Balloon catheter system having repair function

Abstract

A balloon catheter system (100) having a repair function, comprising: a tubular body (130), which has a distal end and a proximal end opposite to each other, the tubular body (130) providing at least a fluid channel (138) and an optical fiber (120) channel; a balloon body (110), which is located at the periphery of the distal portion of the tubular body (130) and is in communication with the fluid channel (138); and an optical fiber (120), which runs through the optical fiber (120) channel and has a light-emitting segment extending to a position where the balloon body (110) is located, the light-emitting segment being configured to emit laser having a repair function, the wavelength of the laser being 400-750nm. The balloon catheter system (100) fastens the vascular wall tear part in a predetermined area, and provides laser with a specific wavelength in the area to effectively repair the vascular wall tear part, so as to effectively prevent restenosis and also prevent neointimal proliferation when a vascular stent is implanted.

Description

Balloon catheter system with repair function Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a balloon catheter system with a repair function. Background Art

[0002] Percutaneous interventional therapy has become one of the commonly used treatment technologies worldwide. For intravascular stenosis lesions, balloon dilatation or stent implantation is usually used for treatment, but both methods have their own shortcomings. Technical issues

[0003] The use of bare balloon dilatation to treat intravascular stenosis has a high chance of restenosis after treatment. Although the use of bare metal stent catheter intervention to treat intravascular stenosis is less likely to cause restenosis, it is easy to cause neointimal proliferation (the process of scar tissue formation in the stent segment). Once vascular restenosis or neointimal proliferation occurs, interventional treatment will be required again. Technical Solutions

[0004] Based on this, a balloon catheter system with repair function is provided, which can solve the problems of restenosis and neointimal proliferation occurring after interventional treatment.

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

[0006] A balloon catheter system with repair function, comprising:

[0007] a tubular body having opposite distal and proximal ends, the tubular body providing at least a fluid passage and an optical fiber passage;

[0008] a balloon body, located at the periphery of the distal end of the tube body and communicated with the fluid channel;

[0009] an optical fiber, passing through the optical fiber channel and having a light-emitting segment extending to the location of the balloon;

[0010] The laser generating module is connected to the proximal end of the optical fiber. The laser generating module emits a laser with a repair function. The wavelength of the laser is 400~750nm.

[0011] Several optional methods are also provided below, but they are not intended to be additional limitations on the above-mentioned overall solution. They are merely further supplements or optimizations. Under the premise that there are no technical or logical contradictions, each optional method can be combined separately for the above-mentioned overall solution, or multiple optional methods can be combined.

[0012] Optionally, the laser generating module outputs a laser with a power of 10-30 mW.

[0013] Optionally, the laser generating module outputs laser light of a predetermined wavelength in each working cycle in the following order:

[0014] Initial stage: power 5-8mW / cm2, lasting 10-20s;

[0015] Intermediate stage: power 10-30mW / cm2, duration 120-180s;

[0016] Ending stage: power 5-8mW / cm2, lasting 10-20s.

[0017] 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 of the balloon body located at the distal end is covered with a black coating.

[0018] Optionally, the refractive index of the high-refractive-index UV glue is 1.50-1.70.

[0019] Optionally, high-refractive-index ultraviolet glue is attached to the periphery of the balloon body at intervals, and the high-refractive-index ultraviolet glue is raised relative to the surface of the balloon body, and the height of the raised portion is 0.20 mm to 0.25 mm.

[0020] Optionally, the high refractive index ultraviolet glue is regularly distributed on the periphery of the balloon.

[0021] Optionally, the high refractive index UV glue is in the form of dot-shaped protrusions and is arranged in a matrix, and the spacing between the dot-shaped protrusions is 3-10 mm.

[0022] Optionally, the high refractive index UV glue is in the form of linear protrusions extending axially along the balloon body and arranged at equal intervals around the circumference of the balloon body, and the number of the linear protrusions is 3-10.

[0023] Optionally, the length of the linear protrusion is adapted to the length of the equal diameter section.

[0024] 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, the hardness of the inner tube of the tube body is 35 D ~ 75D, and the hardness increases continuously or at intervals of predetermined values ​​from the distal end to the proximal end.

[0025] Optionally, the inner tube of the tube body includes at least two first unit segments connected in sequence along the axial direction, and for two adjacent first unit segments, the hardness of the first unit segment closer to the distal end is smaller than the hardness of the first unit segment closer to the proximal end.

[0026] Optionally, the number of the first unit segments is 2 to 4.

[0027] 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 distal end is smaller than the diameter of the first unit segment closer to the proximal end.

[0028] Optionally, the axial length of the first unit segment closest to the proximal end is 20-30 cm.

