CN115844626A

CN115844626A - Ultrasonic knife for trabecular meshwork excision and ultrasonic surgical system device comprising same

Info

Publication number: CN115844626A
Application number: CN202111113873.XA
Authority: CN
Inventors: 齐世龙
Original assignee: Individual
Current assignee: Individual
Priority date: 2021-09-23
Filing date: 2021-09-23
Publication date: 2023-03-28

Abstract

The invention provides an ultrasonic knife for cutting off trabecular meshwork and an ultrasonic surgical system device comprising the same, wherein the ultrasonic knife comprises an ultrasonic handle and a hollow structure knife head detachably fixed at one end of the ultrasonic handle; the ultrasonic handle comprises a shell, wherein a perfusion channel and a suction channel which are mutually independent are arranged in the shell, and the perfusion channel and the suction channel are communicated with the hollow cavity of the cutter head; and the inside of the shell is also provided with a horn and a piezoelectric ceramic crystal stack. The ultrasonic knife provided by the invention combines physical cutting and ultrasonic vibration assisted cutting, further crushes the cut trabecular meshwork fragments by utilizing the high-frequency vibration and cavitation effect of ultrasonic, facilitates subsequent suction, directly sucks out the cut trabecular meshwork through the suction module after the trabecular meshwork is cut, does not need to replace surgical instruments, simplifies surgical steps, shortens surgical time, improves surgical efficiency and can reduce adverse surgical effects.

Description

Ultrasonic knife for trabecular meshwork excision and ultrasonic surgical system device comprising same

Technical Field

The invention belongs to the technical field of medical equipment, and relates to an ultrasonic knife for trabecular meshwork excision and an ultrasonic surgical system device comprising the same.

Background

Glaucoma is a threat and damage to the optic nerve and its visual pathways, ultimately leading to impairment of visual function, primarily associated with pathological elevated intraocular pressure. Glaucoma is classified into primary, secondary, congenital and other glaucoma according to etiology, anatomy, pathogenesis and the like, and is generally treated by ocular hypotensive eye drops, laser, surgery and the like. If no effective treatment is taken, the visual field can be lost altogether, eventually leading to blindness. This blindness of glaucoma is not reversible but avoidable with current medical treatments.

Conventional treatments have focused primarily on lowering IOP with hypotensive drugs or surgically by using laser or incision surgery. One type of ophthalmic surgery used to treat glaucoma is the removal of a tissue strip of known width from an anatomical location within the body of a patient. This ophthalmic procedure is known as goniotomy. In an anterior chamber goniotomy procedure, a device that can cut or resect a tissue strip of about 2-10 mm or more in length and about 50-230 μm in width is inserted into the anterior chamber of the eye and used to remove the entire thickness of the tissue strip from the trabecular meshwork. Trabecular meshwork is a loosely organized, porous tissue network that covers a collection tube known as schlemm's tube. A fluid called aqueous humor is constantly produced in the anterior chamber of the eye. In healthy individuals, aqueous humor flows through the trabecular meshwork, into schlemm's canal, and out of the eye through a series of conduits known as collector channels. In patients with glaucoma, elevated flow resistance through the trabecular meshwork can impair drainage of the aqueous humor of the eye, resulting in elevated intraocular pressure. By removing the entire thickness section of the trabecular meshwork, the goniotomy procedure can restore the normal drainage of aqueous humor from the eye, allowing drainage of aqueous humor through the open area where the trabecular meshwork strip has been removed.

Disclosure of Invention

Aiming at the defects in the prior art, the invention aims to provide an ultrasonic knife for cutting off trabecular meshwork and an ultrasonic surgical system device comprising the same.

In order to achieve the purpose, the invention adopts the following technical scheme:

in a first aspect, the present invention provides an ultrasonic blade for trabecular meshwork resection, the ultrasonic blade comprising an ultrasonic handle and a blade head detachably secured to an end of the ultrasonic handle.

The ultrasonic handle comprises a shell, wherein a perfusion channel and a suction channel which are mutually independent are arranged in the shell, the perfusion channel and the suction channel are communicated with the hollow cavity of the cutter head, perfusion liquid is injected into the front room through the perfusion channel, and the trabecular meshwork which is cut off is sucked out through the suction channel.

The shell is internally provided with a horn and a piezoelectric ceramic crystal pile, the horn is used for transmitting and amplifying ultrasonic amplitude, and the tool bit senses different contact pressures along with the tool bit entering different parts of the tissue of an affected part to promote the piezoelectric ceramic crystal pile to generate different potential differences.

In the specific using process, the ultrasonic knife needs to be connected with the ultrasonic generator for use, ultrasonic energy is output through the ultrasonic generator, the physical cutting of the knife head is matched, and the trabecular meshwork fragments physically cut off are further crushed by utilizing the high-frequency vibration and cavitation effect of ultrasonic waves, so that the follow-up suction is facilitated; in addition, compared with the conventional ultrasonic surgical instruments for cutting and cauterizing, the ultrasonic surgical instrument has lower operation temperature, can directly coagulate tissues in the cutting process, has higher cutting precision, less bleeding in the operation, small wound area, good surgical visual field, fast healing after the operation and the like, reduces the friction resistance of a contact surface by ultrasonic cutting, enables the trabecular meshwork to be crushed, and the crushed trabecular meshwork is mixed with intraocular liquid (such as blood) into chylomicron under the cavitation action and is sucked out through a suction channel.

The use method of the ultrasonic knife provided by the invention comprises the following steps: the ultrasonic generator host transmits electric energy with ultrasonic frequency to the ultrasonic knife, the piezoelectric ceramic crystal pile arranged in the ultrasonic knife is activated to work, the piezoelectric ceramic crystal pile converts the electric energy into mechanical energy vibrating front and back, and the tail end of the working head vibrates in ultrasonic high frequency through the transmission and amplification of the amplitude transformer. The application of the ultrasonic can effectively reduce the friction between the tissues and the blade, reduce the cutting resistance, ensure smooth section and easy operation, and protect the adjacent tissues from being damaged. The blunt surface of the tool bit working tip is attached to the tissue and activates proper ultrasonic energy, so that the protein can be denatured and coagulated, and a bleeding point can be coagulated without large pressure.

It is noted that the term "trabecular meshwork" refers to the region of tissue in the eye near the base of the cornea, near the ciliary body, and is responsible for draining aqueous humor through the eye. The term "anterior chamber" is the area of the anterior angle of the eye covered by the cornea, which is spongy and lined with trabecular cells. It allows fluid to drain into schlemm's canal and ultimately into the blood system. The term "schlemm's canal" refers to the annular channel in the eye that collects aqueous humor from the anterior chamber and delivers it to the bloodstream via the collector channel and the anterior ciliary vein.

As a preferable technical scheme of the invention, the cutter head is of a hollow structure.

Preferably, the cutter head comprises a working tip, the cross section of the cutter head is reduced, expanded and extended along an arc-shaped track to form a slope table, the two side surfaces of the slope table are respectively provided with a cutting edge and a slope back, in the operation process, the working tip penetrates through the trabecular meshwork, the slope table lifts and extends the trabecular meshwork, the slope back is attached to the inner wall of the Schlemm's canal, and the trabecular meshwork is cut through the cutting edge.

Preferably, the sloping table is provided with a deposit groove for temporarily storing the cut trabecular net fragments.

In the invention, under the action of ultrasonic high-frequency vibration and cavitation, trabecular meshwork fragments in the accumulation groove are further crushed and refined and are sucked out by the suction channel.

Preferably, a single-stage stepped limiting table is arranged on the ramp and used for controlling the depth of the working tip entering the Schlemm's tube.

