Balloon catheter system with repair function

Abstract

The present application discloses a balloon catheter system with repair function, comprising: a tube body having opposing distal and proximal ends and having at least a fluid passage and an optical fiber passage; a balloon body disposed on the outer periphery of the distal end of the tube body and communicating with the fluid passage; an optical fiber having a light-emitting section inserted within the optical fiber passage and extending to the balloon body; and a laser generation module connected to the proximal end of the optical fiber and emitting a laser having a repair function and a wavelength of 400 nm to 750 nm. The balloon catheter system provided by the present application can focus a tear in a blood vessel wall on a predetermined area and apply a laser of a specific wavelength to the area to effectively repair the tear in the blood vessel wall, effectively prevent restenosis, and prevent neointimal proliferation even when a vascular stent is placed.

Description

[Technical Field]

[0001] FIELD OF THE INVENTION This application relates to the field of medical devices, and more particularly to balloon catheter systems with restorative capabilities. [Background technology]

[0002] Percutaneous interventional therapy has become one of the most commonly used treatment techniques worldwide, and in the case of intravascular stenotic lesions, they are usually treated using balloon dilatation or stent placement, but both methods have drawbacks. Summary of the Invention [Problem to be solved by the invention]

[0003] The use of conventional balloon dilatation to treat intravascular stenosis increases the likelihood of restenosis after treatment, while the use of a single metal stent catheter intervention to treat intravascular stenosis reduces the likelihood of restenosis, but increases the likelihood of neointimal proliferation (i.e., the process of scar tissue formation in the stent section), and if vascular restenosis or neointimal proliferation occurs, interventional treatment will be required again. [Means for solving the problem]

[0004] Based on this, we provide a balloon catheter system with repair function that can solve the problems of restenosis and neointimal proliferation that occur after interventional treatment.

[0005] The technical solutions provided by this application are as follows:

[0006] 1. A balloon catheter system with repair function, comprising: a tube body having opposed distal and proximal ends and including at least a fluid passageway and an optical fiber passageway; a balloon body disposed on the outer periphery of the distal end of the tube body and in communication with the fluid passage; an optical fiber having a light-emitting section inserted into the optical fiber passage and extending to the balloon body; and a laser generating module connected to the proximal end of the optical fiber, the laser generating module emitting a laser having a wavelength of 400 nm to 750 nm and having repair capabilities.

[0007] Some optional methods are also presented below, but these are not intended as additional restrictions on the overall technical solution above. As long as there is no technical or logical contradiction, each optional method can be combined individually or multiple optional methods can be combined with the overall technical solution above.

[0008] Optionally, the laser power output by the laser generation module is between 10 and 30 mW.

[0009] Optionally, the laser generating module outputs lasers of predetermined wavelengths in the following order within each operating cycle: Initial stage: power 5mW / cm 2 to 8mW / cm 2 , lasting 10s to 20s, Intermediate stage: power 10mW / cm 2 to 30mW / cm 2 , lasting from 120s to 180s, End stage: Power 5mW / cm 2 to 8mW / cm 2 , lasting 10s to 20s.

[0010] Optionally, the balloon body includes a constant diameter section and tapered sections located at both ends of the constant diameter section, and the surface of the tapered section located at the distal end of the balloon body is covered with a black coating.

[0011] Optionally, the high refractive index UV adhesive has a refractive index between 1.50 and 1.70.

[0012] Optionally, a high refractive index ultraviolet adhesive with a spacing distribution is attached to the outer periphery of the balloon body, and the high refractive index ultraviolet adhesive protrudes from the surface of the balloon body, with a protrusion height of 0.20 mm to 0.25 mm.

[0013] Optionally, the high refractive index ultraviolet adhesive is evenly distributed around the periphery of the balloon body.

[0014] Optionally, the high refractive index ultraviolet adhesive is in the form of dots arranged in a matrix, and the pitch of the dots is between 3 mm and 10 mm.

[0015] Optionally, the high refractive index ultraviolet adhesive is in the form of linear protrusions extending along the axial direction of the balloon body, and arranged at equal intervals around the circumference of the balloon body, with the number of linear protrusions being 3 to 10.

[0016] Optionally, the length of the linear projections matches the length of the isodiametric section.

[0017] Optionally, the tube body includes an inner tube and an outer tube fitted 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, and the hardness is continuous or increases at predetermined numerical intervals from the distal end to the proximal end.

[0018] Optionally, the inner layer tube of the tube body includes at least two first unit sections connected in sequence along the axial direction, and for two adjacent first unit sections, the hardness of the first unit section closer to the distal end is less than the hardness of the first unit section closer to the proximal end.

[0019] Optionally, the number of said first unit sections is between two and four.

[0020] Optionally, the diameter of each first unit section is the same, or for two adjacent first unit sections, the diameter of the first unit section closer to the distal end is smaller than the diameter of the first unit section closer to the proximal end.

[0021] Optionally, the axial length of the first unit section closest to the proximal end is 20 to 30 cm.

[0022] Optionally, each first unit section uses a single-layer tube or a multi-layer tube, the material of the single-layer tube can be selected from one of PEBAX, nylon, and TPU, and each layer in the multi-layer tube is relatively slidable, and the material of each layer is independently selected from one of PEBAX, nylon, and PE.

[0023] Optionally, the inner layer tube of the tube body includes a proximal end inner layer tube and a distal end inner layer tube connected along the axial direction, the hardness of the proximal end inner layer tube being 55D to 75D, and the hardness of the distal end inner layer tube being 35D to 55D.

[0024] Optionally, the outer layer tube of the tube body includes at least two second unit sections connected in sequence along the axial direction, and for two adjacent second unit sections, the hardness of the second unit section closer to the distal end is less than the hardness of the second unit section closer to the proximal end.

[0025] Optionally, the number of said second unit sections is from two to four.

