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] This application relates to the field of medical devices, and more particularly to a balloon catheter system having a regenerative function. [Background technology]

[0002] Percutaneous intervention therapy has become one of the most commonly used treatment techniques worldwide. While endovascular stenosis is typically treated with balloon angioplasty or stent placement, both methods have drawbacks. [Overview of the Initiative] [Problems that the invention aims to solve]

[0003] Using conventional balloon dilation to treat vascular stenosis increases the likelihood of restenosis after treatment, while using a single metal stent catheter intervention to treat vascular stenosis reduces the likelihood of restenosis but increases the likelihood of neointima-proliferation (i.e., the process of scar tissue formation in the stent section), and if restenosis or neointima-proliferation occurs, further intervention will be necessary. [Means for solving the problem]

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

[0005] The technical proposal provided by this application is as follows:

[0006] A balloon catheter system having a repair function, A tube body having opposing distal and proximal ends, and comprising at least a fluid passage and an optical fiber passage, A balloon body is positioned on the outer circumference of the distal end of the tube body and communicates with the fluid passage, An optical fiber having a light-emitting section inserted into the optical fiber passage and extending to the position of the balloon body, It includes a laser generating module connected to the proximal end of an optical fiber, which emits a laser with a healing function and a wavelength of 400 nm to 750 nm.

[0007] Several alternative methods are shown below, but these are not intended to be additional limitations on the overall technical proposal above. Provided there are no technical or logical inconsistencies, these alternative methods can be combined individually or in combination with other alternative methods in relation to the overall technical proposal above.

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

[0009] Optionally, the laser generation module outputs lasers of predetermined wavelengths in the following order within each operating cycle: Initial stage: Power 5mW / cm 2 From 8 mW / cm 2 It lasts for 10 to 20 seconds, Intermediate stage: Power 10mW / cm 2 From 30 mW / cm² 2 It lasted from 120s to 180s, Final stage: Power 5mW / cm 2 From 8 mW / cm 2 It lasts for 10 to 20 seconds.

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

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

[0012] Optionally, a high refractive index ultraviolet adhesive with a spaced 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, and the height of the protrusion is from 0.20 mm to 0.25 mm.

[0013] Optionally, the high refractive index ultraviolet adhesives are regularly distributed on the outer periphery of the balloon body.

[0014] Optionally, the high refractive index ultraviolet adhesive is a dot-shaped protrusion arranged in a matrix, and the pitch of the dot-shaped protrusion is from 3 mm to 10 mm.

[0015] Optionally, the high refractive index ultraviolet adhesive is a linear protrusion extending along the axial direction of the balloon body, and is arranged at equal intervals around the circumferential direction of the balloon body, and the number of the linear protrusions is from 3 to 10.

[0016] Optionally, the length of the linear protrusion conforms to the length of the equal-diameter section.

[0017] Optionally, the tube body includes an inner layer tube and an outer layer tube fitted inside and outside, the outer layer tube of the tube body is black, the inner layer tube of the tube body is colorless and transparent, the hardness of the inner layer tube of the tube body is from 35D to 75D, and the hardness is continuous from the distal end to the proximal end or increases at a predetermined numerical interval.

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

[0019] Optionally, the number of the first unit sections is from 2 to 4.

[0020] Optionally, the diameters of each of the first unit sections are 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 of the first unit sections 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. 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 is 55D to 75D, and the hardness of the distal end inner layer tube is 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. For two adjacent second unit sections, the hardness of the second unit section closer to the distal end is smaller than the hardness of the second unit section closer to the proximal end.

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

[0026] Optionally, the diameters of each of the second unit sections are the same, or for two adjacent second unit sections, the diameter of the second unit section closer to the distal end 2 of the unit section is smaller than the diameter of the second unit section closer to the proximal end 2 of the unit section.

[0027] Optionally, each second unit section may use a single-layer or multi-layer tube, with the single-layer tube material being either PEBAX or nylon, and in the multi-layer tube, each layer may be relatively slidable, with each layer independently selected as either PEBAX or nylon.

