A laser ablation assembly and laser ablation system

Abstract

The application provides a laser ablation assembly, comprising an ablation optical fiber and a cooling sleeve; the ablation optical fiber comprises a light-guiding optical fiber and an ablation tip; the cooling sleeve comprises a base, an inner tube and an outer tube, two communication structures are arranged in the base; a first support structure is arranged between the outer tube and the inner tube, a second support structure is arranged on the inner side of the inner tube, the distal end of the outer tube is a blind end, a space between the outer tube and the inner tube forms a first channel, a space between the inner tube and the optical fiber forms a second channel, the first channel and the second channel are in fluid communication at the distal end; the first channel is in fluid communication with one of the communication structures at the proximal end, and the second channel is in fluid communication with the other communication structure at the proximal end.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a laser ablation component and a laser ablation system using the laser ablation component. Background Technology

[0002] Laser ablation is a novel tumor treatment technique that uses optical fibers to deliver light into the human body, causing local biological tissue to coagulate and die upon heating. It can remove tumors or lesions in situ with minimal invasiveness. Compared to traditional surgical resection, this method has advantages such as shorter operation time, smaller surgical trauma, less bleeding, less pain for the patient, better postoperative recovery, and certain anti-inflammatory and antibacterial effects. It shows great promise in disease treatment, especially in tumor research, and is currently used to treat many types of tumors, such as those in the liver, brain, breast, and retina. However, several problems still exist:

[0003] First, during the laser heating process, local tissue overheating and carbonization can occur, hindering further treatment and reducing the treatment area. Therefore, using a cooling sleeve and cooling fluid to cool the ablation fiber is a current solution in this field. However, in existing technologies, gas-cooled solutions are limited by the change in coolant from liquid to gas, resulting in excessively large diameters for the cooling sleeve. Liquid-cooled solutions, due to tissue compression after implantation, sometimes cause adhesion between the outer and inner walls, and between the inner wall and the ablation fiber, affecting the passage of cooling fluid and severely weakening the cooling fluid's heat dissipation effect on the ablation fiber.

[0004] Secondly, because some tissues or tumors have a certain degree of toughness in their outer membrane structure, the ablation cannula cannot penetrate the membrane, causing the ablation fiber to deviate from the preset path, resulting in decreased ablation precision or increased damage to normal tissues.

[0005] Third, when using ablation fibers with directional light output, the ablation fiber needs to maintain its central axis when rotating; otherwise, it will cause a deviation between the actual ablation and the expected ablation.

[0006] Fourth, there is a lack of continuous and accurate temperature monitoring during the ablation process. In current monitoring methods, the separately set sensors need to be implanted separately, and the side-by-side temperature measurement structures will also increase the diameter of the ablation fiber and related structures, increasing the difficulty of implantation and trauma.

[0007] Fifth, ablation fibers require high output power and a large diameter to penetrate deep into tissues. During use, they need to be implanted and rotated. If the fiber or treatment tip breaks during this process, the laser may shoot straight forward along the fiber, damaging healthy tissue. Therefore, continuous detection and monitoring are needed to detect whether the laser transmission fiber and treatment tip break, or whether the treatment tip falls off or burns during laser ablation. This problem has not yet been solved.

[0008] To address at least one or all of the above problems, the present invention proposes a laser ablation component for laser thermotherapy. Summary of the Invention

[0009] The first aspect of the present invention provides a laser ablation assembly, comprising an ablation fiber and a cooling sleeve; the ablation fiber includes a light-guiding fiber and an ablation end; the cooling sleeve includes a base, an inner tube, and an outer tube, wherein the base has two communicating structures; a first support structure is provided between the outer tube and the inner tube, and a second support structure is provided on the inner side of the inner tube; the distal end of the outer tube is a blind end; the space between the outer tube and the inner tube forms a first channel, and the space between the inner tube and the fiber forms a second channel; the first channel and the second channel are in fluid communication at their distal ends; the first channel is in fluid communication with one of the communicating structures at its proximal end, and the second channel is in fluid communication with the other communicating structure at its proximal end.

[0010] Preferably, the axis of the ablation fiber coincides with or nearly coincides with the axis of the inner tube.

[0011] Optionally, the light-guiding fiber of the ablation fiber is a double-clad fiber, which includes a core, a first cladding, and a second cladding. The refractive index of the first cladding is less than that of the core, and the refractive index of the second cladding is less than that of the first cladding. The core can transmit light for temperature monitoring, and the first cladding can transmit light for ablation.

[0012] Furthermore, the first cladding can also transmit monitoring light for detecting fractures.

[0013] Optionally, the first cladding can also transmit indicator light, which is used to emit visible light before treatment, allowing the user to quickly confirm the availability of the ablation fiber.

[0014] The optional ablation tip also includes a beam splitter, which has high transmittance for ablation light and high reflectivity for monitoring light used to detect fractures.

[0015] The beam splitter can be positioned in various ways within the treatment head, as long as it is placed on the optical path after the treatment laser exits the optical fiber. In some embodiments, the beam splitter is placed at the proximal end of the treatment head, i.e., adjacent to the optical fiber; in other embodiments, the beam splitter is placed at the distal end of the treatment head; and in still other embodiments, the beam splitter is placed at the light-emitting portion of the treatment head, i.e., where the treatment light leaves the treatment head.

[0016] Optionally, the treatment tip is also provided with a beam splitter. The beam splitter has high reflectivity for the monitoring light used to detect the break and high transmittance for other light. It can transmit the monitoring light used to detect the break through the first cladding, thereby monitoring whether an optical fiber break has occurred during use.

[0017] The high transmittance of light by the beam splitter mentioned in this invention means that when light passes through the beam splitter, the proportion of light passing through is not less than 90%, preferably not less than 95%, and more preferably not less than 98%.

[0018] The high reflectivity of the beam-splitting film for monitoring light mentioned in this invention means that the monitoring light reflected by the beam-splitting film has a significant difference from the monitoring light returned by other reflective surfaces when it reaches the monitoring light detector, and can be identified by the detector; for example, compared with the monitoring light returned to the detector by other reflective surfaces, the intensity of the monitoring light reflected by the beam-splitting film when it reaches the monitoring light detector is at least 50% higher, preferably more than twice as high.

[0019] In this invention, the treatment end is used to transmit light to a target location and can change the emission direction of the light, or at least a portion of the light. The treatment end can have various options. In some embodiments, the treatment end includes a reflective end face, causing the light to be emitted in a predetermined direction. In other embodiments, the treatment end includes scattering particles, causing the light to be emitted along a direction perpendicular to the long axis of the light transmission structure. In still other embodiments, the treatment end can simultaneously have scattering particles and a reflective surface. In some embodiments, the treatment end has scattering particles and a diffuse reflection surface. The light emitted by the treatment end can include not only therapeutic light but also indicator light, etc. The therapeutic light can include laser light for ablation and light light for other methods such as photodynamic therapy. Therefore, the ablation fiber of this invention can be used not only for laser thermotherapy but also for photodynamic therapy.

[0020] Optionally, the ablation fiber further includes a temperature sensing element, which can be an intrinsic Fabry-Perot cavity sensor or a temperature sensing grating. When the temperature sensing element is an intrinsic Fabry-Perot cavity sensor, the intrinsic Fabry-Perot cavity sensor is configured to be adjacent to the far end of the optical fiber and also adjacent to the ablation end. When the temperature sensing element is a temperature sensing grating, the temperature sensing grating is located at the far end of the fiber core and adjacent to the ablation probe.

[0021] Furthermore, in this invention, the ablation process transmits thermometric light through the fiber core. After the thermometric light reaches the thermometric grating through the fiber core, at least a portion of the thermometric light returns. By measuring the returned thermometric light, the temperature at the thermometric grating (i.e., the proximal end of the treatment tip) can be obtained. Furthermore, by measuring the returned thermometric light, the structural condition from the proximal end of the ablation fiber to the thermometric grating (i.e., whether any breakage or damage has occurred) can also be obtained. When a breakage occurs, the signal obtained from the thermometric grating will change abruptly, allowing the user to be aware of the situation promptly.

[0022] In the laser ablation assembly of the present invention, the number of first support structures can be three or more, such as three, four, five, six, eight, etc. Preferably, the first support structures are symmetrically distributed around the central axis of the cooling sleeve, that is, they are evenly distributed along the circumference of the outer tube in the cross-section. The second support structure allows the ablation fiber to rotate therein. The number of second support structures can be three or more, such as three, four, five, six, eight, etc. Preferably, the second support structures are symmetrically distributed around the central axis of the cooling sleeve, that is, they are evenly distributed along the circumference of the inner tube in the cross-section.

[0023] The first support structure and the second support structure extend axially; optionally, the position of the second support structure at the distal end is closer to the proximal end than the position of the distal end of the inner tube; optionally, the first support structure and the second support structure may be discontinuous in the axial direction.

