Balloon catheter

Abstract

The balloon catheter comprises a balloon, an inner tube, a conveying tube and an outer tube, the inner tube and the conveying tube are sleeved with the outer tube, the far end of the inner tube is exposed out of the far end of the outer tube, the near end of the balloon is connected with the outer tube, the far end of the balloon is connected with the inner tube, and the inner tube is connected with the inner tube. A concave part which is concave inwards is arranged on the circumferential surface of the balloon, the near end of the conveying pipe and the inner pipe are arranged side by side in parallel, and the far end of the conveying pipe is connected with the concave part. According to the balloon catheter, the conveying pipe and the concave part are arranged, so that the functionality of the balloon catheter is improved, for example, the balloon catheter can achieve the functions of medicine feeding, animal modeling, glue feeding and the like, meanwhile, the feeding dosage and position of reagents such as medicine and glue can be controlled, waste caused by the fact that the reagents act on non-lesion areas is avoided, and the service life of the balloon catheter is prolonged. Therefore, the effect of accurately and accurately releasing the reagent is achieved.

Description

Technical Field

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

[0002] Peripheral vascular disease includes diseases of the arterial and venous systems. Arterial disease is usually caused by deposits (plaques) containing fat and cholesterol attached to the walls of arterial blood vessels. This process is called atherosclerosis. Atherosclerosis can cause arterial narrowing, resulting in reduced blood flow through the arteries. Atherosclerosis can affect arterial vessels throughout the body. If atherosclerosis occurs in the arteries that supply blood to the limbs, it will cause peripheral arterial disease. Patients with peripheral arterial disease (PAD) have insufficient blood supply to the upper and lower limbs (commonly in the lower limbs) to meet the body's needs, which may cause symptoms such as upper limb pain, leg muscle pain when walking, leg cramps, and difficulty walking. If peripheral arterial disease worsens, pain may also occur when resting or lying down, and the pain may interrupt sleep. At the same time, plaque accumulation in the arteries may also affect blood vessels in the heart and brain, causing strokes and heart attacks. Venous disease usually includes venous compression syndrome, deep vein thrombosis, etc.

[0003] A balloon catheter is usually needed to treat atherosclerosis. By filling the balloon, the atherosclerotic plaque and diseased blood vessels are expanded to restore smooth blood circulation in the blood vessels. Existing balloon catheters have a single function. For example, the dilation balloon can only play a dilation role, and the drug balloon can only enter the human body to act on the lesion after the dilation balloon has expanded the lesion. At the same time, the existing drug balloons usually coat the drug on the balloon surface, so the drug may act on the non-lesion area and cause waste. Summary of the invention

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

[0005] The solution to the technical problem of the present invention is to provide a balloon catheter, which includes a balloon, an inner tube, a delivery tube and an outer tube. The outer tube is sleeved on the inner tube and the delivery tube, the distal end of the inner tube is exposed at the distal end of the outer tube, the proximal end of the balloon is connected to the outer tube, the distal end of the balloon is connected to the inner tube, a recessed portion recessed inwardly is provided on the circumferential surface of the balloon, the proximal end of the delivery tube is arranged side by side and in parallel with the inner tube, and the distal end of the delivery tube is connected to the recessed portion and communicated with the recessed portion.

[0006] In some embodiments of the present invention, there are two recessed portions, which are arranged on opposite sides of the balloon; there are two delivery tubes, which are arranged on opposite sides of the inner tube; and the distal end of one delivery tube is connected to a recessed portion.

[0007] In some embodiments of the present invention, the recessed portion includes an arc-shaped portion and a straight tube portion, one end of the straight tube portion is smoothly connected to the distal end of the delivery tube, and the other end of the straight tube portion is connected to one end of the arc-shaped portion, and the diameter of the arc-shaped portion gradually decreases from the outer surface of the balloon to the inner side of the balloon.

[0008] In some embodiments of the present invention, the balloon catheter includes a catheter seat and an expansion structure, the expansion structure includes a tubular woven mesh structure woven with metal wires, the expansion structure can be sleeved on the balloon, and the proximal ends of the inner tube, delivery tube and outer tube are fixed in the catheter seat.

[0009] In some embodiments of the present invention, the balloon catheter also includes an operating component, which includes a connector, a sleeve and an operating part, the sleeve is movably mounted on the outer tube, the proximal end of the sleeve passes through the catheter seat and is exposed outside the catheter seat, the operating part is connected to the proximal end of the sleeve, the proximal end of the connector is connected to the distal end of the sleeve, and the distal end of the connector is connected to the proximal end of the expansion structure.

