An intracranial laser balloon dilation catheter

Abstract

The application discloses an intracranial laser balloon dilatation catheter, which comprises a tube body, a balloon body and a laser generating module. The tube body is provided with a fluid channel and an optical fiber channel. The balloon body is located at the outer periphery of the distal end of the tube body and is in communication with the fluid channel. The optical fiber is arranged in the optical fiber channel and has a light-emitting section extending to the position of the balloon body. The elastic member is arranged at the distal end of the inner tube. The diameter of the elastic member gradually increases from the distal end to the proximal end of the elastic member. The laser generating module is connected to the proximal end of the optical fiber. The laser generating module emits laser with a repairing function. The intracranial laser balloon dilatation catheter can avoid intravascular restenosis and ensure the safety and convenience of the operation.

Description

[0001] This application is a divisional application of the invention entitled "Intracranial Laser Balloon Dilation Catheter and its Operation Method" with an application date of "2023 / 11 / 15" and application number "202311525032.9". Technical Field

[0002] This application relates to the field of medical device technology, and in particular to an intracranial laser balloon dilation catheter. Background Technology

[0003] Intracranial balloon dilation catheters are used in interventional procedures by percutaneously inserting a balloon along the blood vessel to the site of intracranial vascular stenosis. After precise positioning, the balloon is dilated by controlled pressure to widen the narrowed intracranial vessel and restore blood flow. However, treating intracranial vascular stenosis with balloon dilation carries a high risk of restenosis. Furthermore, due to the narrowness of intracranial vessels, the required flow rate of the fluid within the balloon during inflation and deflation is also very high. Summary of the Invention

[0004] Based on this, an intracranial laser balloon dilation catheter and its operation method are provided, which can effectively avoid intravascular restenosis, and the flow rate is relatively slow when inflating the balloon and relatively fast when releasing the fluid in the balloon, thus taking into account both the safety and convenience of the operation.

[0005] An intracranial laser balloon dilation catheter, comprising:

[0006] The tube body has a distal end and a proximal end, and includes an inner tube and an outer tube nested together. The radial gap between the inner tube and the outer tube serves as both a fluid channel and an optical fiber channel. An elastic element, which is an exposed helical spring, is welded to the distal end of the inner tube. The tube body includes a distal tube body and a proximal tube body along the axial direction. There is a first radial gap between the inner tube and the outer tube of the distal tube body, and a second radial gap between the inner tube and the outer tube of the proximal tube body. The first radial gap is smaller than the second radial gap.

[0007] The balloon body is located on the outer periphery of the distal end of the tube and is in communication with the fluid channel;

[0008] An optical fiber is inserted through the optical fiber channel and has a light-emitting segment extending to the location of the balloon body;

[0009] The movable component is located within the radial gap between the inner tube and the outer tube, and there is a gap between the movable component and at least one of the inner tube or the outer tube that allows fluid to pass through. The movable component has a first position in the tube body axial direction, at least a portion of which is located in the first radial gap, and a second position in which it is entirely located in the second radial gap. The movable component is provided with a receiving groove to avoid optical fibers.

[0010] A control component is connected to the movable component via a traction wire, controlling the movable component to switch from a first position to a second position;

[0011] The laser generating module is connected to the near end of the optical fiber. The laser generating module emits a laser with a wavelength of 400~750nm that has a repair function.

[0012] Several alternative methods are provided below, but they are not intended as additional limitations on the overall solution above. They are merely further additions or optimizations. Provided there are no technical or logical contradictions, each alternative method can be combined individually with respect to the overall solution above, or multiple alternative methods can be combined with each other.

[0013] Optionally, the movable component is a tube, and the tube has a hollowed-out groove for adjusting the flexibility of the movable component at different axial positions.

[0014] Optionally, there are multiple hollowed-out grooves, extending from the far end to the near end of the movable part, and the hollowed-out grooves satisfy at least one of the following distribution rules:

[0015] a. The distribution of the hollowed-out grooves ranges from dense to sparse;

[0016] b. The area of ​​the hollowed-out region of each hollowed-out groove decreases from large to small.

