Ultrasonic scalpel surgery system and control method thereof

Abstract

The present invention discloses an ultrasonic scalpel surgical system, which includes an ultrasonic scalpel, a transducer and a host. The ultrasonic scalpel is connected to the transducer, and the transducer is connected to the host through a cable. The transducer includes a transducer housing and a transducer vibrator located in the transducer housing; a temperature and humidity sensor is also provided in the transducer housing, and the temperature and humidity sensor is connected to the host through the cable. The present invention also discloses a control method for an ultrasonic scalpel surgical system. The present invention can realize a detachable connection between the external cable and the transducer, and adding a temperature and humidity sensor inside the transducer can monitor the internal temperature and humidity of the transducer in real time, thereby ensuring the safety and effectiveness of the product, and also improving the service life of the transducer.

Description

Technical Field

[0001] The present invention relates to an ultrasonic scalpel surgical system and a control method thereof, belonging to the technical field of ultrasonic scalpel medical instruments. Background Art

[0002] The transducer is an important component of the medical ultrasonic scalpel surgical system. The performance of the transducer directly affects the performance of the entire ultrasonic scalpel surgical system. Usually, the transducer is connected to the ultrasonic scalpel through a thread and then connected to the host through a cable. It converts the electrical signal provided by the host into high-frequency vibration mechanical motion, which is then transmitted to the ultrasonic scalpel, thereby driving the ultrasonic scalpel's blade head to vibrate at high frequency to cut, separate, and stop bleeding in the tissue.

[0003] During surgery, the ultrasonic scalpel's blade continuously cuts tissue, effectively adding a load to the transducer. This prolonged loading can cause the transducer's internal temperature to exceed 85°C. The piezoelectric ceramic within the transducer is susceptible to temperature fluctuations. When the temperature exceeds 85°C, the piezoelectric ceramic's performance degrades significantly, impairing the piezoelectric effect's ability to convert electrical energy into mechanical energy (ultrasound). This degrades the transducer's efficiency, compromising surgical quality and increasing surgical risk. Furthermore, because the front, middle, and rear ends of the transducer are press-fitted together using an interference fit, while sealing rings are installed at the joints, repeated cleaning and sterilization (particularly high-temperature, high-pressure, and wet heat sterilization) can easily degrade the sealing rings, leading to seal failure. This allows high-temperature steam to leak into the transducer, damaging its core components and causing the medical device to malfunction, halting surgery and delaying treatment.

[0004] During ultrasonic scalpel surgery, if the performance of the ultrasonic scalpel and the supporting transducer in the ultrasonic scalpel surgical system deteriorates, the system may not work. Temporarily replacing a new ultrasonic scalpel or transducer not only prolongs the operation time, but also easily brings unexpected risks to the operation. How to evaluate and warn of possible problems with the ultrasonic scalpel and transducer in advance is a technical problem that needs to be solved to improve the reliability of the ultrasonic scalpel surgical system. Summary of the Invention

[0005] In order to improve the stability of the ultrasonic surgical system and minimize the occurrence of failures due to transducer problems, the present invention provides an ultrasonic scalpel surgical system, and the specific technical solution is as follows.

[0006] An ultrasonic scalpel surgical system comprises an ultrasonic scalpel, a transducer, and a host, wherein the ultrasonic scalpel is connected to the transducer, and the transducer is connected to the host via a cable, wherein the transducer comprises a transducer housing and a transducer vibrator located within the transducer housing; and wherein:

[0007] A temperature and humidity sensor is also provided in the transducer housing, and the temperature and humidity sensor is connected to the host through the cable.

[0008] Furthermore, the transducer housing includes a front-end housing, a middle-end housing and a tail-end housing connected in sequence, and a cable connector is provided in the tail-end housing, and the cable connector has an electrode electrically connected to the transducer vibrator. By providing a cable connector in the tail-end housing of the transducer and also providing a corresponding transducer connector at the end of the cable, the cable and the transducer can be detachably connected by simply plugging the cable and the tail-end housing of the transducer. On the one hand, the transducer and the cable are installed in a detachable manner. If the cable is damaged, the cable can be replaced without affecting the use of the transducer, thereby improving the service life of the transducer. And when the cable is entangled with other cables, the cable can be removed from the transducer, which is convenient for untangling and helps to improve the work efficiency of the user.