[0029] Optionally, each first unit segment adopts 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. The layers in the multi-layer tube can slide relatively, and the material of each layer is independently selected from one of PEBAX, nylon, and PE.

[0030] Optionally, 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.

[0031] Optionally, the outer tube of the tube body includes at least two second unit segments connected in sequence along the axial direction, and for two adjacent second unit segments, the hardness of the second unit segment closer to the distal end is smaller than the hardness of the second unit segment closer to the proximal end.

[0032] Optionally, the number of the second unit segments is 2 to 4.

[0033] Optionally, the diameters of the second unit segments are the same, 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.

[0034] Optionally, each second unit segment adopts a single-layer tube or a multi-layer tube. The material of the single-layer tube can be PEBAX or nylon. The layers in the multi-layer tube can slide relatively, and the material of each layer is independently selected from PEBAX or nylon.

[0035] Optionally, an elastic part is welded to the distal end of the inner tube, and the elastic part includes an exposed section and a welding section along the axial direction of the tube body. The ratio of the axial length of the exposed section to the welding section is 1:0.8~1.2, and the diameter of the elastic part gradually increases from the distal end of the exposed section to the proximal end of the welding section.

[0036] Optionally, the elastic member is a coil spring, which is formed by spirally winding a metal wire with a diameter of 0.04-0.1 mm.

[0037] Optionally, the metal wire is made of one of platinum tungsten, platinum iridium, stainless steel, gold, and nickel titanium.

[0038] Optionally, 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.

[0039] Optionally, the axial length of the elastic member is 2-5 mm.

[0040] Optionally, the axial length of the exposed section of the elastic member is 0.5-2 mm, and the axial length of the welding section is 1-3 mm.

[0041] Optionally, the diameter of the exposed section is 0.50-0.70 mm, and the diameter of the welding section is 0.60-1.0 mm.

[0042] Optionally, the ratio of the distal diameter of the exposed section to the proximal diameter of the welding section is 1:1-1.5.

[0043] Optionally, the proximal end of the welding section is formed by bending the metal wire forming the coil spring to form a welding ring welded to the wall of the inner tube.

[0044] Optionally, the tube body includes an inner tube and an outer tube nested inside and outside, the distal end of the balloon body is sealedly connected to the outer wall of the inner tube, and the proximal end of the balloon body is sealedly connected to the outer tube. The radial gap between the inner tube and the outer tube serves as an optical fiber channel, and the arrangement of each optical fiber is parallel to the inner tube, or wrapped around the inner tube.

[0045] Optionally, there are multiple optical fibers, and the optical fibers are evenly distributed around the axis of the tube body.

[0046] Optionally, the diameter of each optical fiber is 0.125 mm to 0.25 mm.

[0047] Optionally, the tube body includes an inner tube and an outer tube nested inside and outside, the distal end of the balloon body is sealedly connected to the outer wall of the inner tube, the proximal end of the balloon body is sealedly connected 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 inner tube lumen is an optical fiber channel.

[0048] Optionally, 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 guidewire channel, the fluid channel and the guidewire channel are isolated from each other, and the fluid channel is connected to the radial gap between the inner tube and the outer tube.

[0049] Optionally, a first guide wire port is provided on the wall of the inner tube extending out of the distal end of the balloon body, and the two ends of the guide wire channel are respectively a second guide wire port and a third guide wire port. The guide wire passes through the first guide wire port, the second guide wire port, and the third guide wire port, and the part of the guide wire between the first guide wire port and the second guide wire port is located outside the balloon body.

[0050] Optionally, the outer surface of the balloon is provided with a drug coating, and the drug is at least one of an anti-proliferative drug, a drug that induces collagen or elastin cross-linking, and an anti-vasospasm drug.

[0051] Optionally, the drug is paclitaxel or rapamycin.

[0052] Optionally, an implantable vascular stent is provided on the outer surface of the balloon. Beneficial effects

[0053] The balloon catheter system provided in the present application concentrates the torn parts of the blood vessel wall in a predetermined area, and provides a laser of a specific wavelength in the area to effectively repair the torn parts of the blood vessel wall, which can effectively prevent the occurrence of restenosis and prevent neointimal proliferation when implanting a vascular stent. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] FIG1 is a schematic diagram of a balloon catheter system with a repair function;

[0055] FIG2 is a schematic diagram of a first distribution of high-refractive-index UV glue on the surface of the balloon;

[0056] FIG3 is a schematic diagram of a second distribution of high-refractive-index UV glue on the surface of the balloon;

[0057] FIG4 is a schematic diagram showing the cross-sectional positional relationship between the optical fiber and the inner tube;

