Balloon catheter

Abstract

The balloon catheter comprises a catheter base, a catheter body, a balloon, an indentation wire and an elastic tube, a medicine coating is arranged on the outer surface of the balloon, the near end of the catheter body is fixed in the catheter base, the balloon is arranged on the far end side of the catheter body, the near end of the elastic tube is fixed in the catheter body, and the indentation wire is arranged on the outer surface of the balloon. The far end of the elastic tube spans the balloon and then is fixed to the far end of the catheter, the nick wire can be arranged in the elastic tube, the catheter and the catheter base in a penetrating mode, and the nick wire can move relative to the elastic tube, the catheter and the catheter base. And the balloon is fully expanded to drive the elastic tube and the nick wire to deform. Through the arrangement of the nick wire and the elastic tube, the balloon not only has the excellent blood vessel dilatation performance of a nick balloon, but also has the function of preventing blood vessel restenosis of a medicine balloon. The use of instruments is reduced, the burden of an operation patient is reduced, the operation time is shortened, and the operation safety is improved.

Description

Technical Field

[0001] The invention relates to the field of interventional medicine, and in particular to a balloon catheter. Background Art

[0002] Interventional therapy is an emerging discipline that has developed rapidly in recent years and integrates imaging diagnosis and clinical treatment. It has now become one of the three major clinical pillars alongside traditional internal medicine and surgery. Among them, peripheral balloon dilatation catheters are mainly used for peripheral arterial disease (PAD). Interventional therapy has the advantages of minimally invasive, simple operation, definite efficacy, and repeatable operation, and is the development direction of diagnosis and treatment of vascular diseases. Percutaneous transluminal angioplasty (PTA) is currently a common method for treating AOS. Its basic principle is to cause excessive stretching of the vascular wall, rupture of the vascular intima and media, and rupture of atherosclerotic plaques through balloon dilatation, thereby reducing the tension of the vascular wall and expanding the lumen. Subsequently, the bare balloon catheter is withdrawn and the drug balloon is reinserted. The anti-proliferative drug is quickly released to the vascular wall through balloon dilatation, inhibiting the growth of the new intima in the blood vessel, thereby reducing the occurrence of restenosis.

[0003] In actual clinical applications, when treating the corresponding stenotic lesions, doctors generally need to use a bare balloon catheter to pre-dilate the lesion area, and then switch to drug balloon dilation treatment after completing the pre-dilation to achieve the best treatment effect. However, this invisibly increases the use of equipment types and increases the duration of surgery, which places a heavy financial burden on patients. If drug balloon dilation is used alone, it may cause drug loss, which is not conducive to the long-term efficacy of the lesion area. At the same time, the drug balloon may hesitate and scratch during transportation or during surgery, causing drug loss, which in turn leads to a decrease in treatment effect. Summary of the invention

[0004] In order to overcome the problems existing in the prior art, the present invention provides a novel balloon catheter.

[0005] The solution to the technical problem of the present invention is to provide a balloon catheter, which includes a catheter seat, a catheter, a balloon, a notched wire and an elastic tube, wherein the outer surface of the balloon is provided with a drug coating, the proximal end of the catheter is fixed in the catheter seat, the balloon is arranged on the distal side of the catheter, the proximal end of the elastic tube is fixed in the catheter, and the distal end of the elastic tube is fixed to the distal end of the catheter after crossing the balloon, the notched wire can be passed through the elastic tube, the catheter and the catheter seat, and the notched wire can move relative to the elastic tube, the catheter and the catheter seat, and the inflation and expansion of the balloon can drive the elastic tube and the notched wire to deform.

[0006] In some embodiments of the present invention, the elastic tube is made of one or a combination of polyurethane, latex, and silicone materials. The wall thickness of the elastic tube ranges from 0.1 mm to 0.2 mm, and the scoring wire is made of a metal material or a polymer material.

[0007] In some embodiments of the present invention, the catheter includes a catheter body, an inner tube, and a tip. The proximal end of the catheter body is fixed within the catheter seat. The proximal end of the balloon is connected to the distal end of the catheter body, and the distal end of the balloon is connected to the tip. The inner tube passes through the catheter body, and the distal end of the inner tube extends out of the distal end of the catheter body, passes through the inside of the balloon, and is connected to the proximal end of the tip.

[0008] In some embodiments of the present invention, a first guide wire cavity and a filling cavity that penetrate from the proximal end face to the distal end face of the catheter body are provided within the catheter body. The filling cavity is in communication with the inside of the balloon. A first scoring wire cavity that penetrates from the proximal end face of the catheter body to the distal outer surface is also provided within the catheter body.

