Intravascular drug perfusion balloon catheter and intravascular drug perfusion balloon catheter system

Abstract

The invention discloses an intravascular perfusion drug balloon catheter and an intravascular perfusion drug balloon catheter system. The balloon catheter comprises a guide wire, an inner tube, a balloon body, a first outer tube, a second outer tube and a tail seat, the near end of the guide wire extends out of the tail seat, and a locking mechanism matched with the guide wire is arranged on the tail seat. According to the balloon catheter for perfusion of the medicine in the blood vessel, the medicine can be better released, the uniformity of light emission is guaranteed, and therefore 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 an intravascular drug perfusion balloon catheter and an intravascular drug perfusion balloon catheter system. Background Art

[0002] Vascular diseases have become a major cause of disease that affects human health. Vascular interventional surgery can effectively diagnose and treat vascular diseases and is the main treatment for such diseases. As a vascular interventional medical device, the balloon catheter can expand the narrow opening or channel of the blood vessel. The fiber optic balloon catheter is a balloon catheter with an optical fiber as a tube power device. It can be used for phototherapy or to promote drug therapy, thereby achieving the treatment of vascular diseases such as vascular stenosis and occlusion.

[0003] At present, drug-loaded fiber optic balloon catheters usually load drugs on the surface of the balloon, and the balloon expands to contact the blood vessel wall, so that the drugs on the surface of the balloon are quickly released and transferred to the local blood vessel wall. The photodynamic device generates light of a specific wavelength, which acts on the blood vessel through the balloon, prompting the drug to form a vascular microstent on the blood vessel wall. This type of balloon catheter can achieve a certain therapeutic effect, but there are problems such as uneven light emission in the balloon, incomplete drug release, and drug residue, which leads to poor treatment effects on blood vessels. Summary of the invention

[0004] In response to the problems of the prior art, the present application provides an intravascular drug perfusion balloon catheter and an intravascular drug perfusion balloon catheter system to improve the treatment effect of vascular diseases.

[0005] The present application provides an intravascular drug perfusion balloon catheter having a distal end and a proximal end opposite to each other, and the intravascular drug perfusion balloon catheter comprises:

[0006] A guide wire having an occluding member fixed at a distal portion thereof;

[0007] an inner tube, slidably sleeved on the outer periphery of the guide wire, the inner tube having a first state and a second state, in the first state, the blocking member seals the distal end of the inner tube, and in the second state, the guide wire moves toward the proximal end, and the blocking member releases the seal on the inner tube, the inner tube having a drug channel, and a first outlet communicating with the drug channel is opened at the distal end of the inner tube;

[0008] An optical fiber extending along the exterior of the inner tube and having a light emitting section at a distal end of the inner tube;

[0009] A balloon body is disposed on the outer periphery of the inner tube, and a distal end of the balloon body is sealed and connected to the outer wall of the inner tube;

[0010] A first outer tube is disposed on the outer periphery of the inner tube and communicates with the proximal side of the balloon body. A radial gap between the first outer tube and the inner tube serves as a fluid passage for inflating the balloon body.

[0011] A second outer tube is disposed on the outer periphery of the inner tube and wraps the light-emitting section of the optical fiber. Both ends of the second outer tube are hermetically connected to the outer periphery of the inner tube. The second outer tube is provided with a second outlet communicating with the drug passage.

[0012] A tailstock, the proximal ends of the inner tube, the optical fiber, and the first outer tube are all connected to the tailstock. The tailstock is provided with a first interface communicating with the drug passage, a second interface communicating with the fluid passage, and an optical path interface corresponding to the optical fiber. The proximal end of the guide wire extends out of the tailstock, and a locking mechanism cooperating with the guide wire is provided on the tailstock.

[0013] The following also provides several optional ways, but it is not an additional limitation to the above overall solution, but only a further supplement or preference. Without technical or logical contradictions, each optional way can be combined with the above overall solution alone, or multiple optional ways can be combined with each other.

[0014] Optionally, the inner wall of the second outer tube is provided with a second installation channel, and the optical fiber extends along the second installation channel.

[0015] Optionally, a sealant is poured into the radial gap between the second outer tube and the inner tube, and the optical fiber is embedded in the sealant.

