Device and method for determining a switch-off time of a medical device
By measuring tissue temperature and energy input, combined with absorption spectroscopy analysis, the shutdown time point of medical devices is controlled in real time, which solves the problem of inaccurate tissue temperature control in bipolar HF technology, and improves the reliability and safety of blood vessel sealing.
Patent Information
- Application Number
- CN202080056150.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2019-08-07
- Filing Date
- 2020-08-06
- Publication Date
- 2025-08-15
- Estimated Expiration
- 2040-08-06
AI Technical Summary
In the prior art, bipolar HF technology is difficult to accurately control tissue temperature during the blood vessel sealing process, resulting in possible overheating or insufficient sealing, resulting in thermal damage and bleeding risks of surrounding tissues.
By measuring tissue temperature and energy input, calculating parameters SP, and combining absorption spectroscopy analysis, the shutdown time point of the medical device is controlled in real time to ensure that the tissue temperature remains within the range of 85-100 degrees Celsius, and the tissue temperature is directly measured near the electrode using an optical temperature measuring device.
Accurate control of tissue temperature is achieved, the risks of overheating and inadequate sealing are reduced, and the reliability and safety of blood vessel sealing are improved.
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Figure CN114206244B_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to a device and a method for measuring the tissue temperature, in particular of human tissue, in medical high-frequency surgical instruments (HF instruments, ultrasound instruments, laser instruments, etc.) during thermal processes. Background Art
[0002] In high-frequency surgery (hereinafter referred to as HF surgery), high-frequency alternating current is directed through the human body or body parts in order to selectively embrittle (coagulate) or cut (electrocute) the tissue due to the resulting heating. The tissue thus damaged is later absorbed by the surrounding healthy tissue. A significant advantage over conventional cutting techniques using a scalpel is that, while cutting, bleeding can be stopped by sealing the affected blood vessels, in the sense of coagulation. In order to reliably seal the blood vessels, so-called sealing and cutting instruments are used. The devices used are also known as electric scalpels.
[0003] At the frequencies used in HF surgery (high-frequency surgery), body tissue exhibits an ohmic resistance (impedance). The specific resistance is highly dependent on the tissue type. Muscle tissue and tissues with a high blood supply have a relatively low specific resistance. Fat has a specific resistance of approximately 15 times higher, and bone has a specific resistance of approximately 1000 times higher. Therefore, the frequency, form, and level of the current must be tailored to the tissue type being operated on.
[0004] Currently, monopolar HF technology is most commonly used in HF surgery. Here, one pole of the HF voltage source is connected to the patient via a counter-electrode with the largest possible area, for example, via contacts on the operating table where the patient is located, via a contact armband or contact footband, or via an adhesive electrode. This counter-electrode is usually called a neutral electrode or neutral electrode. The other pole is connected to the surgical instrument, and this surgical instrument forms the so-called active electrode or active electrode. The current flows from the active electrode to the neutral electrode via the path of least resistance. The current density is highest in the immediate vicinity of the active electrode, where the thermal effect is strongest. The current density decreases with the square of the distance. The neutral electrode should be well connected to the body over the largest possible area so that the current density in the body is kept low and burns do not occur. Due to the large area, the skin on the neutral electrode does not heat up significantly. Strict safety measures are applied when installing the neutral electrode. In order to avoid burns, the appropriate position and good contact of the neutral electrode (depending on the surgical area) are critical.
[0005] In bipolar HF technology, in contrast to monopolar technology, the current flows through a small area of the body where the surgical action (cutting or coagulation) is desired. Two electrodes, insulated from one another (e.g., housed in instrument arms), are guided directly to the surgical site, with an HF voltage applied between them. The circuit is closed by the tissue located between them. A heating effect occurs in the tissue between the electrodes.
[0006] Coagulation clamps are known. Here, high-frequency connections are usually provided on the handles. An insulatingly coated screw usually serves as the hinge axis, by means of which the two clamping arms are also pivotally fastened to each other with their respective handles.
[0007] Utilizing the bipolar HF vessel sealing and / or cutting system, a vessel or tissue bundle can be effectively and durably sealed generally or during cutting, thereby limiting lateral thermal damage to surrounding tissue and minimizing tissue adhesion.
[0008] In medicine, tissue refers to an organic material that includes a group of cells of the same type or with different differentiations that share a common function or structure. In addition to cells, tissue also includes the extracellular matrix (ECM). For example, blood vessels are an example of human tissue.
[0009] The human body, in its chemical composition, consists of approximately 56% oxygen (O), 28% carbon (C), 9% hydrogen (H), 2% nitrogen (N), 1.5% calcium, 1% chlorine (Cl), 1% phosphorus (P), 0.25% potassium (K), 0.2% sulfur (S) and smaller shares of other chemical substances (all data are expressed in percentages by weight).
[0010] The material composition of the human body is composed of about 67% water, 16% protein or albumen (such as collagen), 10% lipids (such as fat), 1% carbohydrates, 1% nucleic acids and 5% various minerals (all data are expressed in weight percentage).
[0011] Collagen is a group of structural proteins ("fibrous bundle-forming proteins") found in humans and animals, primarily in connective tissue (more precisely, the extracellular matrix). Collagen is found in particular in the white, inelastic fibers of tendons, ligaments, bones, and cartilage. The skin layer (subcutis) is also composed of collagen. In the human body, collagen is the most common protein, accounting for over 30% of all protein by mass.
[0012] In living organisms, lipids are primarily used as structural components in cell membranes, as energy stores or as signaling molecules. Often, the term "fat" is used synonymously with lipid, but fat (triglycerides) only refers to a subgroup of lipids.
[0013] The main optical absorbers in tissue, for example blood vessels in the NIR region, are water and collagen. Blood vessels are mostly surrounded by fat.
[0014] When electromagnetic radiation interacts with solids, liquids or gases, different effects occur, such as absorption, reflection, scattering or transmission. In other words, if electromagnetic radiation encounters an obstacle, it is either absorbed (swallowed), scattered (deflected from its original direction), transmitted (transmitted through), or reflected (reflected back), also known as re-emission in the case of reflection.
[0015] In physics, re-reflection is the diffuse (non-directional) reflection of electromagnetic radiation, especially light, that passes through a surface into a scattering medium, interacts with the scattering medium, and then exits through the surface again. This is in contrast to conventional directional reflection, which satisfies the law of reflection. However, of the two cases, reflection is used more frequently. A distinction is then made between specular reflection and diffuse reflection. In the case of re-reflection (diffuse reflection), part of the light is absorbed and transmitted. The measure of re-reflection with respect to a surface is the re-reflectivity.
[0016] Reflection spectroscopy is a subfield of spectroscopy that measures radiation reflected from a sample. It is primarily used for spectroscopic examination of opaque and insoluble samples. The measured reflection spectrum of a sample consists of two components: 1) conventional reflection, in which radiation is reflected specularly from the surface. Conventional reflection is described by the Fresnel equations; and 2) diffuse reflection, in which radiation is emitted from the sample isotropically in all directions. This occurs because the radiation penetrates the sample and, after partial absorption and multiple scattering, returns to the surface.
[0017] The absorption spectra of water, collagen and fat have been measured by many groups. Values for the absorption coefficients are available both in the visible spectral range (VIS) and in the near infrared spectral range (NIR).
[0018] In the prior art, the regulation process in bipolar HF technology is controlled by tissue impedance, which changes during energy input primarily due to water loss. The tissue impedance is calculated from the measured voltage and current values using Ohm's law. Due to the device configuration, the determined impedance is always an average value for the entire system (tissue, device, cable, generator).
[0019] The quality of the blood vessel seal depends crucially on the conditioning process and the associated energy input into the tissue. In addition to overheating the instrument, thermal damage to the surrounding tissue can also occur. Similarly, insufficient energy input can lead to failure / blowout of the fusion site, which can be detected by bleeding. This bleeding often occurs several hours after the actual procedure, so depending on the vessel diameter, emergency surgery may be necessary to stop the bleeding or reliably seal the vessel.
[0020] Therefore, it is known from the prior art to measure tissue temperature and use the measured temperature value for regulating / controlling thermal processes. In order to prevent the temperature measurement result from being distorted by the electrode temperature, a sufficiently large distance or thermal isolation / insulation is required between the tissue temperature sensor and the electrode(s). However, this is disadvantageous in that the measured tissue temperature does not exactly correspond to the tissue temperature directly at the electrode(s). Summary of the Invention
[0021] The object of the present invention is therefore to enable, in addition to or as an alternative to the impedance measurement, the temperature of the tissue to be fused to be measured as accurately as possible, preferably online, in order to carry out a controlled "lesion" directly at the electrode(s) and, if necessary, also to prevent overheating of the instrument. In other words, the object of the present invention is to achieve good coagulation by providing a switch-off criterion for switching off the medical instrument.
