CN116327355B - Laser fiber optic components and laser fiber optic osteotomy systems for osteotomy - Google Patents
Laser fiber optic components and laser fiber optic osteotomy systems for osteotomyInfo
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- CN116327355B CN116327355B CN202310321662.8A CN202310321662A CN116327355B CN 116327355 B CN116327355 B CN 116327355B CN 202310321662 A CN202310321662 A CN 202310321662A CN 116327355 B CN116327355 B CN 116327355B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
- A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
- A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00321—Head or parts thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00773—Sensed parameters
- A61B2018/00791—Temperature
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
- A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
- A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
- A61B2018/2205—Characteristics of fibres
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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Abstract
The application provides a laser optical fiber assembly for osteotomy and a laser optical fiber osteotomy system. The laser fiber assembly comprises an outer sleeve, a perfusion infusion tube, a laser fiber and a temperature fiber, wherein the outer sleeve wraps the perfusion infusion tube, the laser fiber and the temperature fiber, the laser fiber, the temperature fiber and the perfusion infusion tube are fixed, and the front ends of the laser fiber, the temperature fiber and the perfusion infusion tube extend out of the outer sleeve or extend out of an opening formed in the outer sleeve, and the laser fiber is used for transmitting laser energy. The laser fiber assembly comprises the laser fiber, the temperature fiber fixed with the laser fiber and the perfusion infusion tube, so that a doctor can move the temperature fiber, the laser fiber and the perfusion infusion tube simultaneously, and the perfusion infusion tube can be used for cooling bones when performing laser osteotomy on the bones.
Description
Technical Field
The application relates to the technical field of medical equipment, in particular to a laser fiber assembly for osteotomy and a laser fiber osteotomy system.
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, the electric saw is adopted as the osteotomy device, but because the electric saw swings along a straight line, the real osteotomy line is difficult to achieve a perfect arc line anyway, so that the arc shaping effect can be achieved only by continuously cutting the bone for many times by medical staff, the problems of excessive bone quantity cutting, bilateral asymmetry of the osteotomy and the like are easily caused, and deformity and even disfigurement are caused. While practitioners in the art contemplate replacing conventional electric saws with laser devices to eliminate the potential for the physician to be unable to see the surgical site during operation and possibly to cause injury to the patient, the use of laser devices presents new technical problems-how to guide the laser device within the patient, particularly in the vicinity of the surgical site, as intended.
Disclosure of Invention
In order to overcome at least one of the above-mentioned drawbacks of the prior art, an object of the present application is to provide a laser fiber assembly and a laser fiber osteotomy system for osteotomies.
In a first aspect, the application provides a laser fiber assembly for osteotomy, which comprises a jacket, a perfusion infusion tube, a laser fiber and a temperature fiber, wherein the jacket wraps the perfusion infusion tube, the laser fiber and the temperature fiber, the laser fiber, the temperature fiber and the perfusion infusion tube are fixed, the front ends of the laser fiber, the temperature fiber and the perfusion infusion tube extend out of the jacket or extend out of an opening formed in the jacket, and the laser fiber is used for transmitting laser energy and is provided with a temperature measuring grating.
Optionally, the laser transmitted by the laser fiber is 2780nm Er, cr: YSGG laser, 2940nm Er: YAG laser or 10800nm carbon dioxide laser.
Optionally, the light emitting direction of the laser fiber is 70-110 degrees with the extending direction of the laser fiber.
Optionally, the laser fiber sequentially comprises a fiber core, a cladding, a coating layer and at least one protective layer from inside to outside along the radial direction.
Optionally, the laser fiber assembly is a bendable structure.
In a second aspect, the present application provides a laser optical fiber osteotomy system, including an osteotomy guiding structure and a laser optical fiber assembly for osteotomy, wherein the osteotomy guiding structure is formed with an osteotomy guiding slot, the laser optical fiber assembly can move along the osteotomy guiding slot to gradually extend into and bend with the osteotomy guiding slot, and a movement track of the laser optical fiber assembly extending into the osteotomy guiding slot corresponds to a position of an osteotomy line.
Optionally, after the laser fiber assembly stretches into the osteotomy guiding groove, the laser fiber can emit laser used for osteotomy, the perfusion infusion tube can be used for conveying liquid to cool bones, the temperature fiber is provided with a grating and can be matched with a temperature detection device to detect the temperature of the position near the osteotomy point, wherein the osteotomy point is the position where the emitted laser of the laser fiber contacts with the bones.
