Balloon catheter system, balloon catheter system for coronary arteries and method of using same

Abstract

The application discloses a balloon catheter system, a balloon catheter system for coronary artery and a method for using the same. The balloon catheter system comprises a tube body having opposite proximal and distal ends; a balloon body fixed to the distal end of the tube body, the balloon body having opposite inflation and contraction states suitable for interventional delivery, the balloon body having a porous structure; a light-emitting guide wire inserted into the tube body, the light-emitting guide wire comprising an optical fiber, the optical fiber being extendable into the balloon body, and a part of the distal end being exposed and serving as a light-emitting working section; a drug supply device in communication with the proximal end of the tube body and supplying a fluid containing a therapeutic substance; and a light source in optical path connection with the light-emitting guide wire. Compared with the prior art, the application can combine the balloon catheter with the light-emitting guide wire, and through flexible use of chemical and physical means, the treatment effect on the blood vessel lesion section can be improved, so as to effectively prevent blood vessel restenosis.

Description

TECHNICAL FIELD

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

[0002] Vascular disease has approached the first place in the cause of human death, and most of the vascular diseases, whether organic or functional, have the basic pathological change of organ ischemic change caused by vascular lumen stenosis or occlusion, such as neointimal proliferation caused by cell and tissue damage of vascular wall, which is easy to cause restenosis of vascular lumen.

[0003] The drug-loaded balloon catheter system is a commonly used interventional instrument for treating vascular lesions, which uses the balloon body to apply a therapeutic agent, such as an inhibitor for inhibiting the proliferation of vascular intima, to the designated position, but the overall treatment effect is not good. SUMMARY

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

[0005] The balloon catheter system provided by the present application comprises:

[0006] a tube body having opposite proximal and distal ends;

[0007] a balloon body fixed to the distal end of the tube body, the balloon body having opposite inflation and contraction states suitable for interventional delivery, and the balloon wall of the balloon body having a pore structure;

[0008] a drug delivery device for communicating with the proximal end of the tube body and supplying a fluid containing a therapeutic agent;

[0009] a light-emitting guide wire which can be inserted into the tube body, the light-emitting guide wire comprising an optical fiber which can extend into the balloon body and has a part of the distal end exposed as a light-emitting working section;

[0010] a light source for connecting with the light path of the light-emitting guide wire.

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

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

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

[0014] Optionally, the tube body comprises an inner tube and an outer tube, which are sleeved with each other, and the inner tube has a guide wire cavity inside for guiding the light-emitting guide wire;

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

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

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

[0018] a tube body having opposite proximal and distal ends;

[0019] a balloon body fixed to the distal end of the tube body, which is in communication with the inside of the tube body, and the surface of the balloon body is loaded with a therapeutic agent in a coating manner;

[0020] a light-emitting guide wire which can be inserted into the tube body, comprising an optical fiber which can extend into the balloon body, and a part of the distal end is exposed and serves as a light-emitting working section;

[0021] a light source for connecting with the light path of the light-emitting guide wire.

[0022] Optionally, the thickness of the coating is 1-100 μm.

[0023] Optionally, the coating amount of the therapeutic agent in the coating is 1-8 g / m 2 .

[0024] Optionally, it further comprises an optical fiber assembly which is inserted into the tube body and has a light-emitting part extending into the balloon.

[0025] The present application provides a use method of the balloon catheter system, which uses any of the balloon catheter systems, and the use method comprises:

[0026] guiding the light-emitting guide wire along a predetermined path and guiding the balloon catheter through the light-emitting guide wire until the light-emitting working section and the balloon body reach a designated position;

[0027] applying the therapeutic agent to the designated position through the balloon catheter;

[0028] applying light to the designated position through the light-emitting guide wire.

