Expandable balloon
By setting up an infusion tube in the balloon, blood can pass through when the balloon is expanded, thereby avoiding blood vessel blockage, solving the problem of blood flow interruption caused by the balloon dilation time and improving the treatment effect.
Patent Information
- Application Number
- CN202010327970.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2020-04-23
- Publication Date
- 2025-05-13
- Estimated Expiration
- 2040-04-23
AI Technical Summary
In vascular interventional treatment, the balloon dilation time is too long to cause blood vessel blockage, resulting in myocardial ischemia and hemodynamic instability, which in turn affects the effect of stent adherence and drug release.
An expandable balloon is designed with an infusion tube that is not connected to the balloon pressure charging cavity. When the balloon expands, blood can circulate through the infusion tube to avoid blood vessel blockage.
The blood circulation is supplied through the infusion pipeline, which extends the balloon's dilation time in the blood vessel without causing blood vessel blockage, improving the effect of drug absorption and stent adherence.
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Figure CN111529899B_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of interventional medical devices, and in particular to an expandable balloon. Background Art
[0002] Stenosis and occlusion caused by atherosclerosis is a disease with high disability and mortality rates. Vascular interventional treatment technology is one of the main treatment methods for vascular diseases, especially arteriosclerosis, stenosis and occlusion. At present, vascular interventional treatment mainly includes stent implantation and drug-eluting balloon angioplasty. No matter which technology is used, balloon angioplasty is indispensable, that is, sending an expandable balloon to the lesion site, squeezing the plaque outside the blood vessel by filling and expanding the balloon to expand the diameter of the blood vessel lumen, and finally implanting a stent at the lesion site to support the lumen or using drugs locally to inhibit intimal hyperplasia, thereby achieving the purpose of treating vascular stenosis.
[0003] In current interventional technologies, there are certain requirements for the time of balloon expansion. For example, during stent implantation, insufficient balloon expansion will lead to poor stent adhesion, which may further induce acute stent thrombosis and even endanger the patient's life. Another example is that during drug balloon treatment, insufficient or too short expansion of the drug balloon will prevent the drug from being effectively absorbed by the vascular endothelium. Therefore, in order to make the stent more fully expand and adhere to the wall, or the drug in the drug balloon more fully absorbed by the vascular endothelium, the balloon expansion time must be extended as much as possible.
[0004] However, during the implementation of balloon angioplasty, sufficient balloon expansion will lead to interruption of blood flow in the corresponding blood vessels and cause myocardial ischemia. Therefore, when treating coronary blood with a wider blood supply range, such as left main trunk lesions, right coronary artery ostial lesions, or dominant anterior descending branch lesions, large-scale myocardial ischemia may cause myocardial depression and damage, and further lead to hemodynamic instability. Once this happens, the balloon dilation operation will be forced to be interrupted, which will lead to poor stent adhesion or insufficient drug release. Summary of the invention
[0005] Based on this, it is necessary to provide an expandable balloon to effectively expand the blood vessels while avoiding blood vessel blockage and blood flow interruption.
[0006] An expandable balloon comprising:
[0007] A catheter, wherein a charging and discharging cavity and a guidewire cavity are formed in the catheter, wherein the charging and discharging cavity and the guidewire cavity both extend along the axial direction of the catheter and are not connected to each other;
[0008] A balloon having a pressure-filling cavity, the balloon is connected to the catheter, and the pressure-filling cavity is connected to the charging and unloading cavity;
[0009] Among them, an infusion channel is provided in the balloon, and the infusion channel is not connected to the inflation chamber. The opposite ends of the infusion channel are opened on the outer surface of the balloon respectively. When the balloon expands in the blood vessel, blood can pass through the infusion channel.
[0010] In one embodiment, the infusion pipe is connected to a tubular support body, and the tubular support body can support the infusion pipe in a radial direction.
[0011] In one embodiment, the infusion pipeline is formed by surrounding a flexible film material, and the tubular support body is embedded in the flexible film material.
[0012] In one embodiment, the tubular support body is connected to the inner wall of the infusion pipe.
[0013] In one embodiment, the tubular support body is woven from metal wires, or the tubular support body is a metal threaded tube.
[0014] In one embodiment, when the tubular support body is woven with metal wires, the diameter of the metal wires is 45 μm to 55 μm.
[0015] In one embodiment, there are multiple infusion channels, and the multiple infusion channels are evenly distributed on a circumference centered on the axis of the balloon.
