Balloon dilatation catheter

Abstract

The balloon dilatation catheter comprises a multi-cavity tube and a balloon, a guide wire cavity channel and at least one liquid passing cavity channel are formed in the multi-cavity tube, the balloon is connected to the liquid outlet end of the multi-cavity tube, a liquid filling cavity is formed between the balloon and the multi-cavity tube, the liquid passing cavity channel is communicated with the liquid filling cavity, the balloon is provided with an outer surface for bearing an intravascular stent, and the outer surface is communicated with the liquid filling cavity. And array bulges for positioning the intravascular stent are arranged on the outer surface. According to the balloon dilatation catheter, the contact area of the balloon and the intravascular stent can be increased, and the risk that the intravascular stent gets out of load or moves in the conveying and releasing process is reduced.

Description

Technical Field

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

[0002] The balloon-expandable stent is a stent pre-installed on a balloon catheter and made of medical stainless steel and cobalt-chromium alloy. It is delivered to the lesion site together with the balloon, and the balloon is pressurized to release the stent. The expanded stent makes the lesion blood vessel unobstructed.

[0003] For the delivery system of the balloon-expandable stent, the assembly and fit between the stent or covered stent and the balloon dilatation catheter is a key factor in determining the safe delivery and release of the stent. After entering the body through an interventional catheter, both the stent and the balloon need to be compressed and gripped to a certain extent, and the stent or covered stent is fixed to the delivery system so that it can pass through the hemostatic valve of the sheath and then reach the target blood vessel along a sheath of appropriate specifications. During the delivery and release of the stent, the outer surface of the stent will be subject to a certain degree of friction. During the process of releasing the stent or covered stent with the expansion balloon, the balloon will expand unevenly due to the restraint of the stent. The expansion of the balloon and the expansion or movement of the stent restrict each other. For the smooth surface of the balloon body, if you want to increase the firmness of the assembly with the stent and increase the anti-detachment and anti-displacement ability of the stent, the stent needs to be fastened to the balloon body and pressed in a manner similar to forging. However, due to the tight binding effect of the stent on the balloon body, the balloon is bound by the stent and squeezed by space when it is filled, which increases the difficulty of balloon expansion. If the assembly of the stent and the balloon is not firm enough at this time, the risk of the stent jumping out during the expansion process will also increase due to the biased force on one end of the stent, increasing the risk of surgery. If it is easier to fill the balloon body, the clamping of the stent cannot be too tight, which increases the risk of the stent being unloaded when encountering friction and force during transportation and expansion. Therefore, the filling and expansion of the balloon and the stent, and the tightness of the clamping assembly of the stent are mutually restricted, and the risk of displacement, movement or unloading during use is relatively high. A design is needed to balance the assembly state of the two structures and reduce the risk. Summary of the invention

[0004] In order to solve the above-mentioned defects existing in the prior art, the balloon dilatation catheter provided in the present application can increase the contact area between the balloon and the vascular stent, and reduce the risk of unloading, jumping out or shifting of the vascular stent during the transportation and release process.

[0005] The present application provides a balloon dilatation catheter, comprising a multi-lumen tube and a balloon, wherein a guidewire lumen and at least one liquid passage lumen are provided in the multi-lumen tube, the balloon is connected to the liquid outlet end of the multi-lumen tube, a liquid-filled cavity is formed between the balloon and the multi-lumen tube, the liquid passage lumen is connected to the liquid-filled cavity, the balloon has an outer surface that supports a vascular stent, and the outer surface is provided with an array of protrusions for positioning the vascular stent.

[0006] Optionally, the array protrusions include a plurality of first positioning units arranged at intervals from the proximal end to the distal end of the balloon, and each of the first positioning units includes a plurality of first protrusions arranged at intervals around the circumference of the balloon.

[0007] Optionally, the vascular stent comprises a plurality of support rib units extending in a circuitous shape, and each of the support rib units comprises a plurality of circuitous bending portions;

[0008] When the blood vessel stent is sleeved on the balloon, each of the first positioning units is located between two adjacent supporting rib units, and each of the first protrusions is located between the two circuitous bending portions of two adjacent supporting rib units.

[0009] Optionally, the array protrusion also includes a plurality of second positioning units arranged at intervals from the proximal end to the distal end of the balloon, each of the second positioning units is arranged alternately with each of the first positioning units, and each of the second positioning units includes a plurality of second protrusions arranged at intervals around the circumference of the balloon.

