Infusion laser balloon catheter and infusion laser balloon catheter system

By designing an infusion laser balloon catheter with a structure consisting of a guidewire, inner tube, optical fiber, and outer tube, combined with sealant to close the gap, the problems of incomplete drug release and uneven light illumination in existing technologies have been solved, thus improving the treatment effect of vascular diseases.

CN120022512BActive Publication Date: 2026-04-21HANGZHOU MATRIX MEDICAL TECH CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
HANGZHOU MATRIX MEDICAL TECH CO LTD
Filing Date
2023-11-22
Publication Date
2026-04-21

AI Technical Summary

Technical Problem

Existing drug-loaded fiber optic balloon catheters suffer from problems such as uneven luminescence within the balloon, incomplete drug release, and excessive drug residue, leading to poor treatment outcomes for vascular diseases.

Method used

A laser-infused balloon catheter was designed, comprising a guidewire, an inner tube, an optical fiber, a balloon body, and an outer tube. Drug and fluid are delivered through the drug channel and fluid channel of the inner tube, respectively. The optical fiber emits light at the distal end of the inner tube. The gap between the inner and outer tubes is sealed with sealant to ensure uniform drug release and uniform light illumination.

Benefits of technology

It achieves uniform drug release and uniform light exposure, improving the treatment effect on vascular diseases, reducing drug residues, and enhancing the effectiveness of treatment.

✦ Generated by Eureka AI based on patent content.

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Abstract

This application discloses a laser-perfused balloon catheter and a balloon catheter system, having a distal and a proximal end. The laser-perfused balloon catheter includes: a guidewire with a occlusion element fixed at its distal end; an inner tube fixedly sleeved around the guidewire, with its distal end sealed by the occlusion element, the inner tube having a drug channel, and a first outlet communicating with the drug channel at its distal end; an optical fiber extending along the inner tube, with a light-emitting segment at its distal end; a balloon body located around the inner tube, with its distal end sealed to the outer wall of the inner tube; and a first outer tube located around the inner tube and communicating with the proximal side of the balloon body, the radial gap between the first outer tube and the inner tube serving as a fluid channel for inflating the balloon body. The laser-perfused balloon catheter provided by this application can better release drugs and ensure uniform light emission, thereby improving the treatment effect on vascular diseases.
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Description

Technical Field

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

[0002] Vascular diseases have become a major cause of illness affecting human health and quality of life. Interventional vascular surgery is an effective treatment for these diseases and is a primary treatment method. Balloon catheters, as interventional vascular devices, can widen narrowed openings or channels in blood vessels. Fiberoptic balloon catheters, which add fiber optic cables as a power source to balloon catheters, can be used for phototherapy or to enhance drug therapy, thereby achieving therapeutic effects on vascular diseases such as stenosis and occlusion.

[0003] Currently, drug-loaded fiber optic balloon catheters typically load drugs onto the surface of a balloon. As the balloon expands and comes into contact with the blood vessel wall, the drug is rapidly released and transferred to the local vascular endothelium. Specific wavelengths of light are emitted via optical fiber, and this light penetrates the catheter and balloon to act on the blood vessel, either repairing it or promoting the formation of a vascular micro-stent on the vessel wall. While these balloon catheters can achieve some therapeutic effects, they suffer from problems such as uneven light emission within the balloon, incomplete drug release, and significant drug residue, leading to unsatisfactory treatment outcomes for vascular diseases. Summary of the Invention

[0004] In view of the problems of the prior art, this application provides an infusion laser balloon catheter and an infusion laser balloon catheter system to improve the treatment effect of vascular diseases.

[0005] The perfusion laser balloon catheter provided in this application has a distal end and a proximal end, and the perfusion laser balloon catheter includes:

[0006] The guidewire has a sealing element fixed at its distal end;

[0007] An inner tube is fixedly sleeved on the outer periphery of the guide wire, and the distal end of the inner tube is blocked by the sealing member. The inner tube has a drug channel, and the distal end of the inner tube has a first outlet communicating with the drug channel.

[0008] An optical fiber extends along the inner tube, and the optical fiber has a light-emitting segment at the distal end of the inner tube;

[0009] A balloon body is located on the outer periphery of the inner tube, and the distal end of the balloon body is sealed to the outer wall of the inner tube;

[0010] A 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.

