CN115804628B - Medical device and control method thereof, IVL system and energy regulation system - Google Patents

Abstract

The invention discloses a medical device, a control method thereof, an IVL system and an energy adjusting system. Wherein the medical device comprises: a balloon, an energy adjustment device, and an electrode pair disposed within the balloon; the energy adjusting device is used for responding to the energy adjusting requirement of the sacculus in an access state and/or a removal state, the energy adjusting device comprises an electric pulse generating unit, a control unit and an adjusting part, the adjusting part is connected with the control unit, the control unit is connected with the control end of the electric pulse generating unit, the output end of the electric pulse generating unit is connected with the electrode pair, the adjusting part is used for sending an energy adjusting signal according to the energy adjusting requirement, the control unit is used for receiving the energy adjusting signal, and the pulse width and/or the pulse amplitude of a high-voltage electric pulse sent by the electric pulse generating unit are adjusted according to the energy adjusting signal, so that shock waves with proper energy values are generated by the electrode pair to act on calcified tissues, and meanwhile damage or influence on an intravascular membrane caused by too high or too low shock wave energy is reduced.

Description

Medical device and control method thereof, IVL system and energy regulation system

Technical field

The present invention relates to the technical field of medical devices, and in particular, to a medical device and its control method, IVL system, and energy regulation system.

Background technique

Intravascular lithotripsy (IVL) is a new technology for the clinical treatment of arterial calcified lesions. At present, to implement IVL technology, it is necessary to connect the shock wave pulse power supply to the balloon. The shock wave pulse power supply outputs intermittent high-voltage excitation high-voltage electric pulses, which act on the micro-high-voltage discharge device in the balloon. Under the excitation of the high-voltage electric pulses, the ball The electrodes built into the balloon discharge at high voltage in a short period of time, causing part of the mixed solution of normal saline and contrast agent in the balloon to be instantly vaporized, generating non-focused, circumferential pulse sound pressure waves. When the sound pressure waves pass through different media Its effect is positively related to the density of the medium. Solid calcified diseased tissue is the target tissue for shock waves, and its density is much greater than that of normal tissue. Acoustic pressure waves mainly selectively act on solid calcified substances that cause arterial vascular lesions, while It penetrates soft tissues such as blood vessels and muscles of the human body, which are less dense than normal saline, with almost no damage without being absorbed, allowing the calcified material in the target tissue to rupture and loosen the calcified material in the target tissue through the impact of the shock wave.

However, the existing IVL system can only output pulse waves with fixed pulse width and fixed voltage amplitude, that is, it outputs pulse waves with fixed energy. In some patients, the energy is too high, which can cause potential damage to the lining of blood vessels and affect postoperative recovery. If the energy is too low, the fragmentation effect of calcified lesions will not be obvious, which will affect the therapeutic effect. In high-voltage narrow pulse applications, there are generally two ways to adjust the energy of the pulse: adjusting the pulse amplitude and adjusting the pulse width. 1. Adjust the pulse amplitude: When the shock wave balloon structure is fixed, the higher the pulse amplitude, the greater the current that passes through, and the corresponding selection range of high-current and high-voltage power devices becomes narrower, and there are no suitable devices to choose from. 2. Pulse width adjustment: The appropriate shock wave pulse width range is about 0.3us ~ 2us, and the time is very short. If continuous adjustment is performed within this time range, the speed of most logic and analog devices cannot be reached, and it is difficult to implement the program and algorithm. , that is, it is difficult for the control chip to accurately adjust the pulse width within a suitable shock wave pulse width range.

Contents of the invention

The present invention provides a medical device and its control method, IVL system and energy adjustment system to realize pulse shock waves with adjustable output energy, so as to avoid damage or impact caused by high or low shock wave energy acting on target tissues. .

According to one aspect of the present invention, a medical device is provided. The medical device includes:

balloon,

Energy regulating device, the energy regulating device includes an electrical pulse generating unit, a control unit and a regulating component, the regulating component is connected to the control unit, the control unit is connected to the control end of the electrical pulse generating unit, and the output end of the electrical pulse generating unit is connected to the electrode pair;

The energy adjustment device is configured to respond to the energy adjustment demand of the balloon in the insertion state and/or removal state, and the adjustment component sends an energy adjustment signal according to the energy adjustment demand for output to the control unit, and the control unit responds to the received energy. The adjustment signal controls the pulse width and/or pulse amplitude of the high-voltage electric pulse emitted by the electric pulse generating unit,

as well as,

The electrode pair is arranged in the balloon. The high-voltage electric pulse output by the energy adjustment device generates shock waves in the balloon through the electrode pair and acts on the target tissue.

Optionally, the control unit is configured to adjust the electrical pulse generating unit to emit a shock wave with a pulse amplitude that satisfies the preset amplitude interval according to the voltage value of the electrical pulse generating unit and the target voltage amplitude corresponding to the energy adjustment signal. The target voltage amplitude corresponding to the signal adjusts the pulse amplitude emitted by the electrical pulse generating unit to make it equal to or close to the target voltage amplitude, or to maintain the error range between the pulse amplitude and the target pulse amplitude within a certain range. Within, preferably, such as ±5%, etc.

When the difference between the pulse amplitude corresponding to the voltage value of the electrical pulse generating unit and the target voltage amplitude corresponding to the energy adjustment signal exceeds the error range, preferably, such as ±5%, etc., the adjustment component adjusts the target voltage amplitude according to the target voltage amplitude and the current voltage. The difference in value sends an energy adjustment signal, and the control unit is used to receive the energy adjustment signal to adjust the electric pulse generating unit to send out a high-voltage electric pulse with a pulse amplitude that meets the preset amplitude range to act on the electrode pair, in the balloon A shock wave is generated to act on the target tissue, wherein the amplitude of the preset amplitude range at least includes the target voltage amplitude.

Optionally, the control unit is configured to determine the effective shock wave duration that has been generated based on the current response delay duration and current collection duration of the current signal of the electrical pulse generating unit, and the duration of the target pulse width corresponding to the energy adjustment signal, Determine the duration of the pulse output of the electrical pulse generating unit, and issue a pulse instruction to the electrical pulse generating unit according to the calculated duration of the pulse output. The control unit uses the pulse instruction to adjust the electrical pulse generating unit to send out pulses that meet the preset pulse width range. A shock wave with a width, wherein the pulse width of the preset pulse width interval range at least includes the duration of the pulse output.

Optionally, the medical device further includes a detection unit, the first end of the detection unit is connected to the detection end of the electrical pulse generation unit, the second end of the detection unit is connected to the control unit, and the detection unit is configured to collect the current electrical pulse generation unit. The control unit is used to receive the current signal and obtain the shock wave occurrence time based on the current signal.

Optionally, adjusting the electrical pulse generating unit to emit high-voltage electrical pulses with a pulse amplitude that satisfies the preset amplitude range or a high-voltage electrical pulse with a pulse amplitude corresponding to the target energy value includes: when the voltage of the electrical pulse generating unit When the pulse amplitude corresponding to the value does not meet the target voltage amplitude corresponding to the energy adjustment signal, the adjustment component sends out an energy adjustment signal based on the difference between the target voltage amplitude and the current voltage value. The control unit is used to receive the energy adjustment signal to adjust the power supply. The pulse generating unit emits a high-voltage electric pulse with a pulse amplitude that meets the preset amplitude range, acts on the electrode pair, and generates a shock wave in the balloon that acts on the target tissue.

Optionally, adjusting the electrical pulse generating unit through the pulse command to send out high-voltage electrical pulses with a pulse width that meets the preset pulse width interval range includes: collecting the current signal of the electrical pulse generating unit, when the current value of the electrical pulse generating unit is greater than the preset When setting the current threshold, determine the shock wave duration threshold corresponding to the current signal. The duration threshold includes the current collection duration and the current response delay duration;

When the difference between the duration of the target pulse width corresponding to the energy adjustment signal and the duration threshold meets the preset difference value, the control unit controls the electrical pulse generating unit to issue a pulse command, and adjusts the electrical pulse generating unit to issue a pulse that satisfies the preset pulse width interval. A wide high-voltage electrical pulse acts on the electrode pair, generating a shock wave in the balloon and acting on the target tissue.

The preset difference value includes a preset difference range, and/or the preset difference value includes a preset ratio range.

Optionally, the control unit is configured to, when the detection unit collects the current signal, cut off the power supply of the electrical pulse generating unit according to the pulse width adjustment requirement corresponding to the energy adjustment requirement set by the adjustment component. The pulse signal generated by the pulse generating unit.

Optionally, the control unit includes at least one of MCU, DSP, and FPGA; and/or the medical device further includes an inverter boost unit and a power supply unit, and the power supply unit passes the input of the inverter boost unit and the electrical pulse generating unit. terminal connection, the inverter boost unit is used to increase the low voltage output by the power supply unit to high voltage, and the voltage of the pulse output by the electric pulse generating unit is greater than 700V.

Optionally, the device also includes an inverter boost unit, the output end of the inverter boost unit is electrically connected to the input end of the electrical pulse generating unit, the control unit is electrically connected to the control end of the inverter boost unit, and the control unit is used to When the pulse amplitude needs to be adjusted, the inverter boost unit is controlled to adjust the pulse amplitude.

Optionally, the control unit is configured to cut off the pulse signal generated by the electrical pulse generating unit according to the pulse width requirement or energy adjustment requirement corresponding to the target energy shock wave set by the adjusting component when the detection unit collects the current signal.

Optionally, the adjustment component includes at least one of a touch screen, a button, a potentiometer, and an encoder; or the medical device further includes a handle and a host, and the adjustment component includes at least one of a touch screen, a button, a potentiometer, and an encoder, The adjusting component is set on the handle or the main unit;

Among them, the keys include an energy increase key and an energy decrease key, and the energy increase key or the energy decrease key realizes segmented adjustment of the adjusting component; or the potentiometer or encoder includes a knob, and the knob realizes stepless adjustment of the adjusting component; or the touch screen Including energy segmented adjustment buttons or energy stepless adjustment buttons.

Optionally, the medical device includes a voltage dividing unit, one end of the voltage dividing unit is electrically connected to the output end of the electric pulse generating unit, and the other end of the voltage dividing unit serves as an output end and is connected to the electrode pair provided in the balloon for output. The pulse width and/or pulse amplitude of the balloon in the continuous breakdown state after partial pressure and/or current limiting enable the balloon to receive low-energy shock waves in the continuous breakdown state.

According to another aspect of the present invention, a control method for a medical device is provided, which is used to adjust the shock wave energy generated by a pair of electrodes built into a balloon under the excitation of a high-voltage electric pulse output by an electric pulse generating unit. For the medical device according to any embodiment of the present invention, the control method includes:

Adjust the regulating component, the regulating component is used to send out the energy regulating signal;

The control unit receives the energy adjustment signal and adjusts the pulse width and/or pulse amplitude of the high-voltage electric pulse emitted by the electric pulse generating unit according to the energy adjustment signal;

Under the control of the control unit, the electrode pair controls the high-voltage electric pulse emitted by the electric pulse generating unit to generate a shock wave in the balloon, and the shock wave acts on the target tissue.

Optionally, before adjusting the adjustment component, the method further includes:

Determine the energy value of the shock wave generated in the previous balloon according to the voltage value and/or current value of the high-voltage electrical pulse output by the previous electrical pulse generating unit;

Determine whether the energy value of the previous shock wave is consistent with the energy value corresponding to the preset energy adjustment signal. If they are inconsistent, adjust the adjustment component; and,

After the step of sending the energy adjustment signal by the adjusting component, it may also include:

Detect and control the voltage value of this electrical pulse generating unit, detect the current value of this electrical pulse generating unit, and adjust the output pulse width.

Optionally, the step of adjusting the pulse width and/or pulse amplitude of the shock wave emitted by the electrical pulse generating unit according to the energy adjustment signal includes:

Determine the target energy value according to the energy adjustment signal, and adjust the pulse width according to the first ratio according to the target energy value;

Determine the target energy value according to the energy adjustment signal, and adjust the pulse amplitude according to the second ratio according to the target energy value;

Wherein, the pulse width adjusted according to the first ratio and the pulse amplitude adjusted according to the second ratio, the energy of the high-voltage electric pulse emitted is equal to the target energy value.

Wherein, the energy value of the pulse width adjusted according to the first ratio and the energy value of the pulse amplitude adjusted according to the second ratio can both act on the electrode pair built in the balloon to generate a shock wave that meets the target energy value.

