Fabrication method and infusion laser balloon catheter

Abstract

This application discloses a method for processing a laser-perfused balloon catheter. The laser-perfused balloon catheter includes a balloon body, an inner tube, a first outer tube, a second outer tube, and an optical fiber. The processing method includes: step S100, connecting the first outer tube, the balloon body, and the second outer tube end to end to obtain a first preform; step S200, arranging and fixing the optical fiber along the outer periphery of the inner tube to obtain a second preform; step S300, fitting and fixing the first preform onto the outer periphery of the second preform, and filling the radial gap between the inner tube and the second outer tube with sealant, so that the inner tube, sealant, and second outer tube form a composite segment; step S400, the composite segment has an inner lumen and a sidewall surrounding the inner lumen, the sidewall having an opening communicating with the inner lumen. Compared with the prior art, the processing method of this application is simple, and the processed laser-perfused balloon catheter can effectively release drugs and apply uniform illumination to the vascular lesion segment, thereby improving the treatment effect on vascular diseases.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a method for processing an infusion laser balloon catheter and the infusion laser balloon catheter itself. Background Technology

[0002] Vascular diseases are now among the leading causes of death in humans. Most vascular diseases, whether organic or functional, are fundamentally characterized by ischemic changes in organs due to narrowing or occlusion of blood vessels. Currently, angiogenesis is one of the important methods for restoring blood flow to narrowed blood vessels.

[0003] The perfusion laser balloon catheter comprises a tube body, a balloon body, an optical fiber, and a tailstock. The tube body typically consists of multiple segments, with each segment nested within the others. The internal space of each segment and / or the radial gaps between the inner and outer segments are used to provide guidewire lumens, drug delivery channels, and fluid delivery channels, respectively. Existing perfusion laser balloons suffer from problems such as uneven luminescence, incomplete drug release, and significant drug residue, leading to poor therapeutic effects for vascular diseases. Summary of the Invention

[0004] In view of the problems of the prior art, this application provides a method for processing an infusion laser balloon catheter. The processing method is simple, and the prepared infusion laser balloon catheter has good performance.

[0005] The processing method of the laser-perfused balloon catheter disclosed in this application, wherein the laser-perfused balloon catheter includes a balloon body, an inner tube, a first outer tube, a second outer tube, and an optical fiber, and the processing method includes:

[0006] Step S100: Connect the first outer tube, the balloon body, and the second outer tube end to end in sequence to obtain the first prefabricated component;

[0007] Step S200: Arrange and fix optical fibers along the outer periphery of the inner tube to obtain the second preform;

[0008] Step S300: The first preform is fitted and fixed to the outer periphery of the second preform, and sealant is filled into the radial gap between the inner tube and the second outer tube, so that the inner tube, sealant and second outer tube form a composite segment;

[0009] Step S400: The composite section has an inner cavity and a side wall surrounding the inner cavity, and an outlet hole communicating with the inner cavity is provided on the side wall.

[0010] 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.

[0011] Optionally, in step S100, the balloon body has a proximal end and a distal end, the proximal end of the balloon body is connected to the end of the first outer tube, and the distal end of the balloon body is connected to the end of the second outer tube.

[0012] The first outer tube, the balloon body, and the second outer tube are connected by adhesive and / or welding.

[0013] Optionally, in step S200, the distal end of the inner tube is provided with multiple imaging rings at intervals.

[0014] Optionally, in step S200, multiple optical fibers are fixed at intervals along the outer periphery of the inner tube; the optical fibers are fixed by adhesive bonding or welding.

[0015] Optionally, in step S300, the connection between the second outer tube and the balloon body is sealed to the outer wall of the inner tube;

[0016] The free end of the second outer tube is sealed to the outer wall of the inner tube.

[0017] Optionally, the sealing connection method involves using a glue-filling mechanism to fill the radial gap between the inner tube and the second outer tube with glue.

[0018] Optionally, the glue-filling mechanism has a tubular glue-filling head. Before glue filling, the glue-filling head extends into the radial gap until it reaches the connection between the second outer tube and the balloon body. During glue filling, the glue is poured in while the head retracts towards the far end of the inner tube until the radial gap is filled with sealant.

