Self-perfusion balloon dilatation catheter

Abstract

The utility model relates to a self-perfusion balloon dilatation catheter which comprises a balloon, an inner tube, an outer tube and a hypotube, and the outer surface of the outer tube is coated with a hydrophilic coating; the outer tube comprises two outer tube sections with different hardness, and each outer tube section comprises a near-end tube section and a far-end tube section which are spliced with each other; at least two groups of perfusion holes are formed in the part, close to the balloon, of the far-end tube section, and the perfusion holes in different groups are staggered at intervals in the axial direction of the outer tube. The outer surface of the outer tube is coated with the hydrophilic coating, and the two spliced outer tubes with different hardness are combined, so that the passing performance and the pushing performance of the whole catheter can be improved. At least two groups of perfusion holes are formed in the outer tube, and in combination with a staggered arrangement state at intervals, when one group of perfusion holes is blocked by diseased tissues, the other group of perfusion holes can still ensure that blood flows through, so that normal circulation of blood on the front side and the rear side of the balloon is ensured to the greatest extent, the pain of a patient in an operation is reduced, the operation risk is reduced, and the safety in the operation is improved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more specifically, to a self-perfusion balloon dilation catheter. Background Technology

[0002] With the continuous improvement of medical standards and the invention and use of various medical devices, people have discovered that balloon dilation catheters, in conjunction with appropriate stent systems, can physically open up the stenotic lesions of coronary arteries, allowing blood flow to be restored. In addition, the use of drugs that inhibit cell proliferation, such as rapamycin or paclitaxel, can effectively prevent restenosis of the vascular stent, resulting in significant treatment effects and short postoperative recovery time. Balloon dilation catheters and matching stent delivery systems have gradually gained people's trust.

[0003] During PTCA (Percutaneous Transluminal Angioplasty) surgery, doctors typically pre-dilate the blood vessel at the lesion site before stent implantation to ensure the delivery system can effectively reach the lesion. After stent implantation, post-dilation is performed to ensure good adhesion of the stent to the blood vessel wall, achieving the intended purpose of the PTCA procedure.

[0004] Traditional balloon dilation, regardless of the dilation time, always results in 100% blockage of the target vessel at the lesion site, leading to short-term distal ischemia. This can potentially cause adverse reactions such as chest pain during surgery. The unique structure of the self-perfusion port allows blood flow from proximal to distal during balloon dilation at the lesion site, creating a blood flow pathway, improving distal ischemia of the target vessel, reducing patient discomfort, surgical risks, and overall safety. However, existing conventional perfusion port structures and distributions do not achieve ideal blood diversion effects.

[0005] Even with a hydrophilic coating, conventional balloon dilation catheters have poor delivery performance and are not easy to pass through complex lesions or severely blocked lesions. Utility Model Content

[0006] The purpose of this application is to provide a self-perfusion balloon dilation catheter that can enhance the overall pushing performance of the balloon dilation catheter and ensure normal blood flow from the proximal end to the distal end of the balloon through self-perfusion.

[0007] To achieve the above objectives, this utility model provides a self-inflation balloon dilation catheter, comprising: a balloon, an inner tube, an outer tube, and a thiopanthen tube, wherein the outer surface of the outer tube is coated with a hydrophilic coating.

[0008] The outer tube includes two sections of different hardness, which respectively include a proximal section and a distal section spliced ​​together.

[0009] The distal tube section near the balloon is provided with at least two sets of infusion holes, and the infusion holes of different sets are staggered along the axial direction of the outer tube.

[0010] In an optional embodiment, a welding section is provided between the inner tube and the outer tube, the injection hole is provided on the welding section, and the lumen of the inner tube communicates with the injection hole.

[0011] In an optional embodiment, the distal end of the balloon is connected to a balloon tip, the distal end of the inner tube is connected to the balloon tip, and the balloon tip is provided with a plurality of tip holes.

[0012] In an optional embodiment, the injection holes include two sets, each set of injection holes is disposed on the same welding section, and the two sets of injection holes are disposed opposite each other on both sides of the outer tube in the circumferential direction.

[0013] In an optional embodiment, the spacing between the welded sections along the axial direction of the outer tube is 2-5 mm, and multiple injection holes in each group are spaced apart on the welded sections and are all arranged along the axial direction of the outer tube.

[0014] In an optional embodiment, the injection hole has a right-angled trapezoidal structure in the longitudinal section of the outer tube, including a right-angled section at the distal end and an inclined section at the proximal end.

[0015] In an optional embodiment, the hardness of the proximal tube segment is greater than that of the distal tube segment, and the distal end of the submersible tube is inserted into the proximal tube segment.

