CN116473666B

CN116473666B - Temperature control system and method thereof

Info

Publication number: CN116473666B
Application number: CN202310321733.4A
Authority: CN
Inventors: 李青峰; 田秀秀; 雷保军
Original assignee: SHANGHAI RAYKEEN LASER TECHNOLOGY CO LTD; Ninth Peoples Hospital Shanghai Jiaotong University School of Medicine
Current assignee: SHANGHAI RAYKEEN LASER TECHNOLOGY CO LTD; Ninth Peoples Hospital Shanghai Jiaotong University School of Medicine
Priority date: 2023-03-29
Filing date: 2023-03-29
Publication date: 2024-01-30
Anticipated expiration: 2043-03-29
Also published as: CN116473666A

Abstract

The application provides a temperature control system and a method thereof. The temperature control system comprises a laser fiber assembly, an osteotomy guiding structure, a suction assembly and a temperature detection device, wherein the laser fiber assembly comprises a fixed laser fiber, a perfusion infusion tube and a temperature fiber, the osteotomy guiding structure is provided with an osteotomy guiding groove, the laser fiber assembly can move along the osteotomy guiding groove to gradually extend into the osteotomy guiding groove, and the temperature detection device is used for detecting the temperature of the edge of a laser action point through the temperature fiber. The temperature control system can accurately cut bones, monitor the temperature of the edge of the laser action point and control the temperature through the perfusion infusion tube, and avoid damage to tissues near the laser action point caused by overhigh temperature.

Description

Temperature control system and method thereof

Technical Field

The application relates to the technical field of medical instruments, in particular to a temperature control system and a method thereof.

Background

Mandibular angle osteotomy has high risk due to complex surgical procedures, high technical difficulty. The doctor needs to perform the operation in the intraoral incision blind area, namely, the doctor needs to incision from the inside of the oral cavity, and then performs the operation. In the prior art, an electric saw is used as the osteotomy device, and the device is difficult to operate and is not beneficial to the operation implementation. Therefore, the applicant creates a brand new laser osteotomy method, which can detect and/or control the temperature of the laser action point while performing laser osteotomy, and avoid the damage of the laser osteotomy to biological tissues near the laser action point. It should be noted that the problems of performing osteotomy by laser and discovering high-temperature damage caused by laser osteotomy are known in the research process of the applicant, and are not necessarily disclosed in the prior art.

Disclosure of Invention

In order to overcome at least one of the drawbacks of the prior art, an object of the present application is to provide a temperature control system and a method thereof for laser osteotomy.

In a first aspect, the present application provides a temperature control system, including laser fiber assembly, osteotomy guiding structure, suction component and temperature detection device, osteotomy guiding structure is formed with the osteotomy guiding groove, laser fiber assembly can follow osteotomy guiding groove removes in order to stretch gradually into osteotomy guiding groove, osteotomy guiding groove is equipped with first entry and second entry, laser fiber assembly passes through first entry with one of second entry gets into osteotomy guiding groove, suction component passes through first entry with the other of second entry gets into osteotomy guiding groove, laser fiber assembly includes fixed laser fiber, infusion tube and temperature optic fibre, wherein, infusion tube is connected with liquid supply device in order to carry liquid, laser fiber is connected with the laser light source in order to transmit laser energy, suction component is used for sucking liquid, temperature detection device passes through temperature optic fibre in order to detect the temperature at laser action point edge, the laser action point is the position of laser fiber in the bone that goes out.

Optionally, the edge of the laser action point is 0.25-1mm away from the laser action point.

Optionally, the edge of the laser action point is 0.5-1mm away from the laser action point.

Optionally, the osteotomy guiding structure is provided with a thermal insulation layer.

Optionally, the liquid flows along the osteotomy guiding groove under the action of the perfusion infusion tube and the suction assembly, and forms a liquid passage for cooling while removing waste liquid and waste bone fragments.

In a second aspect, the present application provides a temperature control method, which adopts the above temperature control system, including:

step S1, moving the laser fiber assembly along the osteotomy guiding groove, and moving the perfusion infusion tube along with the laser fiber to convey the liquid to the osteotomy guiding groove, and simultaneously, moving the temperature fiber along with the laser fiber to detect the temperature of the edge of the osteotomy point;

and S2, analyzing and judging according to the temperature of the edge of the osteotomy point detected by the temperature detection device, and controlling the laser fiber to stop emitting light and/or increasing the flow of the circulated liquid when the temperature is higher than a preset temperature threshold value so as to control the temperature.

Optionally, the preset temperature threshold includes a first preset temperature threshold and a second preset temperature threshold, and step S2 includes:

When the temperature detection device detects that the temperature of the edge of the laser action point is always lower than a first preset temperature threshold value, the laser fiber continuously emits light.

when the temperature detection device detects that the temperature of the edge of the osteotomy point exceeds the first preset temperature threshold value but is lower than the second preset temperature threshold value, the liquid delivery quantity of the liquid supply device is increased, so that the temperature of the edge of the osteotomy point is controlled to be in a safe temperature range.

when the temperature detection device detects that the temperature of the edge of the osteotomy point exceeds the second preset temperature threshold, the laser light source is controlled to stop emitting laser, and meanwhile, the temperature of the edge of the osteotomy point is continuously detected.

Optionally, the first preset temperature threshold is 42 ℃, and the second preset temperature threshold is 50 ℃.

Alternatively, the flow rate of the liquid is 25-50ml/min, the pulse width of the laser is 100-300us, the repetition rate of the laser is 10-30HZ, and the pulse energy of the laser is 2-4J.