[0009] Furthermore, the cable connector includes an insulator and the electrode, and the electrode passes through the insulator; the tail end shell has an internal threaded hole, and the insulator has an external thread, and the tail end shell and the insulator are threadedly connected.

[0010] Furthermore, the outer surface of the insulator has a circumferential groove, and a sealing ring is disposed within the circumferential groove. When the insulator is threadedly connected to the tail end housing, the sealing ring is used to seal the gap between the insulator and the tail end housing, preventing moisture from entering the interior of the transducer through the gap between the insulator (cable connector) and the tail end housing, thereby affecting the performance of the transducer vibrator.

[0011] Furthermore, the insulator is made of engineering plastic, preferably PSU plastic. The electrodes can be fixed in the insulator by injection molding.

[0012] Furthermore, the inner end surface of the insulator is provided with a positioning groove. When assembling the transducer, a corresponding tool can be inserted into the positioning groove, and the tool can be rotated to threadably connect the insulator and the tail end housing.

[0013] Furthermore, the transducer includes a transducer rubber cover, which is mounted on the middle and tail housings. Preferably, the outer surface of the transducer rubber cover has several protrusions. The transducer rubber cover can increase friction on the outer surface of the transducer, thereby overcoming the problem of slippage when the transducer is rotated and connected to the ultrasonic scalpel.

[0014] Furthermore, the transducer is encapsulated with silicone rubber containing graphite and carbon black. The combination of highly thermally conductive graphite microparticles and carbon black particles significantly improves the thermal conductivity and mechanical properties of the silicone rubber, facilitating heat dissipation of the transducer and ensuring long-term stable operation of the transducer.

[0015] Furthermore, a magnet is provided on the outer end surface of the insulator, and a magnet is also provided in the transducer connector of the cable. When the cable and the transducer are plugged in, the two magnets attract each other, which helps to enhance the connection stability and prevent it from falling off.

[0016] Based on the same inventive concept, the present invention also relates to a control method for an ultrasonic scalpel surgical system, wherein the ultrasonic scalpel surgical system includes an ultrasonic scalpel, a transducer, and a host, the ultrasonic scalpel is connected to the transducer, the transducer is connected to the host via a cable, and the transducer includes a transducer housing and a transducer vibrator located within the transducer housing; the method is characterized in that:

[0017] A temperature and humidity sensor is further provided in the transducer housing, and the temperature and humidity sensor is connected to the host via the cable; the method comprises the following steps:

[0018] S1: When the host is running, the initial temperature and initial humidity inside the transducer are determined by the temperature and humidity sensor, and the initial humidity is compared with a set humidity threshold. If the initial humidity is lower than the threshold, step S2-1 is performed; if the initial humidity is higher than the threshold, step S2-2 is performed.

[0019] S2-1: The host detects whether the transducer can be excited normally;

[0020] S2-2: The host determines whether the transducer is used for the first time. If it is used for the first time, the host proceeds to step S2-1;

[0021] If it is not the first use, the initial humidity is compared with the initial humidity when the transducer was last used. If the initial humidity is not higher than the initial humidity when the transducer was last used, step S2-1 is performed; if the initial humidity is higher than the initial humidity when the transducer was last used, the host issues a prompt to replace the transducer.

[0022] S3: If the transducer cannot be excited normally, the host will issue a prompt to replace the transducer; if the transducer can be excited normally, the host will continue to monitor the temperature and humidity inside the transducer;

[0023] S4: When the temperature inside the transducer is higher than the set temperature threshold, the host stops energy output and issues a temperature alarm.

[0024] Furthermore, if temperature alarms occur twice consecutively during one operation, the host will issue a prompt to replace the transducer.

