CN104116558A - Surgical equipment, surgical instrument control equipment and medical equipment - Google Patents

Abstract

The invention discloses an operation device, an operation device control device and a medical device, and relates to a medical device. The surgical equipment includes: a surgical instrument; a nerve detection electrode arranged outside the operation site of the surgical instrument; wherein, the nerve detection electrode is electrically insulated from the surgical instrument. By setting nerve detection electrodes around surgical instruments, real-time nerve monitoring is performed during surgery with surgical instruments, and a reminder signal is automatically issued and/or the energy output of bipolar coagulation is terminated when the surgical instrument is close to the protected nerve, reducing the need for surgical instruments. The purpose of neuroprotection is achieved while switching.

Description

Surgical equipment, surgical instrument control equipment, and medical equipment

technical field

The invention relates to the technical field of medical instruments, in particular to an operation device, an operation device control device and a medical device.

Background technique

In surgical operations, surgical instruments such as scalpels, electrosurgical scalpels, bipolar coagulators, ultrasonic scalpels, and plasma scalpels are often used. The bipolar coagulator is one of the more frequently used devices in doctors' operations. The bipolar electrocoagulator uses high-frequency alternating current to generate electric heat between the two electrodes, coagulates the tissue clamped between the two electrodes, and completes the effect of hemostasis and cutting on the tissue, with little damage to the surrounding tissue and thorough hemostasis It has become the first choice for many surgeries, especially neck surgeries.

In operations involving motor nerves, such as common neck thyroid surgery and parathyroid surgery, determining the location of motor nerves such as the recurrent laryngeal nerve, accessory nerve, and vagus nerve and protecting the integrity of the nerves is one of the keys to successful surgery. If the function of these nerves is damaged due to mechanical or electric cautery during the operation, part or all of the motor function of the corresponding muscles will be lost after the operation, seriously affecting the quality of life of the patient, and may even be life-threatening. Therefore, in recent years, intraoperative motor nerve monitoring has become one of the focuses and hot spots in the development of medical technology, and has also become an important technical means for surgeons, and has been widely used in clinical work.

The principle of intraoperative nerve monitoring technology is that the monitoring equipment continuously generates a certain intensity of electrical stimulation through the electrodes. If the electrodes are close to or touch the protected motor nerve, the motor nerve will generate an action potential and conduct it to the corresponding muscle. Muscle action potentials are generated, and the receiving electrodes pre-installed on the muscles will extract these muscle potentials, and then input them into the nerve monitoring equipment for amplification and screening. When the set alarm threshold is reached, image and sound signals will be generated to remind clinicians to pay attention The location of the nerve.

In the existing intraoperative nerve monitoring process, in the specific operation, when separating the possible position close to the nerve, first take out the detection electrode to test the suspicious position, if no alarm signal is received, use scissors or bipolar coagulator instead Wait for the surgical instrument to continue to separate for a small step, then switch to the detection electrode for inspection, and then separate and dissect. The whole operation needs to be replaced continuously with surgical instruments and monitoring electrodes, which not only prolongs the operation time, but more importantly, real-time and continuous nerve monitoring cannot be achieved during the dissection process, which may occur every time during the dissection process. Nerve damage, and there is no way to repair the nerve damage discovered after the event.

Contents of the invention

The inventor of the present invention finds that there are problems in the above-mentioned prior art, and therefore proposes a new technical solution for at least one of the problems.

An object of the present invention is to provide a technical solution for an easy-to-use surgical device.

According to the first aspect of the present invention, there is provided a surgical device, comprising: a surgical instrument; a nerve detection electrode arranged outside the operation site of the surgical instrument; wherein, the nerve detection electrode is electrically insulated from the surgical instrument .

Optionally, the surgical instrument is a bipolar coagulator; the surgical device includes two legs, each leg includes a coagulation electrode and a nerve detection electrode; wherein, the electrocoagulation electrode and the electrode are exposed at the tip of each leg. The nerve detection electrode, and the nerve detection electrode is located outside the electrocoagulation electrode.

Optionally, each leg includes an electrocoagulation electrode and two nerve detection electrodes, the electrocoagulation electrode and the nerve detection electrodes have exposed tips and present a "pin" shape or a trapezoid.

