Balloon catheter systems, balloon catheter systems for coronary arteries and methods of use thereof

Abstract

The invention discloses a balloon catheter system, a balloon catheter system for coronary arteries and a use method of the balloon catheter system. The balloon catheter system comprises a catheter body with a near end and a far end which are opposite to each other; the sacculus body is fixed at the far end of the tube body, the sacculus body has a relative inflation state and a contraction state suitable for interventional conveying, and the sacculus wall of the sacculus body is provided with a pore structure; the light-emitting guide wire can be inserted into the tube body, the light-emitting guide wire comprises an optical fiber, the optical fiber can extend into the balloon body, and a part of the far end of the optical fiber is exposed and serves as a light-emitting working section; the dosing device is used for being communicated with the near end of the tube body and supplying fluid, and the fluid contains treatment substances; and the light source is used for being connected with the light-emitting light guide road. Compared with the prior art, the balloon catheter and the light-emitting guide wire can be combined for use, and the treatment effect on the vascular lesion section can be improved by flexibly applying chemical means and physical means, so that the restenosis of the blood vessel is effectively prevented.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a balloon catheter system, a balloon catheter system for coronary arteries, and a method of using the same. Background Art

[0002] Vascular disease is close to the first cause of death in humans. The basic pathological changes of most vascular diseases, whether organic or functional, are organ ischemic changes caused by stenosis or occlusion of the vascular lumen. For example, neointimal proliferation caused by cell and tissue damage in the vascular wall can easily lead to restenosis of the vascular lumen.

[0003] The drug-eluting balloon catheter system is a commonly used interventional device for treating vascular lesions. It uses the balloon to apply therapeutic substances to the designated location, such as inhibitors that inhibit vascular intimal hyperplasia, but the overall treatment effect is not good. Summary of the invention

[0004] In view of the problems in the prior art, the present application provides a balloon catheter system, a balloon catheter system for coronary arteries, and a method of using the same, so as to effectively reduce the risk of restenosis of the blood vessels.

[0005] The balloon catheter system provided in the present application is characterized by comprising:

[0006] a body having opposing proximal and distal ends;

[0007] A balloon body is fixed to the distal end of the tube body, the balloon body has a relatively inflated state and a contracted state suitable for interventional delivery, and the balloon wall of the balloon body has a pore structure;

[0008] a drug delivery device, used for communicating with the proximal end of the tube body and supplying a fluid, wherein the fluid contains a therapeutic substance;

[0009] A light-emitting guidewire can be inserted into the tube body, the light-emitting guidewire includes an optical fiber, the optical fiber can extend into the balloon body, and a portion of the distal end is exposed and serves as a light-emitting working section;

[0010] A light source is used to be connected to the light path of the light-emitting guide wire.

[0011] Optionally, the concentration of the therapeutic substance in the fluid is 0.1-0.6 g / mL.

[0012] Optionally, the pore size of the pore structure is 5 to 100 μm; and the surface porosity of the balloon is 30 to 80%.

[0013] Optionally, the therapeutic agent is at least one of rapamycin, sirolimus, everolimus, zotarolimus, 42-(dimethylphosphinate) rapamycin, defostiolimus, biolimus, umimios, tacrolimus, paclitaxel, protaxel, and docetaxel.

[0014] Optionally, the tube body comprises an inner tube and an outer tube which are sleeved on each other, and the inner tube has a guide wire cavity inside for passing the luminous guide wire;

[0015] The radial gap between the inner tube and the outer tube serves as a perfusion cavity for the fluid, and the perfusion cavity is communicated with the interior of the balloon body.

[0016] Optionally, the light source excites the light-emitting guide wire to emit light with a wavelength of 620 to 760 nm.

[0017] The present application provides a balloon catheter system for coronary arteries, comprising:

[0018] a body having opposing proximal and distal ends;

[0019] A balloon body is fixed to the distal end of the tube body, the balloon body is connected to the interior of the tube body, and the surface of the balloon body is loaded with a therapeutic substance in a coating manner;

[0020] A light-emitting guidewire can be inserted into the tube body, the light-emitting guidewire includes an optical fiber, the optical fiber can extend into the balloon body, and a portion of the distal end is exposed and serves as a light-emitting working section;

[0021] A light source is used to be connected to the light path of the light-emitting guide wire.