[0028] Optionally, an elastic member is welded to the distal end of the inner layer tube, the elastic member comprising an exposed section and a welded section along the axial direction of the tube body, the ratio of the axial lengths of the exposed section to the welded section being 1:0.8 to 1.2, and the diameter of the elastic member gradually increases 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, which is made by spirally winding a metal wire with a diameter of 0.04 to 0.1 mm.

[0030] Optionally, the material of the metal wire may be one of the following: platinum-tungsten, platinum-iridium, stainless steel, gold, or 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 the elastic member is 2 to 5 mm.

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

[0034] Optionally, the diameter of the exposed section is 0.50 to 0.70 mm, and the diameter of the welded section is 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 between 1:1 and 1.5.

[0036] Optionally, the proximal end of the welded section is bent to form a weld ring that is welded to the tube wall of the inner layer tube by bending a metal wire that forms a coil spring.

[0037] 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 sealed to the outer wall of the inner layer tube, the proximal end of the balloon body is sealed to the outer layer tube, the radial gap between the inner layer tube and the outer layer tube serves as an optical fiber passage, and the arrangement of each optical fiber is either parallel to the inner layer tube or wrapped around the inner layer tube.

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

[0039] Optionally, the diameter of each optical fiber ranges from 0.125 mm to 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 sealed to the outer wall of the inner layer tube, the proximal end of the balloon body is sealed to the outer layer tube, the inner layer tube and the outer layer tube have a radial gap, 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 includes a fluid passage and a guide wire passage, the fluid passage and the guide wire passage are isolated from each other, and the fluid passage communicates with the radial gap between the inner layer tube and the outer layer tube.

[0042] Optionally, a first guidewire port is provided in the tube wall of the inner layer tube extending from the distal end of the balloon body, and the ends of the guidewire passage are a second guidewire port and a third guidewire port, respectively, and 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, the outer surface of the balloon body is coated with a drug, the drug being at least one of the following: an anti-neoplastic agent, a drug that induces cross-linking of collagen or elastin, and an anti-vasospasmodic agent.

[0044] Optionally, the drug may be paclitaxel or rapamycin.

[0045] Optionally, a removable vascular stent is provided on the outer surface of the balloon body. [Effects of the Invention]

[0046] The balloon catheter system provided by this invention concentrates the tear in the blood vessel wall in a predetermined area, applies a laser of a specific wavelength to that area to effectively repair the tear, effectively prevent restenosis, and also prevents the proliferation of neointimal tissue during vascular stent placement. [Brief explanation of the drawing]

[0047] [Figure 1] This is a schematic diagram of a balloon catheter system with a repair function. [Figure 2] This is a schematic diagram showing the distribution of the first type of high refractive index ultraviolet adhesive on the surface of the balloon body. [Figure 3] This is a schematic diagram illustrating the distribution of the second type of high refractive index UV adhesive on the surface of the balloon body. [Figure 4] This is a schematic diagram showing the cross-sectional positional relationship between the optical fiber and the inner layer tube. [Figure 5] This is a schematic diagram of the first type of positional relationship between the optical fiber and the inner layer tube. [Figure 6] This is a schematic diagram of the second type of positional relationship between the optical fiber and the inner layer tube. [Figure 7] This is a schematic diagram of the outer layer tube within the main tube body. [Figure 8] This is a schematic diagram of a balloon catheter system with a repair function (the guidewire is located outside the balloon body). [Figure 9] This is an enlarged view of section A in Figure 8. [Figure 10] Figure 8 is a schematic diagram showing the positions of the main tube body, double-lumen tube, and balloon body. [Figure 11] This is a schematic cross-sectional view of a double-lumen tube. [Modes for carrying out the invention]

[0048] The embodiments of this application will be clearly described below with reference to the attached drawings. Note that the following embodiments are merely examples that embody this application and do not limit the technical scope of this application. All other embodiments that can be obtained by those skilled in the art based on the embodiments of this application without departing from the scope of this application are also within the scope of this application.