[0022] This object is achieved by the features according to the invention.
[0023] The present invention relates to a method for determining a switch-off time of a medical instrument, particularly preferably in a thermal method / process, comprising the steps (preferably in the following sequence):
[0024] - measuring the duration (Dur95) during which the temperature of the tissue is above 85 degrees Celsius, preferably above 95 degrees Celsius and preferably below 110 degrees Celsius, preferably below 100 degrees Celsius,
[0025] - calculating the mean temperature (MeanTempabTmax) from the time when 85 degrees Celsius, preferably 95 degrees Celsius, and preferably below 110 degrees Celsius, preferably below 100 degrees Celsius, is first reached,
[0026] - measuring and / or calculating the energy input (E2Tmax) until reaching 85 degrees Celsius, preferably 95 degrees Celsius and preferably below 110 degrees Celsius, preferably below 100 degrees Celsius
[0027] A parameter SP is calculated, which is correlated with the above result and, at a predetermined value, preferably between 2 and 3, particularly preferably at SP=2.5, switches off the medical instrument or permits switching off starting from this value.
[0028] A thermal procedure is preferably any procedure that produces a thermal effect in tissue by energy output. This also includes procedures performed using high frequency, ultrasound, laser, and / or temperature. Procedures performed using high frequency, ultrasound, laser, and / or temperature devices (e.g., using thermal mastication) are also included below, or include all medical devices that produce a thermal effect in tissue by energy output.
[0029] The method preferably further comprises at least one of the following steps:
[0030] - emitting light having an excitation spectrum preferably in the VIS / NIR range into the tissue by means of at least one illumination unit,
[0031] - receiving re-emissions of light having a re-emission spectrum from the tissue by means of at least one detector, preferably a sensor,
[0032] - converting the re-emission spectrum into a detector signal, preferably an electrical signal / data signal, by means of a detector,
[0033] - sending the detector signal to a computing unit, preferably a CPU,
[0034] - calculating the re-emission spectrum from the detector signal by means of a calculation unit,
[0035] - calculating the absorption spectrum of the tissue by comparing the excitation spectrum with the re-emission spectrum with the aid of a calculation unit,
[0036] - calculating at least one absorption maximum from the absorption spectrum by means of a calculation unit,
[0037] Calculating the temperature in the tissue by means of a calculation unit by comparing the absorption maximum with at least one reference, preferably stored in the calculation unit
[0038] -Calculate the switch-off time of the medical device based on the temperature.
[0039] Preferably, the step of calculating the shutdown time point of the medical device based on the temperature includes the individual steps of measuring the duration (Dur95) during which the temperature of the tissue is above 85 degrees Celsius, preferably above 95 degrees Celsius and preferably below 110 degrees Celsius, preferably below 100 degrees Celsius, calculating the average temperature (MeanTempabTmax) from the first time 85 degrees Celsius, preferably 95 degrees Celsius and preferably below 110 degrees Celsius, preferably below 100 degrees Celsius is reached, measuring and / or calculating the energy input (E2Tmax) until 85 degrees Celsius, preferably 95 degrees Celsius and preferably below 110 degrees Celsius, preferably below 100 degrees Celsius is reached, and calculating a parameter SP, which is associated with the above result and, at a predetermined value, preferably between 2 and 3, particularly preferably at SP=2.5, shuts down the medical device or allows shutdown from this value. In other words, the shutdown criterion can lead to direct shutdown, which means that the device is actively shut down, and indirect shutdown, which means that it is passively possible (by further steps or by personnel) / permitted (by a program on the computer) starting from this value.
[0040] Preferably, the duration (Dur95) during which the temperature of the tissue is above 85 degrees Celsius, preferably above 95 degrees Celsius and preferably below 110 degrees Celsius, preferably below 100 degrees Celsius is calculated as follows: the calculation unit calculates the temperature in the tissue and measures the time from the point in time when the temperature reaches 85 degrees Celsius, preferably 95 degrees Celsius and preferably below 110 degrees Celsius, preferably below 100 degrees Celsius.
[0041] Preferably, the average temperature (MeanTempabTmax) from the time when 85 degrees Celsius, preferably 95 degrees Celsius and preferably below 110 degrees Celsius, preferably below 100 degrees Celsius is first reached is calculated by the calculation unit in the following manner, i.e., the average value of the temperature from the time when 85 degrees Celsius, preferably 95 degrees Celsius and preferably below 110 degrees Celsius, preferably below 100 degrees Celsius is first reached is calculated online, preferably in real time.
[0042] The energy input (E2Tmax) is preferably measured until a temperature of 85 degrees Celsius, preferably 95 degrees Celsius, is reached by incorporating a power meter into the medical device. The power meter measures the power / energy consumed until the temperature of the tissue reaches 95 degrees Celsius. Alternatively, or as needed, in addition, the power can also be determined or calculated based on the tissue impedance or the temperature increase of the tissue over the time until the temperature reaches 85 degrees Celsius, preferably 95 degrees Celsius. The power meter can also be implicitly present in the device via sensors suitable for measuring current and voltage. In other words, the calculation unit can calculate the power using the data from the current and voltage measurements provided for this purpose.
[0043] Preferably, a parameter SP is calculated by multiplying the duration for which the temperature of the tissue is above 85 degrees Celsius, preferably above 95 degrees Celsius, by the average temperature since the temperature was first reached at 95 degrees Celsius, divided by the energy input until 85 degrees Celsius, preferably 95 degrees Celsius, is reached, which parameter links the above result and shuts down the medical device at a predetermined value, preferably between 2 and 3, particularly preferably at SP=2.5.
[0044] The parameter SP determines the optimal time to shut down the medical instrument, preferably during the sealing process, more preferably during the sealing and cutting process. The parameter SP is calculated by multiplying the duration / time the tissue is kept above 85 degrees Celsius, preferably above 95 degrees Celsius, by the average temperature during this time period, divided by the energy required to reach 85 degrees Celsius, preferably 95 degrees Celsius. In other words: parameter SP = (Dur95*MeanTempabTmax) / E2Tmax. The sealing process is terminated when SP > 2.5. A parameter value > 2.5 ensures that the temperature in the sealed tissue remains above 85 degrees Celsius, preferably above 95 degrees Celsius, for a certain period after reaching 85 degrees Celsius, preferably 95 degrees Celsius, or after the impedance transformation, and is maintained at approximately 85 degrees Celsius, preferably 95 degrees Celsius. This results in a portion of the water evaporating during the sealing process, a prerequisite for successful sealing. The variable E2Tmax in the denominator of the quotient depends on the process profile selected in the various sealing procedures and on the quality and composition of the tissue contained between the electrodes. By measuring this parameter, it is possible to infer to some extent the heat capacity and therefore the mass of the tissue in the sealing clamp. The numerator of the equation can be interpreted as an empirical variant of the Arrhenius formula, whereby the degree of tissue denaturation under thermal influence is described in a simplified representation by integrating the tissue temperature over time.
[0045]
[0046] The parameters Ea and A are tissue-specific constants, and R is the general gas constant. Since some, but not too much, tissue water must be removed for a good sealing result, the parameter E2Tmax in the denominator is a correction that results in a longer duration of action at large tissue volumes.
[0047] The parameter SP can be integrated into the sealing process in various ways. One possibility is to integrate the parameter as a trigger for the shutdown process based on the previous impedance shutdown criterion. In other words, if a certain value, preferably 2, particularly preferably 2.5, is exceeded, the sealing is terminated.
[0048] Another possible solution is to set the parameter not as a trigger but as a shutdown criterion. Once the parameter exceeds a threshold of 2.5, the process can be terminated. The shutdown criterion would then be independent of the impedance, which is the characteristic variable of the shutdown criterion.
[0049] Preferably, the (tissue) temperature is not measured directly, but rather determined by measuring other parameters (not equal to temperature) that, on the one hand, allow direct or indirect inference of the current temperature (causal relationship between temperature and parameter) and, on the other hand, are (only) tissue-specific, i.e., not influenced by the electrode(s). The tissue temperature is determined using at least one absorption maximum. More precisely, at least one absorption spectrum of the tissue, preferably of at least one tissue component, is determined by subtracting the re-emission spectrum from the excitation spectrum. Preferred tissue components are water, fat, and / or collagen. From the absorption spectrum thus obtained, the position of at least one absorption maximum of the absorption spectrum of the tissue, preferably of at least one tissue component, can be determined. The absorption maximum, preferably the frequency, wavelength, or position of the absorption maximum, is compared with at least one reference stored on a computing unit, preferably on a storage medium. The at least one stored reference can then be determined from a table or using a reference measurement, thereby determining that a specific temperature exists at a specific position / wavelength / frequency of the absorption maximum in the tissue. If the position / wavelength / frequency of the absorption maximum is not to be stored in the table, the temperature in the tissue can be calculated on the computing unit using the calculated position / wavelength / frequency of the absorption maximum as a shift from the stored position / wavelength / frequency of the absorption maximum. Instead of the absorption maximum, any other position / wavelength / frequency in the absorption spectrum with a significantly recurring identified value (e.g., a maximum or minimum) can also be used.