[0024] In some embodiments, the first support structure and the outer tube of the cooling sleeve of the laser ablation component of the present invention are an integral structure, that is, the first support structure is disposed on the inner wall of the outer tube; further, the outer wall of the inner tube may be provided with a groove for matching the first support structure; or the end of the first support structure near the central axis in the cross section has an arc that matches the outer diameter of the inner tube, that is, the end of the first support structure near the central axis in the cross section is a concave arc that matches the convex arc of the outer wall of the inner tube.

[0025] In other embodiments, the first support structure and the inner tube of the cooling sleeve of the laser ablation component of the present invention are an integral structure, that is, the first support structure is disposed on the outer wall of the inner tube, and the first support structure, the inner tube and the second support structure are an integral structure; furthermore, the end of the first support structure near the outer tube in cross-section has an arc that matches the inner diameter of the outer tube, that is, the end of the first support structure near the outer tube in cross-section is a convex arc that matches the concave arc of the inner wall of the outer tube; or the inner side of the outer tube is provided with a groove, and the groove provided on the inner side of the outer tube matches the first support structure disposed on the outer wall of the inner tube.

[0026] In some other embodiments, a portion of the first support structure of the cooling sleeve of the laser ablation component of the present invention is an integral structure with the outer tube, and the remaining first support structures are an integral structure with the inner tube. That is, a portion of the first support structure is disposed on the inner wall of the outer tube, and the remaining first support structures are disposed on the outer wall of the inner tube. Further, the first support structure disposed on the inner wall of the outer tube and the first support structure disposed on the outer wall of the inner tube are spaced apart.

[0027] In some embodiments, in the cooling sleeve of the laser ablation assembly of the present invention, the outer tube, the first support structure, and the inner tube are an integral structure, that is, the outer tube, the first support structure, the inner tube, and the second support structure are integrated. This integrated structure is beneficial for manufacturing and processing, omits the assembly process, and makes it more convenient to use. Furthermore, when the outer tube, the first support structure, the inner tube, and the second support structure are an integral structure, the inner tube can be connected to the outer tube at its distal end, and a connecting hole is provided at the distal end of the inner tube to allow fluid communication between the first channel and the second channel.

[0028] In the cooling sleeve of the laser ablation component of the present invention, the end of the second support structure near the axis matches the ablation fiber. Optionally, in cross-section, the end of the second support structure near the axis is concave, which matches the convex surface of the outer diameter of the fiber; alternatively, the end of the second support structure near the axis is convex, which corresponds to the convex surface of the outer diameter of the fiber. Compared with the aforementioned concave structure, the contact area is smaller and the resistance to fiber rotation is smaller.

[0029] The base has two connecting structures, each with a port. One of the connecting structures is in proximal fluid communication with the first channel through its port, and the other of the connecting structures is in proximal fluid communication with the second channel through its port.

[0030] In some embodiments, in the cooling sleeve of the present invention, a first port is provided on the first connecting structure, the first port being in communication with a first circulating fluid, and a second port is provided on the second connecting structure, the second port being in communication with a second channel.

[0031] The cooling fluid enters the first channel from the first port on the first connecting structure, flows from the near end to the far end of the first channel, absorbs heat after reaching the far end of the cooling sleeve, then flows back to the near end of the second channel, and finally flows out from the second port on the second connecting structure, thereby reducing the temperature of the ablation fiber.

[0032] Alternatively, the cooling fluid enters the second channel from the second port on the second connecting structure, flows from the near end to the far end of the second channel, absorbs heat after reaching the far end of the cooling sleeve, then flows back to the near end of the first channel, and finally flows out from the first port on the first connecting structure, thereby reducing the temperature of the ablation fiber.

[0033] In other embodiments, in the cooling sleeve of the present invention, a first port is provided on the first connecting structure, the first port being in fluid communication with the second channel, and a second port is provided on the second connecting structure, the second port being in communication with the first circulating fluid.

[0034] The cooling fluid enters the first channel from the second port of the second connecting structure, flows from the near end to the far end of the first channel, absorbs heat after reaching the far end of the cooling sleeve, then flows back to the near end of the second channel, and finally flows out from the first port of the first connecting structure, thereby reducing the temperature of the ablation fiber.

[0035] Alternatively, the cooling fluid enters the second channel from the first port on the first connecting structure, flows from the near end to the far end of the second channel, absorbs heat after reaching the far end of the cooling sleeve, then flows back to the near end of the first channel, and finally flows out from the second port on the second connecting structure, thereby reducing the temperature of the ablation fiber.

[0036] The cooling fluid can be any fluid suitable for cooling, preferably including double-distilled water, medical saline, etc.

[0037] Secondly, the present invention provides a laser ablation system, comprising: a control center, at least one treatment light source module, a cooling circulation module, and at least one laser ablation component of this application. The control center includes a host computer and input / output devices. The host computer can load software programs for implementing treatment, and the input / output devices are used to display and receive instructions.

[0038] The treatment light source module includes one or more treatment light generators, which can generate one or more types of light for treatment (treatment light), such as commonly used ablation lasers such as 980nm and 1064nm; the treatment light generator may include several sets of lasers and corresponding controllers.

[0039] In some embodiments, the laser ablation system further includes a monitoring module and an ablation fiber with a beam splitter. The monitoring module includes at least one monitoring light generator, a wavelength combining module, a transceiver splitter, and at least one photodetector. The treatment light (i.e., ablation laser) generated by the treatment light source module and the monitoring light generated by the monitoring light generator are processed by the wavelength combining module before entering the transmission fiber. During use, the monitoring light is generated by the monitoring light generator. After passing through the transceiver splitter, the monitoring light is combined with the treatment light in the wavelength combining module and then enters the ablation fiber. Part of the monitoring light is reflected at the beam splitter and returns, re-entering the transceiver splitter and finally reaching the photodetector. The photodetector continuously monitors the returning monitoring light to ensure that there are no problems such as fiber breakage in the optical path and to determine whether the structure of the ablation fiber is intact.

[0040] Preferably, the monitoring light generator is selected from: a red laser that generates any wavelength in the 630-660nm band, a near-infrared laser that generates any wavelength in the 1300-1320nm band, and a near-infrared laser that generates any wavelength in the 1520-1565nm band.

[0041] Optionally, the laser ablation system may also include a beam splitter that connects the transmission fiber and the ablation fiber. The beam splitter receives the light transmitted through the transmission fiber and distributes it to two or more ablation fibers. In this case, the wavelength of the monitoring light returned by the beam splitter corresponding to each ablation fiber is different.

[0042] At least a portion of the light can be detected by a photodetector through reflection from a beam splitter. The photodetector can employ various technologies, such as a photodiode (PD), an avalanche photodiode (APD), or a photomultiplier tube.

[0043] In some implementations, the monitoring light can serve as both the detection light and the indicator light. That is, by controlling the reflection ratio of the beam splitter and the intensity of the monitoring light, the portion of the monitoring light emitted through the beam splitter can be used as the indicator light; a separate indicator light module or indicator laser is no longer required. The monitoring light can use visible light wavelengths, and the normality of the optical path can be determined by directly observing the monitoring light emitted from the ablation fiber.

[0044] In this application, the light generator, including the therapeutic light generator and the monitoring light generator, can include one or more light source modules and a corresponding controller. The controller can control the emission parameters of the light source modules, such as the output power, output time period, output time domain, etc.

[0045] The therapeutic light generator can produce light for treatment, i.e., therapeutic light. Furthermore, two or more therapeutic light generators can be provided, or a therapeutic light generator can include two or more light source modules, so that the laser treatment system of the present invention can output two or more different wavelengths of therapeutic light in various time-domain modes. For example, in some embodiments, two therapeutic lights can be output simultaneously; in other embodiments, the first therapeutic light can be output separately first, followed by the second therapeutic light; in still other embodiments, the two therapeutic lights can be output alternately at fixed time intervals.

[0046] The monitoring light generator can generate light used to monitor whether a break has occurred in the ablation fiber, i.e., monitoring light; two or more treatment light generators can be set, or the monitoring light generator can include two or more light source modules, so that the laser ablation system of the present invention can output two or more monitoring lights of different wavelengths.

[0047] Preferably, the wavelength of the monitoring light is different from the wavelength of the treatment light; more preferably, the wavelength of the monitoring light is significantly different from or easily distinguishable from the wavelength of the treatment light.

[0048] The cooling circulation module and cooling sleeve are used in combination to cool the ablation fiber. The cooling circulation module includes a pumping device (e.g., a peristaltic pump) and a cooling medium. In use, the ablation fiber is placed in the cooling sleeve, and the peristaltic pump pumps the cooling medium into the cooling sleeve to absorb the heat from the ablation fiber before flowing out of the cooling sleeve, thereby reducing the temperature of the ablation fiber and the surrounding tissue. The circulation of the cooling fluid is as described above.