[0049] To better describe and illustrate embodiments of this application, it is desirable to refer to one or more drawings, but any additional details or examples used to illustrate the drawings should not be considered to limit the scope of any invention, embodiment, or preferred form of this application.

[0050] To clarify, when a component is said to be "connected" to another component, that component may be directly connected to the other component, or there may be an intermediate component involved. When a component is said to be "installed" in another component, that component may be directly installed in the other component, or there may be an intermediate component involved.

[0051] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art to which this application pertains. The terms used herein in the description of this application are for the sole purpose of describing specific embodiments and are not intended to limit this application.

[0052] As shown in Figure 1, the balloon catheter system 100 having a repair function is A tube body 130 having opposing distal and proximal ends, and having at least a fluid passage and an optical fiber passage, A balloon body 110 is positioned on the outer circumference of the distal end of the tube body 130 and communicates 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, It includes a laser generating module connected to the proximal end of an optical fiber 120, which emits a laser with a healing function and a wavelength of 400 nm to 750 nm.

[0053] The regenerative balloon catheter system 100, when used, first injects fluid into the balloon body 110 through the fluid passage of the tube body 130 to fill the balloon body 110. Then, the laser generation 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 inside the balloon body 110, and the scattering of the balloon body 110. Under normal circumstances, the ideal effect can be achieved by continuing to apply the laser for a predetermined time to perform the treatment.

[0054] The outer circumference of the balloon body 110 is coated with a high refractive index ultraviolet adhesive in a spaced distribution. The high refractive index ultraviolet adhesive is regularly distributed on the outer surface of the balloon body 110. When the inside of the balloon body 110 is filled with fluid, the balloon body 110 expands and dilates the blood vessel wall. During the process of dilation, the structure of the blood vessel wall is locally torn, filling the dilation of the blood vessel wall. The tears in the blood vessel wall concentrate in the areas where the high refractive index ultraviolet adhesive is distributed, and the high refractive index ultraviolet adhesive protrudes from the outer wall of the balloon body 110. As a result, when it acts on the blood vessel wall, stress concentration regions are more easily formed. By installing the high refractive index ultraviolet adhesive, the tears in the blood vessel wall, which are normally distributed in a disordered manner, are concentrated in the areas where the high refractive index ultraviolet adhesive is present. Furthermore, the laser focusing effect of the high refractive index ultraviolet adhesive in these areas allows the laser to act more intensely on the torn areas of the blood vessel wall, thereby completing the repair of those areas.

[0055] This invention aims to more effectively repair unavoidable and disordered tears in the blood vessel wall by concentrating a high refractive index ultraviolet adhesive protruding from the outer surface of the balloon body 110 in a specific region. This specific region is where the high refractive index ultraviolet adhesive is present, and simultaneously, based on the concentrated effect of the high refractive index ultraviolet adhesive on the laser in this specific region, the tears in the blood vessel wall can be repaired more effectively.

[0056] Lasers act on the area to be repaired, promoting the repair of damaged blood vessels and effectively preventing restenosis.

[0057] The laser generation module provides a low-power pulsed or continuous output laser, conducts it inside the balloon body 110 through the optical fiber 120, and the light-emitting section inside the balloon body 110 of the optical fiber 120 applies the low-intensity laser to the site to be repaired. The low-intensity laser has a light regulation effect, and such an effect occurs in the photochemical effect rather than the thermal effect, which can promote the repair of cells and tissues and accelerate the removal of inflammatory mediators and the absorption of tissue edema.

[0058] After balloon catheter dilation, it is easy to cause damage to the vascular endothelium. The light-emitting section of the optical fiber 120 is used to emit red light of a specific wavelength, which is scattered by the balloon body 110 and applied to the damaged site of the vascular endothelium, promoting the proliferation of vascular endothelial cells and anti-inflammatory apoptosis, accelerating the recovery of the blood vessels to a stable state, and preventing postoperative restenosis of the blood vessels.

