Balloon catheter

Abstract

The invention provides a balloon catheter, and belongs to the technical field of medical instruments. The balloon catheter comprises a catheter body, an operation part is arranged at the near end of the catheter body, a balloon used for expanding blood vessels is arranged at the position, close to the far end, of the catheter body by a set distance, and a limiting unit is arranged on the outer side wall of the balloon and used for assisting the balloon in uniform deformation in the expansion process; the balloon is mainly used for solving the technical problems that in the prior art, due to uneven deformation caused by uneven distribution of blood vessel plaques in the dilation process of a balloon, the blood vessel dilation effect is affected, and the blood vessel wall is possibly damaged.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a balloon catheter. Background Art

[0002] Chronic Total Occlusion (CTO) refers to the complete blockage of the coronary artery or other arteries due to lesions such as atherosclerosis. The primary pathogenesis is the gradual deposition of lipids in the blood within the vessel wall, forming atherosclerotic plaques. As the plaques grow, the vessel lumen gradually narrows, ultimately leading to complete blockage.

[0003] Balloon therapy, as an interventional treatment, aims to dilate narrowed or occluded blood vessels and restore normal blood flow. During the specific operation, the doctor will use interventional catheter technology to precisely insert a catheter with a balloon into the site of the diseased blood vessel, and then inject contrast agents and other fluids into the balloon to expand it. The outward pressure generated by the balloon expansion can directly mechanically expand the blood vessel lumen and reshape the blood vessel morphology to a certain extent, thereby effectively increasing the inner diameter of the blood vessel and improving blood circulation. For chronically occluded blood vessels, balloon dilation can achieve vascular recanalization by squeezing plaques and stretching the endothelium and media.

[0004] However, when vascular plaques become highly calcified or fibrotic, their hardness increases significantly, seriously affecting the effectiveness of balloon therapy. Due to the uneven distribution of new plaques and hardened plaques in the stenotic area of the blood vessel, the balloon is easier to expand in areas with lower hardness during expansion, while it is difficult to expand in areas with higher hardness. This causes uneven deformation of the balloon, which in turn prevents the blood vessels from expanding evenly. As a result, over-inflated areas of the balloon are prone to damage the blood vessel wall, while areas that are not fully expanded cannot effectively improve the stenosis of the blood vessel, ultimately leading to poor treatment results. In addition, especially for annular plaques, the uneven deformation of the balloon makes it impossible to better expand that part of the blood vessel.

[0005] Therefore, it is necessary to provide an improved technical solution to the above-mentioned deficiencies in the prior art. Summary of the Invention

[0006] The purpose of the present invention is to provide a balloon catheter to solve the technical problem in the prior art that the balloon deforms unevenly during expansion due to uneven distribution of vascular plaques, thereby affecting the vascular expansion effect and possibly damaging the vascular wall.

[0007] In order to achieve the above-mentioned object, the balloon catheter of the present invention provides the following technical solutions:

[0008] A balloon catheter comprises a catheter body, wherein an operating portion is provided at the proximal end of the catheter body, a balloon for dilating blood vessels is arranged at a set distance near the distal end of the catheter body, and a limiting unit is arranged on the outer wall of the balloon for assisting the balloon to deform uniformly during the expansion process.

[0009] As a further optimized technical solution, the limiting unit includes a plurality of supporting ribs evenly spaced along the circumference of the balloon, and two ends of each of the supporting ribs are fixedly connected to two ends of the balloon respectively.

[0010] As a further optimized technical solution, the support rib includes a support portion located in the middle and telescopic portions located at both ends of the support portion, the support portion is arranged in the middle of the balloon, and the telescopic portions are arranged in the diameter-changing sections at the ends of the balloon;

[0011] During the deformation of the balloon, the length of the telescopic portion changes with the deformation of the balloon, so that the overall length of the supporting ribs conforms to the deformation of the balloon.

[0012] As a further optimized technical solution, the cross-section of the support ribs is arc-shaped. When the balloon is fully deflated, the supporting parts of all the support ribs are enclosed to form a cylindrical structure that fits the outer wall of the balloon.

[0013] As a further optimized technical solution, the length direction of any one of the supporting ribs is parallel to the axial direction of the catheter body.

