Laser fiber optic components and laser fiber optic osteotomy systems for osteotomy

Abstract

The application provides a laser fiber assembly for osteotomy and a laser fiber osteotomy system. The laser fiber assembly comprises a sheath, a perfusion tube, a laser fiber and a temperature fiber. The sheath covers the perfusion tube, the laser fiber and the temperature fiber. The laser fiber, the temperature fiber and the perfusion tube are fixed, and the front ends of the laser fiber, the temperature fiber and the perfusion tube are extended out of the sheath or extended out of the opening formed in the sheath. The laser fiber is used for transmitting laser energy. The laser fiber assembly comprises the temperature fiber and the perfusion tube in addition to the laser fiber. Therefore, the doctor can move the temperature fiber, the laser fiber and the perfusion tube simultaneously. The doctor can use the perfusion tube to cool the bone while performing laser osteotomy on the bone.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a laser fiber optic assembly and a laser fiber optic osteotomy system for osteotomy. Background Art

[0002] Mandibular angle osteotomy is a complicated surgical procedure with high technical difficulty and high risk. The doctor needs to perform the surgery in the blind spot of the intraoral incision, that is, the incision needs to be made from inside the mouth before the surgery. Existing technologies all use electric saws as osteotomy devices, but because the electric saw swings in a straight line, no matter how the osteotomy line is designed, it is difficult for the real osteotomy line to achieve a perfect arc line. As a result, medical staff usually need to perform multiple osteotomies in succession to achieve an arc-shaped plastic surgery effect, which can easily lead to problems such as excessive bone removal and bilateral asymmetry of osteotomy, resulting in deformities or even disfigurement. Although practitioners in this field have envisioned replacing traditional electric saws with laser equipment to eliminate the hidden dangers of doctors being unable to see the surgical site during operation and possible injuries to patients, the application of laser equipment has brought new technical problems - how to guide the laser equipment in the patient's body, especially in the vicinity of the surgical site, in the expected direction. Summary of the Invention

[0003] In order to overcome at least one of the defects described in the above-mentioned prior art, the purpose of the present application is to provide a laser fiber assembly and a laser fiber osteotomy system for osteotomy.

[0004] In a first aspect, the present application provides a laser fiber assembly for osteotomy, comprising an outer sleeve, an irrigation and infusion tube, a laser fiber, and a temperature fiber, wherein the outer sleeve wraps the irrigation and infusion tube, the laser fiber, and the temperature fiber, and the laser fiber, the temperature fiber, and the irrigation and infusion tube are fixed; and the front ends of the laser fiber, the temperature fiber, and the irrigation and infusion tube extend out of the outer sleeve, or extend through an opening formed in the outer sleeve; wherein the laser fiber is used to transmit laser energy, and the temperature fiber is provided with a temperature measuring grating.

[0005] Optionally, the laser transmitted by the laser optical fiber is a 2780nm Er,Cr:YSGG laser, a 2940nm Er:YAG laser or a 10800nm ​​carbon dioxide laser.

[0006] Optionally, the light emitting direction of the laser optical fiber is 70-110° to the extension direction of the laser optical fiber.

[0007] Optionally, the laser optical fiber includes a core, a cladding, a coating layer and at least one protective layer in sequence from the inside to the outside in the radial direction.

[0008] Optionally, the laser fiber assembly is a bendable structure.

[0009] In a second aspect, the present application provides a laser fiber osteotomy system, comprising an osteotomy guide structure and a laser fiber assembly for osteotomy, wherein the osteotomy guide structure is formed with an osteotomy guide groove, and the laser fiber assembly can move along the osteotomy guide groove to gradually extend into and bend therewith, and the movement trajectory of the laser fiber assembly extending into the osteotomy guide groove corresponds to the position of the osteotomy line.

[0010] Optionally, when the laser fiber assembly is extended into the osteotomy guide groove, the laser fiber can emit laser for osteotomy, the perfusion infusion tube can be used to transport liquid to cool the bone, and the temperature fiber is provided with a grating and can cooperate with a temperature detection device to detect the temperature near the osteotomy point, wherein the osteotomy point is the position where the laser emitted by the laser fiber contacts the bone.

[0011] Optionally, the osteotomy guide groove cooperates with the bone to form a channel for the liquid ejected from the perfusion infusion tube to flow.

[0012] Optionally, the laser fiber osteotomy system also includes a handle, which is formed with a laser inlet and a liquid inlet; the laser inlet is connected to the laser fiber, and the liquid inlet is connected to the water pipe; the handle is also provided with an identification point, and when the laser fiber assembly is inserted into the handle, the light output direction of the laser fiber in the laser fiber assembly is opposite to the position of the identification point; and when the laser fiber assembly is inserted into the handle, the laser inlet is connected to the laser fiber, and the liquid inlet is connected to the perfusion infusion tube.

[0013] Optionally, a suction component is further included, which enters the osteotomy guide groove to suck out waste materials in the osteotomy guide groove.

[0014] This application proposes a laser fiber assembly for osteotomy. In addition to a fixed laser fiber, this assembly also includes a fixed temperature fiber and an irrigation tube. This allows the surgeon to simultaneously move the temperature fiber, laser fiber, and irrigation tube, allowing the irrigation tube to cool the bone while laser osteotomy is being performed. This application also proposes a laser fiber osteotomy system. In addition to the laser fiber assembly and osteotomy guide structure, this system also includes a suction assembly to remove waste fluid and bone fragments from the osteotomy guide groove. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 Schematic diagram of the structure of the front end of the laser fiber assembly in one embodiment of the present disclosure.

