Balloon microcatheter

Abstract

The utility model provides a kind of balloon microcatheter, it is related to medical instrument technical field, including inner tube component, outer tube component;Outer tube component is set to the outer tube component of inner tube component, and coaxial setting forms infusion channel;Balloon part, the balloon part one end is connected with the outer tube component, the other end is connected with the inner tube component;Supporting piece, interval is set between the inner tube component and outer tube component, for supporting infusion channel, the supporting piece is equipped with the through hole of penetration;The distal end of the outer tube component is equipped with conical section.The utility model is set supporting piece in the whole length direction of outer tube component and inner tube component, so that the torsion of rotating or pushing outer tube component is stably, synchronously conducted to inner tube component, improves the synchronism, torsion control of inner tube component and outer tube component.

Description

Technical Field

[0001] This utility model belongs to the field of medical device technology, specifically relating to a balloon microcatheter. Background Technology

[0002] With the continuous advancement of interventional techniques, balloon angioplasty and stenting are widely used to open narrowed lumens, reducing the risk of local thrombosis or acute occlusion. For example, in patients with intracranial arterial stenosis, drug therapy often fails to achieve ideal clinical outcomes; in such cases, stent implantation is frequently used to effectively improve blood flow and reduce the risk of disease progression. Currently, this type of procedure typically uses a balloon catheter for pre-dilation and a microcatheter as the delivery channel for the stent delivery system. During the procedure, the surgeon needs to withdraw the pre-dilation balloon catheter from the patient's body before stent delivery to make room for the microcatheter. A balloon-microcatheter is an interventional medical device that combines a pre-dilation balloon catheter and a microcatheter into a single unit, reducing the number of exchanges and enabling pre-dilation and stent release in a single step.

[0003] Traditional balloon microcatheters consist of an inner tubule assembly and an outer tubule assembly, with their proximal and distal ends connected to the catheter hub and balloon, respectively. However, during the advancement or rotation of the balloon microcatheter, the inner and outer tubule assemblies may experience uneven force transmission due to asynchronous force application. This phenomenon often manifests as relative displacement of the inner and outer tubule assemblies within the angiography catheter or tortuous blood vessels, leading to difficulties in advancement. Furthermore, when high-viscosity contrast agents are aspirated, the distal inner and outer tubules are prone to adhere to the vessel wall under negative pressure, causing channel blockage.

[0004] To address the aforementioned issues, a balloon microcatheter is provided. Utility Model Content

[0005] The purpose of this invention is to provide a balloon microcatheter with supports arranged along the entire outer tube, improving the synchronization of the inner and outer tubes during proximal manipulation and enhancing its torsional control. This addresses the problem of uneven mechanical transmission caused by asynchronous force distribution between the inner and outer tube assemblies in existing technologies. Furthermore, this optimized design prevents the inner and outer tubes from adhering to the wall during contrast agent aspiration, thus preventing channel blockage.

[0006] To achieve the above objectives, this utility model provides the following technical solution:

[0007] A balloon microcatheter includes an inner tube assembly and an outer tube assembly;

[0008] The outer tube assembly is disposed outside the inner tube assembly and is coaxially arranged to form an infusion channel;

[0009] The balloon section has one end connected to the outer tube assembly and the other end connected to the inner tube assembly;

[0010] A support member is spaced between the inner tube assembly and the outer tube assembly to support the infusion channel, and the support member is provided with a through hole;

[0011] The outer tube assembly has a tapered section at its distal end.

[0012] Preferably, in the contracted state, the outer diameter of the balloon portion is less than or equal to the outer diameter of the outer tube assembly.

[0013] Preferably, the support member is a polyurethane component, and the hardness of the support member is 50A-80A.

[0014] Preferably, the spacing between the support members is 15mm-20mm.

[0015] Preferably, the through holes are provided in multiple portions and are evenly distributed around the axis of the support member.

[0016] Preferably, the support member has an inner hole in the middle for the inner tube assembly to pass through, the outer wall of the support member is in contact with the inner wall of the outer tube assembly, and the inner diameter of the outer tube assembly is consistent with the maximum outer diameter of the support member.

