Balloon catheter

Abstract

The invention relates to a balloon catheter. The balloon catheter comprises a pushing assembly, a catheter body and a balloon assembly. Wherein the guide pipe is detachably connected to the pushing assembly; the balloon assembly is connected to the catheter and comprises at least two balloons, the at least two balloons are sequentially arranged outside the catheter in a sleeving mode in the radial direction of the catheter, the diameters of the balloons are gradually increased from inside to outside, the catheter is communicated with the balloons and used for injecting fluid into the balloons, and blasting points are formed on the outer wall face of the balloon on the inner side. And when the balloon on the inner side is filled to exceed the preset volume, the blasting point is broken, so that the balloon is broken. The balloon catheter has the advantages that by arranging the balloons with different diameters, the balloon catheter can be expanded to different diameters, so that the balloon catheter can adapt to narrow lumen with different widths, and more personalized and accurate treatment can be provided for patients. In addition, due to multi-diameter expansion, the balloon catheter can be conveniently inserted and positioned, so that the operation complexity of a doctor is well reduced.

Description

Technical Field

[0001] The present application belongs to the technical field of intravascular puncture guidance, and specifically relates to a balloon catheter. Background Art

[0002] Balloon catheter technology, especially percutaneous transluminal angioplasty and percutaneous transluminal coronary angioplasty, has become an important means of treating vascular stenosis or occlusion. Traditional single-diameter balloon catheters have certain limitations in the expansion process. For example, a single-diameter balloon can only provide one size of expansion force at a time, which leads to insufficient adaptability to the lesion site. Therefore, how to improve the adaptability of the balloon catheter is a technical problem that needs to be solved urgently. Summary of the invention

[0003] The present application provides a balloon catheter to solve the technical problem of improving the adaptability of the balloon catheter.

[0004] In order to solve the above technical problems, a technical solution adopted in the present application is: a balloon catheter, comprising: a pushing assembly; a catheter, detachably connected to the pushing assembly; a balloon assembly, connected to the catheter, the balloon assembly comprising at least two balloons, at least two balloons are sequentially sleeved outside the catheter along the radial direction of the catheter, the diameter of the balloon gradually increases from the inside to the outside, the catheter and the balloon are connected, and are used to inject fluid into the balloon, a bursting point is formed on the outer wall surface of the inner balloon, and when the inner balloon is filled to exceed a preset volume, the bursting point ruptures to cause the balloon to rupture.

[0005] According to one embodiment of the present application, the blasting point is circular, or the blasting point is square.

[0006] According to one embodiment of the present application, the balloon includes: a balloon body, the bursting point is set on the balloon body; a first retracted end, connected to the balloon body, the first retracted end is retracted toward one end of the catheter and forms a first opening, the first opening is connected to the catheter for injecting fluid into the balloon; a second retracted end, connected to an end of the balloon body away from the first retracted end, and retracted toward a side away from the catheter.

[0007] According to one embodiment of the present application, the pushing assembly includes: a metal hypotube connected to the proximal end of the catheter, the metal hypotube being used to push the guide wire; an injection part connected to one end of the proximal end of the catheter of the metal hypotube, the injection part being used to apply a pushing force to the metal hypotube.

[0008] According to one embodiment of the present application, the pushing assembly further includes a transition unit, which is disposed between the metal hypotube and the catheter, and is used for transmitting the pushing force.

[0009] According to one embodiment of the present application, the balloon catheter further includes a transition unit, the transition unit includes a quick exchange port, the quick exchange port is a through hole formed at the distal end of the transition unit, and the through hole is used for the guide wire to pass through.

[0010] According to one embodiment of the present application, a reinforcement line is provided on the inner wall of the transition unit, and the reinforcement line passes through the quick exchange port and is provided on the inner wall of the catheter.

[0011] According to one embodiment of the present application, the balloon assembly further includes a pointed end, the pointed end being connected to the second retracted end, and the pointed end extending toward an end away from the balloon body.

[0012] According to one embodiment of the present application, a radioactive marker is provided on the tip, and the radioactive marker is used to position the balloon catheter under X-rays.

[0013] According to an embodiment of the present application, along the extension direction of the tip, the outer diameter of the tip gradually decreases, and the wall thickness of the tip also gradually decreases.