[0022] Optionally, the coating has a thickness of 1 to 100 μm.

[0023] Optionally, the coating amount of the therapeutic substance in the coating is 1 to 8 g / m2 relative to the unit balloon surface area. 2 .

[0024] Optionally, it also includes an optical fiber component, which is inserted into the tube body and has a light-emitting portion extending into the balloon.

[0025] The present application provides a method for using a balloon catheter system, using any of the balloon catheter systems described above, the method comprising:

[0026] Passing the luminous guidewire along a predetermined path and passing the balloon catheter through the luminous guidewire until the luminous working section and the balloon body reach a designated position;

[0027] administering medication to a specific location via a balloon catheter;

[0028] The light is applied to the designated location via the light-emitting guide wire.

[0029] Compared with the prior art, the drug-eluting balloon catheter system in the present application combines a luminous guidewire with a drug-eluting balloon catheter, and by flexibly using chemical and physical means, it can enhance the therapeutic effect on the diseased segment of the blood vessel, thereby effectively preventing restenosis of the blood vessel. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 is a schematic structural diagram of a balloon catheter system in one embodiment;

[0031] Figure 2 for Figure 1 Enlarged view of part A in the middle;

[0032] Figure 3 is a schematic structural diagram of a balloon catheter system for coronary arteries in one embodiment;

[0033] Figure 4 for Figure 3 The enlarged schematic diagram of the middle B part;

[0034] Figure 5 is a cross-sectional view of a balloon catheter system in one embodiment;

[0035] Figure 6 A schematic diagram of the structure of a light-emitting guide wire in an embodiment

[0036] Figure 7 is a cross-sectional view of a light-emitting guide wire in one embodiment;

[0037] Figure 8 is a schematic diagram of the structure of an optical fiber in an embodiment;

[0038] Fig. 9 Schematic diagram of the structure of a balloon catheter system in another embodiment.

[0039] The reference numerals in the figures are described as follows:

[0040] 100, light-emitting guide wire; 110, optical fiber; 111, core; 112, wrapping layer; 113, light-emitting working section; 120, push rod; 121, reduced diameter end; 130, guide head; 131, spherical crown; 132, cylindrical part; 140, support member; 141, first support section; 142, hollow section; 143, second support section; 150, connector; 151, cone structure; 152, closing structure; 160, protective tube;

[0041] 200. Pipe body; 210. Inner tube; 220. Outer tube;

[0042] 300, balloon body; 310, balloon wall; 320, pore structure;

[0043] 400, coating;

[0044] 500, light source;

[0045] 600. Drug delivery device;

[0046] 700, optical fiber components;

[0047] 800, Blood vessel wall

[0048] L1, the span of the radial gap in the axial direction of the optical fiber; L2, the span of the hollow section in the axial direction of the optical fiber. DETAILED DESCRIPTION

[0049] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0050] 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 a central 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 a central component at the same time.

[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 belongs. The terms used herein in the specification of this application are only for the purpose of describing specific embodiments and are not intended to limit this application. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0052] refer to Figure 1 , 2 The balloon catheter system provided by an embodiment of the present application includes a tube body 200, a balloon body 300, a light guide wire 100, a drug delivery device 600 and a light source 500, wherein the tube body 200 has a relative proximal end and a distal end, and the balloon body 300 is fixed to the distal end of the tube body 200. The balloon body 300 has a relative inflated state and a contracted state. The contracted state of the balloon body 300 is suitable for interventional delivery, and then the balloon body 300 is inflated by filling the fluid into the balloon body 300 to make it inflated. The body 300 acts on the blood vessel wall 800, and the balloon wall 310 of the balloon body 300 has a pore structure 320; the drug delivery device 600 is used to communicate with the proximal end of the tube body 200 and supply fluid, and the fluid contains a therapeutic substance; the light-emitting guidewire 100 can be inserted into the tube body 200, and the light-emitting guidewire 100 includes an optical fiber, which can be extended into the balloon body 300, and a part of the distal end is exposed and used as a working section; the light source 500 is used to be connected to the optical path of the light-emitting guidewire 100.