[0029] Compared with the prior art, the drug-loaded balloon catheter system in the application combines the light-emitting guide wire with the drug-loaded balloon catheter, and through flexible use of chemical and physical means, the treatment effect on the blood vessel lesion section can be improved to effectively prevent blood vessel restenosis. BRIEF DESCRIPTION OF DRAWINGS

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

[0031] Figure 2 Fig. 2 is an enlarged view of part A in Fig. 1; Figure 1

[0032] Figure 3 Fig. 3 is a structural schematic diagram of a balloon catheter system for coronary artery in an embodiment;

[0033] Figure 4 Fig. 4 is an enlarged view of part B in Fig. 3; Figure 3

[0034] Figure 5 Fig. 5 is a sectional view of the balloon catheter system in an embodiment;

[0035] Figure 6 Fig. 6 is a structural schematic diagram of a light-emitting guide wire in an embodiment

[0036] Figure 7 Fig. 7 is a sectional view of the light-emitting guide wire in an embodiment;

[0037] Figure 8 Fig. 8 is a structural schematic diagram of an optical fiber in an embodiment;

[0038] Figure 9 Fig. 9 is a structural schematic diagram of a balloon catheter system in another embodiment.

[0039] The reference signs in the drawings are explained as follows:

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

[0041] 200, tube body; 210, inner tube; 220, outer tube;

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

[0043] 400, coating layer; ​​

[0044] 500, light source;

[0045] 600, administration device;

[0046] 700, optical fiber assembly;

[0047] 800, blood vessel wall

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

[0049] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, but not all the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work fall within the scope of protection of the present application.

[0050] It should be noted that when an assembly is referred to as being "connected" with another assembly, it can be directly connected with the other assembly or there can be a middle assembly. When an assembly is referred to as being "disposed on" another assembly, it can be directly disposed on the other assembly or there can be a middle assembly.

[0051] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0052] Reference Figure 1 、 2 The balloon catheter system provided by an embodiment of the present application includes a tube 200, a balloon body 300, a light-emitting guide wire 100, an administration device 600, and a light source 500. The tube 200 has opposite proximal and distal ends. The balloon body 300 is fixed to the distal end of the tube 200. The balloon body 300 has opposite inflated and deflated states. The deflated state of the balloon body 300 is suitable for interventional delivery. The balloon body 300 is inflated by being filled with fluid, so that the balloon body 300 acts on the blood vessel wall 800. The balloon wall 310 of the balloon body 300 has a porous structure 320. The administration device 600 is used to communicate with the proximal end of the tube 200 and supply fluid containing a therapeutic substance. The light-emitting guide wire 100 can be inserted into the tube 200. The light-emitting guide wire 100 includes an optical fiber, can be extended into the balloon body 300, and has a portion of the distal end exposed as a working section. The light source 500 is used to be connected with the light path of the light-emitting guide wire 100.

[0053] In this embodiment, the tube body 200, the balloon body 300 and the administration device 600 can constitute a conventional balloon catheter, and the light-emitting guide wire 100 can serve as both a light emitter and a guide wire, having the functions of light emission and interventional guidance. The light-emitting guide wire 100 can be combined with the balloon catheter to meet various application requirements.

[0054] In terms of preventing vascular restenosis, the naked balloon dilation method for treating intravascular stenosis has a high probability of restenosis after treatment, even with the physical means of light-assisted repair. For example, red light has a photobiomodulation effect, which is generated by photochemical effect rather than thermal effect, and can promote cell and tissue repair. Although red light can quickly restore the elasticity of the vascular tissue wall in a short time and prevent the vascular wall 800 from collapsing and deforming, the range of action of red light is small, and the repaired blood vessels are still prone to lesions leading to restenosis in the short term. In this embodiment, the balloon catheter can be used to apply a therapeutic agent to the blood vessel, such as an inhibitor for inhibiting the proliferation of the intima of the blood vessel. The physical means of light-assisted repair combined with chemical means can effectively improve the treatment effect on vascular lesions and significantly reduce the risk of vascular restenosis.