[0010] Optionally, each of the circuitous curved portions comprises an inner curved wall and an outer curved wall arranged opposite to each other, and a hollow area is formed between the two inner curved walls of two adjacent support rib units;

[0011] When the blood vessel stent is sleeved on the balloon, each of the first protrusions is located between the two outer curved walls of two adjacent support rib units;

[0012] Each of the second protrusions is in the shape of an elongated strip, and each of the second protrusions is arranged along the axial direction of the balloon; when the vascular stent is sleeved on the balloon, each of the second protrusions is arranged corresponding to the hollow area, and the two ends of each of the second protrusions are respectively in contact with or adjacent to the two inner curved walls of two adjacent support rib units.

[0013] Optionally, the height of the array protrusions is greater than or equal to the thickness of the vascular stent.

[0014] Optionally, the multi-lumen tube includes a first tube body and a second tube body, one end of the second tube body is connected to the first tube body, the other end of the second tube body forms a plug, the guide wire lumen is formed in the first tube body and the second tube body, the liquid passage lumen is formed in the first tube body, the proximal end of the balloon is connected to the first tube body, the distal end of the balloon is connected to the plug, and the part of the second tube body away from the plug is located in the liquid-filled cavity.

[0015] Optionally, at least two liquid-passing cavities are formed in the first tube body, and the balloon dilatation catheter also includes at least one drainage tube, the drainage tube is arranged in the liquid-filled cavity, a drainage channel is formed in the drainage tube, and the drainage channel forms a liquid inlet and a liquid outlet at both ends of the drainage tube, respectively, the drainage tube is connected to the first tube body, the liquid inlet is connected to one of the liquid-passing cavities, and the liquid outlet is connected to the liquid-filled cavity.

[0016] Optionally, at least one side hole is provided on the tube wall of the drainage tube, and the side hole connects the liquid filling cavity and the drainage channel.

[0017] Optionally, at least three liquid-passing cavities are formed in the first tube body, and the balloon dilatation catheter includes at least two drainage tubes of different lengths, each of the drainage tubes is connected to the liquid-passing cavities respectively, the liquid outlet of at least one of the drainage tubes is arranged near the distal end of the balloon, and the liquid outlet of at least one of the drainage tubes is located in the area between the proximal end and the distal end of the balloon.

[0018] Optionally, the balloon dilatation catheter further includes a first developing ring and a second developing ring, wherein the first developing ring and the second developing ring are located in the liquid-filled cavity and fixed on the second tube body.

[0019] Optionally, the balloon includes an inner balloon body and an outer balloon membrane disposed on the outer surface of the inner balloon body, and the array protrusions are formed on the outer balloon membrane.

[0020] The outer surface of the balloon of the balloon dilatation catheter of the present application is provided with an array of protrusions, which can increase the contact area between the balloon and the vascular stent, increase the friction between the two, have a strong ability to resist falling off or displacement, and reduce the risk of the vascular stent becoming unloaded or displaced during transportation and release. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 It is a schematic structural diagram of the balloon dilatation catheter of the first embodiment of the present application.

[0022] Figure 2 yes Figure 1 A schematic diagram of the partial structure of a balloon dilatation catheter is shown.

[0023] Figure 3 yes Figure 2 A schematic diagram of the partial cross-sectional structure of a balloon dilatation catheter is shown.

[0024] Figure 4 It is a schematic diagram of the cross-sectional structure of the balloon and the vascular stent of the present application at the first positioning unit.

[0025] Figure 5 It is a schematic diagram of the partial structure of the vascular stent of the present application.

[0026] Figure 6 It is a schematic diagram of the cross-sectional structure of the balloon and the vascular stent of the present application at the second positioning unit.

[0027] Figure 7 It is a schematic diagram of the partial cross-sectional structure of the balloon dilatation catheter of the second embodiment of the present application.

[0028] Figure 8 It is a schematic diagram of the partial cross-sectional structure of the balloon dilatation catheter of the third embodiment of the present application.

[0029] Fig. 9 It is a schematic diagram of the partial cross-sectional structure of the balloon dilatation catheter of the fourth embodiment of the present application.

[0030] Fig.10 It is a schematic diagram of the partial cross-sectional structure of the balloon dilatation catheter of the fifth embodiment of the present application.

[0031] Fig.11 It is a schematic diagram of the partial cross-sectional structure of the balloon dilatation catheter of the sixth embodiment of the present application. DETAILED DESCRIPTION

[0032] The following is an explanation of the implementation of the present application by means of specific embodiments. People familiar with the art can easily understand other advantages and effects of the present application from the contents disclosed in this specification.

[0033] In the following description, reference is made to the accompanying drawings, which describe several embodiments of the present application. It should be understood that other embodiments may be used and that mechanical, structural, electrical, and operational changes may be made without departing from the spirit and scope of the present application. The following detailed description should not be considered limiting, and the terms used herein are only for the purpose of describing specific embodiments and are not intended to limit the present application.