[0017] Preferably, it also includes a catheter seat connected to the outer tube assembly, the catheter seat having two cavities respectively communicating with the inner tube assembly and the infusion channel.

[0018] Preferably, a stress relief tube is provided at the joint between the conduit seat and the outer tube assembly to prevent the outer tube assembly from bending at the connection with the conduit seat.

[0019] Preferably, the inner tube assembly has a first imaging ring located 1mm-2mm from its distal end.

[0020] Preferably, the inner tube assembly is provided with second radiopaque rings located at the distal and proximal ends of the balloon portion, respectively.

[0021] Beneficial effects:

[0022] (1) By setting a support between the outer tube assembly and the inner tube assembly, the torque of rotating or pushing the outer tube assembly is stably and synchronously transmitted to the inner tube assembly, thereby improving the synchronization and torque control of the inner tube assembly and the outer tube assembly.

[0023] (2) By providing support members at intervals along the entire length of the outer tube assembly and the inner tube assembly, the support members act as infusion channels, preventing the outer tube assembly from collapsing under negative pressure and blocking the infusion channel with the inner tube assembly after the contrast agent is extracted, thus affecting the recovery of the balloon.

[0024] (3) By setting up a support component made of PU and connecting them by melting, this utility model can reduce the assembly difficulty and improve the connection stability between the support component and the inner tube assembly and the outer tube assembly. Attached Figure Description

[0025] The accompanying drawings, which form part of this application, are used to provide a further understanding of the present invention. The illustrative embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an undue limitation of the present invention. Wherein:

[0026] Figure 1 This is a schematic diagram of the balloon microcatheter according to an embodiment of the present invention;

[0027] Figure 2 This is a cross-sectional view of the channel of the balloon microcatheter according to an embodiment of the present invention;

[0028] Figure 3 This is a cross-sectional view of the distal structure of the balloon microcatheter according to an embodiment of the present invention;

[0029] Figure 4 This is a sectional view of the support component;

[0030] Figure 5 This is a cross-sectional view of another embodiment of the support member.

[0031] In the diagram: 1. Inner tube assembly; 2. Outer tube assembly; 21. Conical section; 3. Infusion channel; 4. Balloon section; 5. Support component; 51. Through hole; 52. Inner hole; 6. Catheter seat; 7. Stress relief tube; 8. First contrast ring; 9. Second contrast ring. Detailed Implementation

[0032] The technical solutions in the embodiments of this utility model will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of this utility model, and not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art are within the protection scope of this utility model.

[0033] In the description of this utility model, it should be understood that the directional descriptions, such as up, down, front, back, left, right, etc., indicate the directional or positional relationship based on the directional or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model.

[0034] In the description of this utility model, "several" means one or more, "multiple" means two or more, "greater than," "less than," and "exceeding" are understood to exclude the stated number, while "above," "below," and "within" are understood to include the stated number. If "first" or "second" is used in the description, it is only for the purpose of distinguishing technical features and should not be construed as indicating or implying relative importance, or implicitly indicating the number of indicated technical features, or implicitly indicating the order of the indicated technical features.

[0035] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined as "first" and "second" may explicitly or implicitly include one or more features.

[0036] In the description of this utility model, it should be noted that, unless otherwise explicitly specified and limited, the term "connection" should be interpreted broadly. For example, it can be a fixed connection or a movable connection, a detachable connection or a non-detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection or a connection that can communicate with each other; it can be a direct connection or an indirect connection through an intermediate medium; it can be a connection within two elements, an indirect connection, or an interaction between two elements.

[0037] In the description of this utility model, "distal end" refers to the end that is farther away from the doctor during surgery, and "proximal end" refers to the end that is closer to the doctor during surgery.

[0038] In the description of this utility model, "before use" refers to the state before the balloon microcatheter is used, before it enters the human body, or before it comes into contact with bodily fluids such as blood and tissue fluid in the human body, while "during use" refers to the state after the balloon microcatheter has entered the human body or come into contact with bodily fluids such as blood and tissue fluid in the human body.

[0039] In the description of this utility model, "internal environment" refers to the environment below the epidermis of the skin where body fluids are present, such as the dermis and subcutaneous tissue, or the inside of blood vessels and organs.

