Balloon catheter system with repair function

Abstract

A balloon catheter system (100) with a repairing function, comprising: a tube body (130) having opposite distal and proximal ends, the tube body (130) providing at least a fluid channel (138) and an optical fiber (120) channel; a balloon body (110) located at the outer periphery of the distal end of the tube body (130) and in communication with the fluid channel (138); and an optical fiber (120) arranged in the optical fiber (120) channel and having a light emitting section extending to the location of the balloon body (110), the light emitting section being used to emit laser light with a repairing function, the wavelength of the laser light being 400-750 nm. The balloon catheter system (100) concentrates the torn part of the blood vessel wall in a predetermined area and provides laser light of a specific wavelength in the area to effectively repair the torn part of the blood vessel wall, thereby effectively preventing the occurrence of restenosis and preventing the proliferation of neointima when implanting a blood vessel stent.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a balloon catheter system with repair function. Background Technology

[0002] Percutaneous interventional therapy has become one of the commonly used treatment techniques worldwide. For endovascular stenosis, balloon dilation or stent implantation are usually used for treatment. However, both methods have their own shortcomings. When using bare balloon dilation to treat endovascular stenosis, the probability of restenosis after treatment is very high. When using bare metal stent catheter intervention to treat endovascular stenosis, although restenosis is less likely, it is prone to neointimal proliferation (i.e., the process of scar tissue formation occurring in the stent segment). Once endovascular restenosis or neointimal proliferation occurs, interventional therapy is required again. Summary of the Invention

[0003] Based on this, a balloon catheter system with repair function is provided, which can solve the problems of restenosis and neointimal proliferation after interventional treatment.

[0004] The technical solution provided in this application is as follows: A balloon catheter system with repair function, comprising: A tube body having a distal end and a proximal end, the tube body providing at least a fluid channel and an optical fiber channel; The balloon body is located on the outer periphery of the distal end of the tube and is in communication with the fluid channel; An optical fiber is inserted through the optical fiber channel and has a light-emitting segment extending to the location of the balloon body; The laser generating module is connected to the near end of the optical fiber. The laser generating module emits a laser with repair function, and the wavelength of the laser is 400~750nm.

[0005] 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.

[0006] Optionally, the laser generating module outputs a laser with a power of 10~30mW.

[0007] Optionally, the laser generating module outputs laser light of a predetermined wavelength in each working cycle in the following order: Initial stage: Power 5-8mW / cm 2 Lasts 10-20 seconds; Intermediate stage: Power 10-30mW / cm 2Lasts 120-180 seconds; Final stage: Power 5-8mW / cm 2 It lasts for 10-20 seconds.

[0008] Optionally, the balloon body includes an isodiameter segment and conical segments located at both ends of the isodiameter segment, and the surface of the conical segment at the distal end of the balloon body is covered with a black coating.

[0009] Optionally, the high refractive index UV adhesive has a refractive index of 1.50-1.70.

[0010] Optionally, a high-refractive-index UV adhesive is attached to the outer periphery of the balloon body at intervals. The high-refractive-index UV adhesive protrudes relative to the surface of the balloon body, and the protrusion height is 0.20 mm to 0.25 mm.

[0011] Optionally, the high-refractive-index UV adhesive is regularly distributed on the outer periphery of the capsule.

[0012] Optionally, the high-refractive-index UV adhesive consists of dot-shaped protrusions arranged in a matrix, with the spacing between the dot-shaped protrusions being 3-10 mm.

[0013] Optionally, the high-refractive-index UV adhesive consists of linear protrusions extending along the axial direction of the capsule and arranged at equal intervals around the capsule in the circumferential direction, with the number of linear protrusions being 3-10.

[0014] Optionally, the length of the linear protrusion is adapted to the length of the equal-diameter section.

[0015] Optionally, the tube body includes an inner tube and an outer tube nested inside and outside. The outer tube of the tube body is black, the inner tube of the tube body is colorless and transparent, and the hardness of the inner tube of the tube body is 35D to 75D, with the hardness increasing continuously or at predetermined intervals from the distal end to the proximal end.

[0016] Optionally, the inner tube of the tube body includes at least two first unit segments connected sequentially along the axial direction, wherein for two adjacent first unit segments, the first unit segment closer to the distal end has a lower hardness than the first unit segment closer to the proximal end.

[0017] Optionally, the number of the first unit segments is 2 to 4.

[0018] Optionally, the diameters of the first unit segments are the same, or for two adjacent first unit segments, the diameter of the first unit segment closer to the far end is smaller than the diameter of the first unit segment closer to the proximal end.

[0019] Optionally, the axial length of the first unit segment closest to the proximal end is 20~30cm.

[0020] Optionally, each first unit segment adopts a single-layer pipe or a multi-layer pipe. The material of the single-layer pipe can be one of PEBAX, nylon, and TPU. In the multi-layer pipe, each layer can slide relative to the other, and the material of each layer is independently selected from one of PEBAX, nylon, and PE.

[0021] Optionally, the inner tube of the tube body includes a proximal inner tube and a distal inner tube connected along the axial direction, wherein the hardness of the proximal inner tube is 55D~75D and the hardness of the distal inner tube is 35D~55D.

[0022] Optionally, the outer tube of the tube body includes at least two second unit segments connected sequentially along the axial direction, wherein for two adjacent second unit segments, the second unit segment closer to the distal end has a lower hardness than the second unit segment closer to the proximal end.

[0023] Optionally, the number of the second unit segments is 2 to 4.

[0024] Optionally, the diameters of the second unit segments are the same, or for two adjacent second unit segments, the diameter of the second unit segment closer to the far end is smaller than the diameter of the second unit segment closer to the proximal end.