In the invention, the working tip at the front end of the cutter head is provided with a sharp pointed end which is easy to penetrate through the trabecular meshwork; the sloping bench can lift and extend the trabecular meshwork; the slope back is attached to the inner wall of the Schlemm's tube; then, ultrasonic is applied, the cutting edge creates a parallel notch in the trabecular meshwork, the cutting edge is an inclined knife edge with a wide upper part and a narrow lower part, the cutting is easier, the notch is formed at the tip, and the groove is expanded at the rear end. The application of the ultrasound can reduce the friction resistance, is more beneficial to cutting through and into the trabecular meshwork, and can select proper gears to apply the ultrasonic energy in the whole process; the accumulation groove is used for temporarily storing the cut trabecular net fragments. The limiting table can control the depth of the working tip entering the Schlemm's tube, and excessive extrusion and even damage to the inner wall of the Schlemm's tube are avoided. Optionally, the part of the cutter head entering the anterior chamber is designed to be bent, the curvature is equivalent to that of the crystalline lens, the space limit of the crystalline lens can be avoided, and the operation is more free and flexible. The fillet structure of heel prevents the scratch in the cutting process. The slope back is attached to the bleeding position, and the device can be used for bleeding point hemostasis in an excitation blasting mode.

The material of the cutter head provided by the invention is preferably a titanium alloy material, so that the strength requirement and the biocompatibility requirement can be met.

As a preferred technical solution of the present invention, the piezoelectric ceramic crystal stack includes at least two piezoelectric ceramic plates stacked in sequence along the axial direction of the housing, and preferably, the number of the piezoelectric ceramic plates is even.

Preferably, piezoceramics piece be the loop configuration, the inside dead lever that is provided with of shell, the one end of dead lever with the tool bit can be dismantled and be connected, the outer peripheral face of the other end of dead lever is provided with the annular plane that contracts in, piezoceramics piece stack gradually set up in the annular plane on, the one end that the tool bit was kept away from to the dead lever is provided with the detachable fixed block, through the fixed block be fixed in the annular plane with piezoceramics piece on.

Preferably, one end of the fixing rod is detachably connected with the cutter head through threads.

Preferably, the fixed block is a tubular structure provided with internal threads, an external thread meshed with the internal threads of the fixed block is arranged at one end, far away from the cutter head, of the fixed rod, and the fixed block is fixed at one end of the fixed rod through threads.

In the invention, as an energy conversion device for converting electric energy into mechanical vibration, an energy converter (comprising a fixed block, an amplitude transformer and a piezoelectric ceramic crystal stack) in an ultrasonic knife adopts a sandwich type structural design, the amplitude transformer is used for amplifying amplitude, the piezoelectric ceramic sheets sleeved on the amplitude transformer form the piezoelectric ceramic crystal stack, a back block is a metal part with a threaded hole in the center, the amplitude transformer and the piezoelectric ceramic crystal stack are positioned and constrained by utilizing threads, and certain pretightening force is applied, so that the amplitude transformer and the piezoelectric ceramic crystal stack are fixed to form the ultrasonic transducer.

Preferably, the cutter head is provided with at least one marking line on the periphery, and the marking line is used for indicating the depth of the cutter head extending into the tube cavity.

Preferably, at least one pressure relief hole is formed in the side wall of the cutter head, and the pressure relief hole is communicated with the inner cavity of the cutter head.

According to the invention, the cut trabecular meshwork needs to be sucked out through the suction channel, and after tissue fragments are sucked out, the negative pressure is instantly reduced to zero through the pressure relief hole at the cutter head, so that the anterior chamber is prevented from being sucked and collapsed due to high negative pressure with too low flow. Optionally, the pressure relief hole is located at a position, close to the deposit groove, of the front end of the cutter head, and a pressure relief hole may be formed in the advancing direction of the cutting edge, or a pressure relief hole may be formed in the direction perpendicular to the advancing direction of the cutting edge, or a pressure relief hole may be formed in each of the two directions.

In a second aspect, the present invention provides an ultrasonic surgical system apparatus including the ultrasonic scalpel of the first aspect, the ultrasonic surgical system apparatus includes a host, an ultrasonic scalpel, a perfusion module, a suction module and a control module, the ultrasonic scalpel is electrically connected to an ultrasonic output port of the host, the control module is electrically connected to the host, and the control module switches a working mode of the ultrasonic scalpel; the perfusion module and the injection and suction module are respectively and independently connected with the ultrasonic knife, and the perfusion module injects perfusion liquid into the anterior chamber through the ultrasonic knife to stabilize the pressure of the anterior chamber and prevent the anterior chamber from collapsing; the injection and suction module is used for pumping negative pressure to the ultrasonic knife so as to suck out the cut trabecular meshwork.

As a preferred technical solution of the present invention, a processor, an ultrasonic generating module and a contact feedback module are disposed in the host, the ultrasonic generating module and the contact feedback module are electrically connected to the processor, respectively, an output end of the ultrasonic generating module is electrically connected to the ultrasonic knife, ultrasonic energy is emitted to the ultrasonic knife through the ultrasonic generating module, and the knife head cuts the trabecular meshwork under the action of ultrasonic vibration.

It should be noted that a signal generator and a matching unit are also provided in the host, the signal generator includes a DAC circuit to convert a digital input from the processor to an analog output, the analog output is fed to a power amplifier for signal conditioning and amplification, and the output of the amplifier is coupled to an output transformer and a tuning inductor, and finally to an ultrasonic knife in contact with the patient.

The matching unit comprises an output transformer and a tuning inductance, the ultrasound transducer can be modeled as an equivalent circuit comprising a first branch with a static capacitance and a second "dynamic" branch with an inductance, a capacitance and a resistance connected in series, which define the electromechanical properties of the resonator. The known ultrasonic generator may comprise a tuning inductance for detuning the static capacitance at the resonance frequency, so that substantially all of the generator's drive signal current flows into the dynamic branch. Thus, by using a tuned inductance, the generator's drive signal current is representative of the dynamic branch current, and thus the generator can control its drive signal to maintain the resonant frequency of the ultrasound transducer. The tuning inductance may also transform the phase impedance map of the ultrasonic transducer to improve the frequency locking capability of the generator. However, the tuning inductance must match the particular static capacitance of the ultrasound transducer at the operating resonant frequency.

Preferably, the contact feedback module include the controller and with controller feedback control's alarm, the brilliant electric connection of piezoceramics heap of supersound sword the controller, along with the tool bit gets into the different positions of affected part tissue, the tool bit perception arrives different contact pressure and impels the brilliant heap of piezoceramics to produce different potential differences, the controller sends different instruction audio according to different potential differences control alarm.

Preferably, when the cutter head contacts the trabecular meshwork, the contact pressure sensed by the cutter head enables the potential difference generated by the two poles of the piezoelectric ceramic crystal stack to exceed the set contact voltage, and the alarm gives out a low-frequency sound effect.

Preferably, when the cutter head penetrates through the trabecular meshwork and enters the Schlemm's canal, the contact pressure sensed by the cutter head enables the potential difference generated by the two poles of the piezoelectric ceramic crystal stack to exceed the break-through voltage, and the alarm gives out a medium-frequency sound effect.

Preferably, when the cutter head contacts with the Schlemm's canal and generates pressure on the inner wall of the Schlemm's canal, the contact pressure sensed by the cutter head enables the potential difference generated by the two poles of the piezoelectric ceramic crystal stack to exceed the alarm voltage, the alarm sends out a high-frequency sound effect, and simultaneously sends out a control instruction to the processor to cut off the ultrasonic energy output.

The contact feedback function utilizes the piezoelectric effect of the piezoelectric ceramic crystal stack, and the magnitude of the contact pressure can be judged by capturing the electric charge quantity or the potential difference caused by the pressure; when the cutter head contacts the trabecular meshwork, the contact pressure sensed by the cutter head enables the potential difference generated by the two poles of the piezoelectric ceramic crystal pile to exceed the set contact voltage, and the alarm sends 300Hz audio as a prompt signal; when the cutter head penetrates through the trabecular meshwork and enters the Schlemm's tube, the contact pressure sensed by the cutter head enables the potential difference generated by the two poles of the piezoelectric ceramic crystal pile to exceed the puncture voltage, and the alarm sends 500Hz audio as a prompt signal; when the cutter head contacts with the Schlemm's tube and generates pressure on the inner wall of the Schlemm's tube, the contact pressure sensed by the cutter head enables the potential difference generated by the two poles of the piezoelectric ceramic crystal stack to exceed the alarm voltage, the alarm sends out 800Hz audio serving as a prompt signal, meanwhile, the ultrasonic energy output is cut off immediately, and no external manual control or pedal ultrasonic trigger signal is considered, so that the inner wall of the Schlemm's tube is prevented from being damaged.