[0034] Although the terms first, second, etc. are used herein to describe various elements in some instances, these elements should not be limited by these terms. These terms are only used to distinguish one element from another element.

[0035] Furthermore, as used in this article, the singular forms "one", "an" and "the" are intended to include plural forms as well, unless there is an indication to the contrary in the context. It should be further understood that the terms "comprise", "include" indicate the presence of features, steps, operations, elements, components, projects, kinds, and / or groups, but do not exclude the presence, occurrence or addition of one or more other features, steps, operations, elements, components, projects, kinds, and / or groups. The terms "or" and "and / or" used herein are interpreted as inclusive, or mean any one or any combination. Therefore, "A, B or C" or "A, B and / or C" means "any of the following: A; B; C; A and B; A and C; B and C; A, B and C". Only when the combination of elements, functions, steps or operations is inherently mutually exclusive in some way, will there be an exception to this definition.

[0036] First embodiment

[0037] Figure 1 is a schematic structural diagram of a balloon dilatation catheter according to a first embodiment of the present application, Figure 2 yes Figure 1 The schematic diagram of the local structure of the balloon dilatation catheter shown in FIG. Figure 3 yes Figure 2 The partial cross-sectional structure diagram of the balloon dilatation catheter shown in FIG. Figure 1 , Figure 2 and Figure 3 As shown, the balloon dilatation catheter includes a multi-lumen tube 11 and a balloon 12. The multi-lumen tube 11 is provided with a guidewire lumen and at least one liquid passage lumen 103. The balloon 12 is connected to the liquid outlet end of the multi-lumen tube 11. A liquid-filled cavity 101 is formed between the balloon 12 and the multi-lumen tube 11. The liquid passage 103 is connected to the liquid-filled cavity 101. The balloon 12 has an outer surface that supports a vascular stent 20, and the outer surface is provided with an array of protrusions for positioning the vascular stent 20.

[0038] When the vascular stent 20 is sleeved and pressed on the balloon 12, the array protrusions are stuck in the gaps of the vascular stent 20 and abut against the structural frame of the vascular stent 20, thereby increasing the contact area between the balloon 12 and the vascular stent 20, that is, increasing the axial friction resistance, so that the vascular stent 20 is not easy to shift axially during the delivery and release process. For example, when the balloon dilatation catheter fixed with the vascular stent 20 is inserted into the blood vessel, the vascular stent 20 and the hemostatic valve form an axial thrust on the vascular stent 20 during the process of the distal end of the balloon dilatation catheter passing through the protective sheath hemostatic valve. In the process of pushing the vascular stent 20 to the target lesion location, there is a certain degree of friction between the vascular stent 20 and the sheath wall, the blood vessel wall and the lesion. At this time, the vascular stent 20 The resistance between the array protrusions on the balloon 12 can prevent the vascular stent 20 from falling off or shifting to a great extent; when the balloon 12 expands, since it takes time for the balloon 12 to be filled with liquid and flow, the proximal end of the balloon 12 is easier to be filled and expanded. At this time, the proximal end of the vascular stent 20 is expanded first, which gradually increases the axial thrust of the vascular stent 20 toward the distal end. At this time, the axial resistance of the array protrusions plays a role, preventing the vascular stent 20 from moving toward the distal end and reducing the risk of unloading; during the expansion of the balloon 12, the array protrusions will decrease as the balloon 12 is filled; when the balloon 12 is fully expanded and unfolded, the resistance and friction generated between the array protrusions and the vascular stent 20 are reduced to a very small level, and the balloon dilation catheter can be easily decompressed and withdrawn.

[0039] The outer surface of the balloon 12 of the balloon dilatation catheter of the present application is provided with an array of protrusions, which can increase the contact area between the balloon 12 and the vascular stent 20, increase the friction between the two, have a strong ability to resist falling off or displacement, and reduce the risk of the vascular stent 20 being unloaded, jumping out or displacing during transportation and release.

[0040] Optionally, the array protrusions refer to a plurality of protrusions distributed on the outer surface of the balloon 12, each protrusion is arranged to protrude relative to the outer surface of the balloon 12, and each protrusion is used to be inserted into the gap of the vascular stent 20 and abut against the skeleton structure of the vascular stent 20. In this embodiment, the plurality of protrusions are the following plurality of first protrusions 1211 and / or plurality of second protrusions 1221.