[0050] Tissue components have typical absorption characteristics. Thus, water has an absorption maximum at approximately 1470 nm at room temperature, while collagen has an absorption maximum at approximately 1500 nm, and fat has absorption maxima at 1210 nm and approximately 1400 nm, respectively. The absorption maximum of water is preferably at 1470 nm + / - 20 nm, particularly preferably at 1470 nm + / - 10 nm, and even more preferably at 1470 nm + / - 5 nm. The absorption maximum of collagen is preferably at 1500 nm + / - 20 nm, particularly preferably at 1500 nm + / - 10 nm, and even more preferably at 1500 nm + / - 5 nm. The absorption maximum of fat is preferably at 1210 and 1400 nm + / - 20 nm, particularly preferably at 1210 and 1400 nm + / - 10 nm, and even more preferably at 1210 and 1400 nm + / - 5 nm.
[0051] Preferably, the method further comprises the steps of:
[0052] Storing at least one reference, preferably in the form of an absorption maximum for water and / or fat and / or collagen at a specific temperature, in the computing unit, preferably in a storage medium in the computing unit.
[0053] The temperature prevailing in the tissue can preferably be determined using a calculation unit based on the characteristic absorption spectrum of water as a reference. The calculation unit or storage medium stores the fact that water has a specific absorption maximum at a specific temperature (e.g., 1470 nm at room temperature). By comparing the deviation of the absorption maximum with a pre-stored value and / or comparing it with a plurality of preset corresponding values in a stored table, it is possible to determine the temperature prevailing in the tissue water at the wavelength of the absorption maximum. The characteristic absorption spectrum of water is easiest to determine, as the tissue composition in the body is known, and water is present in tissue at its highest concentration, approximately 67%. Based on the measured absorption spectrum, the deviation of the spectral absorption maximum of water can be calculated / determined. The temperature can be determined from this deviation of the absorption maximum, which is approximately 0.5 nm / K. This applies similarly to fat and / or collagen and / or other tissue components.
[0054] In addition to water, the above-described steps for measuring absorption spectra can also be applied similarly to fat, collagen, or other tissue components. Thus, from the absorption spectra acquired by the detector and determined by the calculation unit, the individual absorption spectra of water, fat, and collagen in the tissue can be determined.
[0055] Preferably, the method further comprises the steps of:
[0056] - Applying the illumination part and the detector to the tissue. Advantageously, the detector and the illumination part are thus in direct contact with the tissue.
[0057] Preferably, the method further comprises the steps of:
[0058] - controlling and / or regulating and / or switching off a device, preferably a medical instrument, by means of a computing unit based on the calculated temperature and / or tissue impedance.
[0059] Preferably, the control and / or regulation and / or switching off is performed when a predetermined temperature is reached, preferably a temperature above 85 degrees Celsius, preferably above 95 degrees Celsius and below 110 degrees Celsius, preferably below 100 degrees Celsius. Tissue coagulation achieves optimal results at a temperature (preferably a constant temperature) exceeding 85 degrees Celsius, preferably exceeding 95 degrees Celsius, and further preferably below 110 degrees Celsius, preferably 100 degrees Celsius.
[0060] Preferably, all steps occur online / in real time. This means that the medical device is controlled and / or regulated and / or shut down online, preferably in real time. In other words, the absorption spectrum of the tissue is measured online, preferably in real time, allowing the temperature in the tissue to be calculated online, i.e., in real time. The temperature then preferably contributes to the online, preferably real-time, control / regulation of at least one electrode / ultrasonic oscillator / laser source of the medical device, preferably a cutting and sealing device.
[0061] The method for temperature measurement is preferably carried out during the sealing process, particularly preferably in tissue in a medical device.
[0062] Preferably, the detector is designed and adapted to detect re-emission, preferably a re-emission spectrum, in the NIR range of 1000 nm to 1700 nm, particularly preferably in the range of 1400 nm to 1600 nm.
[0063] Preferably, in the medical instrument, the at least one illumination unit and the at least one detector are spaced apart.
[0064] Preferably, the method for measuring tissue temperature is used in a medical device.
[0065] Preferably, the temperature measuring device has a storage medium on which at least one of the following steps is stored (preferably in this order in the case of a plurality of steps):
[0066] Storing at least one reference, preferably in the form of an absorption maximum for water and / or fat and / or collagen at a specific temperature, in the computing unit, preferably in a storage medium in the computing unit.
[0067] - Applying the illumination part and the detector to the tissue. Advantageously, the detector and the illumination part are thus in direct contact with the tissue.
[0068] - emitting light with an illumination spectrum preferably in the VIS / NIR range into the tissue by means of at least one illumination unit,
[0069] - receiving re-emissions of light having a re-emission spectrum from the tissue by means of at least one detector, preferably a sensor,
[0070] - converting the re-emission spectrum into a detector signal, preferably an electrical signal / data signal, by means of a detector,
[0071] - sending the detector signal to a computing unit, preferably a CPU,
[0072] - calculating the re-emission spectrum from the detector signal by means of a calculation unit,
[0073] - calculating the absorption spectrum of the tissue by comparing the illumination spectrum with the re-emission spectrum with the aid of a calculation unit,
[0074] - calculating at least one absorption maximum from the absorption spectrum by means of a calculation unit,
[0075] - calculating the temperature in the tissue by means of a calculation unit by comparing the absorption maximum with at least one reference, preferably stored in the calculation unit,
[0076] - controlling and / or regulating and / or switching off a device, preferably a medical instrument, by means of a computing unit based on the calculated temperature and / or tissue impedance.
[0077] In other words, during the sealing process, the temperature is measured online by a detector that detects the re-emission spectrum in the NIR range of 1000 nm to 1700 nm. The shift in the position of the absorption maximum, derivable from the received spectrum, can be used to infer the temperature of the tissue contained within the device with sufficient accuracy for the application. As temperature increases, the absorption peak shifts toward shorter wavelengths. This shift is approximately 0.5 nm / K. As the tissue cools further, the absorption peak shifts again toward longer wavelengths. Because water is the primary absorber in the tissue to be sealed in the wavelength range of approximately 1470 nm, the temperature determined in this manner reflects the temperature of the tissue's water content. A particular advantage of this temperature measurement method is that it allows the actual temperature in the tissue to be measured, as NIR radiation can penetrate the entire thickness of the tissue layer due to scattering. In contrast, when measuring temperature during sealing using thermocouples, only the temperature of the contact surface is measured. The temperature and heat capacity of the electrodes are interfering variables in determining the tissue temperature in this method. This results in a deterioration in the delay time and the true tissue temperature. Therefore, this method does not reflect the tissue temperature, but rather the temperature of the environment in contact with the thermocouple. Optical temperature determination allows the acquisition of important parameters for controlling the sealing process. Furthermore, the determined temperature can serve as a switch-off / regulation / control criterion / process parameter or for process regulation / process control.
[0078] It has been shown that light of a preferably specific wavelength (e.g., white light in the VIS-NIR range) is re-emitted by body tissue, wherein the spectrum of the light reflected by the body tissue varies depending on the temperature. It is therefore possible to direct the illumination / illumination output for illuminating the body tissue and the detector / detector input for detecting the light reflected from the body tissue directly to the electrode(s), and thus determine the temperature of the tissue directly adjacent to (between) the electrode(s) from the detour of the detected reflected light and its spectral distribution.
[0079] Therefore, in a preferred embodiment, the medical device (of the HF design) has
[0080] at least one instrument branch, which forms at least one energizable electrode for sealing and / or cutting tissue, or is arranged in or on the at least one energizable electrode for sealing and / or cutting tissue, wherein the energization of the electrode is controllable and / or adjustable by a computing unit, and
[0081] - At least one temperature measuring device having at least one lighting unit and at least one light detector, which are each (alternately) constructed or arranged in relative positions in or on at least one instrument branch or in or on both instrument branches and are electrically connected to the computing unit.
[0082] Preferably, the medical instrument is a surgical instrument, a monopolar instrument, a bipolar instrument, an electrosurgical instrument, a surgical clamp, a surgical clip, a surgical forceps, a surgical scissors, a scalpel, or the like. Particularly preferably, the medical instrument is a sealing and cutting instrument that is configured and adapted to cut and simultaneously seal tissue using HF technology. Monopolar instruments have the advantage that, since they are formed as a single shell (only a single instrument branch), a compact design is achieved and their production is therefore less expensive. Bipolar instruments (two opposing instrument branches) have the advantage that better resolution can be achieved and bipolar instruments are more versatile in their replicability.