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

[0060] The power of the laser output by the laser generation module is 10 to 30 mW. More preferably, the power of the laser output by the laser generation module is 10 to 15 mW.

[0061] The laser generation module outputs a laser of a predetermined wavelength in the following order within each operating cycle. Initial stage: Power 5 mW / cm 2 to 8 mW / cm 2 lasting for 10 s to 20 s, Intermediate stage: Power 10 mW / cm 2 to 30 mW / cm 2 lasting for 120 s to 180 s, End stage: Power 5 mW / cm2 From 8 mW / cm 2 It lasts for 10 to 20 seconds.

[0062] Each operating cycle is a complete cycle corresponding to the laser generation module's action on the blood vessel wall. In the initial stage, low power and short duration laser output are used to adapt the blood vessel to laser irradiation and prepare it for subsequent treatment. In the intermediate stage, power is increased to perform healing treatment on torn blood vessels and prevent postoperative restenosis. In the final stage, low power and short duration laser output is used to buffer the postoperative state and reduce the burden on the blood vessel.

[0063] If the laser power output from the laser generation module is too low, the repair effect will not be ideal, and if the power is too high, the heat will be too high, causing burns to blood vessels. Preferably, the power is 10 m / cm² in the intermediate stage. 2 W to 15 mW / cm² 2 This lasts for 120 to 180 seconds.

[0064] The balloon body 110 may be a regular balloon with a smooth surface or a special balloon. The material of the balloon body 110 must have sufficient flexibility and good passability, be able to reach the desired location smoothly, and satisfy 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 balloon body material is PEBAX or nylon.

[0065] As shown in Figure 10, the balloon body 110 includes an equal-diameter section 113 and tapered sections 114 located at both ends of the equal-diameter section 113, the surface of which the tapered section 114 located at the distal end (see the black-filled area in Figure 10) is covered with a black coating. The material of the black coating 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 rather are portions that are close to tapered, formed simply by the change in the diameter of the balloon body.

[0066] The distal end of the balloon body 110 is covered with a black coating, which acts as a barrier to the laser, preventing the laser from causing burns to a predetermined external area.

[0067] As shown in Figure 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 a fluid passage and an optical fiber passage, respectively, the optical fiber 120 extending from the optical fiber passage and then connected to a laser generation module via an optical fiber connector 160.

[0068] The laser emitted from the light-emitting section is focused in the region of the high refractive index ultraviolet adhesive, ensuring that the laser intensity applied to the area to be repaired is sufficient. Preferably, the refractive index of the high refractive index ultraviolet adhesive is 1.50 to 1.70. More preferably, the refractive index of the high refractive index ultraviolet adhesive is 1.54 to 1.62.

[0069] To concentrate the tearing of the blood vessel wall at a predetermined location and avoid complicating the tearing process, the high refractive index UV adhesive is regularly distributed around the outer circumference of the balloon body 110, and the adhesive protrudes from the surface of the balloon body, with a protrusion height of 0.20 mm to 0.25 mm.

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

[0071] As shown in Figure 3, the high refractive index ultraviolet adhesive is a linear projection 112 extending along the axial direction of the balloon body 110, arranged at equal intervals around the circumferential direction of the balloon body 110, with the number of linear projections 112 ranging from 3 to 5. The height of the linear projections 112 (i.e., shown as H2 in Figure 3) is 0.20 mm to 0.25 mm. The balloon body 110 includes an equidiameter section 113 and tapered sections 114 located at both ends of the equidiameter section, the length of the linear projections 112 matching the length of the equidiameter section 113, and a smooth transition is formed between the ends of the linear projections 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 inflate the balloon body 110, the high refractive index ultraviolet adhesive can focus the laser, and the focused laser is applied more intensively to the area to be repaired, avoiding leakage of the treatment area.

