters EP can be determined as required.
  • a magnetic field characteristic C can be known in the evaluation unit 35.
  • the magnetic field characteristic C can be stored in a memory of the evaluation unit 35 and/or provided to the evaluation unit 35 in another way, for example by an internet service (cloud service) or another external device with which the evaluation unit 35 is connected for communication purposes (shown by way of example in Figures 1 and 2).
  • the magnetic field characteristic C specifies a relationship between the at least one operating parameter EP and the at least one sensor signal S of the at least one magnetic field sensor 30, which optionally also depends on at least one further parameter. can ( Figure 12 ).
  • the magnetic field characteristic C can be in the form of one or more characteristic curves, functions, tables, or maps. Additionally or alternatively, the magnetic field characteristic C can also include or utilize an artificial intelligence (AI) component or a machine learning component.
  • AI artificial intelligence
  • a component is understood to be a device and/or a procedure and/or a method. Such a component can be part of the evaluation unit 35 or be provided by an external device or an internet service (cloud service).
  • An artificial intelligence component can be any known form, such as an artificial neural network (ANN), a semantic network, frames, predicate logic, or support vector machines (SVMs).
  • ANN artificial neural network
  • SVMs support vector machines
  • Known machine learning methods can be used, for example, supervised machine learning, unsupervised machine learning, reinforcement learning, etc. For example, pattern recognition, pattern analysis, or pattern prediction methods can be used.
  • a distance parameter that specifies a distance d of the magnetic field sensor 30 or of at least one of the existing magnetic field sensors 30 and thus of the tool part 19 to a peripheral nerve 39 (Figure 3).
  • a distance d can, for example, indicate to an operator displayed on the display device 36.
  • a signal can also be generated via the display device 36 (optical and/or acoustic and/or haptic). This prevents the tool part 19 from coming too close to a peripheral nerve 39 and injuring it when the medical instrument 16 is used to influence or treat biological tissue 20 in the immediate vicinity of a peripheral nerve 39.
  • a length L of a means of the medical instrument 16 or electromedical instrument 17 describes the area of the biological tissue 20 affected in an associated spatial direction.
  • a length parameter or a length L can be determined for each of the different spatial directions.
  • the change can be a spatial change and/or a temporal change.
  • To detect the magnetic field direction preferably two or more magnetic field sensors 30 are arranged on the tool part 19.
  • a current tissue state Z and/or a current tissue state change DZ can optionally be determined location-dependently, for example by using multiple magnetic field sensors 30.
  • the aforementioned operating parameters EP are determined or known by other means, these parameters can also be used as input parameters PI for the magnetic field characteristic C.
  • the force F between the tool part 19 and the biological tissue 20 and/or the temperature T of the biological tissue 20 and/or the humidity H of the biological tissue 20 can be sensorially detected and used as input parameters PI.
  • the input parameters PI for the magnetic field characteristic C can also be the parameters known from the power supply unit 25 or the high-frequency generator 26, such as one or more of the following parameters: an amplitude and/or a frequency of the high-frequency voltage u G ; an amplitude and/or a frequency of the high-frequency current i G ;
  • an impedance of the tissue 20 which can be determined, for example, based on the high-frequency voltage U G and the high-frequency current I G ;
  • the magnetic field characteristic C can be determined by training data, machine learning, simulations, empirical tests, or similar methods.
  • the expected magnetic fields 38 or magnetic field strengths B and/or temporal and/or spatial distributions or changes of the magnetic field 38 can be determined.
  • the at least one input parameter EP can then be determined by determining and monitoring the magnetic field 38 based on the magnetic field characteristic C, for example, by checking whether, in the current application, the available input parameters PI and/or the at least one sensor value S represent a pattern that is identical or sufficiently similar to one in the magnetic field characteristic.
  • C defined comparison patterns.
  • Such comparison patterns can be generated, stored, and optionally updated, for example, through machine learning.
  • the evaluation unit 35 has a photodetector in the exemplary embodiments illustrated here.
  • the photodetector 42 is connected to the optical transmission link 34 and generates at least one corresponding electrical sensor signal depending on the at least one received optical sensor signal S ⁇ sub> opt ⁇ /sub> from the at least one magnetic field sensor 30.