[0014] As a further optimized technical solution, the length direction of any one of the supporting ribs has a set angle with the axial direction of the catheter body.

[0015] As a further optimized technical solution, the length directions of all the supporting ribs have the same angle with the axial direction of the catheter body.

[0016] As a further optimized technical solution, the limiting unit further includes a protective component, which is arranged on the outside of the supporting rib.

[0017] As a further optimization, the protective component is an elastic sheath that is sleeved on the outside of the supporting rib.

[0018] As a further optimized technical solution, the material of the telescopic part is silicone; the material of the supporting part is nickel-titanium alloy.

[0019] Beneficial effect: By setting a limiting unit on the outer side wall of the balloon, it is used to assist the balloon in uniform deformation during the expansion process, thereby enabling the balloon to uniformly expand the blood vessels and improve the blood vessel expansion effect.

[0020] Furthermore, the balloon is constrained circumferentially by using support ribs, and the telescopic portion can dynamically adjust its length as the balloon deforms. This fundamentally solves the problem of uneven deformation of the balloon during expansion due to uneven distribution of vascular plaques, enabling the balloon to expand the blood vessels evenly and effectively, significantly improving the vascular expansion effect, avoiding damage to the blood vessel wall caused by over-inflation of the balloon, reducing surgical risks, and improving the safety and effectiveness of balloon treatment.

[0021] Furthermore, the arc-shaped support ribs, when contracted, form a cylindrical structure that fits the outer wall of the balloon, which can effectively improve the support performance of the balloon itself, thereby facilitating the simultaneous entry of the balloon and the limiting unit into the internal space of the annular plaque. Later, as the balloon gradually expands, under the limiting action of the support ribs, the balloon expands radially and uniformly at the position of the annular plaque, thereby fully expanding the annular plaque, causing the annular plaque to break and be squeezed outward by the balloon, thereby ensuring the therapeutic effect at this position.

[0022] Furthermore, the provision of protective components further reduces the potential damage of the supporting ribs to the blood vessel wall, while the material combination of nickel-titanium alloy and silicone takes into account both support performance and elasticity requirements, optimizes the overall performance of the balloon catheter, and provides more reliable technical support for vascular interventional treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The accompanying drawings, which constitute part of this application, are intended to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are intended to explain the present invention and do not constitute an undue limitation of the present invention. Among them:

[0024] Figure 1 This is a schematic diagram of the overall structure of an embodiment of the present invention;

[0025] Figure 2 This is a schematic diagram of the balloon position structure according to an embodiment of the present invention;

[0026] Figure 3 A schematic half-section diagram of the balloon position structure along the axial direction according to one embodiment of the present invention;

[0027] Figure 4 is a schematic cross-sectional view of a balloon position structure along the circumferential direction according to an embodiment of the present invention;

[0028] Figure 5 This is a schematic diagram of the balloon position structure according to another embodiment of the present invention.

[0029] In the figure: 1. Catheter body; 101. Perforation; 2. Operating part; 3. Balloon; 4. Limiting unit; 401. Support rib; 4011. Support part; 4012. Telescopic part; 402. Protective part; 5. Development part. DETAILED DESCRIPTION

[0030] The following is a clear and complete description of the technical solutions in the embodiments of the present invention. Obviously, the embodiments described are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field are within the scope of protection of the present invention.

[0031] In the description of the present invention, the terms "longitudinal", "transverse", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing the present invention and do not require that the present invention must be constructed and operated in a specific orientation. Therefore, they should not be understood as limitations on the present invention. The terms "connected" and "connected" used in the present invention should be understood in a broad sense. For example, it can be a fixed connection or a detachable connection; it can be directly connected or indirectly connected through an intermediate component. For ordinary technicians in this field, the specific meanings of the above terms can be understood according to specific circumstances.

[0032] The present invention will be described in detail below with reference to the accompanying drawings and in combination with embodiments. It should be noted that, in the absence of conflict, the embodiments and features of the embodiments of the present invention can be combined with each other.

[0033] The shapes and sizes of the components in the drawings do not reflect the actual proportions of the products, and are only intended to illustrate the contents of the present invention.