[0041] Alternatively, if Figure 2 and Figure 3As shown, the array protrusions include a plurality of first positioning units 121 arranged in a spaced relationship from the proximal end to the distal end of the balloon 12 (the plurality of first positioning units 121 are arranged in a spaced relationship in sequence along the axial direction of the balloon dilatation catheter), and each first positioning unit 121 includes a plurality of first protrusions 1211 arranged in a spaced relationship around the circumference of the balloon 12; the plurality of first protrusions 1211 may be arranged uniformly, i.e., the spacing between any two adjacent first protrusions 1211 is the same, or may be arranged non-uniformly, i.e., the spacing between at least two adjacent first protrusions 1211 is different from the spacing between other first protrusions 1211. In this embodiment, the first protrusions 1211 of each first positioning unit 121 are formed by tooling, and the structure and shape are stable; the plurality of first protrusions 1211 are matched and nested with the gaps of the vascular stent 20 one by one; each first positioning unit 121 forms a resistance of nearly one circle, and the plurality of first positioning units 121 form multiple annular resistances, which can further prevent the vascular stent 20 from moving during the transportation and release process.

[0042] Optionally, the number of the first positioning units 121 is, for example, 7-18; the number of the first protrusions 1211 is, for example, 7-18, which can be freely increased or decreased according to actual needs.

[0043] Optionally, Figure 4 is a schematic diagram of the cross-sectional structure of the balloon and the vascular stent of the present application at the first positioning unit, Figure 5 Schematic diagram of the local structure of the vascular stent of the present application, such as Figure 4 and Figure 5 As shown, the vascular stent 20 is in a segmented grid form; the vascular stent 20 includes a plurality of support rib units 21 extending in a circuitous shape, and each support rib unit 21 includes a plurality of circuitous bending portions 211; when the vascular stent 20 is sleeved on the balloon 12, each first positioning unit 121 is located between two adjacent support rib units 21, and each first protrusion 1211 is located between two circuitous bending portions 211 of two adjacent support rib units 21. In this embodiment, the first protrusion 1211 contacts the two circuitous bending portions 211 of two adjacent support rib units 21, thereby increasing the axial friction resistance and effectively preventing the vascular stent 20 from moving along the axial direction of the balloon dilatation catheter.

[0044] Alternatively, if Figure 2 and Figure 3As shown, the array protrusions also include a plurality of second positioning units 122 arranged at intervals from the proximal end to the distal end of the balloon 12, each second positioning unit 122 is arranged alternately with each first positioning unit 121, and each second positioning unit 122 includes a plurality of second protrusions 1221 arranged at intervals around the circumference of the balloon 12; the plurality of second protrusions 1221 can be arranged uniformly, that is, the spacing between any two adjacent second protrusions 1221 is the same, or can be arranged non-uniformly, that is, the spacing between at least two adjacent second protrusions 1221 is different from the spacing between other second protrusions 1221. In this embodiment, the second protrusions 1221 of each second positioning unit 122 are formed by tooling, and the structure and shape are stable; the plurality of second protrusions 1221 are matched and nested with the gaps of the vascular stent 20 one by one; each first protrusion 1211 cooperates with each second protrusion 1221 to position the vascular stent 20 in all directions to prevent the vascular stent 20 from moving during the transportation and release process.

[0045] Optionally, the number of the second positioning units 122 is, for example, 7-18; the number of the second protrusions 1221 is, for example, 7-18, which can be freely increased or decreased according to actual needs.

[0046] Optionally, each second protrusion 1221 of this embodiment is a protrusion extending along the axial direction of the balloon 12, and can be a regular strip or an irregular strip. In this embodiment, the second protrusion 1221 is rectangular or elliptical.

[0047] Optionally, Figure 6 Schematic diagram of the cross-sectional structure of the balloon and the vascular stent of the present application at the second positioning unit, such as Figure 5 and Figure 6 As shown, each circuitous curved portion 211 includes an inner curved wall 2111 and an outer curved wall 2112 that are arranged opposite to each other, and a hollow area 201 is formed between the two inner curved walls 2111 of two adjacent support rib units 21;

[0048] When the vascular stent 20 is sleeved on the balloon 12, each first protrusion 1211 is located between two outer curved walls 2112 of two adjacent support rib units 21;

[0049] Each second protrusion 1221 is in the shape of an elongated strip and is arranged along the axial direction of the balloon 12; when the vascular stent 20 is sleeved on the balloon 12, each second protrusion 1221 is arranged corresponding to the hollow area 201, and the two ends of each second protrusion 1221 are respectively in contact with or adjacent to the two inner curved walls 2111 of two adjacent support rib units 21.

[0050] Optionally, the height of the array protrusions is greater than or equal to 1 / 2 of the thickness of the vascular stent 20.

[0051] Optionally, the height of the array protrusions is greater than or equal to the thickness of the vascular stent 20 .