[0009] In some embodiments of the present invention, the tip is provided with a second guide wire cavity that penetrates from the proximal end face to the distal end face. The proximal end of the inner tube is received within the first guide wire cavity, and the distal end of the inner tube is received within the second guide wire cavity. The tip is also provided with a second scoring wire cavity that penetrates from the proximal outer surface to the distal end face. The proximal end of the elastic tube is fixed within the first scoring wire cavity, and the distal end of the elastic tube is fixed within the second scoring wire cavity.

[0010] In some embodiments of the present invention, a portion of the scoring wire is disposed within the first scoring wire cavity, the elastic tube, and the second scoring wire cavity, and the distal end of the scoring wire is always exposed beyond the distal end of the second scoring wire cavity before the balloon is filled.

[0011] In some embodiments of the present invention, the number of the elastic tubes is multiple, and the multiple elastic tubes are uniformly arranged in the circumferential direction of the balloon. The projection of the elastic tube on the balloon is parallel to the axial direction of the balloon.

[0012] In some embodiments of the present invention, the number of the elastic tubes is multiple, and the multiple elastic tubes are uniformly arranged in the circumferential direction of the balloon. The projection of the elastic tube on the balloon is angled with respect to the axial direction of the balloon. The proximal end of one elastic tube coincides with the distal end of an adjacent elastic tube in the projection on the cross-section of the balloon catheter perpendicular to its longitudinal central axis. The distal end of this elastic tube coincides with the proximal end of another adjacent elastic tube in the projection on the cross-section of the balloon catheter perpendicular to its longitudinal central axis.

[0013] In some embodiments of the present invention, the elastic tube spirally extends from the proximal end to the distal end of the balloon, and a first notch wire cavity is provided in the catheter body, which penetrates from the proximal end face of the catheter body to the distal outer surface, and the first notch wire cavity is coaxially arranged with the catheter body.

[0014] In some embodiments of the present invention, a guiding portion is provided at the distal end of the first notch wire cavity. The proximal end of the elastic tube is connected to the distal end of the guiding portion, and the proximal end of the guiding portion is connected to the distal end of the first notch wire cavity. The guiding portion is an arc-shaped structure or a spiral structure. The proximal end of the guiding portion is coaxially arranged with the first notch wire cavity, and the tangential direction of the distal end of the guiding portion is the same as the tangential direction of the proximal end of the elastic tube.

[0015] Compared with the prior art, a balloon catheter and a delivery system of the present invention have the following advantages: The notch wire can provide a supporting effect for the elastic tube, thereby ensuring that the elastic tube can continuously abut against the blood vessel wall. Therefore, after the balloon is inflated and expanded, the elastic tube and the notch wire can expand the diseased area, so that the blood vessel lumen in the diseased area is restored to patency. When the elastic tube and the notch wire can expand the diseased area, due to the supporting effect of the notch wire, the balloon does not contact the inner wall of the blood vessel. Therefore, it can be avoided that the drug on the balloon is scraped off by the blood vessel wall in the non-diseased area when expanding the blood vessel wall, thereby ensuring that more drugs act on the diseased position and improving the treatment effect of the balloon catheter. Through the arrangement of the notch wire and the elastic tube, the balloon has both excellent blood vessel expansion performance of a notched balloon and the function of a drug balloon to prevent blood vessel restenosis. During the operation, the use of instruments can be reduced, the cost can be saved, the burden on the surgical patient can be reduced, the operation time can be shortened, and the safety of the operation can be improved. Description of the Drawings

[0016] Figure 1 is a three-dimensional structural schematic diagram of the balloon catheter provided by an embodiment of the present invention.

[0017] Figure 2 is Figure 1 the enlarged view at A in

[0018] Figure 3 is a schematic diagram of the balloon filling state of the balloon catheter provided by an embodiment of the present invention.

[0019] Figure 4 is a schematic diagram of the combined state of the balloon, the elastic member, and the tip head of the balloon catheter provided by an embodiment of the present invention.

[0020] Figure 5 is a schematic cross-sectional structure diagram of the catheter of the balloon catheter provided by an embodiment of the present invention.

[0021] Figure 6It is a schematic three-dimensional structure diagram of another embodiment of the balloon catheter provided by the embodiment of the present invention.

[0022] Figure 7 It is a schematic cross-sectional structure diagram of the balloon of another embodiment of the balloon catheter provided by the embodiment of the present invention.

[0023] Figure 8 It is a schematic three-dimensional structure diagram of another embodiment of the balloon catheter provided by the embodiment of the present invention.

[0024] Description of the reference numerals in the drawings:

[0025] 100. Balloon catheter; 11. Catheter hub; 12. Catheter; 13. Balloon; 14. Notch wire; 15. Elastic tube; 121. Catheter body; 122. Tip head; 1211. First guide wire lumen; 1212. Inflation lumen; 1213. First notch wire lumen; 1221. Second guide wire lumen; 1222. Second notch wire lumen. Detailed implementation manners

[0026] Hereinafter, the exemplary embodiments of the present invention will be described in more detail with reference to the drawings. Although the exemplary embodiments of the present invention are shown in the drawings, it should be understood that the present invention can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided so that the present invention can be more thoroughly understood and the scope of the present invention can be fully conveyed to those skilled in the art.

