Balloon dilatation catheter

Abstract

The application relates to a balloon dilatation catheter, which comprises a balloon, a score structure, a score structure accommodating cavity, a first limiting block, a second limiting block and a pushing rod, the score structure accommodating cavity is arranged on the outer tube and is adjacent to the proximal end of the balloon; the pushing rod is connected with the score structure; the first limiting block is adjacent to the proximal end of the score structure, and the second limiting block is located outside the proximal end of the score structure accommodating cavity; the first limiting block and the second limiting block are sleeved on the outer tube; the pushing rod is moved, the first limiting block and the second limiting block can be axially moved along the outer tube and the pushing rod and the score structure synchronously, the score structure is realized to enter the score structure accommodating cavity or to be wrapped on the balloon. The application can freely select whether to use the score wire according to actual needs, and the optimal configuration can be facilitated according to specific treatment targets.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a balloon dilation catheter. Background Technology

[0002] In angioplasty and other interventional procedures, dilatation balloons are commonly used medical devices to restore or improve the patency of narrowed blood vessels. Traditionally, dilatation balloons are equipped with scoring wires that cover the balloon surface, allowing for the treatment of severe calcifications or refractory stenosis through physical cutting or scratching. However, this fixed design presents certain limitations and challenges.

[0003] In existing technologies, the scoring wire is permanently wrapped around the balloon, meaning that the need for scoring cannot be selected based on specific circumstances during use. Using a balloon with a scoring wire when no additional cutting force is required may lead to vessel wall damage or other complications, increasing patient risk. Because the design of the scoring wire is fixed, physicians cannot flexibly adjust the choice of tool according to the specific characteristics of the lesion (such as the degree and location of calcification). This limits the flexibility and personalization of treatment plans.

[0004] In addition, the presence of the scoring wire may also affect the delivery performance of the balloon, especially in tortuous or narrow blood vessels, increasing the difficulty and technical requirements of the operation. Utility Model Content

[0005] Based on this, this application provides a balloon dilation catheter that can freely choose whether to use a notched wire according to actual needs, and can be optimized according to specific treatment goals (such as dilation or drug release).

[0006] To address the aforementioned problems, this utility model provides a balloon dilation catheter, comprising an outer tube, an inner tube, a catheter seat, a balloon, a notched structure, a notched structure receiving cavity, a first limiting block, a second limiting block, and a push rod.

[0007] The grooved structure receiving cavity is disposed on the outer tube and is adjacent to the proximal end of the balloon;

[0008] The push rod is connected to the grooved structure;

[0009] The first limiting block is adjacent to the proximal end of the scoring structure, and the second limiting block is located on the outside of the proximal end of the scoring structure's receiving cavity; the first limiting block and the second limiting block are fitted onto the outer tube;

[0010] The movable push rod, the first limiting block and the second limiting block can move synchronously along the outer tube, the push rod and the scoring structure, so that the scoring structure enters the scoring structure receiving cavity or covers the balloon.

[0011] Furthermore, the scoring structure includes scoring wires and a thin film, wherein the thin film has a cavity structure and the scoring wires are disposed on the thin film.

[0012] Furthermore, the film is in the form of a membrane or a mesh, and micropores capable of containing drugs are provided on the film.

[0013] Furthermore, the push rod, starting from the position of the second limiting block and moving towards the balloon, adheres tightly to the surface of the outer tube; pulling the push rod until the first limiting block engages with the inner wall of the near end of the grooved structure receiving cavity, the grooved structure is housed within the grooved structure receiving cavity; pushing the push rod causes the grooved structure to open along the balloon surface until the second limiting block engages with the outer wall of the near end of the grooved structure receiving cavity, thus completing the encapsulation of the balloon by the grooved structure.

[0014] Furthermore, the scoring wire is parallel to the axis of the outer tube, and at least one scoring wire is provided; when the number of scoring wires is at least two, the scoring wires are evenly distributed in the circumferential direction on the outer surface of the balloon.

[0015] Furthermore, the distal end of the etched wire is designed as a sphere, making smooth contact with the surface of the balloon.

[0016] Furthermore, the outer tube is sleeved on the outside of the inner tube, the proximal end of the outer tube is sealed to the catheter seat, the distal end of the outer tube is connected to the proximal end of the balloon, and the distal end of the balloon is sealed to the outer wall of the inner tube.

[0017] The inner wall of the outer tube and the outer wall of the inner tube form a balloon inflation cavity, which communicates with the inner cavity of the balloon.

[0018] Furthermore, it also includes a radiopaque ring, at least one of which is disposed on the inner tube located in the balloon.

[0019] Furthermore, the catheter seat is provided with an air inlet and a guidewire passage port. The air inlet is connected to the inner cavity of the balloon through the balloon inflation chamber, which can inflate or deflate the balloon. The inner cavity of the inner tube is the guidewire cavity, which is connected to the guidewire passage port.