[0019] Optionally, in step S400, a laser drilling method is used to drill holes from the outside to the inside of the side wall of the composite section, sequentially penetrating the second outer tube, sealant and inner tube to form the liquid outlet hole.

[0020] Optionally, the refractive index of the sealant is 1.4 to 1.7.

[0021] Optionally, multiple optical fibers are arranged at circumferential intervals along the inner tube, and the composite segment has two drainage holes in the area between two adjacent optical fibers.

[0022] The liquid outlet is a round hole or a slit hole; the porosity of the composite section is 40-70%.

[0023] This application also provides an infusion laser balloon catheter, which is manufactured using the aforementioned processing method.

[0024] Compared with the prior art, the processing method provided in this application is simple, and the resulting perfusion laser balloon catheter has good luminescence uniformity and drug release effect, which is beneficial to improving the therapeutic effect on blood vessels. Attached Figure Description

[0025] Figure 1 This is a flowchart of a method for fabricating a laser-infused balloon catheter according to one embodiment of this application;

[0026] Figure 2 This is a schematic diagram of the perfusion laser balloon catheter in one embodiment;

[0027] Figure 3 This is a schematic diagram of the perfusion laser balloon catheter in another embodiment;

[0028] Figure 4 This is a schematic diagram of the structure of the inner tube, optical fiber, and second outer tube in one embodiment;

[0029] Figure 5 This is a schematic diagram of the structure of the inner tube, optical fiber, sealant, and second outer tube in one embodiment;

[0030] Figure 6 This is a schematic diagram of the composite segment in one embodiment;

[0031] Figure 7 This is a schematic diagram of the composite segment in another embodiment;

[0032] Figure 8 This is a schematic diagram of the structure of the balloon body, inner tube, and first outer tube in one embodiment;

[0033] Figure 9 This is a schematic diagram of the distal structure of the laser-infused balloon catheter in the first state.

[0034] Figure 10 This is a schematic diagram of the distal structure of the perfusion laser balloon catheter in the second state.

[0035] The annotations in the figure are explained as follows:

[0036] 100. Infusion laser balloon catheter; 110. Guidewire; 111. Body segment; 112. Occlusion element; 113. Guiding segment; 120. Inner tube; 121. Drug channel; 122. First outlet; 130. Optical fiber; 131. Light-emitting segment; 140. Balloon body; 150. First outer tube; 151. Fluid channel; 160. Second outer tube; 161. Second mounting channel; 162. Second outlet; 170. Sealant; 171. Intermediate channel; 180. Imaging ring; 190. Tailstock; 191. First interface; 192. Second interface; 193. Optical path interface; 194. Stress relief tube; 195. First tailstock; 196. Second tailstock; 197. Locking mechanism; 1971. Locking sleeve; 1972. Locking cap;

[0037] 200. Light source device; 210. Fiber optic connector; 220. Fiber optic protective sleeve;

[0038] 1. Proximal end; 2. Distal end. Detailed Implementation

[0039] 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.

[0040] 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.

[0041] 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 limit the scope of the application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0042] See Figures 1-10 One embodiment of this application provides a method for processing an infusion laser balloon catheter 100. The infusion laser balloon catheter 100 includes a balloon body 140, an inner tube 120, a first outer tube 150, a second outer tube 160, and an optical fiber 130. The processing method includes:

[0043] Step S100: Connect the first outer tube 150, the balloon body 140 and the second outer tube 160 end to end to obtain the first prefabricated component;

[0044] Step S200: Arrange and fix the optical fiber 130 along the outer periphery of the inner tube 120 to obtain the second preform;

[0045] Step S300: The first preform is fitted and fixed to the outer periphery of the second preform, and sealant 170 is filled into the radial gap between the inner tube 120 and the second outer tube 160, so that the inner tube 120, sealant 170 and the second outer tube 160 form a composite segment.

[0046] Step S400: The composite section has an inner cavity and a side wall surrounding the inner cavity, and an outlet hole communicating with the inner cavity is opened on the side wall.

[0047] In the processing method, steps S100 and S200 are performed in any order, followed by steps S300 and S400.