[0010] In some embodiments of the present invention, the proximal end of the expansion structure is fixedly connected to the connecting piece, or the proximal end of the expansion structure is tightly sleeved on the outer tube after being pre-shaped, and the connecting piece is detachably connected to the proximal end of the expansion structure.

[0011] In some embodiments of the present invention, the operating component also includes a support rod and a positioning ring, the proximal end of the support rod is connected to the distal end of the sleeve, the distal end of the support rod is connected to the positioning ring, and the positioning ring is movably mounted on the outer tube, and the positioning ring can support the proximal end of the expansion structure.

[0012] In some embodiments of the present invention, the balloon catheter also includes a support assembly, which includes a deformable rod, a connecting head and a pushing rod. The distal side of the deformable rod is deformable, the proximal end of the deformable rod is connected to the distal end of the connecting head, and the proximal end of the connecting head is connected to the distal end of the pushing rod; the distal end of the support assembly can enter from the proximal end of the delivery tube, pass through the straight tube portion and the arc-shaped portion, and support the deformable rod on the arc-shaped portion.

[0013] In some embodiments of the present invention, there are multiple deformable rods, and the multiple deformable rods are evenly arranged on the circumference of the connector, and the distal ends of the multiple deformable rods extend in a smooth arc shape in a direction away from the central axis of the connector.

[0014] In some embodiments of the present invention, the support assembly also includes a coating, the distal end of the deformable rod is connected to the coating, the coating covers the arc portion, and the coating includes a plurality of reinforcing rods arranged on the coating, one ends of the plurality of reinforcing rods converge at a central position of the coating, and the other ends of the plurality of reinforcing rods are evenly dispersed around the circumference of the coating.

[0015] Compared with the prior art, a balloon catheter of the present invention has the following advantages: the present invention improves the functionality of the balloon catheter by setting a delivery tube and the recessed portion. For example, the drug can be injected from the proximal end of the delivery tube, and the drug will flow out from the recessed portion and act on the lesion position corresponding to the recessed portion, thereby achieving the drug delivery function and accurately delivering the drug. For example, the recessed portion is aligned with the lesion position in the blood vessel, and the drug is accurately acted on the lesion position, thereby avoiding the drug from acting on the non-lesion area and causing the waste of the drug. At the same time, the drug dosage can also be accurately controlled to avoid excessive drug delivery. The delivery tube and the recessed portion can also play the role of animal modeling. For example, the puncture needle can be inserted into the delivery tube and passed out of the balloon from the recessed portion, thereby causing a fixed-point injury to the blood vessel to build an animal model of vascular injury. The delivery tube can also deliver glue, and the glue is delivered to the damaged position of the blood vessel through the recessed portion, and the blood flow will not be flushed to the recessed portion, thereby ensuring that the blood flow will not affect the coagulation of the glue. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0017] Figure 2 It is a perspective structural schematic diagram of a balloon, an inner tube, an outer tube, and a delivery tube of a balloon catheter provided in an embodiment of the present invention.

[0018] Figure 3 It is a perspective structural schematic diagram of the balloon catheter after being filled provided by an embodiment of the present invention.

[0019] Figure 4 It is a perspective structural schematic diagram of a balloon catheter after being filled provided by another embodiment of the present invention.

[0020] Figure 5 It is a perspective structural diagram of a balloon filled with a balloon catheter with an expansion structure provided by an embodiment of the present invention.

[0021] Figure 6 yes Figure 1 Enlarged view of point A in the middle.

[0022] Figure 7 It is a schematic diagram of the expansion structure of the balloon catheter and the withdrawal process of the operating component provided by an embodiment of the present invention.

[0023] Figure 8 It is a perspective schematic diagram of the balloon filling of the balloon catheter with an expansion structure and a support component provided by an embodiment of the present invention.

[0024] Fig. 9 It is a schematic diagram of the three-dimensional structure of the support assembly of the balloon catheter provided by an embodiment of the present invention.

[0025] Fig.10 It is a schematic diagram of the three-dimensional structure of the support assembly of the balloon catheter provided by an embodiment of the present invention from another angle.

[0026] Fig.11 It is a perspective structural schematic diagram of the retraction process of the support assembly of the balloon catheter provided by an embodiment of the present invention.