[0016] Figure 2 for Figure 1 Cross-sectional view of the laser fiber assembly in Figure 1.

[0017] Figure 3 Schematic diagram of the cooperation between the laser fiber assembly and other devices in one embodiment of the present disclosure.

[0018] Figure 4 This is a schematic diagram of the temperature optical fiber and the temperature detection device.

[0019] Figure 5-10 Schematic diagram of the structure of the osteotomy guide structure at various angles in a certain embodiment of the present disclosure.

[0020] Figure 11 This is a structural diagram of the laser fiber assembly and the osteotomy guide structure.

[0021] Figure 12-14 Schematic diagram of the structure at various angles when the osteotomy guide structure cooperates with the mandible.

[0022] Figure 15 Schematic diagram of the mandibular structure.

[0023] Figure 16 This is a schematic diagram of the structure of the mandible, osteotomy guide structure and handle when they are in coordination.

[0024] Figure 17 From another angle Figure 15 Schematic diagram of the structure of the mandible, osteotomy guide structure and handle when they are in coordination.

[0025] Figure 18 This is a partial schematic diagram of a modified body in a certain embodiment of the present disclosure.

[0026] Markings in the figure: 100, laser fiber assembly; 110, protective cover; 120, laser fiber; 130, perfusion tube; 140, temperature fiber; 141, grating; 150, outer cover; 200, osteotomy guide structure; 210, body; 211, osteotomy guide groove; 212, osteotomy opening; 213, first entrance; 214, second entrance; 215, first groove; 216, second groove; 220, first positioning portion; 230, second positioning portion Position part; 240, left wing; 250, right wing; 260, hollowing; 270, modified layer; 300, bone; 310, osteotomy line; 320, notch; 400, handle; 500, suction component; 600, temperature detection device; 610, detection light source; 620, spectrometer; 710, first joint; 720, second joint; 730, water source; 800, laser light source; A: boundary line; M, first direction; N, second direction. DETAILED DESCRIPTION

[0027] For better understanding and implementation, the technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application.

[0028] In the description of this application, it should be noted that the terms "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "far", "near", etc., indicating directions or positional relationships, are based on the directions or positional relationships shown in the accompanying drawings. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operated in a specific direction. Therefore, they should not be understood as limitations on this application.

[0029] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which this application pertains. The terms used herein in the specification of this application are for the purpose of describing specific embodiments only and are not intended to limit this application.

[0030] Since the existing electric saw osteotomy method is not conducive to the doctor's operation, the applicant has come up with a new laser osteotomy method and has developed a new laser fiber assembly and laser fiber osteotomy system for this method. Figure 1-4 As shown, in one embodiment of the present disclosure, the laser fiber assembly 100 includes a jacket 150, an irrigation and infusion tube 130, a laser fiber 120, and a temperature fiber 140. The jacket 150 tightly encases the laser fiber 120, the temperature fiber 140, and the irrigation and infusion tube 130, thereby fixing the relative positions of the laser fiber 120, the temperature fiber 140, and the irrigation and infusion tube 130. The laser fiber 120 is used to transmit laser energy for osteotomy (the laser energy is the energy contained in the laser, which can be used to perform osteotomy). The temperature fiber 140 is provided with a temperature measuring grating that cooperates with the temperature detection device 600 to measure temperature. The irrigation and infusion tube 130 is used to deliver liquid to the surface of the bone 300 to cool the bone 300. Among them, the outer jacket 150 wrapping the laser fiber 120, the temperature fiber 140 and the perfusion infusion tube 130 means that the outer jacket 150 is arranged outside the laser fiber 120, the temperature fiber 140 and the perfusion infusion tube 130 in the radial direction, which does not mean that the axial length of the outer jacket 150 is greater than the length of the laser fiber 120, the temperature fiber 140 and the perfusion infusion tube 130.

[0031] For ease of understanding, this disclosure Figure 1 and Figure 4The first direction M is marked in the figure, where the first direction M is the axial direction of the laser fiber 120, the temperature fiber 140, the irrigation and infusion tube 130, and the laser fiber assembly 100. That is, the laser fiber 120, the temperature fiber 140, the irrigation and 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 flexible structure and can bend to a certain extent. Moreover, the number of irrigation and infusion tubes 130 can be adjusted according to the situation and can be one, two, or more.

[0032] Specifically, the rear end of the laser optical fiber 120 is connected to the laser light source 800 to transmit laser light, and the front end of the laser optical fiber 120 emits laser light to cut the bone 300 .

[0033] At the same time, the rear end of the perfusion tube 130 is connected to the water source 730 via a pump (the pump delivers liquid into the perfusion tube 130), and the front end of the perfusion tube 130 can spray liquid onto the bone 300 to cool the bone 300. Optionally, the front end of the perfusion tube 130 can be aligned with the osteotomy point to precisely cool the osteotomy point and its edges.

[0034] It should be noted that, after the laser is transmitted from the front end of the laser optical fiber 120 , the point where the laser contacts the bone 300 is the osteotomy point.