[0014] The beneficial effects of the present application are as follows: the catheter in the present application is detachably connected to the push assembly; the balloon assembly is connected to the catheter, the balloon assembly includes at least two balloons, at least two balloons are sequentially sleeved outside the catheter along the radial direction of the catheter, the diameter of the balloon gradually increases from the inside to the outside, the catheter and the balloon are connected, and are used to inject fluid into the balloon, and a bursting point is formed on the outer wall surface of the inner balloon, and when the inner balloon is filled to more than the preset volume, the bursting point ruptures to cause the balloon to rupture. By setting a plurality of balloons of different diameters, the balloon catheter is expanded to different diameters, so that the balloon catheter can adapt to different widths of lumen stenosis, and can provide patients with more personalized and accurate treatment. In addition, the expansion of multiple diameters can also facilitate the insertion and positioning of the balloon catheter, so as to greatly reduce the complexity of the doctor's operation. Further, by the expansion of the balloon in the longitudinal direction of the catheter, the accuracy of the positioning of the balloon catheter can also be well improved to ensure the treatment effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings required for use in the description of the embodiments are briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative work, among which:

[0016] Figure 1 It is a front structural schematic diagram of a balloon catheter of an embodiment of the present application;

[0017] Figure 2 It is a partial structural schematic diagram of an embodiment of a balloon catheter of the present application;

[0018] Figure 3 It is a schematic diagram of the cross-sectional structure of an embodiment of a balloon catheter of the present application. DETAILED DESCRIPTION

[0019] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. It is to be understood that the specific embodiments described herein are only used to explain the present application, rather than to limit the present application. It should also be noted that, for ease of description, only some structures related to the present application are shown in the accompanying drawings, rather than all structures. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of this application.

[0020] Reference to "embodiments" herein means that a particular feature, structure, or characteristic described in conjunction with the embodiments may be included in at least one embodiment of the present application. The appearance of the phrase in various locations in the specification does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment that is mutually exclusive with other embodiments. It is explicitly and implicitly understood by those skilled in the art that the embodiments described herein may be combined with other embodiments.

[0021] It should be noted that the definitions of "proximal" and "distal" in this article are: "proximal" usually refers to the end of the medical device close to the operator during normal operation, while "distal" usually refers to the end of the medical device that first enters the patient's body during normal operation.

[0022] See also Figure 1 to Figure 2 , Figure 1 It is a front structural schematic diagram of a balloon catheter of an embodiment of the present application; Figure 2 It is a schematic diagram of the partial structure of an embodiment of a balloon catheter of the present application.

[0023] An embodiment of the present application provides a balloon catheter 10. The balloon catheter 10 includes a push assembly 11, a catheter 12, and a balloon assembly 13. The catheter 12 is detachably connected to the push assembly 11; the balloon assembly 13 is connected to the catheter 12, and the balloon assembly 13 includes at least two balloons 131, at least two balloons 131 are sequentially sleeved outside the catheter 12 along the radial direction of the catheter 12, and the diameter of the balloon 131 gradually increases from the inside to the outside. The catheter 12 and the balloon 131 are connected to each other for injecting fluid into the balloon 131. A bursting point (not shown in the figure) is formed on the outer wall surface of the inner balloon 131. When the inner balloon 131 is filled to exceed the preset volume, the bursting point ruptures to rupture the balloon 131.

[0024] As can be seen from the above structure, the push assembly 11 can be used to inject fluid into the balloon assembly 13, the catheter 12 can guide the balloon assembly 13 to the treatment site, and the provision of at least two balloons 131 enables the balloon catheter 10 to adapt to blood vessels with a variety of different degrees of stenosis. Specifically, at least two balloons 131 are sequentially sleeved outside the catheter 12, and the diameter of the balloon 131 gradually increases from the inside to the outside. In the process of injecting fluid into the balloon 131, as the fluid in the balloon 131 increases, the balloon 131 is gradually filled. When the balloon 131 is filled to the preset volume of the inner balloon 131, if the volume of the balloon 131 at this time cannot meet the stenosis of the blood vessel, the fluid is continuously injected into the balloon 131, and then the burst point ruptures to rupture the balloon 131. Since the catheter 12 and the balloon 131 are connected, under the action of the catheter 12, the fluid can be continuously injected into the balloon 131 to further fill the outer balloon 131 until the expanded volume of the balloon 131 can adapt to the stenosis of the blood vessel. By setting a plurality of balloons 131 with different diameters, the balloon catheter 10 can be expanded to different diameters, so that the balloon catheter 10 can adapt to the stenosis of the lumen of different widths, and can provide more personalized and accurate treatment for patients. In addition, the expansion of multiple diameters can also facilitate the insertion and positioning of the balloon catheter 10, thereby greatly reducing the complexity of the doctor's operation. Further, by expanding the balloon 131 in the longitudinal direction of the catheter 12, the accuracy of positioning the balloon catheter 10 can also be greatly improved to ensure the treatment effect.