[0026] Optionally, the diameter of each second unit section is the same, or for two adjacent second unit sections, the diameter of the first unit section closer to the distal end is smaller than the diameter of the first unit section closer to the proximal end.

[0027] Optionally, each second unit section uses a single-layer tube or a multi-layer tube, the material of the single-layer tube can be selected from PEBAX or nylon, and each layer in the multi-layer tube can slide relative to each other, and the material of each layer can be independently selected from PEBAX or nylon.

[0028] Optionally, an elastic member is welded to the distal end of the inner layer tube, the elastic member including an exposed section and a welded section along the axial direction of the tube body, the axial length ratio of the exposed section to the welded section being 1:0.8 to 1.2, and the diameter of the elastic member gradually increasing from the distal end of the exposed section to the proximal end of the welded section.

[0029] Optionally, the elastic member is a coil spring, the coil spring being made of a metal wire wound in a spiral shape with a diameter of 0.04 to 0.1 mm.

[0030] Optionally, the metal wire is made of one of platinum-tungsten, platinum-iridium, stainless steel, gold, and nickel-titanium.

[0031] Optionally, the pitch of the exposed sections is equal to the diameter of the metal wire and the pitch of the welded sections is 1 to 3 times the diameter of the metal wire.

[0032] Optionally, the axial length of said elastic member is between 2 and 5 mm.

[0033] Optionally, the exposed section of the elastic member has an axial length of 0.5 to 2 mm and the welded section has an axial length of 1 to 3 mm.

[0034] Optionally, the exposed section has a diameter of 0.50 to 0.70 mm and the welded section has a diameter of 0.60 to 1.0 mm.

[0035] Optionally, the ratio of the diameter of the distal end of the exposed section to the diameter of the proximal end of the welded section is 1:1 to 1.5.

[0036] Optionally, the proximal end of the welded section bends the metal wire forming the coil spring to form a welded ring that is welded to the tube wall of the inner tube.

[0037] Optionally, the tube body includes an inner tube and an outer tube fitted together, the distal end of the balloon body is hermetically connected to the outer wall of the inner tube, and the proximal end of the balloon body is hermetically connected to the outer tube, the radial gap between the inner tube and the outer tube serves as an optical fiber passage, and the optical fibers are arranged parallel to the inner tube or wrapped around the inner tube.

[0038] Optionally, the optical fibers are multiple and each optical fiber is uniformly distributed around the axis of the tube body.

[0039] Optionally, the diameter of each optical fiber is between 0.125 mm and 0.25 mm.

[0040] Optionally, the tube body includes an inner layer tube and an outer layer tube fitted inside and outside, the distal end of the balloon body is sealingly connected to the outer wall of the inner layer tube, the proximal end of the balloon body is sealingly connected to the outer layer tube, the inner layer tube and the outer layer tube have a radial gap, and the radial gap is a fluid passage, and the lumen of the inner layer tube is an optical fiber passage.

[0041] Optionally, at least one axial section of the tube body is a double-lumen tube, the double-lumen tube including a fluid passage and a guidewire passage, the fluid passage and the guidewire passage being isolated from each other, and the fluid passage communicating with a radial gap between the inner layer tube and the outer layer tube.

[0042] Optionally, a first guidewire port is provided in the wall of the inner layer tube extending from the distal end portion of the balloon body, and both ends of the guidewire passage 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.

[0043] Optionally, a drug coating is provided on the outer surface of the balloon body, the drug being at least one of an antineoplastic drug, a drug that induces cross-linking of collagen or elastin, and an anti-vasospastic drug.

[0044] Optionally, the drug is paclitaxel or rapamycin.

[0045] Optionally, the balloon body has an outer surface provided with a deployable vascular stent. [Effects of the Invention]

[0046] The balloon catheter system provided by the present application can concentrate the tear in the blood vessel wall in a specific area and apply a laser of a specific wavelength to that area to effectively repair the tear in the blood vessel wall, effectively prevent the occurrence of restenosis, and prevent neointimal proliferation even when a vascular stent is placed. [Brief explanation of the drawings]

[0047] [Figure 1] 1 is a schematic diagram of a balloon catheter system with repair capabilities. [Figure 2] 1 is a schematic diagram of the distribution of the first type of high refractive index ultraviolet adhesive on the surface of the balloon body. [Figure 3] 10 is a schematic diagram of the distribution of a second type of high refractive index ultraviolet adhesive on the surface of the balloon body. [Figure 4] 3 is a schematic diagram showing the cross-sectional positional relationship between the optical fiber and the inner tube. FIG. [Figure 5] FIG. 2 is a schematic diagram showing a first type of positional relationship between an optical fiber and an inner tube. [Figure 6] FIG. 10 is a schematic diagram showing a second type of positional relationship between the optical fiber and the inner tube. [Figure 7] FIG. 2 is a schematic diagram of an outer layer tube in a tube body. [Figure 8] FIG. 1 is a schematic diagram of a balloon catheter system with repair function (guidewire located outside the balloon body). [Figure 9] FIG. 9 is an enlarged view of part A in FIG. 8. [Figure 10] FIG. 9 is a schematic diagram showing the positions of the tube body, the double lumen tube, and the balloon body in FIG. 8. [Figure 11] FIG. 1 is a cross-sectional schematic diagram of a double lumen tube. DETAILED DESCRIPTION OF THE INVENTION

[0048] Hereinafter, the embodiments of the present application will be described in detail with reference to the accompanying drawings. Note that the following embodiments are merely examples of the present application and do not limit the technical scope of the present application. All other embodiments that can be obtained by those skilled in the art based on the embodiments of the present application without departing from the scope of the present application are also within the scope of the present application.

[0049] To better describe and illustrate the embodiments of the present application, reference may be made to one or more drawings; however, any additional details or examples used to illustrate the drawings should not be considered as limitations on the scope of any of the inventions, embodiments or preferred forms of the present application.

