Anti-fracture high-pressure balloon dilatation catheter

Abstract

The utility model relates to an anti-fracture high-pressure balloon dilatation catheter. A balloon body of a high-pressure balloon comprises three layers of structures which are sequentially attached to form a whole. The inner layer is made of materials capable of tolerating high pressure, the middle layer is of a net-shaped structure formed by weaving metal nets, the structure can guarantee that the balloon does not deform under the high pressure condition, meanwhile, the original vein stent can not make direct contact with the materials of the inner layer, cutting of the stent to the balloon body is eradicated, and the balloon is prevented from being broken. The outer layer is made of materials with high toughness and abrasion resistance, it can be guaranteed that the metal net cannot be tangled with the intravenous stent in the expansion and contraction process of the balloon, contraction and withdrawing of the balloon are facilitated, the outer layer is not prone to being damaged by the edge of the stent due to the high toughness and abrasion resistance of the balloon, and even if the outer layer is damaged, the balloon can not be damaged. And the stent still cannot be in direct contact with the inner-layer balloon body, so that the balloon body cannot be broken.

Description

Technical Field

[0001] The utility model relates to a high-pressure balloon dilation catheter with anti-rupture function, belonging to the technical field of medical devices. Background Art

[0002] At present, for the stenosis or occlusive lesions of deep veins (such as inferior vena cava, iliac vein, femoral vein), it is often necessary to implant a venous stent to open it. However, when chronic occlusion occurs in and around the venous stent, a high-pressure balloon is usually required to dilate the occluded segment. Currently, relatively common high-pressure resistant balloons such as Mustang balloon of Boston Scientific and Atlas Gold balloon of BD. The membrane of these balloons is relatively thick, which can generate a relatively high pressure on chronic occlusive lesions and is not easily ruptured. However, when dilating the proximal and distal ends of the stent, the edge of the stent will cut the balloon body. Therefore, even the above-mentioned high-pressure balloons often rupture, which in turn affects the treatment effect of interventional surgery.

[0003] The Chinese patent document with publication number CN117482365A and publication date February 2, 2024 discloses "a balloon dilation catheter with anti-rupture function". This balloon dilation catheter reduces the risk of balloon rupture by setting axial extension units at the proximal and distal ends. However, this balloon still cannot withstand high pressure and cannot ensure that the balloon does not deform under high pressure. Therefore, the dilation effect on chronic occlusive lesions in the stent is not good.

[0004] When performing balloon dilation on chronic occlusive lesions in a venous stent, it is required that the balloon does not deform under high pressure, and at the same time, the balloon is not easily ruptured when contacting the edge of the metal stent for dilation. Summary of the Invention

[0005] The purpose of this utility model patent is to provide a high-pressure balloon dilation catheter for intravascular stent occlusion. The balloon body of this balloon consists of three layers. The inner layer is made of a material that can withstand relatively high pressures, and materials such as the Mustang balloon materials (Pebax 7033 and Vestamid L2101F) of Boston Scientific Corporation can be referred to. The middle layer is a mesh structure formed by weaving metal wires. This structure can ensure that the balloon does not deform under high pressure, and at the same time, it can also ensure that the original venous stent does not directly contact the inner balloon body (inner layer material), eliminating the cutting of the balloon body by the stent and avoiding balloon rupture. The outer layer material is selected from materials with strong toughness and wear resistance, such as ultra-high molecular weight polyethylene fiber. The outer layer material can ensure that the metal mesh does not become entangled with the intravascular stent during the expansion and contraction of the balloon. Its high toughness and wear resistance make the outer layer material not easily damaged by the stent edge, facilitating the contraction and retraction of the balloon. Even if the outer layer material is damaged, since the stent still cannot directly contact the inner balloon body, it will not cause the rupture of the inner layer of the balloon.

