Intravascular drug-infusion balloon catheters and intravascular drug-infusion balloon catheter systems

Abstract

This application discloses an intravascular drug-inflation balloon catheter and an intravascular drug-inflation balloon catheter system. The intravascular drug-inflation balloon catheter includes: a guidewire, an inner tube, a balloon body, a first outer tube, a second outer tube, and a tailstock. The proximal end of the guidewire extends into the tailstock, which is equipped with a locking mechanism that engages with the guidewire. The intravascular drug-inflation balloon catheter provided by this application can better release drugs and ensure uniform luminescence, thereby improving the therapeutic effect on vascular diseases.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to an intravascular drug-infusion balloon catheter and an intravascular drug-infusion balloon catheter system. 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 on the balloon surface is rapidly released and transferred to the local vascular endothelial wall. A photodynamic device then emits light of a specific wavelength, which passes through the balloon and acts on the blood vessel, promoting the formation of a vascular micro-stent on the vessel wall. While this type of balloon catheter can achieve some therapeutic effect, problems such as uneven light emission within the balloon, incomplete drug release, and drug residue exist, leading to unsatisfactory therapeutic outcomes for the blood vessels. Summary of the Invention

[0004] To address the problems of the prior art, this application provides an intravascular drug-infusion balloon catheter and an intravascular drug-infusion balloon catheter system to improve the treatment effect of vascular diseases.

[0005] This application provides an intravascular drug infusion balloon catheter having a distal end and a proximal end, the intravascular drug infusion balloon catheter comprising:

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

[0007] An inner tube is slidably sleeved on the outer periphery of the guidewire. The inner tube has a first state and a second state. In the first state, the sealing member seals the distal end of the inner tube. In the second state, the guidewire moves to the proximal end, and the sealing member releases the seal on the inner tube. 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 outside of the inner tube and 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] 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.

[0011] The second outer tube is located on the outer periphery of the inner tube and wraps around the light-emitting section of the optical fiber. Both ends of the second outer tube are sealed to the outer periphery of the inner tube. The second outer tube is provided with a second outlet that communicates with the drug channel.

[0012] The tailstock is connected to the proximal ends of the inner tube, the optical fiber, and the first outer tube. 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 out of the tailstock, and the tailstock is provided with a locking mechanism that cooperates with the guidewire.

[0013] 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.

[0014] Optionally, the inner wall of the second outer tube has a second mounting channel, along which the optical fiber extends.

[0015] 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.

[0016] Optionally, the sealant has an intermediate channel connecting the first outlet and the second outlet.

[0017] Optionally, the guide wire may further include a body section and a guide section connected to both ends of the occlusion element, the guide section extending beyond the distal end of the inner tube.

[0018] Optionally, in the first state, the guide segment extends 3-5 cm beyond the distal end of the inner tube.

[0019] Optionally, the distal end of the inner tube has a reduced diameter section with a gradually decreasing inner diameter, and in the first state, the sealing element seals the reduced diameter section.

[0020] Optionally, the sealing element is a cone with a gradually decreasing diameter from the proximal end to the distal end. In the first state, the distal end of the cone seals the distal end of the inner tube.

[0021] Optionally, the tailstock includes a detachable first tailstock and a second tailstock. The first tailstock is provided with a first interface communicating with the drug channel, and the second tailstock is provided with a second interface communicating with the fluid channel and an optical path interface corresponding to the optical fiber.

[0022] Optionally, the locking mechanism includes a locking sleeve and a locking cap that fit together, wherein the locking cap is provided with a deformation member for locking the guide wire, and one of the tailstock and the guide wire is connected to the locking sleeve and the other is connected to the locking cap;

[0023] The connection method is either a fixed connection or a movable connection.

[0024] Optionally, the locking sleeve is fixedly connected to the tailstock, and the locking cap is movably connected to the guide wire; in the first state, the locking cap and the locking sleeve cooperate with each other and drive the deformation element to lock the guide wire.

[0025] This application also provides an intravascular drug infusion balloon catheter system, comprising:

[0026] An intravascular drug-infusion balloon catheter, specifically the aforementioned intravascular drug-infusion balloon catheter;

[0027] A drug delivery device for supplying a fluid containing a drug to the drug channel;

[0028] An inflation device for supplying fluid to the fluid channel to inflate the balloon body;

[0029] A light source device for connecting to the optical fiber path.

[0030] Compared with existing technologies, the intravascular drug infusion balloon catheter provided in this application has good luminescence uniformity, simple drug release, and is less prone to drug residue, which can effectively improve the treatment effect of vascular diseases. Attached Figure Description

[0031] Figure 1 This is a schematic diagram of the intravascular drug infusion balloon catheter in one embodiment of this application;

[0032] Figure 2 This is a schematic diagram of a partial structure of an intravascular drug infusion balloon catheter in one embodiment;

[0033] Figure 3 This is a schematic diagram of the distal structure of the intravascular drug infusion balloon catheter in the first state.

