High pressure resistant balloon and balloon dilatation catheter

Abstract

The application discloses a high-pressure-resistant balloon and a balloon dilatation catheter, and relates to the technical field of medical devices, which comprises position limiters arranged in an axial symmetry, balloon end bodies fixedly connected to the outer surfaces of the two position limiters, the two balloon end bodies being arranged in an axial symmetry, a balloon middle body fixedly connected to the surfaces of the two balloon end bodies on the side close to each other, and a flexible tip arranged on the side away from the balloon end body of one of the position limiters, wherein the outer surface of the balloon middle body is circumferentially provided with a plurality of braided fiber filaments; the braided fiber filaments, the flexible fiber filament one and the flexible fiber filament two are arranged to form a braided layer for increasing the strength of the balloon, improving the high-pressure resistance of the balloon, and making the strength of the middle part of the balloon smaller than the strength of the two ends, so that the balloon can still deform to some extent after being inflated, thereby facilitating the balloon to conform to the shape of a blood vessel.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a high-pressure-resistant balloon and a balloon dilatation catheter. BACKGROUND

[0002] The balloon dilatation catheter is an intravascular catheter integrated with an inflatable balloon structure near the distal end. By inserting into an artery or vein, the mechanical expansion force after the balloon is filled is used to improve one or more narrowings, occlusions or other lesions in the vascular system.

[0003] To enhance the high-pressure resistance of the balloon, the prior art often covers the surface of the balloon with a film to form a covered balloon. This method increases the high-pressure resistance of the balloon while reducing the elasticity of the balloon surface. When the balloon is inflated in a relatively narrow blood vessel in the human body, the balloon is difficult to enter the inside of the blood vessel. Moreover, due to the complex shape of the blood vessels inside the human body, the balloon with reduced elasticity cannot adapt to the complex shape of the blood vessels. When the blood vessels have sharp turns (such as the physiological bending angle of the carotid artery siphon being 90°), the low-elasticity balloon cannot achieve axial compression deformation to adapt to the change in curvature, resulting in an enlarged area of local support force deficiency. In addition, the balloon with reduced elasticity is difficult to enter the inside of the blood vessels of the patient, and increases the resistance to the advancement of the balloon dilatation catheter inside the blood vessels.

[0004] To solve the above problems, the present application provides a high-pressure-resistant balloon and a balloon dilatation catheter. SUMMARY

[0005] Technical problems to be solved

[0006] Therefore, in view of the deficiencies of the prior art, the present application provides a high-pressure-resistant balloon and a balloon dilatation catheter to solve the problems presented in the background.

[0007] Technical scheme

[0008] To achieve the above-mentioned purpose, the present application provides the following technical scheme: a high-pressure-resistant balloon, comprising two limiters arranged in an axisymmetric manner, the outer surfaces of the two limiters are fixedly connected with two balloon end bodies, the two balloon end bodies are arranged in an axisymmetric manner, the proximal surfaces of the two balloon end bodies are fixedly connected with a balloon middle body, one of the limiters is provided with a flexible tip on the side away from the two balloon end bodies, the outer surface of the balloon middle body is circumferentially arranged with a plurality of braided fiber filaments, the outer surfaces of the two balloon end bodies and the balloon middle body are circumferentially arranged with flexible fiber filaments I, flexible fiber filaments II are arranged between adjacent two flexible fiber filaments I, two positioners are arranged in an axisymmetric manner inside the balloon middle body, and elastic fiber filaments are fixedly connected between the outer surfaces of the two positioners and the inner wall of the balloon middle body.

[0009] Preferably, each of the braided fiber filaments is spirally glued and wound on the outer surface of the middle balloon body, each of the braided fiber filaments does not contact each other, and the pitch between adjacent spirals of each of the braided fiber filaments gradually decreases along the middle part of the middle balloon body to both sides.