[0006] The utility model adopts the following technical solutions:

[0007] A high-pressure balloon dilation catheter with anti-rupture function, the balloon body of the high-pressure balloon includes three layers that are attached to each other in sequence to form an integral structure: the inner layer is made of nylon elastomer material; the middle layer is a mesh structure formed by weaving metal wires; the outer layer is made of high molecular fiber material.

[0008] Preferably, the metal mesh used in the mesh structure of the middle layer is made of a material that resists tensile deformation. After being subjected to a tensile force, it is not prone to elastic deformation or plastic deformation. In this way, the metal mesh will not be stretched under external forces, which can ensure that after the balloon expands to a certain size, increasing the pressure further will not cause it to continue to expand or deform, and can avoid damage to blood vessels.

[0009] Preferably, the inner layer of the three-layer structure is the Mustang balloon material of Boston Scientific Corporation.

[0010] Further, the grade of the Mustang balloon material is Pebax 7033 or Vestamid L2101F.

[0011] Preferably, the outer layer of the three-layer structure is made of ultra-high molecular weight polyethylene fiber material.

[0012] Preferably, the mesh structure includes multiple groups of longitudinal metal wires 4 along the length direction and multiple groups of circular circumferential metal wires 5 along the circumferential direction.

[0013] Preferably, it further includes an inner tube 6. The inner tube 6 passes through the balloon body of the high-pressure balloon. Its proximal end is a guide wire channel 2, and a balloon inflation channel 3 is opened on the side wall of the guide wire channel 2.

[0014] Furthermore, the high molecular weight polyethylene fiber material is a material with good toughness and wear resistance.

[0015] The beneficial effects of the present utility model are as follows:

[0016] 1) The balloon body is designed to be composed of a three-layer structure. The material properties of each of the three layers are different. The inner layer uses a material that can withstand relatively high pressure. The middle layer is a mesh structure formed by weaving metal wires. This structure can ensure that the balloon does not deform under high pressure, and at the same time, it can also ensure that the original venous stent does not directly contact the inner balloon body (inner layer material), eliminating the cutting of the balloon body by the stent and avoiding balloon rupture.

[0017] 2) The outer layer material is selected as a material with strong toughness and wear resistance, such as ultra-high molecular weight polyethylene fiber. The outer layer material can ensure that the metal mesh does not become entangled with the venous stent during the expansion and contraction of the balloon, facilitating the contraction and retraction of the balloon. Its high toughness and wear resistance also make the outer layer material not easily damaged by the stent edge. Even if the outer layer material is damaged, since the stent still cannot directly contact the inner balloon body, it will not cause the rupture of the balloon body. Description of the Drawings

[0018] Figure 1 is a schematic external view of the high-pressure balloon dilation catheter with anti-rupture of the present utility model. In order to show the mesh structure formed by weaving the metal wires in the middle layer, the outer layer is set to be transparent.

[0019] Figure 2 is a schematic diagram of the running directions of the first metal wire and the second metal wire of the mesh structure formed by weaving the metal wires in the middle layer.

[0020] Figure 3 is a schematic cross-sectional view of the high-pressure balloon dilation catheter with anti-rupture of the present utility model.

[0021] In the figure, 1. balloon body (including 11. inner layer, 12. middle layer metal mesh, 13. outer layer), 2. guide wire channel, 3. balloon inflation channel, 4. longitudinal metal wire, 5. circumferential metal wire, 6. inner tube. Detailed Embodiment

[0022] To make the objectives, advantages, and features of the present utility model clearer, the following further describes the present invention in detail with reference to the accompanying drawings and specific embodiments. It should be noted that the accompanying drawings are all in a very simplified form and not drawn to scale, only for the purpose of facilitating and clearly assisting in explaining the objectives of the embodiments of the present invention. In addition, the structures shown in the accompanying drawings are often part of the actual structures. In particular, the accompanying drawings need to show different emphases, and sometimes different scales are used.