According to another aspect of the present invention, an IVL system is provided, including a balloon. Under the action of high-voltage electric pulses, the balloon is capable of breakdown discharge and generates shock waves that act on the electrode pairs built into the balloon. The IVL system An energy adjustment device is also provided, which responds to the energy adjustment requirements of the balloon in the insertion state and/or removal state, and the energy adjustment device includes an electrical pulse generation unit, a control unit and an adjustment component;

In the working state, the regulating component is configured to obtain the pulse width and/or pulse amplitude of the high-voltage electric pulse emitted by the electric pulse generating unit according to the energy regulation demand and adjusted by the control unit. The high-voltage electric pulse acts on the electrode pair, in the ball. A shock wave is generated within the capsule and acts on the target tissue.

Optionally, the IVL system also includes: a detection unit, the first end of the detection unit is connected to the detection end of the electrical pulse generation unit, the second end of the detection unit is connected to the control unit, the detection unit is used to collect the current of the electrical pulse generation unit signal, the control unit is used to receive the current signal and obtain the moment when the shock wave occurs, and the control unit is used to adjust the target pulse width corresponding to the signal according to the duration of the energy adjustment signal, determine the duration of the pulse output of the electrical pulse generation unit, and send the signal to the pulse generator according to the duration of the pulse output. The electrical pulse generating unit issues pulse instructions to adjust the pulse width.

Optionally, the IVL system also includes: an inverter boost unit and a power supply unit. The power supply unit is connected to the input end of the electrical pulse generating unit through the inverter boost unit. The inverter boost unit is used to boost the low voltage output by the power supply unit. to high pressure.

According to another aspect of the present invention, a shock wave energy adjustment system is provided, which is characterized in that the system includes: a shock wave sending module and a shock wave receiving module, an energy adjustment device,

Among them, one end of the energy adjustment device is connected to the shock wave emitting module, and the other end is connected to the shock wave receiving module. The energy adjustment device is used to monitor the energy adjustment needs of the shock wave receiving module, determine the energy adjustment signal of the energy adjustment device, and adjust the shock wave emission according to the energy adjustment signal. The shock wave energy of the module acts on the shock wave receiving module.

The technical solution of the embodiment of the present invention is to adjust the adjustment component, which sends out an energy adjustment signal. After the control unit receives the energy adjustment signal, it adjusts the pulse width and/or pulse amplitude of the shock wave emitted by the electric pulse generating unit according to the energy adjustment signal. , thereby adjusting the energy of the pulse wave output by the energy adjustment device, and thereby adjusting the energy of the shock wave generated by the electrode pair. Therefore, during treatment, the pulse width and/or pulse amplitude of the high-voltage electric pulse can be adjusted according to actual needs to adjust the energy generated by the electrode pair to avoid the low energy of the shock wave generated by the electrode pair, resulting in poor therapeutic effect. problem; it can also avoid the problem that the shock wave generated by the electrode pair has high energy and causes damage to the patient's vascular intima, thereby realizing a pulse shock wave with adjustable output energy and reducing the damage to the patient's vascular intima due to excessive shock wave energy. damage.

In addition, compared with directly adjusting the voltage value of the pulse wave according to the required voltage amplitude, this embodiment can adjust the voltage amplitude and/or pulse width by generating an adjustable energy adjustment signal according to the actual energy adjustment demand. The shock wave outputting appropriate energy value acts on the target calcified tissue, which is beneficial to improving the user experience and making the treatment safer and more reliable. Moreover, adjusting the energy of the shock wave can adjust the output energy of the shock wave to an appropriate energy value according to the actual situation of the patient's arterial calcification lesions, which can not only increase the energy of the shock wave, but also reduce the energy of the shock wave.

In addition, in the clinical treatment of vascular stenosis and blockage caused by various types of arterial calcification, the calcification that actually appears at the lesion is soft and irregular. Low-energy shock wave dredging and impact through the shock wave balloon can remove the calcification. The material vibrates smoothly, smoothing and unblocking the uneven tissue, thereby solving the problem of vascular stenosis and blockage. It enables certain uneven calcified tissues to be dredged through low-energy shock wave vibration without the need to place interventional stents, thus solving problems such as arterial stenosis and blockage. It has the positive effect clinical significance and effects.

In addition, compared with the continuous high-voltage shock wave, the voltage dividing unit mentioned in this embodiment not only achieves reliable breakdown of the shock wave balloon, but also effectively reduces the breakdown current of the shock wave balloon, thereby producing the impact of calcified diseased tissue. A lower energy shock wave is required; after the balloon electrode breaks down, the voltage carried by the voltage dividing unit allows the balloon to receive a lower energy shock wave, and the voltage received by the balloon and/or the breakdown current flowing through it are reduced. The appropriate energy value corresponding to the low energy demand is achieved, which avoids burning and damage of the built-in electrode of the shock wave balloon, and greatly improves the safety and reliability of IVL clinical treatment.

In addition, the adjustable energy adjustment signal corresponds to the adjustment of voltage amplitude and/or pulse width, acting on the calcified target tissue. The appropriate energy value further ensures the safety and reliability of IVL surgery.

It should be understood that what is described in this section is not intended to identify key or important features of the embodiments of the invention, nor is it intended to limit the scope of the invention. Other features of the present invention will become easily understood from the following description.

Description of the drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings needed to be used in the description of the embodiments will be briefly introduced below. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, other drawings can also be obtained based on these drawings without exerting creative efforts.

Figure 1 is a schematic structural diagram of a medical device provided by Embodiment 1 of the present invention;

Figure 2 is a waveform diagram of a shock wave provided by Embodiment 1 of the present invention;

Figure 3 is a waveform diagram of another shock wave provided by Embodiment 1 of the present invention;

Figure 4 is a waveform diagram of yet another shock wave provided by Embodiment 1 of the present invention;

Figure 5 is a waveform diagram of yet another shock wave provided by Embodiment 1 of the present invention;

Figure 6 is a waveform diagram of yet another shock wave provided by Embodiment 1 of the present invention;

Figure 7 is a waveform diagram of yet another shock wave provided by Embodiment 1 of the present invention;

Figure 8 is a waveform diagram of yet another shock wave provided by Embodiment 1 of the present invention;

Figure 9 is a schematic circuit structure diagram of a medical device provided in Embodiment 2 of the present invention;

Figure 10 is a schematic circuit structure diagram of a medical device provided in Embodiment 3 of the present invention;

Figure 11 is a schematic circuit structure diagram of a medical device provided in Embodiment 4 of the present invention;

Figure 12 is a schematic circuit structure diagram of a medical device provided in Embodiment 5 of the present invention;

Figure 13 is a schematic circuit structure diagram of a medical device provided in Embodiment 6 of the present invention;

Figure 14 is a schematic circuit structure diagram of a medical device provided in Embodiment 7 of the present invention;

Figure 15 is a schematic circuit structure diagram of a medical device provided in Embodiment 8 of the present invention;

Figure 16 is a schematic structural diagram of a medical device provided in Embodiment 4 of the present invention;

Figure 17 is a schematic circuit structure diagram of yet another medical device provided in Embodiment 9 of the present invention;

Figure 18 is a schematic circuit structure diagram of yet another medical device provided by Embodiment 10 of the present invention;

Figure 19 is a schematic diagram of the circuit structure of a low-energy shock wave of another medical device provided by Embodiment 10 of the present invention;

Figure 20 is a flow chart of a control method for a medical device provided by Embodiment 11 of the present invention;

Figure 21 is a flow chart of a control method for a medical device provided in Embodiment 12 of the present invention.

Detailed ways

In order to enable those skilled in the art to better understand the solutions of the present invention, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only These are some embodiments of the present invention, rather than all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts should fall within the scope of protection of the present invention.

It should be noted that the terms "first", "second", etc. in the description and claims of the present invention and the above-mentioned drawings are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It is to be understood that the data so used are interchangeable under appropriate circumstances so that the embodiments of the invention described herein are capable of being practiced in sequences other than those illustrated or described herein. In addition, the terms "including" and "having" and any variations thereof are intended to cover non-exclusive inclusions, e.g., a process, method, system, product, or apparatus that encompasses a series of steps or units and need not be limited to those explicitly listed. Those steps or elements may instead include other steps or elements not expressly listed or inherent to the process, method, product or apparatus.

In related embodiments of the present application, the shock wave energy corresponding to the pulse amplitude in the preset amplitude range and/or the pulse width in the preset pulse width range can be used to preset the treatment effect and calcified lesions according to the degree of calcification of the target tissue. The actual situation and so on are set, for example, the energy value corresponding to the preset energy adjustment signal involved in this application, the appropriate energy value, the predetermined energy and its energy interval, etc. Those skilled in the art can also make settings according to actual needs. Settings are not limited here. In the relevant embodiments of the present application, the shock waves involved should at least include boost shock waves applied to IVL systems. Persons skilled in the art can also set the setting according to actual needs for clinical application. This is not limited.

Embodiment 1

Figure 1 is a schematic structural diagram of a medical device provided in Embodiment 1 of the present invention. Referring to Figure 1, a medical device may be, for example, a balloon catheter that supports modulation of shock wave energy to target tissue. The medical device includes: a balloon assembly 100 and an energy regulating device 300 . The balloon assembly 100 includes a balloon 110 and an electrode pair 120. The electrode pair 120 is disposed in the balloon 110. For the technical solution of the balloon 110 and the electrode pair 120, reference can be made to the existing technology and will not be described again here.

The energy adjustment device 300 is configured to respond to the energy adjustment needs of the balloon in the insertion state and/or the removal state, and the energy adjustment device further includes an electrical pulse generating unit 310, a control unit 320 that receives an energy adjustment signal, and an adjustment component 330. , the adjusting component 330 is configured to adjust the pulse width and/or pulse amplitude of the shock wave emitted by the electrical pulse generating unit through the control unit 320,

as well as,

The electrode pair is arranged in the balloon. The high-voltage electric pulse output by the energy adjustment device generates shock waves in the balloon through the electrode pair and acts on the target tissue.

The control unit 320 is configured to adjust the electrical pulse generating unit 310 to emit a shock wave with a pulse amplitude that satisfies the preset amplitude interval according to the voltage value of the electrical pulse generating unit 310 and the target voltage amplitude corresponding to the energy adjustment signal.

The adjusting component 330 is connected to the control unit 320 , the control unit 320 is connected to the control end of the electric pulse generating unit 310 , and the output end of the electric pulse generating unit 310 is connected to the electrode pair 120 . The adjustment component 330 is used to send an energy adjustment signal according to energy adjustment requirements, and the control unit 320 is used to receive the energy adjustment signal and adjust the pulse width and/or pulse amplitude of the shock wave sent by the electrical pulse generation unit 310 according to the energy adjustment signal. Specifically, the adjustment component 330 may, for example, send out an adjustment signal to increase energy, or may send out an adjustment signal to decrease energy. More specifically, the adjusting component 330 may, for example, send out a signal to increase/decrease the pulse width, or send out a signal to increase/decrease the pulse amplitude, or simultaneously increase/decrease the pulse amplitude and pulse width, so Realize the change of shock wave energy to eliminate or reduce the damage or impact caused by high or low shock wave energy. Under the control of the control unit, the electric pulse generating unit 310 can output high-voltage electric pulses with adjustable energy to the electrode pair 120 in the balloon assembly 100. The electrode pair 120 breaks down and discharges, generating a high-voltage shock wave with corresponding energy. Within 110, a short-time high-voltage discharge causes part of the mixed solution of physiological saline and contrast agent in the balloon 110 to be instantly vaporized under the action of high-voltage breakdown discharge, generating non-focused, circumferential pulsed sound pressure waves. The pressure wave mainly acts on the solid calcified substances that cause arterial vascular disease, and penetrates soft tissues such as human blood vessels and muscles with a density close to normal saline with almost no damage, so that it can safely impact and fragment the superficial and deep diseased blood vessels. The calcified substance causes the calcification to rupture and loosen, and the blood vessels to be moderately softened, thus significantly improving the compliance of the blood vessels and facilitating the subsequent implantation of stents or drug balloons.

