Self-perfusion cutting balloon

Abstract

The utility model relates to a self-perfusion cutting balloon, which comprises a balloon catheter, the balloon catheter comprises an outer tube and an inner tube, the far end of the outer tube is connected with a cutting balloon, the far end of the inner tube is connected with the far end of the cutting balloon, the balloon catheter is provided with a perfusion hole, the perfusion hole is communicated with the inner tube, and the outer tube is connected with the outer tube. A welding section with at least one length is arranged on the balloon catheter, and the perfusion hole is formed in the welding section; a cutting assembly is installed on the cutting balloon and comprises a cutter base and a great-wall-shaped cutting blade capable of protruding out of the surface of the balloon. When the cutting balloon is filled and expanded, blood circulation can be kept, and meanwhile the cutting effect of the cutting blade on the diseased region is enhanced.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a self-perfusing cutting balloon. Background Art

[0002] The cutting balloon is an interventional device used to treat vascular stenosis or occlusion. The balloon is equipped with a sharp cutting blade and can be delivered to the stenotic or occluded site through the blood vessel under the guidance of a guidewire. When the balloon reaches the stenotic or occluded site, the doctor will expand the balloon to make it adhere to the inner wall of the blood vessel.

[0003] On the surface of the cutting balloon, 3-4 rows of blades are installed longitudinally to cut the plaques neatly. When expanding, the balloon expansion pressure and the elastic retraction rate of the blood vessels are reduced accordingly on the basis of reducing the circumferential stress of the blood vessel wall, thereby cutting the blood vessel wall. The existing cutting balloon blades are usually straight blades, which have a large force area and low pressure when cutting plaques, and the cut plaques are shallow. Although the serrated shape has a greater pressure, the force area is too small, which makes it easy to cut a "pit" on the plaque, and the cutting effect is not ideal.

[0004] At the same time, blood flow will be blocked during balloon expansion. If the time is too long, it may cause adverse events such as myocardial ischemia and hemodynamic disorders, which may lead to myocardial damage or myocardial infarction. Utility Model Content

[0005] The purpose of the present application is to provide a self-perfusing cutting balloon that can maintain blood circulation when the cutting balloon is filled and expanded, while enhancing the cutting effect of the cutting blade on the lesion site.

[0006] In order to achieve the above-mentioned purpose, the utility model provides a self-perfusion cutting balloon, including a balloon catheter, the balloon catheter including an outer tube and an inner tube, the distal end of the outer tube is connected to the cutting balloon, the distal end of the inner tube is connected to the distal end of the cutting balloon, the balloon catheter is provided with a perfusion hole, the perfusion hole is communicated with the inner tube, the balloon catheter is provided with at least a welding section of a length, the perfusion hole is opened on the welding section; a cutting assembly is installed on the cutting balloon, the cutting assembly includes a tool seat and a Great Wall-shaped cutting blade that can protrude from the surface of the balloon.

[0007] In an optional embodiment, the welding section is disposed at a location located at the proximal end of the cutting balloon, is formed by welding the inner tube and the outer tube, and is disposed on one side of the balloon catheter.

[0008] In an optional embodiment, the welding section includes a smooth welding surface, and the injection hole is opened on the welding surface and penetrates the entirety in a thickness direction of the welding section.

[0009] In an optional embodiment, the perfusion holes include a plurality of holes, the plurality of holes are spaced apart along the axial direction of the balloon catheter, each of the holes is a straight through hole, and the axial direction of the straight through hole is perpendicular to the axial direction of the balloon catheter.

[0010] In an optional embodiment, the cutting balloon includes a balloon tip, the balloon tip includes an open port at the distal end, and the distal tube opening of the inner tube is connected to the open port of the balloon tip.

[0011] In an optional embodiment, the cutting balloon includes a balloon body, a mounting groove is provided on the side wall of the balloon body, the tool seat is installed in the mounting groove, and the balloon body, the mounting groove and the tool seat are of the same length.

[0012] In an optional embodiment, the cutting blade is heat-welded to the tool seat by a heating mold, and a connecting hole is provided at the root of the cutting blade.

[0013] In an optional embodiment, the heating mold includes a split mold frame, which, when docked, forms a regulating cavity for accommodating the tool seat. The tool seat is heated and melted in the regulating cavity and partially fills into the connecting hole. After cooling, the root of the cutting blade is welded and fixed to the tool seat.

[0014] In an optional embodiment, the cutting blade comprises a plurality of cutting blades, and the plurality of cutting blades are arranged at intervals in the length direction of the tool holder.

[0015] In an optional embodiment, the cutting components are evenly spaced around the circumference of the cutting balloon, and the sharp corners of each cutting blade are provided with chamfers.