[0058] FIG5 is a schematic diagram of a first positional relationship between the optical fiber and the inner tube;

[0059] FIG6 is a schematic diagram of a second positional relationship between the optical fiber and the inner tube;

[0060] FIG7 is a schematic diagram of the outer tube in the tube body;

[0061] FIG8 is a schematic diagram of a balloon catheter system with repair function (the guidewire is located outside the balloon body);

[0062] FIG9 is an enlarged view of portion A in FIG8 ;

[0063] FIG10 is a schematic diagram showing the positions of the tube body, double-lumen tube, and balloon body in FIG8 ;

[0064] FIG11 is a schematic cross-sectional view of a double-lumen tube.

[0065] In the figure: 100, balloon catheter system; 110, balloon body; 111, dot-shaped protrusion; 112, linear protrusion; 113, equal-diameter section; 114, tapered section; 120, optical fiber; 130, tube body; 131, outer tube; 132, inner tube; 133, double-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 part; 171, exposed section; 172, welding section; 173, welding ring; 180, guidewire. Modes for Carrying Out the Invention

[0066] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0067] In order to better describe and illustrate the embodiments of the present application, reference may be made to one or more drawings, but the additional details or examples used to describe the drawings should not be considered as limiting the scope of the invention of the present application, any of the currently described embodiments or preferred methods.

[0068] It should be noted that when a component is referred to as being "connected" to another component, it may be directly connected to the other component or there may be an intermediate component. When a component is referred to as being "disposed on" another component, it may be directly disposed on the other component or there may be an intermediate component.

[0069] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which this application pertains. The terms used herein in the specification of this application are for the purpose of describing specific embodiments only and are not intended to limit this application.

[0070] Referring to FIG1 , a balloon catheter system 100 with a repair function includes:

[0071] The tube body 130 has a distal end and a proximal end opposite to each other, and the tube body 130 provides at least a fluid channel and an optical fiber channel;

[0072] The balloon body 110 is located at the outer periphery of the distal end of the tube body 130 and is in communication with the fluid channel;

[0073] The optical fiber 120 is disposed in the optical fiber channel and has a light-emitting section extending to the location of the balloon body 110;

[0074] The laser generating module is connected to the proximal end of the optical fiber 120 . The laser generating module emits laser light with a repair function. The wavelength of the laser light is 400-750 nm.

[0075] When the balloon catheter system 100 with a repair function is in use, fluid is first injected into the balloon body 110 through the fluid channel of the tube body 130 to fill the balloon body 110. Then, a laser with a wavelength of 400~750nm is emitted by the laser generating module. The laser is emitted through the light-emitting segment of the optical fiber 120, passes through the balloon body 110, the fluid in the balloon body 110 and is scattered by the balloon body 110, and is applied to the part to be repaired. Under normal circumstances, continuous application of laser for a predetermined time for treatment can achieve the ideal effect.

[0076] The periphery of the balloon body 110 is attached with spaced-apart high-refractive index UV glue, which is regularly distributed on the outer surface of the balloon body 110. When the interior of the balloon body 110 is filled with fluid, the balloon body 110 expands to expand 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 of the blood vessel wall. The tearing of the blood vessel wall will be concentrated in the area where the high-refractive index UV glue is distributed. Because the high-refractive index UV glue protrudes relative to the outer wall of the balloon body 110, it is more likely to form a stress concentration area when acting on the blood vessel wall. Through the setting of the high-refractive index UV glue, the originally disorderly distributed blood vessel wall tearing is concentrated in the area where the high-refractive index UV glue exists. At the same time, the high-refractive index UV glue enriches the laser in this area, so that the laser acts more concentratedly on the torn area of ​​the blood vessel wall, thereby completing the repair of the area.

[0077] The present application concentrates the inevitable disordered tearing of the blood vessel wall in a specific area by using the high-refractive index ultraviolet glue protruding from the outer surface of the balloon body 110. The specific area is also the area where the high-refractive index ultraviolet glue exists. At the same time, based on the focusing effect of the high-refractive index ultraviolet glue on the laser in this specific area, the repair of blood vessel tears can be achieved more effectively.

[0078] Laser acting on the area to be repaired can promote the repair of damaged blood vessels and effectively prevent the occurrence of restenosis.

[0079] The laser generating module provides low-power laser light in pulsed or continuous output, which is transmitted to the interior of the balloon body 110 through the optical fiber 120. The light-emitting section of the optical fiber 120 inside the balloon body 110 applies low-intensity laser light to the area to be repaired. The low-intensity laser light has a light-regulating effect, which is produced by a photochemical effect rather than a thermal effect. It can promote the repair of cells and tissues, accelerate the removal of inflammatory mediators and the absorption of tissue edema.