[0017] Optionally, the hollowed-out groove is a single spiral line distributed around the pipe fitting, with the pitch of the spiral line gradually increasing from the far end to the near end of the movable part.

[0018] Optionally, the distal tube body includes a distal outer tube and a distal inner tube nested together, and the proximal tube body includes a proximal outer tube and a proximal inner tube nested together. The proximal inner tube and the distal inner tube have the same outer diameter, the inner diameter of the distal outer tube is smaller than the inner diameter of the proximal outer tube, and the hardness of the distal outer tube is smaller than the hardness of the proximal outer tube. The distal outer tube and the proximal outer tube are smoothly connected.

[0019] Optionally, the movable part is sleeved on the inner tube and tightly fitted with the outer wall of the inner tube.

[0020] Optionally, it also includes a catheter seat connected to the proximal end of the tube body, the catheter seat having a first interface communicating with the fluid channel, the control element being inserted into the first interface, and the traction wire extending through the first interface and connected to the control element.

[0021] Optionally, the diameter of the elastic element gradually increases from its distal end to its proximal end.

[0022] Optionally, the helical spring is made of a metal wire with a diameter of 0.03-0.1 mm wound in a spiral, and the pitch of the helical spring is equal to the diameter of the metal wire.

[0023] This application also provides a method for operating an intracranial laser balloon dilation catheter, including:

[0024] In the initial state, at least a portion of the moving part is located at a first position within the first radial clearance;

[0025] Inflate the balloon with fluid;

[0026] The laser generating module emits laser light with a wavelength of 400~750nm and applies it to the desired area through the light-emitting segment;

[0027] The control component uses a traction wire to pull the movable component to switch it to the second position, which is entirely located in the second radial gap.

[0028] Release the fluid inside the balloon.

[0029] The intracranial laser balloon dilation catheter and its operation method provided in this application have at least one of the following beneficial effects:

[0030] (1) Photorepair of damaged vascular tissue after balloon dilation can effectively prevent intravascular restenosis;

[0031] (2) An elastic element is set at the end of the tube body, which makes it more flexible and fits the guide wire better, avoiding the "fish mouth" phenomenon. The elastic element is made of metal wire and has imaging function, which makes it easy to identify the location of blood vessels and avoids causing blood vessel perforation.

[0032] (3) The distal and proximal ends of the tube are designed with varying hardness, and the flexible movement of the movable parts is combined to improve the pushability and tracking of the balloon dilation catheter.

[0033] (4) The flow rate is relatively slow when the balloon is inflated and relatively fast when the fluid in the balloon is released, which takes into account both the safety and convenience of the operation. Attached Figure Description

[0034] Figure 1 This is a schematic diagram of the intracranial laser balloon dilation catheter of this application;

[0035] Figure 2a This is a schematic diagram showing the movable element in the intracranial laser balloon dilation catheter of this application in the first position;

[0036] Figure 2b for Figure 2a Sectional view along line AA in the middle;

[0037] Figure 2c For active parts in Figure 2a The diagram shows the position of the control unit in the indicated state;

[0038] Figure 3a This application presents a schematic diagram showing the movable element in the second position of the intracranial laser balloon dilation catheter;

[0039] Figure 3b for Figure 3a BB-direction sectional view in the middle;

[0040] Figure 3c For active parts in Figure 3a The diagram shows the position of the control unit in the indicated state;

[0041] Figure 4a This is a schematic diagram of the first embodiment of the movable component;

[0042] Figure 4b This is a schematic diagram of the first embodiment of the movable component (from another perspective);

[0043] Figure 5a This is a schematic diagram of the second embodiment of the movable component;

[0044] Figure 5b This is a schematic diagram of a second embodiment of the movable component (from another perspective);

[0045] Figure 6a for Figure 1 Enlarged view of section C in the image;

[0046] Figure 6b This is a three-dimensional view of the elastic element.