[0050] For clarity, when a component is said to be "connected" to another component, the component may be directly connected to the other component, or there may be intermediate components present. When a component is said to be "attached" to another component, the component may be directly attached to the other component, or there may also be intermediate components present.

[0051] 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 description of this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0052] As shown in FIG. 1, the repairable balloon catheter system 100 includes: a tube body 130 having opposed distal and proximal ends and having at least a fluid passageway and an optical fiber passageway; a balloon body 110 disposed on the outer periphery of the distal end of the tube body 130 and communicating with the fluid passage; an optical fiber 120 having a light-emitting section inserted into the optical fiber passage and extending to the position of the balloon body 110; and a laser generating module connected to the proximal end of the optical fiber 120 and emitting a laser having a wavelength of 400 nm to 750 nm with repair capabilities.

[0053] When using the balloon catheter system 100 with repair function, first, fluid is injected into the balloon body 110 through the fluid passage of the tube body 130 to fill the balloon body 110, and then the laser generating module emits a laser with a wavelength of 400 to 750 nm. The laser is emitted through the light emitting section of the optical fiber 120 and applied to the area to be repaired by the balloon body 110, the fluid within the balloon body 110, and scattering by the balloon body 110. Under normal circumstances, the laser can be continuously applied for a predetermined period of time to perform treatment, thereby achieving an ideal effect.

[0054] The balloon body 110 is coated with a high-refractive index UV adhesive with a regular interval distribution on its outer surface. When the balloon body 110 is filled with fluid, the balloon body 110 expands, expanding the blood vessel wall. During the expansion process, the structure of the blood vessel wall is torn locally, thereby satisfying the expansion of the blood vessel wall. The tears in the blood vessel wall are concentrated in the areas where the high-refractive index UV adhesive is distributed. Since the high-refractive index UV adhesive protrudes from the outer wall of the balloon body 110, stress concentration areas are more likely to form when acting on the blood vessel wall. The application of the high-refractive index UV adhesive concentrates the tears in the blood vessel wall, which would normally be distributed randomly, in the areas where the high-refractive index UV adhesive is present. In addition, the high-refractive index UV adhesive focuses the laser light in these areas, allowing the laser to more intensively act on the torn areas of the blood vessel wall, thereby completing the repair of the area.

[0055] The present application aims to prevent unavoidable and disorderly tears in the blood vessel wall by concentrating the high refractive index ultraviolet adhesive protruding from the outer surface of the balloon body 110 in a specific area, where the high refractive index ultraviolet adhesive is present. At the same time, the high refractive index ultraviolet adhesive's concentrated action on the laser in the specific area can more effectively repair tears in the blood vessel wall.

[0056] The laser acts on the area to be repaired, promoting the repair of damaged blood vessels and effectively preventing the occurrence of restenosis.

[0057] The laser generating module provides a low-power pulsed or continuous output laser, which is transmitted into the interior of the balloon body 110 via the optical fiber 120, and the light-emitting section of the optical fiber 120 inside the balloon body 110 applies a low-intensity laser to the area to be repaired. The low-intensity laser has a photomodulatory effect, which occurs through a photochemical effect rather than a thermal effect, and can promote cell and tissue repair and accelerate the removal of inflammatory media and the absorption of tissue edema.

[0058] After balloon catheter dilatation, damage to the vascular endothelium is likely to occur. Therefore, red light of a specific wavelength is emitted using the light-emitting section of the optical fiber 120, and is scattered by the balloon body 110 and delivered to the site of vascular endothelial damage, promoting vascular endothelial cell proliferation and anti-inflammatory apoptosis, accelerating the recovery of the blood vessel to a stable state, and preventing postoperative vascular restenosis.

[0059] The laser generating module emits a laser beam with a wavelength of 400 nm to 750 nm, and within this wavelength range, the laser beam exhibits red color, which can promote the repair of cell nuclei and tissues, accelerate the removal of inflammatory mediators, and accelerate the absorption of tissue edema. More preferably, the laser generating module emits a laser beam with a wavelength of 630 nm to 700 nm.

[0060] The laser power output by the laser generating module is 10 to 30 mW, and more preferably, the laser power output by the laser generating module is 10 to 15 mW.

[0061] The laser generating module outputs laser beams of predetermined wavelengths in the following order within each operating cycle: Initial stage: power 5mW / cm 2 to 8mW / cm 2 , lasting 10s to 20s, Intermediate stage: power 10mW / cm 2 to 30mW / cm 2 , lasting from 120s to 180s, End stage: Power 5mW / cm2 to 8mW / cm 2 , lasting 10s to 20s.

[0062] Each operating cycle is one complete cycle corresponding to the action of the laser generating module on the blood vessel wall, in the initial stage, low-power and short-duration laser output is used to adapt the blood vessel to laser irradiation and prepare it for subsequent treatment; in the middle stage, power is increased to perform healing treatment on the torn blood vessel and prevent post-operative restenosis; and in the final stage, low-power and short-duration laser output is used to provide post-operative cushioning and reduce the burden on the blood vessel.

[0063] If the laser power output from the laser generating module is too low, the repair effect will not be ideal; if the power is too high, the heat will be too high, which will cause burns to the blood vessels. Preferably, in the intermediate stage, the power should be 10 m / cm 2 W to 15mW / cm 2 lasts for 120 to 180 seconds.

[0064] The balloon body 110 may be a regular balloon or a special balloon with a smooth surface. The material of the balloon body 110 must have sufficient flexibility and good passability, allowing it to smoothly reach the desired site, as well as excellent processability, good resilience, fatigue resistance, and dimensional stability. Preferably, the material of the balloon body is one of PEBAX, nylon, and TPU. More preferably, the material of the balloon body is PEBAX or nylon.