[0080] After balloon catheter dilatation, the inner wall of the blood vessel is easily damaged. The optical fiber 120 light segment emits red light of a specific wavelength, which is scattered by the balloon body 110 and then applied to the damaged part of the inner wall of the blood vessel. This can promote the proliferation of endothelial cells and anti-inflammatory apoptosis, accelerate the recovery of blood vessels to a stable state, and prevent restenosis of blood vessels after surgery.

[0081] The laser generating module emits laser light with a wavelength of 400-750 nm. Within this wavelength range, the laser light appears red, which can promote the repair of cell nuclei and tissues, accelerate the removal of inflammatory mediators, and absorb tissue edema. Further preferably, the laser generating module emits laser light with a wavelength of 630-700 nm.

[0082] The laser generating module outputs a laser with a power of 10 to 30 mW. More preferably, the laser generating module outputs a laser with a power of 10 to 15 mW.

[0083] The laser generating module outputs laser light of a predetermined wavelength in each working cycle in the following order:

[0084] Initial stage: power 5-8mW / cm2, lasting 10-20s;

[0085] Intermediate stage: power 10-30mW / cm2, duration 120-180s;

[0086] Ending stage: power 5-8mW / cm2, lasting 10-20s.

[0087] Each working cycle corresponds to a complete cycle of the laser generating module acting on the blood vessel wall. In the initial stage, low-power, short-duration laser output is used to adapt the blood vessels to laser irradiation and prepare for subsequent treatment. In the middle stage, the torn blood vessels are healed by increasing the power to prevent postoperative restenosis. In the final stage, low-power, short-duration laser output is used to perform postoperative buffering and reduce the burden on the blood vessels.

[0088] If the power of the laser output by the laser generating module is too low, the repair effect will be unsatisfactory. If the power is too high, it will cause excessive heat and cause blood vessel burns. Preferably, in the intermediate stage, the power is 10-15mW / cm2 and lasts for 120~180s.

[0089] The balloon 110 can be a smooth bare balloon or a shaped balloon. The balloon material must be sufficiently flexible and have good permeability to ensure smooth delivery to the intended site, while also providing excellent processability, resilience, fatigue resistance, and dimensional stability. Preferably, the balloon is made of PEBAX, nylon, or TPU. More preferably, the balloon is made of PEBAX or nylon.

[0090] As shown in Figure 10 , balloon body 110 includes a constant diameter section 113 and tapered sections 114 at either end of the constant diameter section 113. The surface of the distal tapered section 114 (see the black filled area in Figure 10 ) is covered with a black coating. The black coating is made of one of PTFE, mixed-color shellac, or mixed-color UV glue. The tapered sections 114 at either end of balloon body 110 are not strictly conical; they merely resemble a cone due to the varying diameter of the balloon.

[0091] The distal end of the balloon body 110 is covered with a black coating, which can block the laser and prevent the laser from causing burns to unintended parts.

[0092] As shown in Figure 1, 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 interfaces respectively connected to the fluid channel and the optical fiber channel. 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.

[0093] The laser light emitted by the light-emitting section is focused on the high-refractive index UV adhesive to ensure sufficient laser intensity applied to the repaired area. 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.

[0094] The high-refractive-index UV glue concentrates the tearing of the blood vessel wall at the expected location. In order to prevent the tearing of the blood vessel wall from being complicated, the high-refractive-index UV glue is regularly distributed on the periphery of the balloon body 110. The high-refractive-index UV glue is raised relative to the surface of the balloon body, and the height of the raised portion is 0.20 mm to 0.25 mm.

[0095] As shown in Figure 2 , the high-refractive-index UV adhesive is arranged in a matrix of dot-shaped projections 111. The spacing between these projections 111 is 3-10 mm, and each projection 111 is equidistant from its neighbors. Each dot-shaped projection 111 is hemispherical, with the flat surface of the hemispherical shape fixedly connected to the outer surface of the balloon. The height of each dot-shaped projection 111 (indicated by H1 in Figure 2 ) is 0.20 mm to 0.25 mm.

[0096] As shown in Figure 3 , the high-refractive-index UV adhesive is formed as linear protrusions 112 extending axially along the balloon body 110 and arranged at equal intervals around the circumference of the balloon body 110. The number of linear protrusions 112 ranges from 3 to 5. The height of the linear protrusions 112 (indicated by H2 in Figure 3 ) is 0.20 mm to 0.25 mm. The balloon body 110 includes a constant-diameter section 113 and tapered sections 114 at either end of the constant-diameter section. The length of the linear protrusions 112 matches that of the constant-diameter section 113, and a smooth transition is formed between the ends of the linear protrusions 112 and the tapered sections 114.