[0027] It should be understood that the terms used herein are only for the purpose of describing specific exemplary embodiments and are not intended to be limiting. Unless otherwise clearly indicated in the context, the singular forms "a", "an", and "the" as used herein may also include the plural forms. The terms "comprising", "including", "containing", and "having" are inclusive and thus specify the presence of the stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring them to be performed in the particular order described or illustrated, unless the order of performance is explicitly stated. It should also be understood that additional or alternative steps may be used.

[0028] Although terms such as first, second, third, etc. may be used herein to describe multiple elements, components, regions, layers, and / or sections, these elements, components, regions, layers, and / or sections should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or section from another region, layer, or section. Unless the context clearly indicates otherwise, terms such as "first", "second", and other numerical terms do not imply an order or sequence when used herein. Thus, the first element, component, region, layer, or section discussed below may be referred to as the second element, component, region, layer, or section without departing from the teachings of the exemplary embodiments.

[0029] For ease of description, spatial relative relationship terms may be used herein to describe the relationship of one element or feature shown in the figures to another element or feature, such as "inner", "outer", "inside", "outside", "below", "beneath", "above", "over", etc. Such spatial relative relationship terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is flipped, an element described as "below" or "beneath" another element or feature will then be oriented "above" or "over" the other element or feature. Thus, the exemplary term "below" can include both upward and downward orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions) and the spatial relative relationship descriptors used herein are to be interpreted accordingly.

[0030] To more clearly describe the structure of the present application, the terms "proximal end" and "distal end" are defined herein as conventional terms in the field of interventional medicine. Specifically, the "distal end" refers to the end away from the operator during the surgical operation, the "proximal end" refers to the end close to the operator during the surgical operation, the "axial direction" refers to its length direction, and the "radial direction" refers to the direction perpendicular to the "axial direction".

[0031] Please refer to Figure 1 and Figure 2 , an embodiment of the present invention provides a balloon catheter 100, the balloon catheter 100 includes a catheter hub 11, a catheter 12, a balloon 13, a scoring wire 14, and an elastic tube 15, and a drug coating is provided on the outer surface of the balloon 13. It can be understood that the balloon 13 in the embodiment of the present invention is a drug balloon, the balloon 13 can be a semi-compliant balloon, and an anti-proliferative drug and a hydrophilic coating are coated on the surface of the balloon 13. The main function of the drug is to prevent vascular endothelial regeneration and thus prevent vascular restenosis. The drug can be rapamycin, paclitaxel, etc.

[0032] The proximal end of the catheter 12 is fixedly mounted within the catheter hub 11. The balloon 13 is disposed at the distal end of the catheter 12. The proximal end of the elastic tube 15 is fixedly mounted within the catheter 12, and the distal end of the elastic tube 15 is fixedly mounted at the distal end of the catheter 12 via the balloon 13. The scoring wire 14 is disposed within the catheter 12, the elastic tube 15, and the catheter hub 11, and the scoring wire 14 is movable relative to the catheter 12, the elastic tube 15, and the catheter hub 11. The inflation and expansion of the balloon 13 drives the elastic tube 15 and the scoring wire 14 to deform.

[0033] It should be noted that the balloon catheter 100 provided in the embodiment of the present invention is particularly suitable for treating atherosclerosis. During the treatment of atherosclerosis, atherosclerotic plaques are attached to the outer layer of the inner wall of the blood vessel. First, the atherosclerotic plaques need to be dilated to cause the atherosclerotic plaques to rupture, and then the drug balloon is brought into contact with the atherosclerotic plaques, so that the drug can penetrate into the atherosclerotic plaques and reach the diseased area of the diseased blood vessel wall. The balloon catheter 100 of the present invention will be described in detail by taking the operation of treating atherosclerosis as an example.