[0083] Preferably, at least one instrument branch is understood to be a portion / end of a medical instrument that can come into contact with tissue. Further preferably, at least one instrument branch is a jaw branch. At least one instrument branch can be configured as an electrode for sealing tissue, preferably being integral / consisting of a single component made of conductive metal or graphite. Alternatively, the electrode can be configured / arranged / embedded in and / or on and / or on the instrument branch, preferably in which case the instrument branch is made of an insulator or electrically insulating material.
[0084] The medical instrument preferably has two opposing instrument branches, which are preferably movable / pivotable relative to one another, and at their ends are arranged / configured with mutually facing sides / jaws / regions / instrument branch ends that can contact tissue. The instrument branches themselves can be configured as electrodes for sealing tissue, preferably being made of conductive metal or graphite and insulated from one another. However, electrodes can also be configured / arranged / embedded in and / or on the instrument branches, preferably being each made of an insulator or electrically insulating material or metal and insulated from the electrodes.
[0085] Preferably, at least one electrode is controllable and / or adjustable by the computing unit. More precisely, the current intensity, voltage, phase and / or frequency of the current applied to the electrode are controllable or adjustable.
[0086] Preferably, the temperature measuring device is an optical temperature measuring device / thermometer having an optical emitter in the form of an illumination part and an optical receiver in the form of a light detector.
[0087] Preferably, the term "illumination unit" is understood to include at least one light source / excitation light source, and optionally, additional optical components, such as a light channel having an optical waveguide / reflector / lens / reflective inner wall / scattering medium, etc. Further preferably, the light source can be understood to include a white light source / LED (in the VIS range and / or IR range and / or UV range), a deuterium lamp (in the UV range), and / or a halogen lamp (in the VIS range). In other words, the light at / in / on the instrument branch can be generated directly by the light source at an entrance location / at at least one entrance port, or by guiding the light from the light source to an entrance location / light entry opening / light entrance port of a contact surface of the instrument branch, which is configured and adapted for tissue contact, by means of an optical waveguide / reflector / lens / light channel / scattering medium, etc. Further preferably, the light of the illumination unit is incident at a specific angle relative to the tissue contact surface of the corresponding instrument branch or electrode, i.e., the illumination unit has an exit port and / or light radiation arranged at an angle / tilt in / at / on the instrument branch. In other words, the light source itself is arranged obliquely / at an angle on / at / in the instrument branch or has a surface that is oblique / at an angle relative to the tissue contact surface or light exit surface. Alternatively, an optical element, such as a reflector and / or an optical waveguide, can be arranged obliquely on / at / in the contact surface of the instrument branch (the surface configured and adapted to contact tissue) and guide light from the light source to the incident location or contact surface.
[0088] White light sources, i.e., light sources that emit electromagnetic radiation across the entire VIS range, have the advantage of allowing for more information to be obtained from the illuminated tissue, thereby enabling tissue identification and / or multivariate data analysis. Furthermore, it is possible to perform multiple different measurements. For example, the instrument branches can be equipped with at least one illumination unit having a white light source and at least one detector configured and adapted to measure spectral ranges, preferably using different sensors (e.g., Si sensors, InGaAs sensors, etc.).
[0089] Light sources with a smaller spectral bandwidth have the advantage that they are simple to implement, are cost-effective, can achieve high temporal scanning, and can achieve distances of more than 2 mm from one another and / or from the detector, since higher intensities are possible in a specific spectral range.
[0090] Preferably, a detector or light detector is understood to include at least one sensor / photodiode and / or photomultiplier (PMT) and, if necessary, other optical components, such as an optical channel, which may include an optical waveguide / mirror / lens / reflective inner wall / scattering medium, etc. In other words, light from a detector / detector component installed in / at / on the instrument branch can be measured directly at the reflection point by a sensor located there, such as a detector located there, or can be guided from the contact surface / light inlet of the instrument branch to a sensor located further away from the contact surface or even further away from the instrument branch via an optical channel (which may include an optical waveguide / mirror / lens / reflective inner wall / scattering medium, etc.). Furthermore, preferably, the light is incident from the illumination portion at a specific angle (0° < angle ≤ 90°) relative to the tissue contact surface of the corresponding instrument branch or electrode. Furthermore, preferably, the detector located in / at / on the instrument branch has an inlet that is similarly angled / tilted relative to the contact surface. In other words, the detector itself is arranged obliquely / angledly on / at / in the instrument branch or has a surface that is obliquely / angled relative to the tissue contact surface. Alternatively, an optical element, such as a reflector and / or an optical waveguide, can be arranged obliquely on / at / in the contact surface of the instrument branch (this surface is configured and adapted to contact the tissue) and guide the reflected light to a remote sensor, etc. After incident, the light re-emitted from the body tissue is preferably spectrally resolved in at least two channels (with the aid of a spectrometer, a prism, or different filters) and then detected by at least two sensors, etc., which in turn send at least two signals to a computing unit / CPU, which converts the at least two signals into temperature values.
[0091] The electrodes for sealing tissue are preferably made of metal, conductive ceramic, metallized ceramic, graphite or metallized graphite. The electrodes are also preferably constructed with a surface that is designed and adapted to reflect electromagnetic radiation.
[0092] The computing unit preferably has a processor and a storage medium. The storage medium is configured and adapted to store steps for performing temperature measurement and / or controlling and / or regulating the current of the electrodes.
[0093] The computing unit controls the illumination unit / its light source (duration, intensity, wavelength, etc.) using the first electrical signal. A detector detects (only) light scattered / reflected by the body tissue or re-emission directly at the tissue to be measured / treated (between the instrument branches) and transmits the determined data to the computing unit as a second electrical signal. The computing unit then uses an algorithm on a storage medium to calculate the temperature of the tissue, which can be derived from each second electrical signal. Based on the thus calculated tissue temperature, the current intensity, voltage, and / or frequency to be applied to at least one electrode are calculated online / in real time.
[0094] In addition, in one embodiment, the electrical resistance of the tissue (tissue impedance) can also be determined by the computing unit and included in the calculation. In other words, the tissue impedance of the tissue at / between the electrodes / ultrasound poles can be determined, so that the current intensity, voltage, and / or frequency of the current applied to the electrode(s) or US transducer can be controlled or regulated by the computing unit in response to the determined tissue impedance and in conjunction with the second signal of the (optical) temperature measuring device.
[0095] Preferably, the computing unit is connected to the (optical) temperature measuring device according to the invention so that the current intensity, voltage and / or frequency of the current applied to at least one electrode can be changed in response to the temperature calculated by the computing unit / CPU, preferably automatically and / or by a preset algorithm.
[0096] Preferably, the second electrical signal from the detector corresponds to a spectrum representing the wavelength and intensity of the light detected at the detector. Based on this spectrum, a shift in the spectral absorption maximum of water is calculated / ascertained. The temperature can be determined from this shift of approximately 0.5 nm / K in the absorption maximum. Because the absorption spectrum of water is characteristic, the shift can be determined without and / or with a reference measurement.
[0097] Preferably, the computing unit is configured such that the computing unit performs at least one of the following steps, or stores at least one of the following steps on a storage medium in the computing unit (preferably in the following order):
[0098] - the lighting device is actuated by the computing unit with a first electrical signal, preferably with a current having a specific current intensity and / or a specific voltage and / or a specific frequency,
[0099] - emitting electromagnetic radiation (preferably white light) of the illumination portion into the tissue in a specific area in the immediate vicinity of an electrode or between two opposing electrodes,
[0100] - measuring (with the aid of a detector) the re-emission / diffuse reflection of electromagnetic radiation from body tissue,
[0101] - sending the measurement result from the detector to a computing unit by means of a second electrical signal,
[0102] - converting the second electrical signal into a tissue temperature value,
[0103] - preferably determining the tissue impedance, preferably between two electrodes,
[0104] - processing the tissue temperature value and preferably the ascertained tissue impedance by means of a computing unit, preferably by means of a preprogrammed algorithm on a storage medium, in order to determine a new current intensity, voltage and / or frequency for the current applied to the electrode(s) in order to achieve or approximate a tissue temperature of above 85 degrees Celsius, preferably above 95 degrees Celsius and preferably at the same time below 110 degrees Celsius, preferably below 100 degrees Celsius;
[0105] - continuous calculation of the parameter SP from the continuously determined values Dur95, MeanTempabTmax and E2Tmax;
[0106] - Provides a shutdown trigger.
[0107] In one embodiment, the optical channel connected to the light source can be fed at at least one end of at least one light source, and at least one other end can terminate in the instrument branch. In other words, light from the at least one light source can be guided via an optical waveguide or the like to at least one outlet located at, on, or in the instrument branch. Alternatively, at least one light source (e.g., an LED) can be located directly on, at, or in the instrument branch.