When the pulse amplitude corresponding to the voltage value of the electrical pulse generating unit does not meet the target voltage amplitude corresponding to the energy adjustment signal, the adjustment component sends out an energy adjustment signal based on the difference between the target voltage amplitude and the current voltage value, and the control unit is used to receive The energy adjustment signal is used to adjust the electrical pulse generating unit to emit a shock wave with a pulse amplitude that satisfies a preset amplitude range, and acts on the target tissue, wherein the amplitude of the preset amplitude range at least includes the target voltage amplitude. The preset amplitude range can be set to a voltage amplitude range including the target voltage amplitude, making it equal to or close to the target voltage amplitude, or maintaining the pulse amplitude and the target pulse amplitude. The error range of the value is within a certain range, preferably, such as ±5%. Within this preset amplitude range, the electrode pair is prone to breakdown discharge and generates shock waves, but the voltage amplitude is not too high, causing significant damage to the electrode pair, or the voltage amplitude is too low, making it difficult to breakdown discharge and unable to generate Shock waves, in this range, can safely and reliably generate shock waves, impact and fragment the calcified substances in superficial and deep diseased blood vessels, causing the calcifications to rupture and loosen.

In an exemplary embodiment, taking increasing energy as an example, when the amplitude of the pulse voltage is too low, the electrode pair 120 built into the balloon 110 is difficult to breakdown and discharge, and cannot even generate shock waves, and cannot act on the target tissue to achieve the therapeutic purpose. Therefore, when the energy of the shock wave generated by the electrode pair 120 is lower than the predetermined energy, the adjustment component 330 is adjusted. The adjustment component 330 sends an adjustment signal to increase the energy. After the control unit 320 receives the energy adjustment signal, the control unit 320 controls the electrical pulse generation unit. 310 increases the pulse width of the shock wave, and/or the control unit 320 controls the electrical pulse generating unit 310 to increase the pulse amplitude of the shock wave, thereby increasing the energy of the shock wave generated by the electrode pair 120 . The adjusting component 330 adjusts the signal, and the control unit 320 may adjust the signal, or the adjustment may be performed manually.

In another exemplary embodiment, when the shock wave energy generated by the electrode pair 120 is higher than the predetermined energy and the pulse voltage amplitude is too high, the insulation between the electrode pairs 120 built in the balloon 110 is easily broken down and the ball The built-in electrodes of the balloon 110 are also prone to cause burns and other injuries, affecting the normal service life of the shock wave balloon, thereby affecting surgical treatment. At this time, the adjustment component 330 is adjusted. The adjustment component 330 sends out an energy adjustment signal with reduced energy, and the control unit 320 receives the energy adjustment signal. Finally, the control unit 320 controls the electrical pulse generating unit 310 to reduce the pulse width of the high-voltage electrical pulse, and/or controls the electrical pulse generating unit 310 to increase the pulse amplitude of the high-voltage electrical pulse, thereby reducing the shock wave generated by the electrode pair 120 energy of. In this way, the operator can adjust the energy of the shock wave generated by the electrode pair 120 according to actual needs during use, avoiding the problem that the energy generated by the electrode pair 120 is low, resulting in poor therapeutic effect; it can also avoid the problem that the electrode pair 120 generates The high energy can cause damage to the patient's vascular intima, thus achieving a pulse shock wave with adjustable output energy and reducing the damage caused by excessive shock wave energy to the patient's vascular intima.

In some embodiments of the present application, the energy value of the shock wave can be adjusted in a variety of ways. For example, the energy value of the shock wave can be adjusted by adjusting the voltage amplitude. The control unit 320 is configured to adjust the energy value of the shock wave according to the voltage of the electrical pulse generating unit 310. The electric pulse generating unit 310 adjusts the target voltage amplitude corresponding to the value and the energy adjustment signal to emit a shock wave with a pulse amplitude that meets the preset amplitude interval range. When the voltage value of the electrical pulse generating unit does not meet the target voltage amplitude corresponding to the energy adjustment signal, the control unit 320 adjusts the pulse amplitude of the electrical pulse generating unit 310 . Specifically, after the control unit 320 receives the energy adjustment signal, if the voltage value output by the electrical pulse generation unit 310 meets the target voltage amplitude corresponding to the energy adjustment signal, there is no need to adjust the pulse amplitude of the electrical pulse generation unit 310 . When the voltage value output by the electrical pulse generating unit 310 does not meet the target voltage amplitude corresponding to the energy adjustment signal, the adjustment component 330 sends an energy adjustment signal according to the difference between the target voltage amplitude and the current voltage value, and exemplarily obtains the difference. The specific value of , when the difference does not approach 0, the control unit 320 will adjust the pulse amplitude of the electrical pulse generating unit 310, and adjust the electrical pulse generating unit 310 to send out a pulse amplitude that satisfies the preset amplitude range. The piezoelectric pulse is used to adjust the pulse amplitude of the high-voltage electric pulse output by the electric pulse generating unit 310, so that the difference approaches 0, and the pulse amplitude is adjusted.

As shown in Figure 2, Figure 2 is a waveform diagram of a shock wave provided by Embodiment 1 of the present invention. The voltage amplitude of the first waveform A11 is V1. By adjusting the voltage amplitude, a second waveform with a voltage amplitude of V2 can be obtained. Waveform A12, you can also get the third waveform A13 with a voltage amplitude of V3. The pulse widths of the first waveform A11, the second waveform A12 and the third waveform A13 are all d, that is, the pulse width of the shock wave is kept unchanged, and the pulse width of the shock wave is adjusted. The voltage amplitude can adjust the energy of the shock wave, so that the electrical pulse generating unit 310 emits high-voltage electrical pulses with a pulse amplitude that meets the preset amplitude range. As shown in Figure 3, Figure 3 is a waveform diagram of another shock wave provided by Embodiment 1 of the present invention. The shock wave output by the shock wave generating unit can be a moderate deformation of the rectangular pulse wave. The voltage amplitude of the fourth waveform A21 is V1, By adjusting the voltage amplitude, the fifth waveform A22 with the voltage amplitude V2 can be obtained, the sixth waveform A23 with the voltage amplitude V3 can also be obtained, the pulse widths of the fourth waveform A21, the fifth waveform A22 and the sixth waveform A23 Both are d, that is, keeping the pulse width of the shock wave unchanged and adjusting the voltage amplitude of the high-voltage electric pulse to adjust the shock wave energy.

For example, the energy value of the shock wave can be adjusted by adjusting the pulse width of the high-voltage electric pulse. When the electrode pair 120 in the balloon 110 breaks down and discharges, a shock wave pulse is generated. The control unit 320 is configured to generate a shock wave pulse according to the electric pulse generating unit 310 The duration of the current signal, the duration of the pulse output and the duration of the target pulse width corresponding to the energy adjustment signal adjust the pulse command of the pulse width of the high-voltage electric pulse issued by the electric pulse generating unit 310, and the pulse width of the high-voltage electric pulse is adjusted by the pulse command. , the adjusted electrical pulse generating unit 310 emits a shock wave with a pulse width that meets the preset pulse width interval range, where the pulse width of the preset pulse width interval at least includes the duration of the pulse output. As shown in Figure 4, Figure 4 is a waveform diagram of another shock wave provided by Embodiment 1 of the present invention. The pulse width of the seventh waveform A31 is d1. By adjusting the pulse width, the eighth waveform A32 with a pulse width of d2 can be obtained. , the ninth waveform A33 with a pulse width of d3 can also be obtained. The voltage amplitudes of the seventh waveform A31, the eighth waveform A32 and the ninth waveform A33 are all Vc, that is, the voltage amplitude of the high-voltage electric pulse remains unchanged, and the adjustment The pulse width of the high-voltage electrical pulse can adjust the energy of the shock wave generated by the electrode pair. As shown in Figure 5, Figure 5 is a waveform diagram of another shock wave provided by Embodiment 1 of the present invention. The shock wave output by the shock wave generating unit can be a moderate deformation of the rectangular pulse wave. The pulse width of the tenth waveform A41 is d1. By adjusting the pulse width, you can get the eleventh waveform A42 with a pulse width of d2, you can also get the twelfth waveform A43 with a pulse width of d3, the voltage amplitudes of the tenth waveform A41, the eleventh waveform A42 and the twelfth waveform A43 The values are all Vc, that is, the voltage amplitude of the high-voltage electric pulse is kept unchanged, the pulse width of the high-voltage electric pulse is adjusted to adjust the shock wave energy, and the electric pulse generating unit is adjusted to emit a pulse width that meets the preset pulse width interval. The high-voltage electric pulse, the preset pulse width interval range can be set to a pulse width interval including the pulse width of the target pulse width pulse output, within this pulse width interval, the superficial and deep surfaces can be safely impacted and fragmented The calcified material in the diseased blood vessels causes the calcification to rupture and loosen.

In this embodiment, the energy value of the shock wave can be adjusted in a variety of ways. For example, the energy value of the shock wave can be adjusted by adjusting the voltage amplitude and simultaneously adjusting the pulse width. As shown in Figure 6, Figure 6 is a waveform diagram of another shock wave provided by Embodiment 1 of the present invention. The pulse width of the thirteenth waveform A51 is d1 and the voltage amplitude is V1. By adjusting the pulse width and voltage amplitude, The fourteenth waveform A52 with the pulse width d2 and the voltage amplitude V2 can be obtained, and the fifteenth waveform A33 with the pulse width d3 and the voltage amplitude V3 can also be obtained. As shown in Figure 7, Figure 7 is a waveform diagram of another high-voltage electric pulse provided by Embodiment 1 of the present invention. The high-voltage electric pulse output by the electric pulse generating unit can be a moderate deformation of the rectangular pulse wave. The sixteenth waveform The pulse width of A61 is d1 and the voltage amplitude is V1. By adjusting the pulse width and voltage amplitude, the seventeenth waveform A62 with a pulse width of d2 and a voltage amplitude of V2 can be obtained. It can also be obtained that the pulse width is d3 and the voltage is V2. The eighteenth waveform A63 with amplitude V3. When the electrode pair 120 in the balloon 110 breaks down and discharges, a pulse shock wave is generated. When the pulse voltage amplitude is constant, the pulse width increases, and the generated shock wave energy increases. The pulse width decreases, and the generated shock wave energy decreases. That is, in this application In one embodiment, the pulse width of the high-voltage electric pulse can be adjusted by keeping the voltage amplitude of the high-voltage electric pulse unchanged to achieve adjustment of the shock wave energy.

In this embodiment, the energy value adjustment of the shock wave can be realized in a variety of ways. For example, as shown in FIG. 8 , FIG. 8 is a waveform diagram of yet another shock wave provided by Embodiment 1 of the present invention. The shock wave output by the shock wave generating unit can be a rectangular wave, that is, the first shock wave B1 in Figure 8, or a moderate deformation of the rectangular wave, that is, the second shock wave B2 and the third shock wave B3, thereby realizing the adjustment of the shock wave energy. The moderate deformation of the rectangular wave can also be other forms of shock waves, which are not limited in this embodiment.

It should be understood that the order of adjusting the energy value of the shock wave by adjusting the voltage amplitude and adjusting the energy value of the shock wave by adjusting the pulse width is not limited, and only one adjustment can be performed according to actual needs.

The technical solution of this embodiment is to adjust the adjustment component, and the adjustment component sends out an energy adjustment signal. After the control unit receives the energy adjustment signal, it adjusts the pulse width and/or pulse of the high-voltage electric pulse sent by the electric pulse generation unit according to the energy adjustment signal. Amplitude, thereby adjusting the energy of the shock wave generated by the electrode pair in the balloon. Therefore, during treatment, the shock wave energy generated by the electrode pair can be adjusted according to actual needs to avoid the problem that the shock wave energy generated by the electrode pair is low, resulting in poor therapeutic effect; it can also avoid the problem that the shock wave energy generated by the electrode pair is high, which is harmful to the patient. The problem of damage to the vascular intima is achieved, thereby realizing a pulse shock wave with adjustable output energy and reducing the damage caused by excessive shock wave energy to the patient's vascular intima. In addition, compared with directly adjusting the voltage value of the high-voltage electric pulse acting on the electrode pair according to the required voltage amplitude, this embodiment adjusts the voltage amplitude and/or pulse width according to the adjusted energy adjustment signal, which can Obtaining the required shock wave energy value is beneficial to improving user experience. Moreover, adjusting the energy of the shock wave can not only increase the energy of the shock wave, but also reduce the energy of the shock wave, so that the energy of the shock wave power supply can be adjusted according to different shock wave balloons and the actual conditions of the patients, so that the pulse voltage amplitude and pulse width have a certain range, which can minimize the operation time, reduce the damage to the balloon and the electrode pair, ensure the normal service life of the shock wave balloon, and make the operation safe and reliable.