[0016] In an optional embodiment, the sodium hypochlorite tube includes a rotary-cut sodium hypochlorite filament located at the distal end, the rotary-cut sodium hypochlorite filament having a helical structure wrapped around the inside of the proximal tube segment.

[0017] In an optional embodiment, the proximal end of the self-perfusion balloon dilation catheter is provided with a catheter seat and a catheter reinforcement, and the proximal end of the thiopancreatography (THB) tube is connected to the catheter reinforcement.

[0018] In an optional embodiment, the outer tube is provided with a through side hole, which communicates with the lumen of the inner tube, and a protective steel needle is inserted between the through side hole and the balloon.

[0019] The hydrophilic coating includes a polyvinylpyrrolidone coating.

[0020] By coating the outer surface of the outer tube with a hydrophilic coating, the passage performance of the balloon dilation catheter can be enhanced. Combining the two spliced ​​outer tubes with different hardnesses can increase the overall pushing performance of the catheter.

[0021] At least two sets of irrigation holes are provided in the distal tubing near the balloon. The staggered arrangement of different sets of irrigation holes along the axial direction of the outer tube ensures that even if one set is blocked by diseased tissue, the other set can still ensure blood flow. This maximizes the normal flow of blood on both sides of the balloon, reduces patient pain during surgery, lowers surgical risks, and improves intraoperative safety.

[0022] Other features and advantages of this application will be described in detail in the following detailed description section. Attached Figure Description

[0023] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0024] Figure 1 This is a schematic diagram of the structure of the self-inflation balloon dilation catheter in this application;

[0025] Figure 2 This is a schematic diagram showing the flow of blood at the perfusion port and the tip of the balloon.

[0026] Figure 3 This is a schematic diagram of the injection hole on the longitudinal section of the outer tube.

[0027] icon:

[0028] 1-Balloon; 11-Balloon tip; 12-Tip orifice;

[0029] 2-Inner tube;

[0030] 3-Outer pipe; 31-Proximal pipe section; 32-Distal pipe section; 33-Welded section; 34-Through side hole;

[0031] 4-Thiohlet tube; 41-Spinning thiohlet tube wire;

[0032] 5-Injection hole; 51-Right-angle section; 52-Inclined section;

[0033] 6-Conduit seat;

[0034] 7-Diameter reinforcement;

[0035] 8-Protective steel needle. Detailed Implementation

[0036] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. The components of the embodiments of this application described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0037] In the description of this application, it should be noted that the terms "inner" and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product is in use. They are used only for the convenience of describing this application and for 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 application. Furthermore, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0038] In the description of this application, it should also be noted that, unless otherwise expressly specified and limited, the terms "setup" and "connection" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0039] The self-perfused balloon 1 dilation catheter of this application is mainly used in balloon 1 dilation treatment of vascular lesions. It mainly enhances the permeability, pushability and intraoperative safety of the balloon 1 catheter by improving the structure of the balloon 1 catheter and improving the setting of the perfusion port 5.

[0040] Specifically, see Figure 1 and combined Figures 2-3 The self-inflation balloon 1 dilation catheter of this utility model has a main structure including a balloon 1, an inner tube 2, an outer tube 3 and a hyaluronic acid tube 4, and the outer surface of the outer tube 3 is coated with a hydrophilic coating.

[0041] The hydrophilic coating in this application is a light-cured polyvinylpyrrolidone material, which has better coating firmness and friction, and can reduce the shedding of the polyvinylpyrrolidone layer on the outer tube 3. At the same time, due to its good fluidity, it can reduce the frictional resistance between the outer tube 3 and the blood vessel during the push process, and enhance the overall passability of the balloon 1 catheter.

[0042] From the perspective of enhancing delivery performance, the outer tube 3 in this application includes two sections of outer tube 3 with different hardness, namely a proximal tube section 31 and a distal tube section 32 spliced ​​together. The proximal tube section 31, which is closer to the hypotube 4, is made of a material with higher hardness, such as Nylon 11, while the distal tube section 32, which is closer to the balloon 1, is made of a material with lower hardness, such as Nylon 11+Pebax 6333. This arrangement can effectively enable the outer tube 3 to bear more delivery force and provide overall delivery performance to the distal end of the blood vessel.

[0043] By setting at least two sets of perfusion holes 5 at the distal end of the outer tube 32 near the balloon 1, the number and types of perfusion holes 5 can be increased, thereby increasing the perfusion flux of blood on both sides of the balloon 1.

[0044] By staggering the perfusion holes 5 of different groups along the axial direction of the outer tube 3, the risk of the lesion site completely blocking the perfusion holes 5 can be avoided, ensuring normal blood delivery and perfusion from the proximal end to the distal end of the balloon 1.