As a preferred technical solution of the present invention, the ultrasonic surgical system apparatus includes three different operation modes, which are respectively referred to as a perfusion mode, an output mode and a suction mode.

Preferably, in the perfusion mode, the processor controls the filling module to inject the perfusion fluid into the anterior chamber through the ultrasonic knife.

Preferably, the perfusate is a balanced salt solution.

Preferably, in the output mode, the processor controls the ultrasonic generation module to emit ultrasonic energy to the ultrasound, so that the cutter head vibrates under the action of the ultrasound to cut the trabecular meshwork.

Preferably, in the suction mode, the processor controls the suction module to suck negative pressure to the ultrasonic blade, so as to suck the cut trabecular meshwork out.

Preferably, the control module comprises a foot switch electrically connected to the processor, and the foot switch controls the ultrasonic knife to switch to different working modes through the processor.

Preferably, the foot switch has three gears, which are respectively marked as a perfusion gear, an output gear and a suction gear, and respectively correspond to the perfusion mode, the output mode and the suction mode of the ultrasonic knife.

It should be noted that, in the use process of the ultrasonic surgical system device provided by the invention, the opening of the perfusion mode, the output mode and the suction mode needs to be kept all the time, in the surgical process, the perfusion module continuously injects perfusion liquid into the anterior chamber, and the perfusion liquid is continuously introduced into the anterior chamber through the perfusion module, so that the pressure of the anterior chamber is stabilized, the collapse of the anterior chamber is prevented, and adverse effects on cutting are avoided; meanwhile, the suction module continuously sucks while cutting.

As a preferable technical scheme of the invention, the ultrasonic knife is divided into a linear output mode, a pulse output mode and a blasting output mode according to different output modes of ultrasonic power in the output mode.

Preferably, in the linear output mode, the main machine continuously outputs ultrasound to the ultrasonic blade, and the blade head of the ultrasonic blade continuously vibrates under the action of the ultrasound.

Preferably, in the pulse output mode, the main machine intermittently outputs ultrasound to the ultrasonic blade, and the blade head of the ultrasonic blade intermittently vibrates under the action of the ultrasound.

Preferably, in the blasting output mode, the main machine intermittently outputs ultrasonic waves to the ultrasonic blade, and the power of the ultrasonic waves output in a single time is gradually increased.

In the invention, under the linear excitation mode, the ultrasonic vibration is continuously output, and the cutting efficiency is high; ultrasonic vibration in a pulse excitation mode is output intermittently, an ultrasonic transducer is fully cooled in an intermittent period, long-time working performance of the ultrasonic transducer is improved, a power ultrasonic signal with good quality is obtained, heating and performance attenuation caused by continuous work of a handle are avoided, and the risk of burning of surrounding tissues caused by ultrasonic energy accumulation effect is reduced.

It should be noted that, in the case where the perfusion module and the suction module operate simultaneously, the output mode of the ultrasonic blade may be manually adjusted by the medical practitioner.

Preferably, the control module further comprises a main pedal electrically connected to the processor, and when the ultrasonic surgical system device is switched to the output mode, the main pedal controls the output parameters of different output modes.

Preferably, under the linear output mode and the pulse output mode, the main pedal is used for controlling the ultrasonic output power; in the blasting output mode, the main pedal is used for controlling the intermittent time of ultrasonic output.

In the linear output mode, the ultrasonic cutting power output is controlled by the main pedal, and the maximum output power is a set value. Under the pulse output mode, the ultrasonic cutting power output is controlled by a main pedal, and the maximum output power is a set value; the power output mode is intermittently output according to a set frequency and proportion (percentage of effective ultrasonic excitation time). The working parameter setting area can set the numerical values of parameters such as ultrasonic power, negative pressure, flow, ultrasonic pulse frequency, proportion and the like. Pulse frequency refers to the intermittent frequency of the ultrasound output, and proportionality refers to the percentage of active ultrasound excitation time in a cycle. In the blasting output mode, ultrasonic power is output according to preset power, single blasting time is determined by set pulse width (5-100 ms), power output intermittent time is controlled by a main pedal, and maximum frequency is continuous output; the working parameter setting area can set the numerical values of parameters such as ultrasonic power, negative pressure, flow, ultrasonic pulse width and the like. Once the main pedal is pressed, the change of the negative pressure is displayed in real time.

As a preferred technical solution of the present invention, a touch panel is embedded in the host casing, and the touch panel is divided into an output mode selection area, a state parameter indication area, and a working parameter setting area.

Preferably, the output mode selection area is used for selecting different output modes of the ultrasonic knife, and comprises a linear selection frame, a pulse selection frame and a blasting selection frame.

It should be noted that, the ultrasonic surgical system apparatus provided by the present invention is initially set to the linear mode at the time of shipment, and any one of the three output modes can be selected and stored by the button of the output mode selection area. And when the computer is started next time, the computer directly enters the output mode selected last time before the computer is shut down. For example, the last time before the power-off is set to be in the "pulse mode", the "pulse mode" is directly entered after the power-on.

Preferably, the status parameter indication area displays the current status parameters in real time, including the current working mode, the current negative pressure value, the current ultrasonic output power level, the annular grading diagram and the annular number indication.

Preferably, the annular grading chart is used for indicating the power magnitude in a linear output mode and a pulse output mode; in the blasting output mode, the annular grading graph is used for indicating the interval time of ultrasonic output.

Preferably, the working parameter setting area is divided into a gear adjusting frame, a negative pressure adjusting frame and a flow adjusting frame, and after one output mode is determined in the output mode selecting area, the gear, the negative pressure and the flow under the current output mode are adjusted.

As a preferable technical scheme, the infusion module comprises an infusion bottle, infusion liquid is injected into the infusion bottle, and the infusion bottle is communicated with an infusion channel of the ultrasonic knife through a hose.

Preferably, the hose is provided with a perfusion pump, the perfusion pump is electrically connected with the processor, the hose is provided with a pressure sensor, the pressure sensor is used for detecting pressure change in the anterior chamber, and the processor controls the perfusion pump in a feedback mode to guarantee pressure stability in the anterior chamber.

The ultrasonic operation system device provided by the invention adds active pressure control in the perfusion module, detects the pressure in the anterior chamber in real time through the pressure sensor and feeds the pressure back to the processor, and the processor adjusts the output power of the peristaltic pump according to the pressure change of the anterior chamber so as to keep the pressure of the anterior chamber constant.

Preferably, the hose is provided with an electromagnetic valve, the electromagnetic valve is electrically connected with the processor, the pedal switch is switched to the infusion gear, so that a control command is sent to the processor, the processor controls the electromagnetic valve to be opened after receiving the control command, and infusion liquid in the infusion bottle enters the ultrasonic knife along the hose.

In the invention, an infusion bottle filled with infusion solution can be hung by using an infusion support, balanced salt solution is ensured in the infusion bottle, and the hanging height is that the vertical distance between the liquid level and the negative pressure detection port on the front panel is 80-90 cm. Optionally, a liquid level sensor is added in the infusion bottle, when the liquid level in the infusion bottle is lower than the designated position, a warning prompt tone is given out to remind medical personnel to replace the infusion bottle in time, and the increase of the anterior chamber temperature caused by untimely infusion is avoided.

As a preferable technical scheme of the invention, the injection and suction module comprises a drainage container, and the drainage container is communicated with a suction channel of the ultrasonic knife through a catheter.