Embodiment 2

Based on the foregoing embodiments, FIG. 9 is a schematic circuit structure diagram of a medical device provided in Embodiment 2 of the present invention.

Preferably, referring to FIG. 9 , the medical device further includes a detection unit 410 , the first end of the detection unit 410 is connected to the detection end of the electrical pulse generating unit 310 , and the second end of the detection unit 410 is connected to the control unit 320 . The medical device also includes a detection unit 410. The detection unit 410 is configured to collect the current signal of the electrical pulse generating unit 310, and control the current signal of the electrical pulse generating unit 310 through the control unit 320, when it is necessary to adjust the energy of the output shock wave. When High voltage electrical pulses with a range of pulse widths.

Specifically, the control unit 320 is configured to adjust the height of the pulse width that the electrical pulse generating unit 310 sends out to meet the preset pulse width interval according to the duration of the pulse output of the electrical pulse generating unit 310 and the duration of the target pulse width corresponding to the energy adjustment signal. Piezoelectric pulse.

Specifically, the detection unit 410 is used to collect the current signal of the electrical pulse generation unit 310 when the pulse width needs to be adjusted. The control unit 320 is used to receive current signals. The control unit 320 is used to obtain the shock wave generation time based on the current signal, and the control unit 320 is used to determine the duration of the pulse output of the electrical pulse generation unit 310 based on the duration of the target pulse width corresponding to the energy adjustment signal, and based on the calculated pulse The output duration sends a pulse command to the electrical pulse generating unit 310 .

In some embodiments of the present application, when the pulse width needs to be adjusted, the detection unit 410 collects the current signal of the electrical pulse generating unit 310. The control unit 320 receives the current signal and determines the time when the shock wave occurs based on the current response delay length of the current signal. The control unit 320 calculates the duration of the corresponding target pulse width based on the target pulse width corresponding to the energy adjustment signal. The control unit 320 can obtain the time to stop the high-voltage electric pulse output of the electric pulse generation unit 310 based on the corresponding target pulse width duration and the shock wave generation time (current generation time) (i.e., the time to stop the pulse output = the time of the target pulse width) + shock wave generation time or current generation time), where the duration of the target pulse width is the duration corresponding to the pulse width required for use. The control unit 320 issues a pulse instruction to the high-voltage electric pulse sounding unit 310 according to the duration of the pulse output by the electric pulse generating unit 310. The pulse instruction includes, for example, an instruction to stop outputting current or stopping output of high-voltage electric pulses, so that the electric pulse generating unit 310 outputs a pulse instruction. When the duration of the pulse reaches the target pulse width, the output current is stopped so that the pulse width output by the electrical pulse generating unit 310 meets the target pulse width, and the electrical pulse generating unit 310 is adjusted to emit a high voltage with a pulse width that meets the preset pulse width interval. Electrical pulses act on the electrode pair in the balloon to generate shock waves, which act on the target tissue to loosen calcified tissue. For example, the current response delay time of the current signal is, for example, 0.3 to 0.5 us. Preferably, the detection unit 410 is, for example, a current sensor or a current transformer, or may be other devices that can collect current signals. Preferably, the detection unit 410 uses a Rogowski coil current sensor to detect the shock wave pulse current, which is isolated from high-voltage electric pulses, has high safety and fast response speed. It should be understood that in the balloon 110, a high-voltage pulse wave is generated between the electrode pairs 120. The high-voltage pulse wave requires a high-voltage electric pulse signal, and in the high-voltage electric pulse signal, the pulse output width is difficult to adjust.

In some embodiments of the present application, by setting the detection unit 410 to detect the current signal, the control unit 320 captures and collects the current signal of the detection unit 410, and then determines the time when the shock wave occurs according to the inherent response delay time of the current signal, and then calculates the output The duration of the pulse, when the current value of the electrical pulse generating unit 310 is greater than the preset current threshold, it is determined that an effective shock wave has occurred. Specifically, when the current value of the electrical pulse generating unit 310 is greater than the preset current threshold, it indicates that the electrical pulse generating unit 310 outputs a pulse wave, and then the sum of the current collection duration and the delayed response duration is calculated to determine the value of the detected shock wave. Duration, when the difference between the duration of the target pulse width corresponding to the energy adjustment signal and the duration of the generated shock wave meets the preset difference value, the control unit 320 issues a pulse instruction to the electrical pulse generation unit 310 . Specifically, the pulse command is, for example, a stop output pulse command. The control unit 320 can determine the duration of the target pulse width corresponding to the energy adjustment signal according to the energy adjustment signal. When the difference between the duration of the target pulse width and the duration of the detected shock wave meets the preset difference value, it indicates that the electrical pulse generating unit When the duration of the output pulse of 310 meets the target pulse width, the control unit 320 issues a pulse command to the electrical pulse generating unit 310 and controls the electrical pulse generating unit 310 to stop outputting current, thereby adjusting the pulse width and energy of the pulse wave output by the electrical pulse generating unit 310 The target pulse width corresponding to the signal is consistent, and the energy of the pulse wave is adjusted. A high-voltage electric pulse with a pulse width that meets the preset pulse width range is applied to the electrode pair 120, and a shock wave corresponding to the target energy value is generated in the balloon 110. .

Collect the current signal of the electrical pulse generating unit 310. When the current value of the electrical pulse generating unit 310 is greater than the preset current threshold, determine the shock wave duration threshold corresponding to the current signal. The duration threshold includes the current acquisition duration and the delayed response duration; when the energy adjustment When the difference between the target pulse width corresponding to the signal and the detected shock wave duration threshold meets the preset difference value, the control unit adjusts the electrical pulse generating unit 310 to emit a shock wave with a pulse width that satisfies the preset pulse width interval, acting on The target tissue; wherein the preset difference value includes a preset difference range, and/or the preset difference value includes a preset ratio range. The preset difference range indicates that the duration of the target pulse width can be different from the detected shock wave duration threshold. For example, when the difference is close to 0, it indicates that the duration of the pulse output by the electrical pulse generating unit 310 meets the target pulse width. The preset ratio range can calculate the ratio between the duration of the target pulse width and the duration threshold. For example, when the ratio is close to 1, it indicates that the duration of the pulse output by the electrical pulse generating unit 310 meets the target pulse width, which solves the problem that pulse width adjustment cannot be realized in the existing technology. technical issues.

Preferably, in the balloon catheter, a shock wave is generated between the electrode pairs 120 under the action of a high-voltage electric pulse, and the adjustment of the shock wave pulse width is implemented by the control unit 320 . The control unit 320 is used to calculate the delay cut-off duration of the pulse signal generated by the electrical pulse generation unit 310 according to the target pulse width and the response duration of the current signal when the detection unit 410 collects the current signal. That is, when the control unit 320 detects the occurrence of a current signal, the control unit 320 delays the pulse width adjustment requirement according to the energy adjustment requirement set by the adjustment component 330, that is, according to the difference between the target pulse width and the response time of the current detection signal. Cutting off the electrical pulse generating unit 310 stops the output current and stops the pulse signal generated by the electrical pulse generating unit 310 . It can be understood that when the control delay time of the control unit 320 is ignored, in an ideal situation, the time of the target pulse width = the response time of the current signal + the delay cut-off time. In this way, the pulse width can be adjusted within the microsecond level. Preferably, the pulse width adjustment range can be 0.5us ~ 1.5us.

Preferably, referring to FIG. 9 , the control unit 320 includes at least one of an MCU, a DSP, and an FPGA. Specifically, MCU is a Microcontroller Unit, DSP is Digital Signal Process, and FPGA is Field Programmable Gate Array. The control unit 320 can be implemented by MCU, DSP or FPGA. , it can also be implemented by any combination of MCU, DSP and FPGA chips to realize the control function.

Preferably, as shown in FIG. 9 , the medical device further includes an inverter boosting unit 420 and a power supply unit 430 . The power supply unit 430 is connected to the input end of the electrical pulse generating unit 310 through the inverter boosting unit 420 . The power supply unit 430 provides a power supply voltage. The inverter boost unit 420 is used to increase the low voltage output by the power supply unit 430 to a high voltage. The voltage of the pulse output by the electrical pulse generation unit 310 is greater than 700V, thereby facilitating the electrode pair 120 to generate a high voltage shock wave. Preferably, the pulse voltage is between 700V and 5000V. Even better, the pulse voltage is greater than 1000V. Going one step further, the voltage of the pulse is greater than 1500V.

Preferably, the inverter boost unit 420 is used to raise the low voltage output by the power supply unit to a high voltage or reduce the high voltage output by the power supply unit to a low voltage when the balloon is inserted or removed. The output end of the inverter boost unit 420 is connected to the power supply. The input terminal of the pulse generating unit is electrically connected, and the control unit is electrically connected to the control terminal of the inverter boost unit. The control unit is used to control the inverter boost unit to adjust the pulse amplitude when the pulse amplitude needs to be adjusted.

Preferably, referring to Figure 9, the medical device further includes an inverter boost unit 420. The output end of the inverter boost unit 420 is electrically connected to the input end of the electrical pulse generating unit 310. The control unit 320 is connected to the inverter boost unit 420. The control terminal is electrically connected, and the control unit 320 is used to control the inverter boost unit 420 to adjust the pulse amplitude when the pulse amplitude needs to be adjusted. Specifically, when the energy of the shock wave needs to be adjusted, the pulse amplitude can be adjusted. When adjusting the pulse amplitude, the control unit 320 controls the voltage amplitude output by the inverter boost unit 420 according to the energy adjustment signal, thereby controlling the inverter boost unit 420 to adjust the pulse amplitude and increase or decrease the electrical pulse generating unit 310 The output pulse amplitude is adjusted to adjust the shock wave energy generated by the electrode pair 120 .

Preferably, referring to Figure 9, the electrical pulse generation unit 310 also includes a trigger unit 340 and an energy storage unit 350. The control unit 320 is connected to the energy storage unit 350 through the trigger unit 340. The control unit 320 controls the trigger unit 340 by outputting a control signal. The trigger unit 340 outputs a high-level signal or a low-level signal, thereby controlling whether the energy storage unit 350 outputs a pulse. For example, when the control unit 320 controls the trigger unit 340 to output a high-level signal, the energy storage unit 350 outputs a signal; when the control unit 320 controls the trigger unit 340 to output a low-level signal, and the energy storage unit 350 does not output a signal, thus forming a pulse wave. The detection unit 410 collects the current signal of the electrical pulse generating unit 310 to collect the current signal of the energy storage unit 350 .

Embodiment 3

Based on the foregoing embodiments, FIG. 10 is a schematic circuit structure diagram of yet another medical device provided in Embodiment 3 of the present invention. Referring to FIG. 10 , the pulse current detection unit 410 includes a current sensor 411 , an integrating amplifier circuit 413 , and a voltage comparator 412 . The current sensor 411 can be connected between the energy storage unit 350 and the output interface 390 of the handle 200 to detect the shock wave pulse current. The control unit 320 is equipped with an "ADC" function module inside. The output signal of the current sensor 411 is the differential of the pulse current. After integration The amplifier circuit 413 restores the pulse voltage signal proportional to the pulse current. One of the signals passes through the "ADC" function module inside the control unit 320 for data conversion and processing, and real-time monitoring of the size of the shock wave current signal; at the same time, the other signal, Through the voltage comparator, it is compared with the "current signal threshold" that the balloon can receive. When the real-time monitored shock wave current signal exceeds the "current signal threshold", the voltage comparator 412 outputs a high or low level flip signal, and the control unit 320 responds to the received signal. The received level flip signal of the voltage comparator 412 determines the moment when the pulse current is generated, so that when the duration of the pulse output by the electrical pulse generating unit 310 reaches the duration of the target pulse width, that is, when the target energy value of the shock wave is reached, the output of the current is stopped. , so that the pulse width output by the electrical pulse generating unit 310 meets the target pulse width, thereby realizing the adjustment of shock wave energy. When the control unit 320 detects the occurrence of a current signal, the control unit 320 delays and cuts off the pulse signal generated by the electrical pulse generating unit 310 according to the difference between the target pulse width and the response time of the current signal, thereby controlling the high The pulse width of the piezoelectric pulse realizes the adjustment of shock wave energy.