Optionally, the two nerve detection electrodes of one leg are electrically connected with the two nerve detection electrodes of the other leg according to diagonal positions.

Optionally, each leg includes one nerve detection electrode and one electrocoagulation electrode, the electrocoagulation electrode and the nerve monitoring detection electrode have exposed tips and present a "L" shape or a trapezoid.

Optionally, the electrocoagulation electrodes of each leg are respectively connected to the energy output ports of the main body of the bipolar coagulator; the nerve detection electrodes are connected to the stimulation signal output ports of the main body of the nerve monitor.

Optionally, the surgical instrument is an ultrasonic scalpel, monopolar coagulator, ligasure, electrosurgical scalpel or plasma scalpel.

Optionally, the surgical device includes more than one nerve detection electrode, located on a circle centered on the surgical action site of the surgical device.

According to another aspect of the present invention, a surgical instrument control device is provided, including: a switch adapted to be located on the line between the surgical instrument host and the surgical instrument; a logic protection circuit electrically connected to the switch for Receive a nerve monitoring signal from the nerve monitor host, judge whether the nerve monitor signal is greater than a predetermined threshold, and if so, control the switch to cut off the surgical instrument host from outputting power to the surgical instrument.

Optionally, it further includes: a control selection switch for controlling the electrical connection between the logic protection circuit and the switch.

Optionally, further comprising: a threshold configuration module, configured to configure the predetermined threshold of the logic protection circuit.

Optionally, it also includes: a nerve monitor host, configured to receive the myoelectric signal from the monitored muscle through the nerve monitoring electrodes, obtain the nerve monitoring signal, and send the nerve monitoring signal to the logic protection circuit.

Optionally, it also includes a surgical instrument host, electrically connected to the surgical instrument, and used to output power to the surgical instrument.

Optionally, an information display is also included for displaying the nerve monitoring alarm signal sent by the logic protection circuit and the working status of the logic protection circuit.

Optionally, the switch is a momentary relay.

Optionally, the surgical instrument is a bipolar coagulator, a monopolar coagulator, an ultrasonic knife, ligasure, an electrosurgical knife or a plasma knife.

According to yet another aspect of the present invention, a medical device is provided, including the above-mentioned surgical device, and the above-mentioned surgical instrument control device.

An advantage of the present invention is that the nerve detection electrodes are arranged around the surgical instrument, and the nerve monitoring is performed in real time during the operation using the surgical instrument, and the purpose of nerve protection is realized while reducing the switching of surgical instruments, and is easy to use.

Other features of the present invention and advantages thereof will become apparent from the following detailed description of exemplary embodiments of the present invention with reference to the accompanying drawings.

Description of drawings

The accompanying drawings, which constitute a part of this specification, illustrate the embodiments of the invention and together with the description serve to explain the principles of the invention.

The present invention can be more clearly understood from the following detailed description with reference to the accompanying drawings, in which:

Fig. 1A, 1B are the structural schematic diagrams showing an embodiment of the bipolar coagulator with neuroprotective function according to the present invention;

Fig. 2 is a cross-sectional view showing the electrode tip of the bipolar coagulator in the embodiment of Fig. 1A and 1B;

Fig. 3 is a schematic diagram showing the electrode connection mode in the embodiment of Fig. 1A and 1B;

4 is a cross-sectional view of an electrode tip showing another embodiment of a bipolar electrocoagulator according to the present invention;

Figure 5 is a cross-sectional view showing one embodiment of a monopolar electrocoagulator according to the present invention;

Figure 6 is a tip cross-sectional view showing another embodiment of the surgical device according to the present invention;

FIG. 7 is a block diagram illustrating an embodiment of a medical device according to the present invention;

FIG. 8 is a block diagram showing one embodiment of a surgical instrument control device according to the present invention.

Detailed ways

Various exemplary embodiments of the present invention will now be described in detail with reference to the accompanying drawings. It should be noted that the relative arrangements of components and steps, numerical expressions and numerical values set forth in these embodiments do not limit the scope of the present invention unless specifically stated otherwise.

At the same time, it should be understood that, for the convenience of description, the sizes of the various parts shown in the drawings are not drawn according to the actual proportional relationship.