[0025] Compared with the prior art, the present invention has the following beneficial effects.

[0026] 1. During use, the operator can grasp the temperature and humidity conditions inside the transducer in real time according to the temperature and humidity displayed on the host display. When the temperature is too high or the humidity is too high, the operator can suspend the excitation for cooling or replace the transducer and then work again, thereby effectively ensuring the safety and effectiveness of the transducer and reducing the risk of ultrasonic knife failure during surgery.

[0027] 2. The transducer and cable are installed in a detachable manner. If the cable is damaged, the cable can be replaced without affecting the use of the transducer, thereby increasing the service life of the transducer.

[0028] 3. When the cable is entangled with other cables, the cable can be removed from the transducer to facilitate untangling, which is beneficial to improving the user's work efficiency.

[0029] 4. When connecting the transducer to the ultrasonic knife, the operator can hold the transducer rubber bag to prevent slipping due to the smooth transducer shell. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 Schematic diagram of the ultrasonic scalpel surgical system;

[0031] Figure 2 This is a schematic diagram of the overall structure of the transducer of the present invention without the rubber coating;

[0032] Figure 3 This is a schematic diagram of the overall structure of the transducer of the present invention, which has been covered with transducer rubber;

[0033] Figure 4 This is a schematic diagram of the structure of the transducer encapsulation of the present invention;

[0034] Figure 5 is a partial cross-sectional view of the transducer of the present invention;

[0035] Figure 6 A schematic structural diagram of a transducer cable connector according to the present invention (one perspective);

[0036] Figure 7 A schematic structural diagram of a transducer cable connector according to the present invention (from another perspective);

[0037] Figure 8 Schematic diagram of the cable structure;

[0038] Figure 9 Schematic diagram of the structure of the transducer connector of the present invention;

[0039] Figure 10 This is a schematic diagram of the structure of the transducer joint encapsulation of the present invention;

[0040] Figure 11 An exemplary cross-sectional view of two magnets of opposite polarity attracting each other;

[0041] Figure 12 Another exemplary cross-sectional view of two magnets of opposite polarities attracting each other;

[0042] Figure 13 This is a flow chart of the control method of the present invention.

[0043] In the figure: 1- host, 2- transducer, 3- ultrasonic knife, 4- cable, 5- cable interface, 6- host control display screen, 7- front end shell, 8- middle end shell, 9- tail end shell, 10- transducer guide, 11- transducer rubber coating, 12- temperature and humidity sensor, 13- sealing ring, 14- magnet, 15- cable connector, 15.1- insulator, 16- first electrode, 17- second electrode, 18- third electrode, 19- fourth electrode, 20- fifth electrode, 21- orientation part, 22- protrusion, 23- anti-slip part, 24- transducer host connector, 25- transducer connector, 26- sixth electrode, 27- seventh electrode, 28- eighth electrode, 29- ninth electrode, 30- tenth electrode, 31- cable guide, 32- transducer connector rubber coating, 33- positioning groove, 34- transducer vibrator, 35- circumferential groove. DETAILED DESCRIPTION

[0044] The present invention is further described in detail below with reference to the accompanying drawings.

[0045] See also Figure 1-11 , an ultrasonic scalpel surgical system, including a transducer 2, an ultrasonic scalpel 3, a cable 4 and a host 1. The transducer 2 includes a transducer housing and a transducer vibrator 34. The transducer housing includes a front-end housing 7, a middle-end housing 8 and a tail-end housing 9 connected in sequence, and a transducer rubber bag 11. The transducer rubber bag 11 is tightly mounted on the middle-end housing 8 and the tail-end housing 9 through elastic deformation. The transducer 2 and the cable 4 are split structures. The transducer connector 25 at one end of the cable 4 is connected to the cable connector 15 on the tail-end housing 9, and the transducer host connector 24 at the other end is connected to the cable interface 5 on the host 1. The cable 4 transmits the electrical signal provided by the host 1 to the transducer 2, and the transducer 2 converts the electrical signal of the host into mechanical motion, and then transmits it to the ultrasonic scalpel 3.