[0027] Fig.12 yes Fig.11 Enlarged view of point B in the middle.

[0028] Fig.13 It is a schematic diagram of the coating and reinforcing rod structure of the balloon catheter provided by an embodiment of the present invention.

[0029] Fig.14 It is a schematic diagram of the three-dimensional structure of the covering and reinforcing rod of the balloon catheter provided by an embodiment of the present invention after contraction.

[0030] Explanation of the accompanying drawings: 100, balloon catheter; 11, balloon; 12, inner tube; 13, delivery tube; 14, outer tube; 111, recessed portion; 112, first blocking portion; 113, second blocking portion; 15, catheter seat; 16, expansion structure; 17, operating component; 171, connector; 172, sleeve; 173, operating portion; 174; 175, positioning ring; 1111, arc portion; 1112, straight tube portion; 18, support component; 181, coating; 182, deformation rod; 183, connector; 184, push rod; 1811, reinforcement rod. DETAILED DESCRIPTION

[0031] The exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present invention are shown in the accompanying drawings, it should be understood that the present invention can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided in order to enable a more thorough understanding of the present invention and to fully convey the scope of the present invention to those skilled in the art.

[0032] It should be understood that the terms used herein are only for the purpose of describing specific example embodiments and are not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms "one", "an" and "said" as used herein may also be meant to include plural forms. The terms "include", "comprise", "contain", and "have" are inclusive, and therefore specify the existence of stated features, steps, operations, elements and / or parts, but do not exclude the existence or addition of one or more other features, steps, operations, elements, parts, and / or combinations thereof. The method steps, processes, and operations described herein are not interpreted as necessarily requiring them to be performed in the specific order described or illustrated, unless the execution order is clearly indicated. It should also be understood that additional or alternative steps may be used.

[0033] Although the terms first, second, third, etc. can be used in the text 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 can only be used to distinguish an element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates, terms such as "first", "second" and other numerical terms do not imply order or sequence when used in the text. Therefore, the first element, component, region, layer or section discussed below can be referred to as the second element, component, region, layer or section without departing from the teaching of the example embodiments.

[0034] For ease of description, spatial relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figure, such as "inside", "outside", "inner side", "outer side", "below", "below", "above", "above", etc. Such spatial relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figure. For example, if the device in the figure is turned over, then the elements described as "below other elements or features" or "below other elements or features" will subsequently be oriented as "above other elements or features" or "above other elements or features". Therefore, the example term "below..." can include both upper and lower orientations. The device can be oriented otherwise (rotated 90 degrees or in other directions) and the spatial relative descriptors used in the text are interpreted accordingly.

[0035] In order to more clearly describe the structure of the present application, the terms "proximal end" and "distal end" are defined herein as commonly used terms in the field of interventional medicine. Specifically, "distal end" refers to the end away from the operator during the surgical operation, "proximal end" refers to the end close to the operator during the surgical operation, "axial" refers to its length direction, and "radial" refers to the direction perpendicular to the "axial" direction.

[0036] Please refer to Figure 1 and Figure 2 , an embodiment of the present invention provides a balloon catheter 100, which includes a balloon 11, an inner tube 12, a delivery tube 13, and an outer tube 14. The outer tube 14 is sleeved on the inner tube 12 and the delivery tube 13, and the distal end of the inner tube 12 is exposed outside the distal end of the outer tube 14. The proximal end of the balloon 11 is connected to the outer tube 14, the distal end of the balloon 11 is connected to the inner tube 12, and an inwardly concave recess 111 is provided on the circumferential surface of the balloon 11. The proximal end of the delivery tube 13 is arranged side by side and parallel to the inner tube 12, and the distal end of the delivery tube 13 is connected to the recess 111.