Preferably, the peristaltic pump and the negative pressure detection device are connected to the hose, the peristaltic pump and the negative pressure detection device are respectively and electrically connected to the processor, the foot switch is switched to a suction gear, so that a control command is sent to the processor, the processor receives the control command and then controls the peristaltic pump to be started, the cut trabecular meshwork is sucked into the catheter and enters the drainage container through the catheter, the suction pressure is detected through the negative pressure detection device in the suction process, when the negative pressure detection device detects a sudden pressure drop, the suction channel is indicated to be blocked, a control command is sent to the processor, the processor feeds back and controls the peristaltic pump to stop working, and suction is finished.

It should be noted that the present invention provides a negative pressure detection device for emergency stop of suction operation and optionally alarm to avoid injury to the cornea and anterior chamber due to improper operation once an occlusion is detected.

The ultrasonic surgical system device provided by the invention has three different working modes, namely a perfusion mode, an output mode and a suction mode, and the different working modes are switched by a foot switch, and the ultrasonic surgical system device specifically comprises the following steps:

an operator firstly switches the working mode to a perfusion mode through a foot switch and starts to inject perfusion liquid to the front; in the whole operation process, the perfusion module is always in a perfusion mode, perfusion liquid in a perfusion bottle enters the ultrasonic knife along the hose, the perfusion liquid is injected into the anterior chamber of the eye through the micro-incision, the anterior chamber is stabilized through continuously injecting the perfusion liquid, and the collapse of the anterior chamber is prevented from influencing the cutting of the trabecular meshwork;

then, the working mode is switched to the output mode through a foot switch, the trabecular meshwork is cut, the ultrasonic handle part of the ultrasonic knife is held, the knife is inserted into the to-be-operated area in the eye through the micro-cut, the touch panel is clicked to select different output modes, the main pedal is trampled to control the output parameters of the different output modes, and the cutting of the trabecular meshwork is completed;

the operating mode is switched to the suction mode through the foot switch, the suction module is always in the suction mode in the whole operation process, the peristaltic pump is started to suck out the cut trabecular meshwork, partial blood and perfusion liquid, the trabecular meshwork, the partial blood and the perfusion liquid enter the drainage container through the catheter, and the perfusion, the cutting and the suction are simultaneously carried out while the perfusion, the cutting and the suction are carried out.

The system refers to an equipment system, or a production equipment.

Compared with the prior art, the invention has the beneficial effects that:

in the specific using process, the ultrasonic knife needs to be connected with the ultrasonic generator for use, ultrasonic waves are emitted by the ultrasonic generator, the physical cutting of the knife head is matched, and the high-frequency vibration and cavitation effect of the ultrasonic waves are utilized to further crush the trabecular meshwork fragments physically cut off, so that the follow-up suction is facilitated; in addition, compared with the conventional ultrasonic surgical instruments for cutting and cauterizing, the ultrasonic surgical instrument has lower operating temperature and cutting efficiency, tissues can be directly coagulated in the cutting process, the cutting precision is higher, bleeding in the operation is less, the wound area is small, the surgical field is good, healing after the operation is fast and the like, the trabecular meshwork is crushed by ultrasonic cutting, the crushed trabecular meshwork and intraocular liquid (such as blood) are mixed into a chylomicron shape and are sucked out through a suction channel, in the traditional trabecular meshwork operation process, the trabecular meshwork which is cut needs to be sucked out by replacing a suction device, the ultrasonic knife provided by the invention combines physical cutting and super-vibration auxiliary cutting, the fragments of the cut trabecular meshwork are further crushed, after the trabecular meshwork is cut, the cut trabecular meshwork is directly sucked out through a suction module without replacing the surgical instruments, the operation steps are simplified, the operation time is shortened, the operation efficiency is improved, and adverse reaction of the operation can be relieved.

Drawings

FIG. 1 is a schematic structural diagram of an ultrasonic surgical system apparatus according to an embodiment of the present invention;

FIG. 2 is a schematic view of the internal structure of an ultrasonic blade according to an embodiment of the present invention;

FIG. 3 is a schematic diagram of a tool tip according to an embodiment of the present invention, wherein A is a flat head tool tip and B is an elbow tool tip;

FIG. 4 is a schematic structural view of a cutting head according to an embodiment of the present invention, wherein A is a single relief hole formed along the direction of the cutting edge, B is a double relief hole formed along the direction of the cutting edge, and C is a single relief hole formed perpendicular to the direction of the cutting edge;

FIG. 5 is a schematic view of a tool tip according to an embodiment of the present invention;

FIG. 6 is a schematic view of a tool tip according to an embodiment of the present invention;

FIG. 7 is a schematic view of a tool tip according to an embodiment of the present invention;

FIG. 8 is a schematic view of a tool tip according to an embodiment of the present invention;

FIG. 9 is a schematic view of a tool tip according to an embodiment of the present invention;

FIG. 10 is a schematic view of a tool tip provided in accordance with an embodiment of the invention;

FIG. 11 is a cross-sectional view of an ultrasonic blade provided in accordance with one embodiment of the present invention;

FIG. 12 is a microstructure view of a tool tip according to an embodiment of the invention;

FIG. 13 is a schematic view of a tool tip configuration provided in accordance with an embodiment of the invention;

FIG. 14 is a schematic view of a tool tip configuration according to an embodiment of the present invention;

FIG. 15 is a schematic view of an operation panel according to an embodiment of the present invention;

FIG. 16 is a schematic illustration of a cut away view of a trabecular meshwork, provided in accordance with an embodiment of the present invention;

fig. 17 is a partial block diagram of an eye according to an embodiment of the present invention.

Wherein, 1-a host; 2-a touch panel; 3-an ultrasonic knife; 4-a peristaltic pump; 5-a drainage container; 6-infusion bottle; 7-an electromagnetic valve; 8, fixing blocks; 9-piezoelectric ceramic plate; 10-a horn; 11-a cutter head; 12-accumulation groove; 13-a cutting edge; 14-a ramp; 15-pointed tip; 16-the anterior chamber; 17-a lens; 18-the cornea; 19-trabecular meshwork; 20-Schlemm's tube.

Detailed Description

It is to be understood that in the description of the present invention, the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate orientations or positional relationships based on those shown in the drawings, and are used only for convenience in describing the present invention and for simplicity in description, and do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be taken as limiting the present invention. Furthermore, the terms "first", "second", etc. are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first," "second," etc. may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless otherwise specified.

It should be noted that, in the description of the present invention, unless otherwise explicitly specified or limited, the terms "disposed," "connected" and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art through specific situations.

It should be understood by those skilled in the art that the present invention necessarily includes necessary piping, conventional valves and general pump equipment for achieving the complete process, but the above contents do not belong to the main inventive points of the present invention, and those skilled in the art can select the layout of the additional equipment based on the process flow and the equipment structure, and the present invention is not particularly limited to this.

The technical scheme of the invention is further explained by the specific implementation mode in combination with the attached drawings.

In one embodiment, the present invention provides an ultrasonic blade 3 for trabecular meshwork 19 resection, the ultrasonic blade 3 comprising an ultrasonic handle and a blade 11 detachably secured to one end of the ultrasonic handle, as shown in fig. 2 and 11.

The ultrasonic handle comprises a shell, wherein an infusion channel and a suction channel which are independent from each other are arranged in the shell, the infusion channel and the suction channel are communicated with the hollow cavity of the cutter head 11, infusion fluid is injected into the anterior chamber 16 through the infusion channel, and the infusion fluid is sucked out through the trabecular meshwork 19 which is cut off through suction.

The inside of the shell is also provided with a horn 10 and a piezoelectric ceramic crystal pile, the horn 10 is used for transmitting and amplifying ultrasonic amplitude, and the tool bit 11 senses different contact pressures to promote the piezoelectric ceramic crystal pile to generate different potential differences along with the tool bit 11 entering different parts of tissues of an affected part.