[0023] As used in the present invention, the singular forms "a", "an" and "the" include plural referents, the term "or" is generally used in the sense of including "and / or", and the term "several" is generally used in the sense of including an indefinite number of "more than two". The terms "mounted", "connected" and "coupled" should be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or integrated; it may be a mechanical connection or an electrical connection; it may be directly connected or indirectly connected through an intermediate medium, and it may be the communication inside two elements or the interaction relationship between two elements. In addition, as used in the present invention, when an element is disposed on another element, it generally only indicates that there is a connection, coupling, cooperation or transmission relationship between the two elements, and the two elements may be directly or indirectly connected, coupled, cooperated or transmitted through an intermediate element, rather than being construed as indicating or implying the spatial position relationship between the two elements, that is, an element may be inside, outside, above, below or on one side of another element, etc. in any orientation, unless otherwise explicitly specified in the content. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances. It should be noted that in this text, relational terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations, and even less should be construed as indicating or implying relative importance or implicitly indicating the quantity of the indicated technical features.

[0024] The terms "proximal" and "distal" used herein are described based on the relative orientation and relative position of the respective components and elements of the medical device. Although non-limiting, "proximal" generally refers to the end of the medical device closer to the operator during normal use, and "distal" and "tip" generally refer to the end of the medical device farther from the operator. The term "axial" refers to the direction along the longitudinal axis of the catheter, the term "circumferential" refers to the circumferential direction around the longitudinal axis of the catheter, the term "radial" refers to the direction perpendicular to the longitudinal axis of the catheter, and the "cross-section" refers to the section parallel to the perpendicular line of the longitudinal axis.

[0025] The general concept of this embodiment is to propose a high-pressure balloon dilation catheter for occlusion within a venous stent. The balloon body of the balloon is composed of three layers. The inner layer uses a material that can withstand higher pressures, and the Mustang balloon materials (Pebax 7033 and Vestamid L2101F) of Boston Scientific Corporation can be referred to. The middle layer is a mesh structure formed by weaving metal meshes, and the outer layer material is selected from materials with strong toughness and wear resistance, such as ultra-high molecular weight polyethylene fibers.

[0026] See Figures 1-3, the balloon dilation catheter includes: a balloon body 1 (including an inner layer 11, an intermediate layer metal mesh 12, and an outer layer 13), a guide wire channel 2, a balloon inflation channel 3, longitudinal metal wires 4, circumferential metal wires 5, and an inner tube 6. Figure 1 It is the morphology in the balloon contraction state, and the longitudinal metal wires 4 and the circumferential metal wires 5 are in a curled shape.

[0027] The metal mesh used for the mesh structure in the intermediate layer is made of a material resistant to tensile deformation. After being subjected to a tensile force, it is not easy to undergo elastic deformation or plastic deformation. In this way, the metal mesh will not be stretched under the action of an external force, which can ensure that after the balloon expands to a certain size, increasing the pressure further will not cause it to continue to expand or deform, and damage to the blood vessel can be avoided. See Figure 2 , Figure 2 It is the balloon dilation state. The longitudinal metal wires 4 and the circumferential metal wires 5 are both in an extended state. In this state, even if the balloon pressure is increased further, the balloon size will not continue to increase. The presence of the metal mesh ensures that the balloon is not easily deformed under high pressure. This is the first technical problem solved by this application.

[0028] Figure 3 It is the cross-section of the balloon body 1, which is divided into three layers. The inner layer 11 is made of a material that can withstand a relatively high pressure, such as the mustang balloon materials (Pebax7033 and Vestamid L2101F) of Boston Scientific Corporation, which can ensure that the balloon can withstand a relatively high pressure; the intermediate layer 12 (formed by evenly braiding the metal wires 4 and 5) is a metal mesh, which is evenly braided on the surface of the inner layer 11, preventing the stent from cutting the inner layer 1 of the balloon and avoiding the rupture of the balloon. This is the second technical problem solved by this application.