[0020] Furthermore, the balloon comprises a guide section, an expansion section, and a connecting section in sequence from distal to proximal. The expansion section is smoothly connected to the guide section and the connecting section, respectively. The connecting section is connected to the distal end of the outer tube. The outer diameter of the expansion section is larger than the outer diameter of the guide section and the connecting section.

[0021] Compared with the prior art, the present invention has the following beneficial effects:

[0022] This invention controls the first and second limiting blocks to move synchronously along the outer tube, the pushing rod, and the scoring structure by moving the pushing rod. This allows the scoring structure to enter the scoring structure receiving cavity or cover the balloon. It also allows for the free selection of whether to use scoring wires according to actual needs, facilitating optimized configuration based on specific treatment goals (such as dilation or drug release). Attached Figure Description

[0023] Figure 1 This is a schematic diagram of the structure of an embodiment of the present utility model;

[0024] Figure 2 This is a schematic diagram showing the balloon folded and the scoring wires retracted in an embodiment of the present invention;

[0025] Figure 3 This is a schematic diagram showing the balloon deployment and the use of the scoring wires in an embodiment of the present invention;

[0026] Figure 4 This is a schematic diagram of the structure of the scoring wire and the thin film in the embodiment of this utility model.

[0027] Wherein: 1-balloon, 2-score structure receiving cavity, 3-score wire, 4-outer tube, 5-inner tube, 6-catheter seat, 7-contrast ring, 8-ventilation port, 9-guidewire port, 31-limiting block, 32-sphere, 33-membrane, 34-push rod. Detailed Implementation

[0028] The present application will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the present application and are not intended to limit the scope of the present application.

[0029] This application provides a balloon dilation catheter, such as Figure 1 As shown, in addition to the outer tube 4, inner tube 5, and catheter seat 6 included in the existing structure, one embodiment of the structure of this application further includes: a balloon 1, a notched structure, a notched structure receiving cavity 2, a first limiting block 31, a second limiting block 30, and a push rod 34.

[0030] like Figure 2 As shown, the notched structure receiving cavity 2 is located on the outer tube 4 and is adjacent to the proximal end of the balloon 1. It is used to store or hide the notched structure to ensure that when it is not in use, the notched structure will not affect other operations, including the operation of the balloon 1, or cause unnecessary complications.

[0031] The push rod 34 is connected to the scoring structure via mechanical connections such as threaded connections, snap-fit ​​connections, or sheath connections to effectively control the axial movement of the scoring structure.

[0032] like Figure 3As shown, the first limiting block 31 is located at the proximal end of the scoring structure, limiting the maximum extension length of the scoring structure and preventing over-extension and damage. The second limiting block 30 is located on the proximal outer side of the scoring structure receiving cavity 2, preventing the scoring structure from completely exiting the receiving cavity and providing a clear stopping point for the push rod. Both the first limiting block 31 and the second limiting block 30 are fitted onto the outer tube 4 to ensure that they can slide precisely axially along the outer tube, allowing the scoring structure to enter the scoring structure receiving cavity or cover the balloon. The use of scoring wires can be freely selected according to actual needs, facilitating optimized configuration based on specific treatment goals (such as dilation or drug release).

[0033] As one embodiment of this application, such as Figure 4 As shown, the scoring structure includes a scoring wire 3 and a thin film 33. The thin film 33 has a hollow structure, and the scoring wire 3 is disposed on the thin film 33. Exemplarily, the scoring wire 3 is fixed to the outer surface of the thin film 33 to ensure its stable function during use. The scoring wire 3 can be firmly attached to the thin film 33 by means of adhesives, welding, or mechanical fixation, ensuring that it will not shift or fall off during operation, thereby guaranteeing the safety and effectiveness of the surgery.

[0034] The design of the scoring wire can be adjusted according to specific treatment needs, such as selecting different lengths, diameters, or shapes, to achieve the best cutting or expansion effect. For example... Figure 4 As shown, the scoring wire 3 is parallel to the axis of the outer tube 4, and at least one scoring wire is provided. When there are at least two scoring wires 3, the scoring wires 3 are evenly distributed circumferentially on the outer surface of the balloon 1. Preferably, three scoring wires are provided, and the cross-sectional shape is designed as an equilateral triangle. The scoring wire 3 is made of a high-strength metal material with shape memory properties, corrosion resistance, and biocompatibility, such as stainless steel, nickel-titanium alloy, or platinum-iridium alloy, with nickel-titanium wire being preferred.

[0035] In the above embodiments, the material of the film 33 is selected from polymer or highly elastic materials, such as polyurethane, silicone or Pebax, etc. Its thickness needs to be optimized according to the specific treatment requirements. It needs to be thin enough to reduce the impact on the blood vessel wall, and it also needs to have sufficient strength to support the scoring wire and keep its position unchanged.