[0073] High refractive index ultraviolet adhesives can not only effectively repair torn areas of the blood vessel wall by focusing the laser, but they can also increase the frictional force between the balloon body 110 and the blood vessel wall when the balloon body 110 expands, thereby reducing the slippage of the balloon body 110 against the blood vessel wall, improving the therapeutic effect, and reducing unnecessary damage to non-treatment areas.

[0074] The regularly distributed high-refractive-index UV adhesive can also cut through the lesion site, reducing irregular tearing and dissection of blood vessels.

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

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

[0077] The inner layer tube of the tube body includes at least two first unit sections connected sequentially along the axial direction, wherein 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. The connection between the two first unit sections is achieved by welding.

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

[0079] The diameters of each first unit section are 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. The diameter of the tube body gradually increases from the distal end to the proximal end in the axial direction, which not only ensures the maneuverability of the tube body at the proximal end but also allows for a smaller diameter of the inner tube at the distal end, enabling extension to narrower blood vessels, especially cerebral blood vessels.

[0080] The axial lengths of each first unit section are either 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 PEBAX, nylon, and TPU, and in the multi-layer tube, each layer is relatively slidable, and the material of each layer is independently selected from 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 multilayer tubing, where the material of each multilayer tubing is the same or different, and the thickness of each layer of the multilayer tubing is the same or different.

[0085] Each first unit section uses a three-layer tube, where each layer of the three-layer tube is relatively slidable, and the thickness of each layer from the outside to the inside is 0.04 mm, 0.05 mm, and 0.01 mm, respectively, with each layer being made of HDPE, LDPE, and nylon, respectively.

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

[0087] A three-layer tube is used for the proximal inner layer tube, and a three-layer or single-layer tube is used for the distal inner layer tube.

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

[0089] The outer layer tube of the tube body includes at least two second unit sections connected sequentially along the axial direction, wherein 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. The connection between the two second unit sections is achieved by welding.

[0090] The number of second unit sections is between two and four.

[0091] The diameters of each second unit section are the same, or for two adjacent second unit sections, the diameter closer to the distal end is the same. 2 The diameter of the unit section is the number near the proximal end. 2 It is smaller than the diameter of the unit section. The diameter of the tube body gradually increases from the distal end to the proximal end in the axial direction, which not only ensures the maneuverability of the tube body at the proximal end but also allows for a smaller diameter of the inner tube at the distal end, enabling extension to narrower blood vessels, especially cerebral blood vessels.

[0092] The axial lengths of each second unit section are either the same or different.

[0093] Each second unit section uses either a single-layer tube or a multi-layer tube, with the single-layer tube material being either PEBAX or nylon, and in the multi-layer tube, each layer is relatively slidable, with the material of each layer being independently selected as either PEBAX or nylon.

[0094] Each second unit section uses multilayer tubing, where the material of each multilayer tubing may be the same or different, and the thickness of each layer of the multilayer tubing may be the same or different.

[0095] In this invention, by selecting appropriate materials for the balloon body, inner tube, and outer tube, the transport system formed by the balloon body and the inner and outer tubes is relatively more flexible. By balancing the increase in the hardness of the transport system after the addition of optical fibers, the transport system ultimately achieves an ideal state that combines 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 order along the axial direction, with each second unit section connected by welding. Each second unit section is arranged coaxially. The diameter of second unit section L1 is 0.85 mm and its axial length is 120 mm. The diameter of second unit section L2 is 1.10 mm and its axial length is 140 mm. The diameter of second unit section L3 is 1.10 mm and its axial length is 1300 mm. The material of second unit sections L1 and 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 structure of the inner layer tube is the same as that of the outer layer tube, but the material and diameter are different. When the outer layer tube of the tube body consists of multiple second unit sections as shown in Figure 7, the inner layer tube also consists of corresponding multiple first unit sections, and 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 0.54 mm in all cases, the hardness is 55D, 63D, and 70D respectively, and the materials are Pebax, Pebax, and PA, respectively.