The following description of at least one exemplary embodiment is merely illustrative in nature and in no way taken as limiting the invention, its application or uses.

Techniques, methods and devices known to those of ordinary skill in the relevant art may not be discussed in detail, but where appropriate, such techniques, methods and devices should be considered part of the Authorized Specification.

In all examples shown and discussed herein, any specific values should be construed as illustrative only, and not as limiting. Therefore, other examples of the exemplary embodiment may have different values.

It should be noted that like numerals and letters denote like items in the following figures, therefore, once an item is defined in one figure, it does not require further discussion in subsequent figures.

The inventors found that the surgical instrument and the nerve detection electrode can be combined, and the nerve detection electrode can be set outside the surgical action site of the surgical instrument through the optimal setting of the electrode, so that the nerve can be monitored in real time during the operation using the surgical instrument . The surgical action part of a surgical instrument refers to the part where the surgical instrument and the patient's surgical part interact. For example, for a bipolar coagulator, the part where the coagulation electrode is exposed at the tip to stop bleeding or cut the surgical site is called a bipolar coagulator. The surgical action site of the electrode coagulator. For example, nerve detection electrodes are arranged around the bipolar coagulator to monitor nerves in real time during anatomy using the bipolar coagulator. And through the circuit design, when it is close to the protected nerve, it will automatically send out a reminder signal and/or terminate the energy output of the bipolar coagulator, so as to achieve the purpose of nerve protection while reducing the switching of surgical instruments. Herein, the bipolar coagulator is also referred to as bipolar forceps, bipolar forceps, or bipolar knife.

1A and 1B are structural schematic diagrams showing an embodiment of a bipolar electrocoagulator with neuroprotective function according to the present invention.

As shown in FIGS. 1A and 1B , the bipolar coagulator in this embodiment includes two legs, and the two legs are electrically insulated from each other. Each leg includes a tweezers body 111 , a front end of the tweezers body or a tip 112 of the tweezers body. The two legs are connected to the electrode seat 113 at the rear end of the tweezers body and connected to the conductive wire 114 . Each leg includes electrodes for coagulation and nerve detection. The electrocoagulation electrode and the nerve detection electrode are exposed at the tip of the leg, that is, the front end 112 of the tweezers. The electrocoagulation electrode and the nerve detection electrode are electrically insulated at the tip of the leg, and the nerve detection electrode is located outside the electrocoagulation electrode. In one embodiment, the two legs of the bipolar electrocoagulator are made of insulating engineering plastics or similar insulating materials, and contain three electrodes, including one electrocoagulation power output electrode (abbreviated as electrocoagulation electrode), and the nerve detection electrode. The two electrodes are both wrapped and fixed by insulating material, and only the tip of the front end 112 of the tweezers body is exposed. Under the action of mechanisms such as spring steel sheets or the elasticity of engineering plastics, the two legs are in an open state when not in use. When in use, the surgeon pinches the legs tightly, uses the electrocoagulation electrodes at the tip of the legs to clamp the tissue, and then starts the bipolar coagulation host to output AC power to stop bleeding or cut the tissue between the electrodes.

Fig. 2 is a cross-sectional view showing the electrode tip of the bipolar coagulator in the embodiment of Figs. 1A and 1B. As shown in Figure 2, the tip of each leg includes a coagulation electrode 21, two nerve detection electrodes 22, 23, wherein one nerve detection electrode is positive, such as 22, and the other nerve monitoring detection electrode is negative, such as 23, through The insulator 24 holds the three electrodes 21 , 22 , 23 . The nerve detection electrodes 22 and 23 are located outside the electrocoagulation electrode 21. The electrocoagulation electrodes and the nerve detection electrodes are wrapped and fixed by insulating materials, and the exposed tips are in the shape of a "pin" or a trapezoid.

In the above-mentioned embodiment, nerve detection electrodes are arranged on the periphery of the electrocoagulation electrodes, and nerve monitoring is performed in real time during the dissection process using bipolar coagulation, so that the protected nerves can be found in time during the operation, and there is no need to switch surgical instruments , It is convenient for doctors to operate, and at the same time achieves the purpose of neuroprotection.

