Electromagnetic energy transfer method and apparatus for treating biological tissue

Abstract

An energy source device (40) delivers energy to biological tissue (load 49) during a plurality of time intervals within a treatment period. The energy source device (40) determines one or more instantaneous received powers (IRPs) based on the measured electrical parameters while transmitting portions of the energy within a certain time interval. The energy source device (40) determines a power variation based on the one or more instantaneous received powers at least once during the time interval. The energy source device (40) updates the duration of the one or more time intervals based on determining that the variation in the amount of power variation satisfies the threshold tolerance level. The energy source device (40) adjusts at least one operating condition of the energy generator (41) over a time interval such that the energy transmitted to the biological tissue (load 49) is equal to or substantially equal to the energy determined by the treatment energy preset value.

Description

Technical Field

[0001] The present disclosure relates to apparatus and methods for delivering electromagnetic energy to biological tissue. Technical Background

[0002] The energy source device includes an electromagnetic energy generator that converts electromagnetic energy into different forms of output energy. For example, some energy source devices can convert electromagnetic energy into energy forms that can be absorbed by human tissue, such as radio frequency (RF) current, radio frequency electromagnetic field, electromagnetic radiation, ultrasound, laser form energy and / or similar forms of energy. This enables the energy source device to heat human tissue, thereby triggering a biological response of heating the tissue to achieve a therapeutic effect.

[0003] One of the disadvantages of current energy source devices for tissue treatment is the formation of temperature hot spots. Typically, when energy (e.g., radio frequency current, etc.) is transmitted to tissue through an electrode, the energy is concentrated at the edge of the electrode (especially the sharp edge). This phenomenon is called the edge effect. For a disc-shaped electrode, the edge effect manifests itself as a higher current density at the periphery of the disc and a relatively lower current density in the center. For a square electrode, the entire edge typically has a higher current density, and the current density is even higher at the corners. This concentration of radio frequency current can lead to undesirable temperature hot spots, which can cause pain to patients exposed to the radio frequency current.

[0004] Patient pain is unavoidable when using electromagnetic energy to treat tissue. Pain is usually managed by optimizing the treatment effect and minimizing the patient's discomfort. To reduce pain, patients can be given oral analgesics and / or topical anesthetic creams as an anesthetic. These solutions significantly increase patient preparation time and cost, and are cumbersome for both patients and physicians.

[0005] As described above, higher temperatures near the edge of the electrode can create hot spots that can cause pain to the patient. One solution is for the operator of the energy source device (e.g., a physician) to reduce the energy intensity to offset the effects of the temperature hot spots. This provides a more acceptable treatment experience for the patient. However, the consequence of reducing the energy intensity is that the patient may be undertreated and fail to receive enough treatment energy, thereby affecting the overall treatment effect.

[0006] Many energy source devices use open loop power control. The operator typically selects a treatment intensity level or treatment energy delivery level to determine the output power of the electromagnetic energy generator. However, under fixed operating conditions, the output power is a function of the load impedance. Typically, this relationship between output power and load impedance can be approximated by a Gaussian curve. The output power increases as the load impedance increases, and after reaching a maximum value, the output power decreases as the load impedance increases further. During many treatments using energy source devices, the load impedance is affected by many factors, such as the electrical properties of the patient's tissue, patient movement, blood flow in the tissue, coupling media, contact pressure, and / or similar factors. Therefore, the load impedance often changes throughout the treatment process, resulting in an unstable amount of power delivered to the patient.

[0007] In a distributed system, when a coaxial cable or waveguide is used to transmit energy from an electromagnetic energy generator to a load, and its physical length is not much different from the wavelength of the electromagnetic energy, the load can only receive maximum power when its impedance matches the characteristic impedance of the coaxial cable or waveguide. Any deviation from the characteristic impedance will result in a reduction in the power transmitted to the load.

[0008] This dependency between load impedance and output power is not adequately addressed in energy source devices. The consequences are twofold: First, the power delivered to the patient is uncertain. Therefore, it is unpredictable whether the patient will receive the required therapeutic level of energy. The patient may be over-treated or under-treated, resulting in serious uncertainty in the effectiveness of the treatment. Second, when electromagnetic energy is converted into heat in the patient's tissue to achieve the therapeutic effect, the change in load impedance may cause a sudden increase in the power delivered to the patient. If not properly managed, this sudden surge in delivered power may cause a rapid increase in the temperature of the treated tissue. If the power delivered to the patient is too high, the patient's neural pain receptors may be activated, causing the patient to experience great pain.

[0009] Some modern energy source medical devices use some sensors to provide feedback to adjust the drive level of the electromagnetic energy source device to alleviate some of the above problems. However, these sensors generally do not provide sufficient temporal and spatial resolution. For example, energy source devices typically include contact temperature sensors, such as thermistors or thermocouples, to monitor the temperature of the treated tissue. However, due to the inherent physical structure limitations of these contact temperature sensors, these sensors cannot provide accurate tissue temperature measurements. In addition, the sampling rate of contact sensors is limited due to sensor stability requirements. Some devices use non-contact temperature sensors, such as infrared (IR) sensors. However, these sensors can only accurately detect the temperature closest to the sensor surface. In addition, when the treatment area is covered by coupling gel or related materials or substances, this technology cannot efficiently and / or effectively monitor the patient's temperature.

[0010] Therefore, there is a need for an apparatus and / or method to reduce temperature hot spots associated with tissue treatment, thereby reducing patient discomfort, and to deliver precise power to the patient's tissue to achieve more consistent treatment results. Summary of the invention

[0011] In one aspect of the present invention, a method for transmitting electromagnetic energy by an energy source device to treat biological tissue as part of a treatment process is disclosed. The method includes generating electromagnetic energy by an energy generator under one or more operating conditions for transmission to the biological tissue. The method also includes transmitting electromagnetic energy to the biological tissue by the energy source device, the transmission process is performed in multiple time intervals within a treatment time period, and the treatment time period represents the duration of the treatment process. The method further includes, when a portion of the electromagnetic energy is transmitted in one of the multiple time intervals, determining one or more instantaneous received power values ​​based on the measured electrical parameters. The method further includes, at least once in the time interval, determining a power change based on the one or more instantaneous received power values. The method further includes, based on determining that the change in the power change meets a threshold tolerance level, updating the duration of one or more time intervals in the multiple time intervals. The method further includes adjusting at least one of the one or more operating conditions of the energy generator during the time interval, adjusting the at least one operating condition so that the electromagnetic energy transmitted to the biological tissue is equal to or substantially equal to a preset value of the treatment energy.

[0012] In one embodiment of the present invention, when determining one of the one or more instantaneous received power values, the method includes: determining the instantaneous received power value based on a difference between a measured instantaneous forward power and an instantaneous reflected power.

[0013] In another embodiment of the present invention, the one or more instantaneous received power values ​​are multiple instantaneous received power values. In this embodiment, when determining the power variation, the method includes: determining the power variation based on the difference between the minimum instantaneous received power value and the maximum instantaneous received power value in the multiple instantaneous received power values.

[0014] In another embodiment of the present invention, the one or more instantaneous received power values ​​include only a single instantaneous received power value determined during the time interval. In this embodiment, when determining the power change amount, the method includes: determining the power change amount based on the difference between the single instantaneous received power value determined during the time interval and a previous instantaneous received power value determined during a previous time interval in the plurality of time intervals.

[0015] In another embodiment of the invention, the threshold tolerance level is an upper threshold tolerance level. In this embodiment, when updating the duration of one or more time intervals, the method includes: shortening the duration of one or more time intervals based on determining that the change in the power variation exceeds the upper threshold tolerance level.

[0016] In another embodiment of the present invention, the threshold tolerance level is a lower threshold tolerance level. In this embodiment, when updating the duration of one or more time intervals, the method includes: based on determining that the change in the power change amount is less than the lower threshold tolerance level, extending the duration of the one or more time intervals.

[0017] In another embodiment of the present invention, the treatment time period is further defined as a group of pulse width modulation (PWM) cycles. In this embodiment, the method further includes: determining the remaining electromagnetic energy that needs to be transmitted within the first PWM cycle of a group of PWM cycles at the beginning of the first time interval in the plurality of time intervals; determining the additional time period required to transmit the remaining electromagnetic energy within the first PWM cycle; comparing the duration of the additional time period with the duration of the upcoming time interval in the plurality of time intervals; and selecting the time period for transmitting the remaining electromagnetic energy within the first PWM cycle based on the comparison of the duration of the additional time period with the duration of the upcoming time interval. In this embodiment, when adjusting one or more working conditions, the method includes: adjusting one of the one or more working conditions so that the energy generator transmits the remaining electromagnetic energy within the first PWM cycle within the selected time period. In some embodiments, when selecting the time period for transmitting the remaining electromagnetic energy within the first PWM cycle, the method includes: selecting the additional time period based on determining that the duration of the additional time period does not exceed the duration of the upcoming time interval; or selecting the upcoming time interval based on determining that the duration of the additional time period exceeds the duration of the upcoming time interval. In some embodiments, when determining the additional time period required to transmit the remaining electromagnetic energy within the first PWM cycle, the method includes determining the additional time period using the following formula: t1= Er / P, where t1 is the additional time period, Er is the remaining electromagnetic energy that needs to be transmitted within the first PWM cycle, and P is determined based on one or more instantaneous received power values. P can be determined based on a single instantaneous received power value, multiple instantaneous received power values, an average of multiple instantaneous received power values, and / or similar values, as will be further explained in the specific embodiments.

[0018] In another embodiment of the present invention, the one or more working conditions include at least one of the following: a state of an energy generator of the energy source device, or a driving value of the energy generator.

[0019] In another embodiment of the present invention, each time interval (in one or more time intervals) lasts for a time range of 1 nanosecond (ns) to 10 seconds (s), preferably 100 microseconds (μs) to 10 milliseconds (ms).

[0020] In another embodiment of the present invention, the method further includes: determining that one or more instantaneous received power values ​​are not within a threshold range representing normal operating conditions; and based on determining that multiple instantaneous received power values ​​are not within the threshold range, performing one or more actions, wherein the one or more actions include at least one of the following: pausing the treatment process, terminating the treatment process, adjusting one of one or more working conditions to reduce the transmitted electromagnetic energy by at least 60%, or generating and sending an alarm signal indicating that the energy source device is not operating under normal working conditions.

[0021] Another aspect of the present invention provides an energy source device for treating biological tissue. The energy source device includes an energy generator, a power detection unit, an electromagnetic energy transmission unit and a processor. The energy generator is configured to generate electromagnetic energy and operate under one or more operating conditions to transmit electromagnetic energy to biological tissue. The power detection unit is configured to measure instantaneous power. The electromagnetic energy transmission unit is configured to convert electromagnetic energy into an energy form suitable for treating biological tissue. The processor is configured to instruct the energy generator to generate electromagnetic energy, which will be transmitted to the biological tissue within a plurality of time intervals within a treatment time period representing the duration of the treatment process. When transmitting part of the electromagnetic energy during one of the plurality of time intervals, the processor is further configured to determine one or more instantaneous received power values ​​based on the measured electrical parameters. The processor is further configured to determine a power change based on one or more instantaneous received power values ​​at least once during the time interval. The processor is further configured to update the duration of one or more time intervals in the plurality of time intervals based on determining that the change in the power change meets a threshold tolerance level. The processor is further configured to adjust at least one of the one or more working conditions of the energy generator during the time interval. Adjusting at least one operating condition causes the electromagnetic energy transmitted to the biological tissue to be equal to or substantially equal to a preset therapeutic energy value.