[0034] The present invention provides a balloon catheter designed to address the problems of uneven deformation, poor treatment effect, and susceptibility to vascular damage caused by uneven vascular plaque during balloon expansion. The balloon catheter comprises a catheter body 1, an operating portion 2, a balloon 3, and a limiting unit 4. The limiting unit 4 is composed of a plurality of support ribs 401 evenly spaced along the circumference of the balloon 3 and fixed to the balloon 3 at both ends. The support ribs 401 include a nickel-titanium alloy support portion 4011 in the middle and silicone telescopic portions 4012 at both ends. The length of the support ribs 401 can be adjusted as the balloon 3 deforms. The cross-section of the support ribs 401 is arc-shaped, and when contracted, they form a cylindrical shape. In addition, the limiting unit 4 is further provided with an elastic sheath 402 that is sleeved over the support ribs 401 as a protective component. The length direction of the support ribs 401 can be parallel or arranged at a set angle to the axial direction of the catheter body 1. This balloon catheter constrains the circumferential deformation of the balloon by the limiting unit 4, combined with the dynamic adjustment of the telescopic portion 4012, to achieve uniform vascular expansion, improve treatment effect, reduce the risk of vascular damage, optimize overall performance, and have good clinical application value.

[0035] Example 1

[0036] like Figure 1As shown, the balloon catheter comprises a catheter body 1, which serves as the overall transmission channel. An operating portion 2 is located at its proximal end. The outer surface of operating portion 2 features anti-slip ridges, facilitating precise manipulation of the catheter body 1 for pushing and rotating during surgery. A vascular dilation balloon 3 is positioned 1-2 cm (a predetermined distance) from the distal end of the catheter body 1. Made from a medical polymer with excellent biocompatibility and elasticity, balloon 3 effectively dilates blood vessels upon injection of liquid or gas.

[0037] In this embodiment, the catheter body 1 is provided with a perforation 101 at the location of the balloon 3, which connects the lumen of the catheter body 1 with the cavity of the balloon 3. Perforation 101 connects the lumen of the catheter body 1 with the cavity of the balloon 3. To expand the balloon 3, liquid or gas is filled into the lumen of the catheter body 1 from the proximal end. The liquid or gas enters the cavity of the balloon 3 through perforation 101, thereby expanding the blood vessel wall. To deflate the balloon 3, the liquid or gas in the balloon 3 is regurgitated back into the lumen of the catheter body 1.

[0038] A limiting unit 4 is arranged on the outer side wall of the balloon 3 to assist the balloon 3 in uniformly deforming during the expansion process.

[0039] like Figure 2 、 Figure 3 As shown, the limiting unit 4 includes a plurality of supporting ribs 401 evenly spaced along the circumference of the balloon 3. Both ends of each supporting rib 401 are firmly connected to both ends of the balloon 3 by medical-grade adhesive, thereby constraining the deformation of the balloon 3 in the circumferential direction, thereby preventing the balloon 3 from locally over-expanding or under-expanding when encountering vascular plaques of different hardness.

[0040] The support ribs 401 utilize a composite structure, comprising a central support portion 4011 and telescopic portions 4012 at either end of the support portion 4011. The support portion 4011 is made of nickel-titanium alloy, leveraging its support properties to provide stable support during balloon 3 expansion and maintain its overall shape. The telescopic portions 4012 are located in the variable diameter sections at the ends of the balloon 3. Specifically, they are located at the transition point between the fixed end points and the central portion during balloon 3 deformation. Made of silicone, the excellent elasticity and flexibility of silicone allow them to adjust their length in real time as the balloon 3 deforms. For example, if balloon 3 expands slowly due to a hardened vascular plaque at a certain location, the telescopic portion 4012 at the corresponding location will extend due to increased internal pressure within the balloon 3, allowing the overall length of the support ribs 4011 to adapt to the deformation of the balloon 3. This restrains balloon 3's deformation without restricting its normal expansion.