[0040] The present invention will now be described in detail with reference to the embodiments. It should be noted that, unless otherwise specified, the embodiments and features in the embodiments of the present invention can be combined with each other.

[0041] This invention addresses the problem in the prior art where, during the pushing or rotating of a balloon microcatheter, the inner and outer tubes may experience uneven mechanical transmission due to asynchronous force application. This phenomenon often manifests as relative displacement of the inner and outer tube assemblies within the angiography catheter or curved blood vessel, leading to difficulties in rotation or pushing.

[0042] This invention provides a balloon microcatheter, such as Figures 1 to 4As shown, it includes inner tube assembly 1 and outer tube assembly 2;

[0043] The outer tube assembly 2 is disposed outside the inner tube assembly 1 and is coaxially arranged to form the infusion channel 3;

[0044] The balloon part 4 has one end connected to the outer tube assembly 2 and the other end connected to the inner tube assembly 1;

[0045] Support member 5 is spaced between inner tube assembly 1 and outer tube assembly 2 to support infusion channel 3. Support member 5 is provided with through hole 51.

[0046] The outer tube assembly 2 has a tapered section 21 at its distal end.

[0047] The inner tube assembly 1 has a three-layer structure: an inner liner, a metal layer, and an outer layer. The inner liner is preferably made of PTFE or other materials with a low coefficient of friction and a relatively smooth surface. The metal braided layer is preferably made of a flexible material such as nickel-titanium alloy or stainless steel, and can be braided or spring-loaded. The outer layer is made of a biocompatible material, preferably PU (polyurethane).

[0048] The channel diameter of the outer tube assembly 2 is larger than the maximum diameter of the inner tube assembly 1, and the inner tube assembly 1 passes through the channel of the outer tube assembly 2. The gap between the inner tube assembly 1 and the outer tube assembly 2 forms the infusion channel 3.

[0049] The support member 5 has an axial through hole 51. The function of the through hole 51 is to prevent the support member 5 from completely blocking the infusion channel 3 and reduce the impact on the delivery of contrast agent.

[0050] One end of the balloon section 4 is connected to the outer tube assembly 2 by bonding or melting, and the other end is connected to the inner tube assembly 1 by bonding or melting, forming a sealed structure. This sealed structure means that there is no leakage at the connection between the balloon section 4 and the outer tube assembly 2 and the inner tube assembly 1. The balloon section 4 and the inner tube assembly 1 form a balloon inflation chamber, which is connected to the infusion channel 3. Contrast agent can enter or leave the balloon inflation chamber through the infusion channel 3. After the contrast agent is injected, the balloon section 4 is compressed to inflate it. After the contrast agent is withdrawn, the balloon section 4 contracts under external pressure, thereby controlling the expansion and contraction of the balloon section 4.

[0051] The support member 5 is preferably made of PU and is spaced 15mm-20mm apart. Both ends of the support member 5 are connected to the inner tube assembly 1 and the outer tube assembly 2 respectively, using either adhesive bonding or fusion bonding. The support member 5 provides support when the inner tube assembly 1 and the outer tube assembly 2 are under pressure. By adding the support member 5 along the entire length of the outer tube assembly 2 and the inner tube assembly 1, the torque acting on the outer tube of the balloon microcatheter is stably and synchronously transmitted to the inner tube, enhancing the overall torsional control. Simultaneously, the support member 5 supports the distal end of the outer tube assembly 2, preventing it from collapsing and adhering to the inner tube assembly 1 under negative pressure after the contrast agent is withdrawn, thus affecting the recovery of the balloon portion 4.

[0052] Preferably, the material of the support member 5 contains a radiopaque material, which can be tungsten powder and barium sulfate or other radiopaque materials. Under DSA equipment, the position of the support member 5 can be displayed, thereby assisting the doctor in making a judgment.

[0053] Furthermore, the attachment and fixing process of the support 5 is relatively simple, and it can be fixed by conventional bonding or fusion bonding, which reduces the assembly difficulty.

[0054] Furthermore, the spaced support members 5 can support the middle section of the outer tube assembly 2 and the inner tube assembly 1, thereby improving the overall stability.