[0025] Optionally, each second unit segment may use a single-layer pipe or a multi-layer pipe. The material of the single-layer pipe may be PEBAX or nylon. In the multi-layer pipe, each layer may slide relative to the other, and the material of each layer may be independently selected from PEBAX or nylon.

[0026] Optionally, an elastic element is welded to the distal end of the inner tube. The elastic element includes an exposed section and a welded section along the axial direction of the tube body. The ratio of the axial length of the exposed section to the welded section is 1:0.8~1.2. The diameter of the elastic element gradually increases from the distal end of the exposed section to the proximal end of the welded section.

[0027] Optionally, the elastic element is a helical spring, which is made of metal wire with a diameter of 0.04-0.1 mm wound in a spiral.

[0028] Optionally, the metal wire is made of one of the following materials: platinum-tungsten, platinum-iridium, stainless steel, gold, and nickel-titanium.

[0029] Optionally, the pitch of the exposed section is equal to the diameter of the wire, and the pitch of the welded section is 1-3 times the diameter of the wire.

[0030] Optionally, the axial length of the elastic element is 2-5 mm.

[0031] Optionally, the axial length of the exposed section of the elastic element is 0.5-2 mm, and the axial length of the welded section is 1-3 mm.

[0032] Optionally, the diameter of the exposed section is 0.50-0.70 mm, and the diameter of the welded section is 0.60-1.0 mm.

[0033] Optionally, the ratio of the distal diameter of the exposed section to the proximal diameter of the welded section is 1:1 to 1.5.

[0034] Optionally, the proximal end of the welded section is formed by bending a metal wire that forms a helical spring to form a weld ring that is welded to the inner tube wall.

[0035] Optionally, the tube body includes an inner tube and an outer tube nested inside and outside. The distal end of the balloon body is sealed to the outer wall of the inner tube, and the proximal end of the balloon body is sealed to the outer tube. The radial gap between the inner tube and the outer tube serves as an optical fiber channel. The optical fibers are arranged either parallel to the inner tube or wrapped around the inner tube.

[0036] Optionally, the optical fiber is multiple, and each optical fiber is evenly distributed around the axis of the tube.

[0037] Optionally, the diameter of each optical fiber is 0.125mm to 0.25mm.

[0038] Optionally, the tube body includes an inner tube and an outer tube nested together, the distal end of the balloon body is sealed to the outer wall of the inner tube, the proximal end of the balloon body is sealed to the outer tube, the inner tube and the outer tube have a radial gap and the radial gap is a fluid channel, and the lumen of the inner tube is an optical fiber channel.

[0039] Optionally, at least one section of the tube body in the axial direction is a double-lumen tube, the double-lumen tube including a fluid channel and a guide wire channel, the fluid channel and the guide wire channel being isolated from each other, and the fluid channel communicating with the radial gap between the inner tube and the outer tube.

[0040] Optionally, a first guidewire port is provided on the wall of the inner tube extending from the distal end of the balloon body. The two ends of the guidewire channel are a second guidewire port and a third guidewire port, respectively. The guidewire passes through the first guidewire port, the second guidewire port, and the third guidewire port, and the portion of the guidewire between the first guidewire port and the second guidewire port is located outside the balloon body.

[0041] Optionally, the outer surface of the balloon is provided with a drug coating, wherein the drug is at least one of an anti-proliferative drug, a drug that induces cross-linking of collagen or elastin, and an anti-vasospasm drug.

[0042] Optionally, the drug is paclitaxel or rapamycin.

[0043] Optionally, the outer surface of the balloon body is provided with an implantable vascular stent.

[0044] The balloon catheter system provided in this application concentrates the torn part of the blood vessel wall in a predetermined area and provides a laser of a specific wavelength in that area to effectively repair the torn part of the blood vessel wall. It can effectively prevent restenosis and also prevent neointimal proliferation when implanting a vascular stent. Attached Figure Description

[0045] Figure 1 A schematic diagram of a balloon catheter system with repair capabilities; Figure 2 This is a schematic diagram of the first type of distribution of high-refractive-index UV colloid on the surface of the spherical capsule. Figure 3 This is a schematic diagram of the second type of distribution of high refractive index UV colloid on the surface of the spherical body; Figure 4 This is a schematic diagram showing the positional relationship between the optical fiber and the cross-section of the inner tube; Figure 5 This is a schematic diagram illustrating the first possible positional relationship between the optical fiber and the inner tube. Figure 6 This is a schematic diagram illustrating the second possible positional relationship between the optical fiber and the inner tube. Figure 7 This is a schematic diagram of the outer tube within the tube body; Figure 8 This is a schematic diagram of a balloon catheter system with repair capabilities (the guidewire is located outside the balloon body). Figure 9 for Figure 8 Enlarged view of part A in the image; Figure 10 for Figure 8 A schematic diagram showing the positions of the tubular body, double-lumen tube, and balloon body within the balloon; Figure 11 This is a schematic diagram of the cross-section of a double-lumen tube.

[0046] In the diagram: 100, Balloon catheter system; 110, Balloon body; 111, Dot-like protrusion; 112, Linear protrusion; 113, Constant diameter section; 114, Tapered section; 120, Optical fiber; 130, Tube body; 131, Outer tube; 132, Inner tube; 133, Dual-lumen tube; 134, First guidewire port; 135, Second guidewire port; 136, Third guidewire port; 137, Guidewire channel; 138, Fluid channel; 140, Catheter seat; 150, Stress relief tube; 160, Optical fiber connector; 170, Elastic element; 171, Exposed section; 172, Welded section; 173, Welded ring; 180, Guidewire. Detailed Implementation

[0047] 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.