[0034] Specifically, when the balloon catheter 100 is in use, the sheath and the guide wire can be first inserted into the body according to the position of the diseased area measured by angiography. Subsequently, the balloon catheter 100 is pushed along the guide wire to the diseased position. Then, the doctor can inflate the balloon 13 through the catheter hub 11, so that the balloon 13 is inflated and expanded. After the balloon 13 is inflated and expanded, as Figure 3As shown, the elastic tube 15 outside the balloon 13 first contacts the atherosclerotic plaque of the diseased blood vessel. Since the notched wire 14 is placed in the elastic tube 15, the notched wire 14 can provide a supporting effect for the elastic tube 15, thereby ensuring that the elastic tube 15 can continuously abut against the atherosclerotic plaque. At the same time, since the contact area between the notched wire 14 and the atherosclerotic plaque is small, during the expansion of the balloon 13, the force applied to the atherosclerotic plaque will be focused on the notched wire 14. Therefore, the elastic tube 15 and the notched wire 14 can expand the atherosclerotic plaque more accurately and quickly. When the elastic tube 15 and the notched wire 14 can apply pressure to the atherosclerotic plaque, due to the supporting effect of the notched wire 14 and the accurate and rapid pressure applied by the notched wire 14 to the atherosclerotic plaque, the balloon 13 does not contact the outer layer of the blood vessel wall when the notched wire 14 acts on the atherosclerotic plaque. Therefore, it can be avoided that the drug on the balloon 13 is scraped off by the outer atherosclerotic plaque when the blood vessel wall is expanded, thereby avoiding the drug from not being able to act on the diseased area. After the notched wire 14 and the elastic tube 15 complete the expansion of the diseased area, the notched wire 14 can be withdrawn from the proximal end of the catheter hub 11. The notched wire 14 will follow the elastic tube 15 and the catheter 12, and finally be withdrawn from the proximal end of the catheter hub 11. At this time, since the elastic tube 15 is not supported by the notched wire 14, it will be driven by the balloon 13 and then closely adhere to the atherosclerotic plaque or the diseased area, so that the balloon 13 can completely fit on the diseased blood vessel wall, thereby ensuring that the drug coating on the outer surface of the balloon 13 can penetrate the atherosclerotic plaque and be fully released into the pre-expanded diseased blood vessel wall, thereby ensuring the treatment effect of the balloon catheter 100. At the same time, after the notched wire 14 and the elastic tube 15 are provided, the notched wire 14 and the elastic tube 15 will protrude from the outer surface of the balloon 13. Therefore, it can also be avoided that during the transportation of the balloon catheter 100, the balloon 13 rubs against the packaging, etc., and the drug is scraped off from the outer surface of the balloon 13. Through the setting of the notched wire 14 and the elastic tube 15, the balloon 13 has both the excellent blood vessel expansion performance of the notched balloon and the function of the drug balloon to prevent blood vessel restenosis. During the operation, the use of instruments can be reduced, the cost can be saved, the burden on the surgical patient can be reduced, the operation time can be shortened, and the safety of the operation can be improved. For example, it is not necessary to first expand the blood vessel diseased area with an expansion balloon, then withdraw the expansion balloon, and then send the drug balloon into the blood vessel diseased area.

[0035] It should be noted that the material of the catheter 12 is one or a mixture of two of PEBAX and nylon materials. The material of the balloon 13 is one or a mixture of multiple of polyurethane, nylon, polyethylene, and PEBAX materials. The elastic tube 15 is made of one or a mixture of multiple of polyurethane, latex, and silicone materials, thereby ensuring that the elastic tube 15 has good biocompatibility and good elasticity, and further ensuring that the elastic tube 15 can adaptively deform with the shape change of the balloon 13 when it is inflated or deflated. The wall thickness of the elastic tube 15 is 0.1 mm to 0.2 mm to balance the strength and elasticity of the elastic tube 15. Further, the notched wire 14 can be made of a metal material. For example, the notched wire 14 can be made of stainless steel or nitinol alloy materials, thereby ensuring the support of the notched wire 14. The notched wire 14 can also be made of a polymer material. For example, the notched wire 14 can be made of materials such as nylon, PEBAX, polylactic acid, polyethylene, polyurethane, and silicone rubber, making the notched wire 14 balance support and light weight, and also having a certain elasticity, so that the notched wire 14 deforms more smoothly.

[0036] Please refer to FIG. Figures 3 to 5 , the catheter 12 includes a catheter body 121 and a tip 122. The proximal end of the catheter body 121 is fixed in the catheter seat 11. The proximal end of the balloon 13 is connected to the distal end of the catheter body 121, and the distal end of the balloon 13 is connected to the tip 122. A first guide wire cavity 1211 and a filling cavity 1212 that penetrate from the proximal end face to the distal end face of the catheter body 121 are provided in the catheter body 121. The first guide wire cavity 1211 and the filling cavity 1212 are connected to the inside of the balloon 13. A first notched wire cavity 1213 that penetrates from the proximal end face to the distal outer surface of the catheter body 121 is also provided in the catheter body 121. The tip 122 is provided with a second guide wire cavity 1221 that penetrates from the proximal end face to the distal end face of the tip 122. The tip 122 is also provided with a second notched wire cavity 1222 that penetrates from the proximal outer surface to the distal end face of the tip 122. The proximal end of the elastic tube 15 is fixed in the first notched wire cavity 1213, and the distal end of the elastic tube 15 is fixed in the second notched wire cavity 1222.