In a third aspect, the present application provides a temperature control device, which adopts the above temperature control system for laser osteotomy;

the laser fiber assembly can move along the osteotomy guiding groove, the perfusion infusion tube can move along with the laser fiber to convey the liquid to the osteotomy guiding groove, and the temperature fiber moves along with the laser fiber to detect the temperature of the edge of the osteotomy point;

and when the temperature of the edge of the osteotomy point is higher than a preset temperature threshold, controlling the laser fiber to stop light emission and/or increasing the flow of the liquid.

Optionally, the preset temperature threshold comprises a first preset temperature threshold and a second preset temperature threshold,

and when the temperature detection device detects that the temperature of the edge of the osteotomy point is lower than the first preset temperature threshold, the laser optical fiber continues to emit light.

when the temperature detection device detects that the temperature of the edge of the osteotomy point exceeds the first preset temperature threshold value but is lower than the second preset temperature threshold value, the liquid conveying amount of the liquid supply device is increased, so that the temperature of the edge of the osteotomy point is controlled to be in a safe temperature range.

The application provides a temperature control system, a temperature control method and a temperature control device. The temperature control system realizes accurate cutting of the laser action point through the osteotomy guide groove and the laser fiber assembly. And moreover, the infusion tube and the suction assembly are poured to enable liquid to smoothly flow in the osteotomy guide groove, so that the laser action point is effectively cooled, and the laser osteotomy is ensured to be smoothly carried out without damaging tissues near the laser action point.

Drawings

Fig. 1 is a schematic structural view of a laser fiber assembly and a suction assembly according to an embodiment of the present disclosure in an osteotomy guiding configuration.

Fig. 2 is a schematic view of the mandible, osteotomy guiding structure, and handle configuration when mated.

Fig. 3 is a schematic view of the mandible of fig. 2 at another angle, with the osteotomy guiding structure mated with the handle.

Fig. 4 is a partial schematic view of the laser fiber assembly of fig. 1.

Fig. 5 is a schematic diagram of a laser fiber assembly mated with other devices in an embodiment of the present disclosure.

Fig. 6 is a partial schematic view of a modified bulk in an embodiment of the disclosure.

FIG. 7a is a block flow diagram of an embodiment of the present disclosure;

fig. 7b is a flow chart of temperature control in a preferred embodiment of the present disclosure.

Fig. 8-13 are schematic structural views of various angles of an osteotomy guiding structure in accordance with an embodiment of the present disclosure.

Fig. 14-16 are schematic views of the osteotomy guiding structure at various angles when mated with the mandible.

Fig. 17 is a schematic view of the structure of the mandible.

FIG. 18 is a schematic diagram of a temperature fiber coupled to a temperature sensing device.

Fig. 19 is a schematic view of the handle in combination with the osteotomy guiding structure.

The marks in the figure are as follows: 100. a laser fiber assembly; 110. a protective sleeve; 120. a laser fiber; 130. pouring an infusion tube; 140. a temperature optical fiber; 141. a grating; 150. a jacket; 200. an osteotomy guiding structure; 210. a body; 211. osteotomy guide slots; 212. an osteotomy opening; 213. a first inlet; 214. a second inlet; 215. a first groove; 216. a second groove; 220. a first positioning portion; 230. a second positioning portion; 240. a left wing; 250. a right wing; 260. hollow out; 270. a modified layer; 300. bone; 310. an osteotomy line; 320. a notch; 400. a handle; 500. a suction assembly; 600. a temperature detection device, 610, a probe light source; 620. a spectrum analyzer; 710. a first joint; 720. a second joint; 730. a water source; 800. a laser light source; a: a boundary line; m, a first direction; n, the second direction.

Detailed Description

For a better understanding and implementation, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application.

In the description of the present application, it should be noted that, directions or positional relationships indicated by terms "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "far", "near", etc. are directions or positional relationships based on drawings, are merely for convenience of description of the present application and simplification of description, and do not indicate or imply that the apparatus or element referred to must have a specific direction, be configured and operated in the specific direction, and therefore should not be construed as limiting the present application.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the description of the present application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

In the laser osteotomy process, the local temperature of the laser action point is higher than 300 ℃, so that the osteotomy can be ablated. But the body temperature is about 37 c and the body tissue is also kept substantially between this temperature, with local temperatures below 42 c in a safe interval. According to the biological tissue thermal effect principle, the local temperature is 42-50 ℃, and the local tissue still keeps activity within 1-2 minutes; the local temperature exceeds 50 ℃, the enzyme activity is weakened, and the cells undergo massive apoptosis. It is desirable to monitor the temperature of the laser spot (where the laser spot is at the bone 300) and its edges to reduce the damage that the laser osteotomy causes to the bone tissue at the edge of the laser spot (near the laser spot). However, the applicant considers that the temperature of the laser action point is necessarily higher than 50 ℃ when the bone is cut, and the influence of the laser cutting on bone tissue at the edge of the laser action point cannot be accurately judged by directly measuring the temperature of the laser action point. Accordingly, applicants have devised a novel temperature control system to monitor the temperature of the laser action point edge to avoid damage to bone tissue at the laser action point edge by laser osteotomies. Specifically, as shown in fig. 1-5, the temperature control system includes a laser fiber assembly 100, an osteotomy guiding structure 200, a suction assembly 500, and a temperature detection device 600, the laser fiber assembly 100 including a laser fiber 120, a perfusion infusion tube 130, and a temperature fiber 140 secured to one another by a sheath 150. The osteotomy guiding structure 200 is formed with an osteotomy guiding slot 211, and the laser fiber assembly 100 is movable along the osteotomy guiding slot 211 to extend into the osteotomy guiding slot 211. Wherein, the osteotomy guiding slot 211 is provided with a first inlet 213 and a second inlet 214, the infusion tube 130 and the pumping assembly 500 enter the osteotomy guiding slot 211 through the first inlet 213 and the second inlet 214 respectively, the infusion tube 130 is connected with the liquid supply device for delivering liquid, the pumping assembly 500 is used for pumping liquid, and the laser fiber 120 is connected with the laser light source 800. The temperature detection device 600 detects the temperature of the edge of the laser action point through the temperature fiber 140.

