Processing method of perfusion laser balloon catheter and perfusion laser balloon catheter

Abstract

The invention discloses a processing method of a perfusion laser balloon catheter, the perfusion laser balloon catheter comprises a balloon body, an inner tube, a first outer tube, a second outer tube and an optical fiber, the processing method comprises the following steps: step S100, sequentially connecting the first outer tube, the balloon body and the second outer tube end to end to obtain a first prefabricated member; s200, arranging and fixing optical fibers along the periphery of the inner pipe to obtain a second prefabricated part; s300, the first prefabricated part is arranged on the periphery of the second prefabricated part in a sleeving mode and fixed to the periphery of the second prefabricated part, and a radial gap between the inner pipe and the second outer pipe is filled with sealant, so that the inner pipe, the sealant and the second outer pipe form a composite section; and S400, the composite section is provided with an inner cavity and a side wall surrounding the inner cavity, and the side wall is provided with a part communicating with the inner cavity. Compared with the prior art, the processing method is simple, and the perfusion laser balloon catheter obtained through processing can well release drugs and apply uniform illumination to a vascular lesion section, so that the treatment effect on vascular diseases is improved.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a processing method of a perfusion laser balloon catheter and a perfusion laser balloon catheter. Background Art

[0002] The basic pathological changes of most vascular diseases, whether organic or functional, are organ ischemic changes caused by vascular stenosis or occlusion. Currently, angioplasty is one of the important ways to revascularize vascular stenosis.

[0003] The perfusion laser balloon catheter includes a tube body, a balloon body, an optical fiber and a tail seat. The tube body is usually provided with multiple tubes, each tube is mutually sleeved, and the inner part of each tube and / or the radial gap between the inner and outer tubes are used to provide a guidewire cavity, a drug channel and a fluid channel respectively. The existing perfusion laser balloon has problems such as uneven light emission, incomplete drug release, and much residue, resulting in poor treatment effect on vascular diseases. Summary of the invention

[0004] In view of the problems in the prior art, the present application provides a method for processing a perfusion laser balloon catheter. The processing method is simple, and the prepared perfusion laser balloon catheter has good performance.

[0005] The processing method of the perfusion laser balloon catheter in the present application comprises a balloon body, an inner tube, a first outer tube, a second outer tube and an optical fiber, and the processing method comprises:

[0006] Step S100, connecting the first outer tube, the balloon body and the second outer tube end to end in sequence to obtain a first preform;

[0007] Step S200, arranging and fixing the optical fiber along the outer circumference of the inner tube to obtain a second preform;

[0008] Step S300, sleeve and fix the first preform on the outer circumference of the second preform, and fill the radial gap between the inner tube and the second outer tube with sealant, so that the inner tube, the sealant and the second outer tube form a composite section;

[0009] Step S400: The composite segment has an inner cavity and a side wall surrounding the inner cavity, and a hole communicating with the inner cavity is opened on the side wall.

[0010] Several optional methods are also provided below, but they are not intended to be additional limitations on the above-mentioned overall solution, but are merely further supplements or preferences. Under the premise that there are no technical or logical contradictions, each optional method can be combined with the above-mentioned overall solution separately, and multiple optional methods can also be combined.

[0011] Optionally, in step S100, the balloon body has a proximal end and a distal end opposite to each other, the proximal end of the balloon body is connected to the end of the first outer tube, and the distal end of the balloon body is connected to the end of the second outer tube;

[0012] The first outer tube, the balloon body and the second outer tube are connected by gluing and / or welding.

[0013] Optionally, in step S200, a plurality of developing rings are arranged at intervals at the distal end of the inner tube.

[0014] Optionally, in step S200, a plurality of optical fibers are fixed at intervals along the outer circumference of the inner tube; the optical fibers are fixed by gluing or welding.

[0015] Optionally, in step S300, the connection between the second outer tube and the balloon body is sealed and connected to the outer wall of the inner tube;

[0016] The free end of the second outer tube is sealed and connected to the outer wall of the inner tube.

[0017] Optionally, the sealing connection method is to use a glue pouring mechanism to pour glue into the radial gap between the inner tube and the second outer tube.