[0055] In one embodiment, the concentration of the therapeutic agent in the fluid is 0.1-0.6 g / mL, such as 0.2-0.5 g / mL, and for example, 0.2-0.3 g / mL. On the one hand, the concentration of the therapeutic agent should not be too large to affect the light repair effect.

[0056] The inhibitor can be at least one of rapamycin, sirolimus, everolimus, zotarolimus, 42-(dimethyl phosphine) rapamycin, deforolimus, biolimus, umirolimus, tacrolimus, paclitaxel, prothracin, and docetaxel. These inhibitors can inhibit the proliferation of the intima of the blood vessel caused by the excessive proliferation of smooth muscle cells, thereby inhibiting 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 peripheral environment of the balloon body 300. In one embodiment, the pore size of the pore structure 320 is 5-100 pm, such as 10-80 pm, and for example, 30-50 pm. The porosity of the surface of the balloon body 300 is 30-80%, such as 40-70%, and for example, 45-60%.

[0058] Reference Figure 5In the shown embodiment, the tube body 200 comprises an inner tube 210 and an outer tube 220, the inner tube 210 and the outer tube 220 are sleeved with each other, the inner tube 210 has a guide wire cavity inside, the light-emitting guide wire 100 can be introduced into the light-emitting guide wire 100; the radial gap between the inner tube 210 and the outer tube 220 serves as a perfusion cavity for fluid, and the perfusion cavity is in communication with the inside of the balloon body 300 to facilitate the inflation of the balloon body 300 by fluid.

[0059] The material of the first tube can be selected from block polyether amide resin (PEBAX), nylon or thermoplastic polyurethane elastomer rubber (TPU), and the color is colorless and transparent, which is beneficial to the light transmission of the light-emitting 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 to excite the light-emitting guide wire 100 to emit light with a wavelength of 620-760 nm, which is used to promote the repair of cells and tissues.

[0061] Reference Figures 5 to 8 In the shown embodiment, the light-emitting guide wire further comprises a pushing rod 120, a guide head 130 and a support 140; the optical fiber 110 has opposite proximal and distal ends, and comprises a core 111 and a cladding layer 112 wrapping the core 111, which plays a role in protecting the optical fiber and reducing energy loss of the optical fiber; a part of the core 111 at the distal end of the optical fiber 110 is exposed and serves as a working section; the pushing rod 120 is a hollow tubular structure fixedly sleeved on the outer periphery of the optical fiber 110 for driving the optical fiber 110 to move; the guide head 130 is connected to the distal end of the optical fiber 110 for guiding the light-emitting guide wire 100 to travel in the lumen of human tissue; and the support 140 is located at the periphery of the light-emitting working section 113, and the two ends of the support 140 are respectively connected to the guide head 130 and the pushing rod 120 to provide corresponding support strength. In this embodiment, the optical fiber 110 can serve as both a light emitter and a guide wire, integrating the functions of emitting light and interventional guidance, and the 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 an embodiment, the support 140 can be a mesh tube structure, which comprises a first support section 141, a hollow section 142 and a second support section 143 in sequence from the proximal end to the distal end, wherein the first support section 141 and the second support section 143 are grid-dense sections, and the hollow section 142 is a grid-sparse section. The first support section 141 and the second support section 143 are fixedly connected to the pushing rod 120 and the guide head 130 respectively, which is beneficial to ensuring the support strength of the support 140, and the axial position of the light-emitting working section 113 corresponds to the grid-sparse section, which can ensure the effect of the light-emitting guide wire 100 emitting light.