[0016] Optionally, an intermediate channel communicating the first outlet and the second outlet is provided in the sealant.

[0017] Optionally, the guide wire further includes a body section and a guiding section connected to both ends of the plugging member, and the guiding section extends out of the distal end of the inner tube.

[0018] Optionally, in the first state, the length of the guiding section extending out of the distal end of the inner tube is 3 - 5 cm.

[0019] Optionally, the distal end of the inner tube has a reduced-diameter section with a gradually decreasing inner diameter. In the first state, the plugging member seals the reduced-diameter section.

[0020] Optionally, the plugging member is a cone with a gradually decreasing diameter from the proximal end to the distal end. In the first state, the distal end of the cone seals the distal end of the inner tube.

[0021] Optionally, the tailstock includes a first tailstock and a second tailstock that are detachably matched, the first tailstock being provided with a first interface communicating with the drug channel, the second tailstock being provided with a second interface communicating with the fluid channel, and an optical path interface corresponding to the optical fiber.

[0022] Optionally, the locking mechanism comprises a matching locking sleeve and a locking cap, a deformable member for locking the guide wire is arranged in the locking cap, one of the tailstock and the guide wire is connected to the locking sleeve, and the other is connected to the locking cap;

[0023] The connection mode is a fixed connection or a movable connection.

[0024] Optionally, the locking sleeve is fixedly connected to the tailstock, and the locking cap is movably connected to the guide wire; in the first state, the locking cap and the locking sleeve cooperate with each other and drive the deformable member to lock the guide wire.

[0025] The present application also provides an intravascular drug perfusion balloon catheter system, comprising:

[0026] An intravascular drug perfusion balloon catheter, using the intravascular drug perfusion balloon catheter;

[0027] a drug delivery device for supplying a fluid containing a drug to the drug passage;

[0028] a filling device, for supplying fluid to the fluid channel to inflate the balloon body;

[0029] A light source device is used to connect with the optical fiber light path.

[0030] Compared with the prior art, the intravascular drug perfusion balloon catheter provided by the present application has good luminescence uniformity, simple drug release, and is not prone to drug residue, which can effectively improve the treatment effect of vascular diseases. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 This is a schematic diagram of the structure of an intravascular drug perfusion balloon catheter in one embodiment of the present application;

[0032] Figure 2 A schematic diagram of the partial structure of an intravascular drug perfusion balloon catheter in one embodiment;

[0033] Figure 3 It is a schematic diagram of the distal structure of the intravascular drug perfusion balloon catheter in the first state;

[0034] Figure 4 It is a schematic diagram of the distal structure of the intravascular drug perfusion balloon catheter in the second state;

[0035] Figure 5 This is a schematic diagram of the structure of an inner tube, an optical fiber and a second outer tube in one embodiment;

[0036] Figure 6 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;

[0037] Figure 7 is a schematic structural diagram of a composite section in an embodiment;

[0038] Figure 8 is a schematic structural diagram of a composite section in another embodiment;

[0039] Fig. 9 This is a schematic diagram of the structure of an intravascular drug perfusion balloon catheter in one embodiment;

[0040] Fig.10 The present invention is a flow chart of a method for processing an intravascular drug perfusion balloon catheter in one embodiment.

[0041] The reference numerals in the figures are described as follows:

[0042] 100, intravascular drug perfusion 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, tail stock; 191, first interface; 192, second interface; 193, optical path interface; 194, stress release tube; 195, first tail stock; 196, second tail stock; 197, locking mechanism; 1971, locking sleeve; 1972, locking cap;

[0043] 200, light source device; 210, optical fiber connector; 220, optical fiber protective cover;

[0044] 1. Proximal end; 2. Distal end. DETAILED DESCRIPTION

[0045] 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.

[0046] 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.

[0047] 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.

[0048] See also Figures 1 to 9 An embodiment of the present application provides an intravascular drug perfusion balloon catheter 100, which has a proximal end 1 and a distal end 2 relative to each other. The intravascular drug perfusion balloon catheter 100 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 tail seat 190. 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.

[0049] 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.