[0046] The cable connector 15 has an electrode electrically connected to the transducer vibrator 34; the cable connector 15 is made of high-temperature resistant insulating materials such as engineering plastic PSU and is encapsulated on the outer surfaces of the first, second, third, fourth and fifth electrodes by injection molding. The engineering plastic is formed into an insulator 15.1, and the electrode passes through the insulator 15.1; the tail end shell 9 has an internal threaded hole, and the insulator 15.1 has an external thread, and the tail end shell 9 and the insulator 15.1 are threadedly connected.

[0047] A temperature and humidity sensor 12 is provided at the inner end of the cable connector 15. The temperature and humidity sensor 12 is connected to the first electrode 16 and the second electrode 17 on the cable connector 15, and is electrically connected to the sixth electrode 26 and the seventh electrode 27 on the transducer connector 25 on the cable 4. The internal circuitry of the transducer is connected to the third electrode 18, the fourth electrode 19, and the fifth electrode 20, respectively, and is electrically connected to the eighth electrode 28, the ninth electrode 29, and the tenth electrode 30 on the transducer connector of the cable 4. The transducer host connector 24 on the cable 4 is then connected to the cable interface 5 on the host, thereby connecting the temperature and humidity sensor 12 and the internal circuitry of the transducer (not shown) to the internal control circuitry of the host (not shown). When the temperature and humidity sensor 12 monitors the temperature and humidity inside the transducer, the information is input to the internal control circuitry of the host 1 via the cable 4. The host 1 then controls the host control display 6 through the internal control circuitry to display the temperature and humidity measured by the temperature and humidity sensor 12. When the measured temperature and humidity exceed the preset temperature and humidity, the host control screen will display a corresponding prompt message, reminding the operator to suspend the excitation to cool down or replace the transducer before restarting. It should be noted that the temperature and humidity sensor can detect humidity and temperature at the same time.

[0048] Figure 2 This is a schematic diagram of the overall structure of the transducer of the present invention without rubber coating. The transducer housing includes a front end housing 7, a middle end housing 8, a tail end housing 9 and a transducer rubber coating 11. The front end housing 7, the middle end housing 8 and the tail end housing 9 are made of aluminum alloy. The three are split structures pressed together by interference fit, so a sealing ring 13 is added to their joint area for waterproofing. Because it is made of aluminum alloy, the whole is relatively smooth, and there is a risk of slipping or sliding during use.

[0049] Figure 3 The transducer of the present invention is provided with a transducer rubber coating 11. The transducer rubber coating 11 is tightly wrapped around the outer surface of the middle shell 8 and the tail shell 9 by elastic deformation, or can be injection molded on the outer surface of the middle shell 8 and the tail shell 9. The transducer rubber coating is made of silicone or other soft rubber with good friction and is preferably made of modified silicone by injection molding or compression molding. A number of protrusions 22 are evenly distributed on the entire outer surface, such as Figure 4As shown. The modified silicone is doped with graphite and carbon black. Because the higher the thermal conductivity of the thermal conductive filler, the better the thermal conductivity of the silicone rubber filled with it. The use of high thermal conductivity graphite microparticles and carbon black particles for compounding can significantly improve the thermal conductivity and mechanical properties of silicone rubber. Studies have shown that when the mass ratio of graphite to carbon black is 25 / 5, the thermal conductivity of silicone rubber is 0.65W / (m*K), which is 4-5 times that of ordinary silicone rubber. The thermal conductivity is significantly improved. Therefore, the rubber coating on the aluminum shell will not affect the overall heat dissipation performance of the transducer, ensuring that the transducer can work stably for a long time. When installing the transducer and the ultrasonic knife, the operator can increase the friction when holding the transducer rubber coating 11 and the ultrasonic knife handle, so the operator will not slip or slip during the installation process, thereby improving work efficiency.