Optionally, the osteotomy guiding groove and the bone cooperate to form a channel for the liquid injected from the infusion tube to circulate.
Optionally, the laser fiber osteotomy system further comprises a handle, wherein the handle is provided with a laser inlet and a liquid inlet, the laser inlet is communicated with the laser fiber and the liquid inlet is communicated with the water delivery pipe, the handle is further provided with a marking point, when the laser fiber assembly is inserted into the handle, the light emergent direction of the laser fiber in the laser fiber assembly is opposite to the position of the marking point, and when the laser fiber assembly is inserted into the handle, the laser inlet is communicated with the laser fiber and the liquid inlet is communicated with the perfusion infusion pipe.
Optionally, a suction assembly is also included that enters the osteotomy guide slot to suck waste material located within the osteotomy guide slot.
The application provides a laser fiber assembly for osteotomy, which comprises a fixed laser fiber, a fixed temperature fiber and a perfusion infusion tube, so that a doctor can move the temperature fiber, the laser fiber and the perfusion infusion tube simultaneously, and can adopt the perfusion infusion tube to cool bones while performing laser osteotomy on the bones. The application further provides a laser optical fiber osteotomy system which comprises a laser optical fiber assembly, an osteotomy guiding structure and a suction assembly, so that waste materials comprising waste liquid and broken bones in the osteotomy guiding groove are cleaned.
Drawings
Fig. 1 is a schematic structural view of a front end of a laser fiber assembly according to an embodiment of the present disclosure.
Fig. 2 is a cross-sectional view of the laser fiber assembly of fig. 1.
Fig. 3 is a schematic diagram of a laser fiber assembly mated with other devices in an embodiment of the present disclosure.
FIG. 4 is a schematic diagram of a temperature fiber coupled to a temperature sensing device.
Fig. 5-10 are schematic structural views of various angles of an osteotomy guiding structure in accordance with an embodiment of the present disclosure.
FIG. 11 is a schematic view of a laser fiber assembly mated with an osteotomy guiding structure.
Fig. 12-14 are schematic views of the osteotomy guiding structure at various angles in cooperation with the mandible.
Fig. 15 is a schematic view of the structure of the mandible.
Fig. 16 is a schematic view of the mandible, osteotomy guiding structure, and handle configuration when mated.
Fig. 17 is a schematic view of the mandible of fig. 15 at another angle with the osteotomy guiding structure mated to the handle.
Fig. 18 is a partial schematic view of a modified bulk in an embodiment of the disclosure.
100, Laser fiber components, 110, protective sleeves, 120, laser fibers, 130, perfusion transfusion tubes, 140, temperature fibers, 141, gratings, 150, jackets, 200, osteotomy guiding structures, 210, bodies, 211, osteotomy guiding grooves, 212, osteotomy openings, 213, first inlets, 214, second inlets, 215, first grooves, 216, second grooves, 220, first positioning parts, 230, second positioning parts, 240, left wings, 250, right wings, 260, hollows, 270, modification layers, 300, bones, 310, osteotomy lines, 320, notches, 400, handles, 500, suction components, 600, temperature detection devices, 610, detection light sources, 620, spectrum analyzers, 710, first connectors, 720, second connectors, 730, water sources, 800, laser light sources, A, boundary lines, M, first directions, N, second directions.
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 the terms "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "far", "near", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, are merely for convenience in describing the present application and simplifying the description, and do not indicate or imply that the apparatus or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus 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 application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.
Because the existing electric saw osteotomy mode is not beneficial to doctor operation, the applicant thinks of a brand new laser osteotomy mode, and develops a novel laser optical fiber assembly and a laser optical fiber osteotomy system for the mode. As shown in fig. 1-4, in one embodiment of the present disclosure, the laser fiber assembly 100 includes a jacket 150, a perfusion infusion tube 130, a laser fiber 120, and a temperature fiber 140, the jacket 150 tightly surrounding the laser fiber 120, the temperature fiber 140, and the perfusion infusion tube 130, whereby the relative positions of the laser fiber 120, the temperature fiber 140, and the perfusion infusion tube 130 are fixed. The laser fiber 120 is used for transmitting laser energy to perform osteotomy (the laser energy is energy contained in laser, and osteotomy can be performed by the energy), the temperature fiber 140 is provided with a temperature measuring grating, and is matched with the temperature detecting device 600 to measure temperature, and the infusion tube 130 is used for delivering liquid to the surface of the bone 300 to cool the bone 300. The outer jacket 150 wraps the laser fiber 120, the temperature fiber 140 and the infusion tube 130, which means that the outer jacket 150 is sleeved outside the laser fiber 120, the temperature fiber 140 and the infusion tube 130 along the radial direction, and it does not represent that the length of the outer jacket 150 along the axial direction is greater than the lengths of the laser fiber 120, the temperature fiber 140 and the infusion tube 130.