  • the electrical sensor signal S ⁇ sub>ei ⁇ /sub> is provided to the processing unit 43.
  • the electrical sensor signal S ⁇ sub> ei ⁇ /sub> can be processed and/or evaluated to determine the at least one operating parameter EP. Based on the at least one operating parameter EP, measures can then be initiated by controlling other components of the medical system 15, such as:
  • the evaluation device 35 can also have a spectrometer 44, as shown schematically in Figures 1 and 2.
  • the embodiment of the evaluation device 35 with a spectrometer 44 or with a photodetector 42 and a processing unit 43 connected thereto can be used in all embodiments.
  • the medical system 15 has an excitation device 50.
  • the excitation device 50 is shown in a highly schematic form in Figures 1 and 2.
  • An exemplary setup is shown in the block diagrams according to Figures 4 to 6, whereby this design of the excitation device 50 can be used in all embodiments.
  • the diamond 32 is optically excited, for example , using excitation light AL provided by a light source 51 of the excitation device 50.
  • a laser or a light-emitting diode (LED) can be used as the light source 51.
  • the excitation light AL emitted by the light source 51 can have a defined wavelength or wavelength range adapted to the diamond 32 doped with the NV centers 31.
  • excitation light in the green visible range 500 nm to 560 nm
  • laser light with a wavelength of 532 nm is used, for example, laser light with a wavelength of 532 nm.
  • the internal state of the NV centers 31 of the diamond 32 is influenced and can be brought from the ground state 3 A 2 to the excited state 3 E 2.
  • fluorescence light FL is produced.
  • the wavelength of the fluorescence light is, for example, in a wavelength range of 600 nm to 830 nm.
  • the generation of the fluorescence light FL produces the optical sensor signal S op t, which is transmitted from the diamond 32 of the magnetic field sensor 30 to the evaluation unit 35 via the optical transmission link 34.
  • the optical transmission link 34 can also be used to transmit the excitation light AL.
  • the optical transmission link 34 can have a beam splitter 52 that transmits the excitation light AL from the light source 51 towards the magnetic field sensor 30 or the diamond 32, and directs the optical sensor signal S ⁇ sub> opt ⁇ /sub> generated by the magnetic field sensor 30 or the doped diamond 32 based on the fluorescent light FL to the evaluation unit 35, and does not transmit it, or transmits it only in an insignificant proportion, towards the light source 51.
  • the beam splitter 52 can, for example, be connected to the light source 51, the evaluation unit 35, and the magnetic sensor 30 for optical transmission via optical waveguides 37, as illustrated by way of example in Figures 4 to 6 and 10.
  • a dichroic mirror for example, can be used as the beam splitter.
  • a filter 53 and/or a lens 54 may be arranged in the light path from the magnetic field sensor 30 to the Evaluation unit 35 (for example, for the photodetector 42 or the spectrometer 44) and, for example, between the beam splitter 52 and the evaluation unit 35.
  • the filter 53 serves to remove light wavelength components from the optical sensor signal S op t transmitted by the magnetic field sensor 30 that do not originate from the fluorescent light FL, but are contained as background light.
  • the background light can, for example, be a component of the excitation light AL.
  • the filter 53 can, for example, have a high-pass characteristic or a band-pass characteristic.
  • the optional lens 54 is arranged particularly directly adjacent to the photodetector 42 or the spectrometer 44 and serves to focus the optical sensor signal S op t (here: fluorescence light FL ) onto the slit of the spectrometer 44 and/or a light-sensitive receiving area of the photodetector 42.
  • the optional filter 53 is located in front of the lens 54.
  • the relevant optical waveguide 37 of the optical transmission link 34 can be coupled to the diamond 32 via a coupling device 55.
  • the coupling device 55 can include a lens, for example a GRIN lens.
  • a further filter 56 can be present in the light path of the excitation light AL from the light source to the magnetic field sensor 30 or to the coupling device 55, for example a neutral density filter .
  • the excitation device 50 in the exemplary embodiments illustrated here also includes a vibration excitation arrangement 58.
  • the vibration excitation arrangement 58 has a microwave generator 59 for generating a microwave signal pW.