[0098] If the outer layer tube uses a single tube diameter, the inner layer tube also uses a single tube diameter, and the structures of the inner and outer layer 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. The elastic member 170 includes an exposed section 171 (corresponding to section T1 in Figure 9) and a welded section 172 (corresponding to section T2 in Figure 9) along the axial direction of the tube body. The ratio of the axial lengths of the exposed section 171 to the welded section 172 is from 1:0.8 to 1.2, and 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.

[0100] At the distal end of the tube body, the inner layer tube 132 and the distal end of the balloon body intersect, and an elastic member 170 is welded to the distal end of the inner layer 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 located entirely at the distal end of the inner layer tube 132, and the welded section 172 and the distal end of the inner layer tube 132 overlap and are fixedly connected by the welding process. The exposed section 171 is directly exposed to the outside, is not located on the tube wall of the inner layer tube 132, and is not overlapped and fixed with 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, has the characteristic of being deformable when it encounters a blockage in the blood vessel, thereby avoiding damage to the blood vessel. Furthermore, based on the rebound performance of the elastic member 170, it can recover its shape after the external force is removed.

[0102] The elastic member 170 is a coil spring, which is made by spirally winding a metal wire with a diameter of 0.04 mm to 0.1 mm. More preferably, the coil spring is made by spirally winding a metal wire with a diameter of 0.05 mm to 0.06 mm. The material of the metal wire is one of the following: platinum-tungsten, platinum-iridium, stainless steel, gold, or nickel-titanium.

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

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

[0105] The exposed section 171 is exposed to the outside, and a smaller pitch can increase the rebound performance of the elastic member 170. The welded section 172 needs to be connected to the wall of the inner layer tube 132, so a larger pitch is necessary 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-enhancing function, and the elastic member 170 simultaneously acts as a contrast-enhancing member, indicating 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 elastic member 170's rebound, and if it is too short, it will not be able to follow the blood vessel and guide the balloon body forward.

[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 such that it can fit into narrow blood vessels without compromising rebound performance, and the diameter of the welded section 172 must match the diameter of the inner layer tube 132.

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

[0113] The proximal end of the welded section 172 forms a weld ring 173, which is welded to the tube wall of the inner layer tube 132 by bending a metal wire that forms a coil spring. The weld ring 173 can increase the welding area and ensure the strength of the weld.

[0114] As shown in Figures 4, 5, and 6, there are multiple optical fibers 120, and each optical fiber 120 is uniformly distributed around the axis of the tube body 130.

[0115] As shown in Figure 1, the tube body 130 includes an inner layer tube 132 and an outer layer tube 131 fitted inside and outside, with the radial gap between the inner layer tube 132 and the outer layer tube 131 serving as an optical fiber passage. As shown in Figure 5, the arrangement of each optical fiber 120 is either parallel to the inner layer tube 132, or, as shown in Figure 6, the optical fiber 120 is wound around the inner layer tube 132. The optical fiber 120 is wound around the inner layer tube 132, and the axial length L of one winding unit is 10 mm. Preferably, the arrangement of each optical fiber 120 is parallel to the inner layer tube 132. The optical fiber 120 is fixed or unfixed to the inner layer tube 132.

[0116] The material of the optical fiber 120 is either a plastic optical fiber or a quartz 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 3 optical fibers 120 are arranged at equal intervals around the inner layer tube 132, and the angle of the inner layer tube 132 corresponding to two adjacent optical fibers 120 is 120°.