[0065] As shown in Figure 10, the balloon body 110 includes a constant diameter section 113 and tapered sections 114 located at both ends of the constant diameter section 113. The surface of the tapered section 114 located at the distal end (see the black filled area in Figure 10) is covered with a black coating. The black coating material is one of PTFE, colored shellac, and colored UV adhesive. The tapered sections 114 at both ends of the balloon body 110 are not strictly tapered, but are merely portions that approximate a tapered shape formed by a change in the diameter of the balloon body.

[0066] The black coating on the distal end of the balloon body 110 acts as a laser blocker, preventing the laser from causing burns to external areas.

[0067] As shown in FIG. 1, the balloon catheter system 100 further includes a stress relief tube 150 and a catheter base 140, the stress relief tube 150 being connected between the tube body 130 and the catheter base 140, the catheter base 140 being connected to the proximal end of the tube body 130 and having ports communicating with the fluid passage and the optical fiber passage, respectively, and the optical fiber 120 extending from the optical fiber passage is connected to a laser generating module via an optical fiber connector 160.

[0068] The laser emitted from the light-emitting section is focused on the area of ​​the high refractive index ultraviolet adhesive to ensure sufficient laser intensity is applied to the area to be repaired, and preferably, the high refractive index ultraviolet adhesive has a refractive index of 1.50 to 1.70. More preferably, the high refractive index ultraviolet adhesive has a refractive index of 1.54 to 1.62.

[0069] The high refractive index ultraviolet adhesive concentrates the tearing of the blood vessel wall in a specific area and does not complicate the tearing situation of the blood vessel wall. In order to do so, the high refractive index ultraviolet adhesive is distributed regularly around the outer periphery of the balloon body 110, and the high refractive index ultraviolet adhesive protrudes from the surface of the balloon body, with the height of the protrusions being 0.20 mm to 0.25 mm.

[0070] As shown in Figure 2, the high-refractive-index ultraviolet adhesive is arranged in a matrix of dot-like protrusions 111, with a pitch of 3 to 10 mm and the distance between each dot-like protrusion 111 and its neighboring dot-like protrusions 111 being equal. Each dot-like protrusion 111 is hemispherical, with the flat surface of the hemisphere fixedly connected to the outer surface of the balloon body. The height of each dot-like protrusion 111 (i.e., H1 in Figure 2) is 0.20 to 0.25 mm.

[0071] As shown in Figure 3, the high-refractive-index ultraviolet adhesive is formed as linear protrusions 112 extending along the axial direction of the balloon body 110 and arranged at equal intervals around the circumference of the balloon body 110, with three to five linear protrusions 112. The height of the linear protrusions 112 (i.e., shown as H2 in Figure 3) is 0.20 to 0.25 mm. The balloon body 110 includes a constant diameter section 113 and tapered sections 114 located at both ends of the constant diameter section, with the length of the linear protrusions 112 matching the length of the constant diameter section 113 and a smooth transition formed between the ends of the linear protrusions 112 and the tapered sections 114.

[0072] When fluid is injected into the balloon body 110 through the fluid passage of the tube body 130 to fill and expand the balloon body 110, the high refractive index ultraviolet adhesive can focus the laser, and the focused laser can be applied more intensively to the area to be repaired, preventing leakage of the treatment area.

[0073] The high refractive index ultraviolet adhesive can not only concentrate and effectively repair the torn areas of the blood vessel wall and the focused laser, but also increase the frictional force between the balloon body 110 and the blood vessel wall when the balloon body 110 expands, thereby reducing the sliding of the balloon body 110 against the blood vessel wall, improving the treatment effect and reducing unnecessary damage to the non-treated areas.

[0074] The regularly distributed high refractive index ultraviolet adhesive can also cut the lesion site to reduce irregular tearing and dissection of blood vessels.

[0075] As shown in Figure 1, the tube body 130 includes an inner tube 132 and an outer tube 131 fitted inside and outside. The inner and outer tubes of the tube body may be made of the same or different materials. The inner tube is colorless and transparent, and the outer tube is black. The colorless and transparent inner tube allows light transmitted through the optical fiber to radiate to the outside through the inner tube, while the black outer tube is used to block light emitted from the optical fiber from reaching a predetermined external location.

[0076] The hardness of the inner layer tube of the tube body is 35D to 75D, and the hardness is continuous or increases at predetermined intervals from the distal end to the proximal end.

[0077] The inner layer tube of the tube body includes at least two first unit sections connected in sequence along the axial direction, and the hardness of the first unit section closer to the distal end of each of the two adjacent first unit sections is less than the hardness of the first unit section closer to the proximal end of each of the two first unit sections. The connection between the two first unit sections is achieved by welding.

[0078] The number of first unit sections is two to four.

[0079] The diameter of each first unit section is the same, or for two adjacent first unit sections, the diameter of the first unit section closest to the distal end is smaller than the diameter of the first unit section closest to the proximal end. This gradually increasing diameter along the axial direction of the tube body from the distal end to the proximal end not only ensures the maneuverability of the tube body at the proximal end, but also allows the diameter of the inner tube at the distal end to be made smaller, allowing it to be extended to smaller blood vessels, particularly cerebral blood vessels.

[0080] The axial lengths of the first unit sections may be the same or different.

[0081] The axial length of the first unit section, closest to the proximal end, is 20 to 30 cm.

[0082] Each first unit section uses a single-layer tube or a multi-layer tube, the material of the single-layer tube can be selected from one of PEBAX, nylon, and TPU, and each layer in the multi-layer tube can slide relative to each other, and the material of each layer is independently selected from one of PEBAX, nylon, and PE.

[0083] Each first unit section uses a single-layer tube, and the material of the single-layer tube is nylon or PEBAX.

[0084] Each first unit section uses a multi-layer tube, and the materials of each multi-layer tube may be the same or different, and the thickness of each layer of the multi-layer tube may be the same or different.