[0022] In another embodiment of the present invention, when the processor determines a certain instantaneous received power value among the one or more instantaneous received power values, the processor is configured to determine the instantaneous received power value based on a difference between the measured instantaneous forward power and the instantaneous reflected power.

[0023] In another embodiment of the present invention, the threshold tolerance level is an upper threshold tolerance level. In this embodiment, when updating the duration of one or more time intervals, the processor is configured to reduce the duration of one or more time intervals based on determining that the change in the amount of power change exceeds the upper threshold tolerance level.

[0024] In another embodiment of the present invention, the threshold tolerance level is a lower threshold tolerance level. In this embodiment, when updating the duration of one or more time intervals, the processor is configured to increase the duration of the one or more time intervals based on determining that the change in the amount of power change is less than the lower threshold tolerance level.

[0025] In another embodiment of the present invention, the treatment time period is further defined as a set of pulse width modulation (PWM) cycles. In this embodiment, the processor is also configured to determine the remaining electromagnetic energy that needs to be transmitted within the first PWM cycle at the beginning of the first time interval of the plurality of time intervals. The processor is further configured to determine the additional time period required to transmit the remaining electromagnetic energy within the first PWM cycle. The processor is also configured to compare the duration of the additional time period with the duration of an upcoming time interval in the plurality of time intervals. The processor is further configured to select the time period for transmitting the remaining electromagnetic energy within the first PWM cycle based on comparing the duration of the additional time period with the duration of the upcoming time interval. In this embodiment, when adjusting at least one operating condition, the processor is configured to adjust one of the one or more operating conditions so that the energy generator transmits the remaining electromagnetic energy in the first PWM cycle within the selected time period.

[0026] In another embodiment of the present invention, the one or more working conditions include at least one of the following: a state of an energy generator in the energy source device, or a driving value of the energy generator.

[0027] In another embodiment of the present invention, the processor is further configured to determine that one or more instantaneous received power values ​​are not within a threshold range representing normal operating conditions. The processor is further configured to perform one or more operations based on determining that multiple instantaneous received power values ​​are not within the threshold range.

[0028] In another embodiment of the present invention, the power detection unit includes two directional couplers and one bidirectional coupler. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 Graphical representation illustrating the action potential firing pattern of nociceptors sensing noxious heat.

[0030] Figure 2 Representative action potential waveforms are illustrated.

[0031] Figure 3 The temperature curves associated with different pulse width modulation (PWM) frequencies are illustrated.

[0032] Figure 4 The instantaneous received power measured with respect to time is illustrated.

[0033] Figure 5 A graphical representation of an energy source device determining one or more instantaneous received power values ​​during one or more time intervals is illustrated.

[0034] Figure 6 is a flow chart illustrating an example process for updating time interval data during a treatment period.

[0035] Figure 7 The components of the energy source equipment are described.

[0036] Figure 8 Explained Figure 7 Example of a power detection unit for an energy source device

[0037] Fig. 9 Dynamic PWM without controlling the drive value is illustrated.

[0038] Fig.10 is a flow chart illustrating an example process for power transfer using dynamic PWM without controlling the drive value.

[0039] Fig.11 Dynamic PWM with drive value control is illustrated.

[0040] Fig.12 is a flow chart illustrating an example process of dynamic PWM with drive value control.

[0041] Fig.13 Dynamic amplitude modulation is illustrated.

[0042] Fig.14 is a flow chart illustrating an example process of dynamic amplitude modulation. DETAILED DESCRIPTION

[0043] The following detailed description of example embodiments refers to the accompanying drawings. The same reference numbers in the same drawings may represent the same or similar elements.

[0044] At rest, human skin temperature is considered thermoneutral at about 33°C, with lower temperatures feeling cool or cold and higher temperatures feeling warm or hot. In particular, acute pain is triggered when the temperature exceeds about 43°C. Classic pig skin and human skin experiments have shown that skin burns occur when the skin is exposed to temperatures as low as 44°C for about six hours. In addition, the rate of skin injury increases rapidly with increasing temperature, that is, the time required to cause skin injury is approximately halved for every 1°C increase in surface temperature. Therefore, when the temperature exceeds 50°C, burns occur in seconds; when the temperature exceeds 60°C, burns occur in sub-seconds, which requires rapid detection of high temperatures and withdrawal reactions to avoid severe tissue damage.

[0045] The detection of painful thermal stimuli begins with the depolarization of the terminal terminals of nociceptor C fibers (unmyelinated) and Aδ fibers (thin myelinated) in the skin and mucous membranes in response to noxious temperatures, initiating a train of action potentials. These neurons have a typical pseudo-monopolar morphology with a single axon bifurcating into a peripheral and a central branch. Via this axon, the action potential originating in the periphery is transmitted to the presynaptic head, where the detected information is transmitted to secondary sensory neurons and interneurons. The cell bodies of primary sensory neurons, both nociceptive and non-nociceptive, are located in the spinal ganglia (DRG) close to the spinal cord and in the trigeminal ganglia (TG) in the middle cranial fossa close to the brain.

[0046] Neurons, including the nociceptor spinal cord ganglion (DRG) neurons that transmit cold and heat pain, have their synaptic terminals located in lamina I, II, and V of the dorsal horn of the spinal cord. At these locations, glutamate is released onto second-order sensory neurons that cross the midline and project to the thalamus via the contralateral ascending spinothalamic tract. Signals transmitted via the spinothalamic tract are decoded by the thalamus, sensorimotor cortex, insular cortex, and anterior cingulate gyrus, ultimately resulting in the perception of unpleasant sensations focused on specific areas of the body. Action potentials ascending along the spinobrainstem tract are decoded by the amygdala and hypothalamus, generating a sense of urgency and intensity. Sensory neurons that respond to noxious thermal stimuli remain largely silent at thermoneutral temperatures but exhibit sustained rapid action potential firing in response to sustained noxious heat stimulation. In fact, thermal stimuli are encoded by the action potential firing patterns of different types of temperature-sensitive primary sensory neurons whose cell bodies are located in the spinal cord ganglia and trigeminal ganglia. Humans have little or no adaptive response to noxious temperatures. Fibers involved in sensing noxious heat are typically activated at temperatures above 43°C, with peak discharge occurring in the noxious temperature range (45°C-53°C) and showing little or no adaptive response, such as Figure 1 shown.

[0047] The generation of action potentials in neurons is characterized by the "all or nothing" principle. The "all or nothing" principle states that the strength (or amplitude) of the action potential does not depend on the intensity of the stimulus. If the stimulus exceeds a certain threshold, an action potential is triggered. In essence, the neuron either responds completely to the stimulus or not at all. Physiologically, the frequency of action potentials can typically reach 200-300 Hertz (Hz) per second. Higher frequencies may also be observed, but the maximum frequency is limited by the absolute refractory period (ARP). The absolute refractory period is the period of time during which voltage-gated sodium channels remain inactive, meaning that the sodium channels do not open during depolarization, such as Figure 2As shown in Figure 2, the absolute refractory period is approximately 1 millisecond (ms), so the highest possible frequency at which a neuron can respond to a strong stimulus is limited to approximately 1000 Hz. Therefore, if the noxious thermal stimulus does not last longer than 1 ms, an action potential may no longer be generated at the nerve terminal by the time the axon is ready to transmit another action potential.

[0048] Many energy source devices are unable to generate uniform temperature within the target treatment site or volume. For example, devices based on radio frequency (RF) electrodes, whether monopolar or bipolar, and whether conductively or capacitively coupled, have edge effects that lead to the formation of temperature hot spots. RF devices or devices based on microwave non-contact antennas or antenna arrays often generate non-uniform temperature within the treatment site or volume, mainly due to anisotropic radiation patterns and coherent or destructive interference effects. On the other hand, high-intensity focused ultrasound devices intentionally focus the acoustic energy a few millimeters below the skin surface to form temperature hot spots. Because the pain sensation of nociceptors is caused by temperatures exceeding the nociceptor reporting threshold and is also related to the duration of this harmful temperature above the threshold, it is necessary to avoid excessive accumulation of temperature hot spots or shorten their duration to a time range that is insufficient to form the encoding action potential firing pattern.

[0049] Therefore, in order to reduce the pain caused by noxious heat, two important factors need to be considered: first, to minimize the temperature accumulation in the hot spot area; second, to minimize or minimize the duration of these hot spot temperatures above the reporting threshold of the pain receptors. The former means physiologically that the hot spot temperature should not exceed the nociceptor reporting threshold in the first place to avoid triggering the firing of action potentials, which are perceived by the central nervous system (CNS) as noxious pain. The latter means physiologically that the duration of the hot spot temperature should not exceed the time required to form the encoding action potential train interpreted by the CNS as noxious pain. For example, if the noxious pain sensation requires the firing of five action potentials in succession, each lasting about 2 milliseconds (ms), the entire action potential train takes about 10 ms to complete; if the hot spot temperature drops below the reporting threshold before 10 ms, five consecutive action potentials may not be triggered, thereby reducing the pain sensation.

[0050] Energy source devices can use a variety of techniques to control the output of power or signal strength in electronic systems. Pulse width modulation (PWM) is a technique that operates by quickly switching a signal on and off and for different durations. Different PWM schemes can be implemented to prevent excessive temperature accumulation in the hotspot or to avoid excessive hotspot life. Ideally, during the PWM low time, the energy in the hotspot should be sufficiently thermally relaxed to avoid significant temperature accumulation in the hotspot. This thermal relaxation is achieved by transferring heat from the hotspot to adjacent tissues, such as through thermal conduction, thermal radiation, or thermal convection. Similarly, the frequency of PWM should be high enough to prevent the PWM high time from being too long, thereby avoiding the activation of pain receptors during a single PWM high time. From a thermodynamic point of view, the thermal relaxation time is related to the size of the hotspot. One way to estimate the thermal relaxation time of a hotspot (in seconds) is to determine that its thermal relaxation time is proportional to the square of the size of the hotspot (in millimeters). For example, if the size of a hotspot is about 0.1 mm, it takes about 0.01 seconds for the hotspot to reach a thermally relaxed state, that is, to dissipate about 63% of the energy in the hotspot.

[0051] Figure 3 A first temperature curve 21 and a second temperature curve 22 are shown. The first temperature curve 21 corresponds to a 10 Hz PWM, while the second temperature curve 22 corresponds to a 100 Hz PWM. The PWMs corresponding to each temperature curve have the same exemplary power duty cycle (also called duty cycle) of 40%, so that the average energy transfer in the hotspot is the same when all other conditions are equal. However, because the PWM high time of the first PWM is 40 milliseconds, the temperature in the hotspot corresponding to the first PWM increases more than the temperature in the hotspot corresponding to the second PWM, which has a PWM high time of only 4 milliseconds. The first temperature curve 21 may exceed the nociceptor activation threshold (Tt), which may cause the nociceptors to trigger action potentials, thereby inducing a nociceptive sensation of pain. The second temperature curve 22 may remain below the threshold Tt, meaning that nociceptor action potentials are not triggered. By reducing the PWM cycle time (or increasing the PWM frequency), the temperature fluctuations in the hotspot can be significantly smoothed, thereby avoiding the activation of nociceptors.