[0048] To better describe and illustrate the embodiments of this application, reference may be made to one or more accompanying drawings, but the additional details or examples used to describe the drawings should not be considered as limiting the scope of any of the inventive creations of this application, the embodiments or preferred methods described herein.

[0049] 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.

[0050] 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 in the specification of this application is for the purpose of describing particular embodiments only and is not intended to be limiting of this application.

[0051] See Figure 1 As shown, a balloon catheter system 100 with repair function includes: The tube body 130 has a distal end and a proximal end, and the tube body 130 provides at least a fluid channel and an optical fiber channel; The balloon body 110 is located on the outer periphery of the distal part of the tube body 130 and is in communication with the fluid channel; Optical fiber 120 is inserted into the optical fiber channel and has a light-emitting segment extending to the location of the spherical body 110; The laser generating module is connected to the near end of the fiber optic cable 120. The laser generating module emits a laser with repair function, and the wavelength of the laser is 400~750nm.

[0052] When using the balloon catheter system 100 with repair function, fluid is first injected into the balloon body 110 through the fluid channel of the tube body 130 to inflate the balloon body 110. Then, a laser with a wavelength of 400~750nm is emitted through the laser generation module. The laser is emitted through the light-emitting segment of the optical fiber 120 and is applied to the site to be repaired after being scattered by the balloon body 110, the fluid inside the balloon body 110 and the balloon body 110. Under normal circumstances, the desired effect can be achieved by continuously applying the laser for a predetermined time.

[0053] The outer periphery of the balloon 110 is coated with a high-refractive-index UV adhesive distributed at intervals. The high-refractive-index UV adhesive is regularly distributed on the outer surface of the balloon 110. When the balloon 110 is filled with fluid, the balloon 110 expands and expands the blood vessel wall. During the expansion of the blood vessel wall, the blood vessel wall structure will undergo local tearing to meet the expansion. The tearing of the blood vessel wall will be concentrated in the area where the high-refractive-index UV adhesive is distributed. Because the high-refractive-index UV adhesive protrudes relative to the outer wall of the balloon 110, it is easier to form a stress concentration area when it acts on the blood vessel wall. The high-refractive-index UV adhesive concentrates the originally disordered blood vessel wall tearing into the area where the high-refractive-index UV adhesive exists. At the same time, the high-refractive-index UV adhesive enriches the laser in this area, so that the laser can act more concentratedly on the torn area of ​​the blood vessel wall, thereby completing the repair of this area.

[0054] This application addresses the unavoidable, disordered tearing of the blood vessel wall by concentrating a high-refractive-index UV adhesive protruding from the outer surface of the balloon body 110 in a specific area, which is also the area where the high-refractive-index UV adhesive exists. Furthermore, based on the laser focusing effect of the high-refractive-index UV adhesive in this specific area, the repair of blood vessel tears can be achieved more effectively.

[0055] When laser light is applied to the area to be repaired, it can promote the repair of damaged blood vessels and effectively prevent restenosis.

[0056] The laser generating module provides low-power lasers that are pulsed or continuously output, which are transmitted to the inside of the balloon body 110 through the optical fiber 120. The light-emitting segment of the optical fiber 120 inside the balloon body 110 applies the low-intensity laser to the area to be repaired. The low-intensity laser has a photomodulation effect, which is generated by photochemical effects rather than thermal effects. It can promote the repair of cells and tissues, accelerate the clearance of inflammatory mediators and the absorption of tissue edema.

[0057] After balloon catheter dilation, damage to the vascular endothelium is common. By using the 120 light-emitting segment of the fiber optic cable to emit red light of a specific wavelength, which is then scattered by the 110 light-emitting segment of the balloon and applied to the damaged area of ​​the vascular endothelium, the vascular endothelial cell proliferation and anti-inflammatory apoptosis can be promoted, the blood vessel can be accelerated to return to a stable state, and postoperative restenosis can be prevented.

[0058] The laser generating module emits laser light with a wavelength of 400-750 nm. Within this wavelength range, the laser appears red and can promote the repair of cell nuclei and tissues, accelerate the clearance of inflammatory mediators, and accelerate the absorption of tissue edema. More preferably, the laser generating module emits laser light with a wavelength of 630-700 nm.

[0059] The laser generating module outputs a laser power of 10~30mW. More preferably, the laser generating module outputs a laser power of 10~15mW.

[0060] The laser generating module outputs laser light of a predetermined wavelength in each working cycle in the following order: Initial stage: Power 5-8mW / cm 2 Lasts 10-20 seconds; Intermediate stage: Power 10-30mW / cm 2 Lasts 120-180 seconds; Final stage: Power 5-8mW / cm 2 It lasts for 10-20 seconds.

[0061] Each working cycle corresponds to a complete cycle of the laser generating module's action on the blood vessel wall. In the initial stage, low-power, short-duration laser output allows the blood vessel to adapt to laser irradiation, preparing it for subsequent treatment. In the intermediate stage, increased power is used to heal torn blood vessels and prevent postoperative restenosis. In the final stage, low-power, short-duration laser output is used for postoperative buffering to reduce the burden on the blood vessel.

[0062] If the laser power output by the laser generator module is too low, the repair effect will be unsatisfactory; if the power is too high, it will cause excessive heat and lead to blood vessel burns. Ideally, the power should be 10-15 mW / cm² during the intermediate stage. 2 It lasts for 120-180 seconds.