[0034] Figure 4 This is a schematic diagram of the distal structure of the intravascular drug infusion balloon catheter in the second state;

[0035] Figure 5This is a schematic diagram of the structure of the inner tube, optical fiber, and second outer tube in one embodiment;

[0036] Figure 6 This is a schematic diagram of the structure of the inner tube, optical fiber, sealant, and second outer tube in one embodiment;

[0037] Figure 7 This is a schematic diagram of the composite segment in one embodiment;

[0038] Figure 8 This is a schematic diagram of the composite segment in another embodiment;

[0039] Figure 9 This is a schematic diagram of the structure of an intravascular drug infusion balloon catheter in one embodiment;

[0040] Figure 10 This is a flowchart illustrating the fabrication method of an intravascular drug infusion balloon catheter in one embodiment.

[0041] The annotations in the figure are explained as follows:

[0042] 100. Intravascular drug infusion 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 installation 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;

[0043] 200. Light source device; 210. Fiber optic connector; 220. Fiber optic protective sleeve;

[0044] 1. Proximal end; 2. Distal end. Detailed Implementation

[0045] 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.

[0046] 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.

[0047] 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.

[0048] See Figures 1-9 One embodiment of this application provides an intravascular drug infusion balloon catheter 100, having a proximal end 1 and a distal end 2. The intravascular drug infusion balloon catheter 100 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 element 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 element 112 seals the distal end of the inner tube 120. In the second state, the guidewire 110 moves proximally, and the sealing element 112 releases the seal on the distal end of the inner tube 120. The inner tube 120 has a drug channel 121. For drug release, 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.

[0049] 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.

[0050] The intravascular drug-infusion 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 the drug 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 intravascular drug-infusion 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.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] See Figure 5 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 drugs from adhering to the light-emitting segment 131 and 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 6 .

[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 1.42~1.67, 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 6 The first outlet 122 and the second outlet 162 are aligned, and the intermediate channel 171 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 171 can be set at an angle to the radial direction of the composite section, meaning the drug is released at an angle.

[0058] In addition, depending on the scenario requirements, the composite segment can be divided into multiple release zones, each with a different intermediate channel 171, such as 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.

[0059] 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. See also Figure 7 , 8 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.

[0060] To control the drug release rate, the porosity of the composite section is 40-70%, or for example 50-70%, or for example 65%. Along the circumference of the composite section, at least two drug outlet holes are provided between two adjacent optical fibers 130, for example, two drug outlet holes are provided, and the distance between the two drug outlet holes is 0.5-1mm.

[0061] See Figure 3 , 4 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, in the first state, the length of the guide segment 113 extending beyond the distal end of the inner tube 120 is 3~5cm.

[0062] 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 0.01~0.05mm, for example, 0.03mm. The body section 111 of the guide wire 110 is made of metal wire, such as stainless steel, platinum tungsten, or nickel-titanium alloy wire; the sealing element 112 is made of metal, such as stainless steel.

[0063] The distal end of 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 3 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 , 9 In the illustrated embodiment, the locking mechanism 197 includes a locking sleeve 1971 and a locking cap 1972 that engage and cooperate. A deformation element is provided inside the locking cap 1972, which can lock the guide wire 110 by deforming. One of the tailstock 190 and the guide wire 110 is connected to the locking sleeve 1971, and the other is connected to the locking cap 1972. The connection method can be a fixed connection or a movable connection. The movable connection is, for example, a threaded connection or a movable through-hole connection.

[0065] Specifically, in one embodiment, the locking sleeve 1971 is fixedly connected to the tailstock 190, and the locking cap 1972 has a through hole that allows the guide wire 110 to pass through. The guide wire 110 is movably connected to the locking cap 1972. In a first state, the locking cap 1972 and the locking sleeve 1971 cooperate with each other and drive the deformation element to lock the guide wire 110.

[0066] See Figure 9In 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 the drug channel 121, and the second tailstock 196 is provided with a second interface 192 communicating with the fluid channel 151 and an optical path interface 193 corresponding to the optical fiber 130. 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 196, and a locking mechanism 197 is provided on the first tailstock 195.

[0067] 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.

[0068] See Figure 1 , 9 This application provides an intravascular drug infusion balloon catheter system, including an intravascular drug infusion balloon catheter 100, a drug delivery device, an inflation device, and a light source device 200. The specific structure of the intravascular drug infusion balloon catheter 100 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 200 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 inflate the balloon body 140 to the fluid channel 151 through a second interface 192, and the light source is connected to the optical fiber 130 through an optical path interface 193.

[0069] The light source device 200 includes an optical fiber 130 connector 210 and an optical fiber protective sleeve 220. The optical fiber 130 extends into the optical fiber protective sleeve 220 and one end is connected to the optical fiber connector 210. The optical fiber protective sleeve 220 is made of TPU and can be used to protect the optical fiber 130 from bending.