[0052] In order to achieve safe and effective energy source device treatment, the power delivered to the tissue must be substantially equal to the power required for the specific treatment. However, as described elsewhere in this article, the load impedance is constantly changing and is affected by many factors, including the electrical properties of the biological tissue, patient movement, blood flow in the tissue, coupling media, contact pressure, etc. This causes the instantaneous received power to fluctuate continuously even when the drive value of the energy source device remains constant. Therefore, providing an instantaneous received power that is equal to or substantially equal to the electromagnetic energy required for a specific treatment faces significant engineering challenges.

[0053] Figure 4 A diagram is shown illustrating the instantaneous received power curve measured with respect to time 30. Figure 4 As shown, the instantaneous received power curve 30 can be represented by a set of time intervals. Within each time interval Δt, the change between the instantaneous received power values ​​is less than a threshold tolerance level. The slope of the instantaneous received power curve 30 may vary depending on the nature of the treatment and / or the use method of the energy source device operator. The larger the slope, the smaller the time interval Δt is required to ensure that the change between the instantaneous received power values ​​remains below the threshold tolerance level. Figure 4 The graph in shows a region 32 corresponding to a time interval Δt1 and a region 33 corresponding to a time interval Δt2. As shown, in region 32, the slope of curve 30 is steeper than in region 33. Therefore, the time interval Δt1 corresponding to region 32 (i.e., where the slope of curve 30 is steeper) must be shorter than the time interval Δt2 corresponding to region 33 (i.e., where the slope of curve 30 is shallower).

[0054] In some embodiments, the time interval Δt may be a time between 1 nanosecond (ns) and 10 seconds (s). In some embodiments, the time interval Δt may be a time between 1 microsecond (us) and 1 second (s). In some embodiments, the time interval Δt may be a time between 10 microseconds (us) and 100 milliseconds (ms). In some embodiments, the time interval Δt may be a time between 100 microseconds (us) and 10 milliseconds (ms).

[0055] As used herein, the term "instantaneous received power" refers to the average power at the input end of the electromagnetic energy transmission unit 43, and the calculation range is one electromagnetic energy cycle, and its expression is: Wherein, P is the instantaneous received power, t is the time, T is the period of electromagnetic energy, V(t) and I(t) are the voltage and current at the input end of the electromagnetic energy transmission unit 43 respectively.

[0056] One or more embodiments described herein relate to therapeutic energy preset values. The therapeutic energy preset value identifies the value of electromagnetic energy that needs to be transmitted within a set time period (e.g., a pulse width modulation (PWM) cycle, a time interval, etc.). The therapeutic energy preset value can be expressed in energy measured in joules (J) or power measured in watts (W). When the therapeutic energy preset value is expressed in joules, it can be easily converted to watt power within a time interval Δt, which is obvious to a person of ordinary skill in the art. Similarly, when the therapeutic energy preset value is expressed in watts, it can also be converted to joules, which can also be understood by a person of ordinary skill in the art.

[0057] In some embodiments, the treatment energy presets may be configured based on the type of treatment being performed. That is, different types of treatments may require different power delivery values. In addition, or in the alternative, the treatment energy presets may also be configured based on the expertise level of the operator or physician performing the treatment procedure and / or any other factors known in the art. In some embodiments, the treatment energy presets may be changed one or more times throughout the treatment procedure. For example, a treatment plan may require a first treatment energy preset to be delivered during a first time interval of the treatment procedure and require a second treatment energy preset to be delivered during a second time interval of the treatment procedure.

[0058] Although one or more embodiments described herein use the term "load impedance", it should be understood that this is provided only as an example. In actual operation, many other electromagnetic energy transmission parameters may be used, including voltage standing wave ratio (VSWR), return loss, reflection coefficient, etc. These parameters are mathematically related to the load impedance, as understood by those of ordinary skill in the art.

[0059] Figure 5 is a schematic diagram illustrating a graphical representation of an energy source device determining one or more instantaneous received power values ​​within one or more time intervals. An energy source device includes an energy generator, an electromagnetic detection unit, an electromagnetic energy transmission unit, a processor, and Figure 7 One or more other components of the associated description.

[0060] Figure 5 Graph A in FIG. 1 shows a case where the energy source device determines multiple instantaneous received power values ​​within a time interval Δt. For example, the energy source device (e.g., by using an electromagnetic detection unit) can determine a set of instantaneous received power values ​​(shown as P1, P2, P3, ..., Pn) within the time interval Δt. The description of how to determine the instantaneous received power values ​​will be described below with Figure 6 Provided together.

[0061] Diagram B shows a case where the energy source device determines a single instantaneous received power value in each time interval Δt. For example, the energy source device (e.g., by using an electromagnetic detection unit) can determine a first instantaneous received power value (shown as P1) in a first time interval and determine a second instantaneous received power value (shown as P2) in a second time interval. An explanation of how to determine the instantaneous received power value will be described below with Figure 6 Provided together.

[0062] Figure 6is a flow chart illustrating an example process 35 for updating time interval data throughout a treatment session. For example, an energy source device may update time interval data for the duration of a treatment session, wherein the treatment session represents the total time electromagnetic energy is delivered as treatment.

[0063] In some embodiments, the time interval data may include data identifying a single time interval, which will be updated throughout the treatment process. In some embodiments, the time interval data may include data identifying a group of time intervals (sometimes referred to as discrete time intervals). This group of time intervals may occur continuously, so that this group of time intervals covers the entire treatment period. In this case, the energy source device can update one or more time intervals by updating any subsequent time intervals that have not yet occurred. For example, assume that this group of time intervals includes sixty time intervals of 1 millisecond (ms) each (for example, these time intervals occur within a 60ms treatment period). Further assume that after the first 1ms time interval, the energy source device decides to update this group of time intervals to 0.5ms. In this example, the energy source device can update the time interval data so that the data used to identify the second, third...60th time interval is updated to a value of 0.5ms. It should be noted that this increases the total number of time intervals in the treatment period. For example, if there are five 1ms time intervals, and after the first 1ms time interval, the duration increases to 0.5ms, there will now be eight 0.5ms time intervals in the remaining 4ms treatment period.

[0064] In some embodiments, the energy source device may be configured to include time interval data identifying an initial set of time intervals. The initial set of time intervals may run through the entire treatment period. For example, if the treatment plan specifies that electromagnetic energy is transmitted throughout a 60 millisecond (ms) treatment period, the energy source device may be configured to include time interval data identifying 60 1 millisecond time intervals. As described below, the duration of these time intervals may be updated throughout the treatment period.

[0065] The energy source device can determine one or more instantaneous received power values ​​within each corresponding time interval (step 36). In some embodiments, the energy source device (for example, using an electromagnetic power detection unit) can determine one or more instantaneous received powers based on the measured instantaneous power. The measured instantaneous power may include a measured instantaneous forward power and a measured instantaneous reflected power. In this case, the electromagnetic power detection unit can measure an instantaneous forward power and an instantaneous reflected power, and provide the data of these measured values ​​to the processor of the energy source device. Then, the energy source device (for example, using a processor) can determine the instantaneous received power based on the measured instantaneous power. For example, the energy source device can determine an instantaneous received power by subtracting data identifying the instantaneous reflected power from data identifying the instantaneous forward power.

[0066] Although one or more embodiments describe that the instantaneous received power is determined based on the instantaneous power (forward and reflected), it should be understood that this is only an example. In practical applications, the instantaneous received power can be determined by any other method known in the art. For example, Figure 8 As shown, the instantaneous received power can be determined by voltage and current measurements.

[0067] The energy source device may determine a change in the power variation between at least two instantaneous received power values ​​(step 37). For example, the energy source device (eg, using a processor) may calculate the power variation by the following formula 1 and formula 2: (1) PV = P max –P min

[0068] In Formula 1 and Formula 2, PV represents the power change, P max Represents the maximum instantaneous received power, P min In order to calculate the power change, the energy source device can receive power from the maximum instantaneous power (P max ) minus the minimum instantaneous received power value (P min In order to calculate the change in power variation, the energy source device can divide the power variation by the minimum instantaneous received power value (P min ). For example, assume the following instantaneous received powers: the power at time t1 is 10 watts (W), the power at time t2 is 12 W, the power at time t3 is 15 W, and the power at time t4 is 18 W. In this example, the maximum instantaneous received power is 18 W and the minimum instantaneous received power is 10 W. According to the above formula 1, the energy source device determines that the power variation (PV) is 8 W, and may determine that the change in the power variation is 0.8 or 80% (for example, 8 W / 10 W).

[0069] In some embodiments, the energy source device may determine the power variation between two or more instantaneous received powers within the same time interval. In some embodiments, only one instantaneous received power is determined within each time interval. In this case, the energy source device may determine the power variation between the instantaneous received power of the current time interval and the instantaneous received power of the previous time interval.

[0070] The energy source device can determine whether the change in the amount of power variation meets the threshold tolerance level (step 38). For example, the energy source device can be configured with data identifying one or more threshold tolerance levels. One or more threshold tolerance levels may include an upper threshold tolerance level and / or a lower threshold tolerance level. The upper threshold tolerance level may represent the maximum allowable value of the change in the amount of power variation. For example, if the amount of power variation is higher than the upper threshold tolerance level, the energy source device may need to reduce the time interval so that calculations can be performed more frequently (e.g., to more effectively manage changes in power during transmission). The lower threshold tolerance level may represent the extent to which the amount of power variation is so low that the energy source device operates inefficiently. For example, if the amount of power variation is lower than the lower threshold tolerance level, the energy source device may perform calculations more frequently than is actually required.

[0071] In some embodiments, the upper threshold tolerance level may be less than 200%. In some embodiments, the upper threshold tolerance level may be less than 100%. In some embodiments, the upper threshold tolerance level may be less than 20%. In some embodiments, the upper threshold tolerance level may be less than 5%.

[0072] If the change in the amount of power change satisfies the threshold tolerance level, the energy source device may update the duration of the time interval (step 39). For example, if the change in the amount of power change satisfies (e.g., exceeds) the upper threshold tolerance level, the energy source device may reduce the duration of the time interval. If the change in the amount of power change satisfies (e.g., falls below) the lower threshold tolerance level, the energy source device may increase the duration of the time interval.

[0073] In some embodiments, the energy source device can determine the extent to which the time interval duration needs to be updated. For example, the energy source device (e.g., via a processor) can perform a proportional-integral-derivative (PID) control technique or a similar type of technique to determine the extent to which the time interval duration needs to be updated.

[0074] If the change in the power variation amount does not satisfy the threshold tolerance level, the energy source device may continue to determine one or more instantaneous received powers (step 36 ).

[0075] like Fig.10 , Fig.12 and Fig.14As shown, the energy source device can perform a variety of different calculations to manage the power delivery throughout the treatment period. By managing or updating the duration of the time interval, the energy source device can increase or decrease the frequency of performing these calculations, thereby efficiently and effectively managing the power delivery throughout the treatment period. In addition, by managing or updating the duration of the time interval, the energy source device can ensure that the change in instantaneous received power does not reach a level that triggers the patient's pain receptors, thereby avoiding the output power from triggering a pain response. Similar ranges can be used for related calculations of the lower threshold tolerance level.