[0035] A first connector 710 is provided between the temperature detection device 600 and the temperature optical fiber 140 to facilitate the transmission of the detection light. The first connector 710 is an FC (Ferrule contact) / APC (Angled Physical Contact) connector. A second connector 720 is provided between the laser light source 800 and the laser optical fiber 120 to facilitate the transmission of the laser light. The second connector 720 is an SMA (Small A Type) connector.

[0036] When measuring the temperature at the edge of the osteotomy site, if the temperature fiber 140's detection point is too close to the site, it may be affected by the laser light emitted by the laser fiber 120. Meanwhile, if the temperature fiber 140's detection point is too far away, it may not accurately reflect the temperature of the tissue at the edge of the osteotomy site. Therefore, in some embodiments, the detection point is 0.25 mm to 1 mm from the site. Preferably, the detection point is 0.5 mm to 1 mm from the site.

[0037] Optionally, the temperature optical fiber 140 is used to detect the temperature of one or more detection points. Specifically, in some embodiments, a single grating 141 is used to detect the temperature of a single detection point on the bone, but in other embodiments, multiple gratings 141 may be provided to detect the temperature of multiple detection points.

[0038] Specifically, the rear end of the temperature optical fiber 140 is connected to the temperature detection device 600 (including the spectrum analyzer 620 and the detection light source 610), and the grating 141 is directly engraved on the front end of the temperature optical fiber 140. The temperature optical fiber 140 is connected to the detection light source 610. The detection light emitted by the detection light source 610 will be 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 detection point acts on the grating 141 of the temperature optical fiber 140, it will cause the wavelength of the light in the grating 141 to drift, and the temperature change is fed back by detecting the change in wavelength. Furthermore, the instrument can obtain the temperature information of the position of the grating 141, that is, the front end of the temperature optical fiber, based on the analyzed optical signal. Among them, the detection light emitted by the detection light source 610 is a type of laser with extremely low power, which will not cause damage to the human body. It is a wide-spectrum light source with a wavelength covering the reflection spectrum of the fiber grating.

[0039] Since the human body temperature is about 37°C, human tissues are basically kept within this temperature range. Local temperatures below 42°C are in a safe range. According to the principle of thermal effect of biological tissues, when the local temperature is between 42 and 50 degrees Celsius, the local tissues remain active for 1 to 2 minutes. When the local temperature exceeds 50°C, the enzyme activity weakens and a large number of cells undergo apoptosis. However, during laser osteotomy, the local temperature of the osteotomy point must be higher than 300°C before ablation can be achieved. Therefore, the tissue at the edge of the bone (near the bone) may be damaged during laser osteotomy. Therefore, the present disclosure monitors the temperature of the detection point at a distance from the edge of the osteotomy point (i.e., 0.25 to 1 mm from the osteotomy point) through the grating 141, monitors the temperature of the detection point in real time, and avoids the detection point temperature being too high. Once the monitored temperature exceeds 50°C, the osteotomy is automatically suspended. While ensuring the smooth progress of laser osteotomy, damage to the tissue near the osteotomy point can also be reduced.

[0040] Optionally, the laser transmitted by the laser fiber 120 is a 2780 nm Er,Cr:YSGG laser, a 2940 nm erbium laser (Er:YAG laser), or a 10800 nm carbon dioxide laser (CO2 laser).

[0041] Optionally, the laser fiber 120 includes a core, a cladding, a coating layer, and a first protective layer, wherein the material of the first protective layer is polytetrafluoroethylene. Specifically, the core can be quartz or fluoride, the cladding is fluorine-doped quartz, and the coating layer is a polyimide material. In addition, a second protective layer can be provided outside the first protective layer, and the material of the second protective layer is polyetheretherketone. Therefore, the laser fiber 120 adopts a five-layer structure, which is a fluoride core layer, a cladding, a coating layer, a polytetrafluoroethylene protective layer, and a polyetheretherketone (PEEK) protective layer from the inside to the outside.

[0042] Optionally, the front end of the laser fiber 120 extends out of the outer jacket 150 or the outer jacket 150 is formed with an opening for the laser fiber 120 to emit light, and the light emitting direction of the laser fiber 120 is 70-110 degrees to the extension direction of the laser fiber 120. It should be noted that, if Figure 1 As shown, the front end of the laser fiber 120, the front end of the temperature fiber 140, and the front end of the perfusion tube 130 all extend out of the outer jacket 150, and a protective cover 110 is provided in front of the outer jacket 150 to protect the front end of the laser fiber 120, the front end of the temperature fiber 140, and the front end of the perfusion tube 130. An opening is formed on the side of the protective cover 110 for laser transmission in the laser fiber 120 and liquid transportation in the perfusion tube 130. It should be noted that in some embodiments, the protective cover may not be provided, such as Figure 3 As shown, the side of the outer cover 150 is formed with an opening for emitting laser light from the laser fiber 120 and for spraying water to fill the infusion tube 130.

[0043] Specifically, the light emitting direction of the laser optical fiber 120 is 90° to the extending direction of the laser optical fiber 120 .

[0044] Optionally, the outer jacket 150 is made of polyetheretherketone, wherein the outer jacket 150 is formed with a channel for installing the perfusion tube 130, the laser fiber 120, and the temperature fiber 140. Moreover, in some optional embodiments, the perfusion tube 130, the laser fiber 120, and the temperature fiber 140 can be further fixed in the outer jacket 150 by fixing glue.