[0016] By providing at least a certain length of welding section on the balloon catheter, a welding plane between the outer tube and the inner tube can be formed, eliminating the gap between the outer tube and the inner tube at the welding section. Combined with opening perfusion holes on the welding section, the number and quality of the perfusion holes can be increased, effectively improving the blood flow efficiency.

[0017] The Great Wall-shaped cutting blade included in the cutting assembly can increase the cutting force application area and improve the cutting effect on the plaque in the lesion site compared to the existing serrated blade.

[0018] Other features and advantages of the present application will be described in detail in the subsequent specific implementation section. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

[0020] Figure 1 This is a schematic diagram of the overall structure of the self-perfusion cutting balloon in this application;

[0021] Figure 2 It is a structural schematic diagram of the welding section in this application;

[0022] Figure 3 It is a schematic diagram of the structure of the cutting blade in this application;

[0023] Figure 4 This is a schematic diagram of the matching structure of the cutting blade and the tool holder in this application;

[0024] Figure 5 It is a schematic diagram of the matching structure between the heating mold, the tool holder and the cutting blade.

[0025] icon:

[0026] 1-balloon catheter; 1a-welding section; 11-outer tube; 12-inner tube;

[0027] 2-cutting balloon; 21-balloon body; 22-balloon tip; 23-opening port;

[0028] 3-Infusion hole;

[0029] 4-cutting assembly; 41-tool holder; 42-cutting blade; 43-connecting hole; 44-chamfer;

[0030] 5-heating mold; 51-mold frame; 52-regulating cavity. DETAILED DESCRIPTION

[0031] In order to make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the technical scheme in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all of the embodiments. The components of the embodiments of the present application described and shown in the drawings here can be arranged and designed in various different configurations.

[0032] In the description of this application, it should be noted that the terms "inside", "outside", etc. indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the product of the application is usually placed when in use, which is only for the convenience of describing this application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on this application. In addition, the terms "first", "second", etc. are only used to distinguish the description, and cannot be understood as indicating or implying relative importance.

[0033] In the description of this application, it should also be noted that, unless otherwise clearly specified and limited, the terms "disposed" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be the internal communication of two elements. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0034] join Figure 1 The self-perfusion cutting balloon in the present application mainly performs radial cutting on the plaque at the lesion site when the cutting balloon 2 is pressurized and expanded, so that the plaque forms a cut with a certain depth under the action of the cutting force, thereby ensuring the cutting effect.

[0035] At the same time, by improving the welding structure of the balloon catheter 1 at the perfusion hole 3, the area of ​​the welding part is increased, thereby creating conditions for increasing the number of perfusion holes 3 and ensuring the reliability of the opening part.

[0036] The self-perfusion cutting balloon in the utility model has a main structure including a balloon catheter 1, which is composed of an outer tube 11 and an inner tube 12. The inner tube 12 is mainly used to form a guide wire cavity of the balloon. The distal end of the outer tube 11 is connected to the proximal end of the cutting balloon 2, so that the gap between the outer tube 11 and the inner tube 12 constitutes a balloon inflation cavity.

[0037] The distal end of the inner tube 12 is connected to the distal end of the cutting balloon 2, and a perfusion hole 3 is provided on the balloon catheter 1. Preferably, the perfusion hole 3 is provided at the proximal end of the cutting balloon 2. By making the perfusion hole 3 communicate with the inner tube 12, when the cutting balloon 2 is inflated and expanded, the blood at the proximal end of the balloon can enter the inner tube 12 through the perfusion hole 3, and flow out from the distal end of the balloon through the inner tube 12, thereby maintaining blood circulation and avoiding blocking of blood flow, causing discomfort to the patient, etc.

[0038] In the existing structure of the balloon catheter 1, the perfusion hole 3 is mostly common in the local welding of the outer tube 11 and the inner tube 12, so that the welding part is performed around the perfusion hole 3. Under the pressurized state, the tightness and reliability of the local welding part cannot be guaranteed.

[0039] Combination Figure 2 In the present application, at least a welding section 1a of a certain length is provided on the balloon catheter 1, so that the outer tube 11 and the inner tube 12 are completely welded together at the welding section 1a. Firstly, the reliability of the welding part can be ensured, and then the perfusion hole 3 is opened at the welding section 1a to provide a larger opening area, which can increase the number of perfusion holes 3 opened in the welding section 1a, increase the blood perfusion amount, and improve the blood flow efficiency.

[0040] By opening a hole at a completely welded portion, the reliability of the opening of the injection hole 3 can be ensured, and separation between the outer tube 11 and the inner tube 12 can be prevented, thereby minimizing the risk of pressure leakage.

[0041] The cutting balloon 2 is provided with a cutting assembly 4, which includes a cutter seat 41 and a wall-shaped cutting blade 42 that can protrude from the balloon surface. Figure 3 Compared with the existing serrated structure, the Great Wall-shaped cutting blade 42 can increase the force application area in the radial direction and improve the cutting effect on the plaque at the lesion site.