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

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

[0065] Reference Figure 7 In the embodiment shown, to fix the helical spring, the light-emitting guide wire 100 further comprises a connecting piece 150, the proximal end of the connecting piece 150 is fixedly sleeved 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 helical spring is fixed to the tapered structure 151. In addition, the guide head 130 comprises a spherical cap portion 131 at the distal end and a cylindrical portion 132 proximal to the spherical cap portion 131, and the second support section 143 of the helical spring is fixedly sleeved 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 connecting piece 150 is internally provided with a recess structure 152 for the reduced diameter end 121 to extend into, and the shape of the recess structure 152 is matched with the reduced diameter end 121. During assembly, the reduced diameter end 121 of the push rod 120 is connected with the recess structure 152 of the connecting piece 150; further, the connecting positions of the push rod 120 and the connecting piece 150 are flush with each other, so that the structure of the light-emitting guide wire 100 is compact, which is conducive to subsequent assembly with the balloon catheter assembly. The above-mentioned components can be fixed by laser welding after being connected.

[0067] The taper structure 151 gradually reduces in diameter from the proximal end to the distal end, and the first support section 141 has a radial gap with the taper 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 = 1:1.2-3 times, for example, 1:1.5-2.5, for example, 1:1.5-2, further for example, 1:1.8.

[0068] In order to facilitate the insertion of the optical fiber 110, the connecting piece 150 is in communication with the hollow tubular structure of the push rod 120, and the optical fiber 110 inserted into the push rod 120 extends through the insertion passage of the connecting piece 150.

[0069] In the optical fiber 110, the core 111 can be made of 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 0.1-0.3mm, for example, 0.125-0.25mm, for example, 0.125mm. If the optical fiber 110 is too thin, it is easy to break during use. If the optical fiber 110 is too thick, it will result in an excessively large radial size of the light-emitting guide wire 100, affecting the subsequent application of the light-emitting guide wire. The outer 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 part of the optical fiber 110 in the balloon body 300 is stripped of the optical fiber 110 cladding, and the stripping length of the optical fiber 110 cladding is equal to the axial length of the balloon body 300. The stripping method can be physical stripping (such as 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 body can be an OTW (over-the-wire) or RX (rapid exchange) commonly used balloon body. The coverage of the drug coating can be the entire or partial surface of the balloon body, for example, the balloon body has a folded lobe structure, and the coating can be arranged only in the folded lobe structure.

[0072] ReferenceFigure 3 、 4 Another embodiment of the present application provides a balloon catheter system for coronary artery, comprising a tube 200, a balloon body 300, a light-emitting guide wire 100 and a light source 500, wherein the tube 200 has opposite proximal and distal ends, the balloon body 300 is fixed to the distal end of the tube 200, the balloon body 300 is in communication with the inside of the tube 200, and the balloon body 300 is inflated by filling the tube 200 with a fluid such as normal saline; the surface of the balloon body 300 is loaded with a therapeutic agent in the form of a coating 400; the light-emitting guide wire 100 can be inserted into the tube 200, and comprises an optical fiber, can be extended into the balloon body 300, and has a part of the distal end exposed as a working section; and the light source 500 can be used to connect the light path of the light-emitting guide wire 100, and different light sources 500 can drive the light-emitting guide wire 100 to emit light of different wavelengths. In this embodiment, a specific therapeutic agent is loaded on the balloon body 300 according to the expected therapeutic effect, the balloon body 300 is inflated and acts on the blood vessel to release the therapeutic agent, and 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 agent loaded on the balloon body 300 can be an inhibitor for inhibiting vascular intimal hyperplasia, such as at least one of rapamycin, sirolimus, everolimus, zotarolimus, 42-(dimethyl phosphine) rapamycin, deforolimus, biolimus, umirolimus, tacrolimus, paclitaxel, protaxel, and docetaxel. The light source 500 can be a red light source 500, which can emit light of a wavelength of 620-760 nm. The combination of the drug-loaded balloon catheter and the light-emitting guide wire 100 can be used in the present application, the drug-loaded balloon catheter can administer drugs to the blood vessel, and the red light emitted by the light-emitting guide wire 100 driven by the light source 500 can promote the repair of vascular cells and tissues, so that the therapeutic effect can be improved by combining chemical means with physical means, thereby reducing the risk of vascular restenosis.