[0048] The processing method of this application is simple, and by using sealant 170 to fill the radial gap between the inner tube 120 and the second outer tube 160, a large amount of drug can be prevented from remaining in these gaps, thereby effectively reducing drug residue.

[0049] Specifically, in step S100, the balloon body 140 has a proximal end and a distal end. The proximal end of the balloon body 140 is connected to the end of the first outer tube 150, and the distal end of the balloon body 140 is connected to the end of the second outer tube 160, such that the first outer tube 150, the balloon body 140, and the second outer tube 160 are connected end-to-end. The connection can be achieved by adhesive bonding and / or welding, such as ultrasonic welding and thermocompression welding.

[0050] In step S200, the inner tube 120 has a near end and a far end, and the portion of the optical fiber 130 located at the far end of the inner tube 120 is exposed as the light-emitting segment 131. Specifically, the optical fiber 130 includes a core and a cladding layer. The cladding layer covers the core, serving to protect the optical fiber 130 and reduce energy loss. The cladding layer is removed from the portion of the optical fiber 130 located at the far end of the inner tube 120 to form the light-emitting segment 131. The removal method can be physical removal (e.g., sandblasting, grinding, scraping, etc.) or chemical removal. The surface of the light-emitting segment 131 is polished to make the surface more uniform and improve the uniformity of light emission.

[0051] Multiple optical fibers 130, such as four optical fibers 130, are fixed at intervals along the outer periphery of the inner tube 120. The optical fibers 130 can be fixed by adhesive or welding. In addition, multiple developing rings 180 are provided at intervals at the distal end of the inner tube 120, usually two developing rings 180 are provided, and the two developing rings 180 are respectively sleeved and fixed at both ends of the light-emitting section 131.

[0052] In step S300, when the first preform is fitted and fixed to the outer periphery of the second preform, the second outer tube 160 is fitted to the outer periphery of the light-emitting segment 131.

[0053] The connection between the second outer tube 160 and the balloon body 140 is sealed to the outer wall of the inner tube 120, and the free section of the second outer tube 160 is sealed to the outer wall of the inner tube 120, thus sealing both ends of the second outer tube 160. The sealing connection can be achieved by adhesive bonding or welding.

[0054] For example, in one embodiment, the sealing connection is achieved by using a glue-filling mechanism to fill the radial gap between the inner tube 120 and the second outer tube 160 with glue. Specifically, the glue-filling mechanism has a tubular glue-filling head. Before filling with glue, the glue-filling head extends into the radial gap up to the connection between the second outer tube 160 and the balloon body 140. During glue filling, the glue is poured in while the head is withdrawn towards the distal end of the inner tube 120 until the radial gap is filled with sealant 170.

[0055] Since the optical fiber 130 is embedded in the sealant 170, in order to ensure the light transmission effect, the sealant 170 is made of a transparent adhesive with a high refractive index, such as a UV adhesive with a refractive index of 1.42~1.67, specifically Loctite 3011 UV curing adhesive. The light emitted by the optical fiber 130 is transmitted after refraction, making the illumination more uniform.

[0056] In step S400, laser drilling is used to drill holes from the outside to the inside of the sidewall of the composite section, sequentially penetrating the second outer tube 160, sealant 170, and inner tube 120 to form an outlet. The inner tube 120 has a first outlet 122, the second outer tube 160 has a second outlet 162, and the sealant 170 has an intermediate channel connecting the first outlet 122 and the second outlet 162. This intermediate channel can be a straight channel, with both ends connected to the first outlet 122 and the second outlet 162. See, for example... Figure 5 The first outlet 122 and the second outlet 162 are aligned, and the intermediate channel extends radially along the composite section and communicates with the first outlet 122 and the second outlet 162, meaning the drug is released radially along the composite section. Alternatively, the intermediate channel can be set at an angle to the radial direction of the composite section, meaning the drug is released at an angle.

[0057] In addition, depending on the needs of the scenario, the composite segment can be divided into multiple release zones, each with a different intermediate channel. For example, it can be divided into a proximal release zone, an intermediate release zone, and a distal release zone. In the intermediate release zone, the drug is released radially along the composite segment, while in the proximal and distal release zones, the drug is released at an axial angle relative to the composite segment.