[0016] In one embodiment, the wall thickness h of the infusion pipe is 50 μm to 100 μm, the inner diameter d of the infusion pipe is 200 μm to 250 μm, and the outer diameter D of the infusion pipe is 300 μm to 400 μm.
[0017] In one embodiment, the guidewire cavity and the filling and unloading cavity are coaxial nested cavity structures.
[0018] In one embodiment, the proximal end of the catheter is connected to a filling device via a connector, and the filling device can inject gas or liquid into the filling and unloading chamber through the connector to fill the inflation chamber of the balloon, thereby expanding the balloon.
[0019] The expandable balloon provided by the present invention comprises a catheter and a balloon connected to the catheter. The charging and unloading chamber of the catheter is connected to the charging and unloading chamber of the balloon, so that gas or liquid can be injected into the charging and unloading chamber by utilizing the charging and unloading chamber of the catheter to expand the balloon. An infusion channel which is not connected to the charging and unloading chamber of the balloon is provided in the balloon, and opposite ends of the infusion channel are respectively opened on the outer surface of the balloon. When the balloon expands in a blood vessel, blood can pass through the infusion channel, so that the balloon can supply blood circulation through the infusion channel while maintaining better expansion performance, thereby avoiding the balloon expanding in the blood vessel for too long and blocking the blood vessel. BRIEF DESCRIPTION OF THE DRAWINGS
[0020] Figure 1 A schematic diagram of the structure of an expandable balloon according to an embodiment of the present invention;
[0021] Figure 2 for Figure 1 A schematic diagram of a local structure of an expandable balloon structure is shown;
[0022] Figure 3 For along Figure 2 A schematic diagram of the cross-sectional structure of the II line, showing that the guidewire cavity of the catheter and the filling and unloading cavity are coaxial nested cavity structures;
[0023] Figure 4 This is a schematic structural diagram of an expandable balloon in an embodiment in which the tubular support body in the balloon is a metal threaded tube. DETAILED DESCRIPTION
[0024] In order to facilitate the understanding of the present invention, the present invention will be described more fully below with reference to the relevant drawings. The preferred embodiments of the present invention are given in the drawings. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the disclosure of the present invention more thoroughly understood.
[0025] It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. The terms "vertical", "horizontal", "left", "right" and similar expressions used herein are for illustrative purposes only and do not represent the only implementation method.
[0026] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used herein in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used herein includes any and all combinations of one or more related listed items.
[0027] In the field of interventional medical devices, the end of a medical device implanted in a human or animal body that is closer to the operator is generally called the "proximal end", and the end that is farther from the operator is called the "distal end", and the "proximal end" and "distal end" of any component of a medical device are defined based on this principle. "Axial" generally refers to the length direction of the medical device when it is transported, and "radial" generally refers to the direction of the medical device that is perpendicular to its "axial direction", and the "axial" and "radial" of any component of a medical device are defined based on this principle.
[0028] See also Figure 1 As shown, the expandable balloon 100 according to the embodiment of the present application includes a balloon 10 and a catheter 20 .
[0029] The balloon 10 is connected to the distal end of the catheter 20, and the proximal end of the catheter 20 is connected to an external device (not shown) through a connector 30. For example, in some embodiments, the external device is a filling device that can inject gas or liquid into the balloon 10 through the catheter 20 to expand the balloon 10, and the connector 30 is a connector connected to the proximal end of the catheter 20, so that the filling device is conveniently connected to the catheter 20 by connecting to the connector.
[0030] Combination Figure 2 and Figure 3 As shown, a charging and discharging chamber 21 and a guidewire chamber 22 are formed in the catheter 20. The interior of the balloon 10 is connected to the charging and discharging chamber 21. Specifically, the balloon 10 has a pressure chamber 11, the balloon 10 is connected to the catheter 20, and the pressure chamber 11 is connected to the charging and discharging chamber 21. In this way, gas or liquid can be injected into the punching chamber of the balloon 10 through the charging and discharging chamber 21 of the catheter 20 to expand the balloon.
[0031] The guidewire cavity 22 is used to accommodate the guidewire 101. Specifically, the guidewire 101 can axially pass through the guidewire cavity 22 and pass out from the distal end of the catheter 20, so as to guide the balloon 10 to move to the position in the blood vessel where expansion support is required by the guidewire 101. It should be noted that the charging and unloading cavity 21 and the guidewire cavity 22 both extend along the axial direction of the catheter 20 and are not connected to each other, so as to ensure the sealing of the connection between the charging and unloading cavity 21 and the charging and pressure cavity 11, and to prevent the gas or liquid from leaking from the guidewire cavity 22 when the charging and unloading cavity 21 injects gas or liquid into the charging and pressure cavity 11, thereby affecting the expansion effect of the balloon 10.