[0037] Specifically, the catheter 12 further includes an inner tube (not shown in the figure). The distal end of the inner tube enters and is fixed in the second guide wire cavity 1221 after passing through the first guide wire cavity 1211 and the cavity inside the balloon 13, and the proximal end of the inner tube is fixed in the first guide wire cavity 1211. The inner tube, the first guide wire cavity 1211, and the second guide wire cavity 1221 provide a passage for the guide wire, so that the balloon catheter 100 can be threaded on the guide wire and move along the guide wire to the lesion site. The filling cavity 1212 is used for the liquid to fill the balloon 13 to pass through. That is, by filling the liquid into the filling cavity 1212, the filling liquid will flow along the filling cavity 1212 to reach inside the balloon 13, and then the balloon 13 will be filled and expanded. The first scoring wire cavity 1213 penetrates from the proximal end face of the catheter body 121 to the distal outer surface, and the second scoring wire cavity 1222 penetrates from the proximal outer surface of the tip 122 to the distal end face. Therefore, the distal end of the elastic tube 15 enters the proximal end of the second scoring wire cavity 1222 through the outer surface of the tip 122, and the proximal end of the elastic tube 15 enters the first scoring wire cavity 1213 through the outer surface of the distal end of the catheter body 121. Therefore, the first scoring wire cavity 1213, the second scoring wire cavity 1222 are not communicated with the cavity inside the balloon 13, and the first scoring wire cavity 1213 and the second scoring wire cavity 1222 do not affect the filling of the balloon 13.

[0038] It should be noted that the fixing method of the elastic tube 15 with the first scoring wire cavity 1213 and the second scoring wire cavity 1222 can be by glue dotting and curing, hot melting or laser welding, etc.

[0039] The first notch wire cavity 1213, the elastic tube 15, and the second notch wire cavity 1222 together form the storage space and the movement channel of the notch wire 14. When assembling the notch wire 14 onto the balloon catheter 100, first insert the proximal end of the notch wire 14 into the distal end of the second notch wire cavity 1222, and then push the notch wire 14 so that the proximal end of the notch wire 14 passes through the second notch wire cavity 1222, the elastic tube 15, and the first notch wire cavity 1213 and enters the catheter hub 11. The proximal end of the notch wire 14 is exposed at the proximal end of the catheter hub 11, and the doctor can directly pull the proximal end of the notch wire 14 to withdraw the notch wire 14 from the human body. At the same time, the distal end of the notch wire 14 is exposed at the distal end of the second notch wire cavity 1222. This design is because when the balloon 13 is inflated and expanded, it will drive the notch wire 14 to produce a radial deformation. After the notch wire 14 produces a radial deformation, it will cause the notch wire 14 to simultaneously move axially. To ensure that after the balloon 13 is fully inflated, the distal end of the notch wire 14 will not move into the elastic tube 15, and to ensure that the entire elastic tube 15 still houses the notch wire 14 without any cavity parts, thereby ensuring the expansion ability of the balloon catheter 100 and preventing the drug coating on the balloon 13 from being scratched off. Therefore, in this embodiment, before the balloon 13 is inflated, the distal end of the notch wire 14 needs to be always exposed at the distal end of the second notch wire cavity 1222. It should be noted that after the balloon 13 is inflated, the notch wire 14 can also be exposed at the distal end of the second notch wire cavity 1222, as long as it is ensured that the distal end of the notch wire 14 does not move into the elastic tube 15 after the balloon 13 is inflated.

[0040] It should be noted that the catheter body 121, the tip 122, and the balloon 13 can be coaxially arranged to ensure the overall coaxial arrangement of the balloon catheter 100. Further, the first guide wire cavity 1211 can be coaxially arranged with the catheter body 121. The second guide wire cavity 1221 can be coaxially arranged with the tip 122, so that the first guide wire cavity 1211 and the second guide wire cavity 1221 are coaxially arranged. The first notch wire cavity 1213 and the inflation cavity 1212 can be arranged on the periphery of the first guide wire cavity 1211, and the second notch wire cavity 1222 can be arranged on the periphery of the second guide wire cavity 1221. The outer wall of the inner tube is in close contact with the inner walls of the first guide wire cavity 1211 and the second guide wire cavity 1221 to ensure that the inflation fluid in the balloon 13 does not flow into the gap between the inner tube and the first guide wire cavity 1211 or the second guide wire cavity 1221.

