Balloon dilatation catheter

Abstract

The application discloses a balloon dilatation catheter and relates to the technical field of medical devices. The balloon dilatation catheter comprises a balloon main body, an inner lumen tube and a wire bundle winding structure, and the inner lumen tube is arranged through the balloon main body. The balloon main body comprises an inner layer balloon and an outer layer balloon. The outer layer balloon is arranged around the inner layer balloon. The wire bundle winding structure comprises an intermediate reinforcing structure and an inner lumen protection structure. The intermediate reinforcing structure is arranged between the inner layer balloon and the outer layer balloon, and is used for enhancing the pressure resistance of the balloon main body. The inner lumen protection structure is arranged around the outer periphery of the inner lumen tube, and is used for preventing the inner lumen tube from collapsing and embracing the guide wire inside. The application improves the structure of the balloon, so that the balloon has high pressure resistance, the thickness of the balloon is reduced, the folding and winding capacity of the balloon is improved, the passability of the balloon in blood vessels is improved, and thus the operation difficulty is reduced. In addition, the application improves the effect in treating acute vascular occlusive diseases.

Description

TECHNICAL FIELD

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

[0002] Balloon dilatation catheter is one of the most widely used medical devices in vascular intervention treatment, which is used for treating vascular stenosis or occlusion. The principle is to insert the balloon catheter into the stenosis part of the blood vessel through percutaneous puncture technology, and to expand the balloon under the guidance of medical imaging equipment, so as to expand the stenosis part of the blood vessel and restore to normal lumen diameter. Compared with surgical operation, balloon dilatation technology has the advantages of simple operation, small trauma, few complications, repeatable operation, etc., and the postoperative recovery is fast, safe and reliable.

[0003] The existing single-layer high polymer balloon has poor pressure resistance. In order to improve the pressure resistance of the balloon, the common method at present is to weave fibers onto the outer surface of the balloon by using a weaving machine, and to coat glue for bonding and fixing to form a high-pressure resistant balloon. However, in the weaving process, the fiber layer is mostly plain or twill, and when the fiber is woven to the tapered part of the balloon, the fiber will collapse due to the existence of the inclined surface, so a thicker glue layer is needed to stably connect the fiber layer and the outer surface of the balloon. This method not only increases the thickness of the balloon, but also makes the balloon harder and occupies a larger volume during folding and winding, which affects the passability of the balloon in the blood vessel and increases the difficulty of the operation process. SUMMARY

[0004] The main purpose of the present application is to provide a balloon dilatation catheter, which aims to make the balloon have higher pressure resistance while reducing the thickness of the balloon, improving the folding and winding ability of the balloon, and improving the passability of the balloon in the blood vessel, so as to reduce the difficulty of operation.

[0005] To achieve the above purpose, the present application provides a balloon dilatation catheter, which comprises a balloon main body, an inner lumen tube and a wire bundle winding structure, the inner lumen tube is arranged through the balloon main body, and the balloon main body comprises:

[0006] an inner layer balloon; and

[0007] an outer layer balloon arranged around the inner layer balloon;

[0008] The wire bundle winding structure comprises an intermediate reinforcing structure and an inner lumen protection structure, the intermediate reinforcing structure is arranged between the inner layer balloon and the outer layer balloon, and the intermediate reinforcing structure is used for enhancing the pressure resistance of the balloon main body, and the inner lumen protection structure is arranged around the outer periphery of the inner lumen tube, and the inner lumen protection structure is used for preventing the inner lumen tube from collapsing to embrace the guide wire inside.

[0009] Optionally, the intermediate reinforcing structure is formed by winding a plurality of wires on the outer surface of the inner balloon and fixing the wires to the inner wall of the outer balloon; and / or

[0010] The inner lumen protection structure is formed by winding a plurality of wires on the outer surface of the inner lumen tube and tightly fixing the wires, or the inner lumen protection structure is formed by winding a plurality of wires on the outer surface of the inner lumen tube with a gap between the wires.

[0011] Optionally, each of the wires comprises an intermediate winding segment, a connecting segment and an inner lumen winding segment connected in sequence, at least one group of the intermediate winding segments is wound on the outer surface of the inner balloon to form the intermediate reinforcing structure, at least one group of the inner lumen winding segments is wound on the outer periphery of the inner lumen tube to form the inner lumen protection structure, each group of the intermediate winding segments and each group of the inner lumen winding segments comprises at least one wire coil, the inner balloon is provided with a plurality of wire passing holes communicating with the inner lumen of the inner balloon, and the wire passing holes are used for allowing the connecting segments to pass through so as to connect the intermediate winding segments and the inner lumen winding segments.