[0047] In the diagram: Y refers to the distal end, and J refers to the proximal end. Figure 2a and Figure 3a for Figure 1 A schematic diagram of the area within the dashed box; Figure 2a , Figure 3a The arrow in the image indicates the direction of movement of the movable component as it switches from the first position to the second position; Figure 2c , Figure 3c The arrow in the image indicates the direction of movement of the control unit when switching from the first working position to the second working position;

[0048] 110. Balloon body; 120. Optical fiber; 130. Tube body; 131a. Distal outer tube; 131b. Proximal outer tube; 132a. Distal inner tube; 132b. Proximal inner tube; 140. Catheter seat; 141. First interface; 142. Second interface; 150. Movable component; 151. Hollowed-out groove; 152. Clearance groove; 153. Extension; 160. Control component; 170. Elastic component; 181. First radial gap; 182. Second radial gap; 190. Traction wire. Detailed Implementation

[0049] 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, and 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.

[0050] To better describe and illustrate the embodiments of this application, reference may be made to one or more accompanying drawings, but the additional details or examples used to describe the drawings should not be considered as limiting the scope of any of the inventive creations of this application, the embodiments or preferred methods described herein.

[0051] It should be noted that when a component is said to be "connected" to another component, it can be directly connected to the other component or it can be connected to a component in between. When a component is said to be "set on" another component, it can be directly set on the other component or it may be set to a component in between.

[0052] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0053] See Figure 1 , Figure 2a , Figure 3a As shown, an intracranial laser balloon dilation catheter includes:

[0054] The tube body 130 has a distal end and a proximal end. The tube body 130 includes an inner tube and an outer tube nested inside and outside. The radial gap between the inner tube and the outer tube serves as both a fluid channel and an optical fiber channel. The tube body 130 includes a distal tube body and a proximal tube body along the axial direction. There is a first radial gap 181 between the inner tube and the outer tube of the distal tube body, and there is a second radial gap 182 between the inner tube and the outer tube of the proximal tube body. The first radial gap 181 is smaller than the second radial gap 182.

[0055] The balloon body 110 is located on the outer periphery of the distal part of the tube body 130 and is in communication with the fluid channel;

[0056] Optical fiber 120 is inserted into the optical fiber channel and has a light-emitting segment extending to the location of the spherical body 110;

[0057] The movable part 150 is located within the radial gap between the inner tube and the outer tube, and there is a gap between the movable part 150 and at least one of the inner tube or the outer tube that allows fluid to pass through. The movable part 150 has a first position in the axial direction of the tube body 130, at least part of which is located in the first radial gap 181, and a second position in which it is entirely located in the second radial gap 182. The movable part 150 is provided with a receiving groove to avoid the optical fiber 120.

[0058] The control element 160 is connected to the movable element 150 via a traction wire 190, which controls the movable element 150 to switch from a first position to a second position.

[0059] The laser generating module is connected to the near end of the optical fiber 120. The laser generating module emits a laser with a wavelength of 400~750nm that has a repair function.

[0060] When using the intracranial laser balloon dilation catheter, fluid is first injected into the balloon body 110 through the fluid channel of the tube body 130 to inflate the balloon body 110. Then, a laser with a wavelength of 400~750nm is emitted through the laser generation module. The laser is emitted through the light-emitting segment of the optical fiber 120 and, after being scattered by the fluid inside the balloon body 110 and the balloon body 110, is applied to the site to be repaired. Under normal circumstances, continuous application of laser for a predetermined time can promote the repair of damaged blood vessels and effectively prevent restenosis.

[0061] The laser generating module provides low-power lasers that are pulsed or continuously output, which are transmitted to the inside of the balloon body 110 through the optical fiber 120. The light-emitting segment of the optical fiber 120 inside the balloon body 110 applies the low-intensity laser to the area to be repaired. The low-intensity laser has a photomodulation effect, which is generated by photochemical effects rather than thermal effects. It can promote the repair of cells and tissues, accelerate the clearance of inflammatory mediators and the absorption of tissue edema.

[0062] After balloon catheter dilation, damage to the vascular endothelium is common. By using the 120 light-emitting segment of the fiber optic cable to emit red light of a specific wavelength, which is then scattered by the 110 light-emitting segment of the balloon and applied to the damaged area of ​​the vascular endothelium, the vascular endothelial cell proliferation and anti-inflammatory apoptosis can be promoted, the blood vessel can be accelerated to return to a stable state, and postoperative restenosis can be prevented.