  • the microwave generator 59 is connected to a microwave antenna 60 of the vibration excitation arrangement 58 for transmitting the microwave signal pW.
  • the microwave antenna 60 can, for example, be annular, hollow cylindrical, or helical and surround the diamond 32 of the magnetic field sensor 30, as can be seen by way of example in Figures 4 to 6.
  • FIG. 6 shows an exemplary configuration of a microwave generator 59.
  • the microwave generator 59 can, for example, include a function generator 59a, by means of which a suitable voltage is generated, for example, a sawtooth voltage, a ramp voltage, or the like.
  • a voltage-controlled oscillator can be driven by means of the voltage from the function generator 59a.
  • the microwave signal generated by the oscillator 59b can be in the range of 2.5 GHz to 3.2 GHz.
  • This microwave signal from the oscillator 59b can optionally be amplified by an amplifier 59c of the microwave generator 59.
  • the configuration of the microwave generator 59 described with reference to Figure 6 is exemplary and can be used in all embodiments of the medical system 15.
  • the microwave excitation makes the magnetic resonance frequencies of the NV centers 31 optically readable.
  • the fluorescent light FL and thus also the optical sensor signal S ⁇ sub>opt ⁇ /sub>, depends on the frequency f and has local minima whose spacing—analogous to the spacing of the degenerate spin quantum numbers—depends on the magnitude of the magnetic field strength B and the gyromagnetic ratio y.
  • the optical sensor signal S ⁇ sub>opt ⁇ /sub> is therefore dependent on the magnetic field strength B, so that the magnetic field strength B and/or (e.g., by evaluating the asymmetry in the amplitude of the local minima) the orientation of the field lines can be determined from the optical sensor signal S ⁇ sub>opt ⁇ /sub>.
  • Figures 9 and 10 schematically illustrate constructive embodiments for magnetic field sensors 30.
  • the functional principle and the basic structure of the embodiments of the magnetic field sensor 30 and the associated components of the medical system 15 (in particular the evaluation unit 35 and the excitation unit 50) shown in Figures 9 and 10 correspond—apart from the constructive details—to the principle as explained above in connection with Figure 6.
  • an optical fiber 37 can be omitted in the embodiment according to Figure 9.
  • Figure 9 shows an exemplary embodiment of a magnetic field sensor 30 in an exploded view.
  • the magnetic field sensor 30 is designed as an integrated sensor, in which the sensor components can be arranged on the medical instrument 16 or on the tool part 19.
  • the sensor components are arranged on a multilayer substrate 65 (e.g., a multilayer printed circuit board).
  • the light source 51 is located, in the light path of the light source 51 the diamond 32 with the nitrogen defect centers 31, and in the light path of the generated fluorescence light FL the photodetector 42.
  • One or more connections 66 can be provided on the substrate 65 to connect the magnetic field sensor 30 electrically and/or optically, for example to the evaluation unit 35 and/or the excitation arrangement 50.
  • the optical filter 53 is optional and can be arranged between the diamond 32 and the photodetector 42 in the light path of the fluorescence light FL.
  • the sensor components are arranged remotely from each other, wherein the diamond 32 can be arranged on the medical instrument 16 or the tool part 19, while the other components can be arranged remotely from it, for example in the proximal area of the medical instrument 16 or in the area of the supply device 25.
  • the medical system 15 has, for example, a control unit 61 which is configured to control one or more components of the medical system 15.
  • the control unit 61 can be configured to control the evaluation unit 35 (in particular the processing unit 43) and/or the light source 51 and/or the microwave generator 59 and/or the
  • the number of control signals Osi can vary depending on the design of the medical system 15 and the number of components to be controlled.
  • control unit 61 and/or the evaluation unit 35 and/or the excitation unit 50 can be part of the supply unit 25 or be implemented as individual components that are interconnected or communication-linked.
  • the medical instruments 16, electromedical instruments 17, or electrosurgical instruments 18 can be configured for different applications, for example, for coagulation, cutting, ablation (devitalization), thermofusion, or the like. Accordingly, monopolar or bipolar instruments can be used.
  • FIG 4 shows an application of an electrosurgical instrument 18, which is a bipolar instrument with two electrodes 21 at different electrical potentials.
