Heterogeneous coaxial optical cable for minimally invasive surgery

Abstract

The invention relates to a heterogeneous coaxial optical cable for minimally invasive surgery, which comprises a sheath and a cable core, the sheath comprises a first outer sheath, the cable core is located in the first outer sheath, the cable core comprises a laser transmission optical fiber and at least one functional element, and the functional element is an imaging optical fiber or a memory metal support rod; coating materials of the laser transmission optical fiber and the imaging optical fiber are polyacrylic resin, silicon resin or polyimide. According to the heterogeneous coaxial optical cable for minimally invasive surgery provided by the embodiment of the invention, the laser transmission optical fiber is arranged in the first outer sheath to provide intermediate infrared laser, the surface of the optical fiber is coated with the biocompatible coating, and the material can be polyacrylic resin, silicon resin and polyimide, so that the problems that the existing optical fiber coating is easy to hydrolyze and embrittle after being sterilized, and the service life of the optical fiber is prolonged can be solved. And the mechanical strength of the optical fiber is attenuated due to catalytic corrosion of the optical fiber caused by permeation of acid-base body fluid.

Description

Technical Field

[0001] This application relates to the field of medical optical fiber and cable technology, and in particular to an optical cable for minimally invasive surgery using heterogeneous coaxial optical fiber. Background Technology

[0002] With the rapid development of minimally invasive medical technologies, fiber optic technology is increasingly being used in medical fields such as neuroendoscopic imaging and laser interstitial hyperthermia. For example, novel lensless fiber optic microendoscopic imaging technology, with its tiny probe and high magnification, can greatly reduce patient discomfort; laser interstitial hyperthermia, under stereotactic guidance, allows for precise percutaneous ablation treatment of deep brain lesions. Currently, medical fiber optic systems mainly adopt a split design. Imaging fiber: Mostly multi-component glass fiber with tens of thousands of cores is used. The diameter of a single core is about 1-2μm and the numerical aperture of each core is ≥0.25. Although it can achieve cell-level resolution (10μm axial resolution), the diameter of a single probe is ≥2mm due to the need for strict end face treatment.

[0003] Treatment fiber: For example, a quartz fiber with a core diameter of 200μm and a numerical aperture of 0.22 can transmit high-energy lasers with a wavelength of 1064nm. However, due to the lack of real-time imaging feedback, a secondary intervention is required to locate the lesion.

[0004] However, existing technologies have many limitations. On the one hand, the separation of fiber optic imaging and laser surgery not only requires patients to undergo a second surgery, increasing pain and medical costs, but also means that minor changes in human tissue after the previous imaging can interfere with the effectiveness of subsequent laser surgery.

[0005] The core defects of the aforementioned fiber optic system are as follows: imaging and treatment use different optical fibers, resulting in surgical instruments with excessive diameters that cannot be adapted to a series of minimally invasive scenarios; moreover, the traditional fiber coating will hydrolyze under high-temperature sterilization, and the penetration of acid and alkali body fluids will trigger catalytic corrosion of the fiber, leading to a decrease in the mechanical strength of the fiber. A significant feature is that its fracture stress after being subjected to high temperature is <0.5GPa, which also brings about the problem of poor material compatibility. Summary of the Invention

[0006] This application provides a heterogeneous coaxial optical cable for minimally invasive surgery to solve the problem in related technologies where the coating of traditional optical fibers hydrolyzes under high-temperature sterilization, leading to a decrease in the mechanical strength of the optical fiber.

[0007] This application provides a heterogeneous coaxial optical cable for minimally invasive surgery, which includes a sheath and a core. The sheath includes a first outer sheath, and the core is located inside the first outer sheath. The core includes a laser transmission optical fiber and at least one functional element, which is an imaging optical fiber or a shape memory metal support rod. The coating material for the laser transmission fiber and the imaging fiber is polyacrylic resin, silicone resin or polyimide.

[0008] In one embodiment, the functional element is provided with at least two, at least one of which is an imaging fiber, and at least the other of which is a memory metal support rod, wherein the laser transmission fiber and the imaging fiber are spirally and equidistantly wrapped around the memory metal support rod.

[0009] In one embodiment, the diameter of the shape memory metal support rod is 0.5–1.5 mm; And / or, the shape memory metal support rod is made of nickel-titanium alloy; And / or, the spacing of the helical equiaxial pitch is 120mm to 300mm.

[0010] In one embodiment, the laser transmission fiber is a hollow anti-resonant fiber with a diameter ≤0.6mm. Alternatively, the laser transmission fiber may be a large-core silica fiber with a core diameter of 100–400 μm and a numerical aperture of 0.22–0.25.

[0011] In one embodiment, the hollow anti-resonant optical fiber is a hollow optical fiber composed of a single hole or nested holes, and the core diameter is 100-300μm. And / or, the hollow-core antiresonant optical fiber is made of quartz, with a transmission loss ≤0.5dB / m in the mid-infrared band of 2–6μm; or, the hollow-core antiresonant optical fiber is made of glass doped with As2S3 and As2Se3, glass doped with GeSe2, Sb2Se3, Se and Ga2Se3, or glass doped with ZrF4, BaF2, LaF3, AlF3 and NaF, with a transmission loss ≤2dB / m in the 10.6μm infrared band.