[0063] The laser generating module emits laser light with a wavelength of 400-750 nm. Within this wavelength range, the laser appears red and can promote the repair of cell nuclei and tissues, accelerate the clearance of inflammatory mediators, and reduce tissue edema. More preferably, the laser generating module emits laser light with a wavelength of 600-650 nm. For example, the laser generating module emits laser light with a wavelength of 638 nm.

[0064] The laser generating module outputs a laser power of 10~30mW. More preferably, the laser generating module outputs a laser power of 10~15mW.

[0065] The laser generating module outputs laser light of a predetermined wavelength in each working cycle in the following order:

[0066] Initial stage: Power 5-8mW / cm 2 Lasts 10-20 seconds;

[0067] Intermediate stage: Power 10-30mW / cm 2 Lasts 120-180 seconds;

[0068] Final stage: Power 5-8mW / cm 2 It lasts for 10-20 seconds.

[0069] Each working cycle corresponds to a complete cycle of the laser generating module's action on the blood vessel wall. In the initial stage, low-power, short-duration laser output allows the blood vessel to adapt to laser irradiation, preparing it for subsequent treatment. In the intermediate stage, increased power is used to heal torn blood vessels and prevent postoperative restenosis. In the final stage, low-power, short-duration laser output is used for postoperative buffering to reduce the burden on the blood vessel.

[0070] If the laser power output by the laser generator module is too low, the repair effect will be unsatisfactory; if the power is too high, it will cause excessive heat and lead to blood vessel burns. The optimal power for the intermediate stage is 10-15 mW / cm². 2 It lasts for 120-180 seconds.

[0071] See Figure 2a , Figure 3a As shown, the tube body 130 includes an inner tube and an outer tube nested together. Along the axial direction, the tube body 130 includes a distal tube body and a proximal tube body. The distal and proximal tube bodies are relative concepts; the tube closer to the distal end is the distal tube body, and the tube closer to the proximal end is the proximal tube body. The distal tube body includes an inner and outer tube 131a and an inner tube 132a nested together. A first radial gap 181 is formed between the outer tube 131a and the inner tube 132a, the size of which is the difference in radius between the outer tube 131a and the inner tube 132a. The proximal tube body includes an inner and outer tube 131b and an inner tube 132b nested together. A second radial gap 182 is formed between the outer tube 131b and the inner tube 132b, the size of which is the difference in radius between the outer tube 131b and the inner tube 132b.

[0072] The ratio of the axial length of the distal tube L1 to the proximal tube L2 is 1:3 to 1:5. The first radial clearance 181 is 0.1 to 0.3 mm, the second radial clearance 182 is 0.2 to 0.4 mm, and the movable part 150 is a tube with a wall thickness of 0.1 to 0.25 mm.

[0073] The difference between the first radial clearance 181 and the second radial clearance 182 can be achieved by changing the diameter of the outer tube, see [link to relevant documentation]. Figure 2a , Figure 3a As shown, the distal inner tube 132a and the proximal inner tube 132b have the same outer diameter, while the inner diameter of the distal outer tube 131a is smaller than that of the proximal outer tube 131b. The difference between the first radial clearance 181 and the second radial clearance 182 can also be achieved by changing the diameter of the inner tube. For example, the distal outer tube 131a and the proximal outer tube 131b have the same inner diameter, while the outer diameter of the distal inner tube 132a is larger than that of the proximal inner tube 132b. The difference between the first radial clearance 181 and the second radial clearance 182 can also be achieved by simultaneously changing the diameters of both the inner and outer tubes, which will not be elaborated further.

[0074] When the outer diameters of the distal inner tube 132a and the proximal inner tube 132b are the same, the movable member 150 is set against the inner tube, and a gap is left between the movable member 150 and the outer tube to allow fluid to pass through; when the inner diameters of the distal outer tube 131a and the proximal outer tube 131b are the same, the movable member 150 is set against the outer tube, and a gap is left between the movable member 150 and the inner tube to allow fluid to pass through.