[0045] In one specific embodiment, a welded section 33 is provided between the inner tube 2 and the outer tube 3. The welded section 33 is located on the distal tube section 32 near the balloon 1, and its purpose is to form the basis for opening the injection port 5. The injection port 5 is located on the welded section 33, and the lumen of the inner tube 2 communicates with the injection port 5.

[0046] In the existing conventional setup, the inner tube 2 is located radially inside the outer tube 3, and after passing through the overall axial direction of the balloon 1, the distal end of the inner tube 2 is connected to and communicates with the balloon tip 11 connected to the distal end of the balloon 1. The proximal end of the inner tube 2 intersects with the outer tube 3 at the guidewire opening of the balloon 1 catheter. The above is the general setup of the balloon 1 catheter, and will not be elaborated further.

[0047] By providing an infusion hole 5 on the welded section 33 and connecting the infusion hole 5 with the lumen of the inner tube 2, blood in the blood vessels can be infused into the inner tube 2 on the proximal side of the balloon 1 and flow through the distal end of the balloon tip 11 to the distal downstream end of the balloon 1, thus avoiding short-term ischemia at the distal end of the balloon 1.

[0048] By combining the setting of welding section 33, the impact of opening injection hole 5 on the structural strength of outer tube 3 can be reduced, thus not affecting the overall structural performance of outer tube 3, and ensuring the normal pushing of outer tube 3.

[0049] Under the premise of increasing blood perfusion flux through multiple perfusion ports 5, in order to ensure the outflow of blood at the distal end of balloon 1 and the flow rate of perfused blood, multiple tip holes 12 are provided on the balloon tip 11. This constitutes that the self-perfused blood flow not only flows out through the distal end of balloon tip 11, but also flows out laterally and upward through balloon tip 11, so that the blood flow can flow out at the maximum flow rate, thereby reducing the safety risk of blood flow interruption caused by balloon 1 blocking blood vessels during the operation.

[0050] Meanwhile, by providing multiple tip holes 12 on the balloon tip 11, the risk of the lesion site blocking the balloon tip 11 during the advancement of the balloon 1 catheter can be prevented. This comprehensively considers extremely unfavorable conditions under various circumstances and ensures the perfusion of blood flow.

[0051] In this embodiment, the injection holes 5 include two sets, each set of injection holes 5 is set on the same welding section 33, and the two sets of injection holes 5 are arranged opposite to each other on both sides of the outer tube 3 in the circumferential direction. Specifically, the two sets of injection holes 5 are arranged alternately on the far end section 32 of the outer tube 3, and are arranged alternately opposite to each other in the transverse direction of the outer tube 3 at 180°.

[0052] Based on the arrangement of two sets of injection holes 5, the welding section 33 includes two sections arranged on the distal pipe section 32. The distance between the two welding sections 33 in the axial direction of the outer pipe 3 is 2-5mm. Furthermore, the two injection holes 5 in each set are arranged at intervals on the welding section 33 and are both arranged in the axial direction of the outer pipe 3.

[0053] The above configuration allows the two sets of four irrigation holes 5 to intersect spatially, minimizing the risk of them all being blocked by diseased tissue.

[0054] From the angle that facilitates the flow of blood through the perfusion port 5 from the proximal end to the distal end into the inner tube 2, the perfusion port 5 has a right-angled trapezoidal structure in the longitudinal section of the outer tube 3, including a right-angled section 51 located at the distal end and an inclined section 52 located at the proximal end.

[0055] The shapes of the inclined end face and the right-angle end face can facilitate the blood flow guiding effect, are more suitable for the blood flow direction, and make it easier for blood to flow into the lumen of the inner tube 2 through the perfusion hole 5.

[0056] Furthermore, the diameter of the opening of the infusion port 5 on the inner tube 2, i.e. the smallest opening of the infusion port 5, is 0.013 inches, which can ensure the flow of infused blood.

[0057] In another specific embodiment, the distal end of the hyaluronic acid tube 4 is inserted into the interior of the proximal tube segment 31, and the rigid structure of the hyaluronic acid tube 4 facilitates the provision of better pushing force.

[0058] Overall, the hardness of the outer tube 3 is inevitably less than that of the sodium hypo tube 4. In order to ensure a smooth transition between the outer tube 3 and the sodium hypo tube 4, the sodium hypo tube 4 includes a rotary-cut sodium hypo tube wire 41 located at the distal end. The rotary-cut sodium hypo tube wire 41 is inserted into the proximal tube section 31 of the outer tube 3. Combined with the fact that the proximal tube section 31 also has a certain degree of hardness, this constitutes a compliant transition between the sodium hypo tube 4 and the outer tube 3.