[0032] Continue reading Figure 2 and Figure 3 As shown, an infusion channel 12 is provided in the balloon 10, and the infusion channel 12 is not connected to the pressure chamber 11. Then, the pressure chamber 11 is filled with gas or liquid, so that when the balloon 10 is expanded, no leakage occurs at the infusion channel 12, so as to maintain a better expansion effect of the balloon 10.
[0033] The opposite ends of the infusion channel 12 are respectively opened on the outer surface of the balloon 10, and when the balloon 10 is expanded in the blood vessel, blood can pass through the infusion channel 12. In other words, while the balloon 10 is expanded in the blood vessel to maintain a better expansion performance, the infusion channel 12 of the balloon 10 can still supply blood circulation, thereby preventing the balloon 10 from expanding in the blood vessel for too long and clogging the blood vessel.
[0034] In this embodiment, by setting an infusion tube 12 in the balloon 10, the expansion time in the blood vessel can be prolonged without affecting the expansion performance of the balloon 10 and causing the adverse effect of clogging the blood vessel. Then, the drug balloon 10 using the balloon 10 structure can buy more time for the absorption of the drug, that is, promote the effective absorption of the drug by the blood vessel, so as to improve the performance of the balloon 10.
[0035] In some embodiments, the guidewire cavity 22 and the charging and unloading cavity 21 are coaxial nested cavity structures. Specifically, the cavity wall forming the charging and unloading cavity 21 is sleeved on the cavity wall forming the guidewire cavity 22. By adopting this coaxial nested cavity structure, while maintaining the guidewire cavity 22 and the charging and unloading cavity 21 not being connected to each other, the compactness of the overall structure of the catheter 20 is improved, making the catheter 20 as a whole small.
[0036] In the embodiment where the proximal end of the catheter 20 is connected to the filling device via the connector 30, the filling device can inject gas or liquid into the filling and discharging chamber 21 via the connector 30 to fill the inflation chamber 11 of the balloon 10, so that the balloon 10 expands. The filling device can be a pressure pump or other structures, as long as it can inject gas or liquid into the inflation chamber 11 of the balloon 10 via the filling and discharging chamber 21, and is not limited here.
[0037] In some embodiments, the infusion tube 12 is connected to a tubular support body 13, and the tubular support body 13 can support the infusion tube 12 in the radial direction, that is, the tubular support body 13 can provide supporting force in the infusion tube 12, so that when the balloon 10 is expanded, the infusion tube 12 will not shrink due to the pressure of the gas or liquid injected into the inflation chamber 11 of the balloon 10, and the shape of the infusion tube 12 is maintained to facilitate blood circulation and reduce the risk of blood vessel blockage.
[0038] In some embodiments, the infusion channel 12 is formed by surrounding a flexible film material, so that the infusion channel 12 has good flexibility, so as to avoid scratching the blood vessel wall when entering the blood vessel with the balloon 10. The tubular support 13 is embedded in the flexible film material, so that after the balloon 10 is expanded in the blood vessel, blood flows through the infusion channel 12 to maintain the smooth flow of blood, while the tubular support inside the flexible film material can avoid contact with blood. In this way, the material selection of the tubular support does not need to take into account biocompatibility, and a material with good support performance can be selected.
[0039] In other embodiments, the tubular support body 13 is connected to the inner wall of the infusion tube 12, so as to provide better support for the infusion tube 12 and maintain the shape of the infusion tube 12, so as to facilitate the smooth flow of blood through the infusion tube 12 and reduce the risk of blockage caused by the balloon 10 expanding for too long in the blood vessel.
[0040] In some embodiments, the tubular support body 13 is woven from metal wires, so that the tubular support body 13 has a certain elasticity and flexibility, so that when the balloon 10 is implanted in the blood vessel, it can move smoothly along the blood vessel and avoid scratching the blood vessel wall.
[0041] In the embodiment of the tubular support body 13 woven with metal wires, the diameter of the metal wires used is 45 μm to 55 μm. For example, in some embodiments, the tubular support body 13 is woven with metal wires with a diameter of 50 μm. The tubular support body 13 woven with metal wires with a diameter of 45 μm to 55 μm is selected to prevent the metal wires from being too thick to affect the flexibility and easily scratch the blood vessels. At the same time, the metal wires are too thin to form a good radial support effect on the infusion pipe 12.