[0058] The composite segment has an inner cavity and sidewalls surrounding the inner cavity. A first outlet 122, an intermediate channel, and a second outlet 162 are formed on the sidewalls. The shape of the outlet hole affects the drug release effect. See [reference needed]. Figure 6 , 7 The shape of the drug dispensing hole can be a round hole or a slit hole. The diameter of the round hole is 0.3~2mm, for example, 1mm. The slit hole can be a straight hole with a major diameter of 2~10mm and a minor diameter of 0.01~0.1mm, for example, a major diameter of 5mm and a minor diameter of 0.01mm, or a major diameter of 7mm and a minor diameter of 0.05mm.

[0059] To control the drug release rate, the porosity of the composite section is, for example, 40-70%, or 50-70%, or 65%. Along the circumference of the composite section, at least two liquid outlet holes are provided between two adjacent optical fibers 130, for example, two liquid outlet holes are provided, and the distance between the two liquid outlet holes is 0.5-1mm.

[0060] The laser drilling power is 300-500mW, for example 300-400mW, or even 320mW. Drilling can be performed using medical catheter laser drilling equipment, such as the medical catheter drilling machine from Chuangxuan Laser. By setting different drilling shapes and sizes, round holes and slit holes can be drilled on the catheter; slit holes, for example, are "I"-shaped holes. Specifically, the laser head is usually dot-shaped. Different shapes of effluent holes can be obtained by setting different travel paths of the laser head according to the expected shape of the effluent outlet. Furthermore, the composite section has two rows of effluent outlets in the area between two adjacent optical fibers 130.

[0061] The infusion laser balloon catheter 100 also includes a guidewire 110 inserted into the inner tube 120. The guidewire 110 includes a guide segment 113, a sealing element 112, and a body segment 111 connected in sequence. The guide segment 113 extends beyond the distal end of the inner tube 120, the sealing element 112 seals the distal end of the inner tube 120, and the body segment 111 extends beyond the proximal end of the inner tube 120. The guidewire 110 can be fixedly or slidably inserted into the inner tube 120. The specific operation of fixing involves fixing at least a portion of the distal end of the guidewire 110 to the distal end of the inner tube 120, for example, fixing the sealing element 112 to the distal end of the inner tube 120. The fixing method can be adhesive bonding or welding.

[0062] Regarding the timing of fixing the guide wire 110, in one embodiment, the guide wire 110 is inserted into the second preform in step S200, the surface of the sealing member 112 is pre-coated with adhesive, the sealing member 112 is pushed to a predetermined position in the inner tube 120, and then the sealing member 112 is bonded to the side wall of the inner tube 120 by hot pressing or ultrasonic waves.

[0063] The infusion laser balloon catheter 100 also includes a tailstock 190. After step S400 is completed, a fourth preform is obtained, and the proximal end of the fourth preform is connected to the tailstock 190. The proximal end of the body segment 111 extends out of the tailstock 190. The connection can be made by adhesive bonding and / or welding.

[0064] In another embodiment, after step S400 is completed, a fourth preform is obtained, the guide wire 110 is slidably inserted into the fourth preform, and the proximal end of the fourth preform is connected to the tailstock 190, with the proximal end of the guide wire 110 extending out of the tailstock 190.

[0065] The infusion laser balloon catheter 100 also includes a tailstock 190. The processing method further includes step S500: sliding the guidewire 110 through the fourth preform and then connecting the proximal end of the fourth preform to the tailstock 190, with the proximal end of the guidewire 110 extending out of the tailstock 190.

[0066] The perfusion laser balloon catheter 100 also includes a locking mechanism 197 that cooperates with the tail seat 190. The locking sleeve 1971 of the locking mechanism 197 can be pre-fixed to the tail seat 190. In step S500, the part of the guidewire 110 that extends out of the tail seat 190 is inserted into the locking cap 1972.

[0067] In one embodiment, the tailstock 190 is a detachable structure, including a first tailstock 195 and a second tailstock 196 that can cooperate with each other. In the processing method, the proximal ends of the inner tube 120, the optical fiber 130 and the first outer tube 150 can be fixed to the second tailstock 196 in advance, and the locking sleeve 1971 can be fixed to the first tailstock 195 in advance. In step S500, the part of the guide wire 110 that extends out of the first tailstock 195 is inserted into the locking cap 1972.