[0012] In one embodiment, when the coating material is polyimide, the coating is formed by repeated coating method, the coating thickness is 10-15 μm, the optical fiber breaking stress is ≥500 MPa after sterilization at 120℃, and the tensile strength of the optical cable is ≥30 MPa after immersion in body fluid environment with pH=1-12 for 30 days. And / or, the imaging fiber is a large-core diameter silica fiber with a core diameter of 50 to 500 μm, the diameter of the large-core diameter silica fiber is ≤1.0 mm, and one end face of the large-core diameter silica fiber is hemispherical; or, the imaging fiber is a fiber bundle composed of more than 10,000 multi-component glass fibers with a core diameter of 0.1 to 0.2 μm, the diameter of the fiber bundle is ≤2.0 mm, the numerical aperture is ≥0.5, and the end face of the fiber bundle is processed into a microlens array; And / or, the diameter of the first outer sheath is 1.5mm to 5.0mm, the wall thickness is 0.15 to 0.5mm, the continuous operating temperature is ≥150℃, and the tensile strength is ≥30MPa; And / or, the diameter of the cable core is 1.5mm to 4.0mm; And / or, an end-face sealing filler is provided between the ends of the sheath and the cable core; And / or, the sheath is made of ethylene-tetrafluoroethylene copolymer (ETFE) or polyetheretherketone (PEEK).

[0013] In one embodiment, the sheath further includes a second outer sheath, the first outer sheath being located inside the second outer sheath, and a support element is provided between the first outer sheath and the second outer sheath to form a coolant flow channel between the first outer sheath and the second outer sheath; An end-face sealing filler is provided between the ends of the first outer sheath and the second outer sheath; The second outer sheath is provided with a coolant inlet and a coolant outlet that communicate with the coolant flow channel.

[0014] In one embodiment, the material of the support element is ethylene-tetrafluoroethylene copolymer (ETFE), polyetheretherketone (PEEK), or polyimide. And / or, the coolant used is physiological saline; And / or, the end face sealing filler is made of laser welding material, silicone sealant, antibacterial silicone, or epoxy resin.

[0015] In one embodiment, a laser encapsulation cap is provided at one end of the laser transmission fiber. The laser encapsulation cap is made of sapphire, yttrium aluminum garnet, yttrium oxide, or single-crystal silicon. The exit end face of the laser encapsulation cap is a microlens that matches the numerical aperture of the laser transmission fiber. And / or, the end of the memory metal support rod is provided with a protective cap; And / or, the end of the cable core is provided with an integral encapsulation end cap, and an end face sealing filler is provided between the integral encapsulation end cap and the sheath.

[0016] In one embodiment, the emission end face of the laser packaging cap is coated with a film, and the material of the coating is diamond, sapphire, yttrium aluminum garnet, yttrium oxide or single crystal silicon.

[0017] The beneficial effects of the technical solution provided in this application include: The heterogeneous coaxial minimally invasive surgical optical cable provided in this application embodiment has a laser transmission optical fiber disposed inside the first outer sheath to provide mid-infrared laser. A biocompatible coating is coated on the surface of the optical fiber, and the material can be polyacrylic resin, silicone resin and polyimide. This can solve the problems that existing optical fiber coatings are prone to hydrolysis and embrittlement after sterilization, and that acid and alkali body fluid penetration will cause catalytic corrosion of the optical fiber, resulting in the attenuation of the optical fiber's mechanical strength. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0019] Figure 1 A schematic diagram of an embodiment of the heterogeneous coaxial optical cable for minimally invasive surgery provided in this application (single outer sheath, including laser transmission fiber, large core diameter imaging fiber and memory metal support rod); Figure 2 A schematic diagram of an embodiment of the heterogeneous coaxial optical cable for minimally invasive surgery provided in this application (single-layer outer sheath, including laser transmission fiber, fiber bundle type imaging fiber and memory metal support rod). Figure 3 A schematic diagram of an embodiment of the heterogeneous coaxial minimally invasive surgical optical cable provided in this application (single-layer outer sheath, including laser transmission fiber and imaging fiber). Figure 4 A schematic diagram of an embodiment of the heterogeneous coaxial optical cable for minimally invasive surgery provided in this application (single outer sheath, including laser transmission optical fiber and memory metal support rod). Figure 5 A schematic diagram of an embodiment of the heterogeneous coaxial optical cable for minimally invasive surgery provided in this application (double outer sheath, including laser transmission fiber, large-core imaging fiber and memory metal support rod); Figure 6 A schematic diagram of an embodiment of the heterogeneous coaxial minimally invasive surgical optical cable provided in this application (double outer sheath, including laser transmission fiber, fiber bundle type imaging fiber and memory metal support rod). Figure 7 A schematic diagram of the output end face and coolant flow channel of the heterogeneous coaxial optical cable for minimally invasive surgery provided in this application; Figure 8 This is a schematic diagram of the output end face of the heterogeneous coaxial optical cable for minimally invasive surgery provided in this application.

[0020] In the figure: 1. First outer sheath; 2. Laser transmission fiber; 20. Laser packaging end cap; 21. Overall packaging end cap; 3. Imaging fiber; 30. Microlens array; 4. Memory metal support rod; 40. Protective cap; 5. Second outer sheath; 50. Support element; 51. Coolant flow channel; 52. Coolant inlet; 53. Coolant outlet; 54. End face sealing filler. Detailed Implementation

[0021] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0022] See Figure 1 , Figure 2 , Figure 3 , Figure 4 , Figure 5 and Figure 6 As shown, this application embodiment provides a heterogeneous coaxial optical cable for minimally invasive surgery, which includes a sheath and a core. The sheath includes a first outer sheath 1, and the core is located inside the first outer sheath 1. The core includes a laser transmission fiber 2 and at least one functional element, which is an imaging fiber 3 or a shape memory metal support rod 4. The coating material of the laser transmission fiber 2 and the imaging fiber 3 is polyacrylic resin, silicone resin or polyimide.