[0045] In addition, the present application also provides a laser fiber osteotomy system, including an osteotomy guide structure 200 and a laser fiber assembly 100 for osteotomy, wherein the osteotomy guide structure 200 is formed with an osteotomy guide groove 211, and the laser fiber assembly 100 can move along the osteotomy guide groove 211 to gradually extend into the osteotomy guide groove 211, and the moving trajectory of the laser fiber assembly 100 extending into the osteotomy guide groove 211 corresponds to the position of the osteotomy line 310.

[0046] Furthermore, since the laser fiber assembly 100 is a bendable structure, more specifically, the laser fiber 120, temperature fiber 140, and perfusion tube 130 used in the present disclosure are bendable structures. When properly bent, their functions are not easily affected. This allows the laser fiber assembly 100 of the present disclosure to smoothly move and bend along the osteotomy guide groove 211 and emit laser light to perform osteotomy, temperature measurement, and cooling, thereby greatly improving osteotomy efficiency, reducing the space required for osteotomy, and minimizing damage to the patient.

[0047] Based on the above, the laser fiber osteotomy system also includes a laser light source 800 and a temperature detection device 600. The laser light source 800 provides laser light for the optical fiber, and the temperature detection device 600 is used to detect the temperature of the edge of the osteotomy point. The temperature detection device detects the temperature of the osteotomy point and performs analysis and judgment. When the temperature is higher than the preset temperature threshold, the laser fiber is controlled to stop emitting light (that is, the operation is stopped) and / or the flow rate of the aforementioned circulating liquid is increased to control the surgical temperature.

[0048] More specifically, during the operation, based on the effect of temperature on tissue, the preset temperature threshold includes a first preset temperature threshold and a second preset temperature threshold, and the step of controlling the operation temperature further specifically includes:

[0049] When the temperature detection device detects that the temperature at the edge of the osteotomy point is always lower than the first preset temperature threshold, the osteotomy operation is continued until the osteotomy is completed, and the operation is ended;

[0050] When the temperature detection device detects that the temperature at the edge of the osteotomy point exceeds a first preset temperature threshold but is lower than a second preset temperature threshold, the liquid delivery volume of the liquid supply device is increased to control the temperature during the surgical procedure within a safe temperature range until the osteotomy is completed, and the surgery is concluded. It should be noted that when the surgical temperature exceeds the first preset temperature threshold, the liquid delivery volume can be increased to control the temperature at the detection point to a reasonable temperature for surgical operation, and exceeding the first preset temperature threshold includes reaching the first preset temperature threshold.

[0051] When the temperature detection device detects that the temperature at the edge of the osteotomy point exceeds a second preset temperature threshold, the laser light source is controlled to stop emitting laser light, halting the surgery while continuously monitoring the temperature at the edge of the osteotomy point. The surgery continues when the temperature drops to a safe temperature range until the osteotomy is complete, at which point the surgery ends. It should be noted that exceeding the second preset temperature threshold includes reaching the second preset temperature threshold.

[0052] Optionally, considering the specific impact of temperature on tissue, the first preset temperature threshold is preferably 42°C; the second preset temperature threshold is preferably 50°C.

[0053] In a preferred embodiment provided herein, the temperature detection device 600 can be connected to the laser light source 800 and the liquid supply device via a manual control mechanism, or can be connected to the laser light source 800 and the liquid supply device via a central processing unit. The central processing unit can be a processor. As the nerve center and command center of the temperature control system, the central processing unit can generate operation control signals based on instruction operation codes and timing signals to control instruction fetching and execution. The central processing unit is provided with a memory for storing instructions and data.

[0054] It is necessary to explain in addition that Figure 5-10As shown, the osteotomy guide structure 200 includes a body 210 , which is formed with an osteotomy guide groove 211 , which is formed with an osteotomy opening 212 , and the osteotomy guide groove 211 is used for allowing the laser fiber assembly 100 to move in the osteotomy guide groove 211 .

[0055] It should be noted that the osteotomy opening 212 of the osteotomy guide groove 211 corresponds to the position of the osteotomy line 310. Therefore, when the laser fiber optic assembly 100 gradually extends into the osteotomy guide groove 211 along the osteotomy guide groove 211, the laser transmitted by the laser fiber optic assembly 100 passes through the osteotomy opening 212 and reaches the bone 300 to cut the bone 300 along the osteotomy line 310.

[0056] Unlike existing osteotomy templates, the osteotomy guide groove 211 of the present application is not a simple front-to-back osteotomy guide groove. Instead, the laser fiber assembly 100 of the present application can gradually extend into the osteotomy guide groove 211 along its extension direction, gradually cutting the bone 300 during the extension process. When the doctor uses the laser osteotomy guide structure 200, he only needs to drag the laser fiber assembly 100 at the entrance of the osteotomy guide groove 211, effectively reducing the space required for operation and allowing the doctor to operate in a small area.