For ease of understanding, the present disclosure is labeled in fig. 1 and 4 with a first direction M, 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, that is, 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. The number of infusion tubes 130 may be adjusted according to the situation, and may be one, two or more.
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 bone 300 to cool the bone 300. Optionally, the front end of infusion tube 130 is aligned with the osteotomy point to precisely cool the position of the osteotomy point and its edges.
After the laser light is transmitted from the front end of the laser fiber 120, the point where the laser light contacts the bone 300 is an osteotomy point.
And a first connector 710 is disposed between the temperature detecting device 600 and the temperature 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.
When the temperature optical fiber 140 detects the temperature of the edge of the osteotomy point, the detection point of the temperature optical fiber 140 is too close to the osteotomy 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 temperature of the tissue at the edge of the osteotomy point. Thus, in some embodiments, the detection point is a position 0.25mm-1mm from the osteotomy point. Preferably, the detection point is 0.5mm-1mm from the osteotomy point.
Optionally, the temperature fiber 140 is used to detect the temperature of one or more detection points. Specifically, in some embodiments, one grating 141 is used to detect the temperature at one detection point on the bone, but in other embodiments, multiple gratings 141 may be provided to detect the temperature at multiple detection points.
Specifically, the rear end of the temperature fiber 140 is connected to a temperature detecting device 600 (including a spectrum analyzer 620 and a probe light source 610), and the grating 141 is directly inscribed on the front end of the temperature fiber 140. 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 detection point 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 change in temperature is fed back by detecting the change in wavelength. Further, the instrument can obtain temperature information of the front end of the temperature fiber, which is the position of the grating 141, from the analysis light signal. The detection light source 610 emits a type of laser with extremely low power, which does not damage the human body, and is a broad spectrum light source with a wavelength covering the reflection spectrum of the fiber bragg grating.
Because the human body temperature is about 37 ℃, the human tissue is basically kept at the temperature, the local temperature is lower than 42 ℃ and is in a safe interval, the local temperature is 42-50 ℃ according to the biological tissue thermal effect principle, the local tissue still keeps activity within 1-2 minutes, the local temperature exceeds 50 ℃, the enzyme activity is weakened, and cells undergo massive apoptosis. However, in the laser osteotomy process, the local temperature of the osteotomy point is higher than 300 ℃, so that the osteotomy can be ablated. The laser osteotomy may cause damage to tissue at the bone edge (near the bone). Therefore, the present disclosure monitors the temperature of the detection point at a position away from the edge of the osteotomy point (i.e., 0.25-1 mm from the osteotomy point) through the grating 141, monitors the temperature of the detection point in real time, and avoids the overhigh temperature of the detection point. Once the monitored temperature exceeds 50 ℃, osteotomies are automatically paused. The laser osteotomy is ensured to be carried out smoothly, and simultaneously, the damage to tissues near the osteotomy point can be reduced.
Alternatively, the laser fiber 120 transmits laser light of 2780nm Er, cr: YSGG laser light, 2940nm erbium laser light (Er: YAG laser light), or 10800nm carbon dioxide laser light (CO 2 laser light).
Optionally, the laser fiber 120 includes a core, a cladding, a coating layer, and a first protection layer, where the first protection layer is made of polytetrafluoroethylene. Specifically, the fiber core can be quartz or fluoride, the cladding is fluorine-doped quartz, and the coating layer is made of polyimide material. And a second protective layer is sleeved outside the first protective layer, and the second protective layer is made of polyether-ether-ketone. The laser fiber 120 has a five-layer structure, including a fluoride core layer, a cladding layer, a coating layer, a polytetrafluoroethylene protective layer, and a Polyetheretherketone (PEEK) protective layer from inside to outside.