[0085] Each first unit section uses a three-layer tube, each layer of which is slidable relative to one another. 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.

[0086] The inner layer tube of the tube body includes a proximal end inner layer tube and a distal end inner layer tube connected along the axial direction, the hardness of the proximal end inner layer tube being 55D to 75D, and the hardness of the distal end inner layer tube being 35D to 55D.

[0087] The proximal end inner layer tube is a three-layer tube, and the distal end inner layer tube is a three-layer tube or a single-layer tube.

[0088] The proximal end inner layer tube is a three-layer tube, each layer made of PEBAX, and the distal end inner layer tube is a three-layer tube, each layer made of PEBAX.

[0089] The outer tube of the tube body includes at least two second unit sections connected in sequence along the axial direction, and the hardness of the second unit section closer to the distal end of each of the two adjacent second unit sections is less than the hardness of the second unit section closer to the proximal end of each of the two second unit sections. The connection between the two second unit sections is achieved by welding.

[0090] The number of second unit sections ranges from two to four.

[0091] The diameter of each second unit section is the same, or for two adjacent second unit sections, the diameter of the first unit section closest to the distal end is smaller than the diameter of the first unit section closest to the proximal end. This gradually increasing diameter along the axial direction of the tube body from the distal end to the proximal end not only ensures the maneuverability of the tube body at the proximal end, but also allows the diameter of the inner tube at the distal end to be made smaller, allowing it to be extended to smaller blood vessels, especially cerebral blood vessels.

[0092] The axial lengths of the second unit sections may be the same or different.

[0093] Each second unit section uses a single-layer tube or a multi-layer tube, and the material of the single-layer tube can be selected from PEBAX or nylon. Each layer in the multi-layer tube can slide relative to each other, and the material of each layer can be independently selected from PEBAX or nylon.

[0094] Each second unit section uses a multi-layer tube, and the materials of each multi-layer tube may be the same or different, and the thickness of each layer of the multi-layer tube may be the same or different.

[0095] In the present application, by selecting appropriate materials for the balloon body and the inner and outer tubes, the delivery system formed by the balloon body and the inner and outer tubes is relatively more flexible, and by balancing the increase in stiffness of the delivery system after adding the optical fiber, the delivery system ultimately achieves an ideal state combining radial support and flexibility.

[0096] As shown in Figure 7, in Figure 7, Y indicates the distal end and J indicates the proximal end. From the distal end to the proximal end, the outer layer tube includes second unit sections L1, L2, and L3 connected in sequence along the axial direction, and each second unit section is connected by welding. Each second unit section is arranged coaxially. The diameter of second unit section L1 is 0.85 mm and the axial length is 120 mm. The diameter of second unit section L2 is 1.10 mm and the axial length is 140 mm. The diameter of second unit section L3 is 1.10 mm and the axial length is 1300 mm. The material of second unit section L1 and second unit section L2 is PEBAX, and the material of second unit section L3 is nylon.

[0097] Figure 7 shows the structure of the outer layer tube in the tube body. The inner layer tube has the same structure as the outer layer tube, but is made of different materials and has different diameters. When the outer layer tube of the tube body is composed of multiple second unit sections as shown in Figure 7, the inner layer tube is also composed of multiple first unit sections correspondingly. The number and axial length of the first and second unit sections are the same from the distal end to the proximal end. The diameter of the first unit sections of the inner layer tube is all 0.54 mm, the hardness is 55D, 63D, and 70D, respectively, and the materials are Pebax, Pebax, and PA, respectively.

[0098] When the outer tube has a single diameter, the inner tube also has a single diameter, and the structures of the inner and outer tubes are identical.

[0099] As shown in Figures 8 and 9, an elastic member 170 is welded to the distal end of the inner layer tube 132, and the elastic member 170 includes an exposed section 171 (corresponding to part T1 in Figure 9) and a welded section 172 (corresponding to part T2 in Figure 9) along the axial direction of the tube body, with the axial length ratio of the exposed section 171 to the welded section 172 being 1:0.8 to 1.2, and the diameter of the elastic member 170 gradually increasing from the distal end of the exposed section 171 to the proximal end of the welded section 172.

[0100] At the distal end of the tube body, the inner tube 132 intersects with the distal end of the balloon body, and an elastic member 170 is welded to the distal end of the inner tube 132. The elastic member may also be welded to the distal end of the balloon body at the same time. The elastic member 170 is entirely located at the distal end of the inner tube 132, and the welded section 172 and the distal end of the inner tube 132 overlap and are fixedly connected by a welding process. The exposed section 171 is directly exposed to the outside and is not located on the wall of the inner tube 132 or overlapped or fixed by other members.

[0101] The elastic member 170 has a certain elasticity, and as the part of the tube body that is first inserted into the blood vessel, the elastic member 170 has the characteristic of being deformable when it encounters a blockage in the blood vessel, so that it can avoid damaging the blood vessel, and based on the resilience property of the elastic member 170, it can restore its own shape after the external force is removed.

[0102] The elastic member 170 is a coil spring, which is made of a metal wire with a diameter of 0.04 mm to 0.1 mm wound in a spiral shape. More preferably, the coil spring is made of a metal wire with a diameter of 0.05 mm to 0.06 mm wound in a spiral shape. The material of the metal wire is one of platinum-tungsten, platinum-iridium, stainless steel, gold, and nickel-titanium.

[0103] The elastic member 170 uses a metal wire, i.e., has a structure that does not transmit light, and can block light from the optical fiber at the distal end of the balloon body to avoid radiation damage to unintended areas.

[0104] The pitch of the exposed sections 171 is equal to the diameter of the wire, and the pitch of the welded sections 172 is 1 to 3 times the diameter of the wire. More preferably, the pitch of the welded sections 172 is 1.5 to 2 times the diameter of the wire.