[0057] Optionally, the osteotomy guide groove 211 is formed with a first entrance 213 and a second entrance 214. The first entrance 213 is used to allow the laser fiber assembly 100 to enter the osteotomy guide groove 211, or the second entrance 214 is used to allow the laser fiber assembly 100 to enter the osteotomy guide groove 211. In some embodiments, when the laser fiber assembly 100 extends into the osteotomy guide groove 211 through the first entrance 213, the second entrance 214 can be used as a waste discharge outlet or allow the suction assembly 500 to pass through the second entrance 214 into the osteotomy guide groove 211, so that the corresponding waste can be discharged while the bone 300 is cut. For details, see Figure 11 In some embodiments, the laser fiber assembly 100 may extend into the osteotomy guide groove 211 through the second inlet 214, while the first inlet 213 serves as a waste discharge outlet, or the suction assembly 500 may pass through the first inlet 213 and enter the osteotomy guide groove 211 to aspirate waste within the osteotomy guide groove 211. The suction assembly 500 may be a tubular structure, one end of which is connected to a suction structure such as a vacuum aspirator. The vacuum aspirator may aspirate waste and waste liquid from the osteotomy guide groove 211 through the suction assembly 500.

[0058] Optionally, the main body 210 is fitted to the outside and inside of the mandible. The applicant found that the existing mandibular osteotomy navigation templates are all located on the outside of the mandible, and there is no part located on the inside. Therefore, the osteotomy navigation template cannot be fitted to the inside of the mandible, resulting in unstable installation of the osteotomy guide. If an electric saw is used for osteotomy, the position of the osteotomy guide will be offset due to the high-speed swing of the electric saw. It should be noted that although in the above embodiment, the main body 210 is fitted to the outside and inside of the mandible, for different bones 300, the main body 210 can be fitted to different opposite sides, such as the front and back sides of the bone 300, the upper and lower sides of the bone 300, etc.

[0059] Optionally, the osteotomy guide groove 211 is formed by a first groove 215 and a second groove 216. The first groove 215 and the second groove 216 are located on the lateral and medial sides of the mandible, respectively. The first groove 215 extends from front to back, while the second groove 216 extends from front to back, such that the rear end of the first groove 215 intersects and connects with the rear end of the second groove 216, resulting in a "C" shape. It should be noted that existing osteotomy guides only have an osteotomy guide groove on one side, resulting in a relatively smooth incision on the side of the bone 300 proximal to the osteotomy guide groove, but a relatively uneven incision on the side distal to the groove. In the above embodiment, the first groove 215 and the second groove 216 are located on the lateral and medial sides of the mandible, respectively, and the laser fiber assembly 100 also performs osteotomy along the first groove 215 and the second groove 216. Therefore, after osteotomy, the incisions on both the lateral and medial sides of the mandible are relatively smooth and conform to the osteotomy line 310. In order to better illustrate the positions of the first groove 215 and the second groove 216 , the present application draws a boundary line A. The boundary line A is a virtual line, and the transition between the first groove 215 and the second groove 216 is smooth. The first groove 215 and the second groove 216 are integrated into one to form the osteotomy guide groove 211 .

[0060] Moreover, in some embodiments, the osteotomy guide groove 211 may include other grooves in addition to the first groove 215 and the second groove 216 , and is not limited to the above embodiments.

[0061] Optionally, the first inlet 213 is located at the front end of the first slot 215, and the second inlet 214 is located at the front end of the second slot 216. Specifically, the first inlet 213 and the second inlet 214 are both located at the front side, which facilitates the doctor to operate the laser fiber assembly 100 and the suction assembly 500 at the same time.

[0062] It should be noted that since the rear end of the first groove 215 is connected to the rear end of the second groove 216, the laser fiber assembly 100 can enter the first groove 215 from the first entrance 213, then pass through the first groove 215 and reach the rear end of the second groove 216. Finally, the front end of the laser fiber assembly 100 can also leave the second groove 216 through the second entrance 214.

[0063] Optionally, the bone 300 is a mandibular bone, and the body 210 includes a first positioning portion 220 and a second positioning portion 230 connected to each other. The first positioning portion 220 is located in a recess 320 below the mental foramen of the front of the bone 300, and the second positioning portion 230 is attached to the back side of the bone 300. The first positioning portion 220 and the second positioning portion 230 cooperate with the bone 300 to confirm the installation position of the body 210 on the bone 300. For details, see Figure 12-15 Specifically, when the body 210 is placed in the correct position, the first positioning portion 220 and the second positioning portion 230 engage with the bone 300, making it difficult for the body 210 to fall off the bone 300, thereby ensuring that the body 210 is placed in the correct position.

[0064] For ease of understanding, this application Figure 12 The second direction N is marked in FIG, wherein the second direction N is a direction from the back of the mandible toward the front of the mandible.

[0065] It should be noted that the first positioning portion 220 , the second positioning portion 230 , the left wing 240 and the right wing 250 are an integrated structure, and there is no obvious boundary at the connection between the four.

[0066] Optionally, the middle of the main body 110 is hollowed out 160. The advantage of the hollowing out 160 is that the main body 110 is smaller in size and easier to fit into the surgical area, thereby reducing the size of the incision during the patient's surgery. In addition, the hollowing out 160 in the middle of the main body 110 allows a portion of the mandible to pass through. The hollowing out 160 in the middle of the main body 110, together with the first positioning portion 120, the second positioning portion 130, the left wing 140, and the right wing 150, forms a certain degree of limiting fixation on the mandible, so that the main body 110 fits tightly against the mandible, preventing the main body 110 from falling off the mandible.