[0052] Alternatively, if Figure 3 As shown, the multi-lumen tube 11 includes a first tube body 112 and a second tube body 113, one end of the second tube body 113 is connected to the first tube body 112, the other end of the second tube body 113 forms a plug 1131 (tip), the guide wire lumen is formed in the first tube body 112 and the second tube body 113, the liquid passage lumen 103 is formed in the first tube body 112, the proximal end of the balloon 12 is connected to the first tube body 112, the distal end of the balloon 12 is connected to the plug 1131, and the part of the second tube body 113 away from the plug 1131 is located in the liquid-filled cavity 101. In this embodiment, the liquid passage lumen 103 runs through the distal end of the first tube body 112 and is connected to the liquid-filled cavity 101.

[0053] Optionally, the outer diameter of the first tube body 112 is greater than the outer diameter of the second tube body 113 .

[0054] Optionally, the balloon dilatation catheter further includes a first developing ring 13 and a second developing ring 14, which are located in the liquid filling cavity 101 and fixed on the second tube body 113. In this embodiment, the first developing ring 13 and the second developing ring 14 are platinum-iridium alloy rings for in vivo development.

[0055] Optionally, the balloon dilatation catheter further includes a connector 15 and a stress diffusion tube 16, the connector 15 is connected to the proximal end of the multi-lumen tube 11, the connector 15 includes a wire interface and a liquid inlet interface, the wire interface is connected to the guide wire lumen, the liquid inlet interface is connected to the liquid passage 103, one end of the stress diffusion tube 16 is connected to the tube wall of the multi-lumen tube 11, and the other end of the stress diffusion tube 16 is connected to the connector 15. In this embodiment, the wire interface is used for docking the guide wire, and the liquid inlet interface is used for docking the filling pressure relief device.

[0056] Optionally, the connecting member 15 is made of a polymer material, such as PC, but not limited thereto.

[0057] Optionally, the stress diffusion tube 16 is made of a polymer material, such as silicone or polyurethane, but not limited thereto. The stress diffusion tube 16 functions to diffuse the stress near the connecting member 15 to avoid stress concentration.

[0058] Optionally, the balloon 12 is made of PET, PEBAX, PU, ​​PA or other materials by blow molding using a balloon molding machine.

[0059] Optionally, the shape of the array protrusions (first protrusion 1211 and second protrusion 1221) is adapted to the hollow features on the vascular stent 20, including but not limited to circular, diamond, square, strip and other shapes; the shape of the array protrusions is determined according to the grid hollow shape on the vascular stent 20.

[0060] Optionally, the array protrusions (the first protrusion 1211 and the second protrusion 1221) on the balloon 12 are formed by specific tooling and processes during the balloon molding process, and have stable strength. The connection between the array protrusions and the surface of the balloon 12 has a smooth transition. When nested with the vascular stent 20, the array protrusions are placed exactly in the hollow of the wave rod of the vascular stent 20. This feature can expand and extend together with the balloon 12, and does not affect the expansion of the vascular stent 20 while increasing the firmness of the assembly. This feature mainly matches the vascular stent 20 to increase the resistance when the vascular stent 20 is in a compressed and gripped state. The array protrusions will be relatively weakened with the expansion shape of the balloon 12, so it will not affect the pressure relief and withdrawal of the balloon dilatation catheter after the vascular stent 20 is released, and will not cause damage to the blood vessels and lesion sites.

[0061] Optionally, the array protrusions (the first protrusion 1211 and the second protrusion 1221) are distributed in different directions such as circumferential and axial directions. For the same wave rod of the vascular stent 20, there are multi-faceted contacts, which can limit the movement and rotation of the vascular stent 20 in multiple directions.

[0062] Optionally, the array protrusions (the first protrusion 1211 and the second protrusion 1221) just compensate for the gap between the wave bars of the vascular stent 20, and the height of the array protrusions is equal to or slightly higher than the thickness of the vascular stent 20, contacting the side of the vascular stent 20 to the greatest extent, forming a series of barriers between the wave bars of the vascular stent 20, preventing the vascular stent 20 from moving and shifting in the axial direction.

[0063] Optionally, the array protrusions (first protrusion 1211 and second protrusion 1221) are special-shaped protrusions that match the shape of the hollow gap of the vascular stent 20, which can better assemble the vascular stent 20 and the balloon 12, and make full use of the hollow part of the vascular stent 20 to increase the friction between the vascular stent 20 and the balloon 12, making them more tightly assembled.

[0064] Second embodiment

[0065] Figure 7 FIG. 2 is a partial cross-sectional structural diagram of a balloon dilatation catheter according to a second embodiment of the present application. Figure 7 As shown, the balloon dilatation catheter of this embodiment has substantially the same structure as the balloon dilatation catheter of the first embodiment, except that at least two liquid passages 103 are formed in the first tube body 112. The formation of multiple liquid passages 103 in the first tube body 112 can greatly reduce the filling and pressure relief time, and shorten the time when the blood flow is blocked; the balloon dilatation catheter also includes at least one drainage tube 17, the drainage tube 17 is arranged in the liquid filling cavity 101, a drainage channel is formed in the drainage tube 17, the drainage channel forms a liquid inlet and a liquid outlet at both ends of the drainage tube 17, the drainage tube 17 is connected to the first tube body 112, the liquid inlet is connected to a liquid passage 103, and the liquid outlet is connected to the liquid filling cavity 101.