[0053] In this embodiment, the tube body 200, the balloon body 300 and the drug delivery device 600 can form a conventional balloon catheter. The luminous guidewire 100 can be used as both a light-emitting body and a guidewire, and has two major functions of emitting light and interventional guidance. The balloon catheter and the luminous guidewire 100 can be flexibly combined for use to meet the various needs of application scenarios.

[0054] In terms of preventing vascular restenosis, the naked balloon dilation method treats vascular stenosis. Even with the physical means of light repair, the probability of restenosis after treatment is still very high. For example, red light has a photobiomodulatory effect, which is generated by photochemical effects rather than thermal effects. It can promote the repair of cells and tissues. Although it can quickly restore the elasticity of the vascular tissue wall in a short period of time and prevent the vascular wall from collapsing and deforming, the red light has a small range of action, and the repaired blood vessels are still prone to lesions and restenosis in the short term. In this embodiment, a therapeutic substance can be applied to the blood vessel through a balloon catheter. The therapeutic substance, such as an inhibitor that inhibits vascular intimal hyperplasia, the physical means of light repair combined with chemical means can effectively improve the treatment effect of vascular lesions and significantly reduce the risk of vascular restenosis.

[0055] In one embodiment, the concentration of the therapeutic substance in the fluid is 0.1-0.6 g / mL, for example 0.2-0.5 g / mL, and for example 0.2-0.3 g / mL. On the one hand, the drug treatment effect is guaranteed, and on the other hand, the concentration of the therapeutic substance should not be too high to avoid affecting the light repair effect.

[0056] The inhibitor can be at least one of rapamycin, sirolimus, everolimus, zotarolimus, 42-(dimethylphosphinate) rapamycin, dafolimus, biolimus, umimos, tacrolimus, paclitaxel, protaxel, and docetaxel. These inhibitors can inhibit the intimal hyperplasia caused by excessive proliferation of smooth muscle cells, thereby the proliferation of endothelial cells, and have the effect of preventing and treating vascular restenosis.

[0057] The pore structure 320 affects the output rate of the fluid to the surrounding environment of the balloon body 300. In one embodiment, the pore size of the pore structure 320 is 5-100 μm, for example, 10-80 μm, and for example, 30-50 μm. The porosity of the surface of the balloon body 30010 is 30-80%, for example, 40-70%, and for example, 45-60%.

[0058] refer to Figure 5In the illustrated embodiment, the tube body 200 includes an inner tube 210 and an outer tube 220, which are mutually sleeved, and the inner tube 210 has a guidewire cavity inside, through which the light-emitting guidewire 100 can pass; the radial gap between the inner tube 210 and the outer tube 220 serves as a perfusion cavity for the fluid, and the perfusion cavity is connected to the interior of the balloon body 300 to facilitate the inflation of the balloon body 300 by the fluid.

[0059] The material of the first tube can be selected from block polyetheramide resin (PEBAX), nylon or thermoplastic polyurethane elastomer rubber (TPU), which is colorless and transparent, and is conducive to the light transmission of the luminous guide wire. The material of the second tube can be selected from PEBAX or nylon.

[0060] The light source 500 is a red light source 500, which is used to excite the light-emitting guide wire 100 to emit light with a wavelength of 620 to 760 nm, so as to promote the repair of cells and tissues.

[0061] refer to Figures 5 to 8 In the illustrated embodiment, the light-emitting guidewire further includes a push rod 120, a guide head 130 and a support member 140; the optical fiber 110 has relative proximal and distal ends, and the optical fiber 110 includes a core 111 and a wrapping layer 112, the wrapping layer 112 wraps the core 111, plays a role in protecting the optical fiber and reducing the energy loss of the optical fiber, and a portion of the core 111 at the distal end of the optical fiber 110 is exposed and serves as a working section; the push rod 120 is a hollow tubular structure, which is fixedly sleeved on the outer periphery of the optical fiber 110 to drive the optical fiber 110 to move; the guide head 130 is connected to the distal end of the optical fiber 110, and is used to guide the light-emitting guidewire 100 to move in the lumen of human tissue; the support member 140 is located at the periphery of the light-emitting working section 113, and the two ends of the support member 140 are respectively connected to the guide head 130 and the push rod 120 to provide corresponding support strength. In this embodiment, the optical fiber 110 can be used as both a light source and a guide wire, integrating the two functions of emitting light and interventional guidance. A separate light-emitting guide wire 100 can be combined with various balloon bodies 300, making the processing of the balloon catheter assembly simpler and more convenient.