[0037] Specifically, the distal end of the delivery tube 13 is smoothly curved towards the radial direction of the balloon 11, and a through hole is formed on the circumferential surface of the balloon 11, and this through hole is recessed inward and sealedly connected to the distal end of the delivery tube 13, thereby forming the recess 111. Through the delivery tube 13, it can be communicated to the circumferential surface of the balloon 11, that is, it can enter the delivery tube 13 from the proximal end of the delivery tube 13, and after passing through the recess 111, it moves to the outside of the balloon 11. By providing the delivery tube 13 and the recess 111, the functionality of the balloon catheter 100 is improved. For example, drugs can be injected from the proximal end of the delivery tube 13, and the drugs will flow out from the recess 111 and act on the lesion position corresponding to the recess 111, thereby achieving the drug delivery function and accurately delivering drugs. For example, the recess 111 is aligned with the lesion position in the blood vessel, and the drugs are accurately acted on the lesion position, thereby avoiding the waste of drugs caused by the drugs acting on non-lesion areas. At the same time, the drug dose can also be accurately controlled to avoid over-delivery of drugs. The arrangement of the delivery tube 13 and the recess 111 can also play a role in animal modeling. For example, a puncture needle can be inserted into the delivery tube 13 and passed through the recess 111 to penetrate outside the balloon 11, thereby causing a fixed-point injury to the blood vessel to build an animal model of blood vessel injury.

[0038] It should be noted that the distal end of the delivery tube 13 is smoothly curved towards the radial direction of the balloon 11 and extends a small section, thereby avoiding hindering the contraction of the balloon 11. Since the recess 111 is formed by the self-recession of the balloon 11, the recess 111 does not prevent the contraction of the balloon 11.

[0039] Furthermore, after the balloon 11 is inflated, due to the existence of the recess 111, the balloon 11 will expand and expand to as Figure 3As shown, the balloon 11 located at the distal end of the recessed portion 111 has a first blocking portion 112 that fits the blood vessel wall, and the balloon 11 located at the proximal end of the recessed portion 111 has a second blocking portion 113 that fits the blood vessel wall, thereby ensuring the effect of the balloon 11 in blocking the blood in the blood vessel and preventing the blood flow from scouring the recessed portion 111. Therefore, the delivery tube 13 can also deliver glue, and the glue is delivered to the location of the damaged blood vessel through the recessed portion 111, and the blood flow will not be scour to the recessed portion 111, thereby ensuring that the blood flow will not affect the solidification of the glue. After the glue solidifies, the balloon 11 can be depressurized and withdrawn from the body. When the delivery tube 13 delivers drugs, the drugs will not be scoured by the blood flow, thereby ensuring that the drugs can be fully released at the lesion location, reducing the loss of drugs. When the delivery tube 13 delivers other devices, it can also prevent the blood flow from affecting the function of the device.

[0040] It should be noted that the balloon catheter 100 of the present invention is particularly suitable for the delivery of glue. This is because the existing method of delivering glue to damaged blood vessels is to clamp the blood vessels with a vascular clamp, or to deliver a blocking balloon into the blood vessels to block the blood flow in the blood vessels, and then introduce a catheter specifically for delivering glue to the lesion site to inject glue into the damaged blood vessels. The existing method has cumbersome steps and requires the use of more instruments, which leads to higher surgical risks, longer surgical time, and higher surgical costs. The present invention releases the glue directly through the delivery tube 13 and the recessed portion 111 after the balloon 11 is filled. The operation is simple, and the use of instruments can be reduced, saving costs, and the effect of releasing glue at a fixed point can be achieved.

[0041] See also Figure 4 In other specific embodiments of the present invention, the number of the recessed parts 111 is two, and the two recessed parts 111 are arranged at two opposite sides of the balloon 11. The number of the delivery tubes 13 is two, and the two delivery tubes 13 are arranged at two opposite sides of the inner tube 12, and the distal end of one delivery tube 13 is connected to one recessed part 111. Through the above arrangement, the effect of bidirectional fixed-point delivery can be achieved.

[0042] For further information, please refer to Figures 1 to 3, to further improve the versatility of the balloon catheter 100, the balloon catheter 100 further includes a catheter hub 15 and an expansion structure 16. In a specific embodiment of the present invention, the expansion structure 16 includes a tubular braided mesh structure woven from metal wires. The expansion structure 16 is sleeved on the balloon 11, and the proximal ends of the inner tube 12, the delivery tube 13, and the outer tube 14 are fixed in the catheter hub 15. The provision of the expansion structure 16 enables the balloon 11 to have the function of dilating blood vessels, especially for the dilation of relatively hard atherosclerotic plaques. In the present invention, taking the dilation of atherosclerotic plaques as an example, a detailed description is given. Specifically, the expansion structure 16 can be woven from a metal material with good elasticity. For example, the expansion structure 16 is woven from nitinol wires. The reticular expansion structure 16 has good ductility. Therefore, when the balloon 11 is inflated and expanded, the expansion structure 16 can follow the inflation and expansion of the balloon 11 and then undergo adaptive deformation, so that the expansion structure 16 is always sleeved on the balloon 11, such as Figure 5 shown. The expansion structure 16 will first contact the atherosclerotic plaque of the diseased blood vessel, and the expansion structure 16 made of metal material has good support, so the expansion structure 16 can continuously resist the atherosclerotic plaque. At the same time, compared with the method of expanding by fitting the balloon on the atherosclerotic plaque, since the expansion structure 16 is a braided mesh structure woven from metal wires, the contact area between the expansion structure 16 and the atherosclerotic plaque is small. During the expansion process of the balloon 11, the pressure applied to the atherosclerotic plaque will be concentrated on the expansion structure 16. Therefore, through the provision of the expansion structure 16, the atherosclerotic plaque can be easily and quickly expanded. After the expansion is completed, the balloon 11 can be deflated. After the balloon 11 is deflated, it shrinks, and the expansion structure 16 shrinks along with the shrinkage of the balloon 11.