[0066] Optionally, the length of the drainage tube 17 is set according to the length of the vascular stent 20 and the balloon 12. The drainage tube 17 extends 1-10 mm beyond the distal end of the vascular stent 20 and is used to supplement the expansion of the distal end of the balloon 12. The liquid passage 103 not connected to the drainage tube 17 supplies the filling fluid to the proximal end of the balloon 12.

[0067] Optionally, the drainage tube 17 is fitted and fixed to the outer tube wall of the second tube body 113, and the drainage tube 17 does not move and does not affect subsequent process steps. Its shape and position are also not affected by subsequent process steps.

[0068] Optionally, the drainage tube 17 is made of a material with a suitable melting point and hardness, so as to avoid a thin neck caused by welding of the drainage tube 17 and affect the passage of liquid. After the balloon 12 and the vascular stent 20 are pressed and gripped, they are folded and rolled, but the drainage tube 17 supports a complete channel beside the second tube body 113, and there are gaps on both sides of the drainage tube 17 for the proximal liquid of the balloon 12 to flow to the distal end of the balloon 12.

[0069] During the filling and expansion process of the balloon 12 of the present application, water is discharged first from the liquid passage 103 at the proximal end of the balloon 12. Due to the action of the drainage tube 17, the filling liquid flows naturally from the proximal liquid passage 103 of the balloon 12 to the distal end of the balloon 12 along the gaps on both sides of the second tube body 113 and the gaps supported around the drainage tube 17. At the same time, the liquid outlet of the drainage tube 17 directly drains the liquid to the shoulder and neck space at the distal end of the balloon 12, shortening the delay in filling and expansion of the distal and proximal ends of the balloon 12. The two shoulders and necks of the balloon 12 are filled and expanded at the same time, and the two ends of the blood stent are also unfolded at the same time, which greatly reduces the risk of distal displacement and movement of the vascular stent 20.

[0070] Third embodiment

[0071] Figure 8 FIG. 1 is a partial cross-sectional structural diagram of a balloon dilatation catheter according to a third embodiment of the present application. Figure 8 As shown, the balloon dilatation catheter of this embodiment has a substantially similar structure to the balloon dilatation catheter of the second embodiment, except that at least one side hole 102 is provided on the wall of the drainage tube 17, and the side hole 102 connects the liquid filling cavity 101 with the drainage channel. When the number of drainage tubes 17 increases, although the number of diversion positions and channels increases, the diameter of the balloon 12 itself after folding will also increase, which will also affect the final outer diameter of the product. When the number of drainage tubes 17 is limited, by adding side holes 102 to the drainage tubes 17, the liquid flows faster during filling, and the liquid outflow time of several side holes 102 is similar, thereby achieving diversion at different positions and uniform expansion of the balloon 12.

[0072] Optionally, the number of side holes 102 on the drainage tube 17 can be freely designed according to the length of the balloon 12, and the hole diameters can be the same or different, or can increase in size from the proximal end to the distal end, for example, 1, 2, 3, 4, 5, or 6, but not limited to this.

[0073] Fourth embodiment

[0074] Fig. 9 FIG. 4 is a partial cross-sectional structural diagram of a balloon dilatation catheter according to a fourth embodiment of the present application. Fig. 9 As shown, the balloon dilatation catheter of this embodiment has a substantially similar structure to the balloon dilatation catheter of the first embodiment, except that at least three liquid passages 103 are formed in the first tube body 112, and the balloon dilatation catheter includes at least two drainage tubes 17 of different lengths, each of which is connected to the liquid passage 103, and the liquid outlet of at least one drainage tube 17 is arranged near the distal end of the balloon 12, and the liquid outlet of at least one drainage tube 17 is located in the area between the proximal end and the distal end of the balloon 12. The present application arranges a plurality of drainage tubes 17 of different lengths in the balloon 12, which can ensure the effectiveness and uniformity of timely filling of the balloon 12; when the balloon 12 is filled and expanded, even when the vascular stent 20 is in a tightened and gripped state, it can still form a symmetrical dog-bone shape, and expand symmetrically and evenly from both ends to the middle in sequence, effectively preventing the vascular stent 20 from moving.