[0036] Alternatively, the film 33 can be designed as a membrane or a mesh, with drug-capable micropores formed on it. Exemplarily, the film 33 can be designed as a continuous sheet with uniform thickness and a smooth surface. This design is suitable for applications requiring a large surface area, better supporting the scored filaments and ensuring uniform drug release. The film 33 can also be designed as a mesh structure composed of interlaced fibers or lines to provide more open space, better facilitating fluid exchange and drug penetration. Furthermore, the mesh design enhances the overall flexibility and adaptability of the scored structure, making it easier to navigate curved paths. Drug-capable micropores are formed on the film 33. These micropores can be precisely designed according to therapeutic needs, including parameters such as size, shape, and density. The micropore design on the film 33 not only increases the space for drug storage but also facilitates controlled drug release. The micropores can be manufactured using methods such as laser drilling, electrospinning, or chemical etching, ensuring good consistency and stability for each micropore.

[0037] For example, various drug carriers, such as polymer particles, liposomes, or nanoparticles, can be filled within the micropores. These carriers can not only load a large number of drug molecules but also regulate the drug release rate to achieve long-lasting therapeutic effects. Regarding drug selection, different types of drugs can be chosen based on the specific treatment goal, such as anti-proliferative drugs, anti-inflammatory drugs, or growth factors, for local treatment of vascular diseases or promotion of tissue repair.

[0038] The combined design of the scoring wire 3 and the membrane 33 in the above embodiment, because the scoring wire is fixed on the flexible membrane, reduces direct pressure on the blood vessel wall and lowers the risk of tissue damage compared to traditional rigid stents. Simultaneously, covering the effective working area of ​​the balloon increases the balloon's burst pressure. Furthermore, it ensures precise cutting or expansion of the lesion site while expanding the balloon, helping to improve blood flow and promote treatment efficacy.

[0039] As one embodiment of this application, such as Figure 3As shown, the push rod 34 extends from the position of the second limiting block 30 towards the balloon 1, adhering closely to the surface of the outer tube 4. Pulling the push rod 34 until the first limiting block 31 engages with the inner wall of the proximal end of the scoring structure receiving cavity 2, the scoring structure is housed within the scoring structure receiving cavity 2. Pushing the push rod 34 causes the scoring structure to open along the surface of the balloon 1 until the second limiting block 30 engages with the outer wall of the proximal end of the scoring structure receiving cavity 2, thus completing the covering of the balloon 1. Exemplarily, when a drug-eluting film is required, by pushing the push rod 34 forward, the scoring assembly extends and opens from the receiving cavity 2, covering the effective working area surface of the balloon 1, and the drug begins to be slowly released from the micropores to the lesion site. After treatment, by pulling the push rod 34 backward, the scoring assembly is folded and retracted into the receiving cavity 2, ensuring it does not interfere with subsequent operations or cause unnecessary complications.

[0040] As one embodiment of this application, such as Figure 3 As shown, the distal end of the scoring wire 3 is designed as a sphere 32, which ensures smooth contact with the surface of the balloon 1 and reduces potential damage to the blood vessel wall or other tissues during operation. At the same time, the sphere design makes the scoring wire 3 more flexible in curved paths, better adapting to complex vascular structures and reducing the risk of device jamming or twisting.

[0041] As one embodiment of this application, such as Figure 2 As shown in Figure 3, the device also includes a radiopaque ring 7, at least one radiopaque ring 7 disposed on the inner tube 5 located within the balloon 1, to clearly display the position of the balloon under imaging equipment. Exemplarily, the radiopaque ring 7 is disposed at a critical location in the balloon dilation section, such as the proximal and / or distal end of the balloon, to ensure clear visualization of the balloon's position under imaging equipment. The radiopaque ring 7 can be securely attached to the outer wall of the inner tube 5 by means of welding, adhesive, or mechanical fastening, ensuring that it does not shift or detach during operation.

[0042] In one embodiment of this application, the outer tube 4 is fitted over the inner tube 5 to form a double-layer pipe system, and the two pipes need to have a certain degree of coaxiality. The inner wall of the outer tube 4 and the outer wall of the inner tube 5 form a balloon inflation cavity, which communicates with the inner cavity of the balloon 1, providing additional space for other components or fluid channels.