  • the electrodes 21 are electrically separated from each other in the tool part 19 by electrically insulating material.
  • the high-frequency voltage U provided by the high-frequency generator 26 can be applied to the electrodes 21.
  • both electrodes 21 are in contact with electrically conductive biological tissue 20, a current is generated in the tissue 20, which flows from one electrode 21 through the biological tissue 20 to the other electrode 21 and from there The current flows back to the high-frequency generator 26 (treatment circuit in the bipolar instrument). This allows, for example, tumor tissue to be devitalized.
  • the magnetic field sensor 30 is arranged in the electrically insulating area between the two electrodes 21. In one direction of extension of the tool part 19, the two electrodes 21 are spaced apart from each other in this instrument, and the magnetic field sensor 30 can, for example, be located between the two electrodes 21 in the direction of extension of the tool part 19. As described above, the magnetic field sensor 30 is connected to the excitation device 50 (light source 51 and microwave generator 59) and the evaluation device 35.
  • a test circuit 62 may optionally be provided.
  • the test circuit 62 may correspond to the treatment circuit of a monopolar instrument and may have a test electrode 63 on the tool part 19, which, in the example shown in Figure 4, is arranged at the distal end of the tool part 19.
  • An additional magnetic sensor 30 may be associated with the test electrode 63, which is only schematically indicated in Figure 4 and may be constructed analogously to the previously described embodiments of the magnetic sensor 30.
  • the connection of the magnetic sensor 30 associated with the test electrode 63 to the excitation device 50 and the evaluation device 35 is not shown. The connections are analogous to the embodiments described so far.
  • the test circuit 62 includes, for example, au- Furthermore, a neutral electrode 27 is arranged on the biological tissue 20.
  • the high-frequency generator 26 can be electrically connected to the neutral electrode 27 at one terminal and to the test electrode 63 at the other terminal.
  • the medical system 15 can, for example, have a switching device 64 by means of which the high-frequency generator 26 can be connected either to the test circuit 62 or to the treatment circuit and the electrodes 21 intended for treatment as described above.
  • the switching device 64 can, for example, be controlled by a control signal Osi from the control device 61.
  • the high-frequency generator 26 When the high-frequency generator 26 is connected to the test circuit 62, the high-frequency generator 26 can be brought into a test operating state by means of the control device 61 by applying a voltage between the test electrode 63 and the neutral electrode 27 that cannot cause any tissue changes in the biological tissue 20.
  • a current can flow between the test electrode 63 and the neutral electrode 27, and a magnetic field 38 can be generated based on this current flow.
  • This magnetic field 38 can be used to determine a tissue type parameter EP, which characterizes the type of tissue to be ablated. It is then possible to place the electrodes 21 used for ablation at the desired location in the biological tissue 20 and/or to adjust the control of the high-frequency generator 26 during the treatment of the tissue depending on the detected tissue type.
  • the existing treatment circuit can also be used for testing.
  • the test electrode 63, the switching device 64, and the additional neutral electrode 27 can be omitted.
  • a test voltage or test current can be generated through the biological tissue using the existing electrodes 21 via the control of the high-frequency generator 26 by the control unit 61.
  • Such testing, using the treatment circuit or an additional test circuit 62, can be used in all embodiments of the medical system 15.
  • Figure 5 illustrates a tool part 19 of a bipolar instrument with two electrodes 21, each electrode 21 being arranged on a branch 67 of the tool part 19.
  • the two electrodes 21 are located opposite each other on the facing sides of the branches 67.
  • Biological tissue 20 for example, a blood vessel
  • the two branches 67 are movable relative to each other and, in particular, pivotable via an actuating device of the handle 62, as shown schematically in Figure 2.
  • a magnetic field sensor 30 is arranged in each branch 67j.
  • Each of the magnetic field sensors 30 is connected to a common light source 51 via an optical transmission link 34.
  • a beam splitter 52 can be arranged in each optical transmission link 34 between the common light source and each of the magnetic sensors 30, which in turn is connected via a further section of the optical transmission link 34.
  • a transmission link 34 (for example, an optical fiber 37) is connected to each associated photodetector 42.