[0023] The heterogeneous coaxial optical cable for minimally invasive surgery provided in this embodiment has a laser transmission optical fiber disposed inside the first outer sheath to provide mid-infrared laser. A biocompatible coating is coated on the surface of the optical fiber. The material can be polyacrylic resin, silicone resin, or polyimide. This can solve the problems that existing optical fiber coatings are prone to hydrolysis and embrittlement after sterilization, and that acid and alkali body fluid penetration can cause catalytic corrosion of the optical fiber, leading to a decrease in the mechanical strength of the optical fiber.

[0024] Furthermore, when the coating material is polyimide, the coating can be formed by repeated coating. For example, after 3 to 5 coatings, the coating thickness is 10 to 15 μm. After sterilization at 120°C and high pressure, the optical fiber fracture stress is ≥500 MPa, and the tensile strength of the optical cable is ≥30 MPa after immersion in a body fluid environment with pH=1 to 12 for 30 days.

[0025] Furthermore, the aforementioned functional components can be selected as imaging fiber 3 or shape memory metal support rod 4 according to actual needs.

[0026] For example, see Figure 3As shown, when a small optical cable of approximately 2mm is needed to enter the human body, the memory metal support rod 4 can be removed. In this case, the first outer sheath 1 contains a laser transmission fiber 2 and an imaging fiber 3. The laser transmission fiber 2 and the imaging fiber 3 can be spirally wound around each other at equal axial distances, or one can be used as the central element, with the other spirally wound around the central element at equal axial distances. Alternatively, the imaging fiber 3 can be removed. See [link to documentation]. Figure 4 As shown, the first outer sheath 1 is provided with a laser transmission fiber 2 and a memory metal support rod 4. The laser transmission fiber 2 and the memory metal support rod 4 can be spirally and equidistantly wrapped around each other, or one of them can be the central member and the other spirally and equidistantly wrapped around the central member.

[0027] Furthermore, in order to achieve simultaneous laser transmission and image transmission, the functional element is provided with at least two, at least one of which is an imaging fiber 3, and at least the other of which is a memory metal support rod 4. Both the laser transmission fiber 2 and the imaging fiber 3 are spirally and equidistantly wrapped around the memory metal support rod 4.

[0028] By using shape memory metal as a reinforcement component for optical cables, the problem of rigid shuttle passage of small-diameter optical cables through biological tissues such as blood vessels is solved, thereby forming a multi-modal coexisting optical cable with multifunctional integration and miniaturized synergy.

[0029] The heterogeneous core layer space optimization structure adopts a coaxial nested design of "imaging core-laser core-support rod". The outer diameter of the optical cable can be controlled to ≤5.0mm, and the typical value can be optimized to ≤3.0mm. A support rod with shape memory metal as the core is set in the center. The laser transmission fiber and imaging fiber are wrapped around it at a certain axial distance. The shape memory metal support rod achieves dynamic stiffness switching through rear torque feedback.

[0030] Furthermore, the diameter of the shape memory metal support rod 4 is 0.5 to 1.5 mm; the shape memory metal support rod 4 is made of nickel-titanium alloy or the like; the spacing of the helical equilateral pitch is 120 mm to 300 mm.

[0031] After being helically twisted at equal axial pitch, the diameter of the cable core is 1.5mm to 4.0mm.

[0032] Furthermore, such as Figure 1As shown, the laser transmission fiber 2 preferably uses hollow-core anti-resonant fiber, which can solve the problem of flexible transmission of high-energy lasers. The hollow-core anti-resonant fiber is composed of single-hole or nested-hole hollow fibers, with the number of holes being 7, 8, 9, 10, etc., and the core diameter is 100-300 μm. The diameter of the hollow-core anti-resonant fiber is ≤0.6 mm. The material of the hollow-core anti-resonant fiber can be selected as quartz, with a transmission loss ≤0.5 dB / m in the mid-infrared band of 2-6 μm. Alternatively, the material of the hollow-core anti-resonant fiber can be glass doped with As2S3 and As2Se3, glass doped with GeSe2, Sb2Se3, Se and Ga2Se3, or glass doped with ZrF4, BaF2, LaF3, AlF3 and NaF, with a transmission loss ≤2 dB / m in the 10.6 μm infrared band.

[0033] When transmitting 1μm and 2μm band lasers, the laser transmission fiber 2 can also be a large-core diameter quartz fiber, with a core diameter of 100-400μm and a numerical aperture of 0.22-0.25.

[0034] Furthermore, for narrow channels, the imaging fiber 3 can be a large-core diameter quartz fiber with a core diameter of 50-500μm, integrating multi-mode resolution to improve imaging quality. The diameter of the large-core diameter quartz fiber is ≤1.0mm, and the end face of the large-core diameter quartz fiber on the side entering the biological tissue is hemispherical, thereby better absorbing light.

[0035] For high-precision imaging, when the biological tissue can accommodate a space of 3-5 mm or more, the imaging fiber 3 can be a fiber bundle composed of over 10,000 multi-component glass fibers with a core diameter of 0.1-0.2 μm. The fiber bundle diameter is ≤2.0 mm, and the numerical aperture is ≥0.5. (See [reference needed]). Figure 7 and Figure 8 As shown, the end face of the optical fiber bundle is processed into a microlens array 30, and the overall end face diameter is ≤2.0mm.

[0036] Furthermore, the diameter of the first outer sheath 1 is 1.5mm to 5.0mm, which can just cover the laser encapsulation end cap 20, the wall thickness is 0.15 to 0.5mm, the continuous operating temperature is ≥150℃, and the tensile strength is ≥30MPa; Furthermore, an end-face sealing filler 54 is provided between the ends of the sheath and the cable core to achieve filling and sealing between the end faces.