[0043] In other specific embodiments of the present invention, the expansion structure 16 may further include a distal ring, a proximal ring, and a plurality of metal wires. The plurality of metal wires are made of a metal material with good elasticity, such as nitinol wire. The distal ends of the metal wires are connected to the distal ring, the proximal ends of the metal wires are connected to the proximal ring, and the plurality of metal wires are evenly arranged on the distal ring and the proximal ring. The distal ring is sleeved on the distal side of the balloon 11, and the proximal ring is sleeved on the proximal side of the balloon 11, that is, the plurality of metal wires will be arranged on the outer surface of the balloon 11 along the distal end to the proximal end of the balloon. When the balloon 11 is inflated and expanded, the plurality of metal wires will deform as the balloon 11 is inflated and expanded, and the metal wires will first contact the atherosclerotic plaque of the diseased blood vessel and continuously resist the atherosclerotic plaque. At the same time, since the contact area between the metal wire and the atherosclerotic plaque is small, during the expansion process of the balloon 11, the pressure applied to the atherosclerotic plaque will be focused on the metal wire. Therefore, the atherosclerotic plaque can be easily and quickly expanded by the arrangement of the expansion structure 16.

[0044] Please refer to Figure 1 and Figure 6 , to ensure that the expansion structure 16 will not affect the release of drugs or devices at the diseased location after passing through the recess 111, so the expansion structure 16 is movably sleeved on the balloon 11, and the balloon catheter 100 further includes an operating component 17 for withdrawing the expansion structure 16 from the surface of the balloon 11. The operating component 17 includes a connecting piece 171, a sleeve 172, and an operating part 173. The sleeve 172 is movably sleeved on the outer tube 14, that is, the sleeve 172 can move relative to the outer tube 14. The proximal end of the sleeve 172 passes through the catheter seat 15 and is exposed outside the catheter seat 15. The operating part 173 is connected to the proximal end of the sleeve 172, the proximal end of the connecting piece 171 is connected to the distal end of the sleeve 172, and the distal end of the connecting piece 171 is connected to the proximal end of the expansion structure 16.

[0045] Specifically, when it is necessary to withdraw the expansion structure 16 from the surface of the balloon 11, move the operating part 173 proximally. The movement of the operating part 173 will drive the sleeve 172 to move proximally. The movement of the sleeve 172 will drive the connecting piece 171 to move proximally. The movement of the connecting piece 171 will further drive the expansion structure 16 to move proximally, such as Figure 7As shown until the expansion structure 16 leaves the surface of the balloon 11. At this time, drugs, glue, instruments, etc. can be delivered through the delivery tube 13 and the recess 111. It is also possible to first withdraw the operation assembly 17 and the expansion structure 16 out of the human body through the catheter hub 15 and from the proximal end of the catheter hub 15, and then deliver drugs, glue, instruments, etc. through the delivery tube 13 and the recess 111 to ensure that the expansion structure 16 does not affect the release of drugs or instruments.