[0025] The fluid may be a gas, a liquid, or a gas-liquid mixture, and the specific selection may be made according to the actual surgical situation and is not limited here.

[0026] The number of balloons 131 may be 2, or in some other embodiments, may be 3, or even more, which is not limited here.

[0027] Of course, in some embodiments, the thickness of the balloon 131 can be set to gradually increase from the inside to the outside, so that the bursting force of the inner balloon 131 is small, while the bursting force of the outer balloon 131 is large. When the inner balloon 131 reaches its bursting force, the balloon 131 can burst by itself, which will not be elaborated here.

[0028] In one embodiment of the present application, the burst point is circular, or the burst point is square. Specifically, when the balloon 131 reaches a predetermined volume due to the injection of fluid, and the fluid is continuously injected into the balloon 131, the burst point can generate a circular hole under the action of the fluid pressure. Since the hole is circular in shape, the elastic tension on the surface of the balloon 131 maintains a symmetrical balance around the hole, so that the balloon 131 can slowly rupture. At this time, since the balance of the elastic tension on the surface of the balloon 131 will not be quickly broken, it can facilitate the doctor's judgment on the stenosis of the blood vessel, and then it can buy more time for the doctor to operate, so as to improve the success rate of the operation. Alternatively, when the burst point is square, due to the tension at the upper and lower ends of the hole, the balloon 131 can be quickly ruptured and exploded, which can greatly save the operation time and improve the patient's experience.

[0029] In one embodiment of the present application, the balloon 131 includes a balloon body 132, a first retracted end 133, and a second retracted end 134, wherein the first retracted end 133 is connected to the balloon body 132, the first retracted end 133 is retracted toward one end of the catheter 12 and is formed with a first opening (not shown in the figure), the first opening is connected to the catheter 12, and is used to inject fluid into the balloon 131; the second retracted end 134 is connected to one end of the balloon body 132 away from the first retracted end 133, and is retracted toward a side away from the catheter 12. Specifically, the first opening is connected to the catheter 12, which can facilitate the catheter 12 to inject fluid into the balloon 131, so that the balloon body 132 expands in the radial direction of the catheter 12 under the action of the fluid, thereby improving the accuracy of positioning the balloon 131 to ensure the treatment effect. The folded setting of the first folded end 133 and the second folded end 134 can also facilitate the insertion and positioning of the balloon catheter 10, thereby reducing the complexity of the doctor's operation. In addition, the folding of the second folded end 134 can also greatly reduce the damage to the blood vessel wall, further reducing the surgical risk, and also can reduce the risk of postoperative complications and improve the patient's comfort.

[0030] In one embodiment of the present application, the push assembly 11 includes a metal hypotube 111 and an injection part 112, the metal hypotube 111 is connected to the proximal end of the catheter 12, and the metal hypotube 111 is used to push the guide wire; the injection part 112 is connected to the end of the metal hypotube 111 away from the proximal end of the catheter 12, and the injection part 112 is used to apply a push force to the metal hypotube 111. Specifically, the metal hypotube 111 can be used to push the balloon 131 to the vascular lesion, and the metal hypotube 111 usually has certain flexibility, lubricity, and rapid expansion and contraction properties, so that it can help the balloon catheter 10 enter and transport in the blood vessel. In addition, due to the flexible characteristics of the metal hypotube 111, it can adapt to the complex path of the vascular system, thereby improving the reliability of the process of pushing the balloon catheter 10 into the blood vessel. The injection part 112 can facilitate the doctor to apply a push force to the metal hypotube 111, so that the doctor can save more effort in the process of pushing.

[0031] In one embodiment of the present application, the push assembly 11 further includes a transition unit 113, which is disposed between the metal hypotube 111 and the catheter 12, and is used to transmit the push force. By providing the transition unit 113, on the one hand, the connection strength with the catheter 12 can be improved through the transition unit 113, thereby ensuring a stable connection between the catheter 12 and the metal hypotube 111, and on the other hand, the push force applied by the injection unit 112 to the metal hypotube 111 can be effectively transmitted to the balloon 131, thereby realizing the expansion function of the balloon 131.