[0041] Please continue to refer to Figures 3 to 5, the number of the elastic tubes 15 is multiple, and the multiple elastic tubes 15 are uniformly arranged in the circumferential direction of the balloon 13. The projection of the elastic tube 15 on the balloon 13 is parallel to the axial direction of the balloon 13. Making the projection of the elastic tube 15 on the balloon 13 parallel to the axial direction of the balloon 13 can make the force required for the notch wire 14 to deform smaller when the balloon 13 is filled, and can also make the elastic potential energy of the elastic tube 15 smaller after deformation, ensuring the smoothness when the balloon 13 is filled and expanded. In a specific embodiment of the present invention, the number of the elastic tubes 15 is at least 3, and the number of the corresponding notch wires 14 is at least 3 to ensure the overall stability and expansion ability of the balloon 13 when dilating blood vessels. It should be noted that the number of the elastic tubes 15, the notch wires 14, the first notch wire cavity 1213, and the second notch wire cavity 1222 is the same, so as to ensure that one notch wire 14 correspondingly passes through one first notch wire cavity 1213, one elastic tube 15, and one second notch wire cavity 1222. When the number of the first notch wire cavities 1213 and the second notch wire cavities 1222 is multiple, the multiple first notch wire cavities 1213 can be uniformly arranged in the first guide wire cavity 1211 and the second notch wire cavity 1222. The number of the notch wires 14 and the elastic tubes 15 can be adaptively set according to actual needs. For example, if a stronger expansion ability is required, the number of the notch wires 14 and the elastic tubes 15 can be adaptively increased. If more drugs need to be coated on the surface of the balloon 13, the number of the notch wires 14 and the elastic tubes 15 can be adaptively reduced to increase the drug coating area. Drugs can also be directly coated on the elastic tube 15, so that when the elastic tube 15 and the notch wire 14 are expanded, some drugs that are not scraped off can be carried and directly act on the lesion area.

[0042] It should be noted that since the material of the balloon 13 is one or a mixture of polyurethane, nylon, polyethylene, and PEBAX materials, the balloon 13 made of the above materials has weak deformation ability, that is, the balloon 13 hardly produces elastic deformation when filled, and the balloon 13 hardly expands. Therefore, during the expansion process, the balloon 13 will not deform and protrude between two adjacent elastic tubes 15 and the notch wires 14, further avoiding the situation that the balloon 13 protrudes from the elastic tubes 15 and the notch wires 14 and contacts the atherosclerotic plaque during the expansion process.

[0043] Please refer to FIG. Figures 6 to 7, in other specific embodiments of the present invention, the projection of the elastic tube 15 on the balloon 13 may also be arranged at an angle with respect to the axial direction of the balloon 13. The proximal end of one elastic tube 15 coincides with the distal end of the adjacent elastic tube 15 on the projection of the balloon catheter 100 on a cross-section perpendicular to its longitudinal central axis. The distal end of this elastic tube 15 coincides with the proximal end of another adjacent elastic tube 15 on the projection of the balloon catheter 100 on a cross-section perpendicular to its longitudinal central axis. Specifically, taking the number of the notch wires 14 and the elastic tubes 15 as 3 as an example, after the balloon 13 is axially cut and laid flat as shown in Figure 7 , the proximal end B of the left elastic tube 15 is arranged close to the proximal end of the balloon 13. After the left elastic tube 15 is arranged at an angle with respect to the axial direction, the distal end C of the left elastic tube 15 is arranged on the distal end of the balloon 13. The proximal end D of the middle elastic tube 15 is arranged close to the proximal end of the balloon 13. The connection line between the proximal end D of the middle elastic tube 15 and the distal end C of the left elastic tube 15 is parallel to the axial direction of the balloon 13. After the middle elastic tube 15 is arranged at an angle with respect to the axial direction, the distal end E of the middle elastic tube 15 is arranged on the distal end of the balloon 13. The proximal end F of the right elastic tube 15 is arranged close to the proximal end of the balloon 13. The connection line between the proximal end F of the right elastic tube 15 and the distal end E of the middle elastic tube 15 is parallel to the axial direction of the balloon 13. The distal end G of the right elastic tube 15 is arranged close to the distal end of the balloon 13. After the flat balloon in the figure is re-closed to form the three-dimensional balloon 13, the connection line between the proximal end B of the left elastic tube 15 and the distal end F of the right elastic tube 15 is parallel to the axial direction of the balloon 13. Through the above arrangement, the projection lengths of the plurality of elastic tubes 15 in the axial direction are exactly the circumference of the balloon 13. When the adjacent two elastic tubes 15 are projected axially, they are connected end to end, thereby ensuring that the notch wires 14 and the elastic tubes 15 are arranged around the entire 360 degrees of the balloon 13. After the balloon 13 is expanded, the notch wires 14 can expand the vascular lesion area in all directions within the elastic tubes 15, thereby enhancing the expansion effect and performance of the balloon 13.

[0044] Please refer to Figure 4 , Figure 5 and Figure 8, in other specific embodiments of the present invention, the number of the elastic tube 15 and the notched wire 14 is 1, and the elastic tube 15 spirally extends from the proximal end to the distal end of the balloon 13. A first notched wire cavity 1213 is provided in the catheter body 121 and penetrates from the proximal end face of the catheter body 121 to the distal outer surface. The first notched wire cavity 1213 is coaxially arranged with the catheter body 121, that is, the first notched wire cavity 1213 is on the central axis of the catheter body 121.