Alternatively, the temperature fiber 240 monitors and feeds back the temperature value through the grating at a position that is 0.25mm-1.0mm from the edge of the laser action point. Alternatively, the laser action point edge is 0.5mm-1mm from the laser action point. In the laser osteotomy process, the local temperature of the laser action point is higher than 300 ℃, so that the osteotomy can be ablated, and the influence of the laser osteotomy on the bone tissue at the edge of the laser action point cannot be accurately judged by directly measuring the temperature of the laser action point.

When the temperature optical fiber 140 detects the edge temperature of the laser action point, the detection point of the temperature optical fiber 140 is too close to the laser action point and may be affected by the laser emitted by the laser optical fiber 120, and the detection point of the temperature optical fiber 140 is too far and may not accurately reflect the edge temperature of the laser action point. Thus, the present disclosure monitors the temperature at a location 0.25-1 mm from the laser action point through grating 141. Once the monitored temperature exceeds 50 ℃, osteotomies are automatically paused. The laser bone cutting is ensured to be carried out smoothly, and meanwhile, the damage to tissues near the laser action point can be reduced.

In order to reduce damage to tissue in contact with the osteotomy guiding structure 200 due to heat conduction, in some embodiments, the osteotomy guiding structure 200 is provided with a thermal barrier layer effective to prevent high temperatures from being conducted through the osteotomy guiding structure 200 to the various locations of the bone 300. Optionally, the insulating layer comprises soda-lime-borosilicate glass or silica particles. In some embodiments, the thermal barrier layer is applied by spraying to the exterior of the body 210 of the osteotomy guiding structure, and the thermal barrier layer has a thickness in the range of about 1 μm to 1000 μm. The heat insulating layer has a porous structure as a whole, and is prepared by dispersing and mixing particles having heat insulating properties in a base material such as polyether ether ketone (PEEK) or titanium alloy. Wherein the particles with heat insulation property are sodium calcium borosilicate glass or silicon dioxide particles. The body 210 of the osteotomy guiding structure 200 is made of Polyetheretherketone (PEEK) or titanium alloy. In order to solve the bonding capability of PEEK and titanium alloy with the heat insulation layer, a novel low-temperature plasma bonding process is adopted. Specifically, the body 210 of the laser osteotomy device is subjected to surface treatment by using a plasma flame with a temperature of about 90 to 200 degrees, so that the material surface is modified to form a modified layer 270, see fig. 6. Wherein the thickness of the modified layer 270 is 100 nm-500 nm. Then, soda-lime-borosilicate glass or silica particles are attached to the modified layer 270 to form a thermal insulation layer. Through the heat insulation layer, heat is ensured not to diffuse through the body 210, so that partial tissues in the oral cavity, which are abutted against the body 210, are prevented from being damaged by high temperature.

It should be noted that, the suction assembly 500 may also enter the osteotomy guiding slot 211 through the first inlet 213, and the infusion tube 130 may enter the osteotomy guiding slot 211 through the second inlet 214, which is not particularly limited in this disclosure. In addition, the suction assembly 500 may have a tubular structure, and a suction structure such as a negative pressure aspirator is connected to one end thereof, and the negative pressure aspirator may be passed through the suction assembly 500 to aspirate the waste material and the waste liquid in the osteotomy guide groove 211.

It should be noted that the liquid supply device may include a water source 730 and a pump, and the water in the water source 730 is delivered to the perfusion tube 130 by the pump.

In addition, the present application further provides a temperature control method for performing temperature control during an osteotomy, referring to fig. 7a and 7b, which includes:

step S1, moving the laser fiber assembly along the osteotomy guiding groove to enable laser emitted by the laser fiber to move along an osteotomy line of a bone, moving the infusion tube along with the laser fiber to convey liquid to the osteotomy guiding groove, and simultaneously, moving the temperature fiber along with the laser fiber to detect the temperature of the edge of a laser action point. The temperature optical fiber is fixedly connected with the laser optical fiber and the infusion tube, so that the temperature optical fiber and the infusion tube can move along with the laser optical fiber when the laser optical fiber moves.

In step S1, the liquid flows along the osteotomy guiding slot under the action of the suction assembly 500, so as to form a cooling liquid passage for cooling the bone while removing the waste liquid and the waste bone fragments. The liquid passage is a path through which liquid flows.

And S2, analyzing and judging according to the temperature of the laser action point detected by the temperature detection device, and controlling the laser fiber to stop emitting light (namely stopping the operation) and/or increasing the flow of the circulating liquid when the temperature is higher than a preset temperature threshold value so as to control the temperature.