[0062] In one embodiment, the support member 140 may be a mesh tube structure, which includes a first support segment 141, a hollow segment 142, and a second support segment 143 from the proximal end to the distal end, wherein the first support segment 141 and the second support segment 143 are mesh dense segments, and the hollow segment 142 is a mesh sparse segment. The first support segment 141 and the second support segment 143 are respectively fixedly connected to the push rod 120 and the guide head 130, which is conducive to ensuring the support strength of the support member 140. The axial position of the light-emitting working segment 113 corresponds to the mesh sparse segment, which can ensure the effect of the light-emitting guide wire 100 emitting light.

[0063] refer to Figure 6 , 7In another embodiment shown, the support member 140 is a spiral structure, such as a spiral spring, and the support member 140 includes a first support segment 141, a hollow segment 142, and a second support segment 143 from the proximal end to the distal end, wherein the pitch of the hollow segment 142 is greater than the pitch of the first support segment 141 and the second support segment 143, wherein the pitch of the first support segment 141 and the second support segment 143 is 0.04-0.1mm, for example, 0.05-0.06mm; the pitch of the hollow segment 142 is 0.1-0.4mm, for example, 0.2-0.35mm, and another example is 0.3mm. The first support segment 141 and the second support segment 143 are fixedly connected to the push rod 120 and the guide head 130 respectively to provide sufficient support strength, and the axial position of the light-emitting working segment 113 corresponds to the hollow segment 142 to ensure the effect of light-emitting guide wire 100 emitting light. To ensure that the light transmittance of the light-emitting working section 113 after emitting light is above 80%, the hollowing ratio of the hollow section 142 is at least 80%, such as at least 90%, and for example at least 95%.

[0064] The support strength of the support member 140 and the light transmittance after the light-emitting working section 113 is allowed to emit light are related to the specific structure of the coil spring. The coil spring can be formed by spirally winding a metal wire, and the diameter of the metal wire is 0.04-0.1mm, and it is further preferably formed by spirally winding a metal wire with a diameter of 0.05-0.06mm. The material of the metal wire is one of platinum tungsten, platinum iridium, stainless steel, gold, and nickel titanium. The diameter of the coil spring should be moderate. If the diameter is too large, the radial size of the light-emitting guide wire will increase, and if the diameter is too small, the support strength of the coil spring will be affected. The coil spring can be 0.2-0.5mm, for example, 0.2-0.4mm, and another example is 0.35mm. In addition, the length of the hollow section 142 is 2-4cm, for example, 2-3cm, and another example is 3cm, so that the light-emitting guide wire can be adapted to the corresponding balloon body when used.

[0065] refer to Figure 7 In the illustrated embodiment, in order to fix the coil spring, the light guide wire 100 further includes a connector 150, the proximal end of the connector 150 is sleeved and fixed to the distal end of the push rod 120, the distal end is a tapered structure 151 with a gradually reduced diameter, and the first support section 141 of the coil spring is fixed to the tapered structure 151. In addition, the guide head 130 includes a spherical crown portion 131 at the distal end and a cylindrical portion 132 located at the proximal end of the spherical crown portion 131, and the second support section 143 of the coil spring is sleeved and fixed to the cylindrical portion 132.

[0066] The distal end of the push rod 120 is a reduced diameter end 121, and the proximal end of the connector 150 is provided with a closing structure 152 for the reduced diameter end 121 to extend into, and the shape of the closing structure 152 is adapted to the reduced diameter end 121. During assembly, the reduced diameter end 121 of the push rod 120 is connected with the closing structure 152 of the connector 150; further, the connection parts of the push rod 120 and the connector 150 are flush, so that the structure of the light guide wire 100 is compact, which is conducive to the subsequent assembly with the balloon catheter assembly. After the above components are connected, they can be fixed by laser welding.