[0105] The exposed section 171 is exposed to the outside, and a smaller pitch can increase the rebound performance of the elastic member 170, while the welded section 172 needs to be connected to the wall of the inner layer tube 132, so a larger pitch is required to avoid excessively reducing the flexibility of the inner wall and making it more susceptible to damage to the blood vessel wall.

[0106] The metal wire has a contrast function, and the elastic member 170 also functions as a contrast member, making it possible to indicate the position of the balloon body inside the body.

[0107] The axial length of the elastic member is 2 mm to 5 mm. More preferably, the axial length of the elastic member 170 is 3 mm to 5 mm.

[0108] The axial length of the elastic member 170 must be appropriate; if it is too long, it will be detrimental to the resilience of the elastic member 170, and if it is too short, it will not follow the blood vessel and guide the advancement of the balloon body.

[0109] The axial length of the exposed section of the elastic member is 0.5 mm to 2 mm, and the axial length of the welded section is 1 mm to 3 mm. More preferably, the axial length of the exposed section 171 of the elastic member 170 is 1 mm to 2 mm, and the axial length of the welded section 172 is 2 mm to 3 mm.

[0110] The diameter of the exposed section is 0.50 mm to 0.70 mm and the diameter of the welded section is 0.60 mm to 1.0 mm. More preferably, the diameter of the exposed section 171 is 0.5 mm to 0.6 mm and the diameter of the welded section 172 is 0.6 mm to 0.7 mm.

[0111] The diameter of the exposed section 171 must be large enough to fit into small blood vessels without impairing resilience, and the diameter of the welded section 172 must match the diameter of the inner tube 132 .

[0112] The ratio of the diameter of the distal end of the exposed section to the diameter of the proximal end of the welded section is 1:1 to 1.5. More preferably, the ratio of the diameter of the distal end of the exposed section 171 to the diameter of the proximal end of the welded section 172 is 1:1 to 1.2.

[0113] The proximal end of the weld section 172 is formed by bending the metal wire forming the coil spring to form a weld ring 173 that is welded to the tube wall of the inner tube 132. The weld ring 173 increases the welding area and ensures the strength of the weld.

[0114] As shown in FIGS. 4, 5 and 6, there are a plurality of optical fibers 120, and the optical fibers 120 are uniformly distributed around the axis of the tube body .

[0115] As shown in FIG. 1, the tube body 130 includes an inner tube 132 and an outer tube 131 fitted together, with the radial gap between the inner tube 132 and the outer tube 131 serving as an optical fiber passage. As shown in FIG. 5, the optical fibers 120 are arranged parallel to the inner tube 132, or as shown in FIG. 6, the optical fibers 120 are wound around the inner tube 132. The optical fibers 120 are wound around the inner tube 132, with the axial length L of one winding unit being 10 mm. Preferably, the optical fibers 120 are arranged parallel to the inner tube 132. The optical fibers 120 may be fixed or unfixed to the inner tube 132.

[0116] The material of the optical fiber 120 is a plastic optical fiber or a silica optical fiber. Preferably, it is a plastic optical fiber, and the diameter of the optical fiber 120 is 0.125 mm to 0.25 mm. Preferably, the diameter of the optical fiber 120 is 0.125 mm.

[0117] The number of optical fibers is 1 to 13, preferably 3 to 6. Most preferably, the number of optical fibers is 3, and as shown in Figure 4, the three optical fibers 120 are equally spaced around the inner tube 132, and the angle between the corresponding two adjacent optical fibers 120 in the inner tube 132 is 120°.

[0118] The manufacturing method of the light-emitting section of the optical fiber 120 is to strip the cladding of the optical fiber 120 from the portion of the optical fiber 120 that is within the balloon body 110, and the stripped length of the cladding of the optical fiber 120 is equal to the axial length of the balloon body 110. The stripping method may be physical stripping (e.g., sandblasting, polishing, scratching, etc.) or chemical stripping.

[0119] As shown in Figures 8 and 10, the tube body 130 includes an inner tube 132 and an outer tube 131 fitted together, the distal end of the balloon body 110 is hermetically connected to the outer wall of the inner tube 132, and the proximal end of the balloon body 110 is hermetically connected to the outer tube 131. There is a radial gap between the inner tube 132 and the outer tube 131, and this radial gap is a fluid passage, and the lumen of the inner tube 132 is an optical fiber passage.

[0120] At least one axial section of the tube body 130 is a double-lumen tube 133, which includes a fluid passage 138 and a guidewire passage 137, which are parallel to and isolated from each other, and which communicates with the radial gap between the inner tube 132 and the outer tube 131. As shown in FIG. 11, the cross-sectional area of ​​the fluid passage 138 is larger than the cross-sectional area of ​​the guidewire passage 137.

[0121] A first guidewire port 134 is provided in the wall of the inner-layer tube 132 extending from the distal end of the balloon body 110. A second guidewire port 135 and a third guidewire port 136 are provided at either end of a guidewire passage 137. The direction of travel of a guidewire 180, as shown in Figure 8, is as follows: in use, the guidewire 180 enters the guidewire passage 137 of the double-lumen tube from the third guidewire port 136, then extends to the exterior of the balloon body 110 from the second guidewire port 135, and enters the lumen of the inner-layer tube from the first guidewire port 134. The diameter of the lumen of the inner-layer tube is 0.54 mm to 0.80 mm. More preferably, the diameter of the lumen of the inner-layer tube is 0.54 mm to 0.74 mm.

[0122] As shown in Figure 10, the first guidewire port, the second guidewire port, and the third guidewire port are directly opposite each other in 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 mm to 20 mm, and the distance D2 between the second guidewire port and the proximal end of the balloon body is 10 mm to 30 mm. More preferably, the distance D1 between the first guidewire port and the distal end of the balloon body is 5 mm to 15 mm, and the distance D2 between the second guidewire port and the proximal end of the balloon body is 10 mm to 30 mm.