[0063] The balloon body 110 can be a smooth, bare balloon or a non-standard balloon. The material of the balloon body needs to have sufficient flexibility and good permeability to smoothly reach the intended location, while also meeting requirements for excellent processability, good resilience, fatigue resistance, and dimensional stability. Preferably, the balloon body is made of one of PEBAX, nylon, or TPU. More preferably, the balloon body is made of PEBAX or nylon.

[0064] See Figure 10 As shown, the balloon body 110 includes an isodiameter segment 113 and conical segments 114 located at both ends of the isodiameter segment 113, wherein the distal conical segment 114 (see...) Figure 10 The surface of the black-filled area is covered with a black coating. The material of the black coating is one of PTFE, mixed shellac, or mixed UV glue. The conical segments 114 at both ends of the sac body 110 are not strictly conical, but are only approximately conical parts formed by the change in diameter of the sac body.

[0065] A black coating is applied to the distal end of the balloon body 110 to block the laser and prevent it from burning unintended areas.

[0066] See Figure 1As shown, the balloon catheter system 100 also includes a stress relief tube 150 and a catheter seat 140. The stress relief tube 150 is connected between the tube body 130 and the catheter seat 140. The catheter seat 140 is connected to the proximal end of the tube body 130 and has an interface that communicates with the fluid channel and the optical fiber channel respectively. After the optical fiber 120 extends out of the optical fiber channel, it is connected to the laser generating module through the optical fiber connector 160.

[0067] The laser emitted from the light-emitting segment is focused in the high-refractive-index UV adhesive region to ensure sufficient laser intensity applied to the area to be repaired. Preferably, the refractive index of the high-refractive-index UV adhesive is 1.50-1.70. More preferably, the refractive index of the high-refractive-index UV adhesive is 1.54-1.62.

[0068] The high-refractive-index UV adhesive concentrates the tear in the blood vessel wall at the intended location. In order to prevent the tear from becoming too complicated, the high-refractive-index UV adhesive is regularly distributed on the outer periphery of the balloon body 110. The high-refractive-index UV adhesive protrudes relative to the surface of the balloon body, and the protrusion height is 0.20mm~0.25mm.

[0069] See Figure 2 As shown, the high-refractive-index UV adhesive consists of dot-shaped protrusions 111 arranged in a matrix, with a spacing of 3-10 mm between each protrusion 111. Each protrusion 111 is equidistant from its adjacent counterparts. Each protrusion 111 is hemispherical, with its plane fixedly connected to the outer surface of the capsule. The height of each protrusion 111 (i.e.,...) Figure 2 The thickness (H1 in the figure) is 0.20mm~0.25mm.

[0070] See Figure 3 As shown, the high-refractive-index UV adhesive consists of linear protrusions 112 extending axially along the capsule body 110 and arranged at equal intervals circumferentially around the capsule body 110. The number of linear protrusions 112 is 3-5. The height of the linear protrusions 112 (i.e., Figure 3 The diameter (H2 in the figure) is 0.20 mm to 0.25 mm. The balloon body 110 includes an equal diameter section 113 and conical sections 114 located at both ends of the equal diameter section. The length of the linear protrusion 112 is adapted to the length of the equal diameter section 113, and a smooth transition is formed between the end of the linear protrusion 112 and the conical section 114.

[0071] When fluid is injected into the balloon 110 through the fluid channel of the tube 130, causing the balloon 110 to inflate, the high refractive index ultraviolet gel can focus the laser. The focused laser is then applied more concentratedly to the area to be repaired, avoiding omissions in the treatment area.

[0072] In addition to effectively repairing torn blood vessels using focused laser treatment, the high-refractive-index UV gel can also increase the friction between the balloon 110 and the blood vessel wall during balloon expansion, thereby reducing the slippage of the balloon 110 relative to the blood vessel wall, improving treatment efficacy, and reducing unnecessary damage to non-treatment areas.

[0073] The regularly distributed high-refractive-index UV adhesive can also cut the lesion site, reducing irregular tearing and dissection of blood vessels.

[0074] See Figure 1 As shown, the tube body 130 includes an inner tube 132 and an outer tube 131 nested together. The inner and outer tubes can be made of the same material or different materials. The inner tube is colorless and transparent, while the outer tube is black. The colorless and transparent inner tube allows the light transmitted through the optical fiber to radiate outwards, while the black outer tube is used to block the light emitted from the optical fiber from shining on unintended areas.

[0075] The inner tube hardness of the tube body is 35D to 75D, and the hardness increases continuously or at predetermined intervals from the distal end to the proximal end.

[0076] The inner tube of the tube body comprises at least two first unit segments connected sequentially along the axial direction. For two adjacent first unit segments, the first unit segment closer to the distal end has a lower hardness than the first unit segment closer to the proximal end. The connection between the two first unit segments is achieved by welding.

[0077] The first unit consists of 2 to 4 segments.

[0078] Each first unit segment has the same diameter, or for two adjacent first unit segments, the diameter of the first unit segment closer to the distal end is smaller than the diameter of the first unit segment closer to the proximal end. Along the axial direction of the tube, the diameter gradually increases from the distal end to the proximal end. This ensures the maneuverability of the tube at the proximal end while allowing the inner diameter of the distal end to be smaller, enabling it to extend into finer blood vessels, especially cerebral blood vessels.

[0079] The axial lengths of each first unit segment may be the same or different.

[0080] The axial length of the first unit segment closest to the proximal end is 20~30cm.

[0081] Each first unit segment adopts a single-layer pipe or a multi-layer pipe. The material of the single-layer pipe can be one of PEBAX, nylon, and TPU. In the multi-layer pipe, each layer can slide relative to the other, and the material of each layer is independently selected from one of PEBAX, nylon, and PE.