[0018] Optionally, the glue pouring mechanism has a tubular glue injection head. Before glue pouring, the glue injection head extends into the radial gap until the connection between the second outer tube and the balloon body; when pouring glue, the glue injection head withdraws toward the distal end of the inner tube while pouring glue until the radial gap is filled with sealant.

[0019] Optionally, in step S400, laser drilling is used to drill holes from the outside to the inside of the side wall of the composite section, and the second outer tube, the sealant and the inner tube are sequentially penetrated to form the above.

[0020] Optionally, the refractive index of the sealant is 1.4 to 1.7.

[0021] Optionally, a plurality of optical fibers are arranged at intervals along the circumference of the inner tube, and the composite section is provided with two liquid discharge holes in the area between two adjacent optical fibers;

[0022] The liquid outlet hole is a circular hole or a slit hole; the porosity of the composite section is 40-70%.

[0023] The present application also provides a perfusion laser balloon catheter, which is manufactured by adopting the processing method.

[0024] Compared with the prior art, the processing method provided in the present application is simple, and the obtained perfusion laser balloon catheter has good luminescence uniformity and drug release effect, which is beneficial to improving the therapeutic effect on blood vessels. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1This is a flow chart of a processing method for a perfusion laser balloon catheter in one embodiment of the present application;

[0026] Figure 2 This is a schematic diagram of the structure of a perfusion laser balloon catheter in one embodiment;

[0027] Figure 3 It is a schematic structural diagram of a perfusion laser balloon catheter in another embodiment;

[0028] Figure 4 This is a schematic diagram of the structure of an inner tube, an optical fiber and a second outer tube in one embodiment;

[0029] Figure 5 This is a schematic diagram of the structure of an inner tube, an optical fiber, a sealant, and a second outer tube in one embodiment;

[0030] Figure 6 This is a schematic diagram of the structure of a composite section in an embodiment;

[0031] Figure 7 is a schematic structural diagram of a composite section in another embodiment;

[0032] Figure 8 This is a schematic structural diagram of a balloon body, an inner tube, and a first outer tube in one embodiment;

[0033] Fig. 9 It is a schematic diagram of the distal structure of the perfusion laser balloon catheter in the first state;

[0034] Fig.10 Schematic diagram of the distal structure of the perfusion laser balloon catheter in the second state.

[0035] The reference numerals in the figures are described as follows:

[0036] 100, perfusion laser balloon catheter; 110, guide wire; 111, main body section; 112, plugging piece; 113, guide section; 120, inner tube; 121, drug channel; 123, first outlet; 130, optical fiber; 131, light-emitting section; 140, balloon body; 150, first outer tube; 151, fluid channel; 160, second outer tube; 161, second installation channel; 162, second outlet; 170, sealant; 171, middle channel; 180, developing ring; 190, tailstock; 191, first interface; 192, second interface; 193, optical path interface; 194, stress release tube; 195, first tailstock; 196, second tailstock; 197, locking mechanism; 1971, locking sleeve; 1972, locking cap;

[0037] 200, light source device; 210, optical fiber connector; 220, optical fiber protective cover;

[0038] 1. Proximal end; 2. Distal end. DETAILED DESCRIPTION

[0039] 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.

[0040] 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.

[0041] 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.

[0042] See also Figures 1 to 10 An embodiment of the present application provides a method for processing a perfusion laser balloon catheter 100. The perfusion laser balloon catheter 100 includes a balloon body 140, an inner tube 120, a first outer tube 150, a second outer tube 160, and an optical fiber 130. The processing method includes:

[0043] Step S100, connecting the first outer tube 150, the balloon body 140 and the second outer tube 160 end to end in sequence to obtain a first preform;

[0044] Step S200, arranging and fixing the optical fiber 130 along the outer circumference of the inner tube 120 to obtain a second preform;

[0045] Step S300, sleeve and fix the first preform on the outer circumference of the second preform, and fill the radial gap between the inner tube 120 and the second outer tube 160 with sealant 170, so that the inner tube 120, the sealant 170 and the second outer tube 160 form a composite section;

[0046] Step S400: The composite section has an inner cavity and a side wall surrounding the inner cavity, and a liquid outlet hole communicating with the inner cavity is provided on the side wall.