[0108] In one embodiment, an optical channel connected to a detector may have at least one sensor at at least one end and terminate at at least one other end in an instrument branch. In other words, light / reflected light from at least one inlet on / in an instrument branch may be directed to at least one sensor / photodiode / photomultiplier, etc. via a reflective optical channel / optical waveguide, etc. Alternatively, at least one sensor / photodiode / photomultiplier may be located / arranged on / at / in the instrument branch.
[0109] Preferably, the illumination portion and the detector can share the end of an optical channel. In other words, the path of the light source and the path of the sensor / photodiode / photomultiplier can share the optical channel so that both are in optical contact with the body tissue via a single optical opening, which forms both the entrance and exit of light on / at / in the instrument branch.
[0110] Preferably, a plurality of detectors and a plurality of illumination units are arranged on at least one instrument branch. In this case, the detectors or illumination units can be arranged on the instrument branches in a predetermined pattern. The pattern is preferably linear. Alternatively, at least one detector and / or illumination unit can be arranged on a first instrument branch, and at least one detector and / or illumination unit can be arranged on a second instrument branch, preferably on mutually facing sides of opposite instrument branches. In other words, in this embodiment, for a bipolar instrument, light from the illumination device can be introduced into the tissue, and on the opposite side, the detector can measure the light re-emitted by the tissue.
[0111] The distance between the at least one illumination unit and the at least one detector is preferably between 0 and 5 mm, particularly preferably between 0 and 1 mm, since the intensity of the re-emission is very high there.
[0112] Preferably, at least one instrument branch of each lighting section has multiple detectors, and particularly preferably, the detectors are arranged at the same and / or different distances from the lighting section. In other words, the distance from one lighting section to the second detector can be greater than the distance to the first detector.
[0113] The illumination preferably comprises discrete light sources, preferably with a defined bandwidth, particularly preferably with a bandwidth of less than 100 nm.
[0114] Preferably, the (optical) temperature measuring device is arranged in a plane of the instrument branch that is lower than the contact surface of the electrode. In other words, the contact surface of the electrode and / or the instrument branch that contacts the tissue forms a plane. This plane is higher (closer to the tissue) in the contact direction than the plane in which the at least one illumination unit and / or the at least one detector are arranged.
[0115] Preferably, the (optical) temperature measuring device enables real-time / online determination of the temperature during the sealing process. This online determination is particularly important for the quality of the seal. The measurement represents the temperature in the tissue / tissue temperature and does not exhibit a lag time or distort the measured temperature due to the heat capacity of the measuring device, for example, due to the heat capacity of metal electrodes. An advantage of optical temperature measurement that is sensitive to water in the contained / contacted tissue is that the temperature measuring device does not have a significant heat capacity.
[0116] Preferably, the re-emission measurement can be performed in the instrument branch or in the jaw portion of the sealing and cutting instrument, regardless of the location of tissue contact with the instrument branch. In other words, the temperature measuring devices are distributed, preferably evenly distributed, on the surface of the instrument branch in the area designed and adapted for tissue contact. As described above, at least one instrument branch can have multiple excitation paths and detection paths / illumination paths or detection paths, preferably along and / or within the electrodes.
[0117] As mentioned above, in addition to or as an alternative to measuring impedance, temperature should also be measured. Preferably, the temperature in the tissue to be fused is measured directly between two opposing instrument branches and specifically preferably during the (time) process of energizing / heating the tissue. This allows for direct / online detection of changes in tissue state and thus also for reacting thereto. By expanding the algorithm with additional control parameters / regulating parameters, the energy input into the tissue can be better evaluated and thus the fusion of the tissue can be better controlled / regulated. In addition, other properties of the tissue, such as the water content / water content in the tissue, can also be measured using the temperature measuring device according to the present invention.
[0118] Preferably, the electrode has at least one first electrode surface on a surface that is configured and adapted to contact the tissue. The electrode is preferably located on the instrument branch body of the instrument branch (in the jaw portion) or is formed by the instrument branch. In the electrode and / or the instrument branch, at least one light source / at least one light guide / at least one optical component (color separation mirror / beam splitter / reflector) and / or at least one light detector (or part thereof) having at least one sensor and, if necessary, a light guide is preferably introduced. A photodiode or a photomultiplier can also be understood as a sensor. The electrode preferably has at least one light exit port, from which light from the light source is emitted / passes through the light exit port from the electrode surface and / or enters the tissue. The electrode preferably has at least one light inlet port, through which light (only) is radiated / re-emitted / reflected from the tissue into the electrode surface / radiated / re-emitted / reflected through the electrode surface into the sensor (re-emitted). The electrode preferably has at least one channel, which is configured and adapted to conduct data to at least one computing unit by means of at least one cable / wire, or to conduct light to a remote sensor by means of at least one scattering medium / at least one optical waveguide / at least one mirrored surface, which in turn conducts data to at least one computing unit by means of at least one cable / wire. If the present invention has more than one electrode surface or more than one instrument branch, the electrode surfaces / instrument branches are preferably spaced apart in parallel from one another. The space between the electrode surfaces / instrument branches is preferably configured and adapted to insertably accommodate a cutting device, such as a blade, a scalpel, an HF scalpel, etc., which is configured and adapted to separate / cut tissue. Thus, electrode surfaces / branch surfaces are formed on at least two sides of the incision in the tissue in order to coagulate the tissue by means of HF technology.
[0119] A narrowband filter is preferably arranged upstream of the sensor. The optical channel can be formed in the electrodes and / or the instrument branches. In other words, the optical channel can guide light through the instrument branches and / or at least one electrode. All embodiments can be combined with one another.
[0120] According to the present invention, with respect to a medical device, the object of the present invention is achieved in that the medical device is configured and adapted to carry out the method according to the present invention. In particular, the medical device can have a shutoff device / device for determining a shutoff time that is configured and adapted to carry out the method according to the present invention. BRIEF DESCRIPTION OF THE DRAWINGS
[0121] The present invention will be described in more detail below based on preferred embodiments with the aid of the accompanying drawings.
[0122] Figure 1 shows the region of the branching of the instrument according to a first embodiment,
[0123] Figure 2 A first lighting and detection arrangement of an instrument branch is shown,
[0124] Figure 3 shows a second lighting and detection arrangement for the instrument branch,
[0125] Figure 4 shows a third lighting and detection arrangement of the instrument branch,
[0126] Figure 5 shows the region of the branch of the instrument according to the second embodiment,
[0127] Figure 6 shows the light guidance in the region of the branches of the instrument according to the second embodiment,
[0128] Figure 7 shows the region of the branch of the instrument according to a third embodiment,
[0129] Figure 8 shows the light guidance in the region of the branches of an instrument according to a third embodiment,
[0130] Figure 9 shows the region of the branch of the instrument according to a fourth embodiment,
[0131] Figure 10 shows the light guidance in the region of the branches of an instrument according to a fourth embodiment,
[0132] Figure 11 shows the region of the branch of the instrument according to a fifth embodiment,
[0133] Figure 12 shows the light guidance in the region of the branches of an instrument according to a fifth embodiment,
[0134] Figure 13 shows the region of the branch of the instrument according to a sixth embodiment,
[0135] Figure 14 shows the light guidance in the region of the branches of the instrument according to a sixth embodiment,
[0136] Figure 15 shows the region of the branching of the instrument according to a seventh embodiment,
[0137] Figure 16 shows the light guidance in the region of the branches of the instrument according to a sixth embodiment,
[0138] Figure 17 shows the region of the branching of the instrument according to an eighth embodiment,
[0139] Figure 18shows the light guidance in the region of the branches of the instrument according to an eighth embodiment,
[0140] Figure 19 shows the region of the branching of the instrument according to a ninth embodiment,
[0141] Figure 20 shows the light guidance in the region of the branches of the instrument according to a ninth embodiment,
[0142] Figure 21 shows the region of the branch of the instrument according to a tenth embodiment,
[0143] Figure 22 shows the light guidance in the region of the branches of the instrument according to a tenth embodiment,
[0144] Figure 23 shows a bipolar instrument branch according to the aforementioned embodiment,
[0145] Figure 24 shows the relative detector and illumination on a bipolar HF device,
[0146] Figure 25 shows a schematic diagram of a medical device according to the present invention, and
[0147] Figure 26 A schematic diagram of the temperature profile during the method is shown.
[0148] The accompanying drawings are schematic in nature and are only used to understand the present invention. Identical elements are provided with identical reference numerals. Features of various embodiments may be substituted for each other.