[0074] Specifically, the thickness of the coating 400 is 1-100 μm, such as 10-80 μm, and for example, 20-50 μm, which on the one hand ensures the drug treatment effect, and on the other hand, the concentration of the therapeutic agent should not be too large to affect the light repair effect.

[0075] Compared with the use of a drug-loaded balloon alone, the use of auxiliary physical light can correspondingly reduce the amount of therapeutic agent. For example, in one embodiment, the coating amount of the therapeutic agent in the coating 400 is 1-8 g / m 2 , such as 2-6 g / m 2 , and for example, 2-4 g / m 2 .

[0076] The above balloon catheter system and the balloon catheter system for a coronary artery, the therapeutic agent can also be a photosensitive crosslinking agent, such as at least one of porphyrin, porphyrin derivative compound, phthalocyanine, chlorin, purpurin, 5-hydroxyacetic acid, 4-amino-1,8-naphthalimide, 1,8-naphthalimide, 1,8-naphthalimide multimer, dimer naphthalimide compound, 2,2'-((ethane-1,2-dioxy)di(ethane-2,1-diyl)di(6-((2-(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-dioxobenzo[de]isoquinoline-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-nitrobenzoyloxy succinimidyl, N-(beta-maleimidopropoxy)succinimidyl ester, N-[e-maleimidylacetoxy]succinimidyl ester, N-[gamma-maleimidobutyryloxy]succinimidyl, succinimidyl-6-(3-[2-pyridyldithio]-propionamido)hexanoate, m-maleimidobenzoyl-N-hydroxysuccinimidyl 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-[beta-maleimidopropionamido]hexanoate, N-succinimidyl 3-[2-pyridyldithio]-propionate, sulfosuccinimidyl 6-(3'-[2-pyridyldithio]-propionamido)hexanoate, m-maleimidobenzoyl-N-hydroxysulfosuccinimidyl ester, N-sulfosuccinimidyl-6-[4'-azido-2'-nitrophenylamino]hexanoate, and sulfosuccinimidyl-4-[N-maleimidomethyl]cyclohexane-1-carboxylate.

[0077] Different light sources 500 can drive the light-emitting guide wire 100 to emit light of different wavelength ranges. According to application requirements, selecting different light sources 500 can make the light-emitting guide wire 100 play different functions, for example: selecting a blue light source 500, exciting the light-emitting guide wire 100 to emit blue light, and promoting the photosensitive crosslinking agent to react to form a vascular microstent; selecting a red light source 500, the light-emitting guide wire 100 emits red light, and repairs the cells and tissues of the blood vessel.

[0078] In another embodiment, the above balloon catheter system and the therapeutic agent in the balloon catheter system for coronary arteries include an inhibitor and a photosensitive crosslinking agent. When the therapeutic agent is loaded in a fluid manner, the inhibitor and the photosensitive crosslinking agent can be configured into solutions respectively and injected into the balloon body 300 respectively, or both are pre-configured into a mixed solution and injected into the balloon body 300. The concentration of the photosensitive crosslinking agent in the fluid is 0.1-1.2 g / mL.

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

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

[0081] Referring to Figure 9 The above balloon catheter system and the balloon catheter system for coronary arteries also include an optical fiber assembly 700, which is inserted into the tube body, such as the perfusion lumen, and has a light-emitting part 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 the balloon catheter system, which uses any of the above balloon catheter systems, including:

[0083] The light-emitting guide wire 100 is introduced along a predetermined path, and the balloon catheter is introduced through the light-emitting guide wire 100 until the light-emitting working section and the balloon body 300 reach the designated position;

[0084] The balloon catheter is used to administer the therapeutic agent to the designated position;

[0085] The light is applied to the designated position through the light-emitting guide wire 100.