[0067] The cone structure 151 gradually decreases in diameter from the proximal end to the distal end, and a radial gap is provided between the first support section 141 and the cone structure 151, and the radial gap gradually increases from the proximal end to the distal end. The span of the radial gap in the axial direction of the optical fiber 110 is L1, and the span of the hollow section 142 in the axial direction of the optical fiber 110 is L2, and L1:L2=1:1.2 to 3 times, for example, 1:1.5 to 2.5, for example, 1:1.5 to 2, and further for example, 1:1.8.

[0068] To facilitate the threading of the optical fiber 110 , the connector 150 is connected to the pushing rod 120 of the hollow tubular structure, and the optical fiber 110 that has passed through the pushing rod 120 extends through the threading channel of the connector 150 .

[0069] In the optical fiber 110, the material of the core 111 can be plastic optical fiber 110 or quartz optical fiber 110, preferably plastic optical fiber 110, which has good flexibility and elasticity and is suitable for use as a guide wire. The diameter of the optical fiber 110 can be 0.1-0.3 mm, for example, 0.125-0.25 mm, and for example, 0.125 mm. If the optical fiber 110 is too thin, it is easy to break during use. If the optical fiber 110 is too thick, the radial size of the light-emitting guide wire 100 will be too large, affecting the subsequent application of the light-emitting guide wire. The periphery of the optical fiber 110 can also be wrapped with a protective tube 160 to protect the optical fiber.

[0070] The light-emitting guide wire 100 can be used in combination with different balloon bodies 300. According to the axial length of the balloon body 300, the fiber 110 cladding is stripped from the portion of the fiber 110 in the balloon body 300, and the stripping length of the fiber 110 cladding is equal to the axial length of the balloon body 300. The stripping method can be physical stripping (for example, sandblasting, grinding, scraping, etc.) or chemical stripping. The surface of the light-emitting working section 113 is ground to make the surface more uniform and improve the uniformity of light emission.

[0071] The above-mentioned balloon can be a commonly used balloon for OTW (coaxial exchange) and RX (rapid exchange). The coverage of the drug coating can be the entire or partial surface of the balloon. For example, if the balloon has a flap structure, the coating can be only disposed in the flap structure.

[0072] refer to Figure 3 , 4 Another embodiment of the present application provides a balloon catheter system for coronary arteries, comprising a tube body 200, a balloon body 300, a light-emitting guidewire 100 and a light source 500, wherein the tube body 200 has a relative proximal end and a distal end, the balloon body 300 is fixed to the distal end of the tube body 200, the balloon body 300 is connected to the inside of the tube body 200, and the balloon body 300 is inflated by filling a fluid such as physiological saline through the tube body 200; the surface of the balloon body 300 is loaded with a therapeutic substance in the form of a coating 400, the light-emitting guidewire 100 can be inserted into the tube body 200, the light-emitting guidewire 100 includes an optical fiber, which can extend into the balloon body 300, and a part of the distal end is exposed and used as a working section, the light source 500 can be used to connect with the light path of the light-emitting guidewire 100, and different light sources 500 can drive the light-emitting guidewire 100 to emit light of different wavelengths. In this embodiment, according to the expected treatment effect, a specific therapeutic substance is loaded into the balloon body 300. After the balloon body 300 is inflated, it acts on the blood vessel and releases the therapeutic substance. The light source 500 drives the light-emitting guide wire 100 to emit light of a specific wavelength.

[0073] In terms of preventing vascular restenosis, the therapeutic substance loaded by the balloon body 300 can be an inhibitor of vascular intimal hyperplasia, such as at least one of rapamycin, sirolimus, everolimus, zotarolimus, 42-(dimethylphosphinate) rapamycin, dafoslimus, biolimus, umimus, tacrolimus, paclitaxel, protaxel, and docetaxel. The light source 500 can be a red light source 500, which can emit light with a wavelength of 620 to 760 nm. The present application can use a combination of a drug-loaded balloon catheter and a light-emitting guidewire 100, and the drug-loaded balloon catheter can administer drugs to the blood vessels. The light source 500 drives the light-emitting guidewire 100 to emit red light, which can promote the repair of vascular cells and tissues. When used for treatment, chemical means can be combined with physical means to improve the treatment effect, which is conducive to reducing the risk of vascular restenosis.