[0076] and Figures 9 to 14 One or more related embodiments may utilize this process to update the duration of a time interval.

[0077] Figure 7 is a schematic diagram of components of an energy source device 40 according to the principles of the present disclosure. The energy source device 40 includes an energy generator 41, a power detection unit 42, an electromagnetic energy transmission unit 43, a processor 44, a memory 45, a communication interface 46, an input component 47, and an output component 48. Communication between multiple components of the energy source device 40 can be achieved through a bus or related hardware.

[0078] The energy generator 41 generates electromagnetic energy in a frequency range from about 30 kHz to about 30 GHz, and more preferably in the range of 300 kHz to 3 GHz.

[0079] The power detection unit 42 is used to measure the instantaneous received power. The power detection unit 42 can be an electromagnetic power detection unit. A variety of different detection units can be implemented to meet the needs of a specific treatment process.

[0080] The electromagnetic energy transmission unit 43 converts the electromagnetic energy generated by the energy generator 41 into a variety of energy forms, which are received by the load 49. The energy forms generated by the electromagnetic energy transmission unit 43 include radio frequency current (RF current), radio frequency electromagnetic field (RF electromagnetic field), electromagnetic radiation (electromagnetic radiation), ultrasonic wave (ultrasound wave), laser (laser) and / or any combination thereof. In the present invention, for the sake of simplicity and clarity, the load 49 mainly refers to the human tissue to be treated. The load impedance in the present invention refers to the electrical impedance of the input end of the electromagnetic energy transmission unit 43. The electrical impedance of human tissue, the coupling mechanism and the coupling material, as well as the inherent impedance of the electromagnetic energy transmission unit 43 itself, may all contribute to the load impedance.

[0081] Typically, the electromagnetic energy transmission unit 43 is also referred to as an energy applicator, so the electromagnetic energy transmission unit and the energy applicator can be used interchangeably in the present invention. The electromagnetic energy transmission unit 43 may include electrodes that directly contact the tissue to be treated to transmit radio frequency current. The electromagnetic energy transmission unit 43 may also include electrodes that do not directly contact the tissue to be treated, for transmitting radio frequency electromagnetic fields; there is usually a thin layer of dielectric material (or air) between the electrode and the tissue, which can block the current but allow the electromagnetic field energy to couple into the tissue. The electromagnetic energy transmission unit 43 may also include an ultrasonic transducer for transmitting sound pressure waves to the tissue to be treated; a coupling gel may be placed between the ultrasonic transducer and the tissue to facilitate energy coupling. The electromagnetic energy transmission unit 43 may also include an antenna structure, through which electromagnetic radiation is transmitted to the tissue to be treated in the form of microwaves. These antenna structures may include monopole antennas, dipole antennas, coaxial single-slot antennas, coaxial multi-slot antennas, waveguide antennas, horn antennas, patch antennas, patch trace antennas, and Vivaldi antennas; these antenna structures may directly contact or not contact the tissue to be treated. Without wishing to be bound by theory, the electromagnetic energy transmission unit 43 can convert electromagnetic energy into energy forms such as radio frequency current, radio frequency electromagnetic field, electromagnetic radiation, ultrasound and laser simultaneously or sequentially, and transmit these energy forms in one treatment process.

[0082] Processor 44 can be implemented by hardware, firmware and / or a combination of hardware and software. Processor 44 may include a central processing unit (CPU), a graphics processing unit (GPU), an accelerated processing unit (APU), a microprocessor, a microcontroller, a digital signal processor (DSP), a field programmable gate array (FPGA), an application specific integrated circuit (ASIC) and / or other types of processing components. In some embodiments, processor 44 includes one or more processors that can be programmed to perform specific functions.

[0083] The processor 44 is in direct electrical communication with the energy generator 41. The processor 44 can adjust the operating conditions of the energy generator 41. Adjusting the operating conditions may include changing or switching the state of the energy generator 41 (e.g., switching between an on state and an off state), and / or increasing or decreasing the drive value of the energy generator 41. Generally, increasing the drive value of the energy generator 41 increases its power output, and vice versa.

[0084] The processor 44 communicates with the power detection unit 42 to instruct the power detection unit 42 to measure the instantaneous received power at least once within each discrete time interval Δt. According to various embodiments of the present invention, obtaining the instantaneous received power includes measuring the instantaneous forward power and the instantaneous reflected power respectively. The instantaneous received power can be calculated by subtracting the instantaneous reflected power (or simply referred to as reflected power) from the instantaneous forward power (or simply referred to as forward power). The instantaneous forward power refers to the power transmitted from the energy generator 41 to the electromagnetic energy transmission unit 43, such as Figure 6 As shown by the long dashed arrow in FIG. 4 . The instantaneous reflected power refers to the power transmitted from the electromagnetic energy transmission unit 43 back to the energy generator 41, as shown in FIG. Figure 6 As shown by the short dashed arrow in . It should be noted that, similar to the definition of instantaneous received power in the present invention, the definition of instantaneous forward power and instantaneous reflected power is based on one cycle of electromagnetic energy. However, due to the limitations of the hardware and sampling speed of the power detection unit 42, it may usually take more than one electromagnetic energy cycle to measure the instantaneous forward power and instantaneous reflected power to obtain the instantaneous received power, which is common knowledge known to those skilled in the art.

[0085] Memory 45 includes random access memory (RAM), read only memory (ROM), and / or other types of dynamic or static storage devices (such as flash memory, magnetic memory, and / or optical memory) for storing information and / or instructions for use by processor 44.

[0086] The processor 44 can communicate with one or more external devices using a communication interface 46. The communication interface 46 includes a transceiver-like component (e.g., a transceiver and / or an independent receiver and transmitter) that enables the energy source device 40 to communicate with other devices via a wired connection, a wireless connection, or a combination of a wired and wireless connection. The communication interface 46 can allow the energy source device 40 to receive information from other devices and / or provide information to other devices. For example, the communication interface 46 may include an Ethernet interface, a fiber optic interface, a coaxial cable interface, an infrared interface, a radio frequency (RF) interface, a universal serial bus (USB) interface, a Wi-Fi interface, a Bluetooth interface, a cellular network interface, and / or a similar interface.

[0087] The processor 44 can communicate with an input component 47 to receive input from a device operator (e.g., a doctor or technician). The input component 47 includes components that allow the energy source device 40 to receive information, such as through user input (e.g., a touch screen display, a keyboard, a keypad, a mouse, a button, a switch, and / or a microphone). The output component 48 includes components for providing output information from the energy source device 40 (e.g., a display, a speaker, and / or one or more light emitting diodes (LEDs), etc.).

[0088] like Figure 8 As shown, the power detection unit 42 can decouple the instantaneous forward power and the reflected power from the main power line 64. The main power line 64 can be in the form of a coaxial cable or a waveguide. The power detection unit 42 can include two independent directional couplers ( Figure 6 (not shown) to detect the instantaneous forward power and reflected power respectively. Alternatively, the power detection unit 42 may include a bidirectional coupler 60. The signal output from port F is directly related to the instantaneous forward power transmitted in the main power line 64, and the signal output from port R is directly related to the instantaneous reflected power transmitted in the main power line 64. These signals can be respectively passed through an RF peak detector 65 (RPD) to convert the alternating current signal (AC) into a direct current signal (DC). The amplitude of the DC signal is proportional to the instantaneous forward or reflected power transmitted in the main power line 64. The DC signal representing the instantaneous forward and reflected power transmitted in the main power line 64 can be selectively connected to a multiplexer 62, which is in turn connected to one or more analog-to-digital converters (ADCs) 61. The ADC can be in electrical communication with the processor 44. The processor 44 instructs the ADC to sample the DC signal at least once within each discrete time interval Δt. Then, the processor 44 calculates the instantaneous received power at least once by subtracting the instantaneous reflected power from the instantaneous forward power.

[0089] In some embodiments, the AC signals at port F and port R can be directly electrically communicated with two ADCs 61 without passing through the RF peak detector. The two ADCs can rely on the clock unit 63 to provide a trigger signal to start sampling. The clock unit 63 is configured to instruct the two ADCs to measure the instantaneous forward and reflected power signals synchronously or asynchronously within each discrete time interval Δt. Each measurement of the instantaneous forward and reflected power signals may require multiple sampling of the respective signals.

[0090] In some embodiments, the ADC uses baseband sampling, that is, the sampling frequency is at least twice greater than the sampled signal frequency. In some embodiments, the ADC uses undersampling. According to the Nyquist sampling theorem, undersampling only requires a sampling frequency greater than twice the Nyquist signal bandwidth, thereby allowing the use of a lower ADC sampling frequency to sample high-frequency signals. The processor 44 can be instructed by the clock unit 63 to obtain digitized instantaneous forward and reflected power signals from the two ADCs and store them in the processor's memory for further processing. These digitized instantaneous forward and reflected power signals can be calculated in the processor 44 by mathematical processing to calculate their amplitudes.

[0091] One form of mathematical processing is a Fourier transform. After performing a Fourier transform on each sampled signal, the amplitude of the target frequency can be calculated. Then, based on the attenuation value provided by the directional coupler or bidirectional coupler 60, the instantaneous forward and reflected power can be inferred. Another advantage of using a Fourier transform is that it can reveal the amplitude information of other harmonics that are missing in the peak-to-peak detection method. The processor 44 then calculates the instantaneous received power by subtracting all the instantaneous reflected powers from all the instantaneous forward powers (i.e., the power of each harmonic). In an alternative embodiment, the two ADCs can be directly controlled by the processor 44 to start sampling and send the digitized instantaneous forward and reflected power signals to the processor 44.

[0092] In some embodiments, obtaining the instantaneous received power within each discrete time interval Δt includes measuring the voltage V(t) and the current I(t) at the input end of the electromagnetic energy transmission unit 43. The processor 44 can then determine the instantaneous received power by integrating the product of the voltage V(t) and the current I(t) within one cycle of the electromagnetic energy. Baseband sampling and / or undersampling can be used to measure the voltage V(t) and the current I(t), and then the processor 44 can process these two waveforms using Fourier transform. According to some alternative embodiments of the present invention, obtaining the instantaneous received power may include measuring the root mean square value (RMS value) of the voltage V(t) and the current I(t), and the phase angle θ between the voltage V(t) and the current I(t). Subsequently, the processor 44 can calculate V RMS ×I RMS × cosθ to determine the instantaneous received power, where V RMS is the RMS value of the voltage V(t), I RMS is the RMS value of the current I(t).

[0093] It should be understood that the above method for obtaining instantaneous received power within each discrete time interval Δt is not intended to be exhaustive and may be modified without departing from the spirit and scope of the present invention.

[0094] In some embodiments, the processor 44 may select a preset time interval Δt value. For example, the processor 44 may select a preset time interval Δt value for a particular treatment regimen. In this case, the processor 44 may store preset time interval Δt values ​​for different treatment regimens and select a value based on the treatment regimen being performed. In this case, the time interval Δt value may be configured based on a priori knowledge of the rate of change of the instantaneous received power for the treatment regimen. In addition, or alternatively, the time interval Δt value may be selected based on device information associated with the energy source device and / or other information available to the processor 44. In some embodiments, the time interval Δt value may be selected based on user input.