[0037] Furthermore, in certain specific scenarios, laser surgery requires prolonged procedures. In such cases, the laser energy transmitted via fiber optic cable may cause a local temperature rise exceeding 10°C in the laser transmission fiber 2. This could lead to thermal creep of the fiber optic cable sheath, causing axial misalignment and resulting in optical path misalignment, thus affecting the success rate of laser ablation and other surgical procedures. It could also adversely affect the tissues in contact with the fiber. To address these issues, see [link to relevant documentation]. Figure 5 , Figure 6 As shown in Figure 7, the sheath also includes a second outer sheath 5, the first outer sheath 1 is located inside the second outer sheath 5, a support element 50 is provided between the first outer sheath 1 and the second outer sheath 5 to form a coolant flow channel 51 between the first outer sheath 1 and the second outer sheath 5; an end face sealing filler 54 is provided between the ends of the first outer sheath 1 and the second outer sheath 5; the second outer sheath 5 is provided with a coolant inlet 52 and a coolant outlet 53 communicating with the coolant flow channel 51.

[0038] Physiological saline is circulated in the coolant channel 51 between the sheaths to improve thermal conductivity. The flow rate is controlled at 0.1-0.3 mL / min to keep the local temperature rise caused by laser transmission below 2℃.

[0039] It is evident that by setting up a double-layer outer sheath, under the premise of controlling the local temperature rise of the optical cable to ≤10℃, the continuity and clarity of real-time imaging can be guaranteed, the imaging signal interference caused by temperature rise can be avoided, and the biological damage caused by heat conduction to the contact tissue can be prevented, thus realizing the coordinated operation of "laser treatment - real-time imaging - thermal protection".

[0040] The first outer sheath 1 and the second outer sheath 5 are made of medical-grade ethylene-tetrafluoroethylene copolymer ETFE or polyether ether ketone (PEEK).

[0041] The material of the support element 50 is ethylene-tetrafluoroethylene copolymer (ETFE), polyetheretherketone (PEEK), or polyimide.

[0042] The end face sealing filler 54 is made of laser welding material, silicone sealant, antibacterial silicone or epoxy resin.

[0043] See Figure 4As shown, one end of the laser transmission fiber 2 is provided with a laser encapsulation cap 20. The laser encapsulation cap 20 is made of sapphire, yttrium aluminum garnet, yttrium oxide, or single-crystal silicon. The exit end face of the laser encapsulation cap 20 is a microlens that matches the numerical aperture of the laser transmission fiber 2. The end face can be coated when necessary. Specifically, the exit end face of the laser encapsulation cap 20 is coated with a material such as diamond, sapphire, yttrium aluminum garnet, yttrium oxide, or single-crystal silicon. After coating with materials such as sapphire, yttrium aluminum garnet, yttrium oxide, or single-crystal silicon, the transmittance of mid-infrared light at 2-5 μm is ≥95%, and at 5-6 μm it is ≥60%. After coating with materials such as diamond, the transmittance at 10.6 μm is ≥70%. When transmitting 1-2 μm laser light, quartz material can be directly used for end face treatment.

[0044] See Figure 4 As shown, a protective cap 40 is provided at the end of the memory metal support rod 4.

[0045] See Figure 7 As shown, the end of the cable core is provided with an integral encapsulation end cap 21, and an end face sealing filler 54 is provided between the integral encapsulation end cap 21 and the sheath.

[0046] The laser encapsulation cap that enters the biological tissue is integrally encapsulated with the end face of the imaging fiber, and sealed with the sheath through the end face sealing filler, which can prevent the biological tissue fluid from corroding the optical fiber cable.

[0047] Current minimally invasive surgery places three demands on fiber optic systems: the ability to integrate "optical imaging + high-energy laser transmission" within an outer diameter range of 3.0–5.0 mm or even smaller; the ability to achieve extreme miniaturization with a certain degree of stiffness and other multimodal functions under flexible bending conditions, making them suitable for ultra-precise surgical scenarios such as skull base tumors and cardiovascular diseases; and in terms of biocompatibility and durability, the ability to maintain transmission stability after multiple bending cycles in body fluid environments with pH=1–12.

[0048] To address the aforementioned needs, in some embodiments of this application, a laser transmission fiber 2 and an imaging fiber 3 are arranged within the outer sheath to achieve the integrated purpose of "optical imaging + high-energy laser transmission". Furthermore, a shape memory metal support rod 4 is provided as a reinforcing member, enabling extreme miniaturization of multi-modal functions such as a certain stiffness shuttle under flexible bending conditions. Further, the laser transmission fiber 2 preferably uses large-core silica fiber or hollow anti-resonant fiber, with its diameter controlled to ≤0.6mm; the imaging fiber 3 preferably uses a fiber bundle composed of large-core silica fiber or multi-component glass fiber, with its diameter controlled to ≤2.0mm; the diameter of the shape memory metal support rod 4 is controlled to be 0.5~1.5mm, resulting in a cable core diameter of 1.5mm~4.0mm; and by adjusting the outer sheath wall thickness to 0.15~0.5mm, the outer diameter of the optical cable is kept within the range of 3.0~5.0mm or even lower. Furthermore, the use of polyacrylic acid resin, silicone resin, or polyimide for the optical fiber coating can solve the problems of existing optical fiber coatings being prone to hydrolytic embrittlement after sterilization, and the catalytic corrosion of the optical fiber caused by the penetration of acid and alkali fluids, leading to the attenuation of the optical fiber's mechanical strength.