More specifically, during the surgical procedure, according to the influence of temperature on the tissue, the preset temperature threshold includes a first preset temperature threshold and a second preset temperature threshold, and step S2 specifically includes:

when the temperature detection device detects that the temperature of the edge of the laser action point is always lower than a first preset temperature threshold value, continuing to perform the laser osteotomy till the end;

when the temperature detection device detects that the temperature of the edge of the laser action point exceeds the first preset temperature threshold value but is lower than the second preset temperature threshold value, the liquid delivery quantity of the liquid supply device is increased to control the temperature of the operation process to be in a safe temperature range (the safe temperature range is below 50 ℃ and the same applies below), and the operation is finished until the osteotomy is finished. It should be noted that, when the surgical temperature exceeds the first preset temperature threshold, the temperature of the detection point can be controlled to be a reasonable temperature at which the surgical operation can be performed by increasing the liquid delivery amount, and exceeding the first preset temperature threshold includes reaching the first preset temperature threshold.

When the temperature detection device detects that the temperature of the edge of the laser action point exceeds a second preset temperature threshold, the laser light source is controlled to stop emitting laser, the operation is stopped, meanwhile, the temperature of the edge of the laser action point is continuously detected, and the laser operation is continuously performed when the temperature is reduced to a safe temperature range until the operation is finished. It should be noted that exceeding the second preset temperature threshold includes reaching the second preset temperature threshold.

Optionally, the local tissue still keeps activity within 1-2 minutes because the local temperature of the human body is between 42 and 50 ℃; the local temperature exceeds 50 ℃, the enzyme activity is weakened, and cells undergo massive apoptosis, and based on the local temperature, the first preset temperature threshold is preferably 42 ℃; the second preset temperature threshold is preferably 50 ℃.

Specifically, the temperature control system further includes a temperature detection device 600, a laser light source 800, and a liquid supply device, and the temperature of the edge of the laser action point is detected by the temperature detection device 600. The laser light source 800 provides laser for the laser fiber 120, and the liquid supply device provides liquid for the perfusion transfusion tube 130, wherein the temperature detection device 600 is respectively connected with the laser light source 800 and the liquid supply device in a signal manner, and when the temperature detection device 600 detects that the temperature of the edge of the laser action point is higher than a preset temperature threshold value, a prompt signal is sent out, and the laser light source 800 is controlled to stop emitting laser and/or the liquid delivery quantity of the liquid supply device is controlled according to the prompt of the prompt signal. More specifically, referring again to fig. 7 a-7 b, when the temperature detection device 600 detects that the temperature of the laser action point edge is always below 42 ℃, then osteotomy is performed until the operation is completed; when the temperature detection device 600 detects that the temperature of the edge of the laser action point is higher than 42 ℃, a first prompt signal is sent out, and at the moment, the bone is cooled by increasing the liquid conveying amount of the liquid supply device, and meanwhile, the temperature detection is carried out, so that the temperature in the operation process is not higher than 50 ℃; when the temperature detection device 600 detects that the temperature of the edge of the laser action point reaches 50 ℃, a second prompt signal is sent out, the laser light source 800 is controlled to stop emitting laser, the liquid conveying amount of the liquid supply device is increased, the temperature of bones is reduced in time, and meanwhile, the temperature is detected. When the temperature detection device 600 detects that the temperature of the edge of the laser action point is lower than 50 ℃ and reaches the safe temperature range, the laser light source 800 continues to emit laser until the laser operation is finished.

In order to ensure that the temperature of the edge of the laser action point can be below 50 ℃ during laser osteotomy, the applicant makes the following experiments, in particular:

the laser fiber assembly 100 and the suction assembly 500 are respectively introduced into the osteotomy guiding slot 211 from the first inlet 213 and the second inlet 214 of the osteotomy guiding slot 211. Wherein, the perfusion transfusion tube 130 of the laser fiber assembly 100 sprays physiological saline, and the pumping assembly 500 simultaneously pumps the waste liquid to form a flow of the physiological saline inside the osteotomy guiding slot 211. Next, the effect of laser energy on the cooling effect was measured.

When the water temperature is 26 ℃ and the flow rate is 15ml/min at the reference test temperature:

the reference test temperature water temperature is 26 ℃, the flow rate is 25ml/min,

the reference test water temperature is 26 ℃ and the flow rate is 50ml/min,

from the above table, it is clear that when the flow rate of the liquid (physiological saline) is 15ml/min and the single pulse energy of the laser is 3J or more, the temperature tends to rise sharply, and the temperature exceeds the safe range, thereby damaging the tissue at the bone edge of the laser action point. The temperature rise speed is controllable when the liquid flow is 25ml/min or 50 ml/min. The laser pulse width in the above embodiment was controlled to be about 200us, and the repetition rate was 20HZ.

In summary, in step S2, when the laser pulse width is controlled to be 200us, the repetition frequency is 20HZ, the cutting single pulse energy is between 2 and 4J, and the circulating water flow is 25 to 50ml/min, the requirements of bone cutting and cooling can be met. Thus, alternatively, the flow rate of the liquid is 25-50ml/min, the pulse width of the laser is 100-300us, the repetition rate of the laser is 10-30HZ, and the pulse energy of the laser is 2-4J. More specifically, the pulse width of the laser may be preferably 200us, and the repetition rate of the laser may be preferably 20HZ.

For a better explanation of the present application, my will continue to describe the temperature control system. Specifically, the laser fiber assembly 100 is of a bendable structure, and because the laser fiber 120, the temperature fiber 140 and the perfusion transfusion tube 130 are of a bendable structure, the functions of the laser fiber assembly 100 are not easily affected after the laser fiber assembly is properly bent, so that the laser fiber assembly 100 can smoothly move along the osteotomy guiding groove 211, and the osteotomy, temperature measurement and temperature reduction functions are completed, thereby greatly improving the osteotomy efficiency, reducing the space required by osteotomy, and reducing the damage to a patient.