[0047] In the processing method, step S100 and step S200 are performed in any order, and then step S300 and step S400 are performed in sequence.

[0048] The processing method of the present application is simple, and the radial gap between the inner tube 120 and the second outer tube 160 is filled with the sealant 170, which can prevent a large amount of drugs from being retained in these gaps, thereby effectively reducing drug residues.

[0049] Specifically, in step S100, the balloon body 140 has a proximal end and a distal end opposite to each other, the proximal end of the balloon body 140 is connected to the end of the first outer tube 150, and the distal end of the balloon body 140 is connected to the end of the second outer tube 160, so that the first outer tube 150, the balloon body 140 and the second outer tube 160 are connected end to end in sequence. The connection can be made by gluing and / or welding, wherein gluing and welding are, for example, ultrasonic welding and hot pressing welding.

[0050] In step S200, the inner tube 120 has a relative proximal end and a distal end, and the portion of the optical fiber 130 located at the distal end of the inner tube 120 is exposed as a light-emitting segment 131. Specifically, the optical fiber 130 includes a core and a sheath, and the sheath wraps the core to protect the optical fiber 130 and reduce the energy loss of the optical fiber 130. The portion of the optical fiber 130 located at the distal end of the inner tube 120 is stripped of the sheath to serve as the light-emitting segment 131. The stripping method may be physical stripping (e.g., sandblasting, grinding, scraping, etc.) or chemical stripping. The surface of the light-emitting segment 131 is ground to make the surface more uniform and improve the uniformity of light emission.

[0051] Multiple optical fibers 130 are fixed at intervals along the outer circumference of the inner tube 120, for example, four optical fibers 130. The optical fibers 130 can be fixed by gluing or splicing. In addition, multiple developing rings 180 are arranged at intervals at the distal end of the inner tube 120, usually two developing rings 180 are arranged, and the two developing rings 180 are respectively sleeved and fixed on the two ends of the light-emitting segment 131.

[0052] In step S300 , when the first preform is sleeved and fixed on the outer circumference of the second preform, the second outer tube 160 is sleeved on the outer circumference of the light-emitting segment 131 .

[0053] The connection between the second outer tube 160 and the balloon body 140 is sealed to the outer wall of the inner tube 120, and the free section of the second outer tube 160 is sealed to the outer wall of the inner tube 120, so that both ends of the second outer tube 160 are closed. The sealing connection can be made by gluing or welding.

[0054] For example, in one embodiment, the sealing connection is achieved by using a glue injection mechanism to inject glue into the radial gap between the inner tube 120 and the second outer tube 160. Specifically, the glue injection mechanism has a tubular glue injection head. Before injecting glue, the glue injection head extends into the radial gap until the connection between the second outer tube 160 and the balloon body 140. When injecting glue, the glue injection head withdraws toward the distal end of the inner tube 120 while injecting glue until the radial gap is filled with the sealant 170.

[0055] Since the optical fiber 130 is embedded in the sealant 170, in order to ensure the light transmission effect, the sealant 170 uses a transparent glue with a high refractive index, such as a UV glue with a refractive index of 1.42 to 1.67, such as Loctite 3011 UV curing glue. The light scattered by the optical fiber 130 is refracted and then transmitted, making the illumination more uniform.

[0056] In step S400, a hole is punched from the outside to the inside of the side wall of the composite section by laser drilling, and the second outer tube 160, the sealant 170 and the inner tube 120 are sequentially penetrated to form a liquid outlet. The inner tube 120 has a first outlet 123, the second outer tube 160 has a second outlet 162, and the sealant 170 has an intermediate channel connecting the first outlet 123 and the second outlet 162. The intermediate channel can be a straight channel, and its two ends are connected to the first outlet 123 and the second outlet 162. For example, see Figure 5 , the first outlet 123 and the second outlet 162 are aligned, the middle channel extends along the radial direction of the composite section and is connected with the first outlet 123 and the second outlet 162, that is, the drug is released along the radial direction of the composite section. For another example, the middle channel can be set at an angle to the radial direction of the composite section, that is, the drug is released obliquely.