FIG. 3 is a schematic diagram showing the electrode connection method of the embodiment in FIG. 1 . As shown in Figure 3, the ends of the six electrodes 21, 22, 23 in the two legs are respectively connected to the conductive wires, wherein the coagulation electrodes 21 on the inner side are respectively connected to the energy output ports of the main body of the bipolar electrocoagulator, and the ends on the outer side Two sets of four nerve detection electrodes 22 and 23 are connected in pairs in diagonal positions, and then the conductive wire 35 is connected to the stimulation signal output port of the nerve monitor host. In the above embodiment, through the diagonal arrangement of the nerve detection electrodes, a three-dimensional detection and stimulation area can be formed around the bipolar coagulation power output electrodes, so as to issue an early warning before the power output electrodes act on the nerves, thereby achieving the goal of separating and dissecting the nerves. The purpose of avoiding damage during the process. In one embodiment, the nerve detection electrode 22 and the nerve detection electrode 23 are positive and negative electrodes respectively, and are electrically connected in a manner that the positive electrode 22 and the negative electrode 23 are connected correspondingly. In this manner, the generated detection current is limited to the surgical site between the positive and negative electrodes of the nerve detection electrode, thereby avoiding influence or interference on other parts of the patient as much as possible.

4 is a cross-sectional view of an electrode tip showing another embodiment of a bipolar electrocoagulator according to the present invention. As shown in FIG. 4 , the tip of each leg includes a coagulation electrode 41 , a nerve detection electrode 43 and an insulator 42 . The electrocoagulation electrode 41 and the nerve detection electrode 43 are fixed and insulated by an insulator 42 . One of the two nerve detection electrodes 43 is a positive electrode, and the other nerve detection electrode is a negative electrode. Each leg exposes its tip and presents a "Lu" shape or a trapezoid. The ends of the four electrodes in the two legs are respectively connected to the conductive wires, among which the coagulation electrodes 41 on the inner side are respectively connected to the energy output port of the main body of the bipolar electrocoagulator, and the nerve detection electrodes 43 on the outer side are connected to the main body of the nerve monitor. The stimulation signal output port is connected.

Those skilled in the art can design other surgical equipment in which the nerve detection electrodes are located around the surgical instrument according to the perspective of the present disclosure, and the specific position and distribution can be selected according to needs.

Fig. 5 is a sectional view showing one embodiment of a monopolar electrocoagulator according to the present invention. As shown in FIG. 5 , the monopolar coagulator includes a coagulation electrode 51 , an insulator material 52 and a nerve detection electrode 53 . The insulator material 52 keeps the electrocoagulation electrode 51 and the nerve detection electrode 53 electrically isolated. The monopolar coagulator exposes the electrocoagulation electrode 51 and the nerve detection electrode 53 at the tip, and the nerve detection electrode 53 is located on the outer circumference of the electrocoagulation electrode 51 .

Fig. 6 is a tip sectional view showing another embodiment of the surgical device according to the present invention. The surgical instrument in this embodiment is, for example, a monopolar coagulator, an ultrasonic knife, an electrosurgical knife or a plasma knife. As shown in FIG. 6 , the tip section includes a monopolar coagulator, an ultrasonic scalpel, an electrosurgical scalpel or a plasma scalpel 61 , a nerve monitoring electrode, a nerve detection electrode 62 and an insulator 63 . Wherein, the nerve monitoring electrode and the nerve detection electrode 62 are located on a circle centered on the monopolar coagulator, ultrasonic scalpel, electrosurgical scalpel or plasma scalpel 61 . It should be understood by those skilled in the art that in some embodiments, more than two nerve detection electrodes 62 may also be included, and these nerve detection electrodes are, for example, distributed in a uniform manner in a monopolar electrocoagulator. , Ultrasonic knife, electrosurgical knife or plasma knife 61 is on the circumference of circle center. The circumference here is not limited to a regular circumference, but generally on the outer circumference.

It should be pointed out that in the cross-sectional views shown in Figures 2-4 and 6, the cross-section of the nerve detection electrode is schematically shown as a regular triangle or trapezoid. In fact, the present invention is not limited thereto, and may also be circular or rectangular. , oval, or irregular shapes. Likewise, the electrocoagulation electrodes are not limited to regular circular or trapezoidal shapes.