[0055] The outer tube assembly 2 has a tapered section 21 with a gradually decreasing outer diameter at its far end. The tapered section 21 is used to reduce the change in outer diameter at the junction of the inner tube assembly 1 and the outer tube assembly 2 to avoid stress concentration points that could lead to bending.

[0056] In a preferred embodiment of this invention, the outer diameter of the balloon portion 4 in the contracted state is less than or equal to the outer diameter of the outer tube assembly 2. This is designed to prevent the balloon portion 4 from radially covering the outer tube assembly 2 during the positioning process, thereby reducing the difficulty of pushing it distally. The positioning process refers to the process of pushing or rotating the balloon portion 4 within the body.

[0057] In a preferred embodiment of this invention, the support member 5 is a polyurethane component with a hardness of 50A-80A. In this invention, "A" refers to Shore hardness, a standard for measuring the hardness of materials, primarily used to measure the hardness of soft plastics, rubber, and other elastomers. The support member 5 is not so hard as to affect the passage of the outer tube assembly 2 within the blood vessel, while simultaneously providing support for the infusion channel 3.

[0058] In a preferred embodiment of this invention, the spacing between the support members 5 is 15mm-20mm. The purpose of the spacing between the support members 5 is to support the infusion channel 3 at regular intervals, ensuring overall torsional stability.

[0059] In a preferred embodiment of this invention, multiple through holes 51 are provided and evenly distributed around the axis of the support member 5. The through holes 51 penetrate the support member 5 axially but not radially, thus establishing a channel connecting the infusion channel 3 and the balloon cavity. By providing multiple evenly distributed through holes 51, the flow efficiency of the contrast agent can be improved, reducing the impact on the flow of the contrast agent.

[0060] In a preferred embodiment of this utility model, the support member 5 has an inner hole 52 in the middle for the inner tube assembly 1 to pass through, the outer wall of the support member 5 is in contact with the inner wall of the outer tube assembly 2, and the inner diameter of the outer tube assembly 2 is consistent with the maximum outer diameter of the support member 5.

[0061] In a preferred embodiment of this invention, a catheter seat 6 connected to the outer tube assembly 2 is further included. The catheter seat 6 has two cavities that are respectively connected to the inner tube assembly 1 and the infusion channel 3. The proximal end of the catheter seat 6 has a Y-shaped structure, with one cavity connected to the infusion channel 3 and the other connected to the inner tube assembly 1, which can facilitate the delivery of contrast agent through the infusion channel 3, allowing the balloon portion 4 to inflate or contract.

[0062] In a preferred embodiment of this invention, a stress relief tube 7 is provided at the junction of the conduit seat 6 and the outer tube assembly 2 to prevent the outer tube assembly 2 from bending at the connection with the conduit seat 6. The stress relief tube 7 is a tube body adapted to the shape of the tapered section 21 and can be made of PTFE or PU. The stress relief tube 7 is snapped into the tapered section 21 to increase the strength of the connection between the outer tube assembly 2 and the conduit seat 6.

[0063] In a preferred embodiment of this invention, a first radiopaque ring 8 is provided 1mm-2mm from the distal end of the inner tube assembly 1. The radiopaque ring exhibits different brightness compared to other parts under DSA equipment, thereby assisting the surgeon in determining the distal position of the inner tube assembly 1 and reducing the difficulty of the procedure.

[0064] In a preferred embodiment of this invention, the inner tube assembly 1 is provided with second contrast-enhancing rings 9 located at the distal and proximal ends of the balloon portion 4, respectively. The second contrast-enhancing rings 9 and the first contrast-enhancing rings 8 are made of the same material, both being platinum-iridium alloy. The second contrast-enhancing rings 9 are used to assist in determining the position of the effective segment of the balloon portion 4, ensuring the balloon portion 4 is positioned where surgery is required, thereby improving surgical outcomes.

[0065] The present invention provides a detailed description of a balloon microcatheter through specific embodiments below.