[0097] When fluid is injected into the balloon body 110 through the fluid channel of the tube body 130 to inflate and expand the balloon body 110, the high refractive index UV glue can focus the laser, and the focused laser is applied more concentratedly to the part to be repaired to avoid missing the treatment area.

[0098] In addition to being able to concentrate the torn area of ​​the blood vessel and focus the laser for effective repair, the high refractive index UV glue can also increase the friction between the balloon body 110 and the blood vessel wall when the balloon body 110 is expanded, thereby reducing the slippage of the balloon body 110 relative to the blood vessel wall, improving the treatment effect, and reducing unnecessary damage to non-treatment areas.

[0099] Regularly distributed high-refractive index UV glue can also cut the diseased area and reduce irregular tearing and dissection of blood vessels.

[0100] As shown in Figure 1 , the tube body 130 comprises an inner tube 132 and an outer tube 131 nested within each other. 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 inner tube is colorless and transparent, allowing light transmitted by the optical fiber to radiate outward. The outer tube is black, preventing light from the optical fiber from reaching unintended locations.

[0101] The hardness of the inner tube of the tube body is 35D~75D, and the hardness increases continuously or at predetermined intervals from the distal end to the proximal end.

[0102] The inner tube of the tubular body includes at least two first unit segments connected in sequence 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 two first unit segments are connected by welding.

[0103] The number of first unit segments is 2 to 4.

[0104] 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. The diameter gradually increases from the distal end to the proximal end along the axis of the tube body. This ensures the tube's maneuverability at the proximal end while allowing the inner tube to have a thinner diameter at the distal end, allowing it to extend into smaller blood vessels, particularly cerebral vessels.

[0105] The axial lengths of the first unit segments are the same or different.

[0106] The axial length of the first unit segment closest to the proximal end is 20-30 cm.

[0107] Each first unit segment adopts 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. The layers in the multi-layer tube can slide relatively, and the material of each layer is independently selected from one of PEBAX, nylon, and PE.

[0108] Each first unit segment adopts a single-layer tube, and the material of the single-layer tube is nylon or PEBAX.

[0109] Each first unit segment adopts a multi-layer tube, the materials of each multi-layer tube are the same or different, and the thickness of each layer of the multi-layer tube is the same or different.

[0110] Each first unit segment adopts a three-layer tube, and each layer in the three-layer tube can slide relatively. From the outside to the inside, the thickness of each layer is 0.04 mm, 0.05 mm, and 0.01 mm respectively, and the materials of each layer are HDPE, LDPE, and nylon respectively.

[0111] 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.

[0112] The proximal inner tube adopts a three-layer tube, and the distal inner tube adopts a three-layer tube or a single-layer tube.

[0113] The proximal inner tube is a three-layer tube, each layer of which is made of PEBAX. The distal inner tube is a three-layer tube, each layer of which is made of PEBAX.

[0114] The outer tube of the tubular body includes at least two second unit segments connected in sequence along the axial direction. 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. The two second unit segments are connected by welding.

[0115] The number of the second unit segments is 2 to 4.

[0116] 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. The diameter gradually increases from the distal end to the proximal end along the axis of the tube body. This ensures the tube's maneuverability at the proximal end while allowing the inner tube to have a thinner diameter at the distal end, allowing it to extend into smaller blood vessels, particularly those in the brain.

[0117] The axial lengths of the second unit segments are the same or different.

[0118] Each second unit segment adopts a single-layer tube or a multi-layer tube. The material of the single-layer tube can be selected from PEBAX or nylon. The layers in the multi-layer tube can slide relatively, and the material of each layer is independently selected from PEBAX or nylon.

[0119] Each second unit segment adopts a multi-layer tube, the materials of each multi-layer tube are the same or different, and the thickness of each layer of the multi-layer tube is the same or different.

[0120] In this application, by selecting appropriate materials for the balloon, inner tube and outer tube, the delivery system formed by the balloon, inner tube and outer tube is relatively softer, so as to balance the increased hardness of the delivery system caused by the addition of optical fiber, so that the delivery system finally presents an ideal state of both radial support and softness.

[0121] As shown in Figure 7, Y in Figure 7 indicates the distal end and J indicates the proximal end. In order from the distal end to the proximal end, the outer tube includes a second unit segment L1, a second unit segment L2 and a second unit segment L3 connected in sequence along the axial direction. The second unit segments are connected by welding and are coaxially arranged. 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. 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 segment L1 and the second unit segment L2 is PEBAX, and the material of the second unit segment L3 is nylon.