Fig. 7 is a block diagram showing one embodiment of a medical device according to the present invention. As shown in FIG. 7 , the medical device includes a surgical instrument host 71 , a surgical instrument 72 and a nerve protection circuit 73 . The surgical instrument 72 is, for example, the surgical instrument integrated with nerve protection function introduced in the above embodiments. The surgical instrument host 71 can be electrically connected to the surgical instrument 72 for outputting power to the surgical instrument 72 . The nerve protection circuit 73 includes: a switch 731, located on the line between the surgical instrument host 71 and the surgical instrument 72; a logic protection circuit 732, electrically connected to the switch 731, for receiving nerve monitoring signals from the nerve monitor host, and judging nerve Monitor whether the signal is greater than a predetermined threshold, and if so, control the switch to cut off the power output from the surgical instrument host 71 to the surgical instrument 72 . The neuromonitor host can be realized by using an existing neuromonitor. In one embodiment, the nerve protection circuit 73 is a comparator, by receiving the electrical signal representing the nerve monitoring signal, comparing it with a preset electrical signal threshold, and sending an electrical signal to turn off the switch 731 when it is greater than the predetermined threshold , so as to cut off the power output from the surgical instrument main unit 71 to the surgical instrument 72 .

FIG. 8 is a block diagram showing one embodiment of a surgical instrument control device according to the present invention. As shown in FIG. 8 , the surgical instrument control device includes a bipolar coagulator host 81 , a nerve protection logic circuit 83 and a nerve monitor 84 . The nerve protection logic circuit 83 includes a logic protection circuit 832 and a momentary relay 831 . The main unit 81 of the bipolar coagulator is electrically connected to the coagulation power output electrode (coagulation electrode) of the bipolar coagulator 82 through the instantaneous relay 831, and is used to output power to the coagulation electrode of the bipolar coagulator. The nerve monitor 84 is electrically connected to the nerve detection electrodes of the bipolar coagulator 84, and is used to output stimulation electric signals to the nerve detection electrodes. The nerve monitor 84 is also electrically connected to a nerve monitor electrode (nerve receiving electrode) 85 . In one embodiment, the nerve monitor 84 receives the myoelectric signal sent by the monitored muscle from the nerve monitor electrode 85, obtains the nerve monitor signal, and sends it to the logic protection circuit 832, and the logic protection circuit 832 receives the nerve monitor 831. Monitor the monitoring signal, and control the instantaneous relay 831 to cut off the output power of the surgical instrument host 81 to the surgical instrument 82 . In one embodiment, a nerve monitoring electrode 85 is also included for obtaining the myoelectric signal from the monitored muscle and sending it to the nerve monitor 831 . In one embodiment, the nerve protection logic circuit 83 further includes an information display 833 for displaying the nerve monitoring alarm signal and the working status of the logic control circuit; or prompting the nerve monitoring alarm signal through sound. The neuroprotection logic circuit 83 also includes a control selection switch 834 . In one embodiment, the nerve protection logic circuit 83 further includes a threshold configuration module (not shown), configured to configure a predetermined threshold of the logic protection circuit 832 .

Its working process includes: the nerve monitor 831 receives the myoelectric signal from the monitored muscle, screens and amplifies the signal, and if the signal reaches the set alarm threshold, sends out sound and image signals, and outputs an alarm signal from the corresponding output port. signal; the alarm electrical signal reaches the logic protection circuit 832, and is processed by the logic circuit. After identifying the alarm signal, the instantaneous relay 82 is controlled to immediately interrupt the power output of the bipolar coagulation 84, thereby avoiding the loss of the monitored nerve, and at the same time, it can be combined with the control Select the switch 834 and the information display 833 to select the threshold value and time gap of the port power output according to specific conditions. Since the nerve detection electrode is arranged around the electrocoagulation electrode, it is closer to the nerve to be protected, so the protection function can be better realized.

In the protection circuit in the above embodiment, after the nerve monitor sends out a warning signal, the warning signal automatically interrupts the power output of the bipolar coagulation through the relay, so as to achieve the purpose of avoiding nerve damage.