[0012] Optionally, the winding direction of the inner lumen winding segment is opposite to the winding direction of the intermediate winding segment.

[0013] Optionally, the wire diameter of the wire is 0.1-2 mm.

[0014] Optionally, the distance between two adjacent intermediate winding segments is 1-2 mm.

[0015] Optionally, the intermediate winding segment is fixed between the inner balloon and the outer balloon by means of glue or heat forming.

[0016] Optionally, the wire is made of high-strength high polymer material.

[0017] Optionally, the balloon dilatation catheter further comprises a terminal tube, the terminal tube is sleeved on the distal tube leg of the balloon main body and the distal outer periphery of the inner lumen tube, or the terminal tube is arranged between the distal tube leg of the balloon main body and the inner lumen tube.

[0018] Optionally, the distal outer diameter of the terminal tube is 0.018-0.045 inch.

[0019] In the technical scheme of the present application, the balloon dilatation catheter comprises a balloon main body, a lumen tube and a wire bundle winding structure, the lumen tube is arranged through the balloon main body; the balloon main body comprises an inner layer balloon and an outer layer balloon; the outer layer balloon is arranged around the inner layer balloon; the wire bundle winding structure comprises an intermediate reinforcing structure and a lumen protection structure, the intermediate reinforcing structure is arranged between the inner layer balloon and the outer layer balloon, and the intermediate reinforcing structure is used for enhancing the pressure resistance of the balloon main body; the lumen protection structure is arranged around the outer periphery of the lumen tube, and the lumen protection structure is used for preventing the lumen tube from collapsing to embrace the guide wire inside. It can be understood that the present application improves the structure of the balloon, by arranging the double-layer balloon structure and arranging the intermediate reinforcing structure between the double-layer balloon, the balloon has high pressure resistance, at the same time, the thickness of the balloon is reduced, the folding and winding capacity of the balloon is improved, the passability of the balloon in the blood vessel is improved, thereby reducing the operation difficulty. In addition, the balloon dilatation catheter of the present application is provided with the lumen protection structure, which effectively prevents the lumen tube from collapsing to embrace the guide wire inside, greatly improves the effect of the balloon dilatation catheter in treating acute vascular occlusive diseases, and reduces the risk of ischemia-reperfusion injury. BRIEF DESCRIPTION OF DRAWINGS

[0020] In order to more clearly illustrate the technical scheme in the embodiments of the present application or the prior art, the drawings needed to be used in the following embodiment or prior art description will be briefly introduced. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative labor on the basis of the drawings shown.

[0021] Figure 1 It is an embodiment of the structure of the balloon dilatation catheter of the present application.

[0022] Figure 2 It is another embodiment of the structure of the balloon dilatation catheter of the present application.

[0023] Explanation of reference numerals:

[0024] 10, balloon main body; 20, lumen tube; 30, end tube; 11, inner layer balloon; 12, outer layer balloon; 13, wire bundle winding structure; 131, intermediate winding section; 132, connecting section; 133, lumen winding section; 21, developing ring.

[0025] The implementation of the object of the present application, functional characteristics and advantages will be further described with reference to the embodiments and the drawings. DETAILED DESCRIPTION

[0026] With reference to the drawings of the embodiments of the present application, the technical solutions in the embodiments of the present application will be clearly and completely described. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments of the present application, all the other embodiments obtained by a person of ordinary skill in the art without creative effort belong to the protection scope of the present application.

[0027] It should be noted that all the directionality indications (such as up, down, left, right, front, back, and the like) in the embodiments of the present application are only used to explain the relative position relationship, movement condition and the like between components in a certain specific posture (as shown in the drawings), and if the specific posture changes, the directionality indications also change accordingly.

[0028] In the description of the present application, it should be noted that unless specifically defined and limited, the terms “mounting”, “connection” and “connecting” should be understood in a broad sense, for example, can be fixed connection, can also be detachable connection, or integrally connected; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, and can be the communication inside two elements. For a person of ordinary skill in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0029] In addition, the description of “first”, “second” and the like in the present application is only for the purpose of description, and cannot be understood as indicating or implying the relative importance of the indicated technical features or implicitly indicating the number of the indicated technical features. Therefore, the features limited by “first” and “second” can explicitly or implicitly include at least one of the features. The meaning of “and / or” appearing throughout the text is to include three parallel solutions, for example, “A and / or B” includes A solution, or B solution, or A and B solutions. The technical solutions of each embodiment can be combined with each other, but it must be based on the fact that a person of ordinary skill in the art can realize it, and when the combination of technical solutions appears contradictory or unachievable, it should be considered that the combination of technical solutions does not exist, and is not within the protection scope of the present application.