[0122] Figure 7 shows the structure of the outer tube within the tube body. The inner tube has the same structure as the outer tube, but with different materials and diameters. When the outer tube is composed of multiple second segments as shown in Figure 7, the inner tube also consists of multiple first segments, with the number and axial length of the first and second segments being the same. From distal to proximal end, the diameter of the first segments of the inner tube is 0.54mm, with hardnesses of 55D, 63D, and 70D, respectively. The materials are Pebax, Pebax, and PA, respectively.

[0123] When the outer tube adopts a single diameter, the inner tube also adopts a single diameter, and the structures of the inner tube and the outer tube remain consistent.

[0124] 8 and 9 , an elastic member 170 is welded to the distal end of the inner tube 132. The elastic member 170 includes an exposed section 171 (corresponding to section T1 in FIG. 9 ) and a welded section 172 (corresponding to section T2 in FIG. 9 ) along the axial direction of the tube body. The ratio of the axial length of the exposed section 171 to the welded section 172 is 1:0.8-1.2. The diameter of the elastic member 170 gradually increases from the distal end of the exposed section 171 to the proximal end of the welded section 172.

[0125] At the distal end of the tube body, the inner tube 132 intersects with the distal end of the balloon body. An elastic part 170 is welded to the distal end of the inner tube 132, and the elastic part may also be welded to the distal end of the balloon body at the same time. The elastic part 170 is located as a whole at the distal end of the inner tube 132. The welding section 172 overlaps with the distal end of the inner tube 132 and is fixedly connected by a welding process, while the exposed section 171 is directly exposed to the outside. It is neither in the tube wall of the inner tube 132 nor overlapped and fixed with other components.

[0126] The elastic part 170 has a certain degree of elasticity. As the part of the tube that first extends into the blood vessel, the elastic part 170 has the characteristic of being deformable when encountering a blood vessel obstruction, which can avoid puncturing the blood vessel. At the same time, based on the rebound performance of the elastic part 170, it can restore its own shape after the external force disappears.

[0127] Elastic member 170 is a coil spring formed by spirally winding a metal wire with a diameter of 0.04-0.1 mm. More preferably, the coil spring is formed by spirally winding a metal wire with a diameter of 0.05-0.06 mm. The metal wire is made of one of platinum tungsten, platinum iridium, stainless steel, gold, and nickel titanium.

[0128] The elastic member 170 is made of metal wire, that is, a light-proof structure, which can block the light emitted by the optical fiber at the distal end of the balloon body to avoid irradiation damage to unintended parts.

[0129] The pitch of the exposed section 171 is equal to the diameter of the metal wire, and the pitch of the welding section 172 is 1 to 3 times the diameter of the metal wire. More preferably, the pitch of the welding section 172 is 1.5 to 2 times the diameter of the metal wire.

[0130] The exposed section 171 is exposed to the outside, and a smaller pitch can increase the resilience of the elastic member 170. However, since the welding section 172 needs to be connected to the wall of the inner tube 132, a larger pitch needs to be set to avoid excessively reducing the softness of the inner wall and easily causing damage to the blood vessel wall.

[0131] The metal wire has a developing function, and the elastic member 170 can also serve as a developing component to indicate the position of the balloon in the body.

[0132] The axial length of the elastic member is 2-5 mm. More preferably, the axial length of the elastic member 170 is 3-5 mm.

[0133] The axial length of the elastic member 170 must be appropriate. If it is too long, it will be detrimental to the rebound of the elastic member 170 . If it is too short, it will not be able to guide the balloon forward along the blood vessels.

[0134] The exposed section of the elastic member has an axial length of 0.5-2 mm, and the welded section has an axial length of 1-3 mm. Further preferably, the exposed section 171 of the elastic member 170 has an axial length of 1-2 mm, and the welded section 172 has an axial length of 2-3 mm.

[0135] 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.

[0136] The diameter of the exposed section 171 needs to be able to enter thinner blood vessels without losing the resilience performance, and the diameter of the welding section 172 matches the diameter of the inner tube 132.

[0137] 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.

[0138] The proximal end of the welding section 172 is bent by forming a metal wire of a coil spring to form a welding ring 173 welded to the wall of the inner tube 132. The welding ring 173 can increase the welding area and ensure the firmness of the welding.

[0139] 4 , 5 and 6 , there are multiple optical fibers 120 , and the optical fibers 120 are evenly distributed around the axis of the tube 130 .