[0041] like Figure 4As shown, the cross-section of the support ribs 401 is designed to be arc-shaped. When the balloon 3 is in a fully contracted state, the support portions 4011 of all the support ribs 401 are spliced together to form a cylindrical structure that fits the outer wall of the balloon 3. This structure can not only reduce the resistance of the balloon 3 during intravascular delivery, but also ensure the stability and smoothness of the balloon 3 in the contracted state. The purpose of this design is particularly suitable for treating annular plaques. In the early stage of the balloon 3 delivery process, the cylindrical structure facilitates the simultaneous entry of the balloon 3 and the limiting unit 4 into the internal space of the annular plaque. Later, as the balloon 3 gradually expands, under the limiting effect of the support ribs 401, the balloon 3 expands radially and uniformly at the annular plaque position, thereby fully expanding the annular plaque, causing the annular plaque to break circumferentially and be squeezed outward by the balloon 3, ensuring the therapeutic effect at this position.

[0042] In this embodiment, the length of each support rib 401 is arranged parallel to the axial direction of the catheter body 1. Because the longitudinal morphology of the lesion in most common vascular stenosis or occlusion is relatively regular, the parallel arrangement of support ribs 401 is sufficient to constrain the deformation of the balloon 3. This parallel arrangement of support ribs 401 effectively addresses common intravascular plaque distribution, ensuring stable and effective expansion of the balloon 3 within common vascular lesions, restoring vascular patency. It has broad applicability and can serve as a standard design solution for addressing common vascular lesions.

[0043] Furthermore, when the support ribs 401 are arranged parallel to the axial direction of the catheter body 1, during the expansion of the balloon 3, each support rib 401 can exert a uniform restraining force on the balloon 3 along the axial direction of the balloon 3. Because the forces acting on the blood vessels in the longitudinal direction are relatively uniform, the parallel arrangement of the support ribs allows the balloon 3 to distribute the forces more evenly when encountering plaques of varying hardness. This effectively prevents over-expansion or under-expansion of the balloon 3 due to uneven forces in a particular area, ensuring uniform deformation of the balloon 3 along its entire length and achieving uniform expansion of the blood vessel.

[0044] Furthermore, the limiting unit 4 also includes a protective component 402, which is an elastic sheath that is sleeved on the outside of the support ribs 401. The elastic sheath is made of medical-grade polyurethane material and has soft and wear-resistant properties. When the balloon 3 contacts the blood vessel wall, the elastic sheath can act as a buffer, reducing direct friction and damage to the blood vessel wall caused by the support ribs 401. At the same time, it protects the support ribs 401 and extends the service life of the balloon 3 catheter. In addition, by providing the protective component 402, which is sleeved on the outside of the support ribs 401 and has a certain thickness, this increases the overall wall thickness of the balloon 3 to a certain extent, so that the balloon 3 will not deform excessively in the softer blood vessel location, further ensuring the uniformity of the balloon 3 expansion.

[0045] Furthermore, if the catheter body 1 is not positioned accurately within the blood vessel, the balloon 3 may cause unnecessary expansion and damage to normal vascular tissue. Therefore, a developing unit 5 is provided at the distal end of the catheter body 1. This allows the doctor to clearly see the position and direction of the catheter, preventing it from entering healthy blood vessel branches and reducing the risk of damage to normal blood vessels.

[0046] Before the vascular interventional procedure, the doctor first conducts a comprehensive preoperative examination of the patient. Using techniques such as angiography, the doctor accurately determines the location and extent of vascular lesions and the distribution of plaques. Based on the examination results, the doctor selects the appropriate balloon catheter.

[0047] During the procedure, the doctor holds the operating unit 2 and inserts the catheter body 1 through a puncture site in a patient's peripheral blood vessel (e.g., the femoral artery). Using the real-time imaging guidance of the angiography device, the doctor slowly advances the catheter body 1, gradually bringing the balloon 3 closer to the diseased blood vessel. Once the balloon 3 reaches the desired location, a syringe filled with liquid or gas is connected to the catheter body 1 through the connection port on the operating unit 2, and the filling medium (such as liquid or gas) is injected into the balloon 3.

[0048] As the filling medium is injected, the balloon 3 begins to expand, and the limiting elements 4 on the outer wall of the balloon 3 begin to function. Multiple support ribs 401, evenly spaced along the circumference of the balloon 3, constrain the radial deformation of the balloon 3, preventing over-expansion and damage to the blood vessel wall.