[0049] Therefore, this application solves the physical space conflict faced when simultaneously integrating multiple functional modes such as "imaging fiber + high-energy mid-infrared wavelength laser transmission channel + flexible bending structure" in small-diameter optical cables of 1.0mm to 5.0mm. In particular, it is necessary to achieve low-loss flexible transmission of high-energy mid-infrared laser to avoid the problems of energy attenuation or structural limitation during transmission. The implementation methods of this application will be described below using specific scenarios: Implementation Scenario 1: Optical Cable for Minimally Invasive Neurointervention For surgical procedures involving laser ablation of cerebral vascular malformations with a surgical channel diameter ≤2.8mm, the following approach is adopted: Figure 3 The heterogeneous coaxial optical cable for minimally invasive surgery shown uses one laser transmission fiber and one imaging fiber.

[0050] The imaging fiber is a large-core quartz fiber with a core diameter of 50–400 μm, and the laser transmission fiber is a hollow fiber with a core diameter of 100–200 μm. The two fibers are twisted together or arranged in parallel with an equiaxial spacing of 180 mm. The laser transmission fiber can be an anti-resonant hollow fiber composed of 7–10 single holes or nested holes. After coating, the diameter of both fibers is controlled to be less than 0.5 mm. The end face sealing filler is made of materials such as silicone, antibacterial silicone, or epoxy resin, forming a cable core diameter of 1.1–1.2 mm. The diameter of the first outer sheath covering the cable core can be 1.5–2.0 mm. The end face of the cable core and the first outer sheath is sealed and filled with materials such as epoxy resin.

[0051] The laser transmission fiber has a loss of less than 0.5dB / m in the mid-infrared band of 2-6μm; it is coated with polyacrylic resin or silicone resin, and uses sapphire, yttrium aluminum garnet, yttrium oxide single crystal silicon and other materials with antireflective coating as end caps. The length is: sapphire, yttrium aluminum garnet ≤1mm, yttrium oxide ≤3mm, single crystal silicon ≤10mm, loss ≤2dB, and can transmit an average power of more than 1W. The seams are coated with medical silicone sealant.

[0052] The imaging fiber is processed with a microlens array with a curvature radius of 200μm at its end face using a femtosecond laser.

[0053] Both the imaging fiber and the laser transmission fiber use polyacrylic resin, silicone resin or polyimide as coatings. When polyimide coating is used, it is applied in 4 layers with a total thickness of 12μm.

[0054] The first outer sheath is made of medical-grade ETFE or PEEK material with a wall thickness of 0.2mm to 0.5mm. It can withstand sterilization at 120℃ and can pass through a curved simulated channel without getting stuck.

[0055] Implementation Scenario 2: Optical cable for skull base tumor treatment (focusing on high-precision imaging and hermetically sealed packaging) For minimally invasive ablation of skull base meningiomas, the surgical access space is ≤4mm, the cerebrospinal fluid pH is 7.3~7.5, real-time imaging guidance is required, and the outer diameter of the optical cable is ≤3.5mm.

[0056] Select a nickel-titanium shape memory metal support rod with a diameter of 0.5–0.7 mm, a torque feedback adjustment range of 0.8–3.0 N·m, a bending stiffness of 15–35 N / m, and a response time of 80 ms; spirally encircle the support rod with a equiaxial spacing of 120–300 mm, with one laser transmission fiber and one fiber bundle as the imaging fiber. The diameter of the laser transmission fiber is ≤0.6 mm, the diameter of the fiber bundle is ≤1.5 mm, and they are filled with antibacterial silicone. The resulting cable core diameter is ≤2.5 mm.

[0057] The imaging fiber consists of 12,000 multi-component glass fibers with a single core diameter of 0.10 μm and a numerical aperture of 0.55. The end face of the fiber that receives the light is treated as a microlens array with a curvature radius of 200 μm and an end face diameter of 1.2 mm, achieving a fluorescence signal acquisition efficiency of ≥90% and enabling the identification of tumor fluorescent markers.

[0058] The laser transmission fiber uses 8-, 9-, or 10-hole hollow-core antiresonant fiber with a core inner diameter of 150–200 μm and a loss ≤0.3 dB / m in the 3–6 μm band. The end caps on the output face are made of materials such as sapphire, yttrium aluminum garnet, yttrium oxide, or single-crystal silicon coated with antireflective coatings. In terms of axial length, sapphire and yttrium aluminum garnet are ≤1 mm, yttrium oxide ≤3 mm, and single-crystal silicon ≤10 mm, with a loss ≤2 dB and an end face diameter of approximately 0.5 mm. These end caps are fused and sealed to the hollow-core fiber at high temperature. Both the imaging fiber and the laser transmission fiber use polyacrylic acid resin, silicone resin, or polyimide as coatings.

[0059] The sheath is made of medical-grade ETFE or PEEK material. The thickness of the first and second outer sheaths is 0.15mm, forming two coolant channels with an inner diameter of 0.2mm. The physiological saline flow rate can withstand 0.2mL / min. The supporting element material directly supporting the coolant channels is PEEK or polyimide, etc. The overall outer diameter of the optical cable is controlled to be ≤3.5mm. After sterilization at 120℃, the breaking stress is greater than or equal to 500MPa. The optical cable remains intact after being soaked in a solution with pH=1~12 for 30 days.

[0060] Implementation Scenario 3: Optical cable for atherosclerotic plaque removal For scenarios involving carotid artery atherosclerotic plaque laser ablation in vessels with an inner diameter of approximately 5mm, continuous operation for about 10-20 minutes is required, with a temperature rise ≤1.8℃ and an optical cable outer diameter ≤5.0mm. A nickel-titanium shape memory metal support rod with a diameter of 0.6-1.0mm is selected. A laser transmission fiber and an imaging fiber bundle are spirally wound around the support rod at an equal axis spacing of 200-300mm. The diameter of the laser transmission fiber is ≤0.6mm, and the diameter of the fiber bundle is ≤1.5mm. Antibacterial silicone is used to fill the bundle, resulting in a cable core diameter ≤2.5mm.