[0075] The difference between the first radial clearance 181 and the second radial clearance 182 makes it possible to adjust the flow rate via the movable element 150. The movable element 150 has the following characteristics within the tube body 130: Figure 2a The first position shown and as Figure 3a The second position shown is such that, in the first position, at least a portion of the movable member 150 is located within the first radial gap 181, and in the second position, all of the movable member 150 is located within the second radial gap 182. Here, "all" means that all of the portion of the movable member 150 that has a significant impact on the flow rate is located within the second radial gap 182.

[0076] When the movable part 150 is located within the first radial gap 181 or the movable part 150 is located within the second radial gap 182, there is a gap between the movable part 150 and at least one of the inner tube or the outer tube, allowing fluid to pass through.

[0077] See Figure 3a As shown, when the balloon 110 is inflated, at least a portion of the movable element 150 is located within the first radial gap 181. Due to the presence of the movable element 150, the channel allowing fluid to pass through the first radial gap 181 is narrower, the inflation speed is slower, and the balloon 110 expands slowly without damaging blood vessels.

[0078] See Figure 3b As shown, when fluid is released from the balloon body 110, the movable part 150 is switched to the second position by the control element 160, that is, the movable part 150 is located in the second radial gap 182. At this time, the channel for fluid to pass through the first radial gap 181 is wider, the release speed is faster, and the operation time is shortened.

[0079] See Figure 2a , Figure 2c , Figure 3a , Figure 3c As shown, a traction wire 190 is connected between the movable component 150 and the control component 160. One end of the traction wire 190 is fixedly connected to the proximal end of the movable component 150, and the other end is fixedly connected to the control component 160. There are at least two traction wires 190, and each traction wire 190 is evenly distributed around the axis of the tube body 130, or each traction wire 190 is axially symmetrically distributed around the axis of the tube body 130.

[0080] See Figure 2a , Figure 3a , Figure 4a , Figure 5a As shown, the movable component 150 is a pipe fitting, and a perforated groove 151 is provided on the pipe fitting to adjust the flexibility of the movable component 150 at different axial positions. The perforated groove 151 refers to a groove that penetrates the pipe wall and is etched or engraved on the pipe wall. Flexibility refers to the ease with which the movable component 150 is bent.

[0081] The proximal inner tube 132b and the distal inner tube 132a have the same outer diameter. The inner diameter of the distal outer tube 131a is smaller than that of the proximal outer tube 131b, and the hardness of the distal outer tube 131a is less than that of the proximal outer tube 131b. The distal outer tube 131a and the proximal outer tube 131b are smoothly connected. The hardness of the distal outer tube 131a is 35D~55D, and the hardness of the proximal outer tube 131b is 55D~75D. The distal outer tube 131a and the proximal outer tube 131b are connected by welding.

[0082] The hardness of the distal outer tube 131a is lower than that of the proximal outer tube 131b. There is an abrupt change in hardness at the welded joint between the two. The addition of the movable part 150 can balance this abrupt change. The movable part 150 has continuously varying flexibility at different axial positions. At the location where the hardness of the outer tube changes abruptly, the addition of the movable part 150 can make the tube body exhibit a more gradual change in hardness, reduce stress concentration at the connection between the distal outer tube 131a and the proximal outer tube 131b, and improve the pushing and tracking performance of the tube body 130.

[0083] The principle for the flexible adjustment of the movable part 150 at different axial positions is as follows: the flexibility at the far end of the movable part 150 is greater than the flexibility at the near end of the movable part 150, and the flexibility changes gradually along the axial direction at a relatively uniform speed.

[0084] There are multiple hollowed-out grooves 151, extending from the far end to the near end of the movable part 150. The hollowed-out grooves 151 shall satisfy at least one of the following distribution rules:

[0085] a. The distribution of the hollowed-out grooves 151 changes from dense to sparse;

[0086] b. The area of ​​the hollowed-out region of each hollowed-out groove 151 decreases from large to small.