[0049] In some embodiments, the laser ablation system of the present invention further includes a temperature measurement module and an ablation fiber with a temperature measurement structure. The temperature measurement module includes a temperature measurement light source and a demodulation module. The temperature measurement light source and the demodulation module can be a suitable combination of devices. For example, in some embodiments, the temperature measurement light source is a C-band tunable laser, and the demodulation module is a photodetector; in other embodiments, the temperature measurement light source is a C-band ASE light source, and the demodulation module is a spectral demodulation module. In still other embodiments, the temperature measurement light source is a halogen tungsten lamp white light source, and the demodulation module is a white light interferometry demodulation module. The temperature measurement light emitted by the temperature measurement light source is transmitted through the fiber core to a temperature measurement grating or a temperature measurement Fabry-Perot cavity sensor and then returns. The demodulation module measures the returned temperature measurement light to obtain the temperature of the temperature measurement grating (e.g., a Bragg grating) or the temperature measurement Fabry-Perot cavity sensor.

[0050] The beam combiner integrates the light generated by the treatment light source module and the temperature sensing module, and then outputs it through the transmission fiber. The coupler connects the transmission fiber to the ablation fiber, so that the light generated by the treatment light source module and the temperature sensing module can reach the target position.

[0051] Optionally, an indicator light source may also be included, which includes a visible light laser that generates visible light for indication. It may be set separately or set in the treatment light source module. That is, the treatment light source module includes not only a laser that emits treatment light, but also a laser that emits indicator light.

[0052] Optionally, a beam splitter is also included. The beam splitter can divide the received light into multiple outputs. The treatment light source module and the temperature sensing module can be connected to n beam splitters (n is a natural number greater than or equal to 2). The n treatment lights and the corresponding n temperature measuring lights output after passing through the n beam splitters are paired up, and then enter the n ablation optical fibers of the present invention after passing through n beam combiners. Furthermore, there can be two or more treatment modules, and each treatment module is used in conjunction with one ablation optical fiber of the present invention.

[0053] In some embodiments, the host can load an ablation program, record temperature in real time through a temperature measurement module, monitor and display the temperature, estimate the ablation status based on temperature and duration and display it on a three-dimensional model, control the output power of the laser generator through temperature and ablation status feedback, and shut down the treatment light generator in an emergency when an abnormal monitoring light signal is received.

[0054] In some embodiments, the laser treatment system of the present invention further includes a temperature measurement module, a monitoring module, and an ablation fiber that simultaneously incorporates a beam splitter and a temperature measurement structure. The temperature measurement module can detect the temperature of the temperature measurement structure and the proximal end of the ablation tip, and can also detect the structural condition from the proximal end to the temperature measurement structure; the monitoring module can monitor the structural condition from the proximal end to the beam splitter, and may include a light guide fiber and an ablation tip.

[0055] In some embodiments, the laser hyperthermia system based on magnetic resonance interstitial tissue of the present invention includes a workstation and the laser hyperthermia system of the present invention. The workstation includes a host and a human-computer interaction module. Further, the system may also include a magnetic resonance (MRI) device. In use, the host is communicatively connected to the MRI device, receives information from the MRI module, and completes at least one of the following based on the patient's digital image information: patient registration, 3D modeling based on preoperative medical image information, and generating a surgical plan; MRI temperature imaging technology generates real-time temperature images based on MRI information, and the temperature images and 3D models are fused and displayed in the human-computer interaction module. The digital image information includes, but is not limited to, CT images and MRI images. The temperature measured by the ablation fiber is used to verify and correct the temperature calculation and ablation assessment based on MRI.

[0056] The host computer is loaded with a temperature measurement program capable of performing temperature correction. This program can execute the following methods:

[0057] The temperature of the proximal end of the treatment tip is continuously obtained using a temperature sensing module as a reference temperature.

[0058] The temperature near the proximal end of the treatment tip, obtained through magnetic resonance thermometry, was used as the calculated temperature.

[0059] After obtaining the calculated temperature, compare the current reference temperature with the calculated temperature.

[0060] When the absolute value of the difference between the reference temperature and the calculated temperature exceeds the threshold, the calculated temperature is corrected.

[0061] The highest temperature extracted from the corrected calculated temperature is compared with the warning temperature. If the warning temperature is exceeded, an instruction to shut down the treatment laser is issued; if the warning temperature is not exceeded, the next round of magnetic resonance thermometry and temperature comparison continues until the predetermined procedure is completed.

[0062] In some embodiments, the threshold can be set as needed, such as 1℃, 1.2℃, 1.5℃, 2℃, 3℃, etc.

[0063] In some embodiments, the warning temperature can be set as needed, such as 85°C, 88°C, 90°C, etc. The host computer also loads a fracture detection program, which can perform the following methods:

[0064] When the monitoring module detects a breakage, it immediately stops generating the therapeutic light to prevent accidental damage.

[0065] The host can also generate a surgical plan, wherein the surgical plan includes information corresponding to the laser ablation component, including but not limited to: planned ablation area and / or planned ablation volume, laser power used to achieve the predetermined ablation result, light emission time, light emission mode, number of ablation channels required, coolant flow rate, and fiber optic conduit insertion path planning.

[0066] Real-time control is achieved by calculating the temperature based on the magnetic resonance image and correcting the temperature image using the temperature measurement structure. The operating parameters of each ablation fiber component in operation, as well as the treatment light source module and cooling circulation module, are adjusted in real time to monitor ablation in real time.

[0067] The comparative analysis compares the information in the surgical plan corresponding to each laser device with the information of the laser device after the operation. Based on the comparison results, ablation result information is generated and displayed in the human-computer interaction module. The comparison content includes the following: the planned ablation area or volume, and the actual ablation area or volume after the operation. The ablation result information includes at least, but is not limited to: ablation area percentage, ablation volume percentage, and a comparison image before and after ablation.

[0068] The laser ablation component of the present invention has at least the following advantages:

[0069] 1. A first support structure is set between the outer tube and the inner tube of the cannula, and a second support structure is set between the inner tube and the medical device (such as ablation fiber, deep electrode, etc.). This enhances the radial strength and prevents the space between the inner tube and the outer tube, and between the medical device and the inner tube from being blocked by tissue compression after implantation, thus ensuring the flow of cooling fluid.

[0070] 2. The axial structural strength of the cooling conduit has been enhanced, making it easier to penetrate the membrane structure while reducing the possibility of deviating from the preset path, improving puncture accuracy, and reducing damage to normal tissues.

[0071] 3. The special support structure design allows medical devices (such as ablation optical fibers, deep electrodes, etc.) to maintain their central axis when rotation is required, enabling more accurate calculation of rotation angles and prediction of ablation and other treatment effects.

[0072] 4. The temperature sensing element can perform real-time and continuous temperature monitoring of the ablation tip;

[0073] 5. The beam splitter can be used to monitor whether a break has occurred in the optical path of the ablation fiber;

[0074] 6. The built-in temperature measurement structure of the ablation fiber can also be used for structural damage detection. When the detector cannot receive the temperature measurement light signal returned by the temperature measurement structure, it indicates that structural damage has occurred in the ablation fiber from the near end to the temperature measurement structure, and the temperature measurement light cannot pass through.

[0075] 7. The present invention is a laser thermotherapy system based on magnetic resonance interstitial fluid. The temperature measurement structure built into the ablation fiber can detect the temperature of the proximal end of the treatment tip in real time. The temperature here is used as a reference temperature and compared with the calculated temperature obtained by the magnetic resonance scanning method, thereby correcting the temperature measurement error of the magnetic resonance scanning method and thus assisting in the correction of the ablation calculation.

[0076] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, preferred embodiments are described below in detail with reference to the accompanying drawings. Attached Figure Description

[0077] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0078] Figure 1 A is a front view of a laser ablation component according to an embodiment of the present invention. Figure 1 B is a sectional view of a portion of the structure. Figure 1 C is a cross-sectional view of the line A-A';

[0079] Figure 2 This is a partial cross-sectional view of a laser ablation component according to another embodiment of the present invention;

[0080] Figure 2 A- Figure 2 D represents some examples of laser ablation components in... Figure 1 Cross-sectional view at position A-A' in B;

[0081] Figure 3 A- Figure 3 D is in some other instances where the laser ablation component is... Figure 1 Cross-sectional view at position A-A' in B;

[0082] Figure 4 A- Figure 4 B represents another example where laser ablation components are used in... Figure 1 Cross-sectional view at position A-A' in B;

[0083] Figure 5 A- Figure 5 B is a cross-sectional view and a cross-sectional view of a laser ablation component in an example, respectively;

[0084] Figure 6 This is a cross-sectional view of the laser ablation component in one embodiment of the present invention;

[0085] Figure 7 This is a cross-sectional view of the laser ablation component in another embodiment of the present invention;

[0086] Figure 8 This is a schematic diagram of an ablation fiber according to an embodiment of the present invention, in which a temperature measuring grating is shown;

[0087] Figure 9 This is a schematic diagram of an ablation fiber according to an embodiment of the present invention, which shows an intrinsic Fabry-Perot cavity sensor;

[0088] Figure 10 A- Figure 10 C is a schematic diagram of the structure of the ablation fiber according to some embodiments of the present invention, showing the different positions of the beam splitter therein;