[0075] Optionally, when the balloon 12 is filled, the filling liquid can be directly diverted to make the balloon 12 expand evenly; especially when it is matched with the vascular stent 20 or the covered stent, the setting of the drainage tube 17 can compensate for the squeezing of the vascular stent 20 on the balloon 12, reduce the difficulty of filling and the restriction of the expansion position, make the balloon 12 and the vascular stent 20 expand evenly, and reduce the risk of unloading of the vascular stent 20. Drainage tubes 17 with different lengths, different numbers, and different side holes 102 can further improve the uniformity and effectiveness of the expansion of the balloon 12, thereby improving the uniformity and stability of the expansion of the vascular stent 20.

[0076] Optionally, at least one drainage tube 17 extends 1-10 mm beyond the distal end of the vascular stent 20 , and at least one drainage tube 17 is 3-10 mm away from the proximal end of the vascular stent 20 .

[0077] Optionally, according to the expansion characteristics of the vascular stent 20 with different structures, drainage tubes 17 of different numbers and lengths can be added to drain the filled liquid to different positions to achieve uniform and safe expansion of the balloon 12 and the vascular stent 20. For example, the first tube body 112 is provided with a liquid passage 103, and drainage tubes 17 are respectively provided at the distal, middle and proximal ends of the balloon 12; when liquid is passed through the connecting piece 15, the balloon 12 expands evenly with the vascular stent 20, better fits the diseased blood vessel, and does not damage the blood vessel.

[0078] The liquid passage 103 of the first tube body 112 which is not connected to the drainage tube 17 is used for filling the proximal end. The drainage tube 17 with a liquid outlet located at the distal end of the balloon 12 transports liquid to the distal end of the balloon 12, thereby achieving uniform expansion of both ends of the balloon 12 and preventing the vascular stent 20 from moving. At the same time, the drainage tube 17 with a liquid outlet located in the middle position of the balloon 12 transports liquid to the middle position of the balloon 12, which can also shorten the time difference between the expansion of the middle position of the vascular stent 20 and the expansion of the two ends, improve the uniformity of the expansion, and prevent the vascular stent 20 from being damaged due to the large difference between the expanded diameters of the two ends of the vascular stent 20 and the middle section.

[0079] Fifth embodiment

[0080] Fig.10 FIG. 1 is a partial cross-sectional structural diagram of a balloon dilatation catheter according to a fifth embodiment of the present application. Fig.10 As shown, the balloon dilatation catheter of this embodiment has a substantially similar structure to the balloon dilatation catheter of the above embodiment, except that the balloon 12 includes an inner balloon body 12a and an outer balloon membrane 12b disposed on the outer surface of the inner balloon body 12a, and array protrusions are formed on the outer balloon membrane 12b. In this embodiment, the material of the outer balloon membrane 12b is the same or better in ductility than the material of the inner balloon body 12a, such as PU, silicone, etc.; through special tooling, circumferential strips, axial strips, or slightly irregularly shaped protrusions are formed on the outer balloon membrane 12b, and are arranged in an orderly manner according to the design of the vascular stent 20.

[0081] Optionally, the inner surface of the outer capsule membrane 12 b is connected to the inner capsule body 12 a , that is, the outer capsule membrane 12 b is attached to the outer surface of the inner capsule body 12 a , and the outer capsule membrane 12 b is in direct contact with the vascular stent 20 .

[0082] Optionally, the array protrusions on the outer capsule membrane 12b are embedded in the hollow area 201 of the vascular stent 20 in a one-to-one correspondence, limiting the displacement of the vascular stent 20 at multiple angles, increasing the contact area, and thus increasing the friction resistance between the vascular stent 20 and the balloon 12. When the balloon 12 is filled and expanded, the outer capsule membrane 12b can be expanded together with the inner capsule 12a because the ductility is equal to or better than that of the inner capsule 12a, without affecting the expansion compliance performance of the inner capsule 12a itself.

[0083] Optionally, the outer capsule membrane 12 b is a polymer film with a certain toughness, and the outer capsule membrane 12 b is adaptively formed into an array of protrusions of a certain shape, size and height according to the design and structure of the matching vascular stent 20 , which can be correspondingly embedded with the vascular stent 20 .

[0084] Sixth embodiment

[0085] Fig.11 FIG. 1 is a partial cross-sectional structural diagram of a balloon dilatation catheter according to a sixth embodiment of the present application. Fig.11As shown, the balloon dilatation catheter of this embodiment has substantially the same structure as the balloon dilatation catheter of the above embodiment, except that the shape of the second protrusion 1221 is different. In this embodiment, the shape of the second protrusion 1221 is a rhombus or irregular strip protrusion.