Embodiment 4

Based on the foregoing embodiments, FIG. 11 is a schematic circuit structure diagram of a medical device provided in Embodiment 4 of the present invention. Based on the above technical solution, preferably, the adjustment component 330 includes at least one of a touch screen 301, a button 302, a potentiometer 303, and an encoder 304. It should be understood that in FIG. 11 , the touch screen 301 represents an implementation form of the adjustment component 330 , and does not mean that the touch screen 301 and the adjustment component 330 are two components. In the following, the expressions of the button 302, the potentiometer 303 and the encoder 304 have the same meaning as the touch screen 301. Preferably, the medical device also includes a handle 200 and a host. The adjustment component 330 includes at least one of a touch screen 301, a button 302, a potentiometer 303, and an encoder 304. The adjustment component 330 is provided on the handle 200 or the host. The design of the handle 200 is ergonomic, making it easy for the operator to operate when holding it. The host is, for example, a shell device, the energy adjustment device 300 is disposed inside the host, and the touch screen 301 can be disposed on the host to facilitate display and operation.

Illustratively, referring to FIGS. 11 and 16 , the energy conditioning device 300 includes a touch screen 301 . The required energy value is input through the touch screen 301 to adjust the energy of the high-voltage pulse wave output by the energy adjustment device 300 . The touch screen 301 can display the size of the energy value, the numerical value of the energy, etc., or the touch screen 301 has energy display of high, medium and low levels, and can display the energy value in segments. The touch screen 301 includes a human-computer interaction interface, through which a specific energy value can be input, or an energy progress bar can be set to realize continuous or segmented adjustment of the energy value. Preferably, the touch screen 301 includes an energy step adjustment button 3011 or an energy stepless adjustment button 3012. The touch screen 301 is provided on the handle 200 or the host computer. Preferably, the touch screen 301 is connected to the control end of the inverter boost unit 420 through the control unit 320, and the touch screen 301 is connected to the trigger unit 340 through the control unit 320. Specifically, the inverter boost unit 420 includes, for example, a DC-DC boost circuit. According to the required energy value, the energy segment adjustment button 3011 or the energy stepless adjustment button 3012 of the touch screen 301 is adjusted. The control unit 320 receives the energy adjustment signal. Then, the control signal is output to the inverter boost unit 420, and the inverter boost unit 420 is controlled to adjust the output DC charging voltage according to the required energy value, thereby adjusting the energy output by the energy storage unit 350, and thereby adjusting the shock wave generated by the electrode pair 120. energy of. For example, when adjusting the energy segment adjustment button 3011, the control unit 320 receives the segment adjustment signal and controls the inverter boost unit 420 to output the corresponding DC charging voltage; when adjusting the energy stepless adjustment button 3012, the control unit 320 320 receives the stepless adjustment signal and controls the inverter boost unit 420 to output the corresponding DC charging voltage to achieve continuous adjustment of the pulse amplitude. According to the required energy value, adjust the energy segment adjustment button 3011 or the energy stepless adjustment button 3012 of the touch screen 301. After receiving the energy adjustment signal, the control unit 320 outputs the control signal to the trigger unit 340, so that the trigger unit 340 adjusts the energy according to the required energy value. The value adjusts the pulse width of the output trigger signal, thereby adjusting the pulse width of the high-voltage electrical pulse output by the energy storage unit 350, thereby adjusting the energy of the shock wave generated by the electrode pair 120. In addition, the touch screen 301 can display the energy value, the DC charging voltage output by the inverter boost unit 420, and the pulse width of the trigger signal output by the trigger unit 340, so that the user can intuitively obtain the status of the medical device. It should be noted that FIG. 12 only shows the case where the touch screen 301 is provided on the handle 200, but this is not limiting.

Embodiment 5

Based on the foregoing embodiments, FIG. 12 is a schematic circuit structure diagram of a medical device provided in Embodiment 5 of the present invention. Optionally, referring to FIG. 12 , the energy adjustment device 300 includes a button 302 . The button 302 is preferably on the handle 200, but may also be provided on the host computer. The keys 302 are, for example, numeric buttons, energy addition and subtraction buttons, and the like. When it is a numeric button, by pressing the button 302, the required energy value can be input, thereby increasing or decreasing the energy of the high-voltage pulse wave output by the energy adjustment device 300. Preferably, the keys 302 include an energy increase key 3021 and an energy decrease key 3022. The energy increase key 3021 or the energy decrease key 3022 implements segmented adjustment of the adjustment components. The energy increase key 3021 is connected to the control unit 320. In this exemplary embodiment, preferably, the energy increase key 3021 is configured to output an amplitude increase signal to the inverter boost unit 420 when activated, so as to increase the DC charging voltage output by the inverter boost unit 420, and/or , when operating, a pulse width increasing signal is output to the trigger unit 340 to increase the pulse width of the trigger signal output by the trigger unit 340 . The energy reduction key 3022 is connected to the control unit 320 . Preferably, the energy reduction key 3022 is configured to output an amplitude reduction signal to the inverter boost unit 420 when activated, so as to reduce the DC charging voltage output by the inverter boost unit 420, and/or to trigger the The unit 340 outputs a pulse width reduction signal to reduce the pulse width of the trigger signal output by the trigger unit 340. For example, when the energy increase key 3021 is pressed, the control unit 320 receives the first energy adjustment signal, controls the amplitude of the DC charging voltage output by the inverter boost unit 420 to increase, and can also control the pulse width output by the trigger unit 340 to increase. Alternatively, when the energy reduction button 3022 is pressed, the control unit 320 receives the second energy adjustment signal and controls the amplitude of the DC charging voltage output by the inverter boost unit 420 to decrease, or it can also control the pulse width output by the trigger unit 340 to decrease. .

Specifically, the first end of the energy increase key 3021 can be connected to the third end of the inverter boost unit 420 through the control unit 320, and the second end of the energy increase key 3021 can be connected to the trigger unit 340 through the control unit 320; when pressed When the energy increase key 3021 is pressed, the control unit 320 receives the first energy adjustment signal, and will control the DC charging voltage amplitude output by the inverter boost unit 420 to increase, and may also control the pulse width output by the trigger unit 340 to increase. Thus, the energy of the high-voltage pulse wave output by the energy storage unit 350 is increased, thereby increasing the energy of the shock wave generated by the electrode pair 120 . The first end of the energy reduction key 3022 can be connected to the fourth end of the inverter boost unit 420 through the control unit 320, and the second end of the energy reduction key 3022 can be connected to the trigger unit 340 through the control unit 320; when pressed When the energy reduction key 3022 is pressed, the control unit 320 receives the second energy adjustment signal, and will control the DC charging voltage amplitude output by the inverter boost unit 420 to decrease, and may also control the pulse width output by the trigger unit 340 to decrease, thereby The energy of the high-voltage pulse wave output by the energy storage unit 350 is reduced, thereby reducing the energy of the shock wave generated by the electrode pair 120 .

Embodiment 6

Based on the foregoing embodiments, FIG. 13 is a schematic circuit structure diagram of a medical device provided in Embodiment 6 of the present invention. Optionally, referring to FIG. 13 , the energy adjustment device 300 includes a potentiometer 303 . The potentiometer 303 is, for example, preferably a rotary potentiometer 303. The resistance value of the potentiometer 303 can be adjusted, and the required energy value can be determined according to the resistance value to adjust the energy of the high-voltage pulse wave output by the energy adjustment device 300.

Preferably, the potentiometer 303 is connected to the control unit 320. In this exemplary embodiment, preferably, the inverter boost unit 420 is configured to output a corresponding DC charging voltage according to the resistance of the potentiometer 303, and/or the trigger unit 340 is configured to output a corresponding DC charging voltage according to the resistance of the potentiometer 303. The value outputs the corresponding trigger signal. Preferably, the potentiometer 303 includes a knob, which realizes stepless adjustment of the adjustment component 330 . Specifically, the inverter boost unit 420 includes, for example, a DC-DC voltage conversion circuit. The potentiometer 303 can be connected to the inverter boost unit 420 through the control unit 320. According to the required energy value, the potentiometer 303 is rotated, and the control unit 320 receives After receiving the energy adjustment signal, the control signal is output to the inverter boost unit 420 to control the inverter boost unit 420 to adjust the output DC charging voltage amplitude according to the required energy value, so that the energy output by the energy storage unit 350 can be continuously and steplessly adjusted. , and then continuously and steplessly adjust the energy of the shock wave generated by the electrode pair 120.

For example, the trigger unit 340 can generate a trigger signal in the form of a pulse, adjust the potentiometer 303 according to the required energy value, and the control unit 320 receives the corresponding resistance value or voltage value, and determines the electrical pulse generating unit according to the corresponding resistance value or voltage value. 310 outputs the pulse duration, thereby controlling the trigger unit 340 to adjust the pulse width of the output trigger signal according to the required energy value. The smaller the pulse width, the smaller the energy output by the energy storage unit 350. The larger the pulse width, the smaller the output energy of the energy storage unit 350. The greater the energy, the energy of the high-voltage pulse wave output by the energy storage unit 350 is adjusted, and the energy of the shock wave generated by the electrode pair 120 is adjusted. For example, when the potentiometer 303 is rotated clockwise, the control unit 320 receives an energy increase signal; when the potentiometer 303 is rotated counterclockwise, the control unit 320 receives an energy decrease signal; or, when the potentiometer 303 is rotated clockwise, the control unit 320 receives an energy decrease signal. When the energy decrease signal is received, the potentiometer 303 is rotated counterclockwise, and the control unit 320 receives the energy increase signal.

Embodiment 7

Based on the foregoing embodiments, FIG. 14 is a schematic circuit structure diagram of a medical device provided in Embodiment 7 of the present invention.

Optionally, referring to FIG. 14 , the energy conditioning device 300 includes an encoder 304 . Preferably, the encoder 304 includes a knob that enables stepless adjustment of the adjustment component 330 . Optionally, the encoder 304 includes, for example, a rotary encoder or an absolute encoder, or may be other encoders. The first end of the encoder 304 is connected to the third end of the inverter boost unit 420 through the control unit 320 , and the second end of the encoder 304 is connected to the trigger unit 340 through the control unit 320 . By rotating the encoder 304, the encoder outputs a series of high-voltage electrical pulse signals, which are decoded by the control unit 320. Rotating the encoder 304 clockwise can, for example, increase the output shock wave energy; rotating the encoder 304 counterclockwise can, for example, reduce the output shock wave. Energy, according to the direction, number of grids and number of turns of the rotary encoder, the required energy value is determined, and the energy of the high-voltage pulse wave output by the energy adjustment device 300 is adjusted. The inverter boost unit 420 is configured to output a corresponding DC charging voltage according to the rotation direction of the encoder 304, the number of rotations, and the number of turns, and/or the trigger unit 340 is configured to output a corresponding DC charging voltage according to the rotation direction of the encoder 304. , the number of grids and turns of rotation outputs the corresponding trigger signal.

Specifically, the inverter boost unit 420 includes, for example, a DC-DC voltage conversion circuit. The first end of the encoder 304 can be connected to the third end of the inverter boost unit 420 through the control unit 320. According to the required energy value, the Adjust the encoder 304 clockwise or counterclockwise. After the control unit 320 receives the energy adjustment signal, the control unit 320 decodes it, outputs the control signal to the inverter boost unit 420, and controls the inverter boost unit 420 to adjust the output according to the required energy value. DC charging voltage amplitude, thereby continuously adjusting the energy output by the energy storage unit 350, thereby achieving stepless adjustment of the energy of the shock wave generated by the electrode pair 120. The trigger unit 340 can, for example, generate a trigger signal in the form of a pulse. The second end of the encoder 304 can be connected to the trigger unit 340 through the control unit 320. The encoder 304 is adjusted according to the required energy value. After the control unit 320 receives the energy adjustment signal, , output the control signal to the trigger unit 340, so that the trigger unit 340 adjusts the pulse width of the output trigger signal according to the required energy value, thereby adjusting the high-voltage pulse wave energy output by the energy storage unit 350, and thereby adjusting the energy of the shock wave generated by the electrode pair 120 .