[0089] Figure 11 A- Figure 11 C represents Figure 10 A and Figure 10 Detailed structural diagram of B and cross-sectional view at AA;

[0090] Figure 12 This is a schematic diagram of an ablation fiber according to one embodiment of the present invention;

[0091] Figure 13 This is a schematic diagram of the composition of a laser therapy system according to an embodiment of the present invention;

[0092] Figure 14 This is a schematic diagram of the composition of a laser therapy system according to an embodiment of the present invention;

[0093] Figure 15 This is a schematic diagram of the composition of a laser therapy system according to an embodiment of the present invention;

[0094] Figure 16 This is a schematic diagram of the composition of a laser therapy system according to an embodiment of the present invention;

[0095] Figure 17 This is a schematic diagram of the composition of a laser therapy system according to an embodiment of the present invention;

[0096] Figure 18 This is a schematic diagram of the composition of a laser therapy system according to an embodiment of the present invention;

[0097] Figure 19 This is a schematic diagram of the composition of a laser therapy system according to an embodiment of the present invention;

[0098] icon:

[0099] 10-Outer tube; 101-First support structure; 1012-First support structure; 102-First channel; 103-Snap-fit ​​structure; 1031-Flow hole; 104-Cone; 20-Inner tube; 201-Second support structure; 202-Second channel; 30-Ablation fiber; 301-Ablation end; 40-First connecting structure; 401-First port; 50-Second connecting structure; 501-Second port; 60-Connection end;

[0100] 1-Therapeutic light generator; 2-Monitoring light generator; 3-Wavelength combining module; 4-Transmitter / receiver splitter; 5-Photodetector / photodetector assembly; 6-Transmission fiber; 7-Ablation fiber; 9-Bundler; 11-Temperature measurement module; 70-Light guide fiber; 71-Beam splitter; 72-Therapeutic end; 74-Directional light emission structure; 701-Fiber core; 702-Cladding; 703-Coating layer; 704-Fiber core; 705-First cladding; 706-Second cladding; 707-Temperature measurement structure; 721-Sleeve; 722-Therapeutic end body; 723-Welding or adhesive bonding; 801-Therapeutic light; 803-Monitoring light; 808-Monitoring light. Detailed Implementation

[0101] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0102] Example

[0103] refer to Figure 1 The diagram shows a cooling sleeve in some embodiments of the present invention. Figure 1A is a front view of the cooling sleeve, where 10 represents the outer tube, 20 the inner tube and 30 the ablation fiber are located therein (not shown), a first connecting structure 40 and a first port 401, a second connecting structure 50 and a second port 501, cooling fluid can enter from the first port and flow out from the second port, or enter from the second port and flow out from the first port; the first port is in fluid communication with the first channel, and the second port is in fluid communication with the inner tube space, or the first port is in fluid communication with the inner tube space and the second port is in fluid communication with the first channel; some specific structures of the first channel, the inner tube space and the cooling device in fluid communication can be found in the inventor's prior patent application "A Water-Cooling Structure for Laser Surgical Instruments" (application number: 20181077693.8), the entire contents of which are incorporated herein by reference. Figure 1 B is Figure 1 The sectional view of the distal portion of the structure circled in A corresponds to... Figure 1 The position of the indicator line B-B' in C shows the outer tube 10, the inner tube 20, the second support structure 201 set inside the inner tube, the ablation fiber 30, and the space between the outer tube 10 and the inner tube 20 forming a first channel 102. The first channel 102 is in fluid communication with the internal space 202 of the inner tube 20 at the distal end. The first support structure 101 and the second support structure 201 are missing at the distal end. The distal end of the inner tube 20 extends beyond the distal end of the second support structure 201, so that the ablation end 301 of the ablation fiber 30 is not affected by the second support structure 201. That is, the transmittance of the ablation end 301 to the ablation laser is basically the same in the direction around the axis. The arrow indicates an example of the flow direction of the cooling fluid in it.

[0104] Figure 1 C is Figure 1 An example of a cross-sectional view at position A-A' in section B shows four first support structures 101 arranged inside the outer tube 10, which divide the first channel 102 into four parts, and four second support structures 201 arranged inside the inner tube 20.

[0105] The number m of the first support structure 101 and the number n of the second support structure 201 can both be any natural number greater than 2. m and n can be the same or different, depending on the requirements. For example, m and n can be 3 and 3; 4 and 4; 8 and 4, etc. Figure 4 A and Figure 4 B illustrates two examples of cooling sleeves having three first support structures 101 and three second support structures 201;

[0106] The shape of the support structure can be adjusted as needed. For example, in terms of cross-section, it can be of uniform width along the radial direction of the cooling sleeve, or it can gradually change width along the radial direction of the cooling sleeve. Figure 3 A- Figure 3 D, which shows multiple cases in which at least a portion of the first and second support structures is radially gradient in the cross-sectional view;

[0107] The first support structure can be located in different positions:

[0108] When the first support structure 101 is only installed on the outer tube 10, see Appendix. Figure 1 C, Appendix Figure 2 A-2B, attached Figure 3 A. Furthermore, corresponding grooves or slots can be provided on the inner tube 20, for example, attached... Figure 2 A-2B facilitates assembly and restricts the rotation of the inner tube 20 relative to the outer tube 10 around its long axis.

[0109] If the first support structure 1012 is only installed on the inner tube 20, please refer to the appendix. Figure 2 C-2D, with attachment Figure 3 C. The first support structure 1012, the second support structure 201, and the inner tube 20 are an integral structure; at this time, a groove or slot can also be provided on the inner wall of the outer tube 10 (see attached diagram). Figure 2 C-2D) is used to facilitate installation and to limit the rotation of the inner tube 20 relative to the outer tube 10 about its long axis;

[0110] The first support structure can also be installed on both the outer wall of the inner tube 20 and the inner wall of the outer tube 10, see Appendix. Figure 3 B, wherein a first support structure 101 is provided on the inner wall of the outer tube 10 and a first support structure 1012 is provided on the inner wall of the inner tube 20. Furthermore, corresponding grooves or slots can be provided on the outer wall of the inner tube and the inner wall of the outer tube respectively. More first support structures further enhance the structural strength and are more conducive to resisting deformation and enhancing puncture strength.

[0111] The cooling sleeve of the present invention may have a groove on the outer wall of the inner tube that matches the first support structure 101 disposed on the inner wall of the outer tube 10, so that the inner tube 20 and the outer tube 10 are assembled by the first support structure 101 and the inner tube 20 is prevented from rotating about its major axis within the outer tube 10. The groove can take various forms, such as a slot, see attached figure. Figure 2 A. In the cross-sectional view, the end of the first support structure 101 near the center resembles a rectangle; the groove can also be an arc shape concave towards the center in the cross-section, corresponding to the end of the first support structure 101 near the center being a convex arc shape, see [reference]. Figure 2 B; Furthermore, the end of the second support structure 201 near the center is also a convex arc shape, thereby minimizing or eliminating the contact area between the ablation fiber and the second support structure 201, resulting in minimal resistance to the rotation of the ablation fiber. This is particularly suitable for situations requiring targeted therapy. See [link to relevant documentation]. Figure 2B.

[0112] The cooling sleeve of the present invention may also have a groove on the inner wall of the outer tube for matching with the first support structure, see [link to relevant documentation]. Figure 2 C and 2D, wherein the first support structure 1012 is disposed on the outer wall of the inner tube 20, and the second support structure 201 is disposed on the inner wall of the inner tube 20, that is, the first support structure 1012, the inner tube 20 and the second support structure 201 are an integral structure. The distribution of the support structures can be designed in various ways. Preferably, a uniform distribution is adopted. For example, in the case of having four support structures, each support structure is perpendicular to the adjacent support structure.

[0113] The cooling sleeve of the present invention can also be a single, integral structure, see [link to previous document]. Figure 3 D, wherein the first support structure 1201 is connected to the inner wall of the outer tube 10 and the outer wall of the inner tube 20; the integrated structure is conducive to manufacturing and processing, omitting the assembly process, and can be used by simply inserting the ablation fiber, which is more convenient.

[0114] The support structure of the cooling sleeve can be discontinuous in the axial direction, for example... Figure 5 A shows a cross-section of an example, where the second support structure 201 is shown as a three-segment structure in the axial direction, with the cross-section at position C-C' ( Figure 5 In B), the second support structure 201 is missing; in this case, the weight of the cooling sleeve is further reduced, making the fluid communication of the four second channels 202 smoother.

[0115] For examples of cooling jackets that further enhance the stability of the inner tube, see [link to relevant documentation]. Figure 6 and Figure 7 A snap-fit ​​structure is provided at the far end of the outer tube. The overall shape of the snap-fit ​​structure 103 is cylindrical. It is fixedly connected to the inner wall of the outer tube 10 (i.e., it is set on the inner side of the far end of the outer tube 10). The inner diameter of the snap-fit ​​structure 103 is equal to or greater than the outer diameter of the inner tube 201, so that in the cooling sleeve after installation or manufacturing, the far end of the inner tube 201 is located in the snap-fit ​​structure 103. Furthermore, a connecting hole can be provided so that the cooling fluid can flow in the direction of the arrow.