[0011] 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.

[0012] Optionally, the perfusion laser balloon catheter further includes a tailstock, the proximal ends of the inner tube, the optical fiber, and the first outer tube are all connected to the tailstock, the tailstock is provided with a first interface communicating with the drug channel, a second interface communicating with the fluid channel, and an optical path interface corresponding to the optical fiber, and the proximal end of the guidewire extends and is connected to the tailstock.

[0013] Optionally, the optical fiber extends along the interior of the inner tube and is fixed to the inner wall of the inner tube.

[0014] Optionally, the inner tube has a first mounting channel in its wall, and the optical fiber extends along the first mounting channel.

[0015] Optionally, the guide wire includes a body section and a guide section respectively connected to both ends of the sealing member, the guide section extending beyond the distal end of the inner tube;

[0016] The guide section extends 3 to 5 cm beyond the distal end of the inner tube.

[0017] Optionally, the optical fiber extends along the outside of the inner tube and is fixed to the outer wall of the inner tube. The infusion laser balloon catheter also includes a second outer tube, which has a second outlet communicating with the drug channel.

[0018] Optionally, the inner wall of the second outer tube has a second mounting channel, along which the optical fiber extends.

[0019] Optionally, sealant is injected into the radial gap between the second outer tube and the inner tube, and the optical fiber is embedded in the sealant.

[0020] Optionally, the sealant has an intermediate channel connecting the first outlet and the second outlet.

[0021] This application also provides an infusion laser balloon catheter system, comprising:

[0022] The infusion laser balloon catheter is the aforementioned infusion laser balloon catheter;

[0023] A drug delivery device for supplying a fluid containing a drug to the drug channel;

[0024] An inflation device for supplying fluid to the fluid channel to inflate the balloon body;

[0025] A light source device for connecting to the optical fiber path.

[0026] Compared with existing technologies, the perfusion laser balloon catheter provided in this application has better luminescence uniformity, simpler drug release, and less drug residue, which can effectively improve the treatment effect on vascular diseases. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the structure of the infusion laser balloon catheter in one embodiment of this application;

[0028] Figure 2 This is a partial structural schematic diagram of the perfusion laser balloon catheter in one embodiment;

[0029] Figure 3 This is a schematic diagram of the distal structure of the laser infusion balloon catheter in one embodiment;

[0030] Figure 4 This is a schematic diagram of the distal structure of the laser-infused balloon catheter in another embodiment;

[0031] Figure 5 This is a schematic diagram of the inner tube and optical fiber in one embodiment;

[0032] Figure 6 This is a schematic diagram of the inner tube and optical fiber in another embodiment;

[0033] Figure 7 This is a schematic diagram of the structure of the inner tube, optical fiber, and second outer tube in one embodiment;

[0034] Figure 8 This is a schematic diagram of the structure of the inner tube, optical fiber, sealant, and second outer tube in one embodiment;

[0035] Figure 9 This is a schematic diagram of the perfusion laser balloon catheter in one embodiment;

[0036] Figure 10 This is a schematic diagram of the composite segment in one embodiment;

[0037] Figure 11 This is a schematic diagram of the composite segment in another embodiment;

[0038] Figure 12 This is a flowchart illustrating the fabrication method of a laser-infused balloon catheter in one embodiment.

[0039] The annotations in the figure are explained as follows:

[0040] 100. Infusion laser balloon catheter; 110. Guidewire; 111. Body section; 112. Occlusion element; 113. Guiding section; 120. Inner tube; 121. Drug channel; 122. First outlet; 123. First mounting channel; 130. Optical fiber; 131. Light-emitting section; 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;

[0041] 200. Light source device; 210. Fiber optic connector; 220. Fiber optic protective sleeve;

[0042] 1. Proximal end; 2. Distal end. Detailed Implementation

[0043] 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.

[0044] 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.

[0045] 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.

[0046] See Figures 1-9An embodiment of this application provides an infusion laser balloon catheter 100, which 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, and a first outer tube 150. The guidewire 110 has a sealing member 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 member 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, and 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.