[0095] In some embodiments, the processor 44 may continuously acquire the instantaneous received power, analyze its rate of change, and dynamically allocate an appropriate time interval Δt (for example, the time interval may change over time). In some embodiments, when the processor 44 detects that the rate of change of the instantaneous received power is too high, so that the currently selected time interval Δt may cause the change of the instantaneous received power to exceed the tolerance, the processor 44 may shorten the time interval Δt. Similarly, when the processor 44 detects that the rate of change of the instantaneous received power is low, so that increasing the current time interval Δt still keeps the change of the instantaneous received power within the tolerance range, the processor 44 may increase the time interval Δt.

[0096] In some embodiments, in addition to the instantaneous received power, the processor 44 may also monitor and analyze other electromagnetic energy transmission parameters, including voltage standing wave ratio (VSWR), return loss, reflection coefficient, etc. It should be noted that the instantaneous received power, instantaneous forward power, instantaneous reflected power, and other electromagnetic energy transmission parameters are mathematically related, which can be understood by ordinary technicians. These parameters can reveal many aspects of the quality of treatment and the status of the energy source device. In some embodiments, abnormal values ​​of these parameters may indicate that the coupling between the electromagnetic energy transmission unit 43 and the load 49 is poor. This poor coupling may be caused by insufficient coupling material, unnecessary bubbles, partial tissue contact, etc. In these cases, the coupling problem needs to be corrected to ensure safe and efficient treatment. In some embodiments, abnormal values ​​of these parameters may indicate that the electromagnetic energy transmission unit 43 may have component aging, contamination, or even failure, which may affect the treatment effect and / or safety. In these cases, the electromagnetic energy transmission unit 43 may need to be repaired.

[0097] In some embodiments, the processor 44 may receive data indicating the measured instantaneous forward power and instantaneous reflected power. In this case, the processor 44 may determine the instantaneous received power, voltage standing wave ratio (VSWR), return loss, and reflection coefficient within the time interval Δt. The processor 44 may calculate the moving average of the above parameters and mark an abnormal situation when the sudden deviation of these parameters from their corresponding moving average exceeds a threshold percentage. In some embodiments, the threshold percentage may exceed 1%. In some embodiments, the threshold percentage may exceed 5%. In a preferred embodiment, the threshold percentage may exceed 10%. When the deviation of these parameters returns to a threshold percentage of their corresponding moving average before not exceeding the abnormal situation, the processor 44 can remove the abnormal situation and resume normal treatment operation.

[0098] In some embodiments, the processor 44 may set predetermined thresholds for parameters such as instantaneous forward power and instantaneous reflected power, calculated instantaneous received power, voltage standing wave ratio (VSWR), return loss, and reflection coefficient. Once the measured or calculated values ​​exceed the threshold, the processor 44 may mark the abnormal situation, and when these values ​​return to the normal range, the processor 44 may remove the abnormal situation and resume normal treatment operation. The processor 44 may perform one or more operations based on the marked abnormal situation. These operations may include completely stopping treatment, pausing treatment, reminding the doctor or device operator to take appropriate measures, reducing the power duty cycle to below the configured value, etc. The configured value may be, for example, below 40%, 20%, 10%, 5%, etc. In a preferred embodiment, the configured value may be below 5%. The power duty cycle refers to the ratio of the power transmission activation time to the sum of the power transmission activation time and the power transmission inactive time. For example, in PWM mode, the power duty cycle is the ratio of the PWM high time to the sum of the PWM high time and the PWM low time, which applies to each PWM cycle.

[0099] In some embodiments, the processor 44 can be configured to perform one or more hysteresis algorithms when marking and removing abnormal conditions to enhance the stability of the treatment. In an exemplary embodiment, if the instantaneous received power is previously recorded to exceed a threshold of 100W and trigger an abnormal state, the processor 44 removes the abnormal state only when the newly obtained instantaneous received power is less than 90W. This monitoring of abnormal conditions is essential to ensure the comfort, safety and efficacy of the treatment. Without wishing to be bound by theory, the determination of these parameter abnormal values ​​may involve other mathematical processing methods familiar to those skilled in the art.

[0100] Fig.10 , Fig.12 and Fig.14 Several processes are described that the energy source device 40 may perform to deliver a preset value of therapeutic energy to biological tissue during a treatment period. The preset value of therapeutic energy may refer to the amount of electromagnetic energy delivered during a specific time period (e.g., a PWM cycle or time interval). Each process (e.g., Fig.10 , Fig.12 and Fig.14 As shown) the electromagnetic energy corresponding to the preset value of the therapeutic energy is transmitted by adjusting one or more working conditions of the energy generator 41 of the energy source device 40. For example, Fig.10 The process shown utilizes dynamic pulse width modulation (PWM) and does not control the drive value to deliver electromagnetic energy corresponding to the preset value of the therapeutic energy. In this case, adjusting one or more operating conditions includes adjusting or switching the energy generator between an "on" state and an "off" state (thereby changing the width or duration of the pulse).

[0101] Another example is, Fig.12 The process shown uses dynamic PWM with drive value control to transmit electromagnetic energy corresponding to a preset value of treatment energy. In this case, adjusting one or more working conditions includes adjusting the power transmitted to the biological tissue during the entire treatment period. To illustrate with another example, Fig.14 The process shown utilizes dynamic amplitude modulation to deliver a target electromagnetic energy preset value. In this case, adjusting one or more operating conditions includes one or both of: adjusting or switching the energy generator between an "on" state and an "off" state, and adjusting the power delivered to the biological tissue over the entire treatment period.

[0102] Reference now Fig. 9 and Fig.10 , the energy source device 40 can use dynamic PWM (without drive value control) to transmit electromagnetic energy to the patient's biological tissue. Dynamic PWM involves changing the width or duration of the electrical pulse during the treatment process. In order to control the electromagnetic energy transmitted to the biological tissue (for example, without using drive value control), the energy source device 40 can adjust or switch the state of the energy generator 41 (for example, between an "on" state and an "off" state), thereby changing the power duty cycle.

[0103] The delivery of electromagnetic energy may be performed as part of a treatment procedure. The duration of the treatment procedure, i.e., the total time that the electromagnetic energy is provided to the biological tissue, is referred to as the treatment period.

[0104] Fig.10 An example process for transmitting electromagnetic energy to biological tissue using dynamic PWM (without drive value control) is described. The energy source device 40 can receive treatment configuration data (step 80). For example, the energy source device 40 can receive treatment configuration data for a specific treatment process. The treatment configuration data can be input by an operator or an administrative user (e.g., via a user interface). The treatment configuration data may include PWM period data, treatment energy delivery data, threshold tolerance level data, initial time interval data, etc.

[0105] The PWM cycle data may include a value for identifying a set of PWM cycles. This set of PWM cycles may run through the entire treatment period. The PWM cycle T represents the duration of a signal to complete a switching cycle.

[0106] In some embodiments, the therapeutic energy delivery data may include a therapeutic energy preset value, which identifies the expected energy delivered to the biological tissue within the first PWM period T. In some embodiments, the therapeutic energy delivery data may include a therapeutic energy preset value, which identifies the expected energy delivered to the biological tissue within the first time interval Δt. Such embodiments may be used with Fig.14In the present invention, the preset value of treatment energy may refer to energy in Joules (J) or power in Watts (W). When the preset value of treatment energy is expressed in Joules, it can be easily converted to Watt power within the PWM period T or discrete time interval Δt, as understood by those skilled in the art. In some embodiments, the preset value of treatment energy may vary depending on the type of treatment performed, the power transmission capability of the energy source device 40, etc.

[0107] The threshold tolerance data may include a value identifying an upper threshold tolerance level and / or a lower threshold tolerance level. In some embodiments, the initial time interval data may include a value identifying a set of time interval durations. These time intervals may span the entire duration of the treatment period. In some embodiments, the initial time interval data may include a value identifying the duration of a single time interval Δt. The time interval Δt may be repeated throughout the treatment period.

[0108] exist Fig.10 In the description of , an illustrative example will be provided by a numerical example. In this example, the energy source device 40 may be configured with the following treatment configuration data: a PWM period T value of 10 milliseconds (ms), a treatment energy preset value of 35 watts (W), an upper threshold tolerance level value of 0.025 (25%), a lower threshold tolerance level value of 0.05 (5%), and a set of time interval values, wherein the initial time interval duration is set to 1 millisecond (ms).

[0109] In some embodiments, the energy source device 40 may store treatment configuration data in memory.

[0110] Next, the energy source device 40 may select a set of time intervals to be used throughout the treatment period (step 81). For example, the energy source device 40 (e.g., via the processor 44) may select the configured initial time intervals as a set of time intervals to be used throughout the treatment period. The duration of these time intervals determines the frequency with which the energy source device 40 performs one or more of the following steps. For example, if the duration of each time interval Δt is configured to be 1 millisecond, then the energy source device 40 may perform at least one of the following steps in each 1 millisecond time interval. Fig.10 In contrast, if the time interval Δt is 0.5 milliseconds, the energy source device 40 may perform at least one step in each 0.5 millisecond time interval. Fig.10 One or more of the steps of (i.e., more frequently than the 1 millisecond example).

[0111] In some embodiments, the energy source device 40 may decide to update the duration of one or more time intervals. For example, the energy source device 40 may decide to update the duration of one or more time intervals. Figure 6 In some embodiments, the energy source device 40 may determine the extent to which the duration of the time interval Δt needs to be updated. For example, the energy source device 40 may implement a proportional-integral-derivative (PID) control technique or a similar type of technique to determine the extent to which the duration of the time interval Δt needs to be updated.

[0112] Next, the energy source device 40 may start the energy generator 41 (step 82). For example, the energy source device 40 (eg, via the processor 44) may start the energy generator 41 to a default drive value.

[0113] The energy source device 40 may wait for the system to enter a stable state (step 83). This waiting time is also shown in Fig. 9 In Chart A and Chart B, they are the first rectangular areas in each chart.

[0114] The energy source device 40 may measure instantaneous power (step 84). For example, the energy source device 40 (e.g., via the power detection unit 42) may measure instantaneous forward power and instantaneous reflected power. Signals indicating these measurements may be transmitted to the processor 44 of the energy source device 40. The instantaneous power may be measured over the entire time interval Δt (and the entire treatment time period). The frequency at which the power detection unit 42 measures the instantaneous power may be configured and / or adjusted over the entire treatment time period.

[0115] Next, the energy source device 40 may determine one or more instantaneous received powers (step 85). For example, the energy source device 40 (e.g., via the processor 44) may determine the instantaneous received power value by subtracting the instantaneous reflected power from the instantaneous forward power. In some embodiments, the energy source device 40 may determine only one instantaneous received power in each time interval Δt. In some embodiments, the energy source device 40 may determine multiple instantaneous received powers in each time interval Δt.

[0116] Continue with Fig.10For example, the energy source device 40 may determine that the first instantaneous received power is 45W, the second instantaneous received power is 50W, and the third instantaneous received power is 55W within the first time interval Δt (1 millisecond). For example, within the first time interval Δt, the energy source device 40 may have measured three instantaneous forward powers and three instantaneous reflected powers. Next, the energy source device 40 may determine each corresponding instantaneous received power based on the difference between the instantaneous forward power and the corresponding instantaneous reflected power. For example, the instantaneous forward power measured for the first time may be 50W, and the corresponding instantaneous reflected power may be 5W. In this example, the energy source device 40 may determine that the first instantaneous received power is 45W by subtracting the reflected power (5W) from the forward power (50W).