[0116] It is understood that the outer diameter of the snap-fit ​​structure 103 can also be equal to or smaller than the inner diameter of the inner tube 201, so that in the cooling sleeve after installation or manufacturing, the far end of the inner tube 201 surrounds the snap-fit ​​structure 103, and a connecting hole can be provided so that the cooling fluid can flow in the direction of the arrow.

[0117] There are several options for setting up connecting holes:

[0118] The connecting hole 1031 is provided only on the snap-fit ​​structure 103. The far end of the inner tube 201 is located in the snap-fit ​​structure 103, but has not yet reached the connecting hole 1031, so as not to block the connecting hole from functioning.

[0119] A connecting hole is provided at the far end of both the snap-fit ​​structure 103 and the inner tube 201.

[0120] This allows the cooling fluid to flow through the flow hole 1031 in the direction of the arrow, or the flow hole can be provided in both the snap-fit ​​structure 103 and the inner tube 201, so that the inner tube 201 can be completely abutted against the far end of the outer tube.

[0121] For examples of cooling sleeves with further enhanced puncture resistance, see [link to example]. Figure 7 The outer tube 10 has a conical structure 104 at its distal end. Through the design of its geometric shape, together with the support structure, it provides better structural strength and stronger puncture capability.

[0122] Example 1

[0123] See Figure 8 The ablation fiber 6 includes a double-clad fiber 60 and a treatment end 66. The double-clad fiber 60 includes a core 61, a first cladding 62, and a second cladding 63. The treatment end 66 can be used for laser thermotherapy or photodynamic therapy. A temperature-sensing grating 67 is provided at the distal end of the core 61 of the double-clad fiber. The distal end of the double-clad fiber and the proximal end of the treatment end are adjacent, and the temperature at this point can be continuously measured through the temperature-sensing grating. This structure is merely exemplary; the axial length of the double-clad fiber is much greater than the axial length of the treatment end, and most of the homogeneous structure at the proximal end is omitted.

[0124] An example of a temperature-measuring grating is the Bragg grating;

[0125] The core 61 of the double-clad optical fiber is a single-mode core, preferably a single-mode core with a diameter of 9 micrometers to 25 micrometers;

[0126] The refractive index of the first cladding 62 of the double-clad fiber is less than that of the core 61, which allows the temperature-measuring laser to be transmitted in the core 61.

[0127] The refractive index of the second cladding 63 of the double-clad optical fiber is less than that of the first cladding 62, which allows the therapeutic laser to be transmitted in the first cladding 62.

[0128] Those skilled in the art will understand that different coating layers 64 can typically be provided on the outer side of the second cladding as needed;

[0129] The treatment tip 66 can change the direction of at least a portion of the emitted light, and various different structures can be used as needed. For example, in some instances, the treatment tip 66 can be a scattering tip that scatters light to achieve emission along a direction perpendicular to the long axis of the light transmission structure; in other instances, the treatment tip 66, based on the aforementioned scattering tip, has a portion of its long axis area covered by reflective material to achieve directional light emission; further specific descriptions of the treatment tip 66 can be found in our prior patent applications: 201810633280.8, Apparatus for Laser Ablation; 201911409241.0, Apparatus for Laser Interstitial Hyperthermia System, the entire contents of which are incorporated herein by reference; in still other instances, the treatment tip 66 can have a refractive surface 661, causing light to emit in a specific direction, see [reference needed]. Figure 10 C.

[0130] Example 2

[0131] refer to Figure 9 In one embodiment of the present invention, the ablation fiber includes: a light guide fiber, a temperature sensing structure, and a treatment end, wherein the light guide fiber is a double-clad fiber 60, wherein:

[0132] 61: The core of the double-clad optical fiber is preferably a single-mode core of 9-25 μm;

[0133] 62: The first cladding of a double-clad optical fiber has a refractive index lower than that of the core.

[0134] 63: The second cladding of a double-clad optical fiber has a lower refractive index than the first cladding.

[0135] 64: Coating layer of double-clad optical fiber; some double-clad optical fibers do not have this layer.

[0136] 66: Treatment end head, a component that converts the laser emitted from the optical fiber into the shape required for treatment, which can be a scattering end head, a reflecting end head, etc.

[0137] The treatment tip 66 can change the direction of at least a portion of the emitted light, and various different structures can be used as needed. For example, in some instances, the treatment tip 66 can be a scattering tip that scatters light to achieve emission along a direction perpendicular to the long axis of the light transmission structure; in other instances, the treatment tip 66, based on the aforementioned scattering tip, has a portion of its long axis area covered by reflective material to achieve directional light emission; further specific descriptions of the treatment tip 66 can be found in our prior patent applications: 201810633280.8, Apparatus for Laser Ablation; 201911409241.0, Apparatus for Laser Interstitial Hyperthermia System, the entire contents of which are incorporated herein by reference; in still other instances, the treatment tip 66 can have a refractive surface 661, causing light to emit in a specific direction, see [reference needed]. Figure 10 C.

[0138] Components 68, 69, and 70 form a temperature sensing structure (an intrinsic Fabry-Pérot cavity sensor). 68 is the sensor substrate, 69 is the sensor diaphragm, and 70 is a Fabry-Pérot cavity formed by a coated surface of the substrate and a coated surface of the diaphragm. This cavity can modulate the incident spectrum, with the peak spacing and phase of the modulated spectrum corresponding one-to-one with the cavity length. When the sensor temperature changes, its cavity length changes accordingly. By demodulating the cavity length, the sensor temperature can be measured.

[0139] The treatment tip can be connected to the optical fiber and the treatment tip in a variety of ways, such as laser welding or adhesive bonding.

[0140] Optionally, if the treatment tip 66 is formed by gel injection molding, the treatment tip also includes a sleeve 65: a sleeve connecting the double-clad fiber body and the beam conversion tip, which can be made of materials such as quartz, sapphire, PC, PTFE, etc., that allow the treatment laser to pass through. After connecting the sleeve 65 to the optical fiber, the treatment tip 66 is then fabricated.

[0141] Example 3

[0142] Reference Figure 10 A shows a schematic diagram of a therapeutic optical fiber, in which a light-guiding optical fiber 70, a beam splitter 71, and a therapeutic end body 72 are arranged sequentially from the near end to the far end.

[0143] Figure 11 A is Figure 10 A detailed partial structural diagram of a therapeutic fiber example shown in Figure A. The optical fiber 70 includes a core 701, a cladding 702, and a coating 703. The therapeutic end 72 includes a sleeve 721 and a therapeutic end body 722. The sleeve 721 is not essential; it is only required when the therapeutic end body 722 is processed using injection molding. When the sleeve 721 is present, it can be connected to the cladding 702 by means of fusion splicing or adhesive bonding, as shown in Figure 723. A beam splitter 71 is disposed between the core 701 and the therapeutic end body 722.

[0144] Example 4

[0145] See Figure 10 Figure B shows a schematic diagram of another type of therapeutic fiber, in which a light guide fiber 70, a therapeutic end body 72, and a beam splitter 71 are arranged sequentially from the proximal end to the distal end.

[0146] Figure 11 B is Figure 10The partial structural detail of the therapeutic fiber example shown in B includes a fiber core 701, a cladding 702, and a coating layer 703; the therapeutic end 72 includes a sleeve 721 and a therapeutic end body 722; the sleeve 721 is not essential and can be omitted in some cases. When the sleeve 721 is present, it can be connected to the cladding 702 by fusion splicing or adhesive bonding, as shown in 723; the beam splitter 71 is located at the distal end of the therapeutic end body 722.

[0147] Example 5

[0148] Reference Figure 10 Figure C shows a schematic diagram of another type of therapeutic optical fiber, in which a light guide fiber 70, a treatment head body 72, a directional light emission structure 74 of the treatment head, and a beam splitter 71 are arranged sequentially from the near end to the far end; wherein the therapeutic light irradiates the tissue to be treated after the directional light emission structure 74 changes direction; the beam splitter 71 is located in the optical path of the therapeutic light emanating from the treatment head body; preferably, the beam splitter 71 covers at least a portion of the area of ​​the therapeutic light emission area, preferably all of the area.

[0149] In this invention, the sleeve can be a tube made of materials that can transmit therapeutic light, such as quartz, sapphire, PC, PTFE, etc.

[0150] In Examples 3 to 5, the optical fiber is preferably a multimode optical fiber with a core diameter of 50 μm to 1200 μm.