[0047] 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 channel 121 and releases it through the first outlet 122 of the inner tube 120. Furthermore, the optical fiber 130 emits light that penetrates the inner tube 120 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, thus improving the therapeutic effect on vascular diseases.

[0048] See Figure 1 , 9 In the illustrated embodiment, the infusion laser balloon catheter 100 further includes a tailstock 190. The proximal ends of the inner tube 120, optical fiber 130, and 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; and 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.

[0049] Specifically, the inner tube 120 also has a guidewire 110 channel, such as a drug channel 121 serving as the guidewire 110 channel. The guidewire 110 passes through the drug channel 121 and extends proximally to connect to the tailstock 190. The proximally end of the guidewire 110 is movably or fixedly disposed in the tailstock 190. For example, the proximally end of the guidewire 110 is locked by a locking mechanism 197 that cooperates with the tailstock 190. The locking mechanism 197 includes a locking sleeve 1971 and a locking cap 1972 that cooperate with each other. The locking sleeve 1971 is fixed to the distal end of the tailstock 190, and the locking cap 1972 is movably engaged with the guidewire 110.

[0050] 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.

[0051] See Figure 9 In the illustrated embodiment, the tailstock 190 includes a detachably fitted first tailstock 195 and a second tailstock 196. The first tailstock 195 is provided with a first interface 191 communicating with a drug channel, and the second tailstock 196 is provided with a second interface 192 communicating with a fluid channel 151 and an optical path interface 193 corresponding to an optical fiber. Specifically, the first tailstock 195 and the second tailstock 196 are connected by a Luer connector. In addition, the inner tube 120, the first outer tube 150, and the proximal end of the optical fiber 130 are all connected to the second tailstock 195, and a locking mechanism 197 is provided on the first tailstock 196.

[0052] Multiple optical fibers 130 are arranged along the circumference of the inner tube 120, for example, four fibers, in a spaced-out configuration, such as evenly spaced along the circumference of the inner tube 120, which can further improve the uniformity of light emission. There are various methods for fixing the optical fibers 130, for example, see [link to relevant documentation]. Figure 5 The optical fiber 130 extends along the interior of the inner tube 120 and is fixed to the inner wall of the inner tube 120, thus avoiding interference with the movement of the guide wire 110. See also, for example... Figure 6 The inner tube 120 has a first installation channel 123 on its wall. The optical fiber 130 extends along the first installation channel 123. On the one hand, this can avoid interfering with the movement of the guide wire 110, and on the other hand, it can prevent the drug from adhering to the light-emitting section 131 of the optical fiber 130 and affecting the light-emitting effect.

[0053] See Figure 7 , 8 In the illustrated embodiment, the optical fiber 130 extends along the outside of the inner tube 120 and is fixed to the outer wall of the inner tube 120. The infusion laser balloon catheter 100 also includes a second outer tube 160, which has a second outlet 162 communicating with the drug channel 121. The drug in the drug channel 121 needs to be released sequentially through the first outlet 122 and the second outlet 162.

[0054] In one embodiment, the inner wall of the second outer tube 160 has a second mounting channel 161, and the optical fiber 130 extends along the second channel, that is, the second outer tube 160 is a multi-cavity tube. Figure 7 This serves to protect the light-emitting segment 131 and prevent the drug from adhering to the light-emitting segment 131, thus affecting the light-emitting effect.

[0055] Because of the gap between the inner tube 120 and the second outer tube 160, drugs can easily become trapped 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 optical fiber 130 is embedded in the sealant 170. The inner tube 120, sealant 170, and second outer tube 160 form a composite segment, see [reference needed]. Figure 8 .

[0056] To avoid affecting the light emission effect of the optical fiber 130, 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 to 1.67, specifically Loctite 3011 UV curing adhesive. The light emitted by the optical fiber 130 is refracted and then transmitted, making the illumination more uniform.