[0067] The present disclosure also provides various methods and structures for preventing the body 210 from falling off the bone 300. For example, because the body 210 is 3D-printed based on CT data of the mandible, the osteotomy guide structure 200 has an inner side surface that aligns with the inner and outer bone surfaces of the mandibular angle. This allows the osteotomy guide structure 200 to fit tightly to the mandible, allowing the body 210 to fit closely to the mandible and other bones 300, making the body 210 less likely to fall off. Alternatively, in some embodiments, the surface of the body 210 is sandblasted to form a rough surface, increasing friction between the body 210 and the bone 300 and more firmly securing the body 210 to the bone 300.

[0068] In order to better explain the function of the laser fiber assembly 100 in this application, it will be described below in conjunction with the above-mentioned osteotomy guide structure 200.

[0069] Specifically, when the osteotomy guide structure 200 is installed on the bone 300, its osteotomy guide groove 211 and the osteotomy opening 212 of the osteotomy guide groove 211 are aligned with the osteotomy line 310 on the bone 300. At this point, the laser fiber assembly 100 can enter the osteotomy guide groove 211 through the first entrance 213 or the second entrance 214. Laser light is then transmitted from the front output end of the laser fiber 120, passes through the osteotomy opening 212 of the osteotomy guide groove 211, reaches the bone 300, and moves along the osteotomy line 310 to complete the osteotomy.

[0070] Since the laser fiber assembly 100 in the present application is a bendable structure and the laser fiber assembly 100 cooperates with the osteotomy guide groove 211, the laser fiber assembly 100 can bend when entering the osteotomy guide groove 211, and then stick to the osteotomy guide groove 211 and the osteotomy point, ensuring that the laser fiber assembly 100 can move along the osteotomy guide groove 211 and is not prone to deviation, thereby ensuring that the laser can be aligned with the osteotomy line 310.

[0071] During laser osteotomy, liquid is sprayed onto the osteotomy site through the infusion tube 130 to cool it. Furthermore, because the bone 300 fits tightly against the osteotomy guide structure 200, the osteotomy opening 212 of the osteotomy guide groove 211 is blocked by the bone 300. This creates a liquid channel in the osteotomy guide groove 211, restricting the flow of the liquid. The cooling liquid flows along the osteotomy guide groove 211 to the first inlet 213 or the second inlet 214, allowing it to exit. At this point, because the liquid is in a flowing state, the heated liquid does not remain within the osteotomy guide groove 211 and can quickly exit through the first inlet 213 or the second inlet 214, ensuring its cooling effect.

[0072] In some embodiments, the temperature detection device 600 is connected to the pump and the laser light source 800. When the temperature detection device 600 detects that the temperature at the osteotomy site is too high, the temperature detection device 600 can automatically or manually control the pump pressure through the central processing unit based on the prompt issued by the temperature detection device 600 based on the detected temperature, thereby increasing the liquid flow in the perfusion tube 130 and enhancing the cooling effect.

[0073] In addition, the suction assembly 500 sucks the bone chips 300 left after osteotomy and also sucks the liquid in the osteotomy guide groove 211, thereby accelerating the flow of the liquid and thereby improving the cooling efficiency of the liquid.

[0074] It should be noted that when the laser light emitted by the laser optical fiber 120 is not aligned with the osteotomy opening 212 but is emitted to the side wall of the osteotomy guide groove 211 , the laser light cannot pass through the osteotomy guide groove 211 .

[0075] Moreover, the laser fiber assembly 100 moves the optical fiber in the osteotomy groove of the osteotomy guide structure 200 to perform osteotomy. The laser fiber assembly 100 uses the interaction mechanism between laser and bone tissue to perform osteotomy. It will not vibrate, will not pull tissue, and will not cause damage to the submental nerve and blunt injury to the facial artery and vein. This is difficult to achieve with other existing osteotomy methods.

[0076] Optional, such as Figure 16 and Figure 17 As shown, the laser fiber assembly 100 is equipped with a handle 400. The handle 400 can be formed with two inlets—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 optic conduit (equipped with two transmission optical fibers, respectively connected to the first connector 710 and the second connector 720). This transmission fiber optic conduit can be inserted into the laser inlet. The liquid inlet is connected to a water source 730 via a water pipe. Since one end of the laser fiber assembly 100 is inserted into the outlet of the handle 400, the laser light transmitted by the laser light source 800 and the detection light transmitted by the temperature detection device 600 can enter the laser fiber 120 and the temperature fiber 140, respectively, through the laser inlet. Liquid from the water source 730 is delivered to the perfusion infusion tube 230 through the liquid inlet. A red marking point is provided on the handle 400. 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, if the marking point is on the left side of the handle 400, the light emitting direction of the laser fiber 120 is to the right. The above-mentioned marking point can roughly know the direction of the laser, which is convenient for the doctor to operate the laser fiber assembly 100 to perform bone cutting. It should be noted that in other embodiments of the present disclosure, a handle may not be provided, and the first connector and the second connector may be directly connected to the laser fiber assembly. 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 position of the marking point is not necessarily opposite to the light emitting position, and other methods of marking the laser light emitting direction by the position of the marking point are also within the scope of protection of this application.