[0032] In one embodiment of the present application, the balloon catheter 10 also includes a switching unit 14, which includes a quick exchange port 141. The quick exchange port 141 is a through hole formed at the distal end of the transition unit 113, and the through hole is used for the guide wire to pass through. Specifically, in the process of replacing other balloons 131, the balloon 131 can be replaced by passing the guide wire through the through hole. The whole process not only does not require the use of an extended guide wire or a replacement guide wire, but can also greatly improve the efficiency and fluency of the operation. It can also shorten the time of pressure relief during the operation, achieve rapid pressure relief, improve the progress of the operation and the comfort of the patient, and reduce the waiting time of the doctor during the operation.

[0033] See also Figures 1 to 3 , Figure 3 It is a schematic diagram of the cross-sectional structure of an embodiment of a balloon catheter of the present application.

[0034] In one embodiment of the present application, the inner wall of the transition unit 113 is fitted with a reinforcing wire 114, and the reinforcing wire 114 passes through the rapid exchange port 141 and is fitted with the inner wall of the catheter 12. By passing the reinforcing wire 114 through the through hole of the rapid relief port, the balloon catheter 10 is not easy to be kinked during the insertion and operation process, which plays a good role in kinking protection, thereby protecting the integrity and functionality of the catheter 12. Through the kink protection function of the reinforcing wire 114, the balloon catheter 10 can smoothly reach the target position for effective treatment or examination, and at the same time, it can also reduce the risk of operation failure or patient discomfort due to kinking, thereby improving the success rate of the operation.

[0035] The reinforcing wire 114 is usually made of high-strength material, such as metal or special synthetic fiber, to ensure that it can withstand various pressures during operation.

[0036] In one embodiment of the present application, the balloon assembly 13 further includes a tip 15, which is connected to the second retracted end 134 and extends toward an end away from the balloon body 132. The setting of the tip 15 can adapt to different vascular anatomical types and can also facilitate the insertion of the catheter 12 to reduce the complexity of the doctor's operation.

[0037] The tip 15 is usually made of soft and wear-resistant material, thereby reducing damage to the blood vessel wall and lowering surgical risks.

[0038] In one embodiment of the present application, in order to facilitate the positioning of the balloon catheter 10, a radioactive marker is also provided on the tip 15, and the radioactive marker is used to position the balloon catheter 10 under X-rays. Specifically, by providing a radioactive substance on the tip 15, the target organ and tissue can be more accurately positioned during the interventional treatment using the balloon catheter 10, guided by the radioactive substance. At this time, the doctor can more accurately control the treatment process to improve the treatment effect, while also reducing damage to surrounding normal tissues. In addition, the provision of the radioactive substance can also facilitate real-time detection of the treatment process to ensure the smooth progress of the treatment.

[0039] In one embodiment of the present application, the outer diameter of the tip 15 gradually decreases along the extension direction of the tip 15, and the wall thickness of the tip 15 also gradually decreases. At this time, the ability of the balloon catheter 10 to pass through the occluded or stenotic lesion can be well enhanced, thereby enhancing the tracking ability of the balloon catheter 10, and at the same time, it can also reduce damage to blood vessels or surrounding tissues to improve the safety of the operation. In addition, it can also adapt to different vascular anatomical structures to improve the adaptability of the balloon catheter 10.

[0040] Among them, the tip 15 is usually made of soft material. On the one hand, it can enhance the ability of the balloon catheter 10 to pass through the lesion, and can also adapt to various surgical needs. Moreover, the design of the tip 15 of soft material can make the balloon catheter 10 more flexible during surgery and can better adapt to the surgical environment and operation requirements.

[0041] In one embodiment of the present application, the material of the balloon 131 is a low-density copolymer or polyetheramide. Since low-density copolymers or polyetheramides generally have excellent mechanical properties, they have high strength, high toughness and good wear resistance, and can resist the erosion of various chemical substances, including certain acids, alkalis, solvents, etc., so that the balloon 131 can adapt well to the intravascular environment to ensure that the balloon 131 will not be damaged due to changes in the intravascular environment during the operation, and the success rate of the operation is improved while ensuring the service life of the balloon 131.