[0070] See Figure 10 This application provides a method for manufacturing an intravascular drug infusion balloon catheter 100, which 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 manufacturing method includes:

[0071] 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;

[0072] Step S200: Arrange and fix the optical fiber 130 along the outer periphery of the inner tube 120 to obtain the second preform;

[0073] 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.

[0074] 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.

[0075] 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.

[0076] In step S200, 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 bonding or welding. 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.

[0077] 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. 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.

[0078] 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.

[0079] 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.

[0080] 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. 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.

[0081] The intravascular infusion balloon catheter 100 also includes a guidewire 110 that slides through the inner tube 120. The guidewire 110 includes a guide segment 113, an occlusion element 112, and a body segment 111 connected in sequence. The guide segment 113 extends out of the distal end of the inner tube 120, the occlusion element 112 occludes the distal end of the inner tube 120, and the body segment 111 extends out of the proximal end of the inner tube 120.

[0082] The intravascular infusion drug balloon catheter 100 also includes a tail seat 190. The processing method further includes step S500: sliding the guide wire 110 through the fourth preform and then connecting the proximal end of the fourth preform to the tail seat 190, with the proximal end of the guide wire 110 extending out of the tail seat 190.

[0083] The intravascular infusion 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 proximal end of the guidewire 110 extending out of the tail seat 190 is inserted into the locking cap 1972.

[0084] When the tailstock 190 is a detachable structure, the inner tube 120, the optical fiber 130 and the proximal end of 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.

[0085] The intravascular drug infusion 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 of vascular diseases.

[0086] 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.

[0087] 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. An intravascular drug-infusion balloon catheter, having a distal and a proximal end, characterized in that, The intravascular drug-infusion balloon catheter includes: The guidewire has a sealing element fixed at its distal end; An inner tube is slidably sleeved on the outer periphery of the guidewire. The inner tube has a first state and a second state. In the first state, the sealing member seals the distal end of the inner tube. In the second state, the guidewire moves to the proximal end, and the sealing member releases the seal on the inner tube. 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 outside of the inner tube and 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 second outer tube is located on the outer periphery of the inner tube and wraps around the light-emitting section of the optical fiber. Both ends of the second outer tube are sealed to the outer periphery of the inner tube. The second outer tube is provided with a second outlet that communicates with the drug channel. The tailstock is connected to the proximal ends of the inner tube, the optical fiber, and the first outer tube. 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 out of the tailstock, and the tailstock is provided with a locking mechanism that cooperates with the guidewire. 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 intravascular drug infusion 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.

3. The intravascular drug infusion balloon catheter according to claim 1, characterized in that, The sealant is a UV sealant with a refractive index of 1.42 to 1.

67.

4. The intravascular drug infusion balloon catheter according to claim 1, characterized in that, After the sealant is injected, the inner tube, the sealant, and the second outer tube form a composite section. The composite section has an inner cavity and a sidewall surrounding the inner cavity. The sidewall is provided with a first outlet, the intermediate channel, and a second outlet.

5. The intravascular drug infusion balloon catheter according to claim 4, characterized in that, The intermediate channel extends radially along the composite segment, or the intermediate channel is set at an angle to the radial direction of the composite segment.

6. The intravascular drug infusion balloon catheter according to claim 1, characterized in that, The guide wire also includes a body section and a guide section connected to both ends of the sealing member, the guide section extending beyond the distal end of the inner tube; In the first state, the guide segment extends 3-5 cm beyond the distal end of the inner tube.

7. The intravascular drug infusion balloon catheter according to claim 1, characterized in that, The distal end of the inner tube has a reduced diameter section with a gradually decreasing inner diameter. In the first state, the sealing element seals the reduced diameter section.

8. The intravascular drug infusion balloon catheter according to claim 1, characterized in that, The sealing element is a cone that gradually narrows from the proximal end to the distal end. In the first state, the distal end of the cone seals the distal end of the inner tube.

9. The intravascular drug infusion balloon catheter according to claim 1, characterized in that, The tailstock includes a detachable first tailstock and a second tailstock. The first tailstock is provided with a first interface communicating with the drug channel, and the second tailstock is provided with a second interface communicating with the fluid channel and an optical path interface corresponding to the optical fiber. The inner tube, the first outer tube, and the near end of the optical fiber are all connected to the second tailpiece.

10. The intravascular drug infusion balloon catheter according to claim 1, characterized in that, The locking mechanism includes a locking sleeve and a locking cap that fit together. The locking cap contains a deformable element that locks the guide wire. One of the tailstock and the guide wire is connected to the locking sleeve, and the other is connected to the locking cap. The connection method is either a fixed connection or a movable connection.

11. The intravascular drug infusion balloon catheter according to claim 10, characterized in that, The locking sleeve is fixedly connected to the tailstock, and the locking cap is movably connected to the guide wire; In the first state, the locking sleeve and the locking cap cooperate with each other and drive the deformable element to lock the guide wire.

12. An intravascular drug-infusion balloon catheter system, characterized in that, include: Intravascular drug infusion balloon catheter as described in any one of claims 1 to 11; 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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