Optionally, the front end of the laser fiber 120 extends out of the outer sleeve 150 or the outer sleeve 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 ° with the extending direction of the laser fiber 120. It should be noted that, as shown in fig. 1, 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 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 sides of the protective sleeve 110 for laser transmission in the laser fiber 120 and liquid transmission of the infusion tube 130. In some embodiments, a protective sleeve may not be provided, and as shown in fig. 3, 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.
Specifically, the light emitting direction of the laser fiber 120 is 90 ° to the extending direction of the laser fiber 120.
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. Moreover, 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.
In addition, the application also provides a laser optical fiber osteotomy system, which comprises an osteotomy guiding structure 200 and a laser optical fiber assembly 100 for osteotomy, wherein the osteotomy guiding structure 200 is provided with an osteotomy guiding groove 211, the laser optical fiber assembly 100 can move along the osteotomy guiding groove 211 to gradually extend into the osteotomy guiding groove 211, and the moving track of the laser optical fiber assembly 100 extending into the osteotomy guiding groove 211 corresponds to the position of the osteotomy line 310.
And because the laser fiber assembly 100 is a bendable structure. More specifically, the laser fiber 120, the temperature fiber 140 and the perfusion infusion tube 130 adopted in the present disclosure are of a bendable structure, and after being bent appropriately, the functions of the laser fiber assembly 100 are not easily affected, so that the laser fiber assembly can smoothly move and bend along the osteotomy guiding slot 211 and emit laser to complete osteotomy, temperature measurement and temperature reduction functions, thereby greatly improving osteotomy efficiency, reducing the space required by osteotomy, and reducing the damage to patients.
Based on the above, the laser optical fiber osteotomy system further includes a laser light source 800 and a temperature detection device 600, the laser light source 800 provides laser for the optical fiber, the temperature detection device 600 is used for detecting the temperature of the edge of the osteotomy point, and analyzing and judging are performed according to the temperature detected by the temperature detection device, when the temperature is higher than the preset temperature threshold, the laser optical fiber is controlled to stop emitting light (i.e. stop the operation) and/or increase the flow of the circulating liquid, so as to control the operation temperature.
More specifically, during the surgical procedure, according to the influence of the temperature on the tissue, the preset temperature threshold includes a first preset temperature threshold and a second preset temperature threshold, and the step of controlling the surgical temperature further specifically includes:
When the temperature detection device detects that the temperature of the edge of the osteotomy point is always lower than a first preset temperature threshold value, continuing osteotomy till the osteotomy is completed, and ending the operation;
When the temperature detection device detects that the temperature of the edge of the osteotomy point exceeds a first preset temperature threshold value but is lower than a 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 until the osteotomy is completed, and then the operation is ended. 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 osteotomy 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 osteotomy point is continuously detected, the operation is continued when the temperature is reduced to a safe temperature range, and the operation is ended until the osteotomy is completed. It should be noted that exceeding the second preset temperature threshold includes reaching the second preset temperature threshold.
Alternatively, the first preset temperature threshold is preferably 42 ℃ and the second preset temperature threshold is preferably 50 ℃ in view of the specific effect of temperature on the tissue.
In the preferred embodiment provided in the present disclosure, the temperature detecting device 600 may be connected to the laser light source 800 and the liquid supply device by manual control mechanism, or may be connected to the laser light source 800 and the liquid supply device by a central processing unit by signals. The central processing unit may be a processor. The central processing unit is used as a nerve center and a command center of the temperature control system, and can generate operation control signals according to instruction operation codes and time sequence signals to finish instruction fetching and instruction execution control. The central processing unit is provided with a memory for storing instructions and data.
It should be noted that, as shown in fig. 5-10, the osteotomy guiding structure 200 includes 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, and the osteotomy guiding slot 211 is used for moving the laser fiber assembly 100 in the osteotomy guiding slot 211.
It should be noted that, the osteotomy opening 212 of the osteotomy guiding slot 211 corresponds to the position of the osteotomy line 310, so when the laser fiber assembly 100 gradually extends into the osteotomy guiding slot 211 along the osteotomy guiding slot 211, the laser light transmitted by the laser fiber assembly 100 passes through the osteotomy opening 212 to reach the bone 300 to cut the bone 300 along the osteotomy line 310.