[0140] As shown in Figure 1 , the tubular body 130 includes an inner tube 132 and an outer tube 131 nested within each other. The radial gap between the inner tube 132 and the outer tube 131 serves as a fiber channel. As shown in Figure 5 , each optical fiber 120 is arranged parallel to the inner tube 132, or as shown in Figure 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 each winding unit being 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.

[0141] The optical fiber 120 is made of plastic optical fiber or quartz optical fiber. Preferably, it is plastic optical fiber. 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.

[0142] The number of optical fibers is 1 to 13, preferably 3 to 6. Most preferably, the number of optical fibers is 3. As shown in FIG4 , the 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 inner tube 132 is 120°.

[0143] The light-emitting segment of optical fiber 120 is fabricated by stripping the cladding of optical fiber 120 from the portion of optical fiber 120 within balloon 110, with the stripped length of optical fiber 120 equal to the axial length of balloon 110. The stripping method can be physical stripping (e.g., sandblasting, polishing, scraping, etc.) or chemical stripping.

[0144] As shown in Figures 8 and 10, the tube body 130 includes an inner tube 132 and an outer tube 131 that are nested inside and outside. The distal end of the balloon body 110 is sealedly connected to the outer wall of the inner tube 132, and the proximal end of the balloon body 110 is sealedly connected 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 lumen of the inner tube 132 is an optical fiber channel.

[0145] At least one section of the tube body 130 in the axial direction is a double-lumen tube 133, and the double-lumen tube 133 includes a fluid channel 138 and a guidewire channel 137. The fluid channel 138 and the guidewire channel 137 are parallel to each other and isolated from each other. The fluid channel 138 is connected to the radial gap between the inner tube 132 and the outer tube 131. As shown in Figure 11, the cross-sectional area of ​​the fluid channel 38 is larger than the cross-sectional area of ​​the guidewire channel 137.

[0146] A first guidewire port 134 is formed on the wall of the inner tube 132 extending from the distal end of the balloon body 110. The guidewire channel 137 has a second guidewire port 135 and a third guidewire port 136 at either end. The direction of the guidewire 180 is shown in FIG8 . 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 exterior 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 to 0.80 mm. More preferably, the diameter of the inner tube lumen is 0.54 to 0.74 mm.

[0147] As shown in Figure 10 , the first, second, and third guidewire ports are aligned along the axis of the tube body. The distance D1 between the first guidewire port and the distal end of the balloon body is 5-20 mm, and the distance D2 between the second guidewire port and the proximal end of the balloon body is 10-30 mm. More preferably, the distance D1 between the first guidewire port and the distal end of the balloon body is 5-15 mm, and the distance D2 between the second guidewire port and the proximal end of the balloon body is 10-30 mm.

[0148] By setting up a double-lumen tube 133 to guide the guide wire to the outside of the balloon body 110, and placing the optical fiber 120 in the lumen of the inner tube 132 that should originally serve as the guide wire channel, the optical fiber 120 and the inner tube 132 are arranged coaxially (within an acceptable error range, strict coaxiality is not required), so that the light emitted by the optical fiber can be more evenly irradiated on the wall of the blood vessel.

[0149] The path portion of the guide wire 180 is outside the balloon body 110 and can also cut the diseased area to reduce irregular tearing and dissection of the blood vessels.

[0150] In order to improve the treatment effect, the outer surface of the balloon body 110 is provided with a drug coating, and the drug is at least one of an anti-proliferative drug, a drug that induces collagen or elastin cross-linking, and an anti-vasospasm drug.

[0151] The drug coating on the outer surface of the balloon body 110 can act on the damaged area, play a corresponding medicinal effect, and help to fully repair the damaged area. Preferably, the drug is paclitaxel or rapamycin.

[0152] As an option, the outer surface of the balloon body 110 is provided with an implantable vascular stent.

[0153] While using a balloon for laser repair, a vascular stent can be implanted into the body at the same time using the balloon, which can achieve two treatment purposes at once. The vascular stent is usually a compressible mesh and will not significantly block the light during the laser repair process, which means it will not affect the effect of the laser repair. At the same time, based on the results of the laser repair, it is not easy to cause the problem of neointimal proliferation after the implantation of the vascular stent.

[0154] The technical features of the above embodiments can be combined arbitrarily. To make the description concise, 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.

[0155] The above embodiments merely represent several implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that a person skilled in the art could make various modifications and improvements without departing from the spirit of the present application, all of which fall within the scope of protection of the present application. Therefore, the scope of protection of the present patent application shall be determined by the appended claims.