[0074] Specifically, the thickness of the coating 400 is 1 to 100 μm, such as 10 to 80 μm, and also such as 20 to 50 μm. On the one hand, the drug treatment effect is ensured, and on the other hand, the concentration of the treatment substance should not be too high to avoid affecting the light repair effect.

[0075] Compared with using only drug-loaded balloons, auxiliary physical light irradiation can reduce the amount of therapeutic agent used. For example, in one embodiment, the coating amount of the therapeutic agent in the coating 400 is 1 to 8 g / m2 relative to the unit balloon surface area. 2 , for example, 2 to 6 g / m 2 , for example 2 to 4 g / m 2 .

[0076] In the above-mentioned balloon catheter system and the balloon catheter system for coronary artery, the therapeutic substance can also be a photosensitive crosslinking agent, such as porphyrin, porphyrin derivative compounds, phthalocyanine, chlorine, purine, 5-hydroxyacetic acid, 4-amino-1,8-naphthalimide, 1,8-naphthalimide, 1,8-naphthalimide polymer, di-naphthalimide compound, 2,2'-((ethane-1,2-di(oxy))bis(ethane-2,1-diyl)bis(6-((2-(2-aminoethoxy)ethyl)amino)-1H-benzo[de]isoquinoline-1,3(2H)-dione), 6-[2-[2-(2-aminoethoxy)ethoxy]ethylamino]-2 -[2-[2-[2-[6-[2-[2-(2-aminoethoxy)ethoxy]ethylamino]-1,3-dioxybenzo[de]isoquinolin-2-yl]ethoxy]ethoxy]benzo[de]isoquinoline-1,3-dione, 2,2'-[1,2-ethanediylbis(oxy-2,1-ethanediyl)]bis[6-({2-[2-(2-aminoethoxy)ethoxy]ethyl}amino)-1H-benzo[de]isoquinoline-1,3(2H)-dione], 1H-benzo[de]isoquinoline-1,3(2H)-dione, 2,2'-[1,2-ethanediylbis(oxy-2,1-ethanediyl)]bis[6-[[2-[2-(2- [aminoethoxy]ethoxy]ethyl]amino]-(9Cl), N-5-azido-2-nitrobenzoyloxysuccinimide, N-(β-maleimidopropoxy)succinimide ester, N-[e-maleimidoacetoxy]succinimide ester, N-[γ-maleimidobutyryloxy]succinimide, succinimidyl-6-(3-[2-pyridyldithio]-propionamido)acetate, m-maleamidobenzoyl-N-hydroxysuccinimide ester, 3-[2-pyridyldithio]propionohydrazide, N-succinimidyl bromoacetate, N-succinimidyl iodoacetate, N-sulfosuccinimidyl iodoacetate, succinimidyl-4- [N-maleimidomethyl]cyclohexane-1-carboxylate, N-succinimidyl 4-[4-maleimidophenyl]butyrate, succinimidyl-6-[β-maleimidopropionamido]acetate, N-succinimidyl 3-[2-pyridyldithio]-propionate, sulfosuccinimidyl 6-(3'-[2-pyridyldithio]-propionamido)hexanoate, m-maleimidobenzoyl-N-hydroxysulfosuccinimide ester, N-sulfosuccinimidyl-6-[4'-azido-2'-nitrophenylamino]hexanoate, and at least one of sulfosuccinimidyl-4-[N-maleimidomethyl]cyclohexane-1-carboxylic acid.

[0077] Different light sources 500 can drive the light-emitting guidewire 100 to emit light of different wavelengths. According to application requirements, selecting different light sources 500 can enable the light-emitting guidewire 100 to perform different functions. For example, selecting a blue light source 500 can excite the light-emitting guidewire 100 to emit blue light, prompting the photosensitive cross-linking agent to react to form a vascular microstent; selecting a red light source 500 can cause the light-emitting guidewire 100 to emit red light to repair vascular cells and tissues.