[0042] In other embodiments, in combination Figure 4 As shown, the tubular support body 13 includes a metal threaded tube 131, which can obtain good radial support to maintain the shape of the infusion tube 12 for blood to pass through. At the same time, the metal threaded tube 131 has good bending performance so that it can move smoothly with the balloon 10 in the blood vessel to a suitable position where expansion is required.
[0043] In one embodiment, the wall thickness h of the infusion pipe 12 is 50 μm to 100 μm, the inner diameter d of the infusion pipe 12 is 200 μm to 250 μm, and the outer diameter D of the infusion pipe 12 is 300 μm to 400 μm. For example, the wall thickness h of the infusion pipe 12 is 75 μm, and the inner diameter d of the infusion pipe 12 is 225 μm, so that the infusion pipe 12 can have a sufficient aperture for blood to pass through, and when the wall thickness h is controlled in the range of 50 μm to 100 μm, it will not be too thick to affect the overall expansion and contraction performance of the balloon 10, and at the same time, it will not be too thin to be easily compressed by the pressure of the charging chamber 11.
[0044] In some embodiments, there are multiple infusion tubes 12 , and the multiple infusion tubes 12 are evenly distributed on a circumference centered on the axis of the balloon 10 .
[0045] It should be noted that, combined with Figure 1 and Figure 2As shown, the distal end of the catheter 20 is provided with one or more charging and discharging ports 201, which are connected to the charging and discharging chamber 21. As the catheter 20 and the balloon 10 cooperate, the charging and discharging ports 201 are located inside the balloon 10, that is, the charging and discharging ports 201 are located in the charging chamber 11 of the balloon 10, so that the charging and discharging chamber 21 of the catheter 20 is connected to the charging and discharging chamber 11 of the balloon 10. Through this structure, the gas or liquid filled in the charging and discharging chamber 21 can be transported to the distal end of the catheter 20 along the charging and discharging chamber 21, and enter the interior of the balloon 10 from the charging and discharging ports 201 to fill the balloon 10.
[0046] The distal end of the catheter 20 located inside the balloon 10 may be provided with a developing ring 102, so that when the balloon 10 is implanted into a blood vessel, the balloon 10 can be pushed to a suitable position according to the developing ring 102. The number of developing rings 102 may be one or more, which is not limited here.
[0047] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.
[0048] The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.
Claims
1. An expandable balloon, characterized in that: include: A catheter, wherein a charging and discharging cavity and a guidewire cavity are formed in the catheter, wherein the charging and discharging cavity and the guidewire cavity both extend along the axial direction of the catheter and are not connected to each other; A balloon having a pressure-filling cavity, the balloon is connected to the catheter, and the pressure-filling cavity is connected to the charging and unloading cavity; In which, an infusion pipe is provided in the balloon, and the infusion pipe is not connected to the charging chamber. The opposite ends of the infusion pipe are respectively opened on the outer surface of the balloon. When the balloon expands in the blood vessel, blood can pass through the infusion pipe. The distal end of the catheter is located in the tube section inside the balloon and is provided with a developing ring. The infusion pipe is connected to a tubular support body, and the tubular support body can support the infusion pipe radially. The tubular support body is woven from metal wires, and the diameter of the metal wires used is 45μm~55μm. The wall thickness h of the infusion pipe is 50μm~100μm, the inner diameter d of the infusion pipe is 200μm~250μm, and the outer diameter D of the infusion pipe is 300μm~400μm.
2. The expandable balloon according to claim 1, characterized in that The infusion pipeline is formed by surrounding a flexible membrane material, and the tubular support body is embedded in the flexible membrane material.
3. The expandable balloon according to claim 1, characterized in that: The tubular support is connected to the inner wall of the infusion pipe.
4. The expandable balloon according to claim 1, characterized in that: There are multiple infusion channels, and the multiple infusion channels are evenly distributed on a circumference centered on the axis of the balloon.
5. The expandable balloon according to claim 1, characterized in that: The guidewire cavity and the filling and unloading cavity are coaxial nested cavity structures.
6. The expandable balloon according to claim 1, characterized in that: The proximal end of the catheter is connected to a filling device through a connector, and the filling device can inject gas or liquid into the filling and unloading cavity through the connector to fill the inflation cavity of the balloon, so that the balloon expands.
Citation Information
Patent Citations
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