[0118] The manufacturing method for the light-emitting section of the optical fiber 120 involves stripping the cladding of the optical fiber 120 from the portion of the optical fiber 120 located within the balloon body 110, with the stripping length of the cladding 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 layer tube 132 and an outer layer tube 131 fitted inside and outside, the distal end of the balloon body 110 is sealed to the outer wall of the inner layer tube 132, the proximal end of the balloon body 110 is sealed to the outer layer tube 131, the inner layer tube 132 and the outer layer tube 131 have a radial gap, which is a fluid passage, and the lumen of the inner layer 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 guide wire passage 137, the fluid passage 138 and the guide wire passage 137 being parallel to and isolated from each other, the fluid passage 138 communicating with the radial gap between the inner layer tube 132 and the outer layer tube 131, and as shown in Figure 11, the cross-sectional area of ​​the fluid passage 138 is larger than the cross-sectional area of ​​the guide wire passage 137.

[0121] A first guidewire port 134 is provided on the tube wall of the inner layer tube 132 extending from the distal end portion of the balloon body 110, and the ends of the guidewire passage 137 are a second guidewire port 135 and a third guidewire port 136, respectively. As shown in Figure 8, in the operating state, the guidewire 180 travels in the direction of the guidewire 180, entering the guidewire passage 137 of the double lumen tube from the third guidewire port 136, extending further from the second guidewire port 135 to the outside of the balloon body 110, and then entering 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 and guiding the guidewire to the outside of the balloon body 110, the optical fiber 120 is positioned within the lumen of the inner layer tube 132, which would normally serve as the guidewire passage. The optical fiber 120 and the inner layer tube 132 are positioned coaxially (within an acceptable margin of error, strict coaxiality is not required), allowing the light from the optical fiber to irradiate the blood vessel wall more uniformly.

[0124] The trajectory portion of the guidewire 180 is located outside the balloon body 110, and can also cut through the lesion site, reducing irregular tearing and dissection of blood vessels.

[0125] To improve the therapeutic effect, the outer surface of the balloon body 110 is provided with a drug coating, and the drug is at least one of the following: an anti-neoplastic agent, a drug that induces cross-linking of collagen or elastin, and an antivasospasmodic agent.

[0126] The drug coating on the outer surface of the balloon body 110 acts on the injured site, exerts the corresponding therapeutic effect, and helps in the omnidirectional repair of the injured site. Preferably, the drug is paclitaxel or rapamycin.

[0127] As an option, a removable vascular stent is provided on the outer surface of the balloon body 110.

[0128] By using a balloon, laser repair can be performed, and a vascular stent can be simultaneously implanted in the body using the balloon. This allows two treatment objectives to be achieved simultaneously in a single intervention. Vascular stents typically have a compressible mesh structure, which does not significantly block the light during the laser repair process, meaning it does not affect the effectiveness of the laser repair. At the same time, based on the results of the laser repair, the problem of neointima-proliferation after implantation of the vascular stent is less likely to occur.

[0129] The technical features of the embodiments described above can be combined in any way; however, for the sake of simplicity, not all possible combinations of the technical features of the embodiments described above are described, but as long as such combinations are inconsistent, they are all considered to be within the scope of this specification.

[0130] The embodiments described above represent only a few embodiments of the present application, and although their descriptions are relatively specific and detailed, they should not be interpreted as limiting the scope of the patent for the present invention. Those skilled in the art should note that several modifications and improvements can be made without departing from the concept of the present application, all of which fall within the scope of protection of this 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 Sections 120 optical fibers 130 Tube Body 131 Outer layer tube 132 Inner layer tube 133 Double Lumen Tube 134 First guide wire port 135 Second guide wire port 136 Third guide wire port 137 Guide wire passage 138 Fluid passage 140 Catheter Base 150 Stress-Relieving Tubes 160 Fiber Optic Connectors 170 Elastic members 171 Exposure Section 172 Welding Section 173 Welding Ring 180 Guidewire

Claims

1. A balloon catheter system having tissue repair function, A tube body having opposing distal and proximal ends, and having at least a fluid passage and an optical fiber passage, A balloon body is positioned on the outer circumference of the distal end of the tube body and communicates with the fluid passage, An optical fiber having a light-emitting section inserted into the optical fiber passage and extending to the position of the balloon body, It includes a laser generating module connected to the proximal end of an optical fiber, which emits a laser with tissue repair capabilities and a wavelength of 400 nm to 750 nm, The laser power output by the aforementioned laser generation module is 10 to 30 mW. A balloon catheter system characterized in that a high refractive index ultraviolet adhesive with a distributed spacing is attached to the outer circumference of the balloon body, the high refractive index ultraviolet adhesive protrudes from the surface of the balloon body, and the refractive index of the high refractive index ultraviolet adhesive is 1.50 to 1.