Embodiment 8

Based on the foregoing embodiments, FIG. 15 is a schematic structural diagram of a medical device provided in Embodiment 8 of the present invention. Optionally, referring to Figure 15, the electrical pulse generation unit 310 also includes a discharge switch 311; the second end of the trigger unit 340 is connected to the second end of the energy storage unit 350 through the discharge switch 311, and the discharge switch 311 is configured to when the trigger signal is Closed at first level. Specifically, the trigger unit 340 outputs a trigger signal to the discharge switch 311. When the trigger signal is a first level, for example, the first level is a high level, the discharge switch 311 is closed, and the energy storage unit 350 outputs a signal. When the trigger signal is the second level, for example, the second level is low level, the discharge switch 311 is turned off, and the energy storage unit 350 does not output a signal. The alternating conversion of the first level and the second level forms a pulse wave, and the energy storage unit 350 outputs the pulse wave to the electrode pair 120, causing the electrode pair 120 to generate a high-voltage shock wave.

Preferably, referring to FIG. 15 , the medical device further includes a treatment switch 360 . The therapy switch 360 is located on the handle 200. Specifically, the treatment switch 360 is placed on the handle 200 for convenient operation. When the treatment switch 360 is pressed, the control unit 320 receives the signal and controls the trigger unit 340 to output a trigger signal, so that the energy storage unit 350 responds to the trigger signal and outputs a pulse wave to the electrode pair 120, and the electrode pair 120 generates a corresponding high-voltage shock wave. The treatment switch 360 controls, for example, the output and shutdown of shock waves.

Preferably, referring to FIG. 15 , the medical device further includes a voltage stabilizing unit 370 . The power supply unit 430 is connected to the first end of the voltage stabilizing unit 370 , and the second end of the voltage stabilizing unit 370 is connected to the first end of the inverter boosting unit 420 . Specifically, the voltage stabilizing unit 370 can ensure that the power supply unit 430 outputs a stable voltage, thereby ensuring that the inverter boosting unit 420 and the energy storage unit 350 can work stably, thereby improving the stability of the medical device.

Preferably, referring to FIG. 15 , the medical device further includes a power switch 380 ; the power unit 430 is connected to the first end of the voltage stabilizing unit 370 through the power switch 380 . Specifically, when using the medical device, press the power switch 380 and the power switch 380 is closed, the power unit 430 can output an electrical signal to the voltage stabilizing unit 370 to provide electrical signals for the inverter boost unit 420 and the control unit 320; when When the medical device is used, press the power switch 380 again, the power switch 380 is turned off, the inverter boost unit 420 and the control unit 320 lose power and stop working.

Preferably, referring to FIG. 15 , the energy conditioning device 300 further includes an output interface 390 ; the energy storage unit 350 is connected to the electrode pair 120 through the output interface 390 . Specifically, the energy storage unit 350 can output the pulse wave to the electrode pair 120 through the output interface 390, so that the electrode pair 120 generates a high-voltage shock wave.

Preferably, referring to Figure 15, the power supply unit 430 includes a lithium battery pack. Specifically, the use of lithium battery packs for power supply makes medical devices portable and does not require access to power at a fixed location; moreover, lithium battery packs store more energy, which can extend the use time of treatment equipment and help improve user experience.

Preferably, referring to Figure 15, the medical device further includes a voltage sampling unit 391, which is connected to the second end of the inverter boost unit 420, and the voltage sampling unit 391 is configured to collect the DC output by the inverter boost unit 420. Charging voltage. Specifically, the voltage sampling unit 391 can collect the DC charging voltage output by the inverter boost unit 420, and can send the DC charging voltage to the touch screen 301. The touch screen 301 can display the amplitude of the DC charging voltage output by the inverter boost unit 420, This allows the user to determine whether the amplitude of the DC charging voltage output by the inverter boost unit 420 reaches the target voltage amplitude; when the amplitude of the DC charging voltage does not match the target voltage amplitude, the user can continue to adjust the touch screen 301, button 302, and potential. 303 or encoder 304 to continue to adjust the DC charging voltage output by the inverter boost unit 420 until the amplitude of the DC charging voltage reaches the target voltage amplitude, thereby ensuring that the energy of the shock wave generated by the electrode pair 120 meets the demand.

This embodiment can achieve segmented and/or continuous adjustment of the output energy of the shock wave power supply, control the output shock wave energy, and improve clinical adaptability during the clinical treatment of the IVL system and related medical research and experiments on arterial vascular calcification lesions. sex. During clinical treatment, the operator can adjust the output shock wave pulse energy according to the patient's actual arterial calcification lesions and treatment effects to effectively break and loosen calcified materials and increase the lumen diameter of the blood vessel to facilitate subsequent vascular stent implantation. and other treatment measures to improve postoperative results and shorten patient recovery time. In addition, it facilitates medical research and experiments related to arterial vascular calcification lesions, assists doctors in conducting refined experiments, analysis, and research on different types of arterial vascular calcification lesions, and promotes the improvement and perfection of clinical treatment methods to further improve and improve arterial vascular calcification lesions. Safety, reliability and effectiveness of clinical treatment of lesions.

Embodiment 9

Based on the foregoing embodiments, FIG. 17 is a schematic circuit structure diagram of yet another medical device provided in Embodiment 9 of the present invention. Referring to Figure 17, the power supply unit 430 includes a lithium battery pack 431, the inverter boost unit 420 includes a DC-DC boost unit 421, and the detection unit 410 includes a current sensor 411. The current sensor 411 can be connected between the energy storage unit 350 and the output interface 390. During the period, the current signal output by the energy storage unit 350 is collected, and the current signal can be output to the control unit 320; the output interface 390 is connected to the control unit 320, and the control unit 320 can control whether the output interface 390 is turned on, and can also detect the output interface. 390 state; the medical device also includes a switch circuit 440, the power switch 380 is connected to the voltage stabilizing unit 370 through the switch circuit 440, and the power switch 380 is connected to the power end of the control unit 320 through the switch circuit 440; the medical device also includes a regulator Unit 450, the control unit 320 is connected to the DC-DC boost unit 421 through the adjustment unit 450. The adjustment unit 450 can adjust the amplitude and pulse width of the control signal output by the control unit 320, thereby adjusting the voltage received by the DC-DC boost unit 421. The control signal is used to adjust the amplitude of the DC charging voltage output by the DC-DC boost unit 421.

Embodiment 10

Based on the foregoing embodiments, FIG. 18 is a schematic circuit structure diagram of yet another medical device provided in Embodiment 10 of the present invention. Due to the physical structure limitations of the shock wave balloon, the high-voltage pulse shock wave excitation signal must reach a certain amplitude, such as DC2000V or above, or the ground is within the range of DC2000V ~ DC3500V, so that the built-in electrode of the shock wave balloon can break down the discharge and generate pulse sound pressure shock waves for treatment. For calcified lesions, if the excitation voltage is too low, the balloon electrode cannot break down and shock waves cannot be generated; if the excitation voltage is too high, the current will be too large during breakdown and discharge of the balloon electrode, and the built-in electrode will easily burn, seriously affecting its service life. The turn-on and turn-off delay times of general high-voltage switching devices are above 0.1us, and the discharge current detection time is generally above 0.2us. When high-voltage pulses are output, even if the width of the trigger control pulse is reduced, it is actually difficult to continue to reduce it. The actual width of the small shock wave pulse cannot continue to reduce the shock wave energy from the pulse width. When the pulsed shock wave generated by the shock wave balloon targets uneven calcified lesions, the calcified material is in a soft and irregular state. A low-energy shock wave is required to vibrate the calcified material flat and smooth out the uneven tissue, thereby smoothing the low-energy calcified material. Shock waves are used in the clinical treatment of arterial stenosis, blockage and other diseases, as well as other application scenarios that require low-energy shock waves. Referring to Figure 18, a voltage dividing unit 460 is provided in the high-voltage pulse discharge circuit provided in this embodiment. One end of the voltage dividing unit 460 is electrically connected to the output end of the electrical pulse generating unit 310, and the other end of the voltage dividing unit serves as an output end. The electrode pairs 120 provided in the balloon 110 are connected, and the voltage dividing unit is used to bear part of the pulse wave voltage and/or limit the pulse wave current. The high-voltage electric pulses emitted by the electric pulse generating unit 310 can be directly output by the high-voltage pulse power supply unit or the high-voltage electric pulses adjusted by the energy adjustment signal, and then divided by the voltage of the voltage dividing unit 460 for outputting the divided voltage. The pulse width and/or pulse amplitude of the balloon after pressure and/or current limiting are in the continuous breakdown state, so that the balloon can receive low-energy shock waves in the continuous breakdown state, so that the discharge breakdown current of the electrode pair is reduced. , the energy of the shock wave is further reduced, achieving a low-energy shock wave that maintains the shock wave balloon in a continuous breakdown state. When the built-in electrode of the shock wave balloon is excited by a high-voltage pulse voltage and undergoes breakdown discharge, the voltage divided by the series voltage dividing unit 460 causes the power supply unit 430 to control a part of the output DC voltage of the power supply unit 430 through the power switch 380 to be directly loaded into the shock wave balloon. On the built-in electrode, the high-voltage pulse output power supply unit 430 is connected in series with the voltage dividing unit 460, so that when the balloon 110 undergoes breakdown discharge under high-voltage excitation, the output voltage of the power supply unit 430 is divided by the voltage dividing unit 460, and the voltage generated by the electrode pair 120 The actual voltage and current of the shock wave energy are controlled by the voltage dividing unit 460 so that the impact energy of the pulse shock wave can be limited within a certain range.

Figure 19 is a schematic diagram of the circuit structure of a low-energy shock wave of a medical device provided in Embodiment 10 of the present invention. Referring to Figure 19, when the power switch Q1 is closed, the conduction voltage drop is very low and can be ignored. When it is necessary to further reduce the high-voltage shock wave energy output by the shock wave generating unit according to the actual calcified material situation, the voltage value provided by the high-voltage pulse output power supply unit 430 is S1, the internal resistance Rs of the power output cable and the balloon catheter, and the power switch Q1 In the on state, the series voltage dividing unit 460 on the discharge path is set as a high voltage dividing and current limiting resistor Rv with a certain variable resistance value. The specific value of Rv can be determined according to the shock wave energy. Through the series voltage dividing and current limiting resistor, Resistor Rv, the internal resistance is basically unchanged after the balloon breaks down, but when the internal resistance is the same, the shock wave energy value can be greatly reduced;

When Rv is not connected in series, or when Rv=0Ω,

For example, S1=3000V, Rs=10Ω, and the internal resistance after balloon breakdown is 1.8Ω, then the pulse discharge current I _Π is:

In this embodiment, after Rv is connected in series, that is, when Rv>0Ω or a certain preset value,

For example, S1 = 3000V, Rv = 12Ω, Rs = 10Ω, the internal resistance does not change after the balloon breaks down and is still 1.8Ω, then the pulse discharge current I _Π is:

The discharge current at this time is nearly 1/2 lower than before the series Rv;

According to the above, since the internal resistance of the balloon remains basically unchanged after breakdown, and when the internal resistance is the same, the shock wave energy of the same pulse width is proportional to the square of the discharge current, so the shock wave energy is reduced to 1/4 of the original, and the shock wave energy is greatly decrease.

In the high-voltage pulse discharge circuit, after the voltage-dividing current-limiting resistor Rv is connected in series, the internal resistance of the balloon is much larger than the voltage-dividing current-limiting resistor Rv under the high-voltage pulse excitation before breakdown discharge, so the high-voltage pulse is almost completely loaded to The balloon ensures that the balloon can penetrate normally and generate shock waves.

After the balloon breaks down normally, the internal resistance becomes smaller instantly due to the formation of a discharge current path. At this time, the shock wave high voltage in the circuit is partially divided by the voltage dividing and current limiting resistor Rv in series, and the shock wave current is divided by the voltage dividing and current limiting resistor Rv. The internal resistance of the cable and balloon catheter is limited to a certain range. Therefore, the high-voltage pulse voltage on the shock wave balloon falls back instantly after the built-in electrode of the balloon breaks down and is maintained within a certain range to ensure that the balloon can continue to breakdown. In this state, a lower energy shock wave is produced.

During the balloon breakdown process, in the high-voltage pulse discharge circuit, after the voltage dividing unit 460 is connected in series, the internal resistance of the balloon 110 is much larger than the resistance Rv of the voltage dividing unit 460 under the high-voltage pulse excitation before breakdown and discharge. At this time, almost all the high-voltage pulses are loaded into the balloon 110, which ensures that the balloon 110 can break down normally and generate a high-voltage pulse shock wave.