[0061] The imaging fiber consists of 10,000 to 15,000 multi-component glass fibers with a single core diameter of 0.10 μm and a numerical aperture of 0.55. The end face of the fiber that receives the light is treated as a microlens array with an end face diameter of 1.2 to 1.5 mm.

[0062] The laser transmission fiber uses a hollow-core anti-resonant fiber composed of nested holes of 8, 9, or 10 holes, with a core inner diameter of 150–200 μm and a loss ≤0.5 dB / m in the 3–6 μm band. The end cap of the output end face is made of materials such as sapphire, yttrium aluminum garnet, yttrium oxide, or single-crystal silicon with anti-reflection coatings. The axial length of the end cap is ≤10 mm, the loss is ≤2 dB, and the end face diameter is approximately 0.5 mm. It is fused and sealed with the hollow-core fiber at high temperature. Both the imaging fiber and the laser transmission fiber use polyacrylic acid resin, silicone resin, or polyimide as coatings.

[0063] The sheaths are made of medical-grade ETFE or PEEK material. Both the first and second outer sheaths are 0.25mm thick, forming two 0.4mm inner diameter coolant channels. The flow rate of physiological saline can withstand 0.3mL / min. The supporting elements directly supporting the coolant channels are made of PEEK or polyimide, etc. The overall outer diameter of the optical cable is controlled to ≤4.8mm. After sterilization at 120℃, the fiber optic fracture stress is greater than or equal to 500MPa. The optical cable remains intact after immersion in a solution with pH=1~12 for 30 days. The lipid plaque ablation efficiency is ≥92%, with no damage to the blood vessel wall; the contrast between the plaque and the normal blood vessel wall is ≥35:1.

[0064] Implementation Scenario 4: Optical Cable for Coronary Artery Blockage Intervention For scenarios involving laser recanalization of acute coronary artery occlusion with an inner diameter of 3.0–4 mm, requiring a small bending radius of the optical cable, resistance to blood flow erosion, and an outer diameter of ≤2.5 mm, a 0.6 mm diameter shape memory metal support rod is selected. A laser transmission fiber and an imaging fiber are spirally wound around the support rod at an equal axis spacing of 200–300 mm. The diameter of the laser transmission fiber is ≤0.5 mm, and the diameter of the imaging fiber is ≤1.0 mm. Antibacterial silicone is filled in, resulting in a cable core diameter of ≤1.5 mm.

[0065] The imaging fiber is a large-core silica fiber with a core diameter of 50-500 μm, a numerical aperture of 0.22-0.25, a fiber diameter ≤1.0 mm, and an end face diameter of 0.8 mm.

[0066] The laser transmission fiber uses a hollow antiresonant fiber composed of 8 or 9 nested holes, with a core inner diameter of 150–200 μm and a loss ≤0.4 dB / m in the 3–6 μm band. The end cap of the output end face is made of materials such as sapphire, yttrium aluminum garnet, or yttrium oxide coated with an antireflection coating. The end cap has an axial length ≤3 mm, a loss ≤2 dB, and an end face diameter of approximately 0.5 mm, and is fused and sealed with the hollow fiber at high temperature. Both the imaging fiber and the laser transmission fiber use polyacrylic acid resin, silicone resin, or polyimide as coatings.

[0067] The sheath is made of medical-grade ETFE or PEEK material, with only the first outer sheath retained. The thickness is 0.3mm. The end caps of the optical cable and the two optical fibers are sealed with epoxy resin. The overall outer diameter of the optical cable is controlled to ≤2.5mm. After sterilization at 120℃, the optical fiber breaking stress is greater than or equal to 500MPa. After immersion in a solution with pH=1~12 for 30 days, the optical cable remains intact. The tensile strength of the optical cable is ≥30MPa. The recanalization rate within 30 minutes of occluded blood vessels is 100%, with no thermal damage.

[0068] Implementation Scenario 5: Optical cable for pancreatic tumor ablation For endoscopic ablation of pancreatic ductal adenocarcinoma, which requires handling pancreatic enzymes at pH 7.8–8.2, continuous operation for over 1 hour, and fiber optic cable outer diameter ≤ 5.0 mm, a 1.0 mm diameter nickel-titanium shape memory metal support rod is selected. A laser transmission fiber and an imaging fiber are spirally wound around the support rod at an equal axis spacing of 120–250 mm. The diameter of the laser transmission fiber is ≤ 0.6 mm, and the diameter of the imaging fiber bundle is ≤ 2.0 mm. The fiber bundle is filled with antibacterial silicone, resulting in a cable core diameter ≤ 3.0 mm.

[0069] The imaging fiber consists of 10,000 to 15,000 multi-component glass fibers with a single core diameter of 0.10 μm to 0.15 μm and a numerical aperture of 0.6. The end face of the fiber that receives the light is treated as a microlens array with an end face diameter of 1.5 to 2.0 mm.

[0070] The laser transmission fiber uses a hollow-core antiresonant fiber composed of 8 or 10 nested holes, with a core inner diameter of 150–200 μm and a loss ≤0.45 dB / m in the 5–6 μm band. The end cap of the output end face is made of materials such as sapphire, yttrium aluminum garnet, or yttrium oxide coated with an antireflection coating. The end cap has an axial length ≤3 mm, a loss ≤2 dB, and an end face diameter of approximately 0.6 mm, and is fused and sealed with the hollow-core fiber at high temperature. Both the imaging fiber and the laser transmission fiber use polyacrylic acid resin, silicone resin, or polyimide as coatings.