[0117] In some embodiments, one or more instantaneous received powers may be determined based on other measured electrical parameters (eg, voltage, current, etc.) Descriptions of these embodiments are provided elsewhere herein.

[0118] The energy source device 40 may determine whether the instantaneous received power is within the normal operating range (step 86). For example, the energy source device 40 may be configured with a lower limit value and an upper limit value that define the boundaries of the normal operating range. The normal operating range may refer to a set of values ​​at which the energy source device 40 is determined to operate in a normal or expected state. In this case, the energy source device 40 may compare each corresponding instantaneous received power with the lower limit value and the upper limit value to determine whether the respective instantaneous received power is within the normal operating range. For example, if the energy source device 40 is not properly connected to the biological tissue or a short circuit occurs, the instantaneous received power will be zero. In this example, the energy source device 40 may determine that the instantaneous received power of zero is not within the normal operating range.

[0119] Although step 86 involves using instantaneous received power to determine whether the working condition is normal, it should be understood that this is only an example. In practice, the energy source device 40 may use other relevant electromagnetic energy transmission parameters to determine whether the working condition is normal, including VSWR parameters, return loss parameters, reflection coefficient parameters, etc.

[0120] If the instantaneous received power is not within the normal operating range, the energy source device 40 can terminate the treatment process, suspend the treatment process, issue an alarm to the operator (e.g., a doctor), and / or adjust one or more working conditions of the energy generator 41 (step 87). Adjusting the working conditions can be achieved by changing the state of the energy generator 41 and / or adjusting the drive value.

[0121] In some embodiments, the energy source device 40 can determine one or more operations to be performed based on the degree to which the instantaneous received power deviates from the normal operating range. For example, the energy source device 40 can refer to a data structure that associates specific operations (such as terminating the treatment process, pausing the treatment process, issuing an alarm to the operator, etc.) with a specific range of operating conditions. For example, if the instantaneous received power is zero, the energy source device 40 may only issue an alarm to the operator. However, if the instantaneous received power is extremely high, the energy source device 40 may pause or terminate the treatment process and then issue an alarm to the operator.

[0122] If the instantaneous received power is within the normal operating range, the energy source device 40 can determine the additional time period required to transmit the remaining electromagnetic energy within one PWM cycle T (step 88). In order to transmit suitable electromagnetic energy throughout the entire treatment time period, the energy source device 40 must transmit x amount of electromagnetic energy within each PWM cycle. That is, if the total amount of electromagnetic energy within the treatment time period is 1000mJ, and the treatment time period is divided into 10 PWM cycles, approximately 100mJ of electromagnetic energy should be transmitted in each PWM cycle (assuming that all other working conditions remain unchanged). However, in reality, working conditions and other factors are not constant. Therefore, at certain moments within a given PWM cycle T, the electromagnetic energy actually transmitted may be ahead of or behind the electromagnetic energy that should be transmitted at that moment. In order to solve this problem, the energy source device 40 may determine the remaining electromagnetic energy that needs to be transmitted within the PWM cycle T at a certain moment within the PWM cycle T, and further determine the additional time period required to transmit the remaining energy.

[0123] In some embodiments, the energy source device 40 can calculate the additional time period according to the following formula (3):

[0124] In formula (3), t1 represents the additional time period, E r represents the remaining electromagnetic energy that needs to be transmitted within a given PWM cycle T, and P represents the instantaneous received power. First, the energy source device 40 can determine the remaining electromagnetic energy E that needs to be transmitted within the PWM cycle T. r Since the electromagnetic energy has not yet been transmitted, this value is also equal to the total electromagnetic energy that needs to be transmitted within the PWM period T. Fig.10 For example, the energy source device 40 can determine the remaining electromagnetic energy Er at the beginning of the first time interval Δt by multiplying the PWM period T (10 milliseconds) by the preset value of the treatment energy (35 watts), and obtain 350 millijoules (mJ). Then, at the beginning of the first time interval Δt (1 millisecond), the energy source device 40 can use formula (3) to determine the additional time period t1, where the remaining electromagnetic energy Er The instantaneous received power P is 350 mJ and 45 W. The value of 45 W is the instantaneous received power value determined by the energy source device 40 at the beginning of the first time interval Δt. Based on these values, the energy source device 40 can determine that the additional time period t1 is 7.78 milliseconds (e.g., 350 mJ / 45 W).

[0125] Next, the energy source device 40 determines whether the additional time period t1 exceeds the PWM period T (step 89). Fig.10 For example, the extra time period is 7.78 milliseconds, and the PWM period T is 10 milliseconds. That is, the extra time period (7.78 milliseconds) does not exceed the PWM period T (10 milliseconds).

[0126] If the additional time period t1 exceeds the PWM period T, the energy source device 40 may terminate the treatment process, pause the treatment process, alert the device operator (e.g., a physician), and / or adjust one or more operating conditions of the energy generator 41 (step 87).

[0127] If the additional time period t1 does not exceed the PWM cycle T, the energy source device 40 may further determine whether the additional time period t1 exceeds the time interval Δt (step 90). If the additional time period t1 does not exceed the time interval Δt, the energy source device 40 may adjust the working condition by shutting down the energy generator 41 after the additional time period t1 ends (step 92). Since the additional time period t1 does not exceed the time interval Δt, the energy source device 40 may select the duration of the additional time period t1 as the time interval for transmitting the remaining electromagnetic energy E. r After the additional time period has elapsed, the energy source device 40 (e.g., using the processor 44) may instruct the energy generator 41 to shut down so that no power is delivered to the biological tissue. This may cause the energy source device 40 to switch from the PWM high time to the PWM low time (steps 92, 93, and Fig. 9 The energy generator 41 may remain in the off state until the PWM period T ends.

[0128] Next, the energy source device 40 can determine whether the treatment time period has ended (step 94). For example, the energy source device 40 can track the total time that the treatment process has been performed, and compare the total time that the treatment process has been performed with the treatment time period representing the total treatment time. If the total time that the treatment process has been performed exceeds the total time period, the energy source device 40 can end the treatment (step 95). If the total time that the treatment process has been performed does not exceed the treatment time period, the energy source device 40 can repeat steps 82-94 (for example, change the working conditions of the energy generator 41 to start the energy generator 41, as shown in step 82).

[0129] If the additional time period t1 exceeds the time interval Δt, the energy source device 40 may continue to transmit power until the time interval Δt ends (step 91). Since the additional time period t1 exceeds the time interval Δt, the energy source device 40 may select the duration of the time interval Δt as the duration for transmitting the remaining electromagnetic energy E r After transmitting power within the time interval Δt, the energy source device 40 can instruct the power detection unit 42 to measure the instantaneous power (step 84). This is very important because if the power transmission time exceeds the time interval Δt, the power variation of the instantaneous received power may exceed the threshold tolerance level. This increases the possibility that the transmitted power causes pain to the patient and increases the possibility of unacceptable power monitoring and / or calculation errors.

[0130] Although not described in the above steps, the energy source device 40 can determine the amount of electromagnetic energy actually transmitted during the first time interval Δt at the end of the first time interval. Fig.10 Taking the example in as an example, the energy source device 40 can multiply the instantaneous received power value 45W by the value of the first time interval Δt 1ms to determine that the amount of electromagnetic energy actually transmitted in the first time interval Δt is 45mJ.

[0131] It will be appreciated by those skilled in the art that, although a single instantaneous received power value of 45 W is used in this calculation, in other embodiments, an average value between multiple instantaneous received power values ​​may be considered. For example, in the first time interval Δt, the instantaneous received power values ​​determined by the energy source device 40 are 45 W, 50 W, and 55 W. If the average value of the instantaneous received power is used to determine the electromagnetic energy actually (or estimated) transmitted in the first time interval Δt, the energy source device 40 may multiply the average instantaneous received power value of 50 W by the value of 1 ms of the first time interval Δt to determine that the amount of electromagnetic energy actually (or estimated) transmitted in the first time interval is 50 mJ.

[0132] In the whole PWM period T, Fig.10 One or more steps in will be repeated. Fig.10 For example, during the second time interval Δt (1 millisecond), the energy source device 40 can determine a new instantaneous received power value of 60W at the beginning of the second time interval Δt. The energy source device 40 can also determine the remaining electromagnetic energy E to be transmitted within the PWM period T at the beginning of the second time interval Δt. r1 .according to Fig.10 In the example in FIG. 1 , the energy source device 40 can subtract the energy (45 mJ) transmitted in the first time interval from the total electromagnetic energy (350 mJ) in the PWM period T to determine the remaining electromagnetic energy E to be transmitted in the PWM period T.r1 305 mJ. Next, the energy source device 40 may determine that the additional time period t1 is 5.08 milliseconds (e.g., 305 mJ / 60 W). The energy source device 40 may determine that the additional time period 5.08 ms (t1) is greater than the duration of the second time interval Δt by 1 millisecond, so the energy source device 40 will continue to transmit power for a duration of 1 millisecond. During this period, the energy source device 40 will continue to measure the instantaneous power. At the end of the second time interval Δt, the energy source device 40 also determines two other instantaneous received power values, which are 70 W and 80 W, respectively.

[0133] The energy source device 40 may then determine the amount of power change between the three instantaneous received power values ​​determined within the second time interval Δt (eg, 60 W, 70 W, and 80 W). Figure 6 The formula discussed in P max –P min , the energy source device 40 determines that the power change is 20W. Subsequently, the energy source device 40 determines that the change in power change is 33.3% (for example, dividing the power change of 20W by 60W of Pmin). The energy source device 40 then compares the change in power change (33.3%) with the upper threshold tolerance level (25%). Since the power change (33.3%) exceeds the upper threshold tolerance level (25%), the energy source device 40 can shorten the duration of the time interval Δt from 1 millisecond to 0.5 milliseconds. The energy source device 40 can also determine the actual electromagnetic energy transmitted during the second time interval Δt (for example, 60W*1 millisecond=60mJ). This value 60mJ can be used for calculations performed during the third time interval Δt (now 0.5 milliseconds) to determine the remaining electromagnetic energy E that needs to be transmitted within the PWM period T. r2 .

[0134] In some embodiments, the duration of the PWM cycle T may be less than the duration of the time interval Δt. In this case, the calculated PWM switching time (power duty cycle) may not be changed for each PWM cycle T, and the calculated PWM power duty cycle may also be applicable to subsequent PWM cycles.

[0135] Reference now Fig.11 and Fig.12 , the energy source device 40 can use dynamic PWM with drive value control to transmit electromagnetic energy to the patient's biological tissue. Dynamic PWM involves changing the width or duration of the electrical pulses during treatment. In order to control the electromagnetic energy transmitted to the biological tissue (e.g., using drive value control), the energy source device 40 can adjust (e.g., increase or decrease) the drive value of the energy generator 41.

[0136] Fig.12 An example process of delivering electromagnetic energy to biological tissue using dynamic PWM with drive control is demonstrated. Fig.12 Additional details on one or more of the steps described in Fig.10 can be found in the description of the corresponding step.

[0137] The energy source device 40 may receive treatment configuration data (step 100). Fig.12 An example will be provided in the description of Fig.12 Example). In this example, the treatment configuration data includes: a PWM period T of 10 milliseconds, a treatment energy preset value of 35 watts, an upper threshold tolerance level of 0.25 (25%), a lower threshold tolerance level of 0.05 (5%), and an initial duration of each time interval Δt of 1 millisecond.