After the balloon breaks down normally, the internal resistance becomes smaller instantly due to the formation of a discharge current path. At this time, part of the shock wave high voltage in the circuit is divided by the voltage dividing unit 460 in series. The shock wave current is divided by the voltage dividing unit 460 and the cable. The internal resistance of the balloon catheter is limited to a certain range, so that the high-voltage pulse voltage received on the balloon 110 falls back instantly after the built-in electrode of the balloon breaks down, and remains in a state that ensures that the balloon can continue to break down, generating a lower energy shock wave. Within the energy range, it acts on the calcification of diseased tissues.

In the shock wave discharge circuit of this embodiment, compared with the continuous high-voltage shock wave, the pressure dividing unit mentioned in this embodiment can reliably penetrate the shock wave balloon by the shock wave of high-voltage energy, and at the same time effectively reduces the shock wave. The breakdown current of the balloon generates a lower energy shock wave required to impact the calcified diseased tissue; after the balloon electrode breaks down, the voltage carried by the voltage dividing unit allows the balloon to receive a lower energy shock wave, which is achieved through the voltage dividing unit For the output of low-energy shock waves, there is no limit on whether the high-voltage electric pulse output by the power supply unit needs to be adjusted. The output of the electric pulse unit can be a high-voltage electric pulse output according to the energy adjustment requirement, or it can be directly output from the high-voltage power supply unit to The high-voltage electric pulse of the electric pulse generating unit passes through the voltage dividing unit to reduce the voltage generated by the balloon's built-in electrode pair and/or the flowing breakdown current to the low or low level required for the target calcified tissue or calcified site. It requires lower energy and avoids burning and damage to the built-in electrode pair of the shock wave balloon, which greatly improves the safety and reliability of IVL clinical treatment.

Embodiment 11

Based on the foregoing embodiments, FIG. 20 is a flow chart of a control method for a medical device provided in Embodiment 11 of the present invention. The control method is used to adjust the shock wave energy of a balloon catheter. The control method adopts the medical device provided in this embodiment. With reference to Figures 1 and 20, the control method includes:

S101. Adjust the adjustment component. The adjustment component is used to send out energy adjustment signals;

Specifically, when the energy of the shock wave generated by the electrode pair 120 is higher or lower than the preset energy, the adjustment component 330 can be adjusted, and the adjustment component 330 sends out an energy adjustment signal. The adjustment component 330 may be adjusted by the control unit 320 or may be adjusted by the user.

S102. The control unit receives the energy adjustment signal, and adjusts the pulse width and/or pulse amplitude of the high-voltage electric pulse sent by the electric pulse generating unit according to the energy adjustment signal. Specifically, after receiving the energy adjustment signal, the control unit 320 adjusts the pulse width and/or pulse amplitude of the high-voltage electric pulse sent by the electric pulse generation unit 310 according to the energy adjustment signal, thereby adjusting the pulse wave output by the energy adjustment device 300. energy, thereby adjusting the energy of the shock wave generated by the electrode pair 120. For example, when the energy of the shock wave generated by the electrode pair 120 is low, by adjusting the adjustment component 330, the adjustment component 330 sends an energy adjustment signal with increased energy, the control unit 320 controls the pulse width of the shock wave emitted by the electrical pulse generation unit 310 to increase, and /Or, the pulse amplitude of the shock wave emitted by the electric pulse generating unit 310 is controlled to increase, thereby increasing the energy of the shock wave generated by the electrode pair 120; when the energy of the shock wave generated by the electrode pair 120 is relatively high, the adjustment component 330 is adjusted. The component 330 sends an energy adjustment signal with reduced energy, and the control unit 320 controls the pulse width of the high-voltage electric pulse sent by the electric pulse generating unit 310 to decrease, and/or controls the pulse amplitude of the high-voltage electric pulse sent by the electric pulse generating unit 310. The value decreases, thereby reducing the energy of the shock wave generated by the electrode pair 120 .

S103. The electrode pair emits a shock wave in the balloon under the control of the control unit, and the shock wave acts on the target tissue. Specifically, the control unit 320 controls the electrode pair 120 to send high-voltage electrical pulses to the balloon 110 . In the balloon 110, a short-term high-voltage discharge can impact and fragment the calcified material in the superficial and deep diseased blood vessels, causing the blood vessels to be moderately softened, thereby significantly improving the compliance of the blood vessels. The energy generated by the electrode pair 120 is adjusted according to the demand to avoid the problem that the energy generated by the electrode pair 120 is low or high, resulting in poor therapeutic effect, or causing damage to the patient's vascular intima.

Based on the above technical solution, optionally, the step of adjusting the pulse width and pulse amplitude of the high-voltage electric pulse emitted by the electric pulse generating unit according to the energy adjustment signal includes:

Step a: Determine the target energy value according to the energy adjustment signal, and adjust the pulse width according to the first ratio according to the target energy value. For example, when the energy needs to be increased by 10%, the first proportion is a%, and the energy increase proportion obtained by adjusting according to the first proportion a% is A%, and A% is not greater than 10%. Optionally, A% can be 0. The adjustment methods for energy reduction and energy increase are similar and will not be described in detail.

Step b: Adjust the pulse amplitude according to the second ratio according to the target energy value. For example, when the energy needs to be increased by 10%, the second proportion is b%, and the energy increase proportion obtained by adjusting according to the second proportion b% is B%, and B% is not greater than 10%. Optionally, B% can be 0. Similarly, the adjustment method of energy reduction will not be described again. The specific values of the first ratio and the second ratio can be determined based on the actual situation, for example, based on the circuit structure and circuit parameters, or based on the most appropriate voltage amplitude and energy corresponding to the physical structure of the balloon component. Wherein, the sum of the energy value of the pulse width adjusted according to the first ratio and the energy value of the pulse amplitude adjusted according to the second ratio is equal to the target energy value. For example, the sum of the energy increase ratio A% obtained by adjusting according to the first ratio a% and the energy increase ratio B% obtained by adjusting the second ratio b% is equal to an energy increase of 10%. When the pulse width and pulse amplitude are adjusted, the sum of the energy values obtained is the target energy value, thereby adjusting the shock wave energy to achieve the shock wave acting on the target tissue.

Optionally, determine the target voltage amplitude and target pulse width corresponding to the energy adjustment signal according to the pre-stored relationship between the energy value, voltage amplitude and pulse width of the energy adjustment signal; or, according to the pre-stored energy adjustment signal The corresponding relationship between energy value, voltage amplitude and pulse width determines the first ratio and the second ratio.

For example, when the shock wave generating unit in the balloon assembly discharges, the energy passing through in a short time (0.1us to 2us) can be approximately equivalent to:

Among them, E is the energy value of the high-voltage shock wave output by the shock wave generating unit, U is the voltage amplitude of the high-voltage shock wave, τ is the pulse width of the high-voltage shock wave, and R is the internal resistance of the discharge path after balloon breakdown and the internal resistance of the discharge line. The sum of obstacles. After the physical structure of the balloon component is determined, the difference in internal resistance after each shock wave breakdown discharge is small and can be ignored. At this time, R can be regarded as a fixed value, and the specific value of R can be determined according to the characteristics of the balloon component. structure is determined.

When the pulse width of the shock wave remains unchanged, the relationship between the voltage amplitude and energy value of the shock wave is as follows:

When the voltage amplitude of the shock wave remains unchanged, the relationship between the pulse width and energy value of the shock wave is as follows:

When the voltage amplitude and pulse width of the shock wave can be adjusted, and when the pulse width is 0.4us-1.6us, simplifying equation (2), the relationship between voltage amplitude, pulse width and energy is obtained as follows:

Among them, the coefficient k ₁ is the square root of the reciprocal of the pulse width τ. Table 1 is the corresponding relationship between the coefficient k ₁ and the pulse width τ. Table 1 only lists the coefficient k ₁ corresponding to part of the pulse width τ. Actual pulse widths include, but are not limited to, the values in Table 1.

Table 1 Correspondence table between coefficient k ₁ and pulse width τ

When the voltage amplitude of the shock wave is 2600V-3200V, simplify equation (2) and obtain the relationship between voltage amplitude, pulse width and energy as follows:

τ＝k ₂ ER(5)

Among them, the coefficient k ₂ is the reciprocal of the square of the voltage amplitude. Table 2 is the corresponding relationship between the coefficient k ₂ and the voltage amplitude. Table 2 only lists the coefficient k ₂ corresponding to some voltage amplitudes. Actual voltage amplitudes include but are not limited to the values in Table 2.

Table 2 Correspondence table between coefficient k ₂ and voltage amplitude

For example, after the physical size and structure of the balloon component are determined, the voltage amplitude and pulse width range of the shock wave are determined. The voltage amplitude and pulse width of the shock wave need to be adjusted within a reasonable range acceptable to the balloon component.

In addition, according to the corresponding energy adjustment range of the balloon component, according to the type of balloon component and its suitable shock wave voltage amplitude range, according to formula (5), a reasonable voltage amplitude can be determined first to determine the coefficient k ₂ and then calculate A second proportion of the corresponding voltage amplitude is determined. In the same way, according to formula (4), first determine a reasonable pulse width to determine the coefficient k ₁ , and then calculate and determine the first ratio of the corresponding pulse width. The energy value of the pulse width obtained by adjusting according to the first ratio is the same as the energy value according to the second ratio. The energy value of the pulse amplitude obtained by the proportional adjustment can act on the electrode pair built into the balloon to generate a shock wave that meets the target energy value.

Embodiment 12

Based on the foregoing embodiments, Figure 21 is a flow chart of a control method for a medical device provided in Embodiment 13 of the present invention. Referring to Figures 9, 10 and 21, the control method for a medical device includes: adjusting an adjustment component. Before,

S201. Determine the energy value of the shock wave received by the balloon 110 last time based on the voltage value and/or current value of the previous electric pulse generating unit 310. Determine the generation of the electrode pair 120 by the pulse width and/or pulse amplitude of the received shock wave. Whether the shock wave meets the needs.

S202. Determine whether the energy value of the previous shock wave is consistent with the energy value corresponding to the preset energy adjustment signal. If they are inconsistent, adjust the adjustment component 330; specifically, the preset energy adjustment signal is, for example, the energy adjustment signal output by the adjustment component 330. , when the energy value of the current shock wave is inconsistent with the energy value corresponding to the preset energy adjustment signal, it indicates that the energy of the shock wave generated by the electrode pair 120 is too low or too high, and does not meet the energy adjustment requirements of the shock wave during the current decomposition of calcified tissue. Make energy adjustments.

Optionally, S2031, when the voltage value of the electrical pulse generating unit does not meet the target voltage amplitude corresponding to the energy adjustment signal, the control unit 320 adjusts the pulse amplitude of the electrical pulse generating unit 310. Specifically, after the control unit 320 receives the energy adjustment signal, if the voltage value output by the electrical pulse generation unit 310 meets the target voltage amplitude corresponding to the energy adjustment signal, there is no need to adjust the pulse amplitude of the electrical pulse generation unit 310. When the voltage value output by the electrical pulse generating unit 310 does not meet the target voltage amplitude corresponding to the energy adjustment signal, the control unit 320 will adjust the pulse amplitude of the electrical pulse generating unit 310 to adjust the pulse wave output by the electrical pulse generating unit 310 The energy is used to output a shock wave with a pulse amplitude within a preset amplitude range, which acts on the target tissue to decompose calcified tissue.

Optionally, S2032, collect the current signal of the electrical pulse generating unit 310 this time, and control the current signal of the electrical pulse generating unit 310 through the control unit 320. When it is necessary to adjust the energy of the output shock wave, the control unit 320 is configured as The energy adjustment signal sends a pulse command to the electrical pulse generating unit 310, and the electrical pulse generating unit 310 is adjusted to send out a shock wave with a pulse width that meets the preset pulse width range, and acts on the target tissue to achieve decomposition of calcified tissue.

It can be understood that the order of steps S2031 and S2032 can be adjusted, for example, S2031 is before or after S2032, or steps S2031 and S2032 are performed only one step, which is not limited here.