[0086] The order of the drug administration and the light application is not limited, and can be adjusted according to the actual application, for example, the drug administration and the light application can be performed simultaneously, or the light application is performed first and then the drug administration, or the drug administration is performed first and then the light application. For example, for the balloon catheter system with the coating 400, the drug administration is usually performed first and then the light application due to the interference of the coating 400 with the light application.

[0087] In one embodiment, the inhibitor is applied to the designated position by the balloon catheter, specifically, the balloon body 300 is inflated with the fluid containing the inhibitor, and 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 to apply light to the designated position of the blood vessel, wherein the time for the drug administration is 1-10 min, the time for the light application is 1-10 min, preferably 1-5 min, and the intensity of the light application is 5-10 mW / cm 2 ; preferably 10-50 mW / cm 2 .

[0088] Example 1

[0089] In the porcine coronary artery model, the stenosis degree of the blood vessel lesion section before the treatment is 70%, the balloon catheter system is pushed to the blood vessel lesion section, the balloon body in the compressed state is expanded and inflated by the perfusion fluid, the pressure is 6 atm, the fluid contains paclitaxel with a concentration of 3 g / m 2 , then the light fiber emits light with a wavelength of 650 nm to irradiate the blood vessel under the condition that the pressure of the balloon body is maintained, each irradiation is performed for 2 min, the irradiation is performed for 4 times, the total treatment time is 10 min, and the intensity of the light application is 40 mW / cm 2 .

[0090] Comparative Example 1

[0091] In the porcine coronary artery model, the stenosis degree of the blood vessel lesion section before the treatment is 70%, the balloon catheter system with the light fiber is pushed to the blood vessel lesion section, the balloon body in the compressed state is expanded and inflated by the perfusion fluid, the pressure is 6 atm, the fluid contains paclitaxel with a concentration of 7 g / m 2 , then the fluid is delivered for 10 min under the condition that the pressure of the balloon body is maintained.

[0092] Comparative Example 2

[0093] In the porcine coronary artery model, the stenosis degree of the blood vessel lesion section before the treatment is 70%, the balloon catheter system is pushed to the blood vessel lesion section, the balloon body in the compressed state is expanded and inflated by the perfusion fluid, the pressure is 6 atm, then the light fiber emits light with a wavelength of 650 nm to irradiate the blood vessel under the condition that the pressure of the balloon body is maintained, each irradiation is performed for 3 min, the irradiation is performed for 4 times, the intensity of the light application is 60 mW / cm 2 , and the total treatment time is 15 min. After the treatment, the stenosis degree of the blood vessel lesion section is measured.

[0094] The results are shown in Table 1:

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

[0096] As shown in Table 1, compared with simple drug treatment or physical treatment, the application can effectively improve the treatment effect by using balloon catheter to implement drug treatment and physical treatment on the blood vessel lesion segment. At the same time, the use power of the optical fiber and the amount of the drug can be reduced.

[0097] The technical features of the above-described embodiments can be combined in any manner. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described, but it should be considered that any combination of the technical features is within the scope of the present disclosure as long as there is no contradiction. When the technical features in different embodiments are embodied in the same drawing, it is considered that the drawing also discloses the combination of each embodiment involved.

[0098] The above-described embodiments only express several implementation manners of the present application, and the description is relatively specific and detailed, but it should not be considered as a limitation on the scope of the patent of the present application. It should be pointed out that, for ordinary skilled in the art, some modifications and improvements can be made without departing from the concept of the present application, and these are within the protection scope of the present application. Therefore, the protection scope of the present application should be subject to the appended claims.