[0068] The tailstock 190 is also provided with a stress relief tube 194 at its proximal end, and the proximal ends of the inner tube 120 and the first outer tube 150 are all connected to the stress relief tube 194.

[0069] See Figures 2-9 This application provides a laser perfusion balloon catheter 100, manufactured using any of the above-described processing methods. The laser perfusion balloon catheter 100 has a proximal end 1 and a distal end 2, and includes a guidewire 110, an inner tube 120, an optical fiber 130, a balloon body 140, a first outer tube 150, a second outer tube 160, and a tailstock 190. The guidewire 110 has a sealing element 112 fixed at its distal end. The inner tube 120 is fixedly sleeved around the outer periphery of the guidewire 110, and its distal end is sealed by the sealing element 112. The inner tube 120 has a drug channel 121, and for effective drug release, a first outlet 122 communicating with the drug channel 121 is opened at the distal end of the inner tube 120. The optical fiber 130 extends along the inner tube 120 and has a light-emitting segment 131 at its distal end for emitting light of a specific wavelength. The balloon body 140 is located on the outer periphery of the inner tube 120, and the distal end of the balloon body 140 is sealed to the outer wall of the inner tube 120. The first outer tube 150 is located on the outer periphery of the inner tube 120 and communicates with the proximal side of the balloon body 140. The radial gap between the first outer tube 150 and the inner tube 120 serves as a fluid channel 151 for inflating the balloon body 140. The second outer tube 160 is provided with a second outlet 162 that communicates with the drug channel 121. The proximal ends of the inner tube 120, optical fiber 130, and the first outer tube 150 are all connected to the tailstock 190. The tailstock 190 is provided with a first interface 191, a second interface 192, and an optical path interface 193. The first interface 191 communicates with the drug channel 121 for infusing fluid drugs; the second interface 192 communicates with the fluid channel 151 for infusing fluid into the fluid channel 151 to inflate the balloon body 140; the optical path interface 193 corresponds to the optical fiber 130 for facilitating the connection of the optical fiber 130 to the light source device 200. The proximal end of the guidewire 110 extends and connects to the tailstock 190.

[0070] See Figures 2-10 Another embodiment of this application provides an infusion laser balloon catheter, manufactured using any of the above-described processing methods. The infusion laser balloon catheter 100 has a proximal end 1 and a distal end 2, and includes a guidewire 110, an inner tube 120, an optical fiber 130, a balloon body 140, a first outer tube 150, a second outer tube 160, and a tailstock 190. A sealing member 112 is fixed to the distal end of the guidewire 110. The inner tube 120 is slidably sleeved on the outer periphery of the guidewire 110. The inner tube 120 has a first state and a second state. In the first state, the sealing member 112 seals the distal end of the inner tube 120. In the second state, the guidewire 110 moves proximally, and the sealing member 112 releases the seal on the distal end of the inner tube 120. The inner tube 120 has a drug channel 121. To release the drug, a first outlet 122 communicating with the drug channel 121 is opened at the distal end of the inner tube 120. An optical fiber 130 extends along the outside of the inner tube 120, and has a light-emitting segment 131 at the distal end of the inner tube 120. A balloon body 140 is located on the outer periphery of the inner tube 120, with its distal end sealed to the outer wall of the inner tube 120. A first outer tube 150 is located on the outer periphery of the inner tube 120 and communicates with the proximal side of the balloon body 140; the radial gap between the first outer tube 150 and the inner tube 120 serves as a fluid channel 151 for inflating the balloon body 140. A second outer tube 160 is located on the outer periphery of the inner tube 120 and wraps around the light-emitting segment 131 of the optical fiber 130; both ends of the second outer tube 160 are sealed to the outer periphery of the inner tube 120. For drug release, the second outer tube 160 has a second outlet 162 communicating with the drug channel 121. The proximal ends of the inner tube 120, optical fiber 130, and the first outer tube 150 are all connected to the tailstock 190. The tailstock 190 is provided with a first interface 191, a second interface 192, and a tubing interface. The first interface 191 communicates with the drug channel 121, the second interface 192 communicates with the fluid channel 151, and the optical path interface 193 corresponds to the optical fiber 130. The proximal end of the guidewire 110 extends out of the tailstock 190, and the tailstock 190 is provided with a locking mechanism 197 that cooperates with the guidewire 110.