[0151] A laser ablation system includes: a treatment light generator 1, a monitoring light generator 2, a beam combiner module 3, a transceiver splitter 4, a photodetector 5, and a transmission optical fiber 6. ablation fiber 7; The light generated by the therapeutic light generator 1 and the monitoring light generator 2 can be combined by the beam combining module 3 and then delivered through the transmission fiber 6; Optionally, the transmission fiber 6 is connected to one or more ablation fibers 7 via a coupler; The therapeutic light generator 1 can generate one or more different wavelengths of therapeutic light, for example, it may include one or more light sources, and the monitoring light generator 2 can generate one or more different wavelengths of monitoring light.

[0152] In some instances, the therapeutic light generator is a semiconductor laser or a solid-state laser;

[0153] The monitoring light generator can also be a laser, such as a red laser with a wavelength of 630-660nm, or a near-infrared laser with a wavelength range of 1300-1320nm or 1520-1565nm.

[0154] The transceiver splitter 4 has three ports: the first port monitors the optical generator 2, the second port connects to the beamforming module 3, and the third port connects to the photodetector 5. It can be any of the following: an optical circulator, an optical fiber coupler / splitter, an isolator with an escape window, and a beam splitter.

[0155] The photodetector 5 is capable of receiving and detecting the monitoring light reflected by the beam splitter 71, and can be selected from any of the following: PIN photodiode, avalanche photodiode (APD), and photomultiplier tube.

[0156] The laser therapy device also includes a control center. The control center can determine whether the transmission optical path is normal based on the monitoring light reflected by the beam splitter 71 detected by the photoelectric detector 5, that is, whether there are problems such as fiber breakage at any point in the optical path. The control center can also be loaded with a treatment plan and send control commands to the treatment light generator according to the treatment plan to generate treatment light according to the pre-designed power and time.

[0157] The ablation laser generated by the ablation laser generator and the detection laser generated by the detection laser generator are processed by the wavelength combining module and then enter the optical fiber.

[0158] Examples 6-8: These are one-to-one corresponding embodiments improved upon Examples 3-5. Specifically, Example 6 is an embodiment described based on Example 3, Example 7 is an embodiment described based on Example 4, and Example 8 is an embodiment described based on Example 5. The difference between these embodiments and their corresponding basic embodiments is that a temperature measurement structure is added to the optical fiber portion. The optical fiber is a double-clad optical fiber, and its specific structure includes a fiber core, a first cladding, and a second cladding. A Bragg grating for temperature measurement is provided at the far end of the fiber core. The refractive index of the first cladding is less than that of the fiber core, and the refractive index of the second cladding is less than that of the first cladding. The fiber core can transmit light for temperature monitoring, and the first cladding can transmit therapeutic light and monitoring light.

[0159] See appendix Figure 12 The structure of Embodiment 7 is described in detail, showing only the structural schematic diagram of the far end of the ablation fiber. It shows the coating layer 703, fiber core 704, first cladding 705, second cladding 706 included in the light guide fiber 70, and the treatment end 72 including the treatment end body 722, sleeve 721, and beam splitter 71. The temperature measuring light 802 is transmitted in the fiber core 704, and returns after reaching the Bragg grating 707, carrying temperature information. The treatment light 801 and the monitoring light 803 are transmitted through the first cladding, and after reaching the beam splitter 71, the monitoring light 808 is folded back to provide feedback on the optical path structure information.

[0160] Example 9

[0161] See appendix Figure 13The diagram illustrates a laser therapy system of the present invention, comprising: a treatment light generator 1, a monitoring light generator 2, a wavelength combining module 3, a transceiver splitter 4, a photodetector 5, a coupler 6, an ablation fiber 7 as described in Examples 1-4, and a control center (not shown). The light generated by the treatment light generator 1 and the monitoring light generator 2 is combined by the wavelength combining module 3 and then delivered via the transmission fiber. The transmission fiber is connected to the ablation fiber 7 via the coupler 6. The monitoring light generated by the monitoring light generator 2 reaches the transceiver splitter 4, then travels through the wavelength combining module, the transmission fiber, and the coupler 6 to the ablation fiber 7. Reflected by the beam splitter 71 in the ablation fiber 7, it returns to the transceiver splitter 4 along the reverse path of the original transmission path, and then reaches the receiving photodetector 5. The receiving photodetector 5 continuously measures the intensity of the received monitoring light to confirm whether the transmission optical path is normal and communicates the result to the control center.

[0162] The therapeutic light generator 1 may include one or more groups of lasers. For example, in the case of three groups of lasers, the first group of lasers can generate a first therapeutic light (e.g., a 980nm laser), the second group of lasers can generate a second therapeutic light (e.g., a 1064nm laser), and the third group of lasers can generate an indicator light. The first and second therapeutic lights can be combined at any time interval and intensity. The 980nm laser heats tissue faster and requires less time, but has weak penetration. The 1064nm laser has strong penetration, but heats tissue slower and requires more time. The controller can be used to combine the 980nm and 1064nm lasers in different time-domain distributions: for example, sequentially, using the 980nm laser for ablation for a period of time, followed by the 1064nm laser for ablation for a period of time; for example, mixed use, first using both 980nm and 1064nm lasers for ablation, then turning off the 980nm laser, and then using the 1064nm laser for continued ablation for a period of time; for example, alternating use, alternating between the 980nm and 1064nm lasers at specific time intervals.

[0163] The monitoring light generator 2 may also include one or more groups of lasers. During use, the monitoring light and the treatment light are significantly different to minimize interference. Each time, a monitoring light with a wavelength significantly different from the treatment light is used. Preferably, visible light can be used as the monitoring light. In this case, the monitoring light can also be used as an indicator light to facilitate a simple system check before use. That is, by controlling the reflection ratio of the beam splitter and the intensity of the monitoring light, the portion of the monitoring light that passes through the beam splitter is sufficient to be directly observed, thereby confirming that the optical path is normal.

[0164] The transceiver splitter 4 has three ports: the first port is connected to the monitoring optical generator 2, the second port is connected to the wavelength combining module 3, and the third port is connected to the photodetector 5. It can be any of the following: an optical circulator, an optical fiber coupler / splitter, an isolator with an escape window, and a beam splitter.

[0165] The photodetector (PD) 5 is capable of receiving and detecting the monitoring light reflected by the beam splitter 71, and can be selected from any of the following: PIN photodiode, avalanche photodiode (APD), and photomultiplier tube.

[0166] The control center can determine whether the transmission optical path is normal based on the monitoring light reflected by the beam splitter 71 detected by the photoelectric detector 5, that is, whether there are problems such as fiber breakage at any point in the optical path; the control center can also load a treatment plan and send control commands to the treatment light generator according to the treatment plan to generate treatment light according to the pre-designed power and time.

[0167] A cooling circulation device (not shown) includes a peristaltic pump, a cooling fluid, and a cooling sleeve, used in combination with the cooling sleeve. The cooling fluid can be any fluid suitable for cooling, preferably including double-distilled water, medical saline, etc. The cooling circulation device may also be equipped with one or more monitoring sensors to measure the pressure in the cooling sleeve, the flow rate of the cooling fluid, etc., and to detect problems such as blockage or cooling sleeve rupture.

[0168] The control center can communicate with the therapeutic light generator 1, the monitoring light generator 2, the photodetector 5, and the cooling circulation device to send commands and receive feedback information, and control the operation of the system by adjusting the power of the therapeutic light and the flow rate of the cooling fluid.

[0169] Example 10

[0170] Reference Figure 14Based on Example 9, the laser treatment system of this example includes: 3 treatment light generators 1, 3 monitoring light generators 2, 3 wavelength combining modules 3, 3 transceiver splitters 4, 3 photodetectors 5, 3 couplers 6, 3 ablation fibers 7 as described in Examples 1-4, and a control center 0. The treatment light generators 1, monitoring light generators 2, wavelength combining modules 3, transceiver splitters 4, photodetectors 5, couplers 6, and ablation fibers 7 form a subsystem, that is, the three subsystems are simultaneously connected to the control center 0. In each subsystem, the light generated by the treatment light generators 1 and monitoring light generators 2 is combined through the wavelength combining module 3 and then delivered through the transmission fiber. The transmission fiber is connected to the ablation fiber 7 through the coupler 6. The monitoring light generated by the monitoring light generator 2 reaches the transceiver splitter 4, then passes through the wavelength combining module, transmission fiber, and coupler 6 to the ablation fiber 7. In the ablation fiber 7, after reflection by the beam splitter 71, it returns to the transceiver splitter 4 along the reverse path of the original transmission path, and then reaches the receiving light detector 5. The receiving light detector 5 continuously measures the intensity of the received monitoring light to confirm whether the transmission optical path is normal and communicates the result to the control center. The control center can control each subsystem separately, meaning that the use of different subsystems does not interfere with each other.

[0171] The therapeutic light generator 1 may include one or more groups of lasers. For example, in the case of three groups of lasers, the first group of lasers is capable of generating a first therapeutic light (e.g., a 980nm laser), the second group of lasers is capable of generating a second therapeutic light (e.g., a 1064nm laser), and the third group of lasers is capable of generating an indicator light. The first and second therapeutic lights may be combined in any time interval and light intensity combination.

[0172] The monitoring light generator 2 may also include one or more sets of lasers.