[0149] Among them, 1, 101, 201, 301, 401, 501, 601, 701, 801, 901: instrument branch; 2, 102, 202, 302, 402, 502, 602, 702, 802, 902: electrode; 4, 104, 204, 304, 404, 604, 804, 904: first electrode surface; 6, 106, 206, 306, 406, 606, 806, 906: second electrode surface; 8, 108, 208, 308, 408, 708: instrument branch body; 10, 1110: light source; 12, 1112: sensor; 14, 114, 214, 314, 414, 514, 614, 714 , 814, 914, 1014, 1114: light incident port; 16, 116, 216, 616, 716, 816, 916, 1016, 1116: light exit port; 18, 1118: channel; 120, 220, 320, 420, 520, 620, 720, 820, 920: light channel; 322, 422: block of material; 524, 924: mirrored inclined plane; 626, 826: partially transparent plane; 1028: bipolar instrument branch; 1130, 1132, 1140, 1142: line; 1134: first electrode; 1136: second electrode; 1138: tissue; 1144: computing unit; 1146: storage medium. DETAILED DESCRIPTION
[0150] Figure 1 An area of an instrument branch 1 according to a first embodiment is shown. The instrument branch 1 has at least one electrode 2, which is embedded in the instrument branch 1 in an insulated manner. The electrode 2 has a first electrode surface 4 and a second electrode surface 6 on the branch side that is arranged and adapted to come into contact with body tissue. The electrode(s) 2 are particularly located in / on the instrument branch body 8 of the instrument branch 1, which is one half of the manipulable instrument jaw part. A light source (LED) 10 and a light detector or sensor 12 are alternately introduced into the electrode 2 or the instrument branch 1 / instrument branch body 8, respectively. The electrode 2 or the instrument branch 1 / instrument branch body 8 has a light exit port 14, through which light from the light source 10 is radiated from the electrode surface 4 and / or 6 or the branch contact surface into the tissue. The electrode 2 or the instrument branch 1 / instrument branch body 8 also has a light entrance port 16, through which light from the tissue is re-emitted into the electrode surface 4 and / or 6 / through the electrode surface or through the branch contact surface into the sensor 12. The electrode 2 or the instrument branch 1 / instrument branch body 8 has at least one (longitudinal) channel 18 which is arranged and adapted to conduct data / signals from the sensor 12 to a computing unit (not shown in greater detail) by means of a cable (not shown in greater detail).
[0151] Figure 2 A first variant of the illumination and detection arrangement of the instrument branch 1 is shown. Each embodiment of the present application can have a first illumination and detection arrangement. Figure 2 The upline of lighting and detection arrangement is arranged / embedded in Figure 1 The second electrode / branch surface is at / in 6. Figure 2 The downlink of the lighting and detection arrangement is arranged / embedded in Figure 1 Detectors / sensors 12 and illumination units / light sources 10 are arranged alternately in the rows. Dark spots represent detectors / sensors 12, and bright spots represent illumination units / light sources 10. A narrowband (optical) filter (not shown) is preferably placed in front of the detectors / sensors 12. More preferably, the optoelectronic components (sensors 12 and illumination units 10) are mounted on a circuit board below the tissue-contacting surface of the electrodes / branches.
[0152] Figure 3 A second variant of the illumination and detection arrangement for the instrument branch is shown. Each embodiment of the present application can have a second variant of the illumination and detection arrangement. Here, the dark spots are sensors 12, and the bright spots are light sources 10. The second variant of the illumination and detection arrangement is designed so that four sensors 12 are each arranged around a light source 10 at the same distance from it, with each light source 10 sharing two sensors 12 with another directly adjacent light source. In other words, the / each light source 10 is located at the center point of an imaginary rectangle, and the sensors 12 are positioned at the corners of the imaginary rectangle.
[0153] Figure 4 A third variant of the illumination and detection arrangement for the device branches is shown. Each embodiment of the present application can have a third variant of the illumination and detection arrangement. Here, the dark spots are sensors 12 and the bright spots are light sources 10. The third variant of the illumination and detection arrangement is identical to the first variant of the illumination and detection arrangement, except that the row of illumination and detection arrangements for the second electrode / branch surface begins where the row of illumination and detection arrangements for the first electrode / branch surface ends.
[0154] Figure 5An area of an instrument branch 101 according to a second embodiment is shown. The instrument branch 101 has an electrode 102. The electrode 102 has a first electrode surface 104 and a second electrode surface 106 on a (branch) surface that is arranged and adapted to come into contact with tissue. In this respect, the branch of the second embodiment corresponds to the branch of the first embodiment. The electrode 102 is in particular located on a distal instrument branch body 108 of the instrument branch 101, which is part of the instrument jaw part. A light source and a sensor (not shown in greater detail) are introduced into the instrument branch 101, which are remote from the tissue contact surface of the instrument branch body 108. The electrode 102 / instrument branch body 108 has a light exit opening 114, through which light from a light source (not shown) is guided and from which light from the electrode surfaces 104 and / or 106 or the tissue contact surface of the instrument branch body 108 is emitted / enters the tissue. The electrode 102 / instrument branch body 108 has a light inlet 116, through which light from the tissue is emitted / enters the electrode surface 104 and / or 106 or the tissue contact surface of the instrument branch body 108 / enters the light channel 120 through the electrode surface and / or the tissue contact surface of the instrument branch body, and the light channel terminates in the sensor. The light from the light source to the light outlet 114 is also guided through preferably other light channels 120. The light channel 120 is filled with air or other gas or has a vacuum. The light channel 120 passes through the instrument branch body 108 and / or the electrode 102. Preferably, the cylindrical light channel 120 has an internal channel surface (in the form of a hollow cylinder), and the internal channel surface has electromagnetic wave (light wave) reflection properties. Therefore, the channel surface on the inner side of the channel is configured and adapted to achieve total reflection.
[0155] Figure 6 The light guidance in the region of the instrument branch / instrument branch body according to the second embodiment is shown in light channel 120. Incident light from a light source is totally reflected on the inner surface of light channel 120 and can thus be guided through light channel 120. By total reflection on the inner side of light channel 1202, light can also be guided through curved regions / at least one arc, etc. In this case, light channel 120 is guided along branch body 108 so as to then reach the tissue contact surface of branch body 108 at an arc of approximately 90° (or at another angle relative to the tissue contact surface), where light channel 120 opens.
[0156] Figure 7 The instrument branch 201 according to the third embodiment is shown in the region. The instrument branch 201 has an instrument branch body 208, which forms part of the instrument jaw part, the instrument jaw part being the electrode or the electrode 202 being insulated and embedded in the instrument jaw part, as shown in FIG. Figure 7As shown in . The electrode 202 has a first electrode surface 204 and a second electrode surface 206 on a branch surface that is configured and adapted to contact the tissue. Therefore, the electrode 202 is on / in the instrument branch body 208 of the instrument branch 201. A light source and a sensor away from the tissue contact surface (not shown) are introduced into the instrument branch 201. The electrode 202 or the instrument branch body 208 respectively has a light exit port 214, through which light from a light source not shown is guided and light from the electrode surface 204 and / or 206 or the tissue contact surface is emitted / enters the tissue from the light exit port. The electrode 202 or the instrument branch body 208 has a light entrance port 216, through which light from the tissue is emitted / enters the electrode surface 204 and / or 206 or the tissue contact surface of the instrument branch body 208 / enters the light channel 220 through the electrode surface and / or or the tissue contact surface of the instrument branch body, and the light channel terminates in the sensor. Light from the light source to the light inlet 214 is also preferably guided through another light channel 220. Light channel 220 is filled with air or another gas, or has a vacuum. Light channel 220 passes through the instrument branch body 208 and / or the electrode 202. Light from the light source is introduced / injected perpendicularly to the opening / perpendicularly to the longitudinal direction of the preferably cylindrical light channel 220. Thus, the light is guided straight / straight through light channel 220. To redirect the light, at least one mirror and / or prism is used in light channel 220 to deflect / guide the light at a desired angle. Channel 220 can have any geometric shape, such as cylindrical, rectangular, etc.
[0157] Figure 8 The light guidance in the region of the instrument branch according to the third embodiment is shown in the light channel 220. The incident light from the light source is fed straight / directionally / parallel into the light channel 220. By guiding the light with the aid of at least one reflector in the light channel 220, the light can also be guided via angled legs / corners, etc.
[0158] Figure 9An area of an instrument branch 301 according to a fourth embodiment is shown. The instrument branch 301 has an electrode 302, which is housed in an instrument branch body 308, which forms a tissue contact surface. The electrode 302 has a first electrode surface 304 and a second electrode surface 306 on a surface that is arranged and adapted to contact the tissue. The electrode 302 is therefore located in / on the instrument branch body 308 of the instrument branch 301. The light source and the sensor are introduced into the instrument branch 301 away from the tissue contact surface of the instrument branch body 308 (not shown). The electrode 302 or the instrument branch body 308 has a light exit port 314, through which light from a light source not shown is guided and light from the electrode surfaces 304 and / or 306 or the instrument branch body 308 is emitted from the light exit port / enters the tissue. The electrode 302 or the instrument branch body 308 has a light inlet (not shown), through which light from the tissue is emitted / enters the electrode surface 304 and / or 306 / passes through the electrode surface or the contact surface of the instrument branch body 308 into a light channel 320, which terminates in the sensor. Light from the light source to the light outlet 314 is also preferably guided through another light channel (not shown). The light channel 320 is filled with a scattering block material 322. The light channel 320 passes through the instrument branch body 308 and / or the electrode 302. In this embodiment, at least two light channels 320 are arranged in parallel in rows / lines in the electrode 302 and / or the instrument branch body 308, so that the rows having the light inlet 314 and the light outlet (not shown) are respectively introduced into the electrode surfaces 304 and 306. In an embodiment not shown, the block material of the fourth embodiment can itself be a light source, that is, the block material can emit light.