[0082] Each first unit section uses a single-layer pipe, and the material of the single-layer pipe is nylon or PEBAX.

[0083] Each first unit segment uses multi-layer pipes, and the materials of each multi-layer pipe may be the same or different, and the thickness of each layer of the multi-layer pipe may be the same or different.

[0084] Each first unit section uses a three-layer pipe, in which each layer can slide relative to the other. From the outside to the inside, the thicknesses of each layer are 0.04 mm, 0.05 mm, and 0.01 mm, respectively, and the materials of each layer are HDPE, LDPE, and nylon, respectively.

[0085] The inner tube of the tube body includes a proximal inner tube and a distal inner tube connected along the axial direction. The hardness of the proximal inner tube is 55D~75D, and the hardness of the distal inner tube is 35D~55D.

[0086] The proximal inner tube uses a three-layer tube, while the distal inner tube uses either a three-layer tube or a single-layer tube.

[0087] The proximal inner tube is made of three layers of PEBAX material, and the distal inner tube is also made of three layers of PEBAX material.

[0088] The outer tube of the tube body comprises at least two second unit segments connected sequentially along the axial direction. For any two adjacent second unit segments, the second unit segment closer to the distal end has a lower hardness than the second unit segment closer to the proximal end. The connection between the two second unit segments is achieved by welding.

[0089] The second unit consists of 2 to 4 segments.

[0090] Each second unit segment has the same diameter, or for two adjacent second unit segments, the diameter of the first unit segment closer to the distal end is smaller than the diameter of the first unit segment closer to the proximal end. Along the axial direction of the tube, the diameter gradually increases from the distal end to the proximal end. This ensures good maneuverability at the proximal end while allowing for a smaller inner tube diameter at the distal end, enabling it to extend into finer blood vessels, especially cerebral vessels.

[0091] The axial lengths of each second unit segment may be the same or different.

[0092] Each second unit section uses a single-layer pipe or a multi-layer pipe. The material of the single-layer pipe can be PEBAX or nylon. In the multi-layer pipe, each layer can slide relative to the other, and the material of each layer is independently selected from PEBAX or nylon.

[0093] Each second unit segment uses multi-layer pipes, and the materials of each multi-layer pipe may be the same or different, and the thickness of each layer of the multi-layer pipe may be the same or different.

[0094] In this application, by selecting appropriate materials for the balloon body, inner tube, and outer tube, the delivery system formed by the balloon body, inner tube, and outer tube is relatively more flexible, so as to balance the increase in rigidity of the delivery system caused by the addition of optical fiber, so that the delivery system ultimately presents an ideal state that combines radial support and flexibility.

[0095] See Figure 7 As shown, Figure 7 In the diagram, Y represents the distal end and J represents the proximal end. Following the order from distal to proximal end, the outer tube includes three second unit segments L1, L2, and L3 connected sequentially along the axial direction. The second unit segments are connected by welding and arranged coaxially. The diameter of the second unit segment L1 is 0.85 mm and the axial length is 120 mm; the diameter of the second unit segment L2 is 1.10 mm and the axial length is 140 mm; and the diameter of the second unit segment L3 is 1.10 mm and the axial length is 1300 mm. The material of the second unit segments L1 and L2 is PEBAX, and the material of the second unit segment L3 is nylon.

[0096] Figure 7 The middle section describes the structure of the outer tube within the pipe body. The inner tube has the same structure as the outer tube, but differs in material and diameter. When the outer tube of the pipe body is made of... Figure 7 When the inner tube is composed of multiple second unit segments, it is also composed of multiple first unit segments, and the number and axial length of the first and second unit segments are the same. From the distal end to the proximal end, the diameter of the first unit segment of the inner tube is 0.54 mm, the hardness is 55D, 63D, and 70D respectively, and the material is Pebax, Pebax, and PA respectively.

[0097] When the outer pipe uses a single diameter, the inner pipe also uses a single diameter, and the structures of the inner and outer pipes are consistent.

[0098] See Figure 8 , Figure 9 As shown, an elastic element 170 is welded to the distal end of the inner tube 132. The elastic element 170 includes an exposed section 171 along the axial direction of the tube body (corresponding to...). Figure 9 Section T1 and welding section 172 (corresponding to) Figure 9 The ratio of the axial length of the exposed section 171 to the welded section 172 (T2 segment) is 1:0.8~1.2. The diameter of the elastic element 170 gradually increases from the far end of the exposed section 171 to the near end of the welded section 172.

[0099] At the distal end of the tube body, the inner tube 132 intersects with the distal end of the balloon body. An elastic element 170 is welded to the distal end of the inner tube 132. The elastic element may also be welded to the distal end of the balloon body. The elastic element 170 is located at the distal end of the inner tube 132. The welded section 172 overlaps with the distal end of the inner tube 132 and is fixedly connected by welding. The exposed section 171 is directly exposed to the outside, neither inside the tube wall of the inner tube 132 nor overlapping or fixed with other components.

[0100] The elastic element 170 has a certain degree of elasticity. As the part of the tube that first extends into the blood vessel, the elastic element 170 has the characteristic of being deformable when it encounters the blood vessel, which can avoid puncturing the blood vessel. At the same time, based on the resilience of the elastic element 170, it can restore its own shape after the external force is removed.

[0101] The elastic element 170 is a helical spring, which is made of a metal wire with a diameter of 0.04-0.1 mm wound in a spiral. More preferably, the helical spring is made of a metal wire with a diameter of 0.05-0.06 mm wound in a spiral. The metal wire is made of one of the following materials: platinum-tungsten, platinum-iridium, stainless steel, gold, or nickel-titanium.