[0078] In another embodiment, the therapeutic substance in the balloon catheter system and the balloon catheter system for coronary artery includes an inhibitor and a photosensitive crosslinker. When the therapeutic substance is loaded in a fluid, the inhibitor and the photosensitive crosslinker can be prepared as solutions and injected into the balloon body 300, or the two can be pre-prepared as a mixed solution and injected into the balloon body 300. The concentration of the photosensitive crosslinker in the fluid is 0.1-1.2 g / mL.

[0079] When the therapeutic substance is loaded in the form of coating 400, coating 400 is any one of the following structures: coating 400 sequentially covers an inhibitor layer and a photosensitive crosslinking agent layer on the outer surface of balloon body 300, and the thickness of each coating 400 is 1-50 μm; or coating 400 is a layer, including an inhibitor and a photosensitive crosslinking agent. The loading method of coating 400 is to prepare a solution of coating 400 in advance, apply the solution to the balloon surface, and then dry it.

[0080] In the fluid or in the coating 400 , the mass ratio of the inhibitor to the photosensitive crosslinker is 1:0.2-5, for example 1:1-4, and for example 1:2-3.

[0081] See also Fig. 9 The above-mentioned balloon catheter system and the balloon catheter system for coronary artery also include an optical fiber assembly 700, which is inserted into the tube body, such as the perfusion cavity, and has a light-emitting portion extending into the balloon. In addition, a separate light source 500 can be configured accordingly for optical connection with the optical fiber assembly 700.

[0082] An embodiment of the present application provides a method for using a balloon catheter system, using any of the above-mentioned balloon catheter systems, including:

[0083] Passing the light-emitting guidewire 100 along a predetermined path and guiding the balloon catheter through the light-emitting guidewire 100 until the light-emitting working section and the balloon body 300 reach a designated position;

[0084] administering medication to a specific location via a balloon catheter;

[0085] Light is applied to a designated location via the light emitting guide wire 100 .

[0086] The order of applying the drug and applying the light is not limited and can be adjusted according to the actual application, for example, the light can be applied while applying the drug, or the light can be applied first and then the drug is applied, or the drug is applied first and then the light can be applied. For another example, for a balloon catheter system loaded with the coating 400, since the coating 400 interferes with the light effect, it is usually necessary to apply the drug first and then the light can be applied.

[0087] In one embodiment, the inhibitor is applied to the designated position through the balloon catheter. Specifically, the balloon body 300 is inflated with a fluid containing the inhibitor. After the balloon body 300 is inflated and stabilized, the light source 500 is turned on to drive the light-emitting guide wire 100 to emit red light, and the designated position of the blood vessel is illuminated. The time for applying the drug is 1 to 10 minutes, and the time for applying the light is 1 to 10 minutes; preferably 1 to 5 minutes, and the intensity of the light is 5 to 10 mW / cm 2 ; preferably 10 to 50 mW / cm 2 .

[0088] Application Example 1

[0089] In a pig coronary artery model, the stenosis degree of the vascular disease segment before treatment was 70%. The balloon catheter system of the present application was pushed to the vascular disease segment, and the compressed balloon body was expanded by perfusing fluid. The pressure was 6 atm, and the fluid contained a concentration of 3 g / m 2 Then, while maintaining the balloon pressure, the optical fiber emits light with a wavelength of 650nm to irradiate the blood vessels. Each irradiation lasts 2 minutes, the number of irradiations is 4 times, the total treatment time is 10 minutes, and the light intensity is 40mW / cm 2 .

[0090] Comparative Example 1

[0091] In the pig coronary artery model, the stenosis degree of the diseased blood vessel segment before treatment was 70%. The balloon catheter system with optical fiber was pushed to the diseased blood vessel segment, and the compressed balloon was expanded by perfusing fluid. The pressure was 6 atm and the fluid concentration was 7 g / m 2 of paclitaxel, and then deliver the fluid for 10 minutes while maintaining the balloon pressure.

[0092] Comparative Example 2

[0093] In the pig coronary artery model, the stenosis degree of the diseased blood vessel segment before treatment was 70%. The balloon catheter system was pushed to the diseased blood vessel segment, and the compressed balloon was expanded by perfusing fluid at a pressure of 6 atm. Then, while maintaining the balloon pressure, the optical fiber emitted a 650nm wavelength of light to irradiate the blood vessel. Each irradiation lasted 3 minutes, the number of irradiations was 4, and the light intensity was 60mW / cm 2 The total treatment time was 15 minutes. After the treatment, the stenosis of the vascular lesion segment was measured.