[0077] Optionally, a heat-insulating layer is provided on the outside of the main body 210. Specifically, the material of the heat-insulating layer can be ceramic or silicon dioxide particles or other heat-resistant materials. In some embodiments, the heat-insulating layer is laid on the outside of the main body 210 by spraying, and the thickness of the heat-insulating layer is in the range of about 1 μm to 1000 μm. The heat-insulating layer is a porous structure as a whole, and the heat-insulating layer is formed by dispersively mixing particles with heat-insulating properties in a base material such as polyetheretherketone (PEEK) or titanium alloy. Among them, the particles with heat-insulating properties can be soda-lime borosilicate glass or silicon dioxide particles, or can be formed by other materials. It should be noted that the material of the main body 210 is polyetheretherketone (PEEK) or titanium alloy. In order to solve the bonding ability of PEEK and titanium alloy with the heat-insulating layer, a new low-temperature plasma bonding process is adopted. Specifically, a plasma flame with a temperature of about 90 to 200 degrees is used to perform surface treatment on the main body 210 of the laser osteotomy device, so that the surface of the material is modified to form a modified layer 270. For details, see Figure 18 The modified layer 270 has a thickness of 100 nm to 500 nm. Ceramic or silica particles are then attached to the modified layer 270 to form a heat-insulating layer. This heat-insulating layer prevents heat from diffusing through the body 210 itself, thereby preventing the oral cavity tissue in contact with the body 210 from being damaged by high temperatures.

[0078] Taking the osteotomy of the mandible as an example, when performing the osteotomy operation, the doctor first needs to cut the osteotomy opening 212 in the oral cavity mucosa to expose the mandibular periosteum. After sufficient separation, the mandible is exposed. Then, the osteotomy guide structure 200 is installed on the mandible. Specifically, the first positioning portion 220 of the main body 210 is located in the recess 320 below the front mental foramen of the bone 300, and the second positioning portion 230 is attached to the back side of the bone 300. The main body 210 is clamped on the mandible through the first positioning portion 220 and the second positioning portion 230. At this time, the position of the osteotomy guide groove 211 corresponds to the osteotomy line 310, and the osteotomy opening 212 of the osteotomy guide groove 211 is directly opposite to the osteotomy line 310. Then, the doctor can insert the laser fiber assembly 100 through the first entrance 213 from the front of the osteotomy guide structure 200 into the osteotomy guide groove 211. The laser from the laser fiber assembly 100 can be directed through the osteotomy opening 212 onto the osteotomy line 310 of the mandible, thereby cutting the mandible. The surgeon can push the laser fiber assembly 100 along the osteotomy guide groove 211, allowing the laser to cut the mandible along the osteotomy line 310. Furthermore, the surgeon can insert the suction assembly 500 through the second entrance 214 and into the osteotomy guide groove 211 from the other side, thereby aspirating bone fragments left after osteotomy. If the laser fiber assembly 100 has difficulty moving from the first groove 215 to the second groove 216, the surgeon can remove the laser fiber assembly 100 from the first entrance 213, remove the suction assembly 500 from the second entrance 214, then insert the laser fiber assembly 100 through the second entrance 214 into the second groove 216, and then insert the suction assembly 500 through the first entrance 213 into the first groove 215 to continue osteotomy. After the osteotomy is completed, the doctor can first remove the laser fiber assembly 100 and the suction assembly 500 from the osteotomy guide structure 200, then remove the osteotomy guide structure 200 from the patient's mouth, and finally suture the wound.

[0079] The present application also discloses a method for preparing an osteotomy guide structure 200. The method includes using digital software to perform personalized settings based on the patient's mandibular angle CT (Computed Tomography, electronic computer tomography) data (specifically, DICOM data. DICOM is Digital Imaging and Communications in Medicine) to determine the position of the osteotomy line 310 while ensuring the safety of the patient's mandibular nerve canal. It should be additionally explained that: since mandibular angle osteotomy includes a variety of osteotomy schemes such as mandibular oblique osteotomy, long arc osteotomy, and arc osteotomy, the subtle dimensions of the osteotomy in each procedure are different, and each person's own bone differences require the design of a personalized osteotomy line 310.

[0080] Specifically, the patient's CT data is first transferred to the 3D reconstruction software, the mandibular 3D model is reconstructed on the computer, the osteotomy line 310 is designed and marked on the virtual 3D model, each landmark point is measured, and then the osteotomy line 310 is marked on the printed mandibular 3D model based on the measured data. Next, 3D software is used to integrate the core data such as the mandibular 3D osteotomy surface, the osteotomy line 310, and the laser surgery osteotomy groove. SLM (selective laser melting) technology is used for direct laser sintering or electron beam melting to print the osteotomy guide structure 200, and the surface of the osteotomy guide structure 200 is sprayed to form an insulation layer. Finally, the osteotomy guide structure 200 is cleaned and sterilized in accordance with the cleaning, disinfection and sterilization technical operating specifications.

[0081] Furthermore, the outer wall of the osteotomy guide structure 200 has no sharp edges and corners, and is not likely to cause damage to the patient.

[0082] In addition, taking full consideration of the problem of narrow incision for mandibular osteotomy, the osteotomy guide structure 200 is hollowed out 260 as much unnecessary parts as possible while ensuring a close fit to the mandible, ensuring the integrity of the osteotomy guide groove 211 and ensuring overall rigidity, and the periphery of the osteotomy guide structure 200 is printed in the form of a curved surface to reduce the size of the incision during the patient's surgery and maintain comfort.