[0050] Figure 5 This is a partial cross-sectional view of the transducer. The electrode closest to the positioning portion 21 on the cable connector 15 is named the first electrode 16. Then, the second electrode 17, the third electrode 18, the fourth electrode 19, and the fifth electrode 20 are evenly distributed counterclockwise around the central axis of the insulator 15.1. The cable connector 15 is made of high-temperature resistant insulating materials such as engineering plastic PSU, and is encapsulated on the outer surfaces of the first, second, third, fourth, and fifth electrodes through injection molding. The temperature and humidity sensor 12 is connected to the inner ends of the first electrode 16 and the second electrode 17. Figure 6-7 As shown, the outer surface of the insulator has a circumferential groove 35, and the circumferential groove 35 is sleeved with a sealing ring 13; the inner end face of the insulator 15.1 has four evenly distributed positioning grooves 33. The positioning grooves 33 are matched with corresponding tooling, and the insulator 15.1 is screwed into the tail end housing 9 through threads. After connection, the sealing ring 13 plays a sealing role, and the temperature and humidity sensor 12 remains inside the transducer to monitor the internal temperature and humidity of the transducer.

[0051] Figure 8This is a schematic diagram of the cable structure of the present invention. The cable 4 connects the transducer 2 and the cable 4 by adding a transducer connector 25 at the transducer end of the cable. The cable guide 31 on the transducer connector 25 cooperates with the transducer guide 10 at the transducer tail end 9. The transducer connector 25 is smoothly inserted into the cable connector 15 through the guidance of the cable guide 31. The electrode corresponding to the position of the cable guide 31 is named the sixth electrode 26. Then the seventh electrode 27, the eighth electrode 28, the ninth electrode 29, and the tenth electrode 30 are evenly distributed clockwise around the central axis. The transducer connector 25 adopts high-temperature resistant insulating materials such as engineering plastic PSU and is injection molded on the outer surfaces of the sixth, seventh, eighth, ninth and tenth electrodes. The sixth to tenth electrodes adopt a female head structure to connect with the first to fifth electrodes adopt a male head structure. After the internal wires of the cable 4 are connected to the corresponding electrodes on the transducer connector 25, the transducer connector glue 32 is injection molded on the outer surface of the transducer connector 25 using silicone material to prevent the cable 4 from breaking due to multiple bending. Figure 8-10 As shown. Figure 6 As shown, the magnet 14 is embedded in the center of the cable connector 15 by interference fit and is located on the outer end surface of the insulator 15.1; Figure 9 As shown, the transducer connector 25 is also provided with a magnet 14, which is pressed into the transducer connector 25 by interference fit and attracts the magnet 14 in the cable connector 15. The magnet is made of high-temperature sintered NdFeB strong magnet, such as 40UH and 30EH series, which can withstand high temperatures above 180°C for a long time. High-temperature resistant samarium cobalt magnets can also be used to ensure that the transducer is not affected by repeated disinfection and sterilization, especially high-temperature and high-pressure steam sterilization. The magnets 14 can be docked with each other, and the magnetization method of the magnets is axial magnetization, such as Figure 11 It can also be as shown. Figure 12 The plug-in design shown here features radial magnetization, increasing the magnetic attraction area and further improving the insertion and removal force between the transducer connector and the cable. The evenly distributed anti-slip features 23 on the transducer connector 25 facilitate smooth insertion and removal of the transducer connector 25 onto the transducer connector 15, preventing slippage.

[0052] Transducers are sterilized and reused repeatedly. Hospitals need to clean and disinfect transducers after use, usually using low-temperature plasma or moist heat sterilization (high-temperature and high-pressure sterilization). Therefore, transducers must adopt a strict waterproof design. The seals between the various components of the transducer are usually filled with rubber or silicone rings to achieve a sealing effect. However, with the repeated disinfection and sterilization of the transducer, the plastic sealing ring will inevitably age and cause the sealing effect to deteriorate. The cleaning and sterilization process, especially the high-temperature and high-pressure steam sterilization at 121°C or 134°C commonly used in hospitals, is likely to break through the sealing barrier and enter the confined space inside the transducer, causing the transducer to degrade in performance or even fail.