[0071] The sheaths are made of medical-grade ETFE or PEEK material. Both the first and second outer sheaths are 0.3mm thick, forming two 0.3mm inner diameter coolant channels. The flow rate of physiological saline can withstand 0.15–0.3 mL / min. The supporting elements directly supporting the coolant channels are made of PEEK or polyimide. The end caps of the optical cable and the two optical fibers are sealed with epoxy resin. The overall outer diameter of the optical cable is controlled to ≤4.8mm. After sterilization at 120℃, the fiber optic fracture stress is greater than or equal to 500MPa. The optical cable remains intact after immersion in a solution with pH=1–12 for 30 days. The tensile strength of the optical cable is ≥30MPa. Transmitting 1W of 6μm laser light for 1.0h results in a temperature rise of less than or equal to 2.0℃.

[0072] Implementation Scenario 6: Fiber Optic Cable for Bile Duct Polyp Removal For scenarios involving laser resection of intrahepatic bile duct polyps with bile pH of 6.0–8.5, an operating space of ≤5mm, and a fiber optic cable outer diameter of ≤5.0mm, a 0.5mm diameter nickel-titanium shape memory metal support rod is selected. A laser transmission fiber and an imaging fiber are spirally wound around the support rod at an equal axis spacing of 120–250mm. The diameter of the laser transmission fiber is ≤0.6mm, and the diameter of the imaging fiber is ≤2.0mm. The fiber is filled with antibacterial silicone, resulting in a cable core diameter of ≤2.8mm.

[0073] The imaging fiber consists of 10,000 multi-component glass fibers with a single core diameter of 0.2 μm and a numerical aperture of 0.6. The end face of the fiber that receives the light is treated as a microlens array with an end face diameter of 2.0 mm.

[0074] The laser transmission fiber uses hollow-core anti-resonant silica fiber composed of 8 nested holes, with a core inner diameter of 150–200 μm and a loss ≤0.5 dB / m in the 5–6 μm band. Alternatively, hollow-core fiber with 9–10 holes and a core inner diameter of 300 μm can be selected, with a loss ≤2.0 dB / m in the 10.6 μm band (material selected from As2S3 and As2Se3 doped glass, GeSe2, Sb2Se3, Se and Ga2Se3 doped glass, or ZrF4, BaF2, LaF3, AlF3 and NaF doped glass). The end cap of the hollow-core fiber at the output end face is made of materials such as sapphire, yttrium aluminum garnet, yttrium oxide, and diamond coated with an antireflection coating. With an end cap axial length ≤3mm, loss ≤2dB, and an end face diameter of approximately 0.6mm, it is fused and sealed with the hollow fiber at high temperature; both the imaging fiber and the laser transmission fiber use polyacrylic resin, silicone resin, or polyimide as coatings.

[0075] The sheaths are made of medical-grade ETFE or PEEK material. Both the first and second outer sheaths are 0.2mm thick, forming two 0.5mm inner diameter coolant channels. The flow rate of physiological saline can withstand 0.15–0.3 mL / min. The supporting elements directly supporting the coolant channels are made of PEEK or polyimide. The end caps of the optical cable and the two optical fibers are sealed with epoxy resin. The overall outer diameter of the optical cable is controlled to ≤4.8mm. After sterilization at 120℃, the optical fiber breaking stress is greater than or equal to 500MPa. The optical cable remains intact after immersion in a solution with pH=1–12 for 30 days. The tensile strength of the optical cable is ≥30MPa. This achieves a polyp removal boundary error of ≤0.5mm and eliminates bile duct perforation.

[0076] Implementation Scenario 7: Optical Cable for Dental Treatment For scenarios involving laser preparation of dental tissue within the root canal, such as oral environments with a pH of 5.5–8.0 and high bacterial counts, and optical cable outer diameters of ≤5.0mm, a 1.5mm diameter nickel-titanium shape memory metal support rod is selected. A laser transmission optical fiber with a diameter of ≤0.6mm is spirally wound around the support rod at an equal axial spacing of 200–300mm. The optical fiber is filled with antibacterial silicone, resulting in a cable core diameter of ≤2.2mm.

[0077] The laser transmission fiber uses a hollow-core anti-resonant silica fiber composed of 8 single holes, with a core inner diameter of 150–200 μm and a loss ≤0.1 dB / m in the 2–5 μm band. Alternatively, a large-core silica fiber with a core diameter of 100–400 μm and a numerical aperture of 0.22–0.25 can be selected, capable of transmitting laser light in the 1–2 μm band with a transmission loss ≤0.01 dB / m. The end cap at the output end of the laser transmission fiber is sealed with a material such as silica, with a length ≤2 mm and an end face diameter of approximately 0.6 mm, and is fused to the laser transmission fiber at high temperature. The laser transmission fiber uses polyacrylic resin, silicone resin, or polyimide as a coating.

[0078] The sheath is made of medical-grade ETFE or PEEK material, consisting of only a first outer sheath with a thickness of 0.5mm. The junction of the optical cable, fiber, and support rod is sealed with epoxy resin. The overall outer diameter of the optical cable is controlled to ≤4.8mm. After sterilization at 120℃, the fiber's breaking stress is greater than or equal to 500MPa. The optical cable remains intact after immersion in a solution with pH=1~12 for 30 days, and its tensile strength is ≥30MPa. It allows for 15 bending and shuttle maneuvers within the root canal without jamming; and there is no carbon deposit on the root canal wall.

[0079] In the description of this application, it should be noted that the terms "upper," "lower," etc., indicating the orientation or positional relationship are based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application. Unless otherwise expressly specified and limited, the terms "installed," "connected," and "linked" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication between two elements. For those skilled in the art, the specific meaning of the above terms in this application can be understood according to the specific circumstances.