[0071] The locking mechanism 197 has a locked state that locks the proximal end of the guide wire 110 and an unlocked state that releases the lock on the guide wire 110. The mutual sliding of the inner tube 120 and the guide wire 110 can cause the sealing member 112 to move toward the distal end of the inner tube 120, thereby sealing the distal end of the inner tube 120. At the same time, the locking mechanism 197 locks the proximal end of the guide wire 110, thereby keeping the inner tube 120 in the first state. Releasing the lock on the guide wire 110 by the locking mechanism 197 and driving the guide wire 110 to slide can cause the sealing member 112 to move toward the proximal end of the inner tube 120, thereby releasing the seal of the sealing member 112 on the distal end of the inner tube 120.

[0072] The laser-perfused balloon catheter 100 is used to treat vascular diseases, such as vascular stenosis. The inflated balloon 140 blocks blood flow to the affected segment within the blood vessel, then delivers medication through the drug delivery channel 121 and releases it sequentially through the first outlet 122 and the second outlet 162. Furthermore, the optical fiber 130 emits light that penetrates the inner tube 120 and the second outer tube 160 to act on the blood vessel or stimulate a drug response to form a vascular micro-stent. Compared to drug-loaded balloon catheters, the laser-perfused balloon catheter 100 provided in this embodiment can release drugs more effectively and exhibits better light uniformity, which is beneficial for improving the treatment effect on vascular diseases.

[0073] The balloon body 140 is made of silicone. The inner tube 120 is made of PTFE, HDPE, PA, or Pebax, preferably PTFE or HDPE, with a wall thickness of 0.025~0.1mm. The first outer tube 150 is made of PA or Pebax, with a wall thickness of 0.025~0.1mm. The second outer tube 160 is made of PA or Pebax, with a wall thickness of 0.025~0.1mm.

[0074] To achieve a seal at the distal end of the inner tube 120, in one embodiment, the distal end of the inner tube 120 has a narrowing section with a gradually decreasing inner diameter. The sealing element 112 is made of a deformable material. In a first state, the sealing element 112 is compressed and deformed in the narrowing section to seal the narrowing section. The deformable material is rubber, PEBAX, or TPU.

[0075] In another embodiment, the sealing element 112 is a cone that gradually narrows from the proximal end to the distal end. In a first state, the distal end of the cone seals the distal end of the inner tube 120. The sealing element 112 is made of metal, such as stainless steel.

[0076] See Figure 4 In the illustrated embodiment, the inner wall of the second outer tube 160 has a second mounting channel, meaning the second outer tube 160 is a multi-cavity tube, and the optical fiber 130 extends along the second mounting channel. The second outer tube 160 can protect the light-emitting segment 131, preventing drug from adhering to the light-emitting segment 131 and affecting the light-emitting effect. Because there are gaps between the inner tube 120 and the second outer tube 160, drugs can easily remain in these gaps, leading to incomplete drug release and drug residue. To solve this problem, in one embodiment, sealant 170 is filled into the radial gap between the second outer tube 160 and the inner tube 120, and the optical fiber 130 is embedded in the sealant 170. The inner tube 120, sealant 170, and second outer tube 160 form a composite segment.

[0077] See Figure 2 , 3This application provides an embodiment of an infusion laser balloon catheter system, including an infusion laser balloon catheter 100, a drug delivery device, an inflation device, and a light source device 200. The specific structure of the infusion laser balloon catheter is described above and will not be repeated here. The drug delivery device supplies drug-containing fluid to the drug channel 121; the inflation device supplies fluid to the fluid channel 151 to inflate the balloon body 140; and the light source device is connected to an optical fiber. The drug delivery device supplies drug-containing fluid to the drug channel through a first interface, the inflation device supplies fluid to inflate the balloon body 140 to the fluid channel through a second interface, and the light source device 200 is connected to an optical fiber 130 through an optical path interface.