[0123] By providing a double lumen tube 133 to guide the guide wire outside the balloon body 110, the optical fiber 120 is placed within the lumen of the inner-layer tube 132, which should be the guide wire passage, and the optical fiber 120 and the inner-layer tube 132 are arranged coaxially (within an acceptable error range, strict coaxiality is not required), allowing the light from the optical fiber to be more uniformly irradiated onto the blood vessel wall.

[0124] The routing portion of the guidewire 180 may be located outside the balloon body 110 to cut the lesion site and reduce irregular tearing and dissection of the blood vessel.

[0125] In order to improve the therapeutic effect, a drug coating is provided on the outer surface of the balloon body 110, and the drug is at least one of an antineoplastic drug, a drug that induces cross-linking of collagen or elastin, and an antivasospastic drug.

[0126] The drug coating on the outer surface of the balloon body 110 acts on the injury site, exerts a corresponding medicinal effect, and helps the injury site to be repaired in all directions. Preferably, the drug is paclitaxel or rapamycin.

[0127] Optionally, the outer surface of the balloon body 110 is provided with a deployable vascular stent.

[0128] Laser repair can be performed using a balloon, and a vascular stent can be implanted into the body using the balloon at the same time, achieving two treatment goals with a single intervention. Vascular stents usually have a compressible mesh structure, which does not have a significant blocking effect on the light used in the laser repair process, i.e., it does not affect the effectiveness of the laser repair. At the same time, based on the results of laser repair, the problem of neointimal hyperplasia is less likely to occur after the vascular stent is implanted.

[0129] The technical features of the above-described embodiments may be combined in any manner; however, for the sake of brevity, not all possible combinations of the technical features in the above-described embodiments are described; however, unless there is a contradiction in the combinations, all are deemed to be within the scope of this specification.

[0130] The above-mentioned embodiments only represent some embodiments of the present application, and although the descriptions thereof are relatively specific and detailed, they should not be construed as limiting the scope of the patent of the present invention. It should be noted that those skilled in the art can make some modifications and improvements without departing from the concept of the present application, all of which fall within the scope of protection of the present application. Therefore, the scope of protection of this patent application should be determined by the appended claims. [Explanation of symbols]

[0131] 100 Balloon Catheter System 110 Balloon body 111 Punctate process 112 Linear process 113 Equal diameter section 114 Tapered Section 120 Optical Fiber 130 Tube body 131 outer tube 132 Inner layer tube 133 Double Lumen Tube 134 First guidewire port 135 Secondary Guidewire Port 136 Third guidewire port 137 Guidewire passage 138 Fluid passage 140 Catheter Base 150 Stress Relief Tube 160 fiber optic connector 170 Elastic member 171 Exposure Section 172 Welding Section 173 Welding Ring 180 Guidewire

Claims

1. 1. A balloon catheter system with repair function, comprising: a tube body having opposed distal and proximal ends and having at least a fluid passageway and an optical fiber passageway; a balloon body disposed on the outer periphery of the distal end of the tube body and in communication with the fluid passage; an optical fiber having a light-emitting section inserted into the optical fiber passage and extending to the balloon body; a laser generating module connected to the proximal end of the optical fiber and emitting a laser having a repair function with a wavelength of 400 nm to 750 nm.

2. 2. The balloon catheter system according to claim 1, wherein the laser power output by the laser generating module is 10 to 30 mW.

3. The laser generating module outputs laser beams of predetermined wavelengths in the following order within each operation cycle: Initial stage: power 5 mW / cm ２ to 8 mW / cm ２ , lasting 10s to 20s, Intermediate stage: power 10 mW / cm ２ to 30 mW / cm ２ , lasting from 120s to 180s, End stage: power 5 mW / cm ２ to 8 mW / cm ２ 2. The balloon catheter system according to claim 1, wherein the duration of the balloon is 10 to 20 seconds.

4. 2. The balloon catheter system according to claim 1, wherein the balloon body includes a constant diameter section and tapered sections located at both ends of the constant diameter section, and the surfaces of the tapered sections located at the distal end of the balloon body are covered with a black coating.

5. 2. The balloon catheter system according to claim 1, wherein the refractive index of the high refractive index ultraviolet adhesive is 1.50 to 1.

70.

6. 2. The balloon catheter system of claim 1, wherein a high refractive index ultraviolet adhesive with a spacing distribution is attached to the outer periphery of the balloon body, the high refractive index ultraviolet adhesive protruding from the surface of the balloon body, and the protrusion height is 0.20 mm to 0.25 mm.

7. The balloon catheter system according to claim 6, wherein the high refractive index ultraviolet adhesive is evenly distributed around the outer periphery of the balloon body.

8. 7. The balloon catheter system according to claim 6, wherein the high refractive index ultraviolet adhesive is in the form of dots arranged in a matrix, and the pitch of the dots is 3 mm to 10 mm.

9. 5. The balloon catheter system according to claim 4, wherein the high refractive index ultraviolet adhesive is in the form of linear protrusions extending along the axial direction of the balloon body, arranged at equal intervals around the circumference of the balloon body, and the number of linear protrusions is 3 to 10.

10. The balloon catheter system according to claim 9, wherein the length of the linear projections matches the length of the isodiametric section.

11. 2. The balloon catheter system of claim 1, wherein the tube body includes an inner tube and an outer tube fitted together, the outer tube of the tube body being black, the inner tube of the tube body being colorless and transparent, and the hardness of the inner tube of the tube body being 35D to 75D, and the hardness is continuous or increases at predetermined intervals from the distal end to the proximal end.

12. 12. The balloon catheter system according to claim 11, wherein the inner layer tube of the tube body includes at least two first unit sections connected in sequence along the axial direction, and the hardness of the first unit section closer to the distal end of two adjacent first unit sections is less than the hardness of the first unit section closer to the proximal end.