[0050] The intravascular drug perfusion 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 intravascular drug perfusion 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.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] See also Figure 5 In the embodiment shown, the inner wall of the second outer tube 160 has 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 and affecting the light-emitting effect.

[0055] Since there is a gap between the inner tube 120 and the second outer tube 160, the drug is easily retained in the gap, 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 section, see Figure 6 .

[0056] To avoid affecting the luminous effect of the optical fiber 130, 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.

[0057] To ensure the smooth release of the drug, the sealant 170 has an intermediate channel 171 connecting the first outlet 123 and the second outlet 162. The intermediate channel 171 can be a straight channel, and its two ends are connected to the first outlet 123 and the second outlet 162. Figure 6 , the first outlet 123 and the second outlet 162 are aligned, the intermediate channel 171 extends along the radial direction of the composite section and is connected to 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 intermediate channel 171 can be set at an angle to the radial direction of the composite section, that is, the drug is released obliquely.

[0058] 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 171, 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 direction relative to the axial direction of the composite segment.

[0059] The composite section has an inner cavity and a side wall surrounding the inner cavity. The side wall is provided with a first outlet 123, a middle channel 171 and a second outlet 162 to form a liquid outlet. The shape of the liquid outlet affects the effect of drug release. Figure 7 , 8 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.

[0060] To control the drug release rate, the porosity of the composite segment is 40-70%, for example 50-70%, and for example 65%. Along the circumference of the composite segment, at least two drug outlet holes are provided between two adjacent optical fibers 130, for example, two drug outlet holes are provided, and the spacing between the two drug outlet holes is 0.5-1 mm.

[0061] See also Figure 3 , 4 In the illustrated embodiment, the guide wire 110 further includes a body section 111 and a guide section 113 respectively connected to both ends of the blocking member 112, wherein the proximal end of the body section 111 extends and is connected to the tailstock 190, and the guide section 113 extends out of the distal end of the inner tube 120. Considering the guiding effect of the guide wire 110, in the first state, the length of the guide section 113 extending out of the distal end of the inner tube 120 is 3 to 5 cm.

[0062] The guide section 113 is an elastic member, such as a spring, which is formed by winding a metal wire, the material of the metal wire is stainless steel or platinum tungsten, and the diameter of the metal wire is 0.01-0.05 mm, such as 0.03 mm. The body section 111 of the guide wire 110 is made of a metal wire, such as stainless steel, platinum tungsten or nickel-titanium alloy wire; the material of the blocking member 112 is metal, such as stainless steel.

[0063] The distal end of the inner tube 120 and the second outer tube 160 is also provided with a developing ring 180, and a plurality of developing rings 180 are usually provided at intervals, for example, Figure 3 Two developing rings 180 are fixed at intervals at the far end of the second outer tube 160 , and the positions of the two developing rings 180 correspond to the two ends of the axial direction of the light-emitting segment 131 respectively.

[0064] See also Figure 1 , 9 In the illustrated embodiment, the locking mechanism 197 includes a locking sleeve 1971 and a locking cap 1972 that match each other. A deformable member is disposed in the locking cap 1972, and the guide wire 110 can be locked by deforming the deformable member. One of the tailstock 190 and the guide wire 110 is connected to the locking sleeve 1971, and the other is connected to the locking cap 1972. The connection mode can be a fixed connection or a movable connection, and the movable connection is, for example, a threaded connection or a movable threading.

[0065] Specifically, for example, in one embodiment, the locking sleeve 1971 is fixedly connected to the tailstock 190, the locking cap 1972 has a through hole allowing the guide wire 110 to pass through, and the guide wire 110 is movably connected to the locking cap 1972. In the first state, the locking cap 1972 and the locking sleeve 1971 cooperate with each other and drive the deformable member to lock the guide wire 110.

[0066] See also Fig. 9In the illustrated embodiment, tailstock 190 comprises a first tailstock 1951 and a second tailstock 196 of detachable matching, the first tailstock 195 is provided with a first interface 191 that is communicated with medicine passage 121, and the second tailstock 196 is provided with a second interface 192 that is communicated with fluid passage 151 and an optical path interface 193 corresponding to optical fiber 130. Specifically, the first tailstock 195 and the second tailstock 196 are connected by a Luer connector. In addition, the proximal ends of interior tube 120, second outer tube 160 and optical fiber 130 are all connected to the second tailstock 196, and locking mechanism 197 is arranged on the first tailstock 195.