[0078] The light source device 200 includes an optical fiber connector 210 and an optical fiber protective sleeve 220, wherein the optical fiber protective sleeve 220 is made of TPU and can be used to protect the optical fiber 130 from bending.

[0079] The processing method provided in this application is simple, and the resulting perfusion laser balloon catheter has good luminescence uniformity and drug release effect, which is beneficial to improving the therapeutic effect on blood vessels.

[0080] The technical features of the embodiments described above can be combined arbitrarily. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as the combination of these technical features does not contradict each other, it should be considered to be within the scope of this specification. When technical features of different embodiments are embodied in the same drawing, it can be regarded as the drawing also disclosing examples of combinations of the various embodiments involved.

[0081] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of this patent application. 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 application should be determined by the appended claims.

Claims

1. A method for fabricating an infusion laser balloon catheter, characterized in that, The infusion laser balloon catheter includes a balloon body, an inner tube, a first outer tube, a second outer tube, and an optical fiber. The processing method includes: Step S100: Connect the first outer tube, the balloon body, and the second outer tube end to end in sequence to obtain the first prefabricated component; Step S200: Arrange and fix optical fibers along the outer periphery of the inner tube to obtain the second preform; Step S300: The first preform is fitted and fixed to the outer periphery of the second preform, and sealant is filled into the radial gap between the inner tube and the second outer tube, so that the inner tube, sealant and second outer tube form a composite segment; Step S400: The composite section has an inner cavity and a side wall surrounding the inner cavity, and a liquid outlet hole communicating with the inner cavity is provided on the side wall; The first outer tube is located on the outer periphery of the inner tube and communicates with the proximal side of the balloon body. The radial gap between the first outer tube and the inner tube serves as a fluid channel for inflating the balloon body. The second outer tube is located on the outer periphery of the inner tube and wraps around the light-emitting segment of the optical fiber. Both ends of the second outer tube are sealed to the outer periphery of the inner tube. In step S400, holes are drilled from the outside to the inside from the side wall of the composite section, sequentially penetrating the second outer tube, sealant and inner tube to form the liquid outlet hole.

2. The processing method according to claim 1, characterized in that, In step S400, the drilling is performed using laser drilling.

3. The processing method according to claim 1, characterized in that, In step S100, the balloon body has a proximal end and a distal end, the proximal end of the balloon body is connected to the end of the first outer tube, and the distal end of the balloon body is connected to the end of the second outer tube; The first outer tube, the balloon body, and the second outer tube are connected by adhesive and / or welding.

4. The processing method according to claim 1, characterized in that, In step S200, the inner tube has a proximal end and a distal end, and the portion of the optical fiber located at the distal end of the inner tube is exposed as a light-emitting segment. The distal end of the inner tube is provided with multiple imaging rings at intervals.

5. The processing method according to claim 1, characterized in that, In step S200, multiple optical fibers are fixed at intervals along the outer periphery of the inner tube; The optical fibers are fixed by adhesive bonding or welding.

6. The processing method according to claim 1, characterized in that, In step S300, the connection between the second outer tube and the balloon body is sealed to the outer wall of the inner tube; The free end of the second outer tube is sealed to the outer wall of the inner tube.

7. The processing method according to claim 6, characterized in that, The sealing connection method involves using a glue-filling mechanism to fill the radial gap between the inner tube and the second outer tube with glue.

8. The processing method according to claim 7, characterized in that, The glue-filling mechanism has a tubular glue-filling head. Before glue filling, the glue-filling head extends into the radial gap up to the connection between the second outer tube and the balloon body. During glue filling, the glue-filling head is simultaneously withdrawn towards the far end of the inner tube until the radial gap is filled with sealant.

9. The processing method according to claim 1, characterized in that, The sealant is a UV sealant with a refractive index of 1.42 to 1.

67.

10. The processing method according to claim 1, characterized in that, Multiple optical fibers are arranged at intervals along the circumference of the inner tube, and the composite section has two drainage holes in the area between two adjacent optical fibers. The liquid outlet is a round hole or a slit hole, and the porosity of the composite section is 40-70%.

11. An infusion laser balloon catheter, characterized in that, It is prepared by any of the processing methods described in claims 1 to 10.

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