[0057] In addition, according to the scene requirements, the composite segment can be divided into multiple release zones, and each release zone is provided with a different intermediate channel, for example, divided into a proximal release zone, an intermediate release zone and a distal release zone. In the intermediate release zone, the drug is released along the radial direction of the composite segment, and in the proximal release zone and the distal release zone, the drug is released at an inclined angle relative to the axial direction of the composite segment.

[0058] The composite section has an inner cavity and a side wall surrounding the inner cavity. The side wall is formed with a first outlet 123, an intermediate channel and a second outlet 162. The shape of the outlet hole affects the effect of drug release. Figure 6 , 7 The shape of the drug outlet hole can be a circular hole or a slit hole, wherein the diameter of the circular hole is 0.3-2 mm, for example, 1 mm; the slit hole can be an "I" hole, and the long diameter of the slit hole is 2-10 mm, and the short diameter is 0.01-0.1 mm, for example, the long diameter is 5 mm, the short diameter is 0.01 mm, and another example is the long diameter is 7, and the short diameter is 0.05 mm.

[0059] To control the drug release rate, the porosity of the composite segment is, for example, 40-70%, 50-70%, or 65%. Along the circumference of the composite segment, at least two liquid outlets are provided between two adjacent optical fibers 130, for example, two liquid outlets are provided, and the spacing between the two liquid outlets is 0.5-1 mm.

[0060] The power of laser drilling is 300-500mW, for example, 300-400mW, and for example, 320mW. Medical catheter laser drilling equipment, such as the medical catheter drilling machine of Chuangxuan Laser, can be used for drilling holes. By setting different drilling shapes and sizes, circular holes and slit holes can be punched on the catheter. The slit holes are, for example, "I" holes. Specifically, the laser head is usually point-shaped. According to the shape of the expected liquid outlet hole, different shapes of liquid outlet holes can be obtained by setting different walking paths of the laser head. Furthermore, the composite section is provided with two rows of liquid outlet holes in the area between two adjacent optical fibers 130.

[0061] The perfusion laser balloon catheter 100 further includes a guide wire 110 inserted into the inner tube 120, and the guide wire 110 includes a guide segment 113, a blocking piece 112, and a body segment 111 connected in sequence, wherein the guide segment 113 extends out of the distal end of the inner tube 120, the blocking piece 112 blocks the distal end of the inner tube 120, and the body segment 111 extends out of the proximal end of the inner tube 120. The guide wire 110 can be fixedly or slidably inserted into the inner tube 120, wherein the specific operation of fixing is to fix at least a portion of the distal end of the guide wire 110 to the distal end of the inner tube 120, for example, to fix the blocking piece 112 to the distal end of the inner tube 120, and the fixing method can be gluing or welding.

[0062] Regarding the timing of fixing the guide wire 110, in one embodiment, the guide wire 110 is inserted into the second preform of step S200, the surface of the sealing member 112 is pre-coated with colloid, the sealing member 112 is pushed to a predetermined position of the inner tube 120, and then the sealing member 112 is bonded to the side wall of the inner tube 120 by heat pressing or ultrasound.

[0063] The perfusion laser balloon catheter 100 further includes a tail seat 190. After step S400 is completed, a fourth preform is obtained, and the proximal end of the fourth preform is connected to the tail seat 190, and the proximal end of the body section 111 extends out of the tail seat 190. The connection method can be gluing and / or welding.

[0064] In another embodiment, after step S400 is completed, a fourth preform is obtained, the guide wire 110 is slidably inserted into the fourth preform, and then the proximal end of the fourth preform is connected to the tail stock 190 , and the proximal end of the guide wire 110 extends out of the tail stock 190 .

[0065] The perfusion laser balloon catheter 100 also includes a tail seat 190 . The processing method also includes step S500 , sliding the guide wire 110 through the fourth preform, and then connecting the proximal end of the fourth preform to the tail seat 190 , and the proximal end of the guide wire 110 extends out of the tail seat 190 .

[0066] The perfusion laser balloon catheter 100 also includes a locking mechanism 197 that cooperates with the tail seat 190 . The locking sleeve 1971 of the locking mechanism 197 can be pre-fixed to the tail seat 190 . In step S500 , the proximal end of the guide wire 110 extending out of the tail seat 190 is passed through the locking cap 1972 .