[0030] The existing single-layer polymer balloon has poor pressure resistance. In order to improve the pressure resistance of the balloon, the common method at present is to weave fibers onto the outer surface of the balloon by using a weaving machine, and to coat glue for bonding and fixing to form a high-pressure resistant balloon. However, in the weaving process, the fiber layer is mostly plain or twill, and when the fibers are woven to the conical part of the balloon, the fibers will collapse due to the existence of the inclined surface, so a thicker layer of glue is needed to stably connect the fiber layer and the outer surface of the balloon. This method not only increases the thickness of the balloon, but also makes the balloon harder and occupies a larger volume during the folding and winding process, affecting the passability of the balloon in the blood vessel and increasing the difficulty of the operation process.

[0031] Moreover, in the prior art, the inner lumen tube of the balloon dilatation catheter is too small, and after inserting a guide wire, blood flow cannot pass smoothly. At the same time, when the balloon is expanded to dilate the lesion under high pressure, the inner lumen tube collapses around the guide wire inside, thereby blocking the blood flow. These problems seriously affect the effect of the balloon dilatation catheter in treating acute vascular occlusive diseases, and increase the risk of ischemia-reperfusion injury.

[0032] Based on this, the present application provides a superhigh-pressure-resistant balloon dilatation catheter to solve the above problems.

[0033] Reference Figure 1 and Figure 2 In some embodiments of the present application, the balloon dilatation catheter comprises a balloon body 10, an inner lumen tube 20 and a wire winding structure 13, the inner lumen tube 20 is arranged through the balloon body 10; the balloon body 10 comprises an inner layer balloon 11 and an outer layer balloon 12; the outer layer balloon 12 is arranged around the inner layer balloon 11; the wire winding structure 13 comprises a middle reinforcing structure and an inner lumen protection structure, the middle reinforcing structure is arranged between the inner layer balloon 11 and the outer layer balloon 12, and is used for enhancing the pressure resistance of the balloon body 10; the inner lumen protection structure is arranged around the outer periphery of the inner lumen tube 20, and is used for preventing the inner lumen tube 20 from collapsing around the guide wire inside.

[0034] In this embodiment, the inner layer balloon 11 is made of high polymer materials such as nylon, and the outer layer balloon 12 can also be made of high polymer materials such as nylon. The inner layer balloon 11 and the outer layer balloon 12 can be single-layer, double-layer or multi-layer structures, which are not limited here.

[0035] In this embodiment, the middle reinforcing structure can be a layer, double layers or multi-layer fiber mesh, or a plurality of spaced wire coils, the wire coils are arranged at the part which is easy to break after the balloon is inflated, or other structures formed by wires, which have a certain elasticity and can enhance the pressure resistance of the balloon body 10 as a whole, and the wire can be made of high-strength high polymer materials, which are not limited here.

[0036] Specifically, the middle reinforcing structure can be formed by winding a plurality of wires on the outer surface of the inner layer balloon 11 and fixing them with the inner wall surface of the outer layer balloon 12.

[0037] In this embodiment, the inner lumen protection structure can be a plurality of spaced wire coils, which are arranged at the position where the inner lumen tube 20 is easy to collapse, or other structures formed by wires, which are not limited in detail.

[0038] Specifically, the inner lumen protection structure is formed by winding a plurality of wires on the outer surface of the inner lumen tube 20 and tightly abutting them, or the inner lumen protection structure is formed by winding a plurality of wires around the outer surface of the inner lumen tube 20 with a gap between them.

[0039] It can be understood that the present application improves the structure of the balloon. By arranging the double-layer balloon structure and the intermediate reinforcing structure between the double-layer balloon, the balloon has high pressure resistance, the thickness of the balloon is reduced, the folding and winding capacity of the balloon is improved, the passing performance of the balloon in the blood vessel is improved, and the operation difficulty is reduced.

[0040] In addition, the balloon dilation catheter of the present application effectively prevents the inner lumen tube 20 from collapsing to embrace the guide wire inside it by arranging the inner lumen protection structure, greatly improves the effect of the balloon dilation catheter in treating acute vascular occlusive diseases, and reduces the risk of ischemia-reperfusion injury.