[0057] To ensure smooth drug release, the sealant 170 includes an intermediate channel 171 connecting the first outlet 122 and the second outlet 162. The intermediate channel 171 can be a straight channel, with both ends connected to the first outlet 122 and the second outlet 162. See, for example... Figure 8 The first outlet 122 and the second outlet 162 are aligned, and the intermediate channel 171 extends radially along the composite section and connects with the first outlet 122 and the second outlet 162, meaning the drug is released radially along the composite section. Alternatively, the intermediate channel 171 can be set at an angle to the radial direction of the composite section, meaning the drug is released at an angle. Furthermore, depending on the scenario requirements, the composite section can be divided into multiple release zones, each with a different intermediate channel 171. 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 section, while in the proximal and distal release zones, the drug is released at an angle relative to the axial direction of the composite section.

[0058] The composite segment has an inner cavity and sidewalls surrounding the inner cavity. The sidewalls have a first outlet 122, an intermediate channel 171, and a second outlet 162 forming a liquid outlet. The shape of the liquid outlet affects the drug release effect. The shape of the liquid outlet can be a circular hole or a slit hole; see [reference needed]. Figure 10 , 11 The diameter of the round hole is 0.3 to 2 mm, for example, 1 mm; the slit hole can be a straight hole, and the long diameter of the slit hole is 2 to 10 mm, and the short diameter is 0.01 to 0.1 mm, for example, the long diameter is 5 mm and the short diameter is 0.01 mm, or the long diameter is 7 mm and the short diameter is 0.05 mm.

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

[0060] See Figure 1 , 3 In the illustrated embodiment, the guidewire 110 further includes a body segment 111 and a guide segment 113 respectively connected to both ends of the occlusion member 112, wherein the proximal end of the body segment 111 extends and connects to the tailstock 190, and the guide segment 113 extends beyond the distal end of the inner tube 120. Considering the guiding effect of the guidewire 110, the length of the guide segment 113 extending beyond the distal end of the inner tube 120 is 3-5 cm.

[0061] The guide section 113 is an elastic element, such as a spring, which is made of wound metal wire. The metal wire is made of stainless steel or platinum tungsten and has a diameter of 0.01 to 0.05 mm, for example, 0.03 mm. The body section 111 of the guide wire 110 is made of metal, such as stainless steel, platinum tungsten, or nickel-titanium alloy wire, and the sealing element 112 is made of metal, such as stainless steel.

[0062] 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 0.025–0.1 mm. The first outer tube 150 is made of PA or Pebax, with a wall thickness of 0.025–0.1 mm. The second outer tube 160 is made of PA or Pebax, with a wall thickness of 0.025–0.1 mm.

[0063] The distal end of the inner tube 120 or the second outer tube 160 is also provided with a developing ring 180. Multiple developing rings 180 are typically spaced apart, for example, see [reference needed]. Figure 4 The second outer tube 160 has two fixed gaps at its distal end, and the positions of the two developing rings 180 correspond to the two ends of the axial direction of the light-emitting segment 131, respectively.

[0064] See Figure 1 , 9One embodiment of this application provides an infusion laser balloon catheter system, including the aforementioned infusion laser balloon catheter 100, a drug delivery device, an inflation device, and a light source device 200. 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 is connected to the optical fiber 130 via a conduit. Specifically, the drug delivery device supplies drug-containing fluid to the drug channel 121 through a first interface 191, the inflation device supplies fluid to the fluid channel 151 to inflate the balloon body 140 through a second interface 192, and the light source is connected to the optical fiber 130 through an optical path interface 193.

[0065] 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.

[0066] See Figure 12 One embodiment of this application provides a method for fabricating an infusion laser balloon catheter 100, comprising:

[0067] 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;

[0068] Step S200: Arrange and fix the optical fiber 130 along the outer periphery of the inner tube 120 to obtain the second preform;

[0069] 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.

[0070] 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.

[0071] 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.

[0072] 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 an inner core 132 and a cladding layer. The cladding layer covers the inner core 132, 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.

[0073] Multiple optical fibers 130, for example 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 splicing. In step S300, when the first preform is sleeved and fixed to the outer periphery of the second preform, the second outer tube 160 is sleeved on the outer periphery of the light-emitting segment 131.

[0074] 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.

[0075] 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.

[0076] 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 to 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.

[0077] 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 a liquid outlet. The laser drilling power is 300-500mW, for example 300-400mW, or even 320mW. The 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 liquid outlet holes can be obtained by setting different travel paths of the laser head according to the expected shape of the liquid outlet. Furthermore, the composite section has two rows of liquid outlets in the area between two adjacent optical fibers 130.