[0067] In one embodiment, the tailstock 190 is a detachable structure, including a first tailstock 195 and a second tailstock 196 that can cooperate with each other. In the processing method, the inner tube 120, the optical fiber 130 and the proximal end of the first outer tube 150 can be pre-fixed to the second tailstock 196, and the locking sleeve 1971 can be pre-fixed to the first tailstock 195; in step S500, the portion where the proximal end of the guide wire 110 extends out of the first tailstock 195 is inserted into the locking cap 1972.

[0068] A stress relief tube 194 is further provided at the proximal end of the tailstock 190 , and the proximal ends of the inner tube 120 and the first outer tube 150 are both connected to the stress relief tube 194 .

[0069] See also Figures 2 to 9 In one embodiment of the present application, a perfusion laser balloon catheter is provided, which is made by any of the above processing methods. The perfusion laser balloon catheter 100 has a relative proximal end 1 and a distal end 2, and includes a guide wire 110, an inner tube 120, an optical fiber 130, a balloon body 140, a first outer tube 150, a second outer tube 160, and a tailstock 190; wherein the guide wire 110 is fixed with a blocking piece 112 at the distal end, the inner tube 120 is fixedly sleeved on the outer periphery of the guide wire 110, and the distal end of the inner tube 120 is blocked by the blocking piece 112, the inner tube 120 has a drug channel 121, and in order to effectively release the drug, the distal end of the inner tube 120 is provided with a first outlet 122 connected to the drug channel 121. The optical fiber 130 extends along the inner tube 120, and a light-emitting section 131 is provided at the distal end of the inner tube 120 for emitting light of a specific wavelength band. The balloon body 140 is disposed on the outer periphery of the inner tube 120, and the distal end of the balloon body 140 is sealedly connected to the outer wall of the inner tube 120; the first outer tube 150 is disposed on the outer periphery of the inner tube 120 and is communicated with the proximal end of the balloon body 140, and the radial gap between the first outer tube 150 and the inner tube 120 serves as a fluid channel 151 for inflating the balloon body 140. The second outer tube 160 is provided with a second outlet 162 communicated with the drug channel 121. The inner tube 120, the optical fiber 130 and the proximal ends of the first outer tube 150 are all connected to the tailstock 190, and the tailstock 190 is provided with a first interface 191, a second interface 192 and an optical path interface 193, wherein the first interface 191 is communicated with the drug channel 121 for injecting fluid drugs; the second interface 192 is communicated with the fluid channel 151 for injecting fluid into the fluid channel 151 to inflate the balloon body 140; the optical path interface 193 corresponds to the optical fiber 130, and is used to facilitate the access of the optical fiber 130 to the light source device 200. The proximal end of the guide wire 110 extends and is connected to the tailstock 190.

[0070] See also Figures 2 to 10 Another embodiment of the present application provides a perfusion laser balloon catheter, which is manufactured by any of the above processing methods. The perfusion laser balloon catheter 100 has a relative proximal end 1 and a distal end 2, and includes a guide wire 110, an inner tube 120, an optical fiber 130, a balloon body 140, a first outer tube 150, a second outer tube 160, and a tailstock 190. Among them, a blocking member 112 is fixed to the distal end of the guide wire 110, and the inner tube 120 is slidably sleeved on the outer periphery of the guide wire 110. The inner tube 120 has a first state and a second state. In the first state, the blocking member 112 seals the distal end of the inner tube 120. In the second state, the guide wire 110 moves toward the proximal end, and the blocking member 112 releases the seal on the distal end of the inner tube 120. The inner tube 120 has a drug channel 121. In order to release the drug, the distal end of the inner tube 120 is provided with a first outlet 123 connected to the drug channel 121. The optical fiber 130 extends along the outside of the inner tube 120, and a light-emitting segment 131 is provided at the distal end of the inner tube 120. The balloon body 140 is located at the periphery of the inner tube 120, and the distal end of the balloon body 140 is sealed and connected to the outer wall of the inner tube 120. The first outer tube 150 is located at the periphery of the inner tube 120 and communicates with the proximal side of the balloon body 140. The radial gap between the first outer tube 150 and the inner tube 120 serves as a fluid channel 151 for inflating the balloon body 140. The second outer tube 160 is located at the periphery of the inner tube 120 and wraps the light-emitting segment 131 of the optical fiber 130. Both ends of the second outer tube 160 are sealed and connected to the periphery of the inner tube 120. In order to release the drug, the second outer tube 160 is provided with a second outlet 162 communicated with the drug channel 121. The inner tube 120, the optical fiber 130 and the proximal ends of the first outer tube 150 are all connected to the tailstock 190, and the tailstock 190 is provided with a first interface 191, a second interface 192 and a pipeline interface, wherein the first interface 191 is communicated with the drug channel 121, the second interface 192 is communicated with the fluid channel 151, and the optical path interface 193 corresponds to the optical fiber 130. The proximal end of the guide wire 110 extends out of the tailstock 190, and the tailstock 190 is provided with a locking mechanism 197 that cooperates with the guide wire 110.