[0087] The denser the distribution of the hollow grooves 151, the greater the flexibility of the moving part 150 in that part; the sparser the distribution of the hollow grooves 151, the less flexible the moving part 150 in that part.

[0088] The larger the area of ​​the hollowed-out region of each hollowed-out groove 151, the greater the flexibility of the moving part 150 in that part; the smaller the area of ​​the hollowed-out region of each hollowed-out groove 151, the less flexible the moving part 150 in that part.

[0089] The shapes of the various cutout grooves 151 may be the same or different. The shape of each cutout groove 151 can be selected as needed; any shape is acceptable, such as a circle, rectangle, ellipse, triangle, etc. (See also...) Figure 5a , Figure 5b As shown, the hollowed-out groove 151 is rectangular, and multiple hollowed-out grooves 151 are arranged sequentially along the axial direction of the pipe fitting. Each hollowed-out groove 151 is arranged around the pipe fitting, and the distance between adjacent hollowed-out grooves 151 gradually increases from the far end to the near end of the movable part 150. Figure 5a , Figure 5b For different perspectives of the same moving part 150, among which Figure 5b The center shows clearance slot 152.

[0090] See Figure 4a , Figure 4b As shown, there is one hollow groove 151, which is a spiral line distributed around the pipe fitting. The pitch of the spiral line gradually increases from the far end to the near end of the movable part 150. The spiral line is not continuously distributed, at least to ensure that the pipe fitting is a whole structure and does not break into several segments. Figure 4a , Figure 4b For different perspectives of the same moving part 150, among which Figure 4b The center shows clearance slot 152.

[0091] See Figure 2b As shown, the cross-section of the fitting is C-shaped, and the C-shaped opening is the clearance groove 152. The clearance groove 152 is used to accommodate the optical fiber 120.

[0092] See Figure 4a As shown, the distal end of the pipe fitting is provided with an extension 153, which is strip-shaped. Figure 4b , Figure 5a , Figure 5bThe middle extension 153 is omitted and not shown.

[0093] See Figure 2a , Figure 3a As shown, the distal tube body includes a distal outer tube 131a and a distal inner tube 132a nested together, and the proximal tube body includes a proximal outer tube 131b and a proximal inner tube 132b nested together. The proximal inner tube 132b and the distal inner tube 132a have the same outer diameter, the inner diameter of the distal outer tube 131a is smaller than the inner diameter of the proximal outer tube 131b, and the distal outer tube 131a and the proximal outer tube 131b are smoothly connected.

[0094] The movable component 150 is fitted onto the inner tube and is tightly fitted against the outer wall of the inner tube. The movable component 150 has a first position and a second position, and must remain in the first and second positions, and cannot move freely within the first radial gap 181 and the second radial gap 182. The movable component 150 is tightly fitted against the outer wall of the inner tube, and only when the control component 160 applies sufficient force can the friction between the movable component 150 and the inner wall be overcome, allowing the movable component 150 to switch from the first position to the second position.

[0095] The tubing can be made of one of the following materials: PEBAX, nylon, or TPU. The moving part 150 can be made of metal alloys such as stainless steel, platinum-tungsten alloy, or nickel-titanium alloy, or it can be a high-strength polymer tubing, such as PEEK.

[0096] The balloon body 110 can be a smooth, bare balloon or a non-standard balloon. The material of the balloon body 110 needs to have sufficient flexibility and good permeability to smoothly reach the intended location, while also meeting requirements for excellent processability, good resilience, fatigue resistance, and dimensional stability. Preferably, the material of the balloon body 110 is one of PEBAX, nylon, or TPU. More preferably, the material of the balloon body 110 is PEBAX or nylon.

[0097] See Figure 1 As shown, the intracranial laser balloon dilation catheter also includes a catheter seat 140 connected to the proximal end of the tube body 130. The catheter seat 140 has a first interface 141 that communicates with the fluid channel. The control element 160 is inserted into the first interface 141. The traction wire 190 extends through the first interface 141 and is connected to the control element 160.