[0066] Example 1

[0067] This embodiment provides a balloon microcatheter, such as Figures 1 to 3As shown, the system includes an inner tube assembly 1 and an outer tube assembly 2 coaxially arranged with the inner tube assembly 1. The gap between the outer tube assembly 2 and the inner tube assembly 1 forms an infusion channel 3. A balloon portion 4 is fused to the distal end of the outer tube assembly 2, and the distal end of the balloon portion 4 is fused to the inner tube assembly 1. The effective section of the balloon portion 4 forms a balloon inflation cavity, which allows the balloon portion 4 to inflate after the contrast agent is injected and to contract under external pressure after the contrast agent is withdrawn. The contrast agent flows into the balloon inflation cavity through the infusion channel 3.

[0068] The inner tube assembly 1 adopts a three-layer structure, which can ensure a certain structural strength.

[0069] The balloon portion 4 is preferably made of biocompatible materials such as Pebax or Nylon, which can expand after being filled with liquid and is not easily ruptured.

[0070] A support member 5, made of PU, is fused together between the inner tube assembly 1 and the outer tube assembly 2. This support member 5 has good flexibility, maintaining a stable connection between the inner tube assembly 1 and the outer tube assembly 2. Even under pressure, it ensures a certain gap between the inner tube assembly 1 and the outer tube assembly 2, preventing blockage of the infusion channel 3.

[0071] like Figures 1 to 4 As shown, the support member 5 has a through hole 51 extending along its own axis. The through hole 51 prevents the support member 5 from blocking the infusion channel 3 and reduces the impact of the support member 5 on the delivery of contrast agent.

[0072] The support members 5 are spaced 15mm-20mm apart; specifically, the spacing between the support members 5 can be 15mm, 16mm, 17mm, 18mm, 19mm, and 20mm. The support members 5 provide support when the inner tube assembly 1 and outer tube assembly 2 are under pressure. By placing the support members 5 along the entire length of the outer tube assembly 2 and inner tube assembly 1, the torque of rotating or pushing the outer tube assembly 2 is stably and synchronously transmitted to the inner tube assembly 1, improving the synchronicity and torque control of the inner tube assembly 1 and outer tube assembly 2. Simultaneously, the support members 5 effectively reduce the deformation of the outer tube assembly 2, preventing it from collapsing under negative pressure and adhering to the wall of the inner tube assembly 1, thus blocking the infusion channel 3 and affecting the recovery of the balloon section 4.

[0073] Compared with the prior art, the attachment and fixing process of the support member 5 of this utility model is simple, which reduces the assembly difficulty. At the same time, the spaced support members 5 also improve the overall stability.

[0074] In other embodiments of this utility model, the support member 5 is fixed by adhesive bonding.

[0075] The distal end of the outer tube assembly 2 is integrally formed with a tapered section 21 with a gradually decreasing outer diameter. The tapered section 21 is used to reduce the change in outer diameter at the junction of the inner tube assembly 1 and the outer tube assembly 2 to avoid stress concentration points that could cause bending.

[0076] In this embodiment, a catheter seat 6 is also included, which is Luer-connected to the outer tube assembly 2. The Luer connection ensures that the connection between the catheter seat 6 and the outer tube assembly 2 is leak-proof. In other embodiments of this invention, the catheter seat 6 can also be sealed using methods such as bonding or fusion bonding. The proximal end of the catheter seat 6 has a Y-shaped structure, with one cavity connected to the infusion channel 3 and the other connected to the inner tube assembly 1. Contrast agent can be delivered through one cavity via the infusion channel 3.

[0077] The inner tube assembly 1 is attached with a first imaging ring 8 1 mm from its distal end. The inner tube assembly 1 is attached with a second imaging ring 9 located at the distal and proximal ends of the balloon part 4. The first imaging ring 8 and the second imaging ring 9 are made of the same material, platinum-iridium alloy. Under DSA equipment, they can help doctors observe the position of the inner tube assembly 1 and the effective segment of the balloon part 4, thereby reducing the difficulty of the doctor's operation.

[0078] A stress relief tube 7 is fitted at the joint between the conduit seat 6 and the outer tube assembly 2. The stress relief tube 7 is used to prevent the outer tube assembly 2 from bending at the connection with the conduit seat 6 and to ensure the strength of the outer tube assembly 2 at the connection with the conduit seat 6.