In the specific using process, the ultrasonic knife 3 needs to be connected with an ultrasonic generator for use, ultrasonic waves are emitted by the ultrasonic generator, the physical cutting of the knife head 11 is matched, and the physically cut pieces of the trabecular meshwork 19 are further crushed by utilizing the high-frequency vibration and cavitation effect of the ultrasonic waves, so that the follow-up suction is facilitated; in addition, compared with the conventional ultrasonic surgical instrument for cutting and cauterizing, the ultrasonic surgical instrument has the advantages of lower operation temperature, capability of directly coagulating tissues in the cutting process, higher cutting precision, less bleeding in the operation, small wound area, good surgical visual field, fast healing after the operation and the like, the ultrasonic cutting enables the trabecular meshwork 19 to be broken, the broken trabecular meshwork 19 and intraocular liquid (such as blood) are mixed into a chy shape and are sucked out through a suction channel, and in the traditional trabecular meshwork 19 operation process, the trabecular meshwork 19 which is cut off is sucked out by replacing a suction device.

The use method of the ultrasonic knife 3 provided by the invention comprises the following steps: the ultrasonic generator host conducts current with ultrasonic frequency to the ultrasonic knife 3, the piezoelectric ceramic crystal pile arranged in the ultrasonic knife 3 is activated to work, the piezoelectric ceramic crystal pile converts electric energy into mechanical energy vibrating front and back, and the tail end of the working head vibrates with ultrasonic high frequency through the transmission and amplification of the amplitude transformer 10. The application of the ultrasonic can effectively reduce the friction between the tissues and the blade, reduce the cutting resistance, ensure smooth section and easy operation, and protect the adjacent tissues from being damaged. The blunt surface of the working tip of the cutter head 11 is attached to the tissue and activates proper ultrasonic energy, so that protein denaturation and coagulation can be realized, and the bleeding point can be coagulated without large pressure.

It is noted that the term "trabecular meshwork 19" refers to the tissue region of the eye near the base of the cornea, near the ciliary body, and is responsible for draining aqueous humor through the eye. The term "anterior chamber 16" is the area of the anterior chamber of the eye covered by the cornea, which is spongy and lined with trabecular cells. It allows fluid to drain into schlemm's canal 20 and ultimately into the blood system. The term "Schlemm's canal 20" refers to the annular channel in the eye that collects aqueous humor from the anterior chamber 16 and delivers it to the bloodstream via the collector channel and the anterior ciliary vein.

It should be noted that the present invention does not require or limit the specific structure of the ultrasonic blade 11, and the existing ultrasonic blade 11 can be used in the present invention, for example: a flat head bit 11 as shown in fig. 3A, and an elbow bit 11 as shown in fig. 3B. Such as the ultrasonic blade 11 of the single-edged saw-tooth structure shown in fig. 5. As shown in FIG. 6, in the ultrasonic scalpel head 11, the cutting edge 13 has a circular cross section, and the tip thereof is provided with 5 semicircular cutter grooves, so that when the ultrasonic scalpel head is used, the trabecular meshwork 19 is opened to manufacture an open channel in accordance with the twisting technique of an operator. As shown in the ultrasonic knife head 11 of fig. 7, the cutting edge 13 is a circular section, 5 twisted sharp cutting edges are arranged on the side wing of the sharp head, the end surface of the sharp head outputs a longitudinal-torsional composite vibration mode under ultrasonic excitation, when in use, an operator can complete the hole opening of the trabecular meshwork 19 without increasing twisting techniques, and the operation risk can be reduced. In the ultrasonic blade tip 11 shown in fig. 8, the cutting edge 13 has a sickle shape with saw teeth, but may not have saw teeth. As shown in fig. 9, in the ultrasonic blade 11, the cutting edge 13 is spoon-shaped, has a hollow pipe, has an auxiliary convex point on the front end surface, and has a smooth back surface; supplementary bump can improve frictional force, and effective control and removal trabecular meshwork 19 piece, simultaneously, the glossy back can be used for stanching, and hollow passageway can increase the endless water route of heat dissipation, also can apply the negative pressure, sucks out broken trabecular meshwork 19. As shown in fig. 10, the cutting edge 13 is diamond-shaped, and has a knife slot on its side surface to reduce the adhesion of chips during cutting; the front face is sharp for cutting and the rear face is relatively smooth for protecting schlemm's canal 20.

Further, the preferred cutter head provided by the invention is of a hollow structure, the structure of the preferred cutter head is shown in fig. 13 and 14, the cutter head 11 comprises a working tip, the section of the cutter head 11 is extended along an arc-shaped track in a reducing way to form a sloping platform 14, two side surfaces of the sloping platform 14 are respectively provided with a cutting edge 13 and a sloping back, in the operation process, the working tip penetrates through the trabecular meshwork 19, the sloping platform 14 lifts and extends the trabecular meshwork 19, the sloping back is attached to the inner wall of the schlemm's canal 20, and the trabecular meshwork 19 is cut through the cutting edge 13.

Further, a material accumulation groove 12 is formed in the ramp 14, as shown in fig. 12, the size of the material accumulation groove 12 is 0.3mm × 0.3mm, and the material accumulation groove 12 is used for temporarily storing the cut pieces of the trabecular meshwork 19. A single-stage stepped limiting table is arranged on the ramp 14 and used for controlling the depth of the working tip entering the Schlemm's tube 20.

In the invention, under the action of ultrasonic high-frequency vibration and cavitation, trabecular meshwork fragments in the accumulation groove 12 are further crushed and refined and are sucked out by the suction channel.

In the invention, the working tip at the front end of the cutter head 11 is provided with a sharp pointed end which is easy to penetrate through the trabecular meshwork 19; the ramp 14 can lift and extend the trabecular net 19; the slope back is attached to the inner wall of the Schlemm's tube 20; then, ultrasonic is applied, the cutting edge 13 creates a parallel incision in the trabecular meshwork 19, the cutting edge 13 is an oblique knife edge with a wide top and a narrow bottom, the incision is easier to cut, the incision is made at the tip, and the groove is expanded at the rear end. The application of the ultrasound can reduce the friction resistance, is more beneficial to cutting through and cutting into the trabecular meshwork 19, and can select a proper gear to apply the ultrasonic energy in the whole process; the accumulation chute 12 is used to temporarily store the cut pieces of trabecular meshwork 19. The limiting table can control the depth of the working tip entering the Schlemm's tube 20, and excessive extrusion and even damage to the inner wall of the Schlemm's tube 20 are avoided. Optionally, the portion of the cutting head 11 entering the anterior chamber 16 is designed to be curved, the curvature is equivalent to that of the crystalline lens, the space limit of the crystalline lens can be avoided, and the operation is more free and flexible. The fillet structure of heel prevents the scratch in the cutting process. The slope back is attached to the bleeding position, and the device can be used for bleeding point hemostasis in an excitation blasting mode.

It should be noted that the material of the cutting head 11 provided by the present invention is preferably a titanium alloy material, which not only meets the strength requirement, but also meets the biocompatibility requirement.

Further, the piezoelectric ceramic crystal stack comprises at least one piezoelectric ceramic plate 9 which is sequentially stacked along the axial direction of the shell, and preferably, the number of the piezoelectric ceramic plates 9 is even.

Further, as shown in fig. 11, the piezoelectric ceramic plate 9 is of an annular structure, a fixing rod is arranged inside the housing, one end of the fixing rod is detachably connected with the tool bit 11, an inner-contracting annular plane is arranged on the outer peripheral surface of the other end of the fixing rod, the piezoelectric ceramic plates 9 are sequentially stacked on the annular plane, a detachable fixing block 8 is arranged at one end of the fixing rod, which is far away from the tool bit 11, and the piezoelectric ceramic plates 9 are fixed on the annular plane through the fixing block 8.

Alternatively, one end of the fixing rod is detachably connected to the tool bit 11 by a screw.

Further, the fixed block 8 is a tubular structure provided with internal threads, an external thread meshed with the internal threads of the fixed block 8 is arranged at one end, far away from the tool bit 11, of the fixed rod, and the fixed block 8 is fixed at one end of the fixed rod through threads.