[0010] Preferably, the flexible fiber filament one and the flexible fiber filament two are glued and pasted on the outer surface of the balloon end balloon body and the balloon middle balloon body, the flexible fiber filament one is provided with four, and the four flexible fiber filament one divides the balloon end balloon body and the balloon middle balloon body into four petals, the flexible fiber filament two is provided with four groups of eight, and the four groups of flexible fiber filament two are respectively arranged at the middle part of the adjacent two flexible fiber filament one, and the four groups of flexible fiber filament two respectively divide the four petals into three parts, and the volume of the part between the two flexible fiber filament two is half of the volume of the part on both sides of the two flexible fiber filament two.

[0011] Preferably, each of the braided fiber filaments is interwoven with the flexible fiber filament one and the flexible fiber filament two, the included angle between each of the braided fiber filaments and the flexible fiber filament one and the included angle between each of the braided fiber filaments and the flexible fiber filament two is between 15° and 20°, the fiber strength of the flexible fiber filament one is greater than the fiber strength of the flexible fiber filament two, and the braided fiber filament, the flexible fiber filament one and the flexible fiber filament two jointly constitute a braided layer covering the outer surface of the balloon end balloon body and the balloon middle balloon body.

[0012] Preferably, the cross section of the positioning member is star-shaped, the star-shaped is composed of four long pointed ends arranged in a circumferential array and four short pointed ends arranged between adjacent two long pointed ends, each of the flexible fiber filament one is in the same plane with each of the short pointed ends, and each group of the flexible fiber filament two is arranged on both sides of the extended line of the central axis of each of the long pointed ends.

[0013] Preferably, the elastic fiber filaments are arranged in a circumferential array on the outer surface of the positioning member, and each of the elastic fiber filaments is fixedly connected with the outer wall on both sides of the long pointed end of the positioning member, and the extended line of each of the elastic fiber filaments intersects with the flexible fiber filament two.

[0014] The balloon dilatation catheter comprises a catheter seat arranged on the side of the other limiting member away from the flexible pointed end, a catheter filling interface fixedly connected with the top end of the catheter seat, an outer tube fixedly connected with the inside of one end of the catheter seat, an inner tube fixedly installed in the inside of the outer tube, and a flow guide groove arranged in a circumferential array on the outer surface of the inner tube.

[0015] Preferably, the flow guide groove is a bionic sharkskin-like micro groove, and the width of the flow guide groove is less than 5μm.

[0016] Preferably, the two limiting members are slidingly installed on the outer surface of the inner tube away from the catheter seat, the inner tube and the guide wire extend to the inside of the balloon two-end balloon body and the balloon middle balloon body, the two positioning members are attached to the outer surface of the inner tube, and the guide wire away from the catheter seat is in contact with the inner wall of the flexible tip.

[0017] Compared with the prior art, the application provides a high-pressure-resistant balloon and a balloon dilatation catheter, which has the following beneficial effects:

[0018] Through the arrangement of the woven fiber wire, the flexible fiber wire I and the flexible fiber wire II, the woven layer composed of the woven fiber wire, the flexible fiber wire I and the flexible fiber wire II is used to increase the strength of the balloon and improve the high-pressure resistance of the balloon, and the arrangement of the woven fiber wire makes the strength of the middle part of the balloon smaller than that of the two ends, so that the balloon can still deform after inflation, thereby facilitating the balloon to conform to the shape of the blood vessel.

[0019] The existence of the flexible fiber wire I and the flexible fiber wire II strengthens the structural strength of the balloon and makes each part of the balloon in a synchronous state during inflation and contraction. The flexible fiber wire I and the flexible fiber wire II form a three-dimensional truss structure, convert the filling pressure into axial tension instead of local radial expansion force, reduce the risk of rupture of the weak point of the balloon, and at the same time, synchronous contraction makes the blood vessel wall points receive uniform inward tension, eliminates the shear stress concentration phenomenon caused by asynchronous motion, and reduces the risk of local blood vessel intima tear caused by non-uniform contraction. BRIEF DESCRIPTION OF DRAWINGS