[0046] It should be noted that after the balloon 11 is filled and expanded, since the proximal and distal ends of the balloon 11 are not filled and expanded, the portions of the expansion structure 16 sleeved on the proximal and distal ends of the balloon 11 will not adhere to the blood vessel wall as the balloon 11 is filled. However, the proximal end of the expansion structure 16 may be slightly expanded around as the middle part of the expansion structure 16 unfolds. If the proximal end of the expansion structure 16 is slightly expanded, it may affect the entry of the expansion structure 16 into the catheter hub 15, and further affect the withdrawal of the expansion structure 16 from the human body. Therefore, the connecting member 171 can be fixedly connected to the proximal end of the expansion structure 16, and the connecting member 171 generates a restraint on the proximal end of the expansion structure 16 to ensure that the portion of the proximal end of the expansion structure 16 connected to the distal end of the connecting member 171 does not deform and expand, so as to ensure that the proximal end of the expansion structure 16 can smoothly enter the catheter hub 15. When the proximal end of the expansion structure 16 smoothly enters the catheter hub 15, due to the good ductility of the expansion structure 16, at this time, by continuing to pull the operation part 173, the entire expansion structure 16 can be withdrawn into the catheter hub 15 and withdrawn from the proximal end of the catheter hub 15 out of the human body. Further, a pre-forming method can also be adopted, such as thermally forming the proximal end of the expansion structure 16 into a shape similar to the size of the outer tube 14, and then pre-forming the proximal end of the expansion structure 16 to be closely sleeved on the outer tube 14, so as to avoid the expansion of the proximal end of the expansion structure 16. The expansion structure 16 made by the pre-forming method can be detachably matched with the connecting member 171, thereby improving the functionality of the balloon catheter 100. For example, when it is necessary to leave the expansion structure 16 in the body, the connecting member 171 can be disengaged from the expansion structure 16, and then the operation assembly 17 can be withdrawn from the human body, leaving the expansion structure 16 in the body.

[0047] In a specific embodiment of the present invention, the connecting member 171 can be made of a metal material, such as the connecting member 171 can be a nitinol wire, a stainless steel rod, etc. The connecting member 171 can also be a medical suture, and is connected to the proximal end of the expansion structure 16 by tying a knot or looping.

[0048] Further, please continue to refer to Figure 1 and Figure 6 , when the balloon catheter 100 is delivered to the lesion site, to avoid a large resistance on the expansion structure 16, which may cause a tendency to move proximally, and further cause the connecting member 171 to bend and break or the expansion structure 16 to move proximally. The operating assembly 17 further includes a support rod 174 and a positioning ring 175. The proximal end of the support rod 174 is connected to the distal end of the sleeve 172, the distal end of the support rod 174 is connected to the positioning ring 175, and the positioning ring 175 is movably sleeved on the outer tube 14. The positioning ring 175 can abut against the proximal end of the expansion structure 16, thereby positioning the expansion structure 16 and preventing the expansion structure 16 from moving proximally. And the support rod 174 has strong support. Through the support of the support rod 174, the connecting member 171 can be prevented from being damaged.

[0049] Please refer to Figure 5 , Figures 8 to 10 , the recessed portion 111 includes an arc portion 1111 and a straight tube portion 1112. One end of the straight tube portion 1112 is smoothly and transitionally connected to the distal end of the delivery tube 13 to ensure the smoothness when the instrument enters the straight tube portion 1112 from the delivery tube 13. The other end of the straight tube portion 1112 is connected to one end of the arc portion 1111. The diameter of the arc portion 1111 gradually decreases from the outer surface of the balloon 11 to the inner side of the balloon 11. Due to the existence of the recessed portion 111, when the balloon 11 expands, the position of the expansion structure 16 corresponding to the recessed portion 111 is not supported by the balloon 11, which may cause the lesion position corresponding to the recessed portion 111 to not expand smoothly. Therefore, the balloon catheter 100 further includes a support assembly 18. The support assembly 18 includes a film 181, a deformation rod 182, a connection head 183, and a push rod 184. The distal end of the deformation rod 182 is connected to the film 181, the proximal end of the deformation rod 182 is connected to the distal end of the connection head 183, and the proximal end of the connection head 183 is connected to the distal end of the push rod 184. The distal end of the support assembly 18 can enter from the proximal end of the delivery tube 13, pass through the straight tube portion 1112 and the arc portion 1111 and unfold the film 181 to cover the arc portion 1111. Through the support of the deformation rod 182 for the film 181 and the support of the film 181 for the expansion structure 16, the support force of the expansion structure 16 corresponding to the recessed portion 111 can be filled.