Claims

1. A balloon catheter system with repair function, characterized in that: include: a tubular body having opposite distal and proximal ends, the tubular body providing at least a fluid passage and an optical fiber passage; A balloon body, located at the periphery of the distal end of the tube body and communicated with the fluid channel; An optical fiber, which is inserted into the optical fiber channel and has a light-emitting section extending to the location of the balloon body; The laser generating module is connected to the proximal end of the optical fiber. The laser generating module emits laser with a repair function. 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 laser power of 10-30 mW.

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 according to the following sequence: Initial stage: power 5-8mW / cm2, lasting 10-20s; Intermediate stage: power 10-30mW / cm2, lasting 120-180s; Ending stage: power 5-8mW / cm2, lasting 10~20s.

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

5. The balloon catheter system with repair function according to claim 1, characterized in that: The refractive index of the high-refractive-index ultraviolet glue is 1.50-1.

70.

6. The balloon catheter system with repair function according to claim 1, characterized in that: The outer periphery of the balloon body is attached with spaced-apart high-refractive-index ultraviolet glue, the high-refractive-index ultraviolet glue is raised relative to the surface of the balloon body, and the height of the raised portion is 0.20 mm to 0.25 mm.

7. The balloon catheter system with repair function according to claim 6, characterized in that: The high refractive index ultraviolet glue is regularly distributed on the periphery of the balloon body.

8. The balloon catheter system with repair function according to claim 6, characterized in that: The high refractive index ultraviolet glue is in the form of dot-shaped protrusions and is arranged in a matrix, and the spacing between the dot-shaped protrusions is 3-10 mm.

9. The balloon catheter system with repair function according to claim 4, characterized in that: The high refractive index ultraviolet glue is a linear protrusion extending along the axial direction of the balloon body and is arranged at equal intervals around the circumference of the balloon body. The number of the 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 comprises 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, the hardness of the inner tube of the tube body is 35D~75D, and the hardness increases continuously or at intervals of a predetermined value 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 in sequence along the axial direction. For two adjacent first unit segments, the hardness of the first unit segment closer to the distal end is smaller than the hardness of 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 the first unit segments are the same, 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.

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 20-30 cm.

16. The balloon catheter system with repair function according to claim 12, characterized in that: Each first unit segment adopts 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. The balloon catheter system with repair function according to claim 11, characterized in that: The inner tube of the tube body comprises 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 in sequence along the axial direction. For two adjacent second unit segments, the hardness of the second unit segment closer to the distal end is smaller 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 segments is 2 to 4.

20. The balloon catheter system with repair function according to claim 18, characterized in that: The diameters of the second unit segments are the same, 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.

21. The balloon catheter system with repair function according to claim 18, characterized in that: Each second unit segment adopts 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. The balloon catheter system with repair function according to claim 11, characterized in that: An elastic part is welded to the distal end of the inner tube, and the elastic part includes an exposed section and a welding section along the axial direction of the tube body. The ratio of the axial length of the exposed section to the welding section is 1:0.8~1.

2. From the distal end of the exposed section to the proximal end of the welding section, the diameter of the elastic part gradually increases.

23. The balloon catheter system with repair function according to claim 22, characterized in that: The elastic member is a coil spring, which is formed by spirally winding a metal wire with a diameter of 0.04-0.1 mm.

24. The balloon catheter system with repair function according to claim 23, characterized in that: The material of the metal wire is one of platinum tungsten, platinum iridium, stainless steel, gold, and 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 welding 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 member is 2-5 mm.

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

5.

30. The balloon catheter system with repair function according to claim 22, characterized in that: The proximal end of the welding section is bent to form a welding ring welded to the wall of the inner tube by forming a metal wire of a spiral 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 which are nested inside and outside. The distal end of the balloon body is sealed and connected to the outer wall of the inner tube, and the proximal end of the balloon body is sealed and connected to the outer tube. The radial gap between the inner tube and the outer tube serves as an optical fiber channel, and the arrangement of each optical fiber is 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: There are multiple optical fibers, and each optical fiber is evenly distributed around the axis of the tube body.

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 sealedly connected to the outer wall of the inner tube, the proximal end of the balloon body is sealedly connected 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 inner tube lumen 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, and 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: A first guide wire opening is provided on the tube wall of the inner tube extending out of the distal end of the balloon body, and two ends of the guide wire channel are respectively a second guide wire opening and a third guide wire opening. The guide wire passes through the first guide wire opening, the second guide wire opening and the third guide wire opening, and the portion of the guide wire between the first guide wire opening and the second guide wire opening 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 body is provided with a drug coating, and the drug is at least one of an anti-proliferative drug, a drug inducing collagen or elastin cross-linking, and an anti-vasospasm drug.

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

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

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