In the invention, as an energy conversion device for converting electric energy into mechanical vibration, an energy converter (comprising a fixed block 8, an amplitude transformer 10 and a piezoelectric ceramic crystal stack) in an ultrasonic knife 3 adopts a sandwich type structural design, the amplitude transformer 10 is used for amplifying amplitude, a piezoelectric ceramic piece 9 sleeved on the amplitude transformer 10 forms the piezoelectric ceramic crystal stack, a back block is a metal part with a threaded hole in the center, the amplitude transformer 10 and the piezoelectric ceramic crystal stack are positioned and restrained by utilizing threads, and a certain pretightening force is applied, so that the amplitude transformer 10 and the piezoelectric ceramic crystal stack are fixed to form the ultrasonic transducer.

Further, the periphery of the cutter head 11 is provided with at least one marking line, and the marking line is used for indicating the depth of the cutter head 11 extending into the tube cavity. At least one pressure relief hole is formed in the side wall of the tool bit 11 and communicated with the inner cavity of the tool bit 11.

In the invention, the cut trabecular meshwork 19 needs to be sucked out through the suction channel, and after tissue fragments are sucked out, the negative pressure is instantly zero through the pressure relief hole at the cutter head 11, so that the anterior chamber 16 is prevented from being sucked and collapsed due to the high negative pressure with low flow. Alternatively, as shown in fig. 4, the relief hole is located at a position close to the deposit groove 12 at the front end of the cutter head 11, and a relief hole may be formed in the traveling direction of the cutting edge 13 (as shown in fig. 4A), a relief hole may be formed in the direction perpendicular to the traveling direction of the cutting edge 13 (as shown in fig. 4C), a relief hole may be formed in each of the two directions, or two relief holes opposite to each other may be formed in the traveling direction of the cutting edge 13 (as shown in fig. 4B).

In another embodiment, the present invention provides an ultrasonic surgical system apparatus including the above-mentioned ultrasonic blade 3, as shown in fig. 1, the ultrasonic surgical system apparatus includes a main machine 1, an ultrasonic handle, a perfusion module, a suction module and a control module, the ultrasonic handle is electrically connected to an ultrasonic output port of the main machine 1, the control module is electrically connected to the main machine 1, and the control module switches the working mode of the ultrasonic handle; the perfusion module and the injection-suction module are respectively and independently connected with the ultrasonic handle, the perfusion module injects perfusion liquid into the anterior chamber 16 through the ultrasonic knife 3, and the injection-suction module is used for pumping negative pressure to the ultrasonic knife 3 so as to suck out the cut trabecular meshwork 19.

Further, a processor, an ultrasonic generation module and a contact feedback module are arranged in the host 1, the ultrasonic generation module and the contact feedback module are respectively and electrically connected with the processor, the output end of the ultrasonic generation module is electrically connected with the ultrasonic knife 3, ultrasonic energy is emitted to the ultrasonic knife 3 through the ultrasonic generation module, and the knife head 11 cuts the trabecular meshwork 19 under the action of ultrasonic vibration.

It should be noted that the host 1 provided by the present invention is further provided therein with a signal generator and a matching unit, the signal generator includes a DAC circuit to convert a digital input from a processor into an analog output, the analog output is fed to a power amplifier for signal conditioning and amplification, an output of the amplifier is coupled to an output transformer and a tuning inductor, and is finally coupled to the ultrasonic blade 3 which is in contact with the patient.

The matching unit comprises an output transformer and a tuning inductance, the ultrasound transducer can be modeled as an equivalent circuit comprising a first branch with a static capacitance and a second "dynamic" branch with an inductance, a capacitance and a resistance connected in series, which define the electromechanical properties of the resonator. The known ultrasonic generator may comprise a tuning inductance for detuning the static capacitance at the resonance frequency such that substantially all of the driving signal current of the generator flows into the dynamic branch. Thus, by using a tuned inductance, the generator's drive signal current is representative of the dynamic branch current, and thus the generator can control its drive signal to maintain the resonant frequency of the ultrasound transducer. The tuning inductance may also transform the phase impedance map of the ultrasonic transducer to improve the frequency locking capability of the generator. However, the tuning inductance must match the particular static capacitance of the ultrasound transducer at the operating resonant frequency.

Further, the contact feedback module comprises a controller and an alarm which is in feedback control with the controller, the piezoelectric ceramic crystal pile of the ultrasonic knife 3 is electrically connected to the controller, the knife head 11 senses different contact pressures to enable the piezoelectric ceramic crystal pile to generate different potential differences along with the fact that the knife head 11 enters different parts of tissues of an affected part, and the controller controls the alarm to send out different indication sound effects according to the different potential differences.

Further, when the tool bit 11 contacts the trabecular meshwork 19, the contact pressure sensed by the tool bit 11 enables the potential difference generated by the two poles of the piezoelectric ceramic crystal stack to exceed the set contact voltage, and the alarm gives out a low-frequency sound effect. When the cutter head 11 passes through the small beam net 19 and enters the Schlemm's tube 20, the contact pressure sensed by the cutter head 11 enables the potential difference generated by the two poles of the piezoelectric ceramic crystal stack to exceed the break-through voltage, and the alarm gives out a medium-frequency sound effect. When the cutter head 11 contacts the Schlemm's tube 20 and generates pressure on the inner wall of the Schlemm's tube 20, the contact pressure sensed by the cutter head 11 enables the potential difference generated by the two poles of the piezoelectric ceramic crystal stack to exceed the alarm voltage, the alarm sends out a high-frequency sound effect and simultaneously sends out a control instruction to the processor to cut off the ultrasonic energy output.

The contact feedback function utilizes the piezoelectric effect of the piezoelectric ceramic crystal stack, and the magnitude of the contact pressure can be judged by capturing the electric charge quantity or the potential difference caused by the pressure; when the cutter head 11 contacts the trabecular meshwork 19, the contact pressure sensed by the cutter head 11 enables the potential difference generated by the two poles of the piezoelectric ceramic crystal stack to exceed the set contact voltage, and the alarm sends 300Hz audio as a prompt signal; when the cutter head 11 passes through the small beam net 19 and enters the Schlemm's tube 20, the contact pressure sensed by the cutter head 11 enables the potential difference generated by the two poles of the piezoelectric ceramic crystal stack to exceed the puncture voltage, and the alarm sends 500Hz audio as a prompt signal; when the cutter head 11 contacts the Schlemm's tube 20 and generates pressure on the inner wall of the Schlemm's tube 20, the contact pressure sensed by the cutter head 11 enables the potential difference generated by the two poles of the piezoelectric ceramic crystal stack to exceed the alarm voltage, the alarm sends 800Hz audio serving as a prompt signal, meanwhile, the ultrasonic energy output is cut off immediately, and the external manual control and pedal ultrasonic trigger signals are not considered, so that the inner wall of the Schlemm's tube 20 is prevented from being damaged.

Further, the ultrasonic surgical system apparatus includes three different modes of operation, respectively, perfusion, output, and suction modes. Specifically, in the perfusion mode, the processor controls the filling module to inject perfusion fluid into the anterior chamber 16 through the ultrasonic blade 3. Optionally, the perfusate is a balanced salt solution. In the output mode, the processor controls the ultrasonic generating module to send ultrasonic energy to the ultrasonic, so that the cutter head 11 vibrates under the action of the ultrasonic to cut off the trabecular meshwork 19. In the suction mode, the processor controls the suction module to draw a negative pressure to the ultrasonic blade 3, thereby sucking out the cut trabecular meshwork 19.

Further, the control module includes a foot switch electrically connected to the processor, and the foot switch controls the ultrasonic blade 3 to switch to different working modes through the processor. Specifically, the foot switch has three gears, which are respectively marked as a perfusion gear, an output gear and a suction gear, and respectively correspond to the perfusion mode, the output mode and the suction mode of the ultrasonic blade 3.