[0102] The elastic element 170 is made of metal wire, which is an opaque structure. It can block the light emitted by the optical fiber at the far end of the balloon body to avoid irradiation damage to unintended areas.

[0103] The pitch of the exposed section 171 is equal to the diameter of the metal wire, and the pitch of the welded section 172 is 1 to 3 times the diameter of the metal wire. More preferably, the pitch of the welded section 172 is 1.5 to 2 times the diameter of the metal wire.

[0104] The exposed section 171 is exposed to the outside, and a smaller pitch can increase the resilience of the elastic element 170. However, the welded section 172 needs to be connected to the wall of the inner tube 132, so a larger pitch is required to avoid excessively reducing the flexibility of the inner wall and easily damaging the blood vessel wall.

[0105] The metal wire has a developing function, and the elastic element 170 can also serve as a developing component to indicate the position of the sac within the body.

[0106] The axial length of the elastic element is 2-5 mm. More preferably, the axial length of the elastic element 170 is 3-5 mm.

[0107] The axial length of the elastic element 170 needs to be appropriate. If the length is too long, it will not be conducive to the rebound of the elastic element 170. If the length is too short, it will not be able to guide the balloon body forward in accordance with the blood vessels.

[0108] The axial length of the exposed section of the elastic element is 0.5-2 mm, and the axial length of the welded section is 1-3 mm. More preferably, the axial length of the exposed section 171 of the elastic element 170 is 1-2 mm, and the axial length of the welded section 172 is 2-3 mm.

[0109] The diameter of the exposed section is 0.50-0.70 mm, and the diameter of the welded section is 0.60-1.0 mm. More preferably, the diameter of the exposed section 171 is 0.5-0.6 mm, and the diameter of the welded section 172 is 0.6-0.7 mm.

[0110] The diameter of the exposed section 171 needs to be able to enter smaller blood vessels without losing elasticity, and the diameter of the welded section 172 matches the diameter of the inner tube 132.

[0111] The ratio of the distal diameter of the exposed section to the proximal diameter of the welded section is 1:1 to 1.5. More preferably, the ratio of the distal diameter of the exposed section 171 to the proximal diameter of the welded section 172 is 1:1 to 1.2.

[0112] The proximal end of the welding section 172 is formed by bending a metal wire that forms a helical spring to create a welding ring 173 that is welded to the wall of the inner tube 132. The welding ring 173 increases the welding area and ensures the strength of the weld.

[0113] See Figure 4 , Figure 5 , Figure 6 As shown, there are multiple optical fibers 120, and each optical fiber 120 is evenly distributed around the axis of the tube body 130.

[0114] See Figure 1 As shown, the tube body 130 includes an inner tube 132 and an outer tube 131 nested together. The radial gap between the inner tube 132 and the outer tube 131 serves as an optical fiber channel. (See also...) Figure 5 As shown, the optical fibers 120 are arranged parallel to the inner tube 132, or see [reference needed]. Figure 6 As shown, optical fibers 120 are wound around the inner tube 132. The axial length L of one winding unit is 10 mm. Preferably, each optical fiber 120 is arranged parallel to the inner tube 132. The optical fibers 120 may or may not be fixed to the inner tube 132.

[0115] The optical fiber 120 is made of plastic optical fiber or silica optical fiber. Preferably, it is made of plastic optical fiber, and the diameter of the optical fiber 120 is 0.125mm to 0.25mm. Preferably, the diameter of the optical fiber 120 is 0.125mm.

[0116] The number of optical fibers is 1 to 13, preferably 3 to 6. Most preferably, the number of optical fibers is 3. See [reference needed]. Figure 4 As shown, three optical fibers 120 are arranged at equal intervals around the inner tube 132, and the angle between two adjacent optical fibers 120 and the corresponding inner tube 132 is 120°.

[0117] The optical fiber 120 light-emitting segment is manufactured by stripping the cladding of the portion of the optical fiber 120 inside the spherical body 110. The stripping length of the optical fiber 120 cladding is equal to the axial length of the spherical body 110. The stripping method can be physical stripping (e.g., sandblasting, grinding, scraping, etc.) or chemical stripping.

[0118] See Figure 8 , Figure 10As shown, the tube body 130 includes an inner tube 132 and an outer tube 131 nested together. The distal end of the balloon body 110 is sealed to the outer wall of the inner tube 132, and the proximal end of the balloon body 110 is sealed to the outer tube 131. The inner tube 132 and the outer tube 131 have a radial gap, and the radial gap is a fluid channel. The cavity of the inner tube 132 is an optical fiber channel.

[0119] At least one axial section of the tube body 130 is a double-lumen tube 133, which includes a fluid channel 138 and a guide wire channel 137. The fluid channel 138 and the guide wire channel 137 are parallel to each other and isolated from each other. The fluid channel 138 communicates with the radial gap between the inner tube 132 and the outer tube 131. See [reference needed] Figure 11 As shown, the cross-sectional area of ​​the fluid channel 38 is larger than the cross-sectional area of ​​the guide wire channel 137.

[0120] The inner tube 132 extends out of the distal portion of the balloon body 110 and has a first guidewire port 134 on its wall. The two ends of the guidewire channel 137 are a second guidewire port 135 and a third guidewire port 136, respectively. The orientation of the guidewire 180 is shown in [reference needed]. Figure 8 As shown, in use, the guidewire 180 enters the guidewire channel 137 of the double-lumen tube through the third guidewire port 136, then extends to the outside of the balloon body 110 through the second guidewire port 135, and then enters the lumen of the inner tube through the first guidewire port 134. The diameter of the inner tube lumen is 0.54~0.80mm. More preferably, the diameter of the inner tube lumen is 0.54~0.74mm.