Claims

1. A balloon catheter system, characterized in that: include: a tubular 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 deflated state suitable for interventional delivery, and the balloon body wall has a porous structure; a drug delivery device, configured to communicate with the proximal end of the tube and supply a fluid containing a therapeutic substance; A light-emitting guidewire can be inserted into the tube body, and the light-emitting guidewire includes an optical fiber, which can extend into the balloon body, with a portion of the distal end exposed and serving as a light-emitting working section; A light source, used to connect to the light guide wire optical path; The light-emitting guidewire further includes a push rod, a guide head and a support member, wherein the guide head is connected to the distal end of the optical fiber, the support member is located at the periphery of the light-emitting working section, and the two ends of the support member are respectively connected to the guide head and the push rod; The support member includes a first support section, a hollow section and a second support section in sequence from the proximal end to the distal end; The first supporting segment and the second supporting segment are fixedly connected to the pushing rod and the guiding head respectively, and the axial position of the luminous working segment corresponds to the hollow segment.

2. The balloon catheter system according to claim 1, wherein: The support member is a mesh tube structure or a spiral structure.

3. The balloon catheter system according to claim 2, characterized in that When the support member is a mesh tube structure, the first support segment and the second support segment are mesh dense segments, and the hollow segment is a mesh sparse segment; When the support member is a spiral structure, the pitch of the hollow segment is greater than the pitch of the first support segment and the second support segment, and the hollow ratio of the hollow segment is at least 80%.

4. The balloon catheter system according to claim 2, characterized in that The spiral structure is a spiral spring, which is wound with a metal wire. The diameter of the metal wire is 0.04-0.1 mm. The diameter of the spiral spring is 0.2-0.5 mm. The length of the hollow section is 2-4 cm.

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

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

7. The balloon catheter system according to claim 1, characterized in that The therapeutic agent is an inhibitor of intimal hyperplasia.

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

9. The balloon catheter system according to claim 1, wherein: 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 fluid perfusion cavity, and the perfusion cavity is communicated with the interior of the balloon body.

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

11. A balloon catheter system for coronary arteries, characterized in that: include: a tubular body having opposing proximal and distal ends; a balloon body fixed to the distal end of the tube body, the balloon body being in communication with the interior of the tube body, and the surface of the balloon body being loaded with a therapeutic substance in the form of a coating; A light-emitting guidewire can be inserted into the tube body, and the light-emitting guidewire includes an optical fiber, which can extend into the balloon body, with a portion of the distal end exposed and serving as a light-emitting working section; A light source, used to connect to the light guide wire optical path; The light-emitting guidewire further includes a push rod, a guide head and a support member, wherein the guide head is connected to the distal end of the optical fiber, the support member is located at the periphery of the light-emitting working section, and the two ends of the support member are respectively connected to the guide head and the push rod; The support member includes a first support section, a hollow section and a second support section in sequence from the proximal end to the distal end; The first supporting segment and the second supporting segment are fixedly connected to the pushing rod and the guiding head respectively, and the axial position of the luminous working segment corresponds to the hollow segment.

12. The balloon catheter system according to claim 11, characterized in that The support member is a mesh tube structure or a spiral structure.

13. The balloon catheter system according to claim 12, characterized in that: When the support member is a mesh tube structure, the first support segment and the second support segment are mesh dense segments, and the hollow segment is a mesh sparse segment; When the support member is a spiral structure, the pitch of the hollow segment is greater than the pitch of the first support segment and the second support segment, and the hollow ratio of the hollow segment is at least 80%.

14. The balloon catheter system according to claim 12, characterized in that The spiral structure is a spiral spring, which is wound with a metal wire. The diameter of the metal wire is 0.04-0.1 mm. The diameter of the spiral spring is 0.2-0.5 mm. The length of the hollow section is 2-4 cm.

15. The balloon catheter system for coronary arteries according to claim 11, characterized in that: The thickness of the coating is 1 to 100 μm; The coating amount of the therapeutic substance in the coating is 1-8 g / m2 relative to the unit balloon surface area. 2 .

16. The balloon catheter system according to claim 11, characterized in that The therapeutic agent is an inhibitor of intimal hyperplasia.

17. The balloon catheter system according to claim 11, 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.

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