[0159] Figure 10 Light guidance in the region of the instrument branch according to the fourth embodiment is shown in an optical channel 320. Incident light from a light source is fed into the optical channel 320, more specifically, into a scattering and / or luminescent bulk material 322 in the optical channel 320. By scattering of the light in the bulk material 322, the light is radiated into the tissue and the re-emitted light is guided / scattered by a further optical channel (not shown) having the same structure to a sensor.
[0160] Figure 11An area of an instrument branch 401 according to a fifth embodiment is shown. The instrument branch 401 has an electrode 402, which in this case is insulated and embedded in an instrument branch body 408. The electrode 402 has a first electrode surface 404 and a second electrode surface 406 on the surface of the instrument branch body 408 that is arranged and adapted to come into contact with the tissue. The electrode 402 is therefore located in / on the instrument branch body 408 of the instrument branch 401. The light source and the sensor are introduced into the instrument branch 401 away from the tissue contact surface of the instrument branch body 408 (not shown). The electrode 402 or the instrument branch body 408 respectively has a light exit port 414, through which light from a light source not shown is guided and light from the electrode surface 404 and / or 406 or the tissue contact surface is emitted / enters the tissue. The electrode 402 or the instrument branch body 408 has a light inlet (not shown) through which light from the tissue is emitted / entered into the electrode surface 404 and / or 406 / passed through the electrode surface or through the tissue contact surface into a light channel 420, which terminates in the sensor. Light from the light source to the light outlet 414 is also guided via preferably other light channels (not shown). The light channels 420 are filled with a structured bulk material 422. The light channels 420 pass through the instrument branch body 408 and / or the electrode 402. In this embodiment, at least two light channels 420 are arranged in parallel in rows / lines in the electrode 402 and / or the instrument branch body 408, so that the rows having the light inlet 414 and the light outlet (not shown) are respectively introduced into the electrode surfaces 404 and 406. In an embodiment not shown, the bulk material of the fifth embodiment itself can be a light source, that is, the bulk material can emit light.
[0161] Figure 12 Light guidance in the region of the instrument branch according to the fifth embodiment is shown in an optical channel 420. Incident light from a light source is fed into the optical channel 420, more specifically, into a structured bulk material 422 in the optical channel 420. Due to the structure used in the bulk material 422, the light is radiated into the tissue and the re-emitted light is guided / scattered by a further optical channel (not shown) having the same structure to a sensor.
[0162] Figure 13An area of an instrument branch 501 according to a sixth embodiment is shown. The instrument branch 501 has an electrode 502, wherein, in this embodiment, the instrument branch body 501 and the electrode 502 correspond to the previous embodiments in terms of their structure and arrangement. A light source and a sensor are introduced into the instrument branch body (not shown). The electrode 502 / instrument branch body has a light exit port 514, through which light from a light source (not shown) is guided and from which the light radiates / enters the tissue. The electrode 502 / instrument branch body has a light entrance port (not shown), through which light from the tissue is emitted / enters a light channel 520, which ends in the sensor. The light from the light source to the light entrance port 514 is guided through at least one light channel 520. In this embodiment, a single light channel 520 is constructed in the electrode 502 and therefore in the instrument branch body 501. A row having a light exit port 514 and a light entrance port (not shown) is introduced into the electrode 502 or the instrument branch body. In the light channel 520, at least one mirrored / reflective inclined / angled plane 524 is formed. The plane 524 can be produced by polishing the electrode or the instrument branch body or by introducing a reflector in the light channel 520. The light channel 520 passes through the instrument branch body. At least one row with light exit openings 514 and light entrance openings (not shown) is introduced in the surface of the electrode 502 / instrument branch body. Alternatively or additionally, a single light channel 520 of this type can be used for excitation and recording of reflected light and have corresponding filters. This means that a filter corresponding to the re-emitted wavelength range is installed behind the light source, but the rest of the light is guided into the tissue and is received by this tissue and / or adjacent openings and guided back to the sensor via the same reflecting plane 524.
[0163] Figure 14 The light guidance in the region of the instrument branch 501 according to the sixth embodiment is shown in the light channel 520. Incident light from a light source is fed into the light channel 520 and deflected at a predetermined angle (preferably between 0° and 90°) at an angled mirror plane 524. Via the reflector / mirror surface / mirror plane 524, the light is radiated into the tissue, and the re-emitted light is guided by a further light channel (not shown) having the same structure to the sensor.
[0164] Figure 15An area of an instrument branch 601 according to a seventh embodiment is shown. The instrument branch 601 has an electrode 602 accommodated by an instrument branch body 608. The electrode 602 has a first electrode surface 604 and a second electrode surface 606 on the surface of the instrument branch body 608 that is configured and adapted to contact the tissue. A light source and a sensor are introduced into the instrument branch body 608 (not shown). The instrument branch body 608 has a light exit port 614, through which light from a light source not shown is guided and emitted from / enters the tissue contact surface. The instrument branch body 608 also has a light inlet port (not shown), through which light from the tissue is radiated / enters the tissue contact surface of the instrument branch body 608 / radiates through the tissue contact surface / enters the light channel 620, which terminates in the sensor. Light from the light source to the light exit port 614 is also guided through a second light channel (not shown). At least one partially light-transmitting surface 626 is introduced into the light channel 620, which transmits a portion of the electromagnetic radiation, i.e., is transparent to a portion of the light and reflects a portion of the light. Preferably, the partially light-transmitting surface is a partially light-transmitting mirror, and further preferably, a plurality of partially light-transmitting surfaces 626 are arranged one after the other in the light channel.
[0165] Figure 16 The light guidance in the region of the instrument branch 601 according to the seventh embodiment is shown in the light channel 620. Incident light from a light source is fed into the light channel 620. The incident light from the light source is fed into the light channel 620 in a straight line / directional / parallel manner. By guiding the light in the light channel 620 with the aid of at least one partially transparent reflector 626, the light is guided / reflected / mirrored at an angled region / angle, etc. The light passing through the partially transparent reflector 626 is incident on another partially transparent reflector 626 arranged at the same angle as the reflector, and so on. The light is radiated into the tissue by the partially transparent reflector / mirror surface / mirror plane 626, and the re-emitted light is guided to the sensor by another light channel (not shown) having the same structure.
[0166] Figure 17 An area of an instrument branch 701 according to an eighth embodiment is shown. The instrument branch 701 has an electrode 702. The electrode 702 is located on the instrument branch body 708 of the instrument branch 701. A light source and a sensor remote from the instrument branch body 708 are preferably introduced externally into the instrument branch 701 (not shown). The instrument branch body 708 has at least one optical channel 720, through which light from a light source not shown is guided and from which the light is emitted / enters the tissue. The instrument branch body 708 has at least one additional optical channel 720, through which light from the tissue is guided to the sensor. In this embodiment, the optical channel 720 is formed by an optical waveguide such as a glass fiber.
[0167] Figure 18 The light guidance in the region of the instrument branch according to the eighth embodiment is shown in the light channel 720. The incident light from the light source is totally reflected on the inner surface of the light channel 720 and can thus be guided through the light channel 720. By total reflection on the inner side of the light channel 720, the light can also be guided through curved regions / at least one arc, etc.
[0168] Figure 19 An area of an instrument branch 801 according to a ninth embodiment is shown. The instrument branch 801 has an electrode 802. The electrode 802 has a first electrode surface 804 and a second electrode surface 806 on a tissue contact surface of its instrument branch body that is arranged and adapted to contact the tissue. A light source and a sensor are introduced into the instrument branch body (not shown). The instrument branch body also includes a light exit port 814, through which light from a light source not shown is guided and radiates / enters the tissue. The instrument branch body also has a light inlet port 816, through which light from the tissue enters the instrument branch body / through the instrument branch body into an optical channel 820, which terminates in the sensor. The light from the light source to the light exit port 814 is guided through the same optical channel. In other words, the light exit port 814 can be used as the light inlet port 816, and vice versa. At least two partially light-transmitting planes 626 are introduced into the optical channel 820, which transmit a portion of the electromagnetic radiation, i.e., are transparent to a portion of the light and reflect a portion of the light. Preferably, the partially transparent plane is a partially transparent mirror, and further preferably, a plurality of partially transparent planes 626 are arranged one after another in the light channel. By this arrangement in this embodiment, the partially transparent mirrors are respectively assigned to the light exit port 814 or the light entrance port 816.