[0020] Figure 1 It is a schematic diagram of the overall appearance structure of the application;

[0021] Figure 2 It is a schematic diagram of the plane structure of the application; Figure 1

[0022] Figure 3 It is a schematic diagram of the internal cross-sectional structure of the balloon middle balloon body of the application;

[0023] Figure 4 It is a schematic diagram of the internal plane structure of the balloon middle balloon body of the application;

[0024] Figure 5 It is a schematic diagram of the position relationship of the flexible fiber wire II of the application;

[0025] Figure 6 It is a schematic diagram of the plane structure of the balloon two-end balloon body of the application;

[0026] Figure 7 It is a schematic diagram of the connection relationship plane structure of the positioning member of the application;

[0027] Figure 8 ​A schematic diagram of a flexible fiber filament connection relationship of the present application;

[0028] Figure 9 A schematic diagram of the internal cross-sectional structure of the catheter seat of the present application.

[0029] In the figure: 11, a limiting member; 12, balloon end bodies; 13, a balloon middle body; 14, a flexible tip; 15, braided fiber filaments; 16, flexible fiber filament one; 17, flexible fiber filament two; 18, a positioning member; 19, elastic fiber filaments;

[0030] 21, a catheter seat; 22, a catheter filling interface; 23, an outer tube; 24, an inner tube; 25, a flow guide groove; 26, a guide wire. DETAILED DESCRIPTION

[0031] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative labor fall within the scope of protection of the present application. Embodiment one

[0032] Please refer to Figures 1 to 8 A high-pressure-resistant balloon, comprising two limiting members 11 arranged in axial symmetry, two balloon end bodies 12 fixedly connected to the outer surfaces of the two limiting members 11, the two balloon end bodies 12 arranged in axial symmetry, a balloon middle body 13 fixedly connected to the surfaces of the two balloon end bodies 12 close to each other, one limiting member 11 provided with a flexible tip 14 away from one side of the balloon end body 12, a plurality of braided fiber filaments 15 arranged in a circumferential array on the outer surface of the balloon middle body 13, flexible fiber filament one 16 arranged in a circumferential array on the outer surfaces of the balloon end bodies 12 and the balloon middle body 13, flexible fiber filament two 17 arranged between any two adjacent flexible fiber filament one 16, two positioning members 18 arranged in axial symmetry inside the balloon middle body 13, and elastic fiber filaments 19 fixedly connected between the outer surfaces of the two positioning members 18 and the inner wall of the balloon middle body 13.

[0033] Each braided fiber filament 15 is spirally glued and wound on the outer surface of the balloon middle body 13, the braided fiber filaments 15 do not contact each other, and the pitch between the adjacent spirals of each braided fiber filament 15 gradually decreases from the middle of the balloon middle body 13 to both sides.

[0034] Flexible fiber filament 16 and flexible fiber filament 27 are glued to the outer surfaces of the two end capsules 12 and the middle capsule 13 of the balloon. There are four flexible fiber filaments 16, which divide the two end capsules 12 and the middle capsule 13 of the balloon into four valves. There are four groups of flexible fiber filaments 27, totaling eight. The four groups of flexible fiber filaments 27 are respectively located in the middle of two adjacent flexible fiber filaments 16. The four groups of flexible fiber filaments 217 divide the four valves into three parts, and the volume of the part located between two flexible fiber filaments 217 is half the volume of the part located on both sides of the two flexible fiber filaments 217.

[0035] Each braided fiber 15 is interwoven with flexible fiber 16 and flexible fiber 2 17. The angle between each braided fiber 15 and flexible fiber 16 and the angle between each braided fiber 15 and flexible fiber 2 17 are between 15° and 20°. The fiber strength of flexible fiber 16 is greater than that of flexible fiber 2 17. The braided fiber 15, flexible fiber 16, and flexible fiber 2 17 together form a braided layer covering the outer surface of the balloon body 12 at both ends and the balloon body 13 in the middle.