[0045] Specifically, after the elastic tube 15 spirally extends from the proximal end to the distal end of the balloon 13 for multiple turns, the distal end of the elastic tube 15 is fixed in the second notched wire cavity 1222. By spirally extending the elastic tube 15 on the balloon 13, only one notched wire 14 is needed to expand the vascular lesion position more comprehensively in the axial and circumferential directions. The coaxial arrangement of the first notched wire cavity 1213 and the catheter body 121 facilitates the withdrawal of the notched wire 14 from the body. When the notched wire 14 needs to be withdrawn, the proximal end of the notched wire 14 can be rotated so that the distal end of the notched wire 14 can retreat along the spiral track of the elastic tube 15 until the distal end of the notched wire 14 retreats into the first notched wire cavity 1213, and then the notched wire 14 can be pulled to move it proximally, thereby withdrawing the notched wire 14 from the body. At the same time, since the first notched wire cavity 1213 is coaxially arranged with the catheter body 121 and the first notched wire cavity 1213 is on the central axis of the catheter body 121, when the notched wire 14 is rotated, the notched wire 14 will only rotate itself relative to the catheter body 121 and will not rotate around the central axis of the catheter body 121, thereby ensuring the feasibility of the above solution.

[0046] It should be noted that, in this embodiment, the first guide wire cavity 1211 and the filling cavity 1212 are arranged on the periphery of the first notched wire cavity 1213. The second notched wire cavity 1222 can be omitted. The distal end of the elastic tube 15 is a closed port, and the distal end of the elastic tube 15 is arranged on the distal end of the balloon 13 without being arranged on the tip, thereby reducing the deformation of the notched wire 14 between the tip 122 and the distal end of the balloon 13, that is, reducing the deformed part of the notched wire 14, so that the notched wire 14 can retreat more smoothly. The number of turns of the elastic tube 15 spirally wound on the balloon 13 should not be too many to avoid affecting the area of the drug coated on the balloon 13. In this embodiment, the elastic tube 15 spirally winds around the balloon 13 for two and a half turns, thereby taking into account the expansion ability of the balloon catheter 100 and the area of the drug coated on the balloon 13.

[0047] In this embodiment, to further ensure the smoothness of the withdrawal of the notched wire 14 from the human body, a guiding portion (not shown in the figure) is provided at the distal end of the first notched wire cavity 1213. The proximal end of the elastic tube 15 is connected to the distal end of the guiding portion, the proximal end of the guiding portion is connected to the distal end of the first notched wire cavity 1213, and the guiding portion is an arc-shaped structure. The proximal end of the guiding portion is coaxially arranged with the first notched wire cavity 1213, and the tangential direction of the distal end of the guiding portion is the same as the tangential direction of the proximal end of the elastic tube 15.

[0048] Specifically, to prevent the angle between the notched wire 14 in the form of a helix and the first notched wire cavity 1213 from being too large when the notched wire 14 enters the first notched wire cavity 1213, which may cause the notched wire 14 to get stuck at the distal end of the first notched wire cavity 1213. A guiding portion is provided at the distal end of the first notched wire cavity 1213, and the tangential direction of the distal end of the guiding portion is the same as the tangential direction of the proximal end of the elastic tube 15, which can ensure that when the notched wire 14 enters the guiding portion, there is no angle between the notched wire 14 and the distal end of the guiding portion, so that the notched wire 14 can smoothly enter the guiding portion. Since the guiding portion is an arc-shaped structure, the notched wire 14 can smoothly pass through the guiding portion along a smooth arc-shaped trajectory. By coaxially arranging the proximal end of the guiding portion with the first notched wire cavity 1213, it is ensured that when the notched wire 14 in the guiding portion enters the first notched wire cavity 1213, there is no angle between the notched wire 14 and the first notched wire cavity 1213, making the notched wire 14 enter the first notched wire cavity 1213 more smoothly.

[0049] In other specific embodiments of the present invention, the guiding portion can also be a spiral structure, which can ensure that when the notched wire 14 rotates and withdraws from the human body, the rotation of the notched wire 14 is smoother.