[0042] In one specific embodiment, the welding section 1a is arranged on the portion of the balloon catheter 1 located at the proximal end of the cutting balloon 2, so that the perfusion hole 3 can be opened at the proximal end of the cutting balloon 2, so that blood can enter the inner tube 12 from the proximal end of the cutting balloon 2 in the inflated and expanded state, thereby maintaining the perfusion and circulation state of blood.

[0043] The welding section 1a is specifically composed of an inner tube 12 and an outer tube 11 welded together. Specifically, in the welding section 1a, the outer wall of the inner tube 12 and the inner wall of the outer tube 11 are fully and completely welded to form a complete welding portion to ensure reliability. Since full and complete welding will cause local deformation of the outer tube 11 and the inner tube 12, the welding section 1a is set on one side of the balloon catheter 1, that is, only one welding portion is set on the balloon catheter 1 at the proximal end of the cutting balloon 2, which effectively prevents the reliability of the balloon catheter 1 from being damaged by double-sided welding.

[0044] Based on the completely tight welding of the inner tube 12 and the outer tube 11, a smooth welding surface can be provided for the welding section 1a. By opening the perfusion hole 3 on the welding surface, the opening quality of the perfusion hole 3 can be guaranteed, and the inner tube 12 and the outer tube 11 at the perfusion hole 3 can be avoided to the greatest extent. Preferably, the perfusion hole 3 is integrally connected in the thickness direction relative to the welding section 1a, so that blood can effectively enter the inner tube 12 located on the inner side through the perfusion hole 3.

[0045] Based on the above-mentioned welding section 1a providing a larger opening area for the perfusion hole 3, the perfusion holes 3 in this embodiment include multiple holes, and combined with the welding section 1a being only provided on one side of the balloon catheter 1, the multiple perfusion holes 3 are arranged at intervals along the axial direction of the balloon catheter 1, so that the multiple perfusion holes 3 are distributed on the same straight line along the axial direction of the balloon catheter 1, thereby improving the uniformity of liquid inflow in the blood perfusion area.

[0046] Furthermore, each perfusion hole 3 is in the form of a straight through hole, and the axial direction of the straight through hole is perpendicular to the axial direction of the balloon catheter 1, which can reduce the stress damage to the balloon catheter 1 caused by the inclined opening and ensure the stability and reliability of the perfusion hole 3.

[0047] From the perspective of facilitating blood perfusion and circulation, the cutting balloon 2 includes a balloon tip 22, and the balloon tip 22 includes an open port 23 located at the distal end. By welding the open tube opening at the distal end of the inner tube 12 to the open port 23 of the balloon tip 22, the lumen of the inner tube 12 can be isolated from the balloon cavity and connected to the external blood vessel cavity, so that the blood can maintain a smooth perfusion and circulation state.

[0048] It should be noted that by using one of the multiple perfusion holes 3 as a guidewire hole connecting the guidewire cavity with the outside world, it is possible to ensure that the guidewire hole on the balloon catheter 1 is connected to the balloon tip 22, which is beneficial for pushing the self-perfusion balloon as a whole to the lesion site under the guidance of the guidewire.

[0049] In another specific embodiment, the cutting balloon 2 includes a balloon body 21, and a mounting groove (not shown in the figure) is provided on the side wall of the balloon body 21. The mounting groove is specifically a mounting groove opened on the outer wall of the balloon body 21. By installing the tool seat 41 in the mounting groove, the cutting assembly 4 can be reliably installed on the cutting balloon 2.

[0050] From the perspective of increasing the cutting length of the cutting balloon 2, the lengths of the balloon body 21, the mounting groove and the tool seat 41 are the same, so that the cutting assembly 4 can be installed in the overall length direction of the balloon body 21 to increase the cutting area in the length direction.

[0051] The common blades of existing cutting balloons are mostly bonded or structurally fixed, and the installation steps are cumbersome and inefficient. Figure 4-Figure 5 The cutting blade 42 is heat-sealed and welded to the tool holder 41 by heating the mold 5, and a connecting hole 43 is provided at the root of the cutting blade 42. The connecting hole 43 is not provided for mechanical clamping with the tool holder 41, but is provided for hot melting the tool holder 41 in the state of regulation and shaping, so that a part of the hot-melted tool holder 41 flows into the connecting hole 43, and the welding of the tool holder 41 and the root of the cutting blade 42 is completed after cooling.

[0052] Furthermore, the heating mold 5 includes a split mold frame 51, which can form a regulating cavity 52 for accommodating the tool seat 41 after the mold frame 51 is docked. During the welding process, the root of the cutting blade 42 is inserted into the installation gap of the tool seat 41, and the tool seat 41 is heated and melted in the regulating cavity 52 and partially fills into the connecting hole 43, and after cooling, the root of the cutting blade 42 is welded and fixed to the tool seat 41.