[0071] The locking mechanism 197 has a locking state for locking the proximal end of the guide wire 110 and a releasing state for releasing the lock on the guide wire 110. The mutual sliding of the inner tube 120 and the guide wire 110 can cause the blocking member 112 to move toward the distal end of the inner tube 120, thereby blocking the distal end of the inner tube 120. At the same time, the locking mechanism 197 locks the proximal end of the guide wire 110, thereby maintaining the inner tube 120 in the first state; releasing the locking mechanism 197 from locking the guide wire 110 and driving the guide wire 110 to slide can cause the blocking member 112 to move toward the proximal end of the inner tube 120, thereby releasing the seal of the blocking member 112 on the distal end of the inner tube 120.

[0072] The perfusion laser balloon catheter 100 is used to treat vascular diseases, such as vascular stenosis. The inflated balloon body 140 can block the blood flow of the diseased segment in the blood vessel, and then deliver the drug through the drug channel 121, and release it through the first outlet 123 and the second outlet 162 in sequence; in addition, the optical fiber 130 can emit light and act on the blood vessel or stimulate the drug reaction through the inner tube 120 and the second outer tube 160 to form a vascular microstent. Compared with the drug-loaded balloon catheter, the perfusion laser balloon catheter 100 provided in this embodiment can better release the drug and has better light uniformity, which is conducive to improving the treatment effect of vascular diseases.

[0073] The material of the balloon body 140 is selected from silicone. The material of the inner tube 120 is selected from one of PTFE, HDPE, PA, and Pebax, preferably PTFE or HDPE, with a wall thickness of 0.025 to 0.1 mm. The material of the first outer tube 150 is selected from PA or Pebax, with a wall thickness of 0.025 to 0.1 mm. The material of the second outer tube 160 is selected from PA or Pebax, with a wall thickness of 0.025 to 0.1 mm.

[0074] In order to seal the distal end of the inner tube 120, in one embodiment, the distal end of the inner tube 120 has a reduced diameter section with a gradually reduced inner diameter, and the plugging member 112 is made of a deformable material. In the first state, the plugging member 112 is squeezed and deformed in the reduced diameter section to seal the reduced diameter section. The deformable material is rubber, PEBAX or TPU.

[0075] In another embodiment, the blocking member 112 is a cone with a gradually decreasing diameter from the proximal end to the distal end, and in the first state, the distal end of the cone seals the distal end of the inner tube 120. The blocking member 112 is made of metal, such as stainless steel.

[0076] See also Figure 4 In the illustrated embodiment, the inner wall of the second outer tube 160 is provided with a second installation channel, that is, the second outer tube 160 is a multi-lumen tube, and the optical fiber 130 extends along the second installation channel. The second outer tube 160 can protect the light-emitting segment 131, and prevent the drug from adhering to the light-emitting segment 131, thereby affecting the light-emitting effect. Since there is a gap between the inner tube 120 and the second outer tube 160, the drug is easily retained in these gaps, resulting in incomplete drug release and drug residue. To solve this problem, in one embodiment, a sealant 170 is poured into the radial gap between the second outer tube 160 and the inner tube 120, and the optical fiber 130 is buried in the sealant 170. The inner tube 120, the sealant 170 and the second outer tube 160 form a composite segment.