[0041] Referring to Figure 1 and Figure 2 In some embodiments, the wire forming the wire bundle winding structure 13 all includes an intermediate winding section 131, a connecting section 132 and an inner lumen winding section 133 connected in sequence, at least one group of intermediate winding sections 131 is arranged on the outer surface of the inner balloon 11 to form an intermediate reinforcing structure, at least one group of inner lumen winding sections 133 is arranged on the outer periphery of the inner lumen tube 20 to form an inner lumen protection structure, each group of intermediate winding sections 131 and each group of inner lumen winding sections 133 all include at least one coil of wire, the inner balloon 11 is provided with a plurality of wire holes communicating with the inner lumen of the inner balloon 11, the wire holes are used for the connecting section 132 to pass through, so that the connecting section 132 connects the intermediate winding section 131 and the inner lumen winding section 133. In this way, it is helpful to improve the convenience of production and manufacturing, save materials, further reduce the thickness of the balloon main body 10, further improve the folding and winding capacity of the balloon, the passing performance of the balloon in the blood vessel is better, and the inner lumen tube 20 can be further prevented from collapsing to embrace the guide wire inside it, the effect of the balloon dilation catheter in treating acute vascular occlusive diseases is further improved, and the risk of ischemia-reperfusion injury is further reduced.

[0042] In the present embodiment, the intermediate winding section 131 can be fixed between the inner balloon 11 and the outer balloon 12 by means of glue or heat forming.

[0043] In order to make the balloon main body 10 have high pressure resistance while reducing the amount of material as much as possible, in the present embodiment, the wire diameter of the wire is preferably 0.1-2mm, and the distance between adjacent two intermediate winding sections 131 is 1-2mm, which is not limited here.

[0044] In some embodiments, as shown in Figure 2 , a gap is left between the wire forming the intermediate winding section 131 and the inner lumen tube 20, and the intermediate winding section 131 is used to prevent the inner lumen tube 20 from collapsing to embrace the guide wire inside it.

[0045] In manufacturing, as shown in Figure 2As shown, one end of the wire can be threaded through the threading hole to the outer surface of the inner balloon 11, and can be wound around the intermediate winding section 131 in the circumferential direction on the outer surface of the inner balloon 11, and then the other end of the wire located in the inner space of the inner balloon 11 can be wound around the lumen winding section 133 on the outer periphery of the inner lumen tube 20 (a gap is left between the wire and the inner lumen tube 20), and then threaded out of the other threading hole arranged at the opposite position of the inner balloon 11, and the next group of intermediate winding sections 131 and lumen winding sections 133 are continuously wound, and a group of intermediate winding sections 131 and lumen winding sections 133 are arranged at intervals along the axial direction of the inner balloon 11; finally, the inner surface of the outer balloon 12 can be fixed to the outer surface of the inner balloon 11 and the wire thereon by using a heat forming or glue connection method.

[0046] The present application sets multiple groups of intermediate winding sections 131, which restrict the balloon when the balloon is inflated, prevent it from deforming more, so that the balloon body 10 can withstand greater pressure.

[0047] The balloon dilation catheter of the present application sets multiple groups of lumen winding sections 133, effectively prevents the inner lumen tube 20 from collapsing and embracing the guide wire inside, greatly improves the effect of the balloon dilation catheter in treating acute vascular occlusive diseases, and reduces the risk of ischemia-reperfusion injury.

[0048] Referring to Figure 1 and Figure 2 In some embodiments, the winding direction of the lumen winding section 133 is opposite to the winding direction of the intermediate winding section 131, which can facilitate winding the wire, facilitate production and processing, and achieve better enhancement and protection effect.

[0049] In some other embodiments, as shown in Figure 1 The wire constituting the intermediate winding section 131 is in close contact with the outer peripheral wall of the inner lumen tube 20, and the intermediate winding section 131 is used to prevent the inner lumen tube 20 from collapsing and embracing the guide wire inside.

[0050] In manufacturing, as Figure 1As shown, one end of the wire can be threaded through the threading hole to the outer surface of the inner balloon 11, and can be wound several times on the outer surface of the inner balloon 11 in the circumferential direction to form the intermediate winding section 131; then, the other end of the wire located in the inner space of the inner balloon 11 is wound several times on the inner lumen tube 20, and is wound in the opposite direction to form the inner lumen winding section 133 (the wire is in close contact with the outer peripheral wall of the inner lumen tube 20), and is then threaded out of the other threading hole arranged at the opposite position of the inner balloon 11, and continues to wind the next group of intermediate winding sections 131, and a group of intermediate winding sections 131 and inner lumen winding sections 133 are arranged at intervals along the axial direction of the inner balloon 11; finally, the inner surface of the outer balloon 12 can be fixed to the outer surface of the inner balloon 11 and the wire thereon by using a heat forming or glue connection method.