[0053] Figure 13 This is a flowchart of the ultrasonic scalpel surgical system of the present invention. When the host system starts to be powered on, the system immediately senses the initial temperature and initial humidity inside the transducer through the temperature and humidity sensor. The initial humidity is compared with the threshold (for example, 90% RH). If it is below the threshold, it means that there is no water leakage or air leakage in the cleaning and sterilization process before use of the transducer. Then the next step of system self-test is carried out to evaluate the performance of the ultrasonic system such as the resonant frequency Fs, capacitance C0 and impedance R. If the self-test performance reaches the set value, normal excitation can be carried out; on the contrary, when the humidity measurement value is higher than the threshold 90% RH, it means that liquid has entered the transducer and the transducer may be damaged. At this time, the system will judge whether the transducer is used for the first time. If it is used for the first time, it will directly enter the next process. If it is a transducer that has been used, the initial humidity measurement value will be compared with the initial humidity measurement value of the last power-on test stored. If the measurement value is lower than or equal to the last measurement value, it means that the transducer did not enter water or air during the cleaning and sterilization process, and the situation has not deteriorated further, then it can continue to work. Otherwise, the host will alarm and prompt to replace the transducer. With the use of ultrasonic scalpel surgical system in surgery, the transducer will heat up due to its own conversion efficiency issues (such as inevitable dielectric loss, frictional heat, etc.). The system monitors the internal working temperature of the transducer in real time through sensors. When the temperature exceeds the set threshold of 85°C, the system stops energy output and prompts the operator on the host control display screen to suspend excitation and cool the instrument. When the temperature is lower than the threshold, the operator is prompted to continue the excitation work. If the temperature alarm appears more than twice in a row during the operation, it means that the transducer has been seriously aged and its performance has degraded. The host will issue an alarm to prompt the operator to replace the transducer.

[0054] The embodiments of the present invention are described above in conjunction with the accompanying drawings. The embodiments of the present invention and the features thereof may be combined with each other unless there is any conflict. The present invention is not limited to the specific embodiments described above. The specific embodiments described above are merely illustrative and not restrictive. Under the guidance of the present invention, those skilled in the art may devise various forms without departing from the spirit of the present invention and the scope of protection of the claims. All of these forms fall within the scope of protection of the present invention.

Claims

1. An ultrasonic scalpel surgical system, comprising an ultrasonic scalpel, a transducer, and a host, wherein the ultrasonic scalpel is connected to the transducer, and the transducer is connected to the host via a cable, wherein the transducer comprises a transducer housing and a transducer vibrator located within the transducer housing; characterized in that: A temperature and humidity sensor is further provided in the transducer housing, and the temperature and humidity sensor is connected to the host through the cable; the ultrasonic scalpel surgical system performs the following method, which includes the following steps: S1: When the host is running, the initial temperature and initial humidity inside the transducer are determined by the temperature and humidity sensor, and the initial humidity is compared with a set humidity threshold. If the initial humidity is lower than the threshold, step S2-1 is performed; if the initial humidity is higher than the threshold, step S2-2 is performed. S2-1: The host detects whether the transducer can be excited normally; S2-2: The host determines whether the transducer is used for the first time. If it is used for the first time, the host proceeds to step S2-1; If it is not the first use, the initial humidity is compared with the initial humidity when the transducer was last used. If the initial humidity is not higher than the initial humidity when the transducer was last used, step S2-1 is performed; if the initial humidity is higher than the initial humidity when the transducer was last used, the host issues a prompt to replace the transducer. S3: If the transducer cannot be excited normally, the host will issue a prompt to replace the transducer; if the transducer can be excited normally, the host will continue to monitor the temperature and humidity inside the transducer; S4: When the temperature inside the transducer is higher than the set temperature threshold, the host stops energy output and issues a temperature alarm.

2. The ultrasonic scalpel surgical system according to claim 1, characterized in that: If temperature alarms occur twice consecutively during one operation, the host will issue a prompt to replace the transducer.

Images