[0078] The perfusion laser balloon catheter 100 is also provided with a imaging ring 180. During processing, the imaging ring 180 can be fixed to the outer periphery of the second preform in step S200, that is, the outer periphery of the inner tube 120; or the imaging ring 180 can be fixed to the outer periphery of the composite section in step S400, that is, the outer periphery of the second outer tube 160.

[0079] The infusion laser balloon catheter 100 also includes a guidewire 110 fixedly 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. At least a portion of the distal end of the guidewire 110 is fixed to the distal end of the inner tube 120, for example, by fixing the sealing element 112 to the distal end of the inner tube 120. The fixing method can be adhesive bonding or welding.

[0080] Regarding the timing of fixing the guide wire 110, in one embodiment, the guide wire 110 is inserted through the second preform in step S200, namely the outer periphery of the inner tube 120. 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.

[0081] The infusion laser balloon catheter 100 also includes a tailstock 190. The processing method further includes step S500. After step S400 is completed, a fourth preform is obtained. The proximal end of the fourth preform is connected to the tailstock 190, and the proximal end of the guidewire 110 extends out of the tailstock 190. The connection method can be adhesive bonding and / or welding.

[0082] The perfusion laser balloon catheter 100 provided in this application has good luminescence uniformity, simple drug release, and is not prone to drug residue, which can effectively improve the treatment effect on vascular diseases.

[0083] 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.

[0084] 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 laser-infused balloon catheter, having a distal and a proximal end, characterized in that, The infusion laser balloon catheter includes: The guidewire has a sealing element fixed at its distal end; An inner tube is fixedly sleeved on the outer periphery of the guide wire, and the distal end of the inner tube is blocked by the sealing member. The inner tube has a drug channel, and the distal end of the inner tube has a first outlet communicating with the drug channel. An optical fiber extends along the inner tube, and the optical fiber has a light-emitting segment at the distal end of the inner tube; A balloon body is located on the outer periphery of the inner tube, and the distal end of the balloon body is sealed to the outer wall of the inner tube; 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 optical fiber extends along the outside of the inner tube and is fixed to the outer wall of the inner tube. The infusion laser balloon catheter also includes a second outer tube, which has a second outlet communicating with the drug channel. The radial gap between the second outer tube and the inner tube is filled with sealant, and the optical fiber is embedded in the sealant. The sealant has an intermediate channel connecting the first outlet and the second outlet.

2. The perfusion laser balloon catheter according to claim 1, characterized in that, The perfusion laser balloon catheter also includes a tailstock, and the proximal ends of the inner tube, the optical fiber, and the first outer tube are all connected to the tailstock. The tailstock is provided with a first interface communicating with the drug channel, a second interface communicating with the fluid channel, and an optical path interface corresponding to the optical fiber. The proximal end of the guidewire extends and is connected to the tailstock.

3. The perfusion laser balloon catheter according to claim 1, characterized in that, The optical fiber extends along the interior of the inner tube and is fixed to the inner wall of the inner tube.

4. The perfusion laser balloon catheter according to claim 1, characterized in that, The inner tube has a first mounting channel on its wall, and the optical fiber extends along the first mounting channel.

5. The perfusion laser balloon catheter according to claim 1, characterized in that, The guidewire includes a body section and a guide section respectively connected to both ends of the sealing member, the guide section extending out of the distal end of the inner tube; The guide section extends 3-5 cm beyond the distal end of the inner tube.

6. The infusion laser balloon catheter according to claim 1, characterized in that, The inner wall of the second outer tube has a second mounting channel, and the optical fiber extends along the second mounting channel.

7. The perfusion laser balloon catheter according to claim 1, characterized in that, The sealant is selected from UV adhesives with a refractive index of 1.42 to 1.

67.

8. A perfusion laser balloon catheter system, characterized in that, include: The infusion laser balloon catheter is the infusion laser balloon catheter as described in any one of claims 1 to 7; A drug delivery device for supplying a fluid containing a drug to the drug channel; An inflation device for supplying fluid to the fluid channel to inflate the balloon body; A light source device for connecting to the optical fiber path.

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