[0169] Figure 20 The light guidance in the region of the instrument branch 801 according to the ninth embodiment is shown in the optical channel 820. Incident light from a light source is fed into the optical channel 820. The incident light from the light source is fed into the optical channel 820 in a straight / directional / parallel manner. By guiding the light in the optical channel 820 with the aid of at least two partially transparent reflectors 826, the light is guided / reflected / mirrored at angled regions / angles, etc. Light passing through a partially transparent reflector 826 is incident on at least one other partially transparent reflector 826 arranged at the same angle as the reflector, and so on. The light is radiated into the tissue by the partially transparent reflector / mirror surface / mirror plane 826, and the re-emitted light is conducted / guided to the sensor by the same optical channel 820, but through an adjacent opening. In other words, the opening serves as both a light exit and a light entrance for the adjacent opening.
[0170] Figure 21An area of an instrument branch 901 according to a tenth embodiment is shown. The instrument branch 901 has an electrode 902, wherein, in this embodiment, the instrument branch body and the electrode correspond to the aforementioned embodiments in terms of their structure and arrangement. Therefore, a light source and a sensor that are away from the tissue contact surface of the instrument branch body are introduced into the instrument branch (not shown). The instrument branch body has a light exit port 914, through which light from a light source not shown is guided and from which the light is emitted / enters the tissue. The instrument branch body also has a light entrance port 916, through which light from the tissue is radiated / emitted into a light channel 920, which terminates in the sensor. The light from the light source to the light exit port 914 is guided through at least one light channel 920. The light from the light entrance port 91 to the sensor is guided through at least one additional light channel 920 (of the same structural type). Therefore, in this embodiment, at least two light channels 920 are constructed in the instrument branch body. One or more light exit ports 914 and one or more light entrance ports 916 are alternately introduced into the instrument branch body. In the light channel 920, at least one mirrored / reflective inclined / angled plane 924 is formed.
[0171] Figure 22 The light guidance in the region of the instrument branch 901 according to the tenth embodiment is shown in the optical channel 920. Incident light from a light source is fed into the optical channel 920 and deflected at a predetermined angle (preferably between 0° and 90°) at an angled mirror plane 924. The light is radiated into the tissue via the reflector / mirror surface / mirror plane 924, and the re-emitted light is guided to the sensor via a further optical channel 924 having the same structure.
[0172] Figure 23 Bipolar instrument branches according to the aforementioned embodiments are shown. Embodiments one to ten are provided and adapted for use in a bipolar medical HF instrument, wherein the two instrument branch bodies are preferably pivotably supported relative to each other and define a tissue receiving gap between them.
[0173] Figure 24 The diagram shows the opposing detector and illumination unit on a bipolar HF instrument. Here, the light exit opening 1014 of the illumination unit and the light entrance opening 1016 of the detector are respectively arranged on opposing instrument branches / instrument branch bodies.
[0174] Figure 25A schematic diagram of a medical device 1100 according to the present invention is shown. A light source 1110 is configured and adapted to emit light. A sensor 1112 is configured and adapted to detect light. The light source emits light through a light outlet 1114. Sensor 1112 receives light via a light inlet 1116. Light source 1110 and sensor 1112 are connected to data lines 1130 and 1132 within a channel 1118. Channel 1118 is constructed within an instrument branch body, which also houses electrodes insulated therefrom. The instrument branch body housing electrode 1134 and the instrument branch body housing counterelectrode 1136 clamp tissue 1138. Electrodes 1134 and 1136 are connected to lines 1140 and 1142. Data lines 1130 and 1132, as well as lines 1140 and 1142, are connected to a computing unit 1144 having a storage medium 1146.
[0175] Figure 26 A schematic diagram of the temperature profile during the method is shown. The temperature v of the tissue is plotted in the graph over time t. t1 marks the point in time at which the tissue reaches a temperature of 85 degrees Celsius, preferably 95 degrees Celsius. t2 marks the point at which the value SP reaches a value of 2.5. From the point in time at which the tissue temperature reaches 85 degrees Celsius, preferably 95 degrees Celsius, the value SP is calculated online. From this point in time, the duration that the tissue temperature remains above 85 degrees Celsius, preferably above 95 degrees Celsius, is measured, and the average temperature (shown here as a dotted line) from the time at which 85 degrees Celsius, preferably 95 degrees Celsius, is calculated online. These two values are multiplied in real time and divided by the energy input until 85 degrees Celsius, preferably 95 degrees Celsius, is reached, thereby preferably calculating the value SP in real time.
Claims
1. A computer-readable storage medium of a medical device, wherein a method for determining a switch-off time of a medical device is stored in the storage medium, the method comprising the steps of: Measuring the duration that the temperature of the tissue is above a threshold of at least 85 degrees Celsius, calculating the average temperature since the temperature first reached said threshold of at least 85 degrees Celsius, measuring and / or calculating the energy input until a temperature of 85 degrees Celsius is reached, calculating a parameter SP that combines the above results and switching off the medical instrument at a predetermined value of the parameter SP, in, These steps are initiated by a computer to perform the method.
2. The storage medium according to claim 1, wherein The parameter SP is the product of the duration of time the temperature of the tissue is above 85 degrees Celsius and the average temperature since the threshold temperature of at least 85 degrees Celsius was first reached, divided by the energy input until the threshold temperature of at least 85 degrees Celsius was reached.
3. The storage medium according to claim 1 or 2, characterized in that The stored method further comprises the steps Light with an excitation spectrum is emitted into tissue by means of at least one illumination unit (10, 1110), and re-emission of light with a re-emission spectrum is received from the tissue via at least one detector (12, 1112). converting the re-emission spectrum into a detector signal by means of the detector (12, 1112), sending the detector signal to the computing unit (1144), calculating the re-emission spectrum from the detector signal by means of the calculation unit (1144), calculating an absorption spectrum of the tissue by comparing the excitation spectrum with the re-emission spectrum using the calculation unit (1144), determining at least one absorption maximum from the absorption spectrum by means of the calculation unit (1144), and The temperature in the tissue is calculated by means of the calculation unit (1144) by comparing the absorption maximum with at least one reference.
4. The storage medium according to claim 2, wherein: The method further comprises the step of storing at least one reference in the form of an absorption maximum at a specific temperature in a storage medium in the computing unit.
5. The storage medium according to claim 3, wherein: The method further comprises the step of applying the illumination portion and the detector (12, 1120) to the tissue.
6. The storage medium according to claim 2, wherein: The method further comprises the step of controlling and / or regulating and / or switching off the medical instrument by means of the computing unit based on the calculated temperature and / or tissue impedance.
7. The storage medium according to claim 6, wherein: Control and / or regulation and / or switching off takes place when a predetermined temperature is reached, which is a temperature above 85 degrees Celsius.
8. The storage medium according to claim 6 or 7, characterized in that The medical device is controlled and / or regulated and / or shut down in real time.
9. The storage medium according to claim 2, wherein: The stored method for temperature measurement is executed during the sealing process.
10. The storage medium according to claim 3, wherein: The detector is configured and adapted to measure re-emission in the NIR range of 1000 nm to 1700 nm.
11. The storage medium according to claim 3, wherein: The illumination portion and the detector are spaced apart.
12. The storage medium according to claim 1, wherein The predetermined value SP is between 2 and 3.
13. A medical device (1110) for sealing and / or cutting tissue, having a temperature measuring device arranged and adapted to measure the temperature of the tissue, and having a computing unit (1144), in, The medical device (1110) is configured and adapted to measure the duration that the temperature of the tissue is above 85 degrees Celsius, wherein the calculation unit (1144) is configured and adapted to calculate an average temperature since the temperature first reached the threshold value of at least 85 degrees Celsius, wherein the medical device (1110) is further adapted to measure and / or calculate energy input until the threshold temperature of at least 85 degrees Celsius is reached, wherein the calculation unit (1144) is configured and adapted to calculate a parameter SP relating the above results of the duration, the average temperature and the energy input, and Therein, the medical device (1110) is adapted to switch off the medical device (1110) at a predetermined value SP and / or starting from a predetermined value.
14. The medical device (1110) according to claim 13, characterized in that The medical instrument (1110) has at least one instrument branch (1, 101, 201, 301, 401, 501, 601, 701, 801, 901), which forms at least one energizable electrode for sealing and / or cutting tissue, or at least one energizable electrode for sealing and / or cutting tissue is arranged in or at the instrument branch, wherein the energization of the electrode is controllable and / or adjustable by the computing unit (1144).
15. The medical device (1110) according to claim 13, characterized in that The predetermined value SP is between 2 and 3.
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