Based on the above embodiment, after the adjustment component 330 sends the energy adjustment signal, the method may also include: detecting and controlling the voltage value of the current electrical pulse generating unit 310, and detecting the current value of the current electrical pulse generating unit 310. , adjust the output pulse width. Specifically, after the adjustment component 330 sends out the energy adjustment signal, it detects the voltage value of the electrical pulse generation unit 310 this time, and adjusts the electrical pulse according to the voltage value of the electrical pulse generation unit 310 this time and the target voltage amplitude corresponding to the energy adjustment signal. The voltage value output by the generating unit 310 until the voltage value output by the electrical pulse generating unit 310 meets the target voltage amplitude. Optionally, detect the current value of the electrical pulse generating unit 310 this time, and adjust the pulse width of the pulse wave output by the electrical pulse generating unit 310 according to the current value of the electrical pulse generating unit 310 and the target pulse width corresponding to the energy adjustment signal. , until the pulse width output by the electrical pulse generating unit 310 meets the target pulse width and the preset pulse width interval range, thereby achieving energy adjustment of the pulse wave output by the electrical pulse generating unit 310, and thereby adjusting the energy of the shock wave generated by the electrode pair 120.

Embodiment 13

IVL is an innovative breakthrough in the field of interventional therapy. Whether it is left main disease, angular disease, incomplete stent expansion, annular, eccentric calcification, superficial or deep calcification, etc., IVL has shown great advantages in clinical application. In the clinical treatment of arterial vascular calcification lesions, it has been increasingly recognized and promoted by the medical system.

Based on the foregoing embodiments, at least one structure or circuit in the second to ninth embodiments will not be described in detail here. The system further includes an IVL system including a balloon 110. The balloon 110 is provided with an electrode pair 120 that generates shock waves in the balloon. The IVL system is also provided with an energy adjustment device that responds to the insertion state and/or movement of the balloon. In addition to the energy adjustment requirements under the state, the energy adjustment device includes an electrical pulse generation unit 310, a control unit 320 and an adjustment component 330;

In the working state, the adjusting component is configured to obtain the pulse width and/or pulse amplitude of the high-voltage electric pulse emitted by the electric pulse generating unit according to the energy adjustment requirement and adjusted by the control unit. The high-voltage electric pulse is emitted in the balloon through the electrode pair. Shock wave, acting on target tissue.

The first end of the detection unit of the IVL system is connected to the detection end of the electrical pulse generation unit, and the second end of the detection unit is connected to the control unit. The detection unit is used to collect the current signal of the electrical pulse generation unit, and the control unit is used to receive the current signal. And obtain the duration of the shock wave that has occurred, as well as the duration of the target pulse width corresponding to the energy adjustment signal used by the control unit, determine the duration of the pulse output of the electrical pulse generation unit, and issue a pulse command to the electrical pulse generation unit based on the duration of the pulse output , to adjust the pulse width.

The IVL system also includes an inverter boost unit and a power supply unit. The power supply unit is connected to the input end of the electrical pulse generating unit through the inverter boost unit. The inverter boost unit is used to boost the low voltage output by the power supply unit to high voltage. In this application example, a system that can adjust the shock wave energy value received by the balloon is designed to adapt to the situation where the shock wave energy value received by the balloon needs to be adjusted for different degrees of calcification during clinical treatment, making IVL clinical treatment and application safer. , efficient.

The IVL system of this embodiment is an application of a balloon whose shock wave energy can be adjusted segmentally and/or continuously to impact calcified tissue in arterial vascular tissue. It can be used in the clinical treatment of the IVL system and related to arterial vascular calcification lesions. In medical research and experiments, the output energy of the shock wave power supply is adjusted in segments and/or continuously to control the output shock wave energy and improve clinical adaptability. During clinical treatment, the operator can adjust the pulse width and/or pulse amplitude of the output high-voltage electric pulse according to the patient's actual arterial calcification lesions and the treatment effect, so that the generated shock wave pulse energy can effectively break and loosen calcified substances. , increasing the lumen diameter of blood vessels to facilitate subsequent treatment measures such as vascular stent implantation, improve postoperative effects and shorten patient recovery time. In addition, it facilitates medical research and experiments related to arterial vascular calcification lesions, assists doctors in conducting refined experiments, analysis, and research on different types of arterial vascular calcification lesions, and promotes the improvement and perfection of clinical treatment methods to further improve and improve arterial vascular calcification lesions. Safety, reliability and effectiveness of clinical treatment of lesions.

Embodiment 14

The technical principle of the present invention is not limited to the energy adjustment of the shock wave balloon. In this embodiment, if a system has a need for shock wave energy adjustment, it includes a shock wave sending module, a shock wave receiving module, and an energy adjustment device. One end of the energy adjustment device is connected The other end of the shock wave sending module is connected to the shock wave receiving module. The energy adjustment device is used to monitor the energy adjustment needs of the shock wave receiving module, determine the energy adjustment signal of the energy adjustment device, and adjust the shock wave energy of the shock wave sending module according to the energy adjustment signal to act on the shock wave reception. The module generates shock wave pulse energy to effectively break and loosen calcified materials.

It should be understood that various forms of the process shown above may be used, with steps reordered, added or deleted. For example, each step described in the present invention can be executed in parallel, sequentially, or in different orders. As long as the desired results of the technical solution of the present invention can be achieved, there is no limitation here.

The above-mentioned specific embodiments do not constitute a limitation on the scope of the present invention. It will be understood by those skilled in the art that various modifications, combinations, sub-combinations and substitutions are possible depending on design requirements and other factors. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention shall be included in the protection scope of the present invention.

Claims (9)

1. A medical device for decomposing calcification of target tissue, characterized in that it includes: a balloon, an energy adjustment device, an electrode pair and a voltage dividing unit; The energy regulating device includes an electrical pulse generating unit, a control unit and a regulating component. The regulating component is connected to the control unit. The control unit is connected to the control end of the electrical pulse generating unit. The electrical pulse generating unit The output end is connected to the electrode pair; the energy adjustment device is configured to respond to the energy adjustment demand of the balloon in the insertion state and/or removal state, and the adjustment component emits energy according to the energy adjustment demand. Adjust the signal and output it to the control unit. The control unit controls the pulse width and pulse amplitude, or pulse width, of the high-voltage electric pulse emitted by the electric pulse generating unit according to the received energy adjustment signal. The electrode pair , the electrode pair is arranged in the balloon, and the high-voltage electric pulse output by the energy adjustment device generates a shock wave in the balloon through the electrode pair and acts on the target tissue; and a voltage dividing unit. One end of the voltage dividing unit is electrically connected to the output end of the electric pulse generating unit, and the other end of the voltage dividing unit serves as an output end and is connected to the electrode pair provided in the balloon. By outputting the pulse width and/or pulse amplitude of the balloon in the continuous breakdown state after partial pressure and/or current limiting, the balloon can receive the low-energy shock wave in the continuous breakdown state. When the shock wave The pulsed shock wave generated by the balloon targets uneven calcified lesions. The calcified material is in a soft and irregular state. Low-energy shock waves are needed to vibrate the calcified material flat and smooth and dredge the uneven tissue, thereby applying low-energy shock waves. In the state of arterial stenosis and blockage; The control unit controlling the pulse width of the high-voltage electric pulse emitted by the electric pulse generating unit according to the received energy adjustment signal includes: The control unit is configured to determine the effective shock wave duration that has been generated based on the current response delay duration and current collection duration of the current signal of the electrical pulse generating unit, and determine the duration of the target pulse width corresponding to the energy adjustment signal, Determine the duration of the pulse output of the electrical pulse generating unit, and send a pulse instruction or signal to the electrical pulse generating unit according to the calculated duration of the pulse output. The control unit adjusts the electrical pulse through the pulse instruction. The generating unit emits a high-voltage electric pulse with a pulse width that meets the preset pulse width range; the control unit is used to when the detection unit collects the current signal, the time according to the target pulse width is equal to the response time of the current signal plus the delay cut-off time. The calculation formula is based on the calculation formula that the time of the target pulse width is equal to the response time of the current signal plus the delay cut-off time; the pulse width adjustment range is 0.5us ~ 1.5us; when the control unit detects that a current signal occurs, according to Based on the difference between the target pulse width time and the response time of the current detection signal, the control unit delays and cuts off the electrical pulse generating unit to stop outputting current, and stops the pulse signal generated by the electrical pulse generating unit to achieve pulse width adjustment within microseconds; Wherein, the pulse width of the preset pulse width interval at least includes the duration of the pulse output, and the preset pulse width interval range is set to a pulse width interval including the pulse width of the target pulse width pulse output. It can safely impact and fragment the calcified material in superficial and deep diseased blood vessels within a wide range, causing the calcification to rupture and loosen; Using the pulse command to adjust the electrical pulse generating unit to generate high-voltage electrical pulses with a pulse width that meets the preset pulse width range includes: Collect the current signal of the electrical pulse generating unit. When the current value of the electrical pulse generating unit is greater than the preset current threshold, determine the shock wave duration threshold corresponding to the current signal. The duration threshold includes the current collection duration and Current response delay time; When the difference between the duration of the target pulse width corresponding to the energy adjustment signal and the duration threshold meets a preset difference value, the control unit controls the electrical pulse generating unit to issue the pulse command to adjust the electrical pulse. The generating unit emits a high-voltage electric pulse with a pulse width that meets the preset pulse width range, acts on the electrode pair, generates a shock wave in the balloon, and acts on the target tissue; the preset difference value includes the preset difference value range, and/or, the preset difference value includes a preset ratio range. 2. The medical device according to claim 1, characterized in that when the pulse amplitude corresponding to the voltage value of the electrical pulse generating unit does not meet the target voltage amplitude corresponding to the energy adjustment signal, the adjustment component The energy adjustment signal is sent out according to the difference between the target voltage amplitude and the current voltage value. The control unit is used to receive the energy adjustment signal to adjust the electrical pulse generating unit to send out an energy adjustment signal that satisfies the preset amplitude interval. A high-voltage electric pulse with a range of pulse amplitudes acts on the electrode pair to generate a shock wave in the balloon that acts on the target tissue, wherein the amplitude of the preset amplitude range at least includes the target voltage amplitude. 3. The medical device according to claim 1, characterized in that the medical device further includes a detection unit, a first end of the detection unit is connected to the detection end of the electrical pulse generating unit, and the detection unit The second end is connected to the control unit. The detection unit is configured to collect the current signal of the electrical pulse generating unit this time. The control unit is used to receive the current signal and obtain the current signal based on the current signal. The moment the shock wave occurs. 4. The medical device according to claim 1, wherein the control unit is configured to adjust the pulse width corresponding to the energy adjustment requirement set by the adjustment component when the detection unit collects the current signal. demand, cut off the pulse signal generated by the electrical pulse generating unit. 5. A medical device according to claim 1, characterized in that, the control unit includes at least one of MCU, DSP, and FPGA; And/or, the medical device further includes an inverter boost unit and a power supply unit. The power supply unit is connected to the input end of the electrical pulse generating unit through the inverter boost unit. The inverter boost unit It is used to increase the low voltage output by the power supply unit to a high voltage, and the voltage of the pulse output by the electric pulse generating unit is greater than 700V. 6. A medical device according to claim 1, characterized in that the medical device further includes an inverter boost unit, and the output end of the inverter boost unit and the input end of the electrical pulse generating unit Electrically connected, the control unit is electrically connected to the control end of the inverter boost unit, and the control unit is used to control the inverter boost unit to adjust the pulse amplitude when the pulse amplitude needs to be adjusted. value. 7. The medical device according to claim 1, wherein the adjustment component includes at least one of a touch screen, a button, a potentiometer, and an encoder; or, the medical device further includes a handle and a host, and the The adjustment component includes at least one of a touch screen, a button, a potentiometer, and an encoder, and the adjustment component is provided on the handle or the host; Wherein, the keys include an energy increase key and an energy decrease key, and the energy increase key or the energy decrease key realizes segmented adjustment of the adjustment component; or, the potentiometer or the encoder includes a knob. , the knob realizes stepless adjustment of the adjustment component; or, the touch screen includes an energy segmented adjustment button or an energy stepless adjustment button. 8. An IVL system comprising the medical device of any one of claims 1-7. 9. A shock wave energy adjustment system, the shock wave energy adjustment system is applied to the medical device according to any one of claims 1 to 7, wherein the system further includes: a shock wave emitting module and a shock wave receiving module , energy regulating device, One end of the energy adjustment device is connected to the shock wave emitting module, and the other end is connected to the shock wave receiving module. The energy adjustment device is used to monitor the energy adjustment needs of the shock wave receiving module and determine whether the energy adjustment device The energy adjustment signal is used to adjust the shock wave energy of the shock wave emitting module to act on the shock wave receiving module according to the energy adjustment signal.