[0067] 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 .

[0068] See also Figure 1 , 9 One embodiment of the present application provides an intravascular drug perfusion balloon catheter system, including an intravascular drug perfusion balloon catheter 100, a drug delivery device, a filling device, and a light source device 200. The specific structure of the intravascular drug perfusion balloon catheter 100 is referred to the above content, which 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; the light source device 200 is used to be connected to the optical fiber 130 pipeline. Specifically, the drug delivery device supplies the fluid containing drugs to the drug channel 121 through the first interface 191, the filling device supplies the fluid to inflate the balloon body 140 to the fluid channel 151 through the second interface 192, and the light source is connected to the optical fiber 130 through the optical path interface 193.

[0069] The light source device 200 includes an optical fiber 130 connector 210 and an optical fiber protective sleeve 220. The optical fiber 130 extends into the optical fiber protective sleeve 220 and one end is connected to the optical fiber connector 210. The optical fiber protective sleeve 220 is made of TPU and can be used to protect the optical fiber 130 from bending.

[0070] See also Fig.10 An embodiment of the present application provides a method for processing an intravascular drug perfusion balloon catheter 100, wherein the intravascular drug perfusion 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, and the processing method includes:

[0071] 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;

[0072] Step S200, arranging and fixing the optical fiber 130 along the outer circumference of the inner tube 120 to obtain a second preform;

[0073] 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;

[0074] 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.

[0075] 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.

[0076] In step S200, a plurality of optical fibers 130, for example, four optical fibers 130, are fixed at intervals along the outer circumference of the inner tube 120. The optical fibers 130 can be fixed by gluing or welding. 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 as the light-emitting segment 131. The stripping method can be physical stripping (for example, 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 the light emission.

[0077] In step S300, when the first preform is sleeved and fixed on the outer periphery of the second preform, the second outer tube 160 is sleeved on the outer periphery of the light-emitting segment 131. The connection between the second outer tube 160 and the balloon body 140 is sealed with the outer wall of the inner tube 120, and the free section of the second outer tube 160 is sealed with 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.

[0078] 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.

[0079] 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.

[0080] 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 160, the sealant 170 and the inner tube 120 are penetrated in sequence to form a liquid outlet. The power of the laser drilling is 300-500mW, for example, 300-400mW, and for example, 320mW. Medical catheter laser drilling equipment can be used for drilling holes, such as the medical catheter drilling machine of Chuangxuan Laser. By setting different drilling shapes and sizes, circular holes and slit holes can be punched on the catheter, and 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, different shapes of liquid outlets can be obtained by setting different walking paths of the laser head. Furthermore, the composite section is provided with two rows of liquid outlets in the area between two adjacent optical fibers 130.

[0081] The intravascular drug perfusion balloon catheter 100 also includes a guide wire 110 slidably inserted into the inner tube 120, and the guide wire 110 includes a guide segment 113, a blocking piece 112 and a main body segment 111 which are 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 main body segment 111 extends out of the proximal end of the inner tube 120.

[0082] The intravascular drug perfusion balloon catheter 100 also includes a tail seat 190 , and 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 .

[0083] The intravascular drug infusion 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.

[0084] When the tailstock 190 is a detachable structure, the inner tube 120, the optical fiber 130 and the proximal end of the first outer tube 150 can be fixed to the second tailstock 196190 in advance, and the locking sleeve 1971 can be fixed to the first tailstock 195190 in advance; in step S500, the portion where the proximal end of the guide wire 110 extends out of the first tailstock 195190 is passed through the locking cap 1972.

[0085] The intravascular drug perfusion balloon catheter 100 provided in the present application has good luminous uniformity, simple drug release, and is not prone to drug residue, which can effectively improve the treatment effect of vascular diseases.

[0086] 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.