  • the photodetectors 42 are part of a common evaluation unit 35 and can be connected to a common processing unit 43 in order to transmit the electrical sensor signal S ⁇ sub> ei ⁇ /sub> provided by the respective magnetic field sensor 30 to the common processing unit 43.
  • the two magnetic field sensors 60 can be connected to a common vibration excitation arrangement 58, as shown in Figure 5 .
  • the excitation device 50 can be used for all existing magnetic field sensors 30. It is therefore sufficient to use a single light source 61 and a single microwave generator 59.
  • the light source 51 is connected to each diamond 32 of each magnetic field sensor 30 via the optical transmission link 34, and the microwave generator 59 can analogously be connected to all microwave antennas 60 on each diamond 32.
  • Figures 7 and 8 show, in a highly simplified schematic representation, different spatial arrangement possibilities for magnetic field sensors 30, using the example of a branch 67 in a top view of an electrode surface of an electrode 21 ( Figure 7) and based on a schematic cross-section through the branches 67 of a tool part 19, respectively.
  • a magnetic field sensor 30 is located on each side of an electrode surface of an electrode 21 in the extension direction of the branch 67 towards its distal end. or several magnetic field sensors 30 are arranged.
  • one or more magnetic field sensors 30 can also be arranged on the side faces of a branch adjacent to the electrodes 21.
  • the embodiments according to Figures 7 and 8 can also be combined with each other.
  • the number of magnetic sensors 30 used and/or their relative positions on the tool part 19 can vary depending on the type of electromedical instrument 17 used and/or the number of electrodes 21 present. This allows spatial parameters of a magnetic field 18 to be determined, adapted to the required application. For example, magnetic field strengths B can be determined at several locations without relative movement of the tool part 19 with respect to the biological tissue 20. Additionally or alternatively, the number of magnetic field sensors 30 used and/or their spatial arrangement in the tool part 19 can be used to determine at least a length value L of a treated or affected zone in the biological tissue 20 and/or to determine a transition point between different tissue types.
  • FIG 11 shows a simplified example of a treatment and a measurement of the treatment progress or success.
  • a test voltage 70 can be applied using the high-frequency generator 26 during a test time interval t ⁇ sub>t ⁇ /sub>, for example, to determine the current initial conditions, such as the type of tissue to be treated and/or the current moisture H of the biological tissue 20 and/or the current temperature T of the biological tissue 20.
  • the biological tissue 20 can be influenced using the electromedical instrument 17, for example, a coagulation voltage 71 can be applied during a coagulation time interval t ⁇ sub> C ⁇ /sub> and/or a cutting voltage 72 can be applied during a dissection time interval t ⁇ sub>cu ⁇ /sub>.
  • one or more measurements can be carried out using the at least one magnetic field sensor 30 to monitor the treatment progress or success. to monitor and determine the completion of the treatment (complete coagulation and/or complete transection of the biological tissue 20). It is also optionally possible to apply a test voltage 70 again after each treatment phase (coagulation time interval or dissection time interval) to determine the tissue change resulting from the treatment without affecting the tissue.
  • the invention relates to a medical system 15 with a medical instrument 16, preferably a- An electromedical instrument 17 or electrosurgical instrument 18.
  • Each magnetic field sensor 30 is configured to detect a magnetic field 38 emanating from the electromedical instrument (17) and/or from a biological tissue 20 and to provide a corresponding sensor signal S, preferably an optical sensor signal S ⁇ sub> opt ⁇ /sub>, which can be evaluated by means of an evaluation unit 35.
  • the evaluation unit 35 determines at least one operating parameter EP.
  • the at least one operating parameter EP describes the biological tissue 20 and/or the effect generated on the biological tissue 20 by the medical instrument 16 or the tool part 19.
  • an operating parameter EP can describe a tissue type, a temporal and/or spatial change in the tissue, a current temperature T, or a spatial and/or temporal change in the temperature T of the biological tissue 20.
  • Such operating parameters EP can be monitored very dynamically by measuring the magnetic field.