[0051] In addition, in some embodiments, with reference to Figure 1 and Figure 2 , the balloon dilation catheter can further include a tip tube 30, which is sleeved on the distal tube leg of the balloon body 10 and the distal outer periphery of the inner lumen tube 20; or the tip tube 30 is arranged between the distal tube leg of the balloon body 10 and the inner lumen tube 20, and the tip tube 30 can be connected together with the tube leg of the balloon body 10 and the inner lumen tube 20 by welding or clamping.

[0052] In this embodiment, the inner lumen tube 20 can be a polyether block polyamide tube or a nylon tube, and is preferably a Pebax tube. The distal outer diameter of the tip tube 30 can be 0.018-0.045 inches.

[0053] In this embodiment, the inner lumen tube 20 can be a polyether block polyamide tube or a nylon tube, and is preferably a Pebax tube. The distal outer diameter of the tip tube 30 can be 0.018-0.045 inches. Figure 1 and Figure 2 In this embodiment, the inner lumen tube 20 can be provided with a developing portion on the part located in the inner lumen of the balloon body 10, which is used to make the balloon visible under the image detection light. Preferably, with reference to Figure 1 and Figure 2 , the developing portion can be a plurality of developing rings 21. This is convenient for the operator to know the position of the balloon body 10 in the human body, and is beneficial to improve the convenience and safety of operation.

[0054] The above description is only an optional embodiment of the present application, and does not limit the patent scope of the present application, and any equivalent structural transformation made under the inventive concept of the present application, or direct / indirect application in other related technical fields is included in the patent protection scope of the present application.

Claims

1. A balloon dilation catheter, characterized in that, The balloon dilation catheter includes a balloon body, an inner lumen, and a wire harness winding structure. The inner lumen extends through the balloon body. The balloon body includes: Inner balloon; and An outer balloon, which is disposed around the inner balloon; The wire harness winding structure includes an intermediate reinforcement structure and an inner cavity protection structure. The intermediate reinforcement structure is disposed between the inner balloon and the outer balloon and is used to enhance the pressure resistance of the balloon body. The inner cavity protection structure is arranged around the outer periphery of the inner tube and is used to prevent the inner tube from collapsing and to surround the guidewire inside it. The intermediate reinforcement structure is formed by winding several wires around the outer surface of the inner balloon and fixing them to the inner wall of the outer balloon; and / or the inner cavity protection structure is formed by winding several wires around the outer surface of the inner cavity tube and the two are in close contact, or the inner cavity protection structure is formed by wrapping several wires around the outer surface of the inner cavity tube and there is a gap between the two. Each of the wires includes an intermediate winding section, a connecting section, and an inner cavity winding section connected in sequence. At least one set of the intermediate winding sections is wound around the outer surface of the inner balloon to form the intermediate reinforcement structure. At least one set of the inner cavity winding sections is wound around the outer periphery of the inner tube to form the inner cavity protection structure. Each set of the intermediate winding sections and each set of the inner cavity winding sections includes at least one loop of wire. The inner balloon is provided with a plurality of through holes communicating with the inner cavity of the inner balloon. The through holes are used for the connecting section to pass through so that the connecting section connects the intermediate winding section and the inner cavity winding section.

2. The balloon dilation catheter as described in claim 1, characterized in that, The winding direction of the inner cavity winding section is opposite to that of the winding direction of the intermediate winding section.

3. The balloon dilation catheter as described in claim 1, characterized in that, The wire diameter is 0.1-2mm.

4. The balloon dilation catheter as described in claim 1, characterized in that, The distance between two adjacent intermediate winding segments is 1-2 mm.

5. The balloon dilation catheter as described in claim 1, characterized in that, The intermediate winding section is fixed between the inner balloon and the outer balloon by glue or thermoforming.

6. The balloon dilation catheter as described in claim 1, characterized in that, The wire is made of high-strength polymer material.

7. The balloon dilation catheter as described in claim 1, characterized in that, The balloon dilation catheter further includes a distal tube, which is sleeved on the distal leg of the balloon body and the distal periphery of the inner lumen tube; or the distal tube is located between the distal leg of the balloon body and the inner lumen tube.

8. The balloon dilation catheter as described in claim 7, characterized in that, The distal outer diameter of the end tube is 0.018-0.045 inches.

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