Unlike the existing osteotomy template, the osteotomy guiding slot 211 of the present application is not a simple through-slot for guiding the osteotomy, and 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 uses the laser osteotomy guiding structure 200, the doctor only needs to drag the laser optical fiber assembly 100 at the entrance of the osteotomy guiding slot 211, so that the space required for operation is effectively reduced, and the doctor can only operate in a small area.
Optionally, the osteotomy guiding slot 211 is formed with a first inlet 213 and a second inlet 214. The first inlet 213 is for the laser fiber assembly 100 to enter the osteotomy guiding slot 211 or the second inlet 214 is for the laser fiber assembly 100 to enter the osteotomy guiding slot 211. In some embodiments, such as when the laser fiber assembly 100 is inserted into the osteotomy guiding slot 211 through the first inlet 213, the second inlet 214 may act as a waste material discharge port or allow the suction assembly 500 to pass through the second inlet 214 into the osteotomy guiding slot 211, so that the corresponding waste material may be discharged while cutting the bone 300, as can be seen in fig. 11. In some embodiments, the laser fiber assembly 100 may also extend into the osteotomy guiding slot 211 through the second inlet 214, while the first inlet 213 serves as a waste discharge outlet or the suction assembly 500 is passed through the first inlet 213 into the osteotomy guiding slot 211 to suck waste material located within the osteotomy guiding slot 211. The suction assembly 500 may be a tubular structure with a suction structure such as a negative pressure aspirator connected to one end thereof, and the negative pressure aspirator may be used to aspirate waste material and waste liquid in the osteotomy guide groove 211 through the suction assembly 500.
Optionally, the body 210 is attached to the outer side and the inner side 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 different opposite sides of the bone 300, such as the front side and the rear side of the bone 300, the upper side and the lower side of the bone 300, etc.
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 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 communicate, and the osteotomy guiding groove 211 presents a "C" shape. It should be noted that, only one side of the conventional osteotomy guide plate is provided with the osteotomy guiding slot, so that the incision on the side of the bone 300 close to the osteotomy guiding slot is smoother, but the incision on the side far from the side is relatively rugged. 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, the 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.
Optionally, the bone 300 is a mandible, the body 210 includes a first positioning part 220 and a second positioning part 230 that are connected to each other, the first positioning part 220 is located in a recess 320 below a chin hole in the front part 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, see fig. 12-15. 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 is labeled in fig. 12 with a second direction N, where 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. The hollow 160 has the advantage that the body 110 has smaller volume and is easier to plug into the space of the operation area, so that the incision size in the operation process of the patient is reduced. 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.
There are various ways and structures for preventing the body 210 from falling off the bone 300, for example, since the body 210 is manufactured by 3D printing according to 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. Or in some embodiments, the surface of the body 210 is sandblasted to form a rough surface, increasing the friction between the body 210 and the bone 300, allowing the body 210 to be more firmly secured to the bone 300.
For convenience and better explanation of the functioning of the laser fiber assembly 100 of the present application, the following description will be provided in connection with the osteotomy guiding structure 200 described above.
Specifically, 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. Laser light is transmitted from the output end of the front end of the laser fiber 120 and passes through the osteotomy opening 212 of the osteotomy guide slot 211 to the bone 300 to move along the osteotomy line 310 to complete the osteotomy.
Because the laser fiber assembly 100 in the application is in a bendable structure and the laser fiber assembly 100 is matched with the osteotomy guiding groove 211, the laser fiber assembly 100 can bend when entering the osteotomy guiding groove 211 and further cling to the osteotomy guiding groove 211 and the osteotomy point, so that the laser fiber assembly 100 can move along the osteotomy guiding groove 211 and is not easy to deviate, and the laser can be aligned to the osteotomy line 310.
At the same time of cutting bone by laser, liquid is sprayed onto the bone cutting point by the perfusion infusion tube 130 to cool the bone cutting point. 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 fluid flowing direction, 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 heated liquid is not always located 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.
In some embodiments, the temperature detection device 600 is connected to a pump and a laser light source 800, respectively. When the temperature detecting device 600 detects that the temperature of the osteotomy point is too high, the temperature detecting device 600 can automatically or manually control the pressure of the pump through the central processing unit according to the prompt sent by the temperature detecting device 600 according to the detected temperature, so as to increase the liquid flow in the perfusion infusion tube 130 and enhance the cooling effect.