[0042] Of course, in some other embodiments, the balloon 131 may also be made of other materials with good elasticity and pressure resistance, which will not be repeated here.

[0043] The process of testing the balloon 131 generally includes a tip 15 deformation test, a balloon 131 elongation test, and a deflation rate test.

[0044] When conducting a deformation test on the tip 15, first, a precisely calibrated compression test device can be prepared to simulate the compression conditions that the tip 15 of the catheter 12 may encounter during actual use. The tip 15 of the catheter 12 is then fixed in the test device, and the pressure is gradually increased until the tip 15 is compressed by 0.5 mm. The pressure required to achieve this compression is recorded, and the change in the diameter of the tip 15 is measured to evaluate the deformation and recovery ability of the tip 15 material.

[0045] During the elongation test of the balloon 131, the balloon catheter 10 is first fixed in a water bath heated to 37°C to simulate the in vivo environment, and then a high-precision pressure sensor and control system are used to inflate the balloon 131 to its rated bursting pressure (RBP). Finally, the longitudinal elongation of the balloon 131 when it reaches the RBP is recorded, and the ratio of elongation to RBP is calculated to evaluate the creep properties of the material.

[0046] During the deflation rate test, first, the inflated balloon catheter 10 is connected to a precise balance to measure the weight change during deflation, the pressure in the balloon 131 is quickly released, the weight reduction displayed on the balance is recorded, the deflation rate is calculated, and the deflation time is estimated.

[0047] In the above manner, statistical analysis can be well performed to evaluate the performance differences of different catheters 12.

[0048] The above description is only an implementation method of the present application, and does not limit the patent scope of the present application. Any equivalent structure or equivalent process transformation made using the contents of the present application specification and drawings, or directly or indirectly used in other related technical fields, are also included in the patent protection scope of the present application.

Claims

1. A balloon catheter, characterized in that: include: Push component; A catheter, detachably connected to the pushing assembly; A balloon assembly is connected to the catheter, and the balloon assembly includes at least two balloons. The at least two balloons are sequentially sleeved outside the catheter along the radial direction of the catheter, and the diameter of the balloons gradually increases from the inside to the outside. The catheter and the balloons are connected for injecting fluid into the balloons. A bursting point is formed on the outer wall surface of the inner balloon. When the inner balloon is filled to exceed a preset volume, the bursting point ruptures to cause the balloon to rupture.

2. The balloon catheter according to claim 1, characterized in that: The blasting point is circular, or the blasting point is square.

3. The balloon catheter according to claim 1, characterized in that: The balloon comprises: A balloon body, wherein the bursting point is arranged on the balloon body; A first folded end connected to the balloon body, the first folded end folds toward one end of the catheter and forms a first opening, the first opening is connected to the catheter, and is used to inject fluid into the balloon; The second folded end is connected to an end of the balloon body away from the first folded end and folded toward a side away from the catheter.

4. The balloon catheter according to claim 1, characterized in that: The push component includes: A metal hypotube connected to the proximal end of the catheter, the metal hypotube being used to push the guidewire; The injection part is connected to one end of the proximal end of the catheter of the metal hypotube principle, and the injection part is used to apply a pushing force to the metal hypotube.

5. The balloon catheter according to claim 4, characterized in that: The pushing assembly also includes a transition unit, which is arranged between the metal hypotube and the catheter and is used for transmitting the pushing force.

6. The balloon catheter according to claim 5, characterized in that: The balloon catheter also includes a transition unit, which includes a quick exchange port. The quick exchange port is a through hole formed at the distal end of the transition unit, and the through hole is used for the guide wire to pass through.

7. The balloon catheter according to claim 6, characterized in that: The inner wall of the transition unit is fitted with a reinforcement line, and the reinforcement line passes through the rapid exchange port and is fitted with the inner wall of the catheter.

8. The balloon catheter according to claim 3, characterized in that: The balloon component further includes a tip connected to the second folded end, and the tip extends toward an end away from the balloon body.

9. The balloon catheter according to claim 8, characterized in that: A radioactive marker is arranged on the tip, and the radioactive marker is used for positioning the balloon catheter under X-ray.

10. The balloon catheter according to claim 9, characterized in that: Along the extension direction of the tip, the outer diameter of the tip gradually decreases, and the wall thickness of the tip also gradually decreases.

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