[0138] The energy source device 40 may select a set of time intervals to be used for the entire treatment period (step 101). Next, the energy source device 40 may turn on the energy generator 41 using a default power (step 102). When the energy source device 40 switches from the PWM low time to the PWM high time, the energy source device 40 may wait for the system to stabilize and may continue in steps 103 and 104. Fig.11 See this in .

[0139] The energy source device 40 can measure the instantaneous power level (step 104). For example, the energy source device 40 (e.g., using the power detection unit 42) can measure the instantaneous forward power and the instantaneous reflected power. The signals of these measurements are provided to the processor 44 of the energy source device 40. The instantaneous power can be measured periodically during the time interval Δt (as well as during the entire treatment period).

[0140] Next, the energy source device 40 may determine one or more instantaneous received powers (step 105). For example, the energy source device 40 (eg, using the processor 44) may determine the instantaneous received power by subtracting the instantaneous reflected power from the instantaneous forward power. Fig.12 In the example in , the energy source device 40 can determine during the first time interval Δt (1 millisecond) that the first instantaneous received power is 55 watts, the second instantaneous received power is 50 watts, and the third instantaneous received power is 45 watts.

[0141] The energy source device 40 can determine whether the instantaneous received power is within the normal operating range (step 106). If the instantaneous received power is not within the normal operating range, the energy source device 40 can terminate the treatment process, suspend the treatment process, issue an alarm to the device operator (such as a doctor), and / or adjust one or more working conditions of the energy generator 41 (step 107).

[0142] If the instantaneous received power is within the normal operating range, the energy source device 40 can determine the additional time period required to transmit the remaining electromagnetic energy within one PWM cycle T (step 108). Fig.10 The additional time period is determined using Formula 3. Fig.12 For example, the energy source device 40 can determine the remaining electromagnetic energy E at the beginning of the first time interval Δt by multiplying the PWM period T (10 milliseconds) by the preset value of the treatment energy (35 watts). r , and thus calculate the remaining electromagnetic energy E r Next, at the beginning of the first time interval Δt (1 millisecond), the energy source device 40 can use Formula 3 to determine the additional time period t1, where the remaining energy E r is 350 mJ, and the instantaneous received power P is 55 W. The value of 55 W represents the instantaneous received power value determined at the beginning of the first time interval Δt. Using these values, the energy source device 40 can determine that the additional time period t1 is 6.36 milliseconds (e.g., 350 mJ / s). 55 watts).

[0143] The energy source device 40 may determine whether the additional time period t1 exceeds the PWM period T (step 109). Fig.12 In the example in FIG. 1 , the additional time period t1 is 6.36 milliseconds, while the PWM period T is 10 milliseconds. That is, the additional time period t1 does not exceed the PWM period T. If the additional time period t1 exceeds the PWM period T, the energy source device 40 may determine whether the maximum drive value of the electromagnetic energy generator 41 has been reached (step 116). If the maximum drive value has been reached, the energy source device 40 may continue to transmit power until the end of the PWM period T (step 118) and / or maintain power transmission during the time interval Δt (step 111).

[0144] After the PWM period T ends, the energy source device 40 may terminate the treatment process, pause the treatment process, alert the device operator (e.g., a physician), and / or adjust one or more operating conditions of the energy generator 41 (step 119). If the maximum drive value of the electromagnetic energy generator 41 has not been reached, the energy source device 40 may increase the drive value, as in steps 117 and Fig.11 As shown in Figure B. Next, the energy source device 40 will repeat step 103 (for example, using PID control technology or similar technology). If the additional time period t1 does not exceed the PWM period T, the energy source device 40 can determine whether the additional time period t1 exceeds the time interval Δt (step 110).

[0145] In some embodiments, if the additional time period t1 exceeds the time interval Δt, the energy source device 40 may allow power to be transmitted within the time interval Δt (step 111) and instruct the power detection unit 42 to continue measuring the instantaneous power level (step 104). In addition, or as an alternative, if the additional time period t1 exceeds the time interval Δt, the energy source device 40 may determine whether the maximum drive value of the electromagnetic energy generator 41 has been reached (step 116). If the maximum drive value of the electromagnetic energy generator 41 has been reached, the energy source device 40 may maintain power transmission within the time interval Δt (step 111), and then the energy source device 40 may instruct the power detection unit 42 to continue measuring the instantaneous power level (step 104). If the maximum drive value of the electromagnetic energy generator 41 has not been reached, the energy source device 40 may increase the drive value (step 117) and repeat step 103.

[0146] If the additional time period t1 does not exceed the time interval Δt, the energy source device 40 may terminate the power transmission of the electromagnetic energy generator 41 immediately after the additional time period t1 ends. This may cause the energy source device 40 to switch from the PWM high time to the PWM low time, as shown in steps 112, 113, and Fig.11 As shown in Figure A of FIG. The energy source device 40 can also track the total time of the treatment process performed, and compare the total time of the treatment process performed with the treatment time period (identifying the total treatment time) (step 114). If the total time of the treatment process performed exceeds the treatment time period, the energy source device 40 can end the treatment (step 115). If the total time of the treatment process performed does not exceed the treatment time period, the energy source device 40 can repeat steps 102-114 (for example, changing the working conditions of the energy generator 41 to start the energy generator 41, as shown in step 102).

[0147] In another embodiment, if the additional time period t1 exceeds the time interval Δt, the energy source device 40 may allow power to be transmitted for the continuous time Δt (step 111), and then the energy source device 40 may instruct the power detection unit 42 to obtain the instantaneous received power again (step 104). Comparing t1 with the time interval Δt is crucial, because once the continuous power transmission time exceeds the time interval Δt, the change in the instantaneous received power may exceed the tolerance, and if the power calculation continues to use the value obtained before Δt, it may cause unacceptable power monitoring or calculation errors.

[0148] exist Fig.12 One or more of the steps shown in will be repeated throughout the PWM period T. Fig.12For example, during the second time interval Δt of 1 millisecond, the energy source device 40 can determine a new instantaneous received power value of 25 watts (W) at the beginning of the second time interval Δt. The energy source device 40 can also determine the remaining electromagnetic energy E to be transmitted within the PWM period T at the beginning of the second time interval Δt. r1 . Reference Fig.10 For example, the energy source device 40 can subtract the energy transmitted during the first time interval (55 mJ) from the total electromagnetic energy transmission value (350 mJ) of the PWM period T, thereby determining the remaining electromagnetic energy E that needs to be transmitted within the PWM period T. r1 is 295mJ. Next, the energy source device 40 can use the formula to calculate that the additional time period t1 is 11.8 milliseconds (for example, 295mJ / 25W). The energy source device 40 can determine that the additional time period t1 (11.8 milliseconds) is greater than the PWM period T (10 milliseconds). That is, even if the power duty cycle is 100%, the transmitted power is still insufficient to meet the energy specified by the preset value of the therapeutic energy. In order to solve this problem, the energy source device 40 can increase the drive value of the energy generator 41 so that the energy generator 41 outputs a higher power value. Energy transmission can continue for a duration of 1 millisecond, and at the same time, the energy source device 40 will continue to determine the instantaneous received power value.

[0149] As the second time interval Δt approaches the end, the energy source device 40 may determine the power variation between the three instantaneous received power values ​​determined within the second time interval Δt (eg, 25 watts, 23 watts, and 21 watts). Figure 6 P max –P min The energy source device 40 determines that the power change is 4 watts. Next, the energy source device 40 calculates that the power change is 19% (for example, by dividing the power change of 4 watts by P min The energy source device 40 then compares the change in the amount of power variation (19%) with the upper threshold tolerance level (25%). Since the change in the amount of power variation (19%) is between the upper threshold tolerance level (25%) and the lower threshold tolerance level (5%), the energy source device 40 can maintain the same time interval duration (e.g., 1 millisecond). In addition, the energy source device 40 can also determine the actual electromagnetic energy transmitted during the second time interval Δt (e.g., 25 watts*1 millisecond=25 millijoules). This value of 25 millijoules can be used in the calculation of the third time interval Δt to determine the remaining electromagnetic energy E that needs to be transmitted within the entire PWM period T. r2 .

[0150] Reference now Fig.13 and Fig.14 The energy source device 40 can use dynamic amplitude modulation to transmit electromagnetic energy to the biological tissue of the patient. The amplitude modulation can be achieved by adjusting one or more working conditions, such as by adjusting the driving value of the energy generator 41.

[0151] The energy source device 40 may receive the treatment configuration data (step 120). The energy source device 40 may select a set of time intervals to be used throughout the treatment period (step 121). Next, the energy source device 40 may turn on the energy generator 41 using the configured power level (step 122). When the energy source device 40 switches from the PWM low time to the PWM high time, the energy source device 40 may wait for the system to stabilize, which may be performed in steps 123 and 124. Fig.13 Seen in.

[0152] The energy source device 40 can measure the instantaneous power (step 124). For example, the energy source device 40 (e.g., through the power detection unit 42) can measure the instantaneous forward power and the instantaneous reflected power. These measured signals can be provided to the processor 44 of the energy source device 40. The instantaneous power can be measured periodically within the time interval Δt (and the entire treatment time period).

[0153] Next, the energy source device 40 may determine one or more instantaneous received powers (step 125). For example, the energy source device 40 (e.g., via the processor 44) may determine the instantaneous received power by subtracting the instantaneous reflected power from the instantaneous forward power. The energy source device 40 may determine whether the instantaneous received power is within a normal operating range (step 126).

[0154] If the parameter is not within the normal range, the energy source device 40 may terminate or suspend the treatment and alert the doctor or device operator to take appropriate measures. The energy source device 40 can also reduce the power duty cycle to below 40%, more preferably below 20%, more preferably below 10%, and most preferably below 5% (step 127). Otherwise, the energy source device 40 will continue to check whether the treatment time period has ended (step 128). If so, the energy source device 40 can end the treatment (step 129). If not, the energy source device 40 will determine whether the instantaneous received power exceeds the preset value of the treatment energy (step 130).

[0155] If the instantaneous received power is equal to the preset value of the treatment energy, the energy source device 40 may not adjust the driving value of the energy generator 41, but continue to execute step 124 after the time interval Δt ends (not in Fig.13If the instantaneous received power is greater than the preset value of the therapeutic energy, the energy source device 40 checks whether the driving value of the energy generator 41 has reached its minimum setting (step 131). If not, the energy source device 40 may maintain power transmission until the time interval Δt ends (step 133).

[0156] The energy source device 40 may then reduce the drive value of the energy generator 41 (step 134) and wait for the system to stabilize before taking the next instantaneous forward power and reflected power measurement (step 123). If the drive value has reached its minimum setting, the energy source device 40 may terminate or suspend treatment and alert the physician or device operator to take appropriate action. The energy source device 40 may also reduce the power duty cycle to below 40%, more preferably below 20%, more preferably below 10%, and most preferably below 5% (step 132). If the instantaneous received power is less than the preset value of the therapeutic energy, the energy source device 40 will check whether the drive value of the energy generator 41 has reached its maximum setting (step 135). If not, the energy source device 40 may maintain power transmission until the end of the time interval Δt (step 136).