70.

2. The laser generation module outputs lasers of predetermined wavelengths in the following order within each operating cycle: Initial stage: Laser intensity 5 mW / cm ２ From 8 m W / cm ２ It lasts for 10 to 20 seconds, Intermediate stage: Laser intensity 10 mW / cm ２ From 30 mW / cm ２ It lasted from 120s to 180s, Final stage: Laser intensity 5 mW / cm ２ From 8 m W / cm ２ The balloon catheter system according to claim 1, characterized in that it lasts for 10 to 20 seconds.

3. The balloon catheter system according to claim 1, characterized in that the balloon body includes an equidiameter section and tapered sections located at both ends of the equidiameter section, and the surface of the tapered section located at the distal end of the balloon body is covered with a black coating.

4. The balloon catheter system according to Claim 1, characterized in that the height of the projection is 0.20 mm to 0.25 mm.

5. The balloon catheter system according to Claim 1, characterized in that the high refractive index ultraviolet adhesive is a linear projection extending along the axial direction of the balloon body, arranged at equal intervals around the circumferential direction of the balloon body, the number of linear projections is 3 to 10, and the length of the linear projections is consistent with the length of the equal diameter section.

6. The balloon catheter system according to claim 1, characterized in that the tube body includes an inner layer tube and an outer layer tube fitted inside and outside, the outer layer tube of the tube body is black, the inner layer tube of the tube body is colorless and transparent, the hardness of the inner layer tube of the tube body is 35D to 75D, and the hardness is continuous from the distal end to the proximal end or increases at predetermined numerical intervals.

7. The inner layer tube of the tube body includes at least two first unit sections connected sequentially along the axial direction, wherein 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, and the number of first unit sections is between two and four. The balloon catheter system according to claim 6, wherein the outer layer tube of the tube body includes at least two second unit sections connected sequentially 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, and the number of the second unit sections is from two to four.

8. The balloon catheter system according to claim 6, characterized in that an elastic member is welded to the distal end of the inner layer tube, the elastic member includes an exposed section and a welded section along the axial direction of the tube body, the ratio of the axial lengths of the exposed section to the welded section is 1:0.8 to 1.2, the diameter of the elastic member gradually increases from the distal end of the exposed section to the proximal end of the welded section, the elastic member is a coil spring, the coil spring is made by spirally winding a metal wire with a diameter of 0.04 mm to 0.1 mm, the pitch of the exposed section is equal to the diameter of the metal wire, and the pitch of the welded section is 1 to 3 times the diameter of the metal wire.

9. 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 sealed to the outer wall of the inner layer tube, the proximal end of the balloon body is sealed to the outer layer tube, the inner layer tube and the outer layer tube have a radial gap, the radial gap is a fluid passage, and the lumen of the inner layer tube is an optical fiber passage. The balloon catheter system according to claim 1, characterized in that at least one axial section of the tube body is a double-lumen tube, the double-lumen tube includes a fluid passage and a guidewire passage, the fluid passage and the guidewire passage are isolated from each other, the fluid passage communicates with the radial gap between the inner layer tube and the outer layer tube, a first guidewire port is provided in the tube wall of the inner layer tube extending from the distal end portion of the balloon body, the 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.

10. The balloon catheter system according to claim 1, characterized in that a drug coating is provided on the outer surface of the balloon body, and the drug is at least one of an anti-neoplastic drug, a drug that induces cross-linking of collagen or elastin, and an anti-vasospasmodic drug.

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