[0173] The subsystem of this embodiment may further be provided with an indicator light module. The indicator light module may be integrated into the treatment light source module or set separately. When set separately, it also enters the ablation fiber through the wavelength combining module.

[0174] It is understood that the first and second therapeutic lights may also use other wavelengths of laser suitable for laser thermotherapy, and these wavelength schemes are all included within the scope of the invention; the indicator light is usually selected as visible light.

[0175] It is understood that the number of subsystems can be arbitrary, such as 2, 4, 5, etc., and these ranges are all included within the scope of this invention.

[0176] This embodiment also includes three cooling circulation devices corresponding to the ablation fiber, that is, each subsystem includes one cooling circulation device. The cooling circulation device includes a peristaltic pump, a cooling fluid, and is used in combination with a cooling sleeve. Each ablation fiber can be used together with a corresponding cooling sleeve. The cooling fluid can be any fluid suitable for cooling, preferably including double-distilled water, medical saline, etc. The cooling circulation device can also be equipped with one or more monitoring sensors to measure the pressure in the cooling sleeve, the flow rate of the cooling fluid, etc., and to detect whether there are problems such as blockage or cooling sleeve rupture.

[0177] The control center simultaneously controls three laser thermotherapy subsystems. The control center can control each subsystem to use the same or different treatment protocols. For example, the first subsystem can use a 980nm wavelength, the second a 1064nm wavelength, and the third a combination of 980nm and 1064nm wavelengths; or all three subsystems can use a combination of 980nm and 1064nm wavelengths, but with different ablation times and intervals. The treatment protocol includes not only wavelength but also parameters such as laser output power, emission time, emission mode, laser emission angle, and cooling fluid flow rate.

[0178] Example 11

[0179] Reference Figure 15 The laser therapy system of this embodiment includes: a treatment light generator 1, a monitoring light generator 2, a wavelength beam combining module 3, a transceiver splitter 4, a photodetector assembly 5, a coupler 6, three ablation optical fibers 7 as described in embodiments 1-4, and a control center 0; wherein, the treatment light generator 1 includes four groups of lasers and controllers, namely the first group, the second group, the third group, and the fourth group. The lasers of the first to third groups can generate treatment light of different wavelengths and can be used individually or in combination. The fourth group of lasers generates indicator light for quickly detecting whether the optical path is normal, that is, it is used separately before use. Turn on the indicator light and observe whether the ablation fiber can emit the indicator light; the monitoring light generator 2 includes 3 lasers (LD1-3), and the photodetector 5 includes 3 photodetectors (PD1-3). The 3 lasers (LD1-3) generate monitoring light of different wavelengths, which can be reflected by the beam splitters of the three ablation fibers respectively. The wavelengths of the detection light all fall within the high reflectivity wavelength range of the beam splitter. After returning from the beam splitter, it can be detected by the 3 detectors of the photodetector assembly 5 through the transceiver splitter 4. That is, the beam splitter of each ablation fiber can reflect monitoring light of different wavelengths.

[0180] The therapeutic light generator 1 may include one or more groups of lasers. For example, in the case of three groups of lasers, the first group of lasers is capable of generating a first therapeutic light (e.g., a 980nm laser), the second group of lasers is capable of generating a second therapeutic light (e.g., a 1064nm laser), and the third group of lasers is capable of generating an indicator light. The first and second therapeutic lights may be combined in any time interval and light intensity combination.

[0181] This embodiment also includes three cooling circulation devices corresponding to the ablation optical fibers, i.e., one cooling circulation device for each ablation optical fiber. Each cooling circulation device includes a peristaltic pump, a cooling fluid, and is used in conjunction with a cooling sleeve. Each ablation optical fiber is used with its corresponding cooling sleeve. The cooling fluid can be any suitable fluid for cooling, preferably including double-distilled water, medical saline, etc. The cooling circulation device may also be equipped with one or more monitoring sensors to measure the pressure in the cooling sleeve, the flow rate of the cooling fluid, etc., to detect problems such as blockage or cooling sleeve rupture. The control center can communicate with and independently control the three cooling circulation devices.

[0182] It is understood that, based on this embodiment, the laser thermotherapy system of the present invention may include other numbers of ablation optical fibers, such as 2, 4, 5, 6, etc.; the therapeutic light generated by the therapeutic light source module and the monitoring light generated by the monitoring module can be divided into corresponding parts by a beam splitter, such as 2 parts, 4 parts, 5 parts, 6 parts, etc., and these schemes are also within the scope of the present invention.

[0183] Example 12

[0184] refer to Figure 16 The following description is based on the scheme of Embodiment 9, but differs from Embodiment 9 in that it also includes a temperature measurement module 9, which includes a temperature measurement light source and a demodulation module; the ablation fiber is the ablation fiber described in Embodiments 5-8. The temperature measurement light generated by the temperature measurement module 11 enters the ablation fiber 7 together with other light (treatment light and monitoring light) through the combiner 9. The temperature measurement light is transmitted through the core of the ablation fiber, while the other light is transmitted through the first cladding.

[0185] Example 13

[0186] refer to Figure 17 The following description is based on the scheme of Embodiment 10, but differs from Embodiment 10 in that each subsystem further includes a temperature measurement module 9, which includes a temperature measurement light source and a demodulation module; the ablation fiber is the ablation fiber described in Embodiments 6-8. The temperature measurement light generated by the temperature measurement module 11 enters the ablation fiber 7 together with other light (treatment light and monitoring light) through the combiner 10. The temperature measurement light is transmitted through the core of the ablation fiber, while the other light is transmitted through the first cladding.

[0187] Example 14

[0188] refer to Figure 18 The following description is based on the scheme of Embodiment 11, but differs from Embodiment 11 in that it also includes a temperature measurement module, which includes a temperature measurement light source and a demodulation module; the ablation fiber is the ablation fiber described in Embodiments 6-8. The temperature measurement light source emits temperature measurement light, which is transmitted through the fiber core to the temperature measurement structure and then returns. The temperature measurement light enters the corresponding first to third ablation fibers together with the treatment light and the monitoring light through the corresponding first to third bundlers. The temperature measurement light is transmitted through the fiber core of the ablation fiber, while the treatment light and the monitoring light are transmitted through the first cladding. After the temperature measurement fiber reaches the temperature measurement module, it returns carrying temperature information. The demodulation module measures the returned temperature measurement light to obtain the temperature of the temperature measurement structure (e.g., a Bragg grating or an intrinsic Faber cavity) of the corresponding ablation fiber.

[0189] The temperature measuring light source and demodulation module can be combined using a suitable combination device:

[0190] When the temperature sensing structure is a Bragg grating or an intrinsic Fabry-Perot cavity:

[0191] Optionally, the temperature measurement light source is a C-band tunable laser, and the demodulation module is a photodetector;

[0192] Optionally, the temperature measurement light source is a C-band ASE light source, and the demodulation module is a spectral demodulation module.

[0193] When the temperature sensing structure is an intrinsic or non-intrinsic cavity:

[0194] Another possible equipment combination is: the temperature measuring light source is a halogen tungsten lamp white light source, and the demodulation module is a white light interference demodulation module.

[0195] This embodiment also includes three cooling circulation devices corresponding to the ablation optical fibers, i.e., one cooling circulation device for each ablation optical fiber. Each cooling circulation device includes a peristaltic pump, a cooling fluid, and is used in conjunction with a cooling sleeve. Each ablation optical fiber is used with its corresponding cooling sleeve. The cooling fluid can be any suitable fluid for cooling, preferably including double-distilled water, medical saline, etc. The cooling circulation device may also be equipped with one or more monitoring sensors to measure the pressure in the cooling sleeve, the flow rate of the cooling fluid, etc., to detect problems such as blockage or cooling sleeve rupture. The control center can communicate with and independently control the three cooling circulation devices.

[0196] It is understood that, based on this embodiment, the laser thermotherapy system of the present invention may include other numbers of ablation fibers, such as 2, 4, 5, 6, etc.; the therapeutic light generated by the therapeutic light source module and the monitoring light generated by the monitoring module can be divided into corresponding parts by a beam splitter, and the temperature measuring light is divided into corresponding fractions by a beam splitter, such as 2, 4, 5, 6, etc., and then enter the corresponding ablation fibers one by one through the corresponding number of beam combiners. These schemes are also within the scope of the present invention.

[0197] Example 15

[0198] Reference Figure 19 The following description is based on the scheme of Embodiment 14. The difference from Embodiment 14 is that the system in this embodiment includes three temperature measurement modules and no longer requires a beam splitter. The temperature measurement light generated by each temperature measurement module enters the corresponding first to third ablation fiber together with the treatment light and the monitoring light through the corresponding first to third beam combiners. The temperature measurement light is transmitted through the core of the ablation fiber, and the treatment light and the monitoring light are transmitted through the first cladding. After the temperature measurement fiber reaches the temperature measurement module, it returns with temperature information. The demodulation module measures the returned temperature measurement light to obtain the temperature of the temperature measurement structure (e.g., Bragg grating or intriguing Faber cavity) of the corresponding ablation fiber.