In addition, the suction assembly 500 sucks the broken bone fragments 300 left after osteotomy and simultaneously sucks the liquid in the osteotomy guiding groove 211, thereby accelerating the flow of the liquid and further improving the cooling efficiency of the liquid.
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 of the osteotomy guiding structure 200 to osteotomy, and the laser fiber assembly 100 performs osteotomy by utilizing the interaction mechanism of laser and bone tissue, 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 of the face, and is difficult to realize in other existing osteotomy modes.
Alternatively, as shown in fig. 16 and 17, 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 transmitted by the laser light source 800 and the probe light transmitted by 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 then 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. 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 light emission are not necessarily opposite, and other positions for marking the direction of the laser light emission through the positions of the marking points are also within the protection scope of the application.
Optionally, a thermal insulation layer is provided outside the body 210. In particular, the material of the insulating layer may be ceramic or silica particles or other heat resistant material. In some embodiments, the insulation layer is applied to the exterior of the body 210 by spraying, and the thickness of the insulation layer is in the range of about 1 μm to 1000 μm. The heat insulating layer has a porous structure as a whole, and particles having heat insulating properties are dispersed and mixed in a base material such as polyether ether ketone (PEEK) or titanium alloy. The particles having heat insulating properties may be soda-lime-borosilicate glass or silica particles, or may be formed of other materials. The material of the body 210 is Polyetheretherketone (PEEK) or a 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 90-200 degrees, so that the material surface is modified to form a modified layer 270, see fig. 18. Wherein the thickness of the modified layer 270 is 100 nm-500 nm. Then, ceramic 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.
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, thereby sucking the 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 suction 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 suction assembly 500 through the first inlet 213 into the first slot 215 to continue osteotomy. 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 preparation method of the osteotomy guiding structure 200. The method includes personalizing settings based on patient mandibular angle CT (Computed Tomography, computerized tomography) data (specifically DICOM data, wherein DICOM is DIGITAL IMAGING AND Communications IN MEDICINE medical digital imaging and Communications) using digitizing software to determine the position of the osteotomy line 310 while ensuring patient mandibular nerve canal safety. It should be additionally noted that, since the mandibular angle osteotomy includes multiple osteotomy schemes such as mandibular inclined plane osteotomy, long arc osteotomy, etc., the fine sizes of the osteotomies of each operation are different, and the bone difference of each person needs to be designed, the personalized osteotomy line 310 is required.
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.
To ensure that the temperature of the bone edge at the osteotomy point is below 50 ℃ during laser osteotomy, the applicant conducted the following experiments, in particular as follows:
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 reference test temperature and water temperature are 26 ℃ and the flow rate is 15 ml/min:
the reference test temperature and water temperature are 26 ℃, the flow rate is 25ml/min,
The reference test temperature is 26 ℃, the flow rate is 50ml/min,
As is clear from the above table, when the liquid flow rate 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 edge of the osteotomy 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 is controlled to be within 200us, and the repetition frequency is 20HZ.
In conclusion, 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.
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 application may occur to one skilled in the art without departing from the principles of the present application and are intended to be within the scope of the present application.
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| CN202310321662.8A CN116327355B (en) | 2023-03-29 | 2023-03-29 | Laser fiber optic components and laser fiber optic osteotomy systems for osteotomy |
| PCT/CN2024/084503 WO2024199380A1 (en) | 2023-03-29 | 2024-03-28 | Laser fiber assembly for osteotomy and laser fiber osteotomy system |
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| CN202310321662.8A CN116327355B (en) | 2023-03-29 | 2023-03-29 | Laser fiber optic components and laser fiber optic osteotomy systems for osteotomy |
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| CN116135168B (en) * | 2023-03-29 | 2024-03-01 | 上海交通大学医学院附属第九人民医院 | Laser osteotomy system and preparation method |
| CN116327355B (en) * | 2023-03-29 | 2025-10-10 | 上海交通大学医学院附属第九人民医院 | Laser fiber optic components and laser fiber optic osteotomy systems for osteotomy |
| CN116473666B (en) * | 2023-03-29 | 2024-01-30 | 上海交通大学医学院附属第九人民医院 | Temperature control system and method thereof |
| CN117838297B (en) * | 2024-02-04 | 2024-06-04 | 武汉长江激光科技有限公司 | Osteotomy robot and use method thereof |
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