In some embodiments, the osteotomy guiding structure 200, referring specifically to fig. 8-13, comprises a body 210, the body 210 is formed with an osteotomy guiding slot 211, the osteotomy guiding slot 211 is formed with an osteotomy opening 212, the osteotomy guiding slot 211 is used for moving the laser fiber assembly 100 within the osteotomy guiding slot 211, wherein the laser fiber assembly 100 is used for transmitting laser light to the bone 300 for osteotomy.

And the osteotomy opening 212 of the osteotomy guiding slot 211 corresponds to the position of the osteotomy line 310, when the laser fiber assembly 100 gradually extends into the osteotomy guiding slot 211 along the osteotomy guiding slot 211, the laser emitted from the laser fiber assembly 100 passes through the osteotomy opening 212 to the bone 300 to cut the bone 300 along the osteotomy line 310.

The laser fiber assembly 100 of the present application can gradually extend into the osteotomy guiding slot 211 along with the extending direction of the osteotomy guiding slot 211, and gradually cut the bone 300 during the extending process. When a doctor cuts bones, the laser fiber assembly 100 is pulled only at the inlet position of the osteotomy guiding groove 211, so that the space required for operation is effectively reduced, and the doctor can only operate in a small area.

Alternatively, as shown in fig. 14-16, the body 210 fits both the outside and inside of the mandible. Applicant has found that existing osteotomy navigation templates for the mandible are all located on the outside of the mandible and have no portion located on the inside. Therefore, the osteotomy navigation template cannot be attached to the inner side of the mandible, so that the installation of the osteotomy guide plate is unstable, and if an electric saw is adopted for osteotomy, the position of the osteotomy guide plate is deviated due to high-speed swing of the electric saw. Although in the above embodiment, the body 210 is attached to the outside and inside of the mandible, the body 210 may be attached to two opposite sides of different bones, such as the front and rear sides of the bone 300, the upper and lower sides of the bone 300, etc., for different bones 300.

Optionally, the osteotomy guiding groove 211 is formed by combining a first groove 215 and a second groove 216, the first groove 215 and the second groove 216 are respectively located on the outer side and the inner side of the mandible, the first groove 215 extends from front to back, and the second groove 216 extends from front to back, so that the rear end of the first groove 215 and the rear end of the second groove 216 meet and are communicated, and the osteotomy guiding groove 211 presents a shape of a "C". In the above-mentioned embodiments, the first groove 215 and the second groove 216 are located on the outer side and the inner side of the mandible respectively, and the laser fiber assembly 100 also performs osteotomy along the first groove 215 and the second groove 216, so that the incisions on the outer side and the inner side of the mandible after osteotomy are relatively smoothly attached to the osteotomy line 310. In order to better show the positions of the first slot 215 and the second slot 216, a boundary line a is drawn in the present application. And the boundary line a is a virtual line, the transition between the first groove 215 and the second groove 216 is smooth, and the first groove 215 and the second groove 216 are integrated into the osteotomy guiding groove 211.

Also, in some embodiments, the osteotomy guiding slot 211 may include other grooves in addition to the first slot 215 and the second slot 216, and is not limited to the above embodiments.

Optionally, the first inlet 213 is located at a front end of the first slot 215 and the second inlet 214 is located at a front end of the second slot 216. Specifically, the first inlet 213 is positioned on the same anterior side as the second inlet 214, facilitating the surgeon's simultaneous operation of the laser fiber assembly 100 and the suction assembly 500.

It should be noted that, since the rear end of the first slot 215 is in communication with the rear end of the second slot 216, the laser fiber assembly 100 may enter the first slot 215 from the first inlet 213, then pass through the first slot 215, reach the rear end of the second slot 216, and finally, the front end of the laser fiber assembly 100 may exit the second slot 216 through the second inlet 214.

Alternatively, as shown in fig. 14-17, the bone 300 is a mandible, the body 210 includes a first positioning part 220 and a second positioning part 230 connected to each other, the first positioning part 220 is located in a recess 320 below a chin hole of the bone 300, the second positioning part 230 is attached to the rear side of the bone 300, and the first positioning part 220 and the second positioning part 230 are matched with the bone 300 to confirm the installation position of the body 210 on the bone 300. Specifically, when the body 210 is placed at the correct position, the first positioning portion 220 and the second positioning portion 230 are engaged with the bone 300, so that the body 210 is not easy to fall off from the bone 300, and the body 210 is determined to be placed at the correct position.

For ease of understanding, the present application labels a second direction N in fig. 14, wherein the second direction N is a direction from the rear of the mandible toward the front of the mandible.

The first positioning portion 220, the second positioning portion 230, the left wing 240, and the right wing 250 are integrally formed, and there is no obvious boundary line between the joints of the four.

Optionally, the middle of the body 110 is hollowed 160. Benefits of the hollowed-out 160 are: the smaller volume of body 110 is easier to pack into the surgical field space, reducing the incision size during patient surgery. Moreover, the hollow 160 in the middle of the body 110 allows a part of the mandible to pass through, and the hollow 160 in the middle of the body 110 cooperates with the first positioning portion 120, the second positioning portion 130, the left wing 140 and the right wing 150 to form a certain limit and fix on the mandible, so that the body 110 is tightly attached to the mandible, and the body 110 is prevented from falling off from the mandible.