[0087] 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. An intravascular drug infusion balloon catheter having opposed distal and proximal ends, It is characterized in that The intravascular drug perfusion balloon catheter comprises: A guide wire having an occluding member fixed at a distal portion thereof; an inner tube, slidably sleeved on the outer periphery of the guide wire, the inner tube having a first state and a second state, in the first state, the blocking member seals the distal end of the inner tube, and in the second state, the guide wire moves toward the proximal end, and the blocking member releases the seal on the inner tube, the inner tube having a drug channel, and a first outlet communicating with the drug channel is opened at the distal end of the inner tube; An optical fiber extends along the outside of the inner tube and has a light-emitting section at a distal end of the inner tube; A balloon body is disposed on the outer periphery of the inner tube, and a distal end of the balloon body is sealed and connected to the outer wall of the inner tube; A first outer tube is disposed on the outer periphery of the inner tube and is connected to the proximal end of the balloon body, wherein a radial gap between the first outer tube and the inner tube serves as a fluid channel for inflating the balloon body; a second outer tube, which is located at the outer periphery of the inner tube and wraps the light-emitting segment of the optical fiber, wherein both ends of the second outer tube are sealedly connected to the outer periphery of the inner tube, and the second outer tube is provided with a second outlet communicated with the drug channel; A tail stock, the inner tube, the optical fiber and the proximal ends of the first outer tube are all connected to the tail stock, the tail stock is provided with a first interface connected to the drug channel, a second interface connected to the fluid channel, and an optical path interface corresponding to the optical fiber, the proximal end of the guide wire extends out of the tail stock, and the tail stock is provided with a locking mechanism that cooperates with the guide wire.

2. The intravascular drug perfusion balloon catheter according to claim 1, It is characterized in that The inner wall of the second outer tube is provided with a second installation channel, and the optical fiber extends along the second installation channel.

3. The intravascular drug perfusion balloon catheter according to claim 1, It is characterized in that A sealant is poured into the radial gap between the second outer tube and the inner tube, and the optical fiber is buried in the sealant; The sealant has a middle channel communicating with the first outlet and the second outlet.

4. The intravascular drug perfusion balloon catheter according to claim 1, It is characterized in that The guide wire further includes a body section and a guide section connected to both ends of the blocking member, and the guide section extends out of the distal end of the inner tube; In the first state, the guide section extends out of the distal end of the inner tube by 3 to 5 cm.

5. The intravascular drug perfusion balloon catheter according to claim 1, It is characterized in that The inner tube has a diameter-reducing section at the distal end thereof with a gradually decreasing inner diameter. In the first state, the blocking member seals the diameter-reducing section.

6. The intravascular drug perfusion balloon catheter according to claim 1, It is characterized in that The blocking member is a cone with a gradually decreasing diameter from the proximal end to the distal end. In the first state, the distal end of the cone seals the distal end of the inner tube.

7. The intravascular drug perfusion balloon catheter according to claim 1, It is characterized in that The tailstock comprises a first tailstock and a second tailstock which are detachably matched, the first tailstock is provided with a first interface communicating with the drug channel, the second tailstock is provided with a second interface communicating with the fluid channel, and an optical path interface corresponding to the optical fiber; The inner tube, the first outer tube and the proximal end of the optical fiber are all connected to the second tailstock.

8. The intravascular drug perfusion balloon catheter according to claim 1, It is characterized in that The locking mechanism comprises a locking sleeve and a locking cap which match each other, a deformable member for locking the guide wire is arranged in the locking cap, one of the tailstock and the guide wire is connected to the locking sleeve, and the other is connected to the locking cap; The connection mode is a fixed connection or a movable connection.

9. The intravascular drug perfusion balloon catheter according to claim 8, It is characterized in that The locking sleeve is fixedly connected to the tailstock, and the locking cap is movably connected to the guide wire; In the first state, the locking sleeve and the locking cap cooperate with each other and drive the deformable member to lock the guide wire.

10. Intravascular drug infusion balloon catheter system, It is characterized in that include: The intravascular drug perfusion balloon catheter according to any one of claims 1 to 9; a drug delivery device for supplying a fluid containing a drug to the drug passage; a filling device, for supplying fluid to the fluid channel to inflate the balloon body; A light source device is used to connect with the optical fiber light path.

Images