[0036] The positioning element 18 has a star-shaped cross-section, which is composed of four long tips arranged in a circular array and four short tips arranged between two adjacent long tips. Each flexible fiber filament 16 is in the same plane as each short tip, and each set of flexible fiber filaments 17 is arranged on both sides of the extension line of the central axis of each long tip.

[0037] Among them, the elastic fiber filaments 19 are arranged in a circumferential array on the outer surface of the positioning member 18, and each elastic fiber filament 19 is fixedly connected to the outer walls on both sides of the long tip of the positioning member 18, and the extension line of each elastic fiber filament 19 intersects with the flexible fiber filament 17.

[0038] Among them, the dimensions of braided fiber 15, flexible fiber 16 and flexible fiber 17 are 80–150 μm.

[0039] Among them, reference Figure 5 The limiting member 11 is used to limit the position of the balloon ends 12. The balloon ends 12 and the balloon middle 13 together constitute an inflatable balloon. When the balloon inflates, the balloon ends 12 and the balloon middle 13, which were originally attached to the surfaces of the two positioning members 18, will gradually inflate until they completely detach from the positioning members 18 and are located inside the patient's blood vessels.

[0040] At this time, the spiral-shaped and circumferentially arrayed braided fiber 15 in the middle of the balloon will expand. The braided layer composed of braided fiber 15, flexible fiber 16 and flexible fiber 17 is used to strengthen the structural strength of the balloon body 12 at both ends and the balloon body 13 in the middle after expansion, thereby improving the balloon's high pressure resistance.

[0041] Furthermore, since the pitch between adjacent spirals of the braided fiber filaments 15 gradually decreases along the direction from the middle of the balloon body 13 to both sides, the density of the braided fiber filaments 15 on both sides of the balloon body 13 is greater than that in the middle of the balloon body 13. In this state, the flexibility of the middle part of the balloon body 13 is greater than that on both sides. While ensuring the overall high pressure resistance of the balloon, the balloon body 13 still has the ability to deform after expansion, so that the balloon can deform along the shape of the blood vessel as it moves in the blood vessel.

[0042] The flexible fiber filament 16 and flexible fiber filament 17 are interwoven and combined with the braided fiber filament 15 to form a braided layer to increase the strength of the balloon. The flexible fiber filament 16 divides the balloon into four valves. In the initial state, the two end valves 12 and the middle valve 13 of the balloon are attached to the surface of the positioning element 18. The presence of the flexible fiber filament 16 and flexible fiber filament 17 ensures that the four valves of the balloon can expand and contract uniformly during inflation. Multiple flexible fiber filaments 16 and 17, along with the braided fiber filament 15, form a mesh support frame that evenly transmits the inflation pressure to the edges of all valves, thereby avoiding the risk of rupture at weak points caused by local overload. The uniform contraction also avoids the shear force generated by local dragging, while maintaining the axial stability of the balloon during inflation and contraction.

[0043] Specifically, when the balloon at both ends 12 and the balloon in the middle 13 inflate, the flexible fiber filament 16 and the flexible fiber filament 2 will deform accordingly, restricting the position of the balloon at both ends 12 and the balloon in the middle 13 inflate. When inflated, the elastic fiber filament 19 located inside the balloon in the middle 13 inflates elastically until the balloon at both ends 12 and the balloon in the middle 13 inflate completely.

[0044] When the balloon ends 12 and the balloon middle 13 contract, the elastic fiber filament 19 will contract first, and during the contraction of the balloon middle 13, it will simultaneously pull the balloon middle 13 to contract synchronously, thus assisting the contraction of the balloon middle 13.