[0059] The spiral-cutting hypotube wire 41 has a spiral structure and is wrapped inside the proximal segment 31 of the outer tube 3. This can enhance the support of the transition part between the hypotube 4 and the outer tube 3, prevent bending at the junction of the outer tube 3 and the hypotube 4, and push the balloon 1 catheter into the blood vessel more flexibly.

[0060] In one preferred embodiment, the proximal end of the self-perfusion balloon 1 dilation catheter is provided with a catheter seat 6 and a catheter reinforcement 7, and the proximal end of the thiopancreatography tube 4 is connected to the catheter reinforcement 7.

[0061] The catheter seat 6 enables effective handheld pushing. Combined with the connection between the proximal end of the thiopancreatography tube 4 and the catheter reinforcement 7, the thiopancreatography tube 4 and the catheter reinforcement 7 are structurally integrated, thereby enhancing the overall structural strength.

[0062] In order to protect the stored balloon 1 catheter and prevent the outer tube 3 from bending and breaking, this utility model also involves the protection of the balloon 1 catheter. Specifically, the outer tube 3 is provided with a through side hole 34, which communicates with the lumen of the inner tube 2. A protective steel needle 8 is inserted between the through side hole 34 and the balloon 1. Furthermore, the tip of the protective steel needle 8 is inserted in reverse from the distal end of the balloon tip 11 and passes through the entire length of the inner tube 2 before exiting from the guide wire opening where the outer tube 3 and the inner tube 2 intersect, thus providing good rigid support.

[0063] The self-perfusion balloon 1 dilation catheter in this invention has good pushing and passing performance, which can ensure the self-perfusion state of blood to the greatest extent and avoid the risk of the lesion site blocking the perfusion hole 5.

[0064] It should be noted that, where there is no conflict, the features in the embodiments of this application can be combined with each other.

[0065] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A self-perfusion balloon dilation catheter, characterized in that, include: The balloon, inner tube, outer tube, and thiopancreatography (THB) tube, wherein the outer surface of the outer tube is coated with a hydrophilic coating; The outer tube includes two sections of different hardness, which respectively include a proximal section and a distal section spliced ​​together. The distal tube section near the balloon is provided with at least two sets of infusion holes, and the infusion holes of different sets are staggered along the axial direction of the outer tube.

2. The self-perfusion balloon dilation catheter according to claim 1, characterized in that, A welding section is provided between the inner tube and the outer tube, and the injection hole is provided on the welding section. The cavity of the inner tube communicates with the injection hole.

3. The self-perfusion balloon dilation catheter according to claim 2, characterized in that, The distal end of the balloon is connected to the balloon tip, and the distal end of the inner tube is connected to the balloon tip. The balloon tip is provided with multiple tip holes.

4. The self-perfusion balloon dilation catheter according to claim 2, characterized in that, The injection holes include two sets, each set of injection holes is located on the same welding section, and the two sets of injection holes are located opposite each other on both sides of the outer tube in the circumferential direction.

5. The self-perfusion balloon dilation catheter according to claim 4, characterized in that, The spacing between the welding sections along the axial direction of the outer tube is 2-5 mm. Multiple injection holes in each group are arranged at intervals on the welding sections and are all arranged along the axial direction of the outer tube.

6. The self-perfusion balloon dilation catheter according to claim 4, characterized in that, The injection hole has a right-angled trapezoidal structure in the longitudinal section of the outer tube, including a right-angled section at the distal end and an inclined section at the proximal end.

7. The self-perfusion balloon dilation catheter according to claim 4, characterized in that, The hardness of the proximal tube segment is greater than that of the distal tube segment, and the distal end of the thiopanthate tube is inserted into the proximal tube segment.

8. The self-perfusion balloon dilation catheter according to claim 4, characterized in that, The sodium hypochlorite tube includes a rotary-cut sodium hypochlorite filament located at the distal end, the rotary-cut sodium hypochlorite filament having a helical structure wrapped around the inside of the proximal tube segment.

9. The self-perfusion balloon dilation catheter according to claim 4, characterized in that, The proximal end of the self-perfusion balloon dilation catheter is provided with a catheter seat and a catheter reinforcement, and the proximal end of the thiopancreatography (THB) tube is connected to the catheter reinforcement.

10. The self-perfusion balloon dilation catheter according to any one of claims 1-9, characterized in that, The outer tube is provided with a through side hole, which communicates with the lumen of the inner tube, and a protective steel needle is inserted between the through side hole and the balloon. The hydrophilic coating includes a polyvinylpyrrolidone coating.

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