It should be noted that there are various ways and structures for preventing the body 210 from falling off from the bone 300, for example: since the body 210 is manufactured by 3D printing according to the CT data of the mandible, the osteotomy guiding structure 200 has an inner side surface that is bonded to the inner and outer side surfaces of the mandible angle, so that the osteotomy guiding structure 200 is tightly bonded to the mandible to enable the body 210 to be extremely bonded to the bone 300 such as the mandible, and the body 210 is not easy to fall off. In some embodiments, the surface of the body 210 is sandblasted to form a rough surface, which increases the friction between the body 210 and the bone 300, and allows the body 210 to be more firmly fixed to the bone 300.

For ease of understanding, the present disclosure labels a first direction M in fig. 4, where the first direction M is an axial direction of the laser fiber 120, the temperature fiber 140, the infusion tube 130, and the laser fiber assembly 100, and specifically, the laser fiber 120, the temperature fiber 140, the infusion tube 130, and the laser fiber assembly 100 extend back and forth along the first direction M. It should be noted that the laser fiber assembly 100 is a bendable structure, which can be bent to some extent.

Specifically, the rear end of the laser fiber 120 is connected to the laser light source 800 to transmit laser light, and the front end of the laser fiber 120 emits laser light to cut the bone 300.

Meanwhile, the rear end of the infusion tube 130 is connected with the water source 730 through a pump (the liquid is delivered into the infusion tube 130 through the pump), and the front end of the infusion tube 130 can spray the liquid to the laser action point 300 to cool the bone 300. Optionally, the front end of infusion tube 130 is aligned with the laser action point to precisely cool the laser action point. The perfusion transfusion tube can be a common pipeline and can be used for conveying liquid.

When the laser light is emitted from the tip of the laser fiber 120, the point where the laser light contacts the bone 300 is the laser light application point. Also, as shown in fig. 18, a first connector 710 is provided between the temperature detecting device 600 and the temperature optical fiber 140 to facilitate transmission of the probe light, wherein the first connector 710 is a FC (Ferrule contact)/APC (Angled Physical Contact) connector. A second connector 720 is provided between the laser light source 800 and the laser fiber 120 to facilitate the transmission of laser light. The second connector 720 is a SMA (Small A Type) connector. Specifically, the temperature detecting device 600 includes a spectrum analyzer 620 and a detecting light source 610, and the grating 141 is directly inscribed on the front end of the temperature fiber 140. The detection light emitted by the detection light source 610 is a laser with extremely low power, which does not damage the human body, and is a broad spectrum light source with wavelength covering the reflection spectrum of the fiber bragg grating. The temperature optical fiber 140 is connected to the probe light source 610, and the probe light emitted by the probe light source 610 is reflected when passing through the grating 141, and the reflected light is connected to the spectrum analyzer 620 through the circulator. When the temperature of the laser action point edge acts on the grating 141 of the temperature fiber 140, a drift in the wavelength of light in the grating 141 is caused, and the temperature change is fed back by the wavelength change. Further, the instrument can obtain temperature information of the grating 141, i.e., the tip of the temperature fiber 140, from the analysis light signal.

Alternatively, the laser light emitted from the laser fiber 120 is 2780nm Er, cr: YSGG laser, 2940nm erbium laser (Er: YAG laser), or 10800nm carbon dioxide laser (CO ₂ Laser).

It should be noted that, as shown in fig. 4, the front end of the laser fiber 120, the front end of the temperature fiber 140 and the front end of the infusion tube 130 all extend out of the outer sleeve 150, and a protective sleeve 110 is disposed in front of the outer sleeve 150 to protect and fix the front end of the laser fiber 120, the front end of the temperature fiber 140 and the front end of the infusion tube 130, and openings are formed on the side of the protective sleeve 110 for the laser in the laser fiber 120 to emit and the water to the infusion tube 130. In some embodiments, a protective sleeve may not be provided, and as shown in fig. 5, an opening may be formed at a side of the outer sleeve 150 for injecting the laser light in the laser fiber 120 and spraying water into the infusion tube 130.

Optionally, the jacket 150 is made of polyetheretherketone, wherein the jacket 150 is formed with channels for installing the infusion tube 130, the laser fiber 120, and the temperature fiber 140. Specifically, the sheath 150 is wrapped over the laser fiber 120, the temperature fiber 140, and the infusion tube 130, such that the relative positions of the laser fiber 120, the temperature fiber 140, and the infusion tube 130 are thereby fixed. Also in some alternative embodiments, the infusion tube 130, the laser fiber 120, and the temperature fiber 140 may be further secured within the outer sleeve 150 by a securing glue.

Specifically, the laser fiber 120 of the present application has an input end and an output end, and the laser emitted by the medical laser therapeutic machine is transmitted to the output end of the laser fiber 1 through the input end of the laser fiber 120 and then deflected by a preset angle α along the axis direction of the laser fiber 220 by refraction, that is, the emitting direction of the laser is different from the axis direction of the laser fiber 220. Specifically, the output end of the laser fiber 220 may be disposed such that the direction in which the laser light exits the laser fiber 220 is 90 ° to the axial direction, that is, the light exiting direction of the laser fiber 120 is 90 ° to the extending direction of the laser fiber 120, so that the laser light can be focused perpendicularly onto the surface of the mandible part.

When the osteotomy guiding structure 200 is mounted to the bone 300, the osteotomy guiding slot 211 and the osteotomy opening 212 of the osteotomy guiding slot 211 are aligned with the osteotomy line 310 on the bone 300. At this time, the laser fiber assembly 100 may enter the osteotomy guiding slot 211 through the first inlet 213 or the second inlet 214. At this time, the laser light is emitted from the output end of the front end of the laser fiber 120 and reaches the bone 300 through the osteotomy opening 212 of the osteotomy guiding slot 211 to complete osteotomy.