[0045] In the above process, four flexible fiber filaments 16 are provided, and the four flexible fiber filaments 16 divide the two end capsules 12 and the middle capsule 13 of the balloon into four flaps. Four groups of flexible fiber filaments 17 are provided, totaling eight. The four groups of flexible fiber filaments 17 are respectively located in the middle of two adjacent flexible fiber filaments 16. The cross-section of the positioning member 18 is set as a star shape. The star shape is composed of four long tips arranged in a circular array and four short tips located between two adjacent long tips. Each group of flexible fiber filaments 17 is respectively located on both sides of the extension line of the central axis of each long tip.

[0046] Furthermore, the structural strength of flexible fiber filament 16 is greater than that of flexible fiber filament 17. Therefore, when the balloon body 13 in the middle contracts, flexible fiber filament 17 is used to limit the position of the balloon body 13 during contraction. During contraction, flexible fiber filament 17 causes the balloon body 13 in the middle to adhere to the two sides of the long tip on the limiting member 11, and simultaneously ensures the uniform contraction of the balloon body 13 in the middle. Uniform contraction ensures that all points on the balloon surface retract at the same rate, eliminating the shear force caused by asynchronous movement and avoiding vascular damage caused by local dragging.

[0047] The angle between the braided fiber 15 and the flexible fiber 16, and the angle between each braided fiber 15 and the flexible fiber 17, are between 15° and 20°. This can decompose the axial load into radial support force and tangential friction force. This force component mechanism can reduce local stress peaks and avoid material fatigue fracture.

[0048] Example 2

[0049] Please see Figures 1 to 4 and Figure 9 The balloon dilation catheter includes a catheter seat 21 disposed on the side of another limiting member 11 away from the flexible tip 14. The top end of the catheter seat 21 is fixedly connected to a catheter filling interface 22. An outer tube 23 is fixedly connected to the inside of one end of the catheter seat 21. An inner tube 24 is fixedly installed inside the outer tube 23. The outer surface of the inner tube 24 is provided with a circumferential array of guide grooves 25. A guide wire 26 is slidably disposed inside the guide grooves 25.

[0050] Among them, the flow guide groove 25 is a biomimetic shark skin-shaped microgroove, and the width of the flow guide groove 25 is less than 5μm.

[0051] Both limiting members 11 are slidably installed on the outer surface of the inner tube 24 away from the catheter seat 21. The inner tube 24 and the guide wire 26 extend to the interior of the balloon body 12 at both ends and the balloon body 13 in the middle. Both positioning members 18 are fitted to the outer surface of the inner tube 24. The end of the guide wire 26 away from the catheter seat 21 abuts against the inner wall of the flexible tip 14.

[0052] The catheter hub 21 is used to restrict the position of the catheter filling interface 22, the outer tube 23, the inner tube 24 and the guidewire 26. The catheter filling interface 22 is used to connect external devices, so that the balloon body 13 in the middle and the balloon bodies 12 at both ends of the balloon expand. The inner tube 24 is used to extend into the patient's blood vessels.

[0053] It should be noted that the outer surfaces of the balloon ends 12, the balloon middle 13, and the inner tube 24 are all coated with a hydrophobic coating that is harmless to the human body.

[0054] Among them, the flow channel 25, which is set with biomimetic shark skin-like microgrooves, reduces the turbulent kinetic energy of the boundary layer of the traditional plate by changing the near-wall velocity gradient distribution. Blood components generate a spiral flow trajectory under the guidance of the channel, thereby reducing the red blood cell aggregation rate and platelet deposition.