[0121] See Figure 10 As shown, the first guidewire port, the second guidewire port, and the third guidewire port are aligned along the axial direction of the tube body. The distance D1 between the first guidewire port and the distal end of the balloon body is 5~20mm, and the distance D2 between the second guidewire port and the proximal end of the balloon body is 10~30mm. More preferably, the distance D1 between the first guidewire port and the distal end of the balloon body is 5~15mm, and the distance D2 between the second guidewire port and the proximal end of the balloon body is 10~30mm.

[0122] By setting up a double-lumen tube 133 to guide the guidewire to the outside of the balloon body 110, and placing the optical fiber 120 inside the lumen of the inner tube 132, which should originally serve as the guidewire channel, the optical fiber 120 and the inner tube 132 are arranged coaxially (within an acceptable error range, strict coaxiality is not required), which can make the light emitted by the optical fiber irradiate the blood vessel wall more evenly.

[0123] The guidewire 180 is located outside the balloon 110, which can also cut the lesion site and reduce irregular tearing and dissection of blood vessels.

[0124] To improve the therapeutic effect, the outer surface of the balloon body 110 is coated with a drug, which is at least one of an anti-proliferative drug, a drug that induces cross-linking of collagen or elastin, and an anti-vasospasm drug.

[0125] The drug coating on the outer surface of the balloon 110 can act on the injured site, exerting a corresponding therapeutic effect and contributing to the comprehensive repair of the injured site. Preferably, the drug is paclitaxel or rapamycin.

[0126] Alternatively, the outer surface of the balloon body 110 is provided with an implantable vascular stent.

[0127] While using a balloon for laser repair, a vascular stent can be implanted into the body simultaneously, achieving two treatment goals in one intervention. The vascular stent is usually a compressible mesh structure, which does not significantly block the light during the laser repair process, thus not affecting the effect of laser repair. At the same time, based on the results of laser repair, the problem of neointimal proliferation is less likely to occur after the vascular stent is implanted.

[0128] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0129] The above embodiments merely illustrate several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A balloon catheter system with repair function, characterized in that, include: A tube body having a distal end and a proximal end, the tube body providing at least a fluid channel and an optical fiber channel; The balloon body is located on the outer periphery of the distal part of the tube body and is in communication with the fluid channel. The outer periphery of the balloon body is coated with a high refractive index ultraviolet adhesive distributed at intervals. The high refractive index ultraviolet adhesive protrudes relative to the surface of the balloon body. An optical fiber is inserted through the optical fiber channel and has a light-emitting segment extending to the location of the balloon body; The laser generating module is connected to the near end of the optical fiber. The laser generating module emits a laser with repair function, and the wavelength of the laser is 400~750nm.

2. The balloon catheter system with repair function according to claim 1, characterized in that, The laser generating module outputs a laser power of 10~30mW.

3. The balloon catheter system with repair function according to claim 1, characterized in that, The laser generating module outputs laser light of a predetermined wavelength in each working cycle in the following order: Initial stage: Power 5-8mW / cm 2 Lasts 10-20 seconds; Intermediate stage: Power 10-30mW / cm 2 Lasts 120-180 seconds; Final stage: Power 5-8mW / cm 2 It lasts for 10-20 seconds.

4. The balloon catheter system with repair function according to claim 1, characterized in that, The balloon body includes a constant diameter section and conical sections located at both ends of the constant diameter section, and the surface of the conical section at the distal end of the balloon body is covered with a black coating.

5. The balloon catheter system with repair function according to claim 1, characterized in that, The high refractive index UV adhesive has a refractive index of 1.50-1.

70.

6. The balloon catheter system with repair function according to claim 1, characterized in that, The protrusion height of the high refractive index UV adhesive is 0.20mm~0.25mm.

7. The balloon catheter system with repair function according to claim 6, characterized in that, The high-refractive-index UV adhesive is regularly distributed on the outer periphery of the capsule.

8. The balloon catheter system with repair function according to claim 6, characterized in that, The high-refractive-index UV adhesive consists of dot-like protrusions arranged in a matrix, with a spacing of 3-10 mm between the protrusions.

9. The balloon catheter system with repair function according to claim 4, characterized in that, The high-refractive-index UV adhesive consists of linear protrusions extending along the axial direction of the capsule and arranged at equal intervals around the capsule. The number of linear protrusions is 3-10.

10. The balloon catheter system with repair function according to claim 9, characterized in that, The length of the linear protrusion is adapted to the length of the equal-diameter section.

11. The balloon catheter system with repair function according to claim 1, characterized in that, The tube body includes an inner tube and an outer tube nested inside each other. The outer tube of the tube body is black, and the inner tube of the tube body is colorless and transparent. The hardness of the inner tube of the tube body is 35D to 75D, and the hardness increases continuously or at predetermined intervals from the distal end to the proximal end.

12. The balloon catheter system with repair function according to claim 11, characterized in that, The inner tube of the tube body includes at least two first unit segments connected sequentially along the axial direction. For two adjacent first unit segments, the first unit segment closer to the distal end has a lower hardness than the first unit segment closer to the proximal end.

13. The balloon catheter system with repair function according to claim 12, characterized in that, The number of the first unit segments is 2 to 4.

14. The balloon catheter system with repair function according to claim 12, characterized in that, The diameters of all first unit segments are the same, or for two adjacent first unit segments, the diameter of the first unit segment closer to the far end is smaller than the diameter of the first unit segment closer to the proximal end.