[0199] It is understood that the aforementioned embodiments of the laser thermotherapy system can be combined with each other, and these solutions are also within the scope of this invention.

[0200] Example 15

[0201] A magnetic resonance-guided laser hyperthermia system includes one or more ablation fibers as described in Examples 1 to 8, or includes one laser ablation system as described in Examples 9 to 14. The magnetic resonance-guided laser hyperthermia system can perform laser ablation of target tissue in a magnetic resonance environment, monitoring the ablation temperature and calculating the ablation volume via magnetic resonance. The basic structural composition of the magnetic resonance-guided laser hyperthermia system can be found in our prior application 201810459539.1.

[0202] The system of the present invention includes:

[0203] Magnetic resonance imaging equipment, workstation, and the laser thermotherapy system described above in this invention;

[0204] Magnetic resonance imaging (MRI) devices can acquire images before and during surgery;

[0205] The workstation includes a host computer and a human-computer interaction module (e.g., a touch screen). The host computer communicates with the magnetic resonance imaging (MRI) device and can receive preoperative and intraoperative medical imaging information from MRI and other imaging devices (e.g., CT). It can also receive patient records, create 3D models based on preoperative medical imaging information, generate surgical plans, generate real-time temperature images based on MRI information, plan treatment areas, display intraoperative information, send control information to the laser hyperthermia device, calculate temperature and predict ablation, and fuse the temperature images with the 3D model in the human-computer interaction module for display.

[0206] The host computer is loaded with a temperature measurement program that can perform temperature calibration. The temperature measurement program can perform the following methods:

[0207] The temperature of the temperature measuring module is continuously obtained using the temperature sensing module as the reference temperature.

[0208] After one round of intraoperative MRI scans is completed, the temperature of the temperature measurement module is calculated using the MRI images as the calculated temperature.

[0209] After obtaining the actual temperature, the absolute value of the difference between the reference temperature and the calculated temperature at the same moment is compared with a preset threshold.

[0210] The treatment laser should be turned off immediately if the reference temperature exceeds the warning temperature.

[0211] When the reference temperature and the calculated temperature exceed the threshold, the calculated temperature is corrected before continuing to the next round of magnetic resonance temperature measurement.

[0212] The host receives feedback information from the monitoring module and immediately shuts down all lasers that generate therapeutic light when it receives a breakage signal to prevent accidental damage.

[0213] The host can also generate a surgical plan, wherein the surgical plan includes information corresponding to the laser ablation component, including but not limited to: planned ablation area and / or planned ablation volume, laser power used to achieve the predetermined ablation result, light emission time, light emission mode, number of ablation channels required, coolant flow rate, and fiber optic conduit insertion path planning.

[0214] Real-time control is achieved by calculating the temperature based on the magnetic resonance image and correcting the temperature image using the temperature measurement structure. The operating parameters of each ablation fiber component in operation, as well as the treatment light source module and cooling circulation module, are adjusted in real time to monitor ablation in real time.

[0215] The comparative analysis compares the information in the surgical plan corresponding to each laser device with the information of the laser device after the operation. Based on the comparison results, ablation result information is generated and displayed in the human-computer interaction module. The comparison content includes the following: the planned ablation area or volume, and the actual ablation area or volume after the operation. The ablation result information includes at least, but is not limited to: ablation area percentage, ablation volume percentage, and a comparison image before and after ablation.

[0216] Those skilled in the art will clearly understand that, for the sake of convenience and brevity, the specific working process of the system and apparatus described above can be referred to the corresponding process in the foregoing method embodiments, and will not be repeated here.

[0217] Furthermore, in the description of the embodiments of the present invention, unless otherwise explicitly specified and limited, the term "connection" should be interpreted broadly. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be a connection within two components. Those skilled in the art can understand the specific meaning of the above terms in the present invention based on the specific circumstances.

[0218] Finally, it should be noted that the above-described embodiments are merely specific implementations of the present invention, used to illustrate the technical solutions of the present invention, and not to limit it. The scope of protection of the present invention is not limited thereto. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that any person skilled in the art can still modify or easily conceive of changes to the technical solutions described in the foregoing embodiments within the technical scope disclosed in the present invention, or make equivalent substitutions for some of the technical features; and these modifications, changes, or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention, and should all be covered within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A laser ablation component, characterized in that, The device includes an ablation fiber and a cooling sleeve. The ablation fiber includes a light-guiding fiber and an ablation end. The cooling sleeve includes a base, an inner tube, and an outer tube. The base has two connecting structures. A first support structure is provided between the outer tube and the inner tube. A second support structure is provided inside the inner tube. The distal end of the outer tube is a blind end. The space between the outer tube and the inner tube forms a first channel, and the space between the inner tube and the ablation fiber forms a second channel. The first channel and the second channel are in fluid communication at their distal ends. The first channel is in fluid communication with one of the connecting structures at its proximal end, and the second channel is in fluid communication with the other connecting structure at its proximal end. The distal end of the second support structure does not exceed the distal end of the light-guiding fiber. The second support structure is symmetrically distributed around the central axis of the cooling sleeve, allowing the ablation fiber to rotate within it.

2. The laser ablation component according to claim 1, characterized in that, The light-guiding fiber of the ablation fiber is a double-clad fiber, which includes a core, a first cladding, and a second cladding. The refractive index of the first cladding is less than that of the core, and the refractive index of the second cladding is less than that of the first cladding. The core can transmit temperature-measuring laser, and the first cladding can transmit ablation laser.

3. The laser ablation component according to claim 2, characterized in that, The ablation fiber also includes a temperature sensing element.

4. The laser ablation component according to claim 3, characterized in that, The temperature sensing element is an intrinsic Fabry-Perot cavity sensor.

5. The laser ablation component according to claim 3, characterized in that, The temperature sensing element is a Bragg grating located at the far end of the fiber core.

6. The laser ablation component according to claim 1, characterized in that, The ablation end also includes a beam splitter, which has high transmittance for the ablation laser and high reflectivity for the monitoring light used to monitor the fracture.

7. The laser ablation assembly according to claim 1, characterized in that, The first support structure and the outer tube are an integral structure.

8. The laser ablation assembly according to claim 7, characterized in that, The outer side of the inner tube is provided with a groove.

9. The laser ablation assembly according to claim 8, characterized in that, The groove on the outer side of the inner tube matches the first support structure.

10. The laser ablation assembly according to claim 1, characterized in that, The first support structure and the inner tube are an integral structure.

11. The laser ablation assembly according to claim 1, characterized in that, The inner side of the outer tube is provided with a groove, and the groove provided on the inner side of the outer tube matches the first support structure.

12. The laser ablation assembly according to claim 1, characterized in that, In some cases, the first support structure and the outer tube are an integral structure, while in others, the first support structure and the inner tube are an integral structure.

13. The laser ablation assembly according to claim 1, characterized in that, The outer tube, the first support structure, and the inner tube are an integral structure.

14. A laser ablation system, characterized in that, It includes a control center, at least one treatment light source module, a cooling circulation module, and at least one laser ablation component as described in any one of claims 1-13.

15. The laser ablation system according to claim 14, characterized in that, It also includes a monitoring module, which includes at least one monitoring light generator, a wavelength beam combiner, a transceiver splitter, and at least one photodetector.

16. The laser ablation system according to claim 15, characterized in that, The therapeutic light generated by the therapeutic light source module and the monitoring light generated by the monitoring light generator are combined by the wavelength combining module and then coupled into the ablation fiber.

17. The laser ablation system according to claim 14, characterized in that, It also includes a temperature measurement module, which comprises a temperature measurement light source and a demodulation module.

18. A magnetic resonance-guided laser ablation system, characterized in that, The laser ablation system included in any one of claims 14 to 17.

19. The magnetic resonance-guided laser ablation system according to claim 18, characterized in that, It also includes a host computer, a display, and the host computer is loaded with a temperature measurement program capable of performing temperature correction. The temperature measurement program can perform the following methods: The temperature of the proximal end of the treatment tip is continuously obtained using a temperature sensing module as a reference temperature. The temperature near the proximal end of the treatment tip, obtained through magnetic resonance thermometry, was used as the calculated temperature. After obtaining the calculated temperature, compare the current reference temperature with the calculated temperature. When the absolute value of the difference between the reference temperature and the calculated temperature exceeds the threshold, the calculated temperature is corrected. The highest temperature extracted from the corrected calculated temperature is compared with the warning temperature. If the warning temperature is exceeded, an instruction to shut down the treatment laser is issued; if the warning temperature is not exceeded, the next round of magnetic resonance thermometry and temperature comparison continues until the predetermined procedure is completed.

20. The magnetic resonance-guided laser ablation system according to claim 18, characterized in that, The host computer also has a fracture detection program loaded, which can perform the following methods: When the monitoring module detects a breakage, it immediately stops generating the therapeutic light to prevent accidental damage.

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