[0049] After the balloon 3 is fully expanded, the doctor uses the operating unit 2 to discharge the filling medium in the balloon 3, causing the balloon 3 to gradually deflate. The balloon 3 returns to its initial state, and the supporting portions 4011 of all supporting ribs 401 once again form a cylindrical structure that fits the outer wall of the balloon 3, making it easier for the doctor to safely remove the balloon 3 catheter from the patient's body.

[0050] Example 2

[0051] Figure 5 Another arrangement of the supporting ribs 401 of the present invention is shown.

[0052] All technical solutions in this embodiment are essentially the same as those in Example 1, with the primary difference being the arrangement of the support ribs 401. In this embodiment, the length direction of any support rib 401 forms a set angle with the axial direction of the catheter body 1. This design ensures that, when the support ribs 401 form a set angle with the axial direction of the catheter body 1, during balloon 3 expansion, the initial position of the support ribs 401 facing the blood vessel will shift circumferentially as the balloon 3 expands. This rotational motion allows the balloon 3 to apply pressure more evenly to the plaque, avoiding localized over- or under-expansion due to uneven force on the plaque, achieving all-around, uniform expansion of the blood vessel and effectively alleviating vascular stenosis. In this embodiment, the length direction of all support ribs 401 forms the same angle with the axial direction of the catheter body 1.

[0053] In summary, the balloon catheter provided by the present invention effectively solves the problem of uneven balloon expansion in the prior art through its unique structural design, improves the effect and safety of vascular interventional treatment, and has broad promotion value in clinical applications.

[0054] It will be understood that the above description is merely exemplary and the embodiments of the present application do not limit this.

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

Claims

1. A balloon catheter, characterized in that: The invention comprises a catheter body (1), wherein an operating portion (2) is provided at the proximal end of the catheter body (1), a balloon (3) for dilating a blood vessel is arranged at a set distance from the distal end of the catheter body (1), and a limiting unit (4) is arranged on the outer wall of the balloon (3) for assisting the balloon (3) to deform uniformly during the expansion process.

2. The balloon catheter according to claim 1, characterized in that The limiting unit (4) comprises a plurality of support ribs (401) arranged at even intervals along the circumference of the balloon (3), and the two ends of each support rib (401) are respectively fixedly connected to the two ends of the balloon (3).

3. The balloon catheter according to claim 2, characterized in that The supporting rib (401) comprises a supporting portion (4011) located in the middle and telescopic portions (4012) located at both ends of the supporting portion (4011), wherein the supporting portion (4011) is arranged in the middle of the balloon (3), and the telescopic portions (4012) are arranged in the diameter-changing sections at the ends of the balloon (3); During the deformation of the balloon (3), the length of the telescopic portion (4012) changes with the deformation of the balloon (3), so that the overall length of the supporting rib (401) conforms to the deformation of the balloon (3).

4. The balloon catheter according to claim 3, characterized in that The cross section of the supporting ribs (401) is arc-shaped. When the balloon (3) is fully contracted, the supporting portions (4011) of all the supporting ribs (401) are enclosed to form a cylindrical structure that fits the outer wall of the balloon (3).

5. The balloon catheter according to claim 4, characterized in that The length direction of any one of the supporting ribs (401) is arranged parallel to the axial direction of the catheter body (1). The balloon catheter according to claim 4 , wherein: The length direction of any one of the supporting ribs (401) has a set angle with the axial direction of the catheter body (1).

7. The balloon catheter according to claim 6, characterized in that The length directions of all the supporting ribs (401) have the same included angle with the axial direction of the catheter body (1).

8. The balloon catheter according to claim 3, characterized in that The limiting unit (4) further comprises a protective component (402), and the protective component (402) is arranged outside the supporting rib (401).

9. The balloon catheter according to claim 8, characterized in that The protective component (402) is an elastic sheath sleeved on the outside of the supporting rib (401).

10. The balloon catheter according to any one of claims 3 to 9, characterized in that: The material of the telescopic part (4012) is silicone; the material of the supporting part (4011) is nickel-titanium alloy.

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