[0029] The outer layer 13 is made of a material with strong toughness and wear resistance, such as ultra-high molecular weight polyethylene fiber. Its high toughness and wear resistance make the outer layer material not easily damaged by the edge of the stent. The outer layer material can ensure that the metal mesh will not become entangled with the venous stent during the expansion and contraction of the balloon, facilitating the contraction and withdrawal of the balloon. This is the third technical problem (and also the primary problem) solved by this application. Even if the outer layer material is damaged, since the stent still cannot directly contact the inner layer 11 of the balloon, it is not easy to cause the rupture of the inner layer of the balloon.

[0030] Continue to refer to Figure 1 , the high-pressure balloon dilation catheter with anti-rupture of the present utility model further includes an inner tube 6. The inner tube 6 passes through the balloon body of the high-pressure balloon. Its proximal end is a guide wire channel 2, and a balloon inflation channel 3 is opened on the side wall of the guide wire channel 2. During use, inflation is carried out through the inflation channel 3, and the balloon 1 can be deformed to expand the blood vessel so as to implant a stent through the guide wire channel. It should be noted that this belongs to the prior art, so this embodiment will not elaborate on this part.

[0031] In summary, the present utility model designs the balloon body of the balloon to be composed of a three-layer structure. The material properties of each of the three-layer structures are different. The inner layer uses a material that can withstand relatively high pressure. The middle layer is a mesh structure formed by weaving metal wires. This structure can ensure that the balloon does not deform under high pressure. At the same time, it can also ensure that the original venous stent does not directly contact the inner balloon body (inner layer material), preventing the stent from cutting the balloon body and avoiding balloon rupture. The outer layer material is selected to be a material with strong toughness and wear resistance, such as ultra-high molecular weight polyethylene fiber. The outer layer material can ensure that the metal mesh does not become entangled with the venous stent during the expansion and contraction of the balloon, facilitating the contraction and retraction of the balloon. Its high toughness and wear resistance also make the outer layer material not easily damaged by the stent edge. Even if the outer layer material is damaged, since the stent still cannot directly contact the inner balloon body, it will not cause the rupture of the balloon body.

[0032] The above are the preferred embodiments of the present utility model. Those of ordinary skill in the art can also make various changes or improvements based on this. Without departing from the general concept of the present utility model, these changes or improvements should all fall within the scope of protection required by the present utility model.

Claims

1. A rupture-resistant high-pressure balloon dilatation catheter, characterized in that: The high-pressure balloon body consists of three layers that are attached in sequence to form an integrated structure: The inner layer is made of nylon elastomer material; The middle layer is a mesh structure formed by weaving metal mesh; The outer layer is made of polymer fiber material.

2. The rupture-resistant high-pressure balloon dilatation catheter according to claim 1, characterized in that: The metal mesh used in the mesh structure of the middle layer is a material that is resistant to tensile deformation.

3. The rupture-resistant high-pressure balloon dilatation catheter according to claim 1, characterized in that: The inner layer of the three-layer structure is the Mustang balloon material of Boston Scientific Corporation.

4. The rupture-resistant high-pressure balloon dilatation catheter according to claim 3, characterized in that: The mustang balloon material is Pebax7033 or Vestamid L2101F.

5. The rupture-resistant high-pressure balloon dilatation catheter according to claim 1, characterized in that: The outer layer of the three-layer structure is an ultra-high molecular weight polyethylene fiber material.

6. The rupture-resistant high-pressure balloon dilatation catheter according to claim 1, characterized in that: The mesh structure comprises a plurality of groups of longitudinal metal wires (4) along the length direction, and a plurality of groups of circular ring-shaped circumferential metal wires (5) along the circumference direction.

7. The rupture-resistant high-pressure balloon dilatation catheter according to claim 1, characterized in that: It also includes an inner tube (6) which passes through the body of the high-pressure balloon, and the proximal end of the inner tube (6) is a guide wire channel (2). A balloon inflation channel (3) is provided on the side wall of the guide wire channel (2).

8. The rupture-resistant high-pressure balloon dilatation catheter according to claim 5, characterized in that: The high molecular weight polyethylene fiber material has good toughness and wear resistance.

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