[0050] Specifically, please combine Fig. 9 and Fig.10, the material of the film 181 can be PET or PTFE, the deformation rod 182 is made of metal material, and the deformation rod 182 takes into account both elasticity and supportability. For example, the deformation rod 182 can be a rod-shaped structure made of nitinol alloy. The number of the deformation rods 182 is multiple, and the multiple deformation rods 182 are evenly arranged in the circumferential direction of the connection head 183 to ensure that the deformation rods 182 can provide more supporting force to the film 181, and also ensure that the deformation rods 182 provide uniform supporting force to the film 181 to prevent the film 181 from tilting after being stressed. The distal ends of the multiple deformation rods 182 extend in a smooth arc shape away from the central axis of the connection head 183 and are connected to the film 181. The distal ends of the deformation rods 182 can deform in the direction close to the central axis of the connection head 183, thereby driving the film 181 to contract. During use, the film 181 and the deformation rods 182 can be compressed and then enter the proximal end of the delivery tube 13, and then the push rod 184 is pushed towards the distal end, so that the film 181 and the deformation rods 182 gradually unfold after entering the arc portion 1111 until the film 181 and the deformation rods 182 are completely unfolded. At this time, the film 181 covers the recessed portion 111. When it is necessary to retract the support assembly 18, the push rod 184 is pulled towards the proximal end, and the deformation rods 182 move towards the proximal end and are resisted by the inner wall of the arc portion 1111, and then gradually deform along the curvature of the arc portion 1111. After the deformation rods 182 are deformed, the central position of the film 181 is driven to contract inwards, as Fig.11 and Fig.12 shown, so that the film 181 contracts and retracts into the arc portion 1111 and the straight tube portion 1112. At this time, when the push rod 184 is continuously pulled, the support assembly 18 can be withdrawn from the human body.

[0051] It should be noted that the diameter of the arc portion 1111 gradually decreases from the outer surface of the balloon 11 to the inner side of the balloon 11, which can ensure that the deformation rods 182 are deformed smoothly and can also ensure that the deformation rods 182 enter the straight tube portion 1112 more smoothly. The curvature of the deformation rods 182 can also be set to be the same as the curvature of the arc portion 1111, so that after the deformation rods 182 are unfolded, the surface of the deformation rods 182 facing the arc portion 1111 can completely fit on the arc portion 1111, so that the arc portion 1111 can provide more supporting force to the deformation rods 182, and the deformation rods 182 can provide more supporting force to the film. At the same time, setting the curvature of the deformation rods 182 to be the same as the curvature of the arc portion 1111 can further improve the smoothness of the deformation rods 182 entering the straight tube portion 1112.

[0052] It should be noted that the film coating 181 can also be omitted, and the expansion structure 16 can be directly supported by the deformation rod 182.

[0053] Please refer to Fig.13 and Fig.14 , to further improve the supporting force of the film coating 181, a plurality of reinforcing rods 1811 are arranged on the film coating 181. One ends of the plurality of reinforcing rods 1811 converge at the central position of the film coating 181, and the other ends of the plurality of reinforcing rods 1811 are evenly dispersed in the circumferential direction of the film coating 181. The reinforcing rods 1811 can be fixed on the film coating 181 by sewing. The reinforcing rods 1811 can be placed on the film coating 181, and then a layer of film is attached to the reinforcing rods 1811, so as to ensure that the reinforcing rods 1811 are fixed on the film coating 181. The reinforcing rods 1811 can provide more support to the expansion structure 16 to ensure the expansion performance of the balloon catheter 100. At the same time, when the film coating 181 shrinks and retracts into the arc portion 1111, the central position of the film coating 181 first contracts towards the position of the deformation rod 182. Since the reinforcing rods 1811 are arranged on the film coating 181 and one ends of the plurality of reinforcing rods 1811 converge at the central position of the film coating 181, the reinforcing rods 1811 can also ensure that when the film coating 181 shrinks, it first starts to shrink from the central position where the plurality of reinforcing rods 1811 converge on the film coating 181. As Fig.14 shown, it can ensure that the film coating 181 can more smoothly enter the arc portion 1111 and the straight pipe portion 1112 when shrinking.