In this application, since the laser fiber assembly 100 is in a bendable structure and the laser fiber assembly 100 and the osteotomy guiding groove 211 can be mutually matched, the laser fiber assembly 100 can be bent when entering the osteotomy guiding groove 211, so that the laser fiber assembly 100 can move along the osteotomy guiding groove 211, and since the osteotomy guiding groove 211 is obtained by modeling and designing an osteotomy according to the CT data of the user, the laser can be aligned to the osteotomy 310 as much as possible.

At the same time as the laser osteotomy is performed, fluid is delivered to the bone 300 through the infusion tube 130 to cool the bone 300. And since the bone 300 is closely attached to the osteotomy guiding structure 200, the osteotomy opening 212 of the osteotomy guiding slot 211 is blocked by the bone 300, the osteotomy guiding slot 211 forms a fluid channel to restrict the flow direction of the fluid, and the fluid for cooling flows along the osteotomy guiding slot 211 to the first inlet 213 or the second inlet 214 to be discharged. At this time, since the liquid is in a flowing state, the warmed liquid will not remain in the osteotomy guiding groove 211, and can rapidly leave from the first inlet 213 or the second inlet 214, thereby ensuring the cooling effect. And the flowing direction of the liquid is limited, so that the liquid cannot splash randomly, and the recycling difficulty of the liquid is reduced.

It should be noted that, when the laser light emitted from the laser fiber 120 is not aligned with the osteotomy opening 212, but is emitted to the side wall of the osteotomy guiding slot 211, the laser light cannot pass through the osteotomy guiding slot 211.

In addition, the laser fiber assembly 100 moves the optical fiber in the osteotomy groove to osteotomy, and the biological effect of light and bone tissue is utilized to osteotomy, so that the laser fiber assembly does not vibrate, does not pull the tissue, does not cause the damage of the subchin nerve and the blunt injury of the artery and vein, and is difficult to realize in other existing osteotomy modes.

Alternatively, as shown in fig. 5 and 19, the laser fiber assembly 100 is provided with a handle 400. The handle 400 may have two inlets formed thereon-a laser inlet and a liquid inlet, and an outlet. The laser light source 800 is connected to the second connector 720 via an optical fiber, and the temperature detection device 600 is connected to the first connector 710 via an optical fiber. The first connector 710 and the second connector 720 are then connected to a transmission fiber pipe (the transmission fiber pipe is provided with two transmission fibers to be connected to the first connector 710 and the second connector 720, respectively), and the transmission fiber pipe can be inserted into the laser inlet. And the liquid inlet is connected to a water source 730 through a water pipe. Since one end of the laser fiber assembly 100 is inserted into the outlet of the handle 400, the laser light emitted from the laser light source 800 and the probe light emitted from the temperature detection device 600 can respectively enter the laser fiber 120 and the temperature fiber 140 through the laser inlet, and the liquid of the water source 730 is delivered to the infusion tube 230 through the liquid inlet. The handle 400 is provided with a red marking point, when the laser fiber assembly 100 is inserted into the handle 400, the light emitting direction of the laser fiber 120 in the laser fiber assembly 100 is opposite to the position of the marking point, for example, the marking point is positioned at the left side of the handle 400, and the light emitting direction of the laser fiber 120 is rightward. The laser direction is generally known by the above-described identification points, which facilitates the physician's manipulation of the laser fiber assembly 100 to osteotomy. In other embodiments of the present disclosure, the handle may not be provided, so that the first connector and the second connector may be directly connected to the laser fiber assembly 100. The color of the marking point is not limited to red, and can be adjusted to blue, green or other colors according to the situation. The positions of the marking points and the positions of the emergent light are not necessarily set to be opposite, and other positions which pass through the marking points mark the emergent light direction of the laser are also within the protection scope of the application.

Taking the osteotomy mandible as an example, in the osteotomy, a doctor needs to first incision the mucosa of the cavity of the osteotomy opening 212 in the oral cavity to expose the mandible, and then fully separate the mandible to be exposed. Then, the osteotomy guiding structure 200 is mounted to the mandible. Specifically, the first positioning portion 220 of the body 210 is located in the notch 320 below the chin hole in the front portion of the bone 300, the second positioning portion 230 is attached to the rear side of the bone 300, and the body 210 is clamped on the mandible by the first positioning portion 220 and the second positioning portion 230. At this time, the positions of the osteotomy guiding groove 211 and the osteotomy line 310 are corresponding, and the osteotomy opening 212 of the osteotomy guiding groove 211 is opposite to the osteotomy line 310. Next, the physician may extend the laser fiber assembly 100 from the front of the osteotomy guiding structure 200 through the first portal 213 into the osteotomy guiding slot 211. And the laser of the laser fiber assembly 100 may be directed through the osteotomy opening 212 onto the osteotomy line 310 of the mandible to cut the mandible. The physician may push the laser fiber assembly 100 along the osteotomy guide slot 211 so that the laser may cut the mandible along the osteotomy line 310. In addition, the physician may also pass the suction assembly 500 through the second inlet 214 from the other side into the osteotomy guiding slot 211, and may further suck bone fragments left after osteotomy through the suction assembly 500. When the laser fiber assembly 100 is difficult to move from the first slot 215 into the second slot 216, the physician may withdraw the laser fiber assembly 100 from the first inlet 213, withdraw the pumping assembly 500 from the second inlet 214, then pass the laser fiber assembly 100 through the second inlet 214 into the second slot 216, and pass the pumping assembly 500 through the first inlet 213 into the first slot 215. After the osteotomy is completed, the physician may first remove the laser fiber assembly 100 and the suction assembly 500 from the osteotomy guiding structure 200, then remove the osteotomy guiding structure 200 from the patient's mouth, and finally suture the wound.