13. The balloon catheter system according to claim 12, wherein the number of the first unit sections is two to four.

14. The balloon catheter system according to claim 12, characterized in that the diameter of each first unit section is the same, or for two adjacent first unit sections, the diameter of the first unit section closer to the distal end is smaller than the diameter of the first unit section closer to the proximal end.

15. 13. The balloon catheter system according to claim 12, wherein the axial length of the first unit section closest to the proximal end is 20 cm to 30 cm.

16. 13. The balloon catheter system of claim 12, wherein each first unit section uses a single-layer tube or a multi-layer tube, the material of the single-layer tube can be selected from one of PEBAX, nylon, and TPU, and the material of each layer is independently selected from one of PEBAX, nylon, and PE.

17. 12. The balloon catheter system according to claim 11, wherein the inner layer tube of the tube body includes a proximal end inner layer tube and a distal end inner layer tube connected along the axial direction, the proximal end inner layer tube having a hardness of 55D to 75D, and the distal end inner layer tube having a hardness of 35D to 55D.

18. 12. The balloon catheter system according to claim 11, wherein the outer layer tube of the tube body includes at least two second unit sections connected in sequence along the axial direction, and the hardness of the second unit section closer to the distal end of two adjacent second unit sections is less than the hardness of the second unit section closer to the proximal end.

19. 19. The balloon catheter system according to claim 18, wherein the number of the second unit sections is two to four.

20. The balloon catheter system of claim 18, wherein the diameter of each second unit section is the same, or for two adjacent second unit sections, the diameter of the first unit section closer to the distal end is smaller than the diameter of the first unit section closer to the proximal end.

21. 19. The balloon catheter system of claim 18, wherein each second unit section uses a single-layer tube or a multi-layer tube, the material of the single-layer tube can be selected from PEBAX or nylon, and the material of each layer is independently selected from PEBAX or nylon.

22. 12. The balloon catheter system of claim 11, wherein an elastic member is welded to the distal end of the inner layer tube, the elastic member including an exposed section and a welded section along the axial direction of the tube body, the axial length ratio of the exposed section to the welded section being 1:0.8 to 1.2, and the diameter of the elastic member gradually increasing from the distal end of the exposed section to the proximal end of the welded section.

23. 23. The balloon catheter system according to claim 22, wherein the elastic member is a coil spring, and the coil spring is made by helically winding a metal wire having a diameter of 0.04 mm to 0.1 mm.

24. 24. The balloon catheter system according to claim 23, wherein the material of the metal wire is one of platinum-tungsten, platinum-iridium, stainless steel, gold, and nickel-titanium.

25. 24. The balloon catheter system of claim 23, wherein the pitch of the exposed sections is equal to the diameter of the metal wire, and the pitch of the welded sections is 1 to 3 times the diameter of the metal wire.

26. 23. The balloon catheter system according to claim 22, wherein the axial length of the elastic member is 2 mm to 5 mm.

27. 23. The balloon catheter system of claim 22, wherein the exposed section of the elastic member has an axial length of 0.5 mm to 2 mm, and the welded section has an axial length of 1 mm to 3 mm.

28. 23. The balloon catheter system of claim 22, wherein the diameter of the exposed section is 0.50 mm to 0.70 mm and the diameter of the welded section is 0.60 mm to 1.0 mm.

29. 23. The balloon catheter system of claim 22, wherein the ratio of the diameter of the distal end of the exposed section to the diameter of the proximal end of the welded section is 1:1 to 1.

5.

30. 23. The balloon catheter system of claim 22, wherein the proximal end of the welded section forms a weld ring that is welded to the tube wall of the inner tube by bending the metal wire that forms the coil spring.

31. 2. The balloon catheter system of claim 1, wherein the tube body comprises an inner tube and an outer tube fitted together, the distal end of the balloon body being hermetically connected to the outer wall of the inner tube and the proximal end of the balloon body being hermetically connected to the outer tube, the radial gap between the inner tube and the outer tube serving as an optical fiber passage, and the optical fibers are arranged parallel to the inner tube or wrapped around the inner tube.

32. 32. The balloon catheter system according to claim 31, wherein the optical fibers are multiple and uniformly distributed around the axis of the tube body.

33. 32. The balloon catheter system of claim 31, wherein the diameter of each optical fiber is between 0.125 mm and 0.25 mm.

34. 2. The balloon catheter system according to claim 1, wherein the tube body comprises an inner tube and an outer tube fitted together, the distal end of the balloon body is hermetically connected to the outer wall of the inner tube, the proximal end of the balloon body is hermetically connected to the outer tube, a radial gap is formed between the inner tube and the outer tube, the radial gap is a fluid passage, and the lumen of the inner tube is a passage for an optical fiber.

35. 35. The balloon catheter system according to claim 34, wherein at least one axial section of the tube body is a double-lumen tube, the double-lumen tube including a fluid passage and a guidewire passage, the fluid passage and the guidewire passage being isolated from each other, and the fluid passage communicating with a radial gap between the inner tube and the outer tube.

36. 36. The balloon catheter system of claim 35, wherein a first guidewire port is provided in the wall of the inner layer tube extending from the distal end portion of the balloon body, and both ends of the guidewire passage 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 a portion of the guidewire between the first guidewire port and the second guidewire port is located outside the balloon body.

37. 2. The balloon catheter system of claim 1, wherein the outer surface of the balloon body is provided with a drug coating, the drug being at least one of an antineoplastic drug, a drug that induces crosslinking of collagen or elastin, and an antivasospastic drug.

38. 38. The balloon catheter system of claim 37, wherein the drug is paclitaxel or rapamycin.

39. 2. The balloon catheter system according to claim 1, wherein an implantable vascular stent is provided on the outer surface of the balloon body.

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