[0054] Compared with the prior art, a balloon catheter of the present invention has the following advantages: By providing the delivery tube and the recess, the functionality of the balloon catheter is improved. For example, drugs can be injected from the proximal end of the delivery tube, and the drugs will flow out from the recess and act on the lesion position corresponding to the recess, so as to achieve the drug delivery function and accurately deliver drugs. For example, the recess is aligned with the lesion position in the blood vessel, and the drugs are accurately acted on the lesion position, so as to avoid the waste of drugs caused by the drugs acting on non-lesion areas. At the same time, the drug dosage can also be accurately controlled to avoid over-delivery of drugs. The provision of the delivery tube and the recess can also play a role in animal modeling. For example, a puncture needle can be inserted into the delivery tube and penetrate out of the balloon from the recess, so as to perform a fixed-point injury on the blood vessel to build an animal model of blood vessel injury. The delivery tube can also deliver glue, and the glue is delivered to the damaged position of the blood vessel through the recess, and the blood flow will not wash to the recess, so as to ensure that the blood flow will not affect the coagulation of the glue.

[0055] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the principles of the present invention shall fall within the protection scope of the present invention.

Claims

1. A balloon catheter, characterized in that: The balloon catheter includes a balloon, an inner tube, a delivery tube, and an outer tube. The outer tube is sleeved on the inner tube and the delivery tube. The distal end of the inner tube is exposed outside the distal end of the outer tube. The proximal end of the balloon is connected to the outer tube, and the distal end of the balloon is connected to the inner tube. An inwardly concave recess is provided on the circumferential surface of the balloon. The proximal end of the delivery tube is arranged side by side and parallel to the inner tube, and the distal end of the delivery tube is connected to and communicates with the recess.

2. The balloon catheter according to claim 1, wherein: The number of the recesses is two, and the two recesses are arranged on opposite sides of the balloon. The number of the delivery tubes is two, and the two delivery tubes are arranged oppositely on both sides of the inner tube. The distal end of one delivery tube is correspondingly connected to one recess.

3. The balloon catheter according to claim 1, characterized in that: The recess includes an arc portion and a straight tube portion. One end of the straight tube portion is smoothly and transitionally connected to the distal end of the delivery tube, and the other end of the straight tube portion is connected to one end of the arc portion. The diameter of the arc portion gradually decreases from the outer surface of the balloon to the inner side of the balloon.

4. The balloon catheter according to claim 3, wherein: The balloon catheter includes a catheter hub and an expansion structure. The expansion structure includes a tubular braided mesh structure woven by metal wires. The expansion structure can be sleeved on the balloon. The proximal ends of the inner tube, the delivery tube, and the outer tube are fixed in the catheter hub.

5. The balloon catheter according to claim 4, wherein: The balloon catheter further includes an operating assembly. The operating assembly includes a connecting member, a sleeve, and an operating portion. The sleeve is movably sleeved on the outer tube. The proximal end of the sleeve passes through the catheter hub and is exposed outside the catheter hub. The operating portion is connected to the proximal end of the sleeve. The proximal end of the connecting member is connected to the distal end of the sleeve, and the distal end of the connecting member is connected to the proximal end of the expansion structure.

6. The balloon catheter according to claim 5, wherein: The proximal end of the expansion structure is fixedly connected to the connecting member, or the proximal end of the expansion structure is tightly sleeved on the outer tube after being pre-shaped, and the connecting member is detachably connected to the proximal end of the expansion structure.

7. The balloon catheter according to claim 5, wherein: The operating assembly further includes a support rod and a positioning ring. The proximal end of the support rod is connected to the distal end of the sleeve, and the distal end of the support rod is connected to the positioning ring. The positioning ring is movably sleeved on the outer tube, and the positioning ring can abut against the proximal end of the expansion structure.

8. The balloon catheter according to claim 4, wherein: The balloon catheter further includes a support assembly. The support assembly includes a deformable rod, a connecting head, and a pushing rod. The distal side of the deformable rod is deformable. The proximal end of the deformable rod is connected to the distal end of the connecting head, and the proximal end of the connecting head is connected to the distal end of the pushing rod. The distal end of the support assembly can enter from the proximal end of the delivery tube, pass through the straight tube portion and the arc portion, and support the deformable rod on the arc portion.

9. The balloon catheter according to claim 8, wherein: The number of the deformable rods is multiple, and the multiple deformable rods are evenly arranged in the circumferential direction of the connecting head. The distal ends of the multiple deformable rods smoothly and arc-shapedly extend in a direction away from the central axis of the connecting head.

10. The balloon catheter according to claim 8, characterized in that: The support assembly further includes a film. The distal end of the deformable rod is connected to the film, and the film covers the arc portion. The film includes a plurality of reinforcing rods arranged on the film. One ends of the plurality of reinforcing rods converge at the central position of the film, and the other ends of the plurality of reinforcing rods are evenly dispersed in the circumferential direction of the film.

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