[0080] It should be noted that in this application, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0081] The above description is merely a specific embodiment of this application, enabling those skilled in the art to understand or implement this application. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of this application. Therefore, this application is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features claimed herein.

Claims

1. A heterogeneous coaxial optical cable for minimally invasive surgery, characterized in that, It includes a sheath and a cable core. The sheath includes a first outer sheath (1). The cable core is located inside the first outer sheath (1). The cable core includes a laser transmission fiber (2) and at least one functional element, which is an imaging fiber (3) or a shape memory metal support rod (4). The coating material of the laser transmission fiber (2) and the imaging fiber (3) is polyacrylic resin, silicone resin or polyimide.

2. The heterogeneous coaxial optical cable for minimally invasive surgery as described in claim 1, characterized in that: The functional element is provided with at least two, at least one of which is an imaging fiber (3) and at least the other of which is a memory metal support rod (4). The laser transmission fiber (2) and the imaging fiber (3) are spirally and equidistantly wrapped around the memory metal support rod (4).

3. The heterogeneous coaxial optical cable for minimally invasive surgery as described in claim 2, characterized in that: The diameter of the memory metal support rod (4) is 0.5 to 1.5 mm; And / or, the shape memory metal support rod (4) is made of nickel-titanium alloy; And / or, the spacing of the helical equiaxial pitch is 120mm to 300mm.

4. The heterogeneous coaxial optical cable for minimally invasive surgery as described in claim 1, characterized in that: The laser transmission fiber (2) is a hollow anti-resonant fiber with a diameter ≤0.6mm. Alternatively, the laser transmission fiber (2) may be a large-core silica fiber with a core diameter of 100-400 μm and a numerical aperture of 0.22-0.

25.

5. The heterogeneous coaxial optical cable for minimally invasive surgery as described in claim 4, characterized in that: The hollow anti-resonant fiber is a hollow fiber composed of a single hole or nested holes, and the core diameter is 100-300μm. And / or, the hollow-core antiresonant optical fiber is made of quartz, with a transmission loss ≤0.5dB / m in the mid-infrared band of 2–6μm; or, the hollow-core antiresonant optical fiber is made of glass doped with As2S3 and As2Se3, glass doped with GeSe2, Sb2Se3, Se and Ga2Se3, or glass doped with ZrF4, BaF2, LaF3, AlF3 and NaF, with a transmission loss ≤2dB / m in the 10.6μm infrared band.

6. The heterogeneous coaxial optical cable for minimally invasive surgery as described in claim 1, characterized in that: When the coating material is polyimide, the coating is formed by repeated coating. The coating thickness is 10-15μm. After sterilization at 120℃, the optical fiber breaking stress is ≥500MPa. After immersion in body fluid environment with pH=1-12 for 30 days, the tensile strength of the optical cable is ≥30MPa. And / or, the imaging fiber (3) is a large-core diameter silica fiber with a core diameter of 50 to 500 μm, the diameter of the large-core diameter silica fiber is ≤1.0 mm, and one end face of the large-core diameter silica fiber is hemispherical; or, the imaging fiber (3) is a fiber bundle composed of more than 10,000 multi-component glass fibers with a core diameter of 0.1 to 0.2 μm, the diameter of the fiber bundle is ≤2.0 mm, the numerical aperture is ≥0.5, and the end face of the fiber bundle is processed into a microlens array (30). And / or, the diameter of the first outer sheath (1) is 1.5mm to 5.0mm, the wall thickness is 0.15 to 0.5mm, the continuous operating temperature is ≥150℃, and the tensile strength is ≥30MPa; And / or, the diameter of the cable core is 1.5mm to 4.0mm; And / or, an end face sealing filler (54) is provided between the ends of the sheath and the cable core. And / or, the sheath is made of ethylene-tetrafluoroethylene copolymer (ETFE) or polyetheretherketone (PEEK).

7. The heterogeneous coaxial optical cable for minimally invasive surgery as described in claim 1, characterized in that: The sheath also includes a second outer sheath (5), the first outer sheath (1) is located inside the second outer sheath (5), and a support element (50) is provided between the first outer sheath (1) and the second outer sheath (5) to form a coolant flow channel (51) between the first outer sheath (1) and the second outer sheath (5). An end face sealing filler (54) is provided between the ends of the first outer sheath (1) and the second outer sheath (5). The second outer sheath (5) is provided with a coolant inlet (52) and a coolant outlet (53) that are connected to the coolant flow channel (51).

8. The heterogeneous coaxial optical cable for minimally invasive surgery as described in claim 7, characterized in that: The material of the support element (50) is ethylene-tetrafluoroethylene copolymer (ETFE), polyetheretherketone (PEEK), or polyimide; And / or, the coolant used is physiological saline; And / or, the end face sealing filler (54) is made of laser welding material, silicone sealant, antibacterial silicone or epoxy resin.

9. The heterogeneous coaxial optical cable for minimally invasive surgery as described in claim 1, characterized in that: One end of the laser transmission fiber (2) is provided with a laser encapsulation cap (20). The laser encapsulation cap (20) is made of sapphire, yttrium aluminum garnet, yttrium oxide or single crystal silicon. The exit end face of the laser encapsulation cap (20) is a microlens that matches the numerical aperture of the laser transmission fiber (2). And / or, the end of the memory metal support rod (4) is provided with a protective cap (40). And / or, the end of the cable core is provided with an integral encapsulation end cap (21), and an end face sealing filler (54) is provided between the integral encapsulation end cap (21) and the sheath.

10. The heterogeneous coaxial optical cable for minimally invasive surgery as described in claim 9, characterized in that: The laser packaging cap (20) has a coating on its emission end face, and the coating material is diamond, sapphire, yttrium aluminum garnet, yttrium oxide or single crystal silicon.

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