[0098] The control component 160 is movably inserted into the first interface 141. The control component 160 has a first working position and a second working position. When the control component 160 is in the first working position, the movable component 150 is in the first position. When the control component 160 is in the second working position, the movable component 150 is in the second position.

[0099] The first interface 141 has a flared structure, and the control component 160 is frustoconical. The extreme position of the control component 160 when inserted into the first interface 141 corresponds to the first working position, and the control component 160 when withdrawing from the first interface 141 to the predetermined stroke corresponds to the second working position.

[0100] During assembly, the movable component 150 of the intracranial laser balloon dilation catheter is in the first position, that is, at least a part of the movable component 150 is within the first radial gap 181, and the traction wire 190 is in a near-tensioned state, but with a margin to prevent improper operation of the control component 160 from pulling the movable component 150 to the second position. When the balloon body 110 is fully inflated and it is necessary to release the fluid in the balloon body 110, the movable component 150 is switched from the first position to the second position by pulling the traction wire 190 through the operation control component 160.

[0101] See Figure 1 As shown, the conduit seat 140 also has a second interface 142 that communicates with the optical fiber channel, and the optical fiber 120 extends out of the second interface 142 to connect with the laser generating module.

[0102] See Figure 1 , Figure 6a , Figure 6b As shown, an elastic element 170 is welded to the end of the inner tube. The elastic element 170 is an exposed helical spring. The diameter of the elastic element 170 gradually increases from the far end to the near end.

[0103] At the distal end of the tube body 130, the inner tube intersects with the distal end of the balloon body 110. An elastic element 170 is welded to the distal end of the inner tube. The elastic element 170 may also be welded to the distal end of the balloon body 110. The elastic element 170 is generally located at the distal end of the inner tube. The end of the elastic element 170 has a welding strip extending axially along the elastic element 170. The welding strip overlaps with the distal end of the inner tube and is fixedly connected by welding. To improve safety, 2-4 turns of metal wire adjacent to the welding strip of the elastic element 170 may also overlap with the distal end of the inner tube and be fixedly connected by welding. Apart from this, the remaining portion of the elastic element 170 is directly exposed to the outside, neither within the inner tube wall nor overlapping or fixed with other components.

[0104] The elastic element 170 has a certain degree of elasticity. As the first part of the tube body 130 to extend into the blood vessel, the elastic element 170 has the characteristic of being deformable when it encounters the blood vessel obstruction, which can avoid puncturing the blood vessel. At the same time, based on the resilience of the elastic element 170, it can restore its own shape after the external force disappears.

[0105] The elastic element 170 provides better tip flexibility, better conforms to the guidewire, and avoids the "fish mouth phenomenon". The metal wire has a imaging function, and the elastic element 170 can also serve as an imaging component, making it easier to identify the position of the balloon body 110 in the body and reducing the risk of vascular perforation.

[0106] The elastic element 170 is a helical spring, which is made of a metal wire with a diameter of 0.03-0.1 mm wound spirally. More preferably, the helical spring is made of a metal wire with a diameter of 0.05-0.06 mm wound spirally. The pitch of the helical spring is equal to the diameter of the metal wire. A smaller pitch can increase the rebound performance of the elastic element 170. The metal wire is made of one of the following materials: stainless steel, nickel-titanium, gold, platinum-iridium alloy, and platinum-tungsten alloy.

[0107] The elastic element 170 is made of metal wire, which is an opaque structure. It can block the light emitted by the optical fiber 120 at the distal end of the balloon body 110 to avoid irradiation damage to unintended areas.

[0108] The axial length of the elastic element 170 is 2-5 mm. More preferably, the axial length of the elastic element 170 is 3-5 mm. The axial length of the elastic element 170 needs to be appropriate. If the length is too long, it will not be conducive to the rebound of the elastic element 170. If the length is too short, it will not be able to play its role in guiding the advancement of the vascular guidance balloon 110.

[0109] The diameter of the elastic element 170 is 0.50-0.70 mm. More preferably, the diameter of the elastic element 170 is 0.5-0.6 mm. The diameter of the elastic element 170 needs to be able to enter relatively small blood vessels without losing its elasticity.