In one embodiment, without modifying the existing bipolar coagulator host or motor nerve monitor host, it can be applied to various existing equipment only by adjusting the signal input port and power input port, without increasing the The extra equipment purchase cost has a wide prospect of popularization and application.

The technical solution disclosed in the present disclosure can be applied to the transformation of other surgical instruments such as laparoscopic surgery through changes in materials and shapes.

The technical solution of the present disclosure can be applied to the transformation of surgical instruments with other working principles such as ultrasonic knife and plasma knife through the change of material and appearance.

So far, the surgical device, surgical instrument control device, and medical device according to the present invention have been described in detail. Certain details well known in the art have not been described in order to avoid obscuring the inventive concept. Based on the above description, those skilled in the art can fully understand how to implement the technical solutions disclosed herein.

Although some specific embodiments of the present invention have been described in detail through examples, those skilled in the art should understand that the above examples are for illustration only, rather than limiting the scope of the present invention. Those skilled in the art will appreciate that modifications can be made to the above embodiments without departing from the scope and spirit of the invention. The scope of the invention is defined by the appended claims.

Claims (12)

1. A surgical device, characterized in that, comprising: Surgical Instruments; A nerve detection electrode arranged outside the surgical action site of the surgical instrument; Wherein, the nerve detection electrode is electrically insulated from the surgical instrument. 2. The surgical device according to claim 1, wherein the surgical instrument is a bipolar coagulator; The surgical device includes two legs, each leg includes an electrocoagulation electrode and a nerve detection electrode; wherein, the electrocoagulation electrode and the nerve detection electrode are exposed at the tip of each leg, and the nerve detection electrode is located at the outside of the electrocoagulation electrode. 3. The surgical device according to claim 2, wherein each leg includes one electrocoagulation electrode and two nerve detection electrodes, the electrocoagulation electrode and the nerve detection electrodes expose the tip and present a "pin" glyph or trapezoid; or Each leg includes a nerve detection electrode and a coagulation electrode, and the electrocoagulation electrode and the nerve monitoring detection electrode have exposed tips and present a "L" shape or a trapezoid. 4 . The surgical device according to claim 3 , wherein the two nerve detection electrodes of one leg are electrically connected with the two nerve detection electrodes of the other leg according to diagonal positions. 5. The surgical device according to claim 2, 3, 4 or 5, wherein the electrocoagulation electrodes of each leg are respectively connected to the energy output port of the bipolar electrocoagulator host; the nerve detection electrodes are connected to the nerve The stimulation signal output port of the monitor host is connected. 6 . The surgical device according to claim 1 , wherein the surgical instrument is an ultrasonic scalpel, a monopolar coagulator, ligasure, an electrosurgical scalpel or a plasma scalpel. 7. The surgical device according to claim 6, characterized in that, the surgical device comprises more than one nerve detection electrode, located on a circle centered on the operating site of the surgical instrument. 8. A surgical instrument control device, characterized in that it comprises: A switch adapted to be located on the line between the surgical instrument host and the surgical instrument; A logic protection circuit, electrically connected to the switch, for receiving the nerve monitoring signal from the nerve monitor host, judging whether the nerve monitor signal is greater than a predetermined threshold, and if so, controlling the switch to cut off the surgical instrument host Power is output to the surgical instrument. 9. The device of claim 8, further comprising: a control selector switch for controlling the electrical connection between the logic protection circuit and the switch; and / or A threshold configuration module, configured to configure the predetermined threshold of the logic protection circuit. 10. The device of claim 8, further comprising: The nerve monitor host is used to receive the myoelectric signal sent by the monitored muscle through the nerve monitoring electrode, obtain the nerve monitoring signal, and send the nerve monitoring signal to the logic protection circuit; and / or a surgical instrument host, electrically connected to the surgical instrument, and used to output power to the surgical instrument; and / or The information display is used to display the nerve monitoring alarm signal sent by the logic protection circuit. 11. The apparatus of claim 8, wherein the switch is a momentary relay; and / or The surgical instrument is a bipolar coagulator, a monopolar coagulator, an ultrasonic knife, ligasure, an electrosurgical knife or a plasma knife. 12. A medical device, characterized by comprising the surgical device according to any one of claims 1-7, and the surgical instrument control device according to any one of claims 8-11.