[0083] In order to ensure that the temperature of the bone edge at the osteotomy point is below 50°C during laser osteotomy, the applicant conducted the following experiments, as follows:

[0084] The laser fiber assembly 100 and the suction assembly 500 were placed into the osteotomy guide 211 through the first inlet 213 and second inlet 214, respectively. The infusion tube 130 of the laser fiber assembly 100 dispensed saline solution, while the suction assembly 500 simultaneously aspirated waste fluid, creating a flow of saline solution within the osteotomy guide 211. The effect of laser energy on the cooling effect was then measured.

[0085] When the benchmark test water temperature is 26°C and the flow rate is 15ml / min:

[0086]

[0087] The benchmark test temperature is 26°C, the flow rate is 25ml / min,

[0088]

[0089] The benchmark test temperature is 26°C and the flow rate is 50ml / min.

[0090] As shown in the table above, when the liquid flow rate is 15 ml / min and the laser pulse energy is above 3 J, the temperature can easily rise rapidly, exceeding the safe range and causing damage to the tissue around the osteotomy site. At liquid flow rates of 25 ml / min or 50 ml / min, the temperature increase rate is controllable. It should be noted that the laser pulse width in the above embodiment is controlled within 200 μs, with a repetition rate of 20 Hz.

[0091] In summary, when the laser pulse width is controlled at 200us, the repetition frequency is 20HZ, the cutting single pulse energy is between 2-4J, and the circulating water flow rate is 25-50ml / min, the bone cutting and cooling requirements can be met.

[0092] The technical means of this application are not limited to the technical means disclosed in the above-mentioned embodiments, but also include technical solutions composed of any combination of the above-mentioned technical features. It should be noted that those skilled in the art can make several improvements and modifications without departing from the principles of this application, and such improvements and modifications are also considered to be within the scope of protection of this application.

Claims

1. A laser fiber osteotomy system, characterized in that: The invention comprises an osteotomy guide structure and a laser fiber assembly for osteotomy, wherein the laser fiber assembly comprises a jacket, an irrigation and infusion tube, a laser fiber and a temperature fiber, wherein the jacket wraps the irrigation and infusion tube, the laser fiber and the temperature fiber, and the laser fiber, the temperature fiber and the irrigation and infusion tube are fixed; and the front ends of the laser fiber, the temperature fiber and the irrigation and infusion tube extend out of the jacket, or extend through an opening formed in the jacket; wherein the laser fiber is used to transmit laser energy for osteotomy, the temperature fiber is provided with a temperature measuring grating, and the irrigation and infusion tube can be used for infusion. Liquid is delivered to cool the bone, and an osteotomy guide groove is formed in the osteotomy guide structure. The laser fiber assembly can move along the extension direction of the osteotomy guide groove to gradually extend into and bend therewith. The movement trajectory of the laser fiber assembly extending into the osteotomy guide groove corresponds to the position of the osteotomy line, wherein the osteotomy guide groove is in a "C" shape, and the osteotomy guide groove is formed with a first entrance and a second entrance, the first entrance is used for the laser fiber assembly to enter the osteotomy guide groove, and the second entrance is a waste discharge outlet or for a suction assembly to pass through the second entrance into the osteotomy guide groove.

2. The laser fiber osteotomy system according to claim 1, characterized in that: The laser transmitted by the laser optical fiber is a 2780nm Er,Cr:YSGG laser, a 2940nm Er:YAG laser or a 10800nm ​​carbon dioxide laser.

3. The laser fiber osteotomy system according to claim 1, characterized in that: The light emitting direction of the laser optical fiber is 70-110° to the extending direction of the laser optical fiber.

4. The laser fiber osteotomy system according to claim 1, characterized in that: The laser optical fiber includes a core, a cladding, a coating layer and at least one protective layer in sequence from the inside to the outside in the radial direction.

5. The laser fiber osteotomy system according to any one of claims 1 to 4, characterized in that: The laser optical fiber assembly is a bendable structure.

6. The laser fiber osteotomy system according to claim 1, characterized in that: When the laser fiber assembly is inserted into the osteotomy guide groove, the laser fiber can emit laser light for osteotomy. The temperature fiber is provided with a grating and can cooperate with a temperature detection device to detect the temperature of the bone.

7. The laser fiber osteotomy system according to claim 6, characterized in that: The osteotomy guide groove cooperates with the bone to form a channel for the liquid ejected from the perfusion infusion tube to flow.

8. The laser fiber osteotomy system according to claim 7, characterized in that: It also includes a handle, which is formed with a laser inlet and a liquid inlet; the laser inlet is connected to the laser optical fiber, and the liquid inlet is connected to the water pipe; the handle is also provided with an identification point, and when the laser optical fiber assembly is inserted into the handle, the light output direction of the laser optical fiber in the laser optical fiber assembly is opposite to the position of the identification point; and when the laser optical fiber assembly is inserted into the handle, the laser inlet is connected to the laser optical fiber, and the liquid inlet is connected to the perfusion infusion tube.

9. The laser fiber osteotomy system according to claim 8, characterized in that: The invention also comprises a suction assembly which enters the osteotomy guide groove to suction waste materials in the osteotomy guide groove.

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