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  • General Physics & Mathematics (AREA)
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Abstract

L'invention concerne un système médical (15) comprenant un instrument médical (16), de préférence un instrument électromédical (17) ou un instrument électrochirurgical (18). Au moins un capteur de champ magnétique (30), qui se présente de préférence sous la forme d'un magnétomètre quantique ou d'un capteur NVCD, est disposé sur une partie outil (19) de l'instrument. Chaque capteur de champ magnétique (30) est conçu pour détecter un champ magnétique (38) émanant de l'instrument électromédical (17) et/ou d'un tissu biologique (20) et pour fournir un signal de capteur correspondant (S), de préférence un signal de capteur optique (Sopt), qui peut être évalué au moyen d'un dispositif d'évaluation (35). Le dispositif d'évaluation (35) détermine au moins un paramètre de fonctionnement (EP). Le ou les paramètres de fonctionnement (EP) décrivent le tissu biologique (20) et/ou l'effet généré par l'instrument médical (16) ou la partie outil (19) sur le tissu biologique (20). Par exemple, un paramètre de fonctionnement (EP) peut décrire le type de tissu, un changement temporel et/ou local dans le tissu, ou la température actuelle (T) ou un changement local et/ou temporel de la température (T) du tissu biologique (20). De tels paramètres de fonctionnement (EP) peuvent être surveillés de manière très dynamique par mesure du champ magnétique.
PCT/EP2024/072431 2024-08-08 2024-08-08 Système médical, procédé de fonctionnement d'un système médical et produit-programme informatique Pending WO2026032502A1 (fr)

Priority Applications (1)

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PCT/EP2024/072431 WO2026032502A1 (fr) 2024-08-08 2024-08-08 Système médical, procédé de fonctionnement d'un système médical et produit-programme informatique

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0813387A1 (fr) 1995-03-03 1997-12-29 Neovision Corporation Procede et appareil destines a la caracterisation et au traitement des tumeurs
EP1511534B1 (fr) 2002-05-27 2011-07-06 Celon AG Medical Instruments Dispositif destine a la sclerose electrochirurgicale de tissus de l'organisme
WO2015047573A1 (fr) * 2013-09-25 2015-04-02 Covidien Lp Instrument chirurgical avec capteur magnétique
WO2018087601A1 (fr) * 2016-11-11 2018-05-17 National University Of Ireland, Galway Dispositifs, systèmes et procédés de spécialisation, de surveillance et/ou d'évaluation d'une neuromodulation nasale thérapeutique
US20200179679A1 (en) * 2018-12-11 2020-06-11 Neurent Medical Limited Systems and methods for therapeutic nasal neuromodulation
EP3831291A1 (fr) 2019-12-05 2021-06-09 Erbe Elektromedizin GmbH Instrument de traitement électrochirurgical
US11207092B2 (en) 2017-03-27 2021-12-28 RELIGN Corporation Arthroscopic devices and methods
US20220110527A1 (en) * 2020-10-09 2022-04-14 QuantuMed Pty Ltd Cellular ionic activity visualisation

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0813387A1 (fr) 1995-03-03 1997-12-29 Neovision Corporation Procede et appareil destines a la caracterisation et au traitement des tumeurs
EP1511534B1 (fr) 2002-05-27 2011-07-06 Celon AG Medical Instruments Dispositif destine a la sclerose electrochirurgicale de tissus de l'organisme
WO2015047573A1 (fr) * 2013-09-25 2015-04-02 Covidien Lp Instrument chirurgical avec capteur magnétique
WO2018087601A1 (fr) * 2016-11-11 2018-05-17 National University Of Ireland, Galway Dispositifs, systèmes et procédés de spécialisation, de surveillance et/ou d'évaluation d'une neuromodulation nasale thérapeutique
US11207092B2 (en) 2017-03-27 2021-12-28 RELIGN Corporation Arthroscopic devices and methods
US20200179679A1 (en) * 2018-12-11 2020-06-11 Neurent Medical Limited Systems and methods for therapeutic nasal neuromodulation
EP3831291A1 (fr) 2019-12-05 2021-06-09 Erbe Elektromedizin GmbH Instrument de traitement électrochirurgical
US20220110527A1 (en) * 2020-10-09 2022-04-14 QuantuMed Pty Ltd Cellular ionic activity visualisation

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