[0110] This application also provides a method for operating an intracranial laser balloon dilation catheter, including:

[0111] In the initial state, at least a portion of the movable part 150 is located in a first position within the first radial clearance 181;

[0112] Inflate the balloon body 110 with fluid;

[0113] The laser generating module emits laser light with a wavelength of 400~750nm and applies it to the desired area through the light-emitting segment;

[0114] The movable part 150 is switched to the second position, which is entirely located in the second radial gap 182, by means of the traction wire 190 pulled by the control element 160.

[0115] Release the fluid inside the balloon 110.

[0116] When the balloon body 110 is inflated, the flow rate is relatively slow because at least a portion of the movable part 150 is located within the first radial gap 181. When the fluid inside the balloon body 110 is released, the flow rate is relatively fast because the first radial gap 181 is fully opened, thus balancing the safety and convenience of the surgery.

[0117] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0118] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. An intracranial laser balloon dilation catheter, characterized by, include: The tube body has a distal end and a proximal end, and the tube body is provided with a fluid channel and an optical fiber channel; The balloon body is located on the outer periphery of the distal end of the tube and is in communication with the fluid channel; An optical fiber is inserted through the optical fiber channel and has a light-emitting segment extending to the location of the balloon body; An elastic element is provided at the distal end of the inner tube, and the diameter of the elastic element gradually increases from the distal end to the proximal end. The laser generating module is connected to the near end of the optical fiber and emits a laser with repair function.

2. The intracranial laser balloon dilation catheter of claim 1, wherein, The elastic element is a helical spring made of metal wire spirally wound together, and the pitch of the helical spring is equal to the diameter of the metal wire.

3. The intracranial laser balloon dilation catheter of claim 2, wherein, The diameter of the metal wire is 0.03~0.1mm.

4. The intracranial laser balloon dilation catheter of claim 2, wherein, The end of the elastic element has a welding strip extending axially along the elastic element, the welding strip overlapping the distal end of the inner tube and being fixedly connected by a welding process.

5. The intracranial laser balloon dilation catheter of claim 4, wherein, The 2-4 turns of metal wire adjacent to the elastic element and the welding strip also overlap with the far end of the inner tube and are fixedly connected by welding. The rest of the elastic element is directly exposed to the outside.

6. The intracranial laser balloon dilation catheter of claim 1, wherein, The axial length of the elastic element is 2~5mm, and the diameter of the elastic element is 0.50~0.70mm.

7. The intracranial laser balloon dilation catheter according to claim 1, characterized in that, The laser generating module emits laser light with a wavelength of 400~750nm, and the output power of the laser light is 10~30mW.

8. The intracranial laser balloon dilation catheter according to claim 7, characterized in that, The laser generating module outputs laser light of a predetermined wavelength in each working cycle in the following order: Initial stage: power density 5-8 mW / cm 2 for 10-20 s; Intermediate stage: power density 10-30 mW / cm 2 for 120-180 s; End phase: power density 5-8 mW / cm 2 for 10-20 s.

9. The intracranial laser balloon dilation catheter according to claim 8, characterized in that, At said intermediate stage, the power density is 10-15 mW / cm 2 .

10. The intracranial laser balloon dilation catheter according to claim 1, characterized in that, The tube body includes an inner tube and an outer tube nested together, and the fluid channel is the radial gap between the inner tube and the outer tube; The tube body includes a distal tube body and a proximal tube body along the axial direction. There is a first radial gap between the inner tube and the outer tube of the distal tube body, and a second radial gap between the inner tube and the outer tube of the proximal tube body. The first radial gap is smaller than the second radial gap. The intracranial laser balloon dilation catheter also includes a movable component, which is located within the radial gap between the inner tube and the outer tube, and there is a gap between the inner tube or the outer tube and the movable component that allows fluid to pass through. The movable component has a first position in the tube body axial direction, at least part of which is located in the first radial gap, and a second position in which it is entirely located in the second radial gap. The movable component is provided with a receiving groove to avoid optical fibers. The intracranial laser balloon dilation catheter also includes a control component that can control the movable component to switch from the first position to the second position.

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