[0079] Example 2

[0080] like Figures 1 to 4 As shown, this embodiment further elaborates on the support member 5 based on embodiment 1.

[0081] Multiple through holes 51 are provided and evenly distributed around the axis of the support member 5. Specifically, the through holes 51 penetrate the support member 5 axially but not radially, thus establishing a channel connecting the infusion channel 3 and the balloon cavity. The support member 5 is a tube with multiple through holes 51, which penetrate the inner wall of the support member 5 and communicate with the side wall of the inner tube assembly 1. By providing multiple evenly distributed through holes 51, the flow efficiency of the contrast agent can be improved, reducing the impact on the flow of the contrast agent.

[0082] like Figure 1 , Figure 2 , Figure 3 and Figure 5 As shown, in another embodiment of this utility model, the through hole 51 is located on the side wall of the support member 5 and does not penetrate both ends in the radial direction.

[0083] In summary, this invention, by providing a support member 5 located between the inner tube assembly 1 and the outer tube assembly 2, ensures that the torque of rotating or pushing the outer tube assembly 2 can be stably and synchronously transmitted to the inner tube assembly 1, thereby improving the synchronicity and torque control of the inner tube assembly 1 and the outer tube assembly 2. Simultaneously, because the support members 5 are spaced apart along the entire length of the inner tube assembly 1 and the outer tube assembly 2, they effectively reduce the deformation of the outer tube assembly 2, preventing it from collapsing under negative pressure and adhering to the wall of the inner tube assembly 1.

[0084] The above description is merely a preferred embodiment of this utility model and is not intended to limit the scope of this utility model. Various modifications and variations can be made to this utility model by those skilled in the art. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of this utility model should be included within the protection scope of this utility model.

Claims

1. A balloon microcatheter, characterized in that, Includes inner tube assembly (1) and outer tube assembly (2); The outer tube assembly (2) is disposed outside the inner tube assembly (1) and is coaxially arranged to form an infusion channel (3); The balloon part (4) is connected at one end to the outer tube assembly (2) and at the other end to the inner tube assembly (1); A support member (5) is spaced between the inner tube assembly (1) and the outer tube assembly (2) to support the infusion channel (3). The support member (5) has a through hole (51). The outer tube assembly (2) has a tapered section (21) at its distal end.

2. The balloon microcatheter according to claim 1, characterized in that, In the contracted state, the outer diameter of the balloon part (4) is less than or equal to the outer diameter of the outer tube assembly (2).

3. The balloon microcatheter according to claim 1, characterized in that, The support member (5) is a component made of polyurethane, and the hardness of the support member (5) is 50A-80A.

4. A balloon microcatheter according to claim 1, characterized in that, The spacing between the support members (5) is 15mm-20mm.

5. A balloon microcatheter according to claim 1, characterized in that, The through holes (51) are provided in multiple portions and are evenly distributed around the axis of the support member (5).

6. A balloon microcatheter according to claim 1, characterized in that, The support member (5) has an inner hole (52) in the middle for the inner tube assembly (1) to pass through. The outer wall of the support member (5) is in contact with the inner wall of the outer tube assembly (2). The inner diameter of the outer tube assembly (2) is consistent with the maximum outer diameter of the support member (5).

7. A balloon microcatheter according to claim 1, characterized in that, It also includes a catheter seat (6) connected to the outer tube assembly (2), and the catheter seat (6) has two cavities that are respectively connected to the inner tube assembly (1) and the infusion channel (3).

8. A balloon microcatheter according to claim 7, characterized in that, A stress relief tube (7) is provided at the joint between the conduit seat (6) and the outer tube assembly (2) to prevent the outer tube assembly (2) from bending at the connection with the conduit seat (6).

9. A balloon microcatheter according to any one of claims 1-8, characterized in that, The inner tube assembly (1) has a first imaging ring (8) located 1 mm to 2 mm from its far end.

10. A balloon microcatheter according to any one of claims 1-8, characterized in that, The inner tube assembly (1) is provided with a second radiopaque ring (9) located at the distal end and proximal end of the balloon portion (4).

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