[0077] See also Figure 2 , 3An embodiment of the present application provides a perfusion laser balloon catheter system, including a perfusion laser balloon catheter 100, a drug delivery device, a filling device, and a light source device 200. The specific structure of the perfusion laser balloon catheter is described above and will not be repeated here; the drug delivery device is used to supply fluid containing drugs to the drug channel 121; the filling device is used to supply fluid to the fluid channel 151 to inflate the balloon body 140; and the light source is used to connect to the optical fiber pipeline. The drug delivery device supplies fluid containing drugs to the drug channel through the first interface, and the filling device supplies fluid to inflate the balloon body 140 to the fluid channel through the second interface. The light source device 200 is connected to the optical fiber 130 through the optical path interface.

[0078] The light source device 200 includes an optical fiber connector 210 and an optical fiber protective cover 220 , wherein the optical fiber protective cover 220 is made of TPU and can be used to protect the optical fiber 130 from bending.

[0079] The processing method provided in the present application is simple, and the obtained perfusion laser balloon catheter has good luminescence uniformity and drug release effect, which is beneficial to improving the therapeutic effect on blood vessels.

[0080] 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.

[0081] 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. Processing method of perfusion laser balloon catheter, It is characterized in that The perfusion laser balloon catheter comprises a balloon body, an inner tube, a first outer tube, a second outer tube and an optical fiber, and the processing method comprises: Step S100, connecting the first outer tube, the balloon body and the second outer tube end to end in sequence to obtain a first preform; Step S200, arranging and fixing the optical fiber along the outer circumference of the inner tube to obtain a second preform; Step S300, sleeve and fix the first preform on the outer circumference of the second preform, and fill the radial gap between the inner tube and the second outer tube with sealant, so that the inner tube, the sealant and the second outer tube form a composite section; Step S400: The composite segment has an inner cavity and a side wall surrounding the inner cavity, and a hole communicating with the inner cavity is opened on the side wall.

2. The processing method according to claim 1, It is characterized in that In step S100, the balloon body has a proximal end and a distal end opposite to each other, the proximal end of the balloon body is connected to the end of the first outer tube, and the distal end of the balloon body is connected to the end of the second outer tube; The first outer tube, the balloon body and the second outer tube are connected by gluing and / or welding.

3. The processing method according to claim 1, It is characterized in that In step S200, the inner tube has a proximal end and a distal end opposite to each other, and a portion of the optical fiber located at the distal end of the inner tube is exposed as a light-emitting segment; A plurality of developing rings are arranged at intervals at the distal end of the inner tube.

4. The processing method according to claim 1, It is characterized in that In step S200, a plurality of optical fibers are fixed at intervals along the outer circumference of the inner tube; The optical fiber is fixed by gluing or welding.

5. The processing method according to claim 1, It is characterized in that In step S300, the connection between the second outer tube and the balloon body is sealed and connected to the outer wall of the inner tube; The free end of the second outer tube is sealed and connected to the outer wall of the inner tube.

6. The processing method according to claim 5, It is characterized in that The sealing connection method is to use a glue injection mechanism to inject glue into the radial gap between the inner tube and the second outer tube.

7. The processing method according to claim 6, It is characterized in that The glue injection mechanism has a tubular glue injection head. Before glue injection, the glue injection head extends into the radial gap until the connection between the second outer tube and the balloon body; during glue injection, the glue injection head withdraws toward the distal end of the inner tube while injecting glue until the radial gap is filled with sealant.

8. The processing method according to claim 1, It is characterized in that In step S400, laser drilling is used to drill holes from the outside to the inside of the side wall of the composite section, and the second outer tube, the sealant and the inner tube are sequentially penetrated to form the above.

9. The processing method according to claim 1, It is characterized in that The optical fibers are arranged at intervals along the circumference of the inner tube, and the composite section is provided with two liquid discharge holes in the area between two adjacent optical fibers; The liquid outlet hole is a circular hole or a slit hole, and the porosity of the composite section is 40-70%.

10. Perfusion laser balloon catheter, It is characterized in that The invention is prepared by the processing method described in any one of claims 1 to 9.

Images