[0055] It should be noted that, in this document, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0056] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A high-pressure resistant balloon, characterized in that: The device includes axially symmetrically arranged limiting members (11), with balloon end caps (12) fixedly connected to the outer surfaces of both limiting members (11). The balloon end caps (12) are axially symmetrically arranged, and a balloon middle cap (13) is fixedly connected to the surface of the balloon end caps (12) on the side closest to each other. A flexible tip (14) is provided on the side of one of the limiting members (11) away from the balloon end caps (12). The outer surface of the balloon middle cap (13) is arranged in a circumferential array with... Multiple braided fiber filaments (15) are arranged in a circular array on the outer surface of the balloon body (12) at both ends and the balloon body (13) in the middle. Flexible fiber filaments (16) are arranged in a circular array. Flexible fiber filaments (17) are arranged between each two adjacent flexible fiber filaments (16). Two positioning elements (18) are arranged axially symmetrically inside the balloon body (13). Elastic fiber filaments (19) are fixedly connected between the outer surface of the two positioning elements (18) and the inner wall of the balloon body (13). Each braided fiber (15) is spirally bonded and wrapped around the outer surface of the middle part of the balloon (13). Each braided fiber (15) does not contact each other, and the pitch between adjacent spirals of each braided fiber (15) gradually decreases along the middle part of the balloon (13) towards both sides. Flexible fiber filament 1 (16) and flexible fiber filament 2 (17) are glued to the outer surface of the two end capsules (12) and the middle capsule (13) of the balloon. There are four flexible fiber filament 1 (16). The four flexible fiber filament 1 (16) divide the two end capsules (12) and the middle capsule (13) of the balloon into four valves. There are four groups of flexible fiber filament 2 (17) with a total of eight. The four groups of flexible fiber filament 2 (17) are respectively located in the middle of two adjacent flexible fiber filament 1 (16). The four groups of flexible fiber filament 2 (17) divide the four valves into three parts. The volume of the part located between two flexible fiber filament 2 (17) is half the volume of the part located on both sides of two flexible fiber filament 2 (17). Each braided fiber filament (15) is interwoven with flexible fiber filament one (16) and flexible fiber filament two (17). The angle between each braided fiber filament (15) and flexible fiber filament one (16) and the angle between each braided fiber filament (15) and flexible fiber filament two (17) is between 15° and 20°. The fiber strength of flexible fiber filament one (16) is greater than that of flexible fiber filament two (17). The braided fiber filament (15), flexible fiber filament one (16) and flexible fiber filament two (17) together constitute a braided layer covering the outer surface of the balloon body (12) at both ends and the balloon body (13) in the middle.

2. The high-pressure resistant balloon according to claim 1, characterized in that: The cross-section of the positioning element (18) is set as a star shape. The star shape is composed of four long tips arranged in a circular array and four short tips arranged between two adjacent long tips. Each flexible fiber filament (16) is in the same plane as each short tip, and each set of flexible fiber filaments (17) is arranged on both sides of the extension line of the central axis of each long tip.

3. A high-pressure resistant balloon according to claim 2, characterized in that: The elastic fiber filaments (19) are arranged in a circumferential array on the outer surface of the positioning member (18), and each elastic fiber filament (19) is fixedly connected to the outer walls on both sides of the long tip of the positioning member (18). The extension line of each elastic fiber filament (19) intersects with the second flexible fiber filament (17).

4. A balloon dilation catheter, used in any one of the high-pressure resistant balloons described in claims 1-3, characterized in that: The device includes a catheter seat (21) located on the side away from the flexible tip (14) of another limiting member (11). The top of the catheter seat (21) is fixedly connected to a catheter filling interface (22). An outer tube (23) is fixedly connected to the inside of one end of the catheter seat (21). An inner tube (24) is fixedly installed inside the outer tube (23). A guide groove (25) is formed in a circular array on the outer surface of the inner tube (24). A guide wire (26) is slidably arranged inside the guide groove (25).

5. A balloon dilation catheter according to claim 4, characterized in that: The guide groove (25) is a biomimetic shark skin-shaped microgroove, and the width of the guide groove (25) is less than 5μm.

6. A balloon dilation catheter according to claim 4, characterized in that: Both limiting members (11) are slidably installed on the outer surface of the inner tube (24) away from the catheter seat (21). The inner tube (24) and the guide wire (26) extend to the interior of the balloon body (12) at both ends and the balloon body (13) in the middle. Both positioning members (18) are fitted to the outer surface of the inner tube (24). The end of the guide wire (26) away from the catheter seat (21) abuts against the inner wall of the flexible tip (14).

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