[0157] The energy source device 40 may then increase the drive value of the energy generator 41 (step 137) and wait for the system to stabilize (step 123) before taking the next instantaneous forward power and reflected power measurement (step 124). If the drive value has reached its maximum setting, the energy source device 40 may terminate or pause the treatment and alert the physician or device operator to take appropriate action. The energy source device 40 may also reduce the power duty cycle to less than 40%, more preferably less than 20%, more preferably less than 10%, and most preferably less than 5% (step 138).

[0158] Without being bound by theory, during a treatment process, the processor 44 may control the energy source device 40 to provide energy substantially equal to a preset value of the treatment energy by switching between different control states of the energy generator 41, wherein the different control states include: dynamic pulse width modulation (dPWM) without controlling the drive value of the energy generator 41, dynamic pulse width modulation (dPWM) with controlling the drive value of the energy generator 41, and dynamic amplitude modulation (dAM).

[0159] In certain embodiments, such as Fig.12 and Fig.14As shown, the energy source device 40 can use a proportional integral differential (PID) control algorithm to increase or decrease the drive value of the energy generator 41 to achieve the following goals: 1) make the instantaneous received power converge to the preset value of the treatment energy faster; 2) minimize the overshoot or deviation of the instantaneous received power relative to the preset value of the treatment energy. In particular, the PID control program can be included in the processor 44. The processor 44 can dynamically adjust the values ​​of key PID control parameters, including Kp, Ki, and Kd, to achieve rapid convergence to the preset value of the treatment energy and minimize the overshoot or deviation of the instantaneous received power relative to the preset value of the treatment energy. According to other embodiments of the present invention, other control algorithms known to ordinary technicians in this field can be used to accelerate the convergence of the instantaneous received power to the preset value of the treatment energy and minimize the overshoot or deviation of the instantaneous received power relative to the preset value of the treatment energy.

[0160] The above disclosure provides exemplary descriptions, but is not intended to be exhaustive of all possibilities or to limit the embodiments to the precise forms disclosed. Modifications and changes may be made in light of the above disclosure or through practice of implementing these embodiments.

[0161] As used herein, the term "component" should be broadly construed to mean hardware, firmware, and / or a combination of hardware and software.

[0162] Certain user interfaces are described herein. User interfaces may include graphical user interfaces, non-graphical user interfaces, text-based user interfaces, and the like. User interfaces may provide information for display. In some embodiments, a user may interact with the information, such as by providing input through an input component of a device, which provides a user interface for display. In some embodiments, the user interface may be configured by the device and / or the user (e.g., the user may change the size of the user interface, the information provided through the user interface, the location of the information on the user interface, and the like). In addition, or as an alternative, the user interface may be preconfigured as a standard configuration, a specific configuration, and / or a set of configurations based on device capabilities and / or specifications, depending on the type of device displaying the user interface.

[0163] It will be apparent that the systems and / or methods described herein can be implemented in hardware, firmware, and / or a combination of hardware and software. The actual dedicated control hardware or software code used to implement these systems and / or methods does not limit these embodiments. Therefore, the description of the operation and behavior of the systems and / or methods herein does not reference specific software code - it is understood that based on the description herein, software and hardware can be used to implement these systems and / or methods.

[0164] Unless explicitly described as critical or essential, any element, behavior or instruction used in this article should not be interpreted as critical or essential. In addition, the articles "a" and "an" used in this article are intended to include one or more items and can be used interchangeably with "one or more". In addition, the term "set" used in this article is intended to include one or more items (e.g., related items, unrelated items, combinations of related and unrelated items, etc.), and can be used interchangeably with "one or more". If only one item is referred to, "only one" or similar language will be used. In addition, the terms "has", "have", "having" or similar terms used in this article are intended to be open terms. In addition, the phrase "based on" is intended to mean "based at least in part on", unless otherwise explicitly stated.

Claims

1. A method for transmitting electromagnetic energy to biological tissue by an energy source device to treat the biological tissue, comprising: generating electromagnetic energy using an energy generator under one or more operating conditions to transmit electromagnetic energy to the biological tissue; transmitting the electromagnetic energy to the biological tissue by the energy source device during a treatment period, wherein the treatment period includes a plurality of time intervals; determining one or more instantaneous received powers based on the measured electrical parameters while transmitting a portion of the electromagnetic energy during one of the plurality of time intervals; determining a power change amount based on the one or more instantaneous received powers at least once within the time interval; updating a duration of one or more of the plurality of time intervals based on determining that the change in the amount of power change satisfies a threshold tolerance level; and Within the time interval, at least one of the one or more working conditions of the energy generator is adjusted, wherein at least one of the one or more working conditions is adjusted so that the electromagnetic energy transmitted to the biological tissue is equal to or approximately equal to the electromagnetic energy determined by a preset value of the therapeutic energy.

2. The method of claim 1, wherein: Determining an instantaneous received power of the one or more instantaneous received powers includes: The instantaneous received power is determined based on the difference between the measured instantaneous forward power and the instantaneous reflected power.

3. The method of claim 1, wherein: The one or more instantaneous received powers include a plurality of instantaneous received powers, and wherein determining the power change amount includes: The power change amount is determined based on a difference between a maximum instantaneous received power and a minimum instantaneous received power among the plurality of instantaneous received powers.

4. The method of claim 1, wherein: The one or more instantaneous received powers include a single instantaneous received power determined only within the time interval, and wherein determining the power change amount includes: The power change amount is determined based on a difference between a single instantaneous received power determined within the time interval and an instantaneous received power determined within a previous time interval.

5. The method of claim 1, wherein: The threshold tolerance level is an upper threshold tolerance level; and wherein updating the duration of the one or more time intervals comprises: Based on determining that the change in the amount of power change exceeds the upper threshold tolerance level, the duration of the one or more time intervals is reduced.

6. The method of claim 1, wherein: The threshold tolerance level is a lower threshold tolerance level; and wherein updating the duration of the one or more time intervals comprises: Based on determining that the change in the amount of power change is less than the lower threshold tolerance level, the duration of the one or more time intervals is increased.

7. The method of claim 1, wherein the treatment period is further defined by a set of pulse width modulation (PWM) cycles; and the method further comprises: At the beginning of a first time interval of the plurality of time intervals, determining a remaining electromagnetic energy to be transmitted in a first PWM cycle of the PWM cycle group; determining an additional time period required to transfer the remaining electromagnetic energy within the first PWM cycle; comparing the duration of the additional time period to the duration of an upcoming time interval in the plurality of time intervals; selecting a time period for transmitting remaining electromagnetic energy within the first PWM cycle based on comparing the duration of the additional time period to the duration of the upcoming time interval; and Adjusting one or more working conditions includes: One of the one or more operating conditions is adjusted so that the energy generator transmits the remaining electromagnetic energy in the first PWM cycle during the selected time period.

8. The method of claim 7, wherein: Selecting a time period for transmitting the remaining electromagnetic energy within the first PWM cycle includes: selecting the additional time period based on a determination that the duration of the additional time period does not exceed the duration of the upcoming time interval; or Based on determining that the duration of the additional time period exceeds the duration of the upcoming time interval, the upcoming time interval is selected.

9. The method of claim 7, wherein: Determining the additional time period required to transmit the remaining electromagnetic energy within the first PWM cycle includes: The additional time period is determined using the following formula: Among them, t1 is the additional time period, E r is the remaining electromagnetic energy that needs to be transmitted within the first PWM period, and P is based on one or more instantaneous received powers.

10. The method of claim 1, wherein: The one or more working conditions include at least one of the following: The state of the energy generator of the energy source device; or The driving value of the energy generator.

11. The method of claim 1, wherein: The duration of each of the one or more time intervals is between 1 nanosecond (ns) and 10 seconds (s), preferably between 100 microseconds (μs) and 10 milliseconds (ms).

12. The method of claim 1, further comprising: determining that the one or more instantaneous received powers are not within a normal operating range; and Performing one or more actions based on determining that the one or more instantaneous received powers are not within a normal operating range, wherein the one or more actions include at least one of the following: Pause the treatment process; Termination of the course of treatment; Adjusting one of the one or more operating conditions to reduce the transmitted electromagnetic energy by at least 60%; or An alarm signal is generated and transmitted indicating that the energy source device is not operating under normal operating conditions.

13. An energy source device for treating biological tissue, the energy source device comprising: an energy generator configured to generate electromagnetic energy and to operate under one or more operating conditions to deliver electromagnetic energy to biological tissue; a power detection unit configured to measure instantaneous power; an electromagnetic energy transmission unit configured to convert the electromagnetic energy into an energy form suitable for treating the biological tissue; and A processor configured to: instructing the energy generator to generate electromagnetic energy to be transmitted to the biological tissue over a treatment period including a plurality of time intervals; determining one or more instantaneous received powers based on the measured electrical parameters while transmitting a portion of the electromagnetic energy during one of the plurality of time intervals; determining a power change amount based on the one or more instantaneous received powers at least once within the time interval; updating a duration of one or more of the plurality of time intervals based on determining that the change in the amount of power change satisfies a threshold tolerance level; and Within the time interval, at least one of the one or more working conditions of the energy generator is adjusted, wherein at least one of the one or more working conditions is adjusted so that the electromagnetic energy transmitted to the biological tissue is equal to or approximately equal to the electromagnetic energy determined by a preset value of the therapeutic energy.

14. The energy source device according to claim 13, wherein: When determining an instantaneous received power of the one or more instantaneous received powers, the processor is configured to: The instantaneous received power is determined based on the difference between the measured instantaneous forward power and the instantaneous reflected power.

15. The energy source device according to claim 13, wherein: The threshold tolerance level is an upper threshold tolerance level; and wherein the processor, when updating the duration of the one or more time intervals, is configured to: Based on determining that the change in the amount of power change exceeds an upper threshold tolerance level, a duration of the one or more time intervals is reduced.

16. The energy source device according to claim 13, wherein: The threshold tolerance level is a lower threshold tolerance level; and wherein the processor, when updating the duration of the one or more time intervals, is configured to: Based on determining that the change in the amount of power change is less than a lower threshold tolerance level, the duration of the one or more time intervals is increased.

17. The energy source device as claimed in claim 13, wherein: The treatment time period is further defined as a plurality of pulse width modulation (PWM) cycles; and wherein the processor is further configured to: At the beginning of a first time interval of the plurality of time intervals, determining a remaining electromagnetic energy to be transmitted in a first PWM cycle of the PWM cycle group; determining an additional time period required to transfer the remaining electromagnetic energy within the first PWM cycle; comparing the duration of the additional time period to the duration of an upcoming time interval in the plurality of time intervals; selecting a time period for transmitting remaining electromagnetic energy within the first PWM cycle based on comparing the duration of the additional time period to the duration of the upcoming time interval; and Adjusting one or more working conditions includes: One of the one or more operating conditions is adjusted so that the energy generator transmits the remaining electromagnetic energy in the first PWM cycle during the selected time period.

18. The energy source device according to claim 13, wherein: The one or more working conditions include at least one of the following: The state of the energy generator of the energy source device; or The driving value of the energy generator.

19. The energy source device according to claim 13, wherein: The processor is also configured to: determining that one or more instantaneous received powers are not within a normal operating range; and Based on determining that the plurality of instantaneous received powers are not within a normal operating range, one or more operations are performed.

20. The energy source device according to claim 13, wherein: The power detection unit includes two directional couplers or one bidirectional coupler.

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