[0094] The results are shown in Table 1:

[0095] Group The degree of vascular stenosis after treatment Application Example 1 10％ Comparative Example 1 20％ Comparative Example 2 30％

[0096] As shown in Table 1, compared with simple drug therapy or physical therapy, the present application can effectively improve the treatment effect by implementing drug therapy and physical therapy on the vascular lesion segment through a balloon catheter. At the same time, it can reduce the power used by the optical fiber and the amount of drug used.

[0097] The technical features of the above-mentioned embodiments can be combined arbitrarily. To make the description concise, not all possible combinations of the technical features in the above-mentioned 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. When the technical features in different embodiments are embodied in the same figure, it can be regarded that the figure also discloses the combination examples of the various embodiments involved.

[0098] The above-described embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the present application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the present application shall be subject to the attached claims.

Claims

1. A balloon catheter system, characterized in that: include: a body having opposing proximal and distal ends; A balloon body is fixed to the distal end of the tube body, the balloon body has a relatively inflated state and a contracted state suitable for interventional delivery, and the balloon wall of the balloon body has a pore structure; a drug delivery device, used for communicating with the proximal end of the tube body and supplying a fluid, wherein the fluid contains a therapeutic substance; A light-emitting guidewire can be inserted into the tube body, the light-emitting guidewire includes an optical fiber, the optical fiber can extend into the balloon body, and a portion of the distal end is exposed and serves as a light-emitting working section; A light source is used to be connected to the light path of the light-emitting guide wire.

2. The balloon catheter system according to claim 1, characterized in that: The concentration of the therapeutic substance in the fluid is 0.1-0.6 g / mL.

3. The balloon catheter system according to claim 1, characterized in that: The pore size of the pore structure is 5 to 100 μm; the surface porosity of the balloon body is 30 to 80%.

4. The balloon catheter system according to claim 1, characterized in that: The therapeutic agent is at least one of rapamycin, sirolimus, everolimus, zotarolimus, 42-(dimethylphosphinate) rapamycin, defostiolimus, biolimus, umimios, tacrolimus, paclitaxel, protaxel, and docetaxel.

5. The balloon catheter system according to claim 1, characterized in that: The tube body comprises an inner tube and an outer tube which are sleeved on each other, and the inner tube has a guide wire cavity for passing the luminous guide wire; The radial gap between the inner tube and the outer tube serves as a perfusion cavity for the fluid, and the perfusion cavity is communicated with the interior of the balloon body.

6. The balloon catheter system according to claim 1, characterized in that: The light source excites the light-emitting guide wire to emit light with a wavelength of 620 to 760 nm.

7. A balloon catheter system for coronary arteries, characterized in that: include: a body having opposing proximal and distal ends; A balloon body is fixed to the distal end of the tube body, the balloon body is connected to the interior of the tube body, and the surface of the balloon body is loaded with a therapeutic substance in a coating manner; A light-emitting guidewire can be inserted into the tube body, the light-emitting guidewire includes an optical fiber, the optical fiber can extend into the balloon body, and a portion of the distal end is exposed and serves as a light-emitting working section; A light source is used to be connected to the light path of the light-emitting guide wire.

8. The balloon catheter system for coronary arteries according to claim 7, characterized in that: The coating has a thickness of 1 to 100 μm; The coating amount of the therapeutic substance in the coating is 1 to 8 g / m2 relative to the unit balloon surface area. 2 .

9. The balloon catheter system according to any one of claims 1 or 7, characterized in that: It also includes an optical fiber component, which is inserted into the tube body and has a light-emitting portion extending into the balloon.

10. A method for using a balloon catheter system, characterized in that: The balloon catheter system according to any one of claims 1 to 9 is used, and the method of use comprises: Passing the luminous guidewire along a predetermined path and passing the balloon catheter through the luminous guidewire until the luminous working section and the balloon body reach a designated position; administering medication to a specific location via a balloon catheter; The light is applied to the designated location via the light-emitting guide wire.

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