[0086] The above embodiments are merely illustrative of the principles and effects of the present application and are not intended to limit the present application. Anyone familiar with the technology may modify or change the above embodiments without violating the spirit and scope of the present application. Therefore, all equivalent modifications or changes made by a person of ordinary skill in the art without departing from the spirit and technical ideas disclosed in the present application shall still be covered by the claims of the present application.

Claims

1. A balloon dilatation catheter, characterized in that: It comprises a multi-lumen tube and a balloon, wherein the multi-lumen tube is provided with a guide wire lumen and at least one liquid passage lumen, the balloon is connected to the liquid outlet end of the multi-lumen tube, a liquid-filled cavity is formed between the balloon and the multi-lumen tube, the liquid passage lumen is communicated with the liquid-filled cavity, the balloon has an outer surface for carrying a vascular stent, and the outer surface is provided with an array of protrusions for positioning the vascular stent.

2. The balloon dilatation catheter according to claim 1, characterized in that: The array protrusions include a plurality of first positioning units arranged at intervals from the proximal end to the distal end of the balloon, and each of the first positioning units includes a plurality of first protrusions arranged at intervals around the circumference of the balloon.

3. The balloon dilatation catheter according to claim 2, characterized in that: The vascular stent comprises a plurality of support rib units extending in a circuitous shape, and each of the support rib units comprises a plurality of circuitous bending portions; When the blood vessel stent is sleeved on the balloon, each of the first positioning units is located between two adjacent supporting rib units, and each of the first protrusions is located between the two circuitous bending portions of two adjacent supporting rib units.

4. The balloon dilatation catheter according to claim 3, characterized in that: The array protrusion also includes a plurality of second positioning units spaced apart from each other from the proximal end to the distal end of the balloon, each of the second positioning units is arranged alternately with each of the first positioning units, and each of the second positioning units includes a plurality of second protrusions spaced apart from each other around the circumference of the balloon.

5. The balloon dilatation catheter according to claim 4, characterized in that: Each of the circuitous curved portions comprises an inner curved wall and an outer curved wall arranged opposite to each other, and a hollow area is formed between the two inner curved walls of two adjacent support rib units; When the blood vessel stent is sleeved on the balloon, each of the first protrusions is located between the two outer curved walls of two adjacent support rib units; Each of the second protrusions is in the shape of an elongated strip, and each of the second protrusions is arranged along the axial direction of the balloon; when the vascular stent is sleeved on the balloon, each of the second protrusions is arranged corresponding to the hollow area, and the two ends of each of the second protrusions are respectively in contact with or adjacent to the two inner curved walls of two adjacent support rib units.

6. The balloon dilatation catheter according to claim 1, characterized in that: The height of the array protrusions is greater than or equal to the thickness of the vascular stent.

7. The balloon dilatation catheter according to any one of claims 1 to 6, characterized in that: The multi-lumen tube includes a first tube body and a second tube body, one end of the second tube body is connected to the first tube body, the other end of the second tube body forms a plug, the guide wire lumen is formed in the first tube body and the second tube body, the liquid passage lumen is formed in the first tube body, the proximal end of the balloon is connected to the first tube body, the distal end of the balloon is connected to the plug, and the part of the second tube body away from the plug is located in the liquid-filled cavity.

8. The balloon dilatation catheter according to claim 7, characterized in that: At least two liquid-passing cavities are formed in the first tube body, and the balloon dilatation catheter also includes at least one drainage tube, which is arranged in the liquid-filled cavity. A drainage channel is formed in the drainage tube, and a liquid inlet and a liquid outlet are formed at both ends of the drainage tube respectively. The drainage tube is connected to the first tube body, the liquid inlet is connected to one of the liquid-passing cavities, and the liquid outlet is connected to the liquid-filled cavity.

9. The balloon dilatation catheter according to claim 8, characterized in that: At least one side hole is provided on the tube wall of the drainage tube, and the side hole communicates the liquid filling cavity with the drainage channel.

10. The balloon dilatation catheter according to claim 8, characterized in that: At least three liquid passages are formed in the first tube body, and the balloon dilatation catheter includes at least two drainage tubes of different lengths, each of the drainage tubes is connected to the liquid passage, the liquid outlet of at least one drainage tube is arranged near the distal end of the balloon, and the liquid outlet of at least one drainage tube is located in the area between the proximal end and the distal end of the balloon.

11. The balloon dilatation catheter according to claim 7, characterized in that: The balloon dilatation catheter also includes a first developing ring and a second developing ring. The first developing ring and the second developing ring are located in the liquid-filled cavity and fixed on the second tube body.

12. The balloon dilatation catheter according to any one of claims 1 to 6, characterized in that: The balloon comprises an inner balloon body and an outer balloon membrane arranged on the outer surface of the inner balloon body, and the array protrusions are formed on the outer balloon membrane.

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