It should be noted that, in the use process of the ultrasonic surgical system device provided by the present invention, the perfusion mode, the output mode and the suction mode need to be always kept open, in the surgical process, the perfusion module continuously injects the perfusion fluid into the anterior chamber 16, and the perfusion fluid is continuously introduced into the anterior chamber 16 through the perfusion module, so as to stabilize the pressure of the anterior chamber 16, and prevent the collapse of the anterior chamber 16 and the adverse effect on the cutting; meanwhile, the suction module continuously sucks while cutting.

Further, the ultrasonic blade 3 is classified into a linear output mode, a pulse output mode, and a blasting output mode in the output mode according to the output mode of the ultrasonic power. Specifically, in the linear output mode, the main machine 1 continuously outputs ultrasound to the ultrasonic blade 3, and the blade 11 of the ultrasonic blade 3 continuously vibrates under the action of the ultrasound. In the pulse output mode, the main machine 1 intermittently outputs ultrasound to the ultrasonic blade 3, and the blade 11 of the ultrasonic blade 3 intermittently vibrates under the action of the ultrasound. In the blasting output mode, the main machine 1 intermittently outputs ultrasound to the ultrasonic blade 3, and the ultrasonic power output at a single time is gradually increased.

It should be noted that, in the case where the perfusion module and the suction module operate simultaneously, the output mode of the ultrasonic blade 3 can be manually adjusted by the doctor.

Furthermore, the control module also comprises a main pedal electrically connected to the processor, and when the ultrasonic operation system device is switched to the output mode, the main pedal controls the output parameters of different output modes. Specifically, in a linear output mode and a pulse output mode, the main pedal is used for controlling the ultrasonic output power; in the burst output mode, the main pedal is used to control the intermittent time of the ultrasonic output.

According to the invention, the blasting interval time is controlled through the main pedal, the main pedal can also be classified, different grades correspond to different blasting interval times, and the corresponding relation is shown in table 1.

TABLE 1

Grading	1	2	3	4	5	6	7	8
									Blasting pause time	1.5s	1s	0.7s	0.45s	0.3s	0.2s	0.1s	0

Further, the touch panel 2 is embedded in the housing of the host 1, and as shown in fig. 15, the touch panel 2 is divided into an output mode selection area, a status parameter indication area and a working parameter setting area.

The output mode selection area is used for selecting different output modes of the ultrasonic blade 3, and comprises a linear selection frame, a pulse selection frame and a blasting selection frame.

It should be noted that, the ultrasonic surgical system apparatus provided by the present invention is initially set to the linear mode at the time of shipment, and any one of the three output modes can be selected and stored by the button of the output mode selection area. And when the computer is started next time, directly entering the last selected output mode before the computer is shut down. For example, the last time before the power-off is set to be in the "pulse mode", the "pulse mode" is directly entered after the power-on.

And displaying the current state parameters including the current working mode, the current negative pressure value, the current ultrasonic output power grade, the annular grading diagram and the annular number indication in real time in the state parameter indication area. In the linear output mode and the pulse output mode, the annular grading graph is used for indicating the power magnitude; in the blasting output mode, the annular grading chart is used for indicating the interval time of the ultrasonic output.

The working parameter setting area is divided into a gear adjusting frame, a negative pressure adjusting frame and a flow adjusting frame, and after one output mode is determined in the output mode selecting area, the gear, the negative pressure and the flow under the current output mode are adjusted.

Further, the infusion module comprises an infusion bottle 6, infusion liquid is injected into the infusion bottle 6, and the infusion bottle 6 is communicated with the infusion channel of the ultrasonic knife 3 through a hose. Be provided with the filling pump on the hose, filling pump electric connection treater is provided with pressure sensor on the hose, and pressure sensor is used for detecting the pressure variation in the anterior chamber, through treater feedback control filling pump, guarantees the pressure stability in the anterior chamber.

Be provided with solenoid valve 7 on the hose, solenoid valve 7 electric connection treater switches foot switch to the pouring position to send control command to the treater, the treater receives control command back control solenoid valve 7 and opens, and the perfusate in the infusion bottle 6 gets into ultrasonic knife 3 along the hose.

In the invention, an infusion bottle 6 filled with infusion solution can be hung by using an infusion support, balanced salt solution is ensured in the infusion bottle 6, the hanging height is that the vertical distance between the liquid level and a negative pressure detection port on a front panel is 80-90 cm, different hanging heights and different infusion pressures are different, and the corresponding relation between the hanging height and the infusion pressure is shown in table 2. Optionally, a liquid level sensor is added in the infusion bottle 6, when the liquid level in the infusion bottle 6 is lower than a specified position, a warning prompt sound is given to remind medical staff to replace the infusion bottle 6 in time, and the temperature rise of the anterior chamber 16 caused by untimely infusion is avoided.

TABLE 2

Height of suspension (cm)	20	40	60	80	90
						Perfusion pressure (mmHg)	14.5±2.5	30.5±2.5	45.5±2.5	58.5±1.5	66.5±1.5

Further, the injection and suction module comprises a drainage container 5, and the drainage container 5 is communicated with the suction channel of the ultrasonic knife 3 through a catheter.

The peristaltic pump 4 and the negative pressure detection device are connected to the hose, the peristaltic pump 4 and the negative pressure detection device are respectively electrically connected with the processor, the foot switch is switched to a suction gear, a control command is sent to the processor, the peristaltic pump 4 is controlled to be started after the processor receives the control command, the cut trabecular meshwork 19 is sucked into the catheter and enters the drainage container 5 through the catheter, in the suction process, the suction pressure is detected through the negative pressure detection device, when the negative pressure detection device detects a sudden pressure drop, the blockage of a suction channel is indicated, a control command is sent to the processor, the peristaltic pump is controlled by the feedback of the processor to stop working, and the suction is finished. The ultrasonic surgical system device provided by the invention has three different working modes, namely a perfusion mode, an output mode and a suction mode, and the different working modes are switched by a foot switch, and the ultrasonic surgical system device specifically comprises the following steps:

an operator firstly switches the working mode to a perfusion mode through a foot switch and starts to inject perfusion liquid to the front; in the whole operation process, the perfusion module is always in a perfusion mode, perfusion liquid in the transfusion bottle 6 enters the ultrasonic knife 3 along the hose, the perfusion liquid is injected into the anterior chamber 16 of the eye through a micro-incision, and the anterior chamber 16 is stabilized through continuously injecting the perfusion liquid, so that the anterior chamber 16 is prevented from collapsing and the trabecular meshwork 19 is prevented from being cut;

then, the working mode is switched to the output mode through a foot switch, the trabecular meshwork 19 is cut, the ultrasonic handle part of the ultrasonic knife 3 is held, the knife is inserted into the region to be operated in the eye through a micro-incision, the touch panel 2 is clicked to select different output modes, the main pedal is stepped to control the output parameters of the different output modes, and the trabecular meshwork 19 is cut, wherein fig. 16 is a cutting diagram of the trabecular meshwork 19, and fig. 17 is a partial structure of glasses, including an anterior chamber 16, a crystalline lens 17, a cornea 18, the trabecular meshwork 19 and a Schlemm's canal 20;

the working mode is switched to the suction mode through the foot switch, the suction module is always in the suction mode in the whole operation process, the peristaltic pump 4 is started to suck out the cut trabecular meshwork 19, partial blood and perfusion liquid, the trabecular meshwork, the partial blood and the perfusion liquid enter the drainage container 5 through the catheter, and the perfusion, the cutting and the suction are simultaneously carried out while the perfusion, the cutting and the suction are carried out.

The applicant declares that the above description is only a specific embodiment of the present invention, but the scope of the present invention is not limited thereto, and it should be understood by those skilled in the art that any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are within the scope and disclosure of the present invention.