[0050] Compared with the prior art, a balloon catheter and a delivery system of the present invention have the following advantages: The scoring wire can provide a supporting effect for the elastic tube, thereby ensuring that the elastic tube can continuously abut against the blood vessel wall. Therefore, after the balloon is inflated and deployed, the elastic tube and the scoring wire can expand the diseased area, so that the blood vessel lumen of the diseased area is restored to patency. When the elastic tube and the scoring wire can expand the diseased area, due to the supporting effect of the scoring wire, the balloon does not contact the inner wall of the blood vessel. Therefore, it can be avoided that the drug on the balloon is scraped off by the blood vessel wall in the non-diseased area when expanding the blood vessel wall, thereby ensuring that more drugs act on the diseased position and improving the treatment effect of the balloon catheter. Through the arrangement of the scoring wire and the elastic tube, the balloon has both excellent blood vessel expansion performance of a scored balloon and the function of a drug balloon to prevent blood vessel restenosis. During the operation, the use of instruments can be reduced, the cost can be saved, the burden on the surgical patient can be reduced, the operation time can be shortened, and the safety of the operation can be improved.

[0051] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, and improvements made within the principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. A balloon catheter, characterized in that: The balloon catheter includes a catheter hub, a catheter, a balloon, a scoring wire, and an elastic tube. A drug coating is provided on the outer surface of the balloon. The proximal end of the catheter is fixed within the catheter hub. The balloon is disposed on the distal side of the catheter. The proximal end of the elastic tube is fixed within the catheter, and the distal end of the elastic tube extends across the balloon and is fixed to the distal end of the catheter. The scoring wire can be threaded through the elastic tube, the catheter, and the catheter hub, and the scoring wire can move relative to the elastic tube, the catheter, and the catheter hub. When the balloon is inflated and expanded, it can drive the elastic tube and the scoring wire to deform.

2. The balloon catheter according to claim 1, wherein: The elastic tube is made of one or a mixture of polyurethane, latex, and silicone materials. The wall thickness of the elastic tube ranges from 0.1 mm to 0.2 mm. The scoring wire is made of a metal material or a polymer material.

3. The balloon catheter according to claim 1, wherein: The catheter includes a catheter body, an inner tube, and a tip. The proximal end of the catheter body is fixed within the catheter hub. The proximal end of the balloon is connected to the distal end of the catheter body, and the distal end of the balloon is connected to the tip. The inner tube passes through the catheter body, and the distal end of the inner tube extends out of the distal end of the catheter body, passes through the interior of the balloon, and is connected to the proximal end of the tip.

4. The balloon catheter according to claim 3, wherein: A first guide wire lumen and a filling lumen that extends from the proximal end face to the distal end face of the catheter body are provided within the catheter body. The filling lumen is in communication with the interior of the balloon. A first scoring wire lumen that extends from the proximal end face to the distal outer surface of the catheter body is also provided within the catheter body.

5. The balloon catheter according to claim 4, characterized in that: The tip is provided with a second guide wire lumen that extends from the proximal end face to the distal end face. The proximal end of the inner tube is received within the first guide wire lumen, and the distal end of the inner tube is received within the second guide wire lumen. The tip is also provided with a second scoring wire lumen that extends from the proximal outer surface to the distal end face. The proximal end of the elastic tube is fixed within the first scoring wire lumen, and the distal end of the elastic tube is fixed within the second scoring wire lumen.

6. The balloon catheter according to claim 5, characterized in that: Part of the scoring wire is disposed within the first scoring wire lumen, the elastic tube, and the second scoring wire lumen, and the distal end of the scoring wire is always exposed beyond the distal end of the second scoring wire lumen before the balloon is inflated.

7. The balloon catheter according to claim 1, wherein: The number of the elastic tubes is multiple. The multiple elastic tubes are evenly arranged circumferentially on the balloon. The projection of the elastic tube on the balloon is parallel to the axial direction of the balloon.

8. The balloon catheter according to claim 1, wherein: The number of the elastic tubes is multiple. The multiple elastic tubes are evenly arranged circumferentially on the balloon. The projection of the elastic tube on the balloon is angled with respect to the axial direction of the balloon. The projection of the proximal end of one elastic tube coincides with the projection of the distal end of an adjacent elastic tube on a cross-section of the balloon catheter perpendicular to its longitudinal central axis. The projection of the distal end of this elastic tube coincides with the projection of the proximal end of another adjacent elastic tube on a cross-section of the balloon catheter perpendicular to its longitudinal central axis.

9. The balloon catheter according to claim 3, wherein: The elastic tube spirally winds and extends from the proximal end to the distal end of the balloon. A first notch wire cavity is provided in the catheter body, which penetrates from the proximal end face of the catheter body to the distal outer surface, and the first notch wire cavity is coaxially arranged with the catheter body.

10. The balloon catheter according to claim 9, wherein: A guiding portion is provided at the distal end of the first notch wire cavity. The proximal end of the elastic tube is connected to the distal end of the guiding portion, and the proximal end of the guiding portion is connected to the distal end of the first notch wire cavity. The guiding portion is an arc-shaped structure or a spiral structure. The proximal end of the guiding portion is coaxially arranged with the first notch wire cavity, and the tangential direction of the distal end of the guiding portion is consistent with the tangential direction of the proximal end of the elastic tube.

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