15. The balloon catheter system with repair function according to claim 12, characterized in that, The axial length of the first unit segment closest to the proximal end is 20~30cm.

16. The balloon catheter system with repair function according to claim 12, characterized in that, Each first unit section uses a single-layer pipe or a multi-layer pipe. The material of the single-layer pipe can be one of PEBAX, nylon, or TPU, and the material of each layer is independently selected from one of PEBAX, nylon, or PE.

17. The balloon catheter system with repair function according to claim 11, characterized in that, The inner tube of the tube body includes a proximal inner tube and a distal inner tube connected along the axial direction. The hardness of the proximal inner tube is 55D~75D, and the hardness of the distal inner tube is 35D~55D.

18. The balloon catheter system with repair function according to claim 11, characterized in that, The outer tube of the tube body includes at least two second unit segments connected sequentially along the axial direction. For two adjacent second unit segments, the hardness of the second unit segment closer to the distal end is less than the hardness of the second unit segment closer to the proximal end.

19. The balloon catheter system with repair function according to claim 18, characterized in that, The number of the second unit segment is 2 to 4.

20. The balloon catheter system with repair function according to claim 18, characterized in that, The diameters of all second unit segments are the same, or for two adjacent second unit segments, the diameter of the second unit segment closer to the far end is smaller than the diameter of the second unit segment closer to the proximal end.

21. The balloon catheter system with repair function according to claim 18, characterized in that, Each second unit section uses a single-layer pipe or a multi-layer pipe. The material of the single-layer pipe can be PEBAX or nylon, and the material of each layer is independently selected from PEBAX or nylon.

22. The balloon catheter system with repair function according to claim 11, characterized in that, An elastic element is welded to the distal end of the inner tube. The elastic element includes an exposed section and a welded section along the axial direction of the tube body. The ratio of the axial length of the exposed section to the welded section is 1:0.8~1.

2. The diameter of the elastic element gradually increases from the distal end of the exposed section to the proximal end of the welded section.

23. The balloon catheter system with repair function according to claim 22, characterized in that, The elastic element is a helical spring, which is made of metal wire with a diameter of 0.04-0.1mm wound in a spiral.

24. The balloon catheter system with repair function according to claim 23, characterized in that, The metal wire is made of one of the following materials: platinum-tungsten, platinum-iridium, stainless steel, gold, or nickel-titanium.

25. The balloon catheter system with repair function according to claim 23, characterized in that, The pitch of the exposed section is equal to the diameter of the metal wire, and the pitch of the welded section is 1-3 times the diameter of the metal wire.

26. The balloon catheter system with repair function according to claim 22, characterized in that, The axial length of the elastic element is 2-5 mm.

27. The balloon catheter system with repair function according to claim 22, characterized in that, The axial length of the exposed section of the elastic element is 0.5-2 mm, and the axial length of the welded section is 1-3 mm.

28. The balloon catheter system with repair function according to claim 22, characterized in that, The diameter of the exposed section is 0.50-0.70 mm, and the diameter of the welded section is 0.60-1.0 mm.

29. The balloon catheter system with repair function according to claim 22, characterized in that, The ratio of the distal diameter of the exposed section to the proximal diameter of the welded section is 1:1 to 1.

5.

30. The balloon catheter system with repair function according to claim 22, characterized in that, The near end of the welded section forms a weld ring that is welded to the inner tube wall by bending a metal wire that forms a helical spring.

31. The balloon catheter system with repair function according to claim 1, characterized in that, The tube body includes an inner tube and an outer tube nested inside and outside. The distal end of the balloon body is sealed to the outer wall of the inner tube, and the proximal end of the balloon body is sealed to the outer tube. The radial gap between the inner tube and the outer tube serves as an optical fiber channel. The optical fibers are arranged either parallel to the inner tube or wrapped around the inner tube.

32. The balloon catheter system with repair function according to claim 31, characterized in that, The optical fiber consists of multiple fibers, each evenly distributed around the axis of the tube.

33. The balloon catheter system with repair function according to claim 31, characterized in that, The diameter of each optical fiber is 0.125mm~0.25mm.

34. The balloon catheter system with repair function according to claim 1, characterized in that, The tube body includes an inner tube and an outer tube nested inside and outside. The distal end of the balloon body is sealed to the outer wall of the inner tube, and the proximal end of the balloon body is sealed to the outer tube. The inner tube and the outer tube have a radial gap, and the radial gap is a fluid channel. The cavity of the inner tube is an optical fiber channel.

35. The balloon catheter system with repair function according to claim 34, characterized in that, At least one section of the tube body in the axial direction is a double-lumen tube, the double-lumen tube includes a fluid channel and a guide wire channel, the fluid channel and the guide wire channel are isolated from each other, and the fluid channel is connected to the radial gap between the inner tube and the outer tube.

36. The balloon catheter system with repair function according to claim 35, characterized in that, The inner tube extends out of the distal part of the balloon body and has a first guidewire port on its tube wall. The two ends of the guidewire channel are a second guidewire port and a third guidewire port, respectively. The guidewire passes through the first guidewire port, the second guidewire port, and the third guidewire port, and the part of the guidewire between the first guidewire port and the second guidewire port is located outside the balloon body.

37. The balloon catheter system with repair function according to claim 1, characterized in that, The outer surface of the balloon is coated with a drug, which is at least one of an anti-proliferative drug, a drug that induces cross-linking of collagen or elastin, and an anti-vasospasm drug.

38. The balloon catheter system with repair function according to claim 37, characterized in that, The drug is either paclitaxel or rapamycin.

39. The balloon catheter system with repair function according to claim 1, characterized in that, The outer surface of the balloon is provided with an implantable vascular stent.

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