The application also discloses a method for preparing the osteotomy guiding structure 200. The method includes personalizing settings based on patient mandibular angle CT (Computed Tomography), which may be DICOM data in particular, where DICOM is Digital Imaging and Communications in Medicine medical digital imaging and communications, using digital software to determine the position of osteotomy line 310 while ensuring patient mandibular nerve canal safety. What should be additionally stated is: because the mandibular angle osteotomy includes multiple osteotomy schemes such as mandibular inclined plane osteotomy, long arc osteotomy, etc., the fine size of each osteotomy is different, and the bone of each individual is different, it is necessary to design a personalized osteotomy line 310.

Specifically, the CT data of the patient is first transferred to 3D reconstruction software, a mandibular three-dimensional model is reconstructed in a computer, an osteotomy line 310 is designed and marked on the virtual three-dimensional model, each marking point is measured, and then the osteotomy line 310 is marked on the printed mandibular 3D model according to the measured data. Then, the 3D data of the 3D osteotomy face, the osteotomy line 310, the laser operation osteotomy groove and the like of the mandible are integrated by using 3D software, the osteotomy guiding structure 200 is directly sintered by adopting an SLM (selective laser melting) technology or is printed by adopting electron beam melting molding, and the osteotomy guiding structure 200 is subjected to surface spraying to form a heat insulation layer. Finally, the osteotomy guiding structure 200 is cleaned and sterilized according to the cleaning and sterilizing specifications.

And the outer wall of the osteotomy guiding structure 200 has no edges and corners, which is not easy to damage the patient.

In addition, the problem of narrow incision of mandibular osteotomy is fully considered, under the premise of ensuring close fit to mandible, ensuring the integrity of the osteotomy guiding groove 211 and ensuring the overall rigidity, the osteotomy guiding structure 200 is hollowed out 260 as much as possible, and the periphery of the osteotomy guiding structure 200 is printed in a curved surface form, so that the incision size in the operation process of a patient is reduced, and the comfort is kept.

It should be noted that the present disclosure also provides a temperature control device, which adopts a temperature control system applied to laser osteotomy;

Optionally, the temperature control system further comprises a central processing unit, and the central processing unit is respectively connected with the temperature detection device, the laser light source and the liquid supply device in a signal manner.

The technical means of the present application is not limited to the technical means disclosed in the above embodiments, but also includes a technical scheme composed of any combination of the above technical features. It should be noted that modifications and adaptations to the principles of the present application may occur to one skilled in the art and are intended to be comprehended within the scope of the present application.

Claims

1. The utility model provides a temperature control system, its characterized in that includes laser fiber component, cuts bone guide structure, suction component and temperature detection device, it is formed with cuts bone guide slot to cut bone guide structure, laser fiber component can follow cut bone guide slot removes in order to stretch gradually cut bone guide slot, it is equipped with first entry and second entry to cut bone guide slot, laser fiber component passes through one of first entry and second entry gets into cut bone guide slot, suction component passes through the other of first entry and second entry gets into cut bone guide slot, laser fiber component includes fixed laser fiber, perfusion transfusion tube and temperature optic fibre, wherein, perfusion transfusion tube is connected with liquid supply device in order to carry liquid, laser fiber is connected with the laser light source in order to transmit laser energy, suction component is used for sucking liquid, temperature detection device passes through temperature optic fibre in order to detect the temperature at laser action point edge, the laser action point is the position of laser fiber's play of bone, the laser action point is 0.25 mm in the edge of laser action point.

2. The temperature control system of claim 1, wherein the laser action point edge is 0.5-1mm from the laser action point.

3. The temperature control system of claim 1, wherein the osteotomy guiding structure is provided with a thermally insulating layer.

4. The temperature control system of claim 1, wherein the liquid flows along the osteotomy guide slot under the action of the infusion tube and the suction assembly, forming a reduced temperature liquid path while removing waste liquid and waste bone fragments.

5. A temperature control device characterized by employing the temperature control system according to any one of claims 1 to 4;

the laser optical fiber assembly can move along the osteotomy guiding groove, the perfusion infusion tube can move along with the laser optical fiber to convey the liquid to the osteotomy guiding groove, and the temperature optical fiber moves along with the laser optical fiber to detect the temperature of the edge of an osteotomy point;

6. The temperature control device of claim 5, wherein the preset temperature threshold comprises a first preset temperature threshold and a second preset temperature threshold,

7. The temperature control device of claim 5, wherein the preset temperature threshold comprises a first preset temperature threshold and a second preset temperature threshold,

8. The temperature control device of claim 5, wherein the preset temperature threshold comprises a first preset temperature threshold and a second preset temperature threshold,

9. The temperature control device according to any one of claims 6 to 8, wherein the first preset temperature threshold is 42 ℃ and the second preset temperature threshold is 50 ℃.

10. The temperature control device according to claim 9, wherein the flow rate of the liquid is 25-50ml/min, the pulse width of the laser is 100-300us, the repetition rate of the laser is 10-30HZ, and the pulse energy of the laser is 2-4J.