Claims

1. An ultrasonic knife for cutting trabecular meshwork is characterized by comprising an ultrasonic handle and a knife head detachably fixed at one end of the ultrasonic handle;

the ultrasonic handle comprises a shell, wherein a perfusion channel and a suction channel which are independent from each other are arranged in the shell, the perfusion channel and the suction channel are communicated with the hollow cavity of the cutter head, perfusion liquid is injected into the anterior chamber through the perfusion channel, and the cut trabecular meshwork is sucked out through the suction channel;

2. The ultrasonic blade of claim 1, wherein the blade is hollow;

preferably, the cutter head comprises a working tip, the section of the cutter head is reduced, expanded and extended along an arc-shaped track to form a slope table, the two side surfaces of the slope table are respectively provided with a cutting edge and a slope back, in the operation process, the working tip penetrates through the trabecular meshwork, the slope table lifts and extends the trabecular meshwork, the slope back is attached to the inner wall of the Schlemm's canal, and the trabecular meshwork is cut through the cutting edge;

preferably, the sloping platform is provided with a deposit groove for temporarily storing the cut trabecular net fragments;

3. The ultrasonic blade of claim 1 or 2, wherein the piezoelectric ceramic crystal stack comprises at least two piezoelectric ceramic plates which are sequentially stacked along the axial direction of the housing, and preferably, the number of the piezoelectric ceramic plates is an even number;

preferably, the piezoelectric ceramic piece is of an annular structure, a fixing rod is arranged in the shell, one end of the fixing rod is detachably connected with the tool bit, an inner-contracting annular plane is arranged on the peripheral surface of the other end of the fixing rod, the piezoelectric ceramic pieces are sequentially stacked on the annular plane, a detachable fixing block is arranged at one end of the fixing rod, which is far away from the tool bit, and the piezoelectric ceramic piece is fixed on the annular plane through the fixing block;

preferably, one end of the fixed rod is detachably connected with the cutter head through threads;

preferably, the fixing block is a tubular structure provided with internal threads, one end of the fixing rod, which is far away from the cutter head, is provided with external threads which are mutually meshed with the internal threads of the fixing block, and the fixing block is fixed at one end of the fixing rod through threads;

preferably, at least one marking line is arranged on the periphery of the cutter head and used for indicating the depth of the cutter head extending into the tube cavity;

4. An ultrasonic surgical system device comprising the ultrasonic scalpel according to any one of claims 1-3, wherein the ultrasonic surgical system device comprises a host, an ultrasonic scalpel, a perfusion module, a suction module and a control module, the ultrasonic scalpel is electrically connected with an ultrasonic output port of the host, the control module is electrically connected to the host, and the control module switches the working mode of the ultrasonic scalpel; the perfusion module and the injection and suction module are respectively and independently connected with the ultrasonic knife, and the perfusion module injects perfusion liquid into the anterior chamber through the ultrasonic knife to stabilize the pressure of the anterior chamber and prevent the anterior chamber from collapsing; the injection and suction module is used for pumping negative pressure to the ultrasonic knife so as to suck out the cut trabecular meshwork.

5. The ultrasonic surgical system device according to claim 4, wherein a processor, an ultrasonic generating module and a contact feedback module are disposed in the main frame, and the ultrasonic generating module and the contact feedback module are electrically connected to the processor, respectively, an output end of the ultrasonic generating module is electrically connected to the ultrasonic blade, ultrasonic energy is emitted to the ultrasonic blade through the ultrasonic generating module, and the cutter head cuts the trabecular meshwork under the action of ultrasonic vibration;

preferably, the contact feedback module comprises a controller and an alarm which is in feedback control with the controller, the piezoelectric ceramic crystal stack of the ultrasonic knife is electrically connected to the controller, the knife head senses different contact pressures to drive the piezoelectric ceramic crystal stack to generate different potential differences along with the fact that the knife head enters different parts of the affected part tissue, and the controller controls the alarm to send out different indication sound effects according to the different potential differences;

preferably, when the cutter head contacts the trabecular meshwork, the contact pressure sensed by the cutter head enables the potential difference generated by the two poles of the piezoelectric ceramic crystal stack to exceed the set contact voltage, and the alarm gives out a low-frequency sound effect;

preferably, when the cutter head penetrates through the trabecular meshwork and enters the Schlemm's canal, the contact pressure sensed by the cutter head enables the potential difference generated by the two poles of the piezoelectric ceramic crystal stack to exceed the break-through voltage, and the alarm gives out a medium-frequency sound effect;

6. The ultrasonic surgical system device according to claim 4 or 5, wherein said ultrasonic surgical system device comprises three different operation modes, respectively, a perfusion mode, an output mode and a suction mode;

preferably, in the perfusion mode, the processor controls the perfusion module to inject perfusion liquid into the anterior chamber through the ultrasonic knife;

preferably, the perfusate is a balanced salt solution;

preferably, in the output mode, the processor controls the ultrasonic generating module to send ultrasonic energy to the ultrasonic knife, so that the knife head vibrates under the action of the ultrasonic energy to cut off the trabecular meshwork;

preferably, in the suction mode, the processor controls the suction module to suck negative pressure to the ultrasonic knife so as to suck out the cut trabecular meshwork;

preferably, the control module comprises a foot switch electrically connected to the processor, and the foot switch controls the ultrasonic knife to switch to different working modes through the processor;

7. The ultrasonic surgical system device of any one of claims 4-6, wherein the ultrasonic blade in the output mode is classified into a linear output mode, a pulse output mode and a burst output mode according to the output mode of the ultrasonic power;

preferably, in the linear output mode, the main machine continuously outputs ultrasound to the ultrasonic knife, and the knife head of the ultrasonic knife continuously vibrates under the action of the ultrasound;

preferably, in the pulse output mode, the main machine intermittently outputs ultrasound to the ultrasonic knife, and the knife head of the ultrasonic knife intermittently vibrates under the action of the ultrasound;

preferably, in the blasting output mode, the main machine intermittently outputs ultrasound to the ultrasonic blade, and the power of the ultrasound output in a single time is gradually increased;

preferably, the control module further comprises a main pedal electrically connected to the processor, and when the ultrasonic surgical system device is switched to the output mode, the main pedal controls the output parameters of different output modes;

8. The ultrasonic surgical system device according to any one of claims 4 to 7, wherein a touch panel is embedded in the housing of the host, and the touch panel is divided into an output mode selection area, a status parameter indication area and a working parameter setting area;

preferably, the output mode selection area is used for selecting different output modes of the ultrasonic knife, and comprises a linear selection frame, a pulse selection frame and a blasting selection frame;

preferably, the current state parameters are displayed in the state parameter indication area in real time, and comprise a current working mode, a current negative pressure value, a current ultrasonic output power grade, an annular grading graph and an annular number indication;

preferably, the annular grading graph is used for indicating the power in a linear output mode and a pulse output mode; in the blasting output mode, the annular grading graph is used for indicating the length of the ultrasonic output interval time;

9. The ultrasonic surgical system device according to any one of claims 4 to 8, wherein the perfusion module comprises an infusion bottle, a perfusion solution is injected into the infusion bottle, and the infusion bottle is communicated with the perfusion channel of the ultrasonic knife through a hose;

preferably, the hose is provided with a perfusion pump, the perfusion pump is electrically connected with the processor, the hose is provided with a pressure sensor, the pressure sensor is used for detecting pressure change in the anterior chamber, and the processor controls the perfusion pump in a feedback mode to ensure that the pressure in the anterior chamber is stable;

10. The ultrasonic surgical system device according to any one of claims 4-9, wherein the suction module comprises a drainage container, and the drainage container is communicated with the suction channel of the ultrasonic blade through a catheter;

preferably, the peristaltic pump and the negative pressure detection device are connected to the conduit, the peristaltic pump and the negative pressure detection device are respectively and electrically connected with the processor, the foot switch is switched to the suction gear, so that a control command is sent to the processor, the peristaltic pump is controlled to be started after the processor receives the control command, the cut trabecular meshwork is sucked into the conduit and enters the drainage container through the conduit, the suction pressure is detected by the negative pressure detection device in the suction process, when the negative pressure detection device detects a sudden pressure drop, the suction channel is indicated to be blocked, a control command is sent to the processor, the processor feeds back and controls the peristaltic pump to stop working, and suction is finished.