[0053] This arrangement simplifies the connection operation between the cutting blade 42 and the tool holder 41 , which makes the operation convenient and greatly improves the connection strength between the cutting blade 42 and the tool holder 41 .

[0054] Furthermore, by heating the regulating cavity 52 of the mold 5, the shape of the tool seat 41 can be stabilized and will not be deformed due to the hot melting of the tool seat 41. The tool seat 41 prepared in this way has low hardness and is easy to bend on the balloon body 21, thereby enhancing the passability of the balloon in the blood vessel.

[0055] In order to further ensure the bendability of the cutting assembly 4, the length of each blade can be reduced and the number of blades can be increased on the same row while ensuring the cutting length. Specifically, the cutting blades 42 in this embodiment include a plurality of blades, which are arranged at intervals in the length direction of the tool holder 41. By leaving a gap between each blade, a bending space is left for the balloon, thereby enhancing the passability of the balloon.

[0056] Each mounting groove and the corresponding cutting assembly 4 installed in the mounting groove constitute a single-row tool seat 41 and a cutting blade 42. In order to form a cutting balloon 2 to cut the diseased plaque in three-dimensional space, multiple rows of tool seats 41 and cutting blades 42 are evenly spaced around the cutting balloon 2 to form a cutting area in the three-dimensional space of the cutting balloon 2, thereby ensuring the cutting effect on the plaque in the diseased area.

[0057] The sharp corners of each cutting blade 42 are provided with chamfers 44, which can prevent the balloon from failing due to the sharp parts piercing the balloon body 21 during folding or use of the balloon.

[0058] The self-perfusion cutting balloon in the present application can ensure the opening quality of the perfusion hole 3 and improve the cutting effect of the plaque at the lesion site while simplifying the connection operation of the cutting component 4.

[0059] It should be noted that, in the absence of conflict, the features in the embodiments of this application may be combined with each other.

[0060] The above are only preferred embodiments of the present application and are not intended to limit the present application. For those skilled in the art, the present application may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A self-perfusing cutting balloon, characterized in that: The invention comprises a balloon catheter, which comprises an outer tube and an inner tube, the distal end of the outer tube is connected to a cutting balloon, the distal end of the inner tube is connected to the distal end of the cutting balloon, the balloon catheter is provided with a perfusion hole, the perfusion hole is communicated with the inner tube, the balloon catheter is provided with a welding section of at least one length, the perfusion hole is opened on the welding section; a cutting assembly is installed on the cutting balloon, the cutting assembly comprises a tool seat and a Great Wall-shaped cutting blade that can protrude from the surface of the balloon.

2. The self-perfusing cutting balloon according to claim 1, characterized in that: The welding section is arranged at a position located at the proximal end of the cutting balloon, is formed by welding the inner tube and the outer tube, and is arranged on one side of the balloon catheter.

3. The self-perfusing cutting balloon according to claim 1, characterized in that: The welding section comprises a smooth welding surface, and the injection hole is arranged on the welding surface and penetrates the entirety in the thickness direction of the welding section.

4. The self-perfusing cutting balloon according to claim 1, characterized in that: The perfusion holes include a plurality of holes, which are spaced apart along the axial direction of the balloon catheter. Each of the perfusion holes is a straight through hole, and the axial direction of the straight through hole is perpendicular to the axial direction of the balloon catheter.

5. The self-perfusing cutting balloon according to any one of claims 1 to 4, characterized in that: The cutting balloon comprises a balloon tip, and the balloon tip comprises an open port at the distal end, and the distal end tube opening of the inner tube is connected to the open port of the balloon tip.

6. The self-perfusing cutting balloon according to any one of claims 1 to 4, characterized in that: The cutting balloon comprises a balloon body, a side wall of the balloon body is provided with a mounting groove, the tool seat is mounted in the mounting groove, and the balloon body, the mounting groove and the tool seat have the same length.

7. The self-perfusing cutting balloon according to claim 6, characterized in that: The cutting blade is heat-sealed and welded on the tool seat by a heating mold, and a connecting hole is arranged at the root of the cutting blade.

8. The self-perfusing cutting balloon according to claim 7, characterized in that: The heating mold includes a split mold frame, which forms a regulating cavity for accommodating the tool seat after the mold frames are connected. The tool seat is heated and melted in the regulating cavity and partially fills into the connecting hole. After cooling, the root of the cutting blade is welded and fixed to the tool seat.

9. The self-perfusing cutting balloon according to claim 6, characterized in that: The cutting blades include a plurality of blades, and the plurality of cutting blades are arranged at intervals in the length direction of the tool holder.

10. The self-perfusing cutting balloon according to claim 6, characterized in that: The cutting components are evenly spaced around the cutting balloon, and the sharp corners of each cutting blade are chamfered.

Images