[0043] As one embodiment of this application, the proximal end of the outer tube 4 is sealed to the catheter hub 6, and the distal end of the outer tube 4 is connected to the proximal end of the balloon 1. The distal end of the balloon 1 is sealed to the outer wall of the inner tube 5. Exemplarily, the proximal end of the outer tube 4 is sealed to the catheter hub 6 using a high-strength sealing material (such as medical-grade silicone or EPDM rubber sealing rings). This seal not only prevents liquid or gas leakage but also enhances the stability of the overall structure. The distal end of the outer tube 4 is directly or via an adapter connected to the proximal end of the balloon 1, ensuring sufficient mechanical strength at the connection point to withstand the stress generated during operation. The distal end of the balloon 1 is sealed to the outer wall of the inner tube 5 by methods such as heat fusion or adhesives to ensure the integrity of the balloon 1 during inflation and deflation and to prevent relative slippage during operation.

[0044] For example, the inner tube 5 and outer tube 4 can be made of polymer materials such as polyurethane (PU), nylon, or polyethylene (PE), which have good flexibility, abrasion resistance, and biocompatibility to suit use in medical environments. The balloon 1 can be made of an elastic material, such as natural latex or synthetic rubber (e.g., Pebax), to allow it to inflate during inflation and return to its original shape after deflation. For certain applications, non-elastic materials (e.g., PET) can also be considered to achieve specific expansion characteristics.

[0045] As one embodiment of this application, balloon 1 comprises, from distal to proximal, a guide section, an expansion section, and a connecting section. The expansion section smoothly transitions to both the guide section and the connecting section, and the connecting section connects to the distal end of the outer tube 4. The outer diameter of the expansion section is larger than that of the guide section and the connecting section. Exemplarily, the guide section is located at the distal end of balloon 1 and is primarily used to guide the entire device into a blood vessel or other cavity. Its outer diameter is small, and it is designed to be tapered or tapered to reduce frontal resistance, ensure smooth insertion, and facilitate passage through narrow or tortuous paths. The expansion section, located between the guide section and the connecting section, is the effective working area of ​​the balloon, responsible for expanding, cutting, or administering medication to the lesion site during inflation. The outer diameter of the expansion section is significantly larger than that of the guide section and the connecting section to provide sufficient surface area for effective treatment; this section has a uniform outer diameter to ensure uniform pressure distribution during expansion. The expansion section is smoothly transitioned to the guide section and the connecting section, avoiding sharp edges or abrupt changes, reducing friction and potential damage during operation. The connecting section is located at the proximal end of the balloon 1 and is used to connect the balloon to the distal end of the outer tube 4. It can be firmly bonded to the outer tube 4 by means of heat fusion, adhesive or mechanical snap-fit, so as to ensure a stable connection throughout the operation.

[0046] As one embodiment of this application, such as Figure 1As shown, the catheter hub 6 is equipped with a vent 8 and a guidewire port 9. The vent 8 communicates with the inner lumen of the balloon 1 through the balloon inflation chamber, allowing the balloon 1 to inflate or deflate. The inner lumen of the inner tube 5 is the guidewire lumen, which communicates with the guidewire port 9. In use, the guidewire enters the guidewire lumen of the scored balloon catheter from the distal tube and is led out of the body through the guidewire port. The guidewire facilitates the delivery of interventional devices based on the scored balloon catheter.

[0047] It should be noted that, in this application, the term "comprising" or any other variation thereof is intended to cover non-exclusive inclusion, such that a method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such an article or apparatus. Without further limitation, an element defined by the phrase "comprising..." does not exclude the presence of other identical elements in the method, article, or apparatus that includes said element.

[0048] The terms "proximal" and "distal" refer to the end closer to the operator and the end further away from the operator, respectively. In this application, the operator is located on the side closer to the catheter hub 6.

[0049] In the description of the embodiments of this application, unless otherwise stated, " / " means "or", for example, A / B can mean A or B; "and / or" in this document is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, and B existing alone. Furthermore, in the description of the embodiments of this application, "multiple" refers to two or more.

[0050] In the description of this application, unless otherwise expressly defined, terms such as "setup," "installation," and "connection" should be interpreted broadly, and those skilled in the art can reasonably determine the specific meaning of the above terms in this application in conjunction with the specific content of the technical solution.

[0051] The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. The same or similar parts between the various embodiments can be referred to each other.

[0052] This application uses specific examples to illustrate the principles and implementation methods of the present invention. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of the present invention. It should be noted that for those skilled in the art, various modifications, combinations, sub-combinations, and substitutions can be made without departing from the principles of the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this application should be included within the scope of protection of this application.

Claims

1. A balloon dilation catheter, comprising an outer tube (4), an inner tube (5), and a catheter seat (6), characterized in that, Also includes: The balloon (1), the grooved structure, the grooved structure receiving cavity (2), the first limiting block (31), the second limiting block (30) and the push rod (34). The grooved structure receiving cavity (2) is disposed on the outer tube (4) and is adjacent to the proximal end of the balloon (1); The push rod (34) is connected to the grooved structure; The first limiting block (31) is adjacent to the proximal end of the scoring structure, and the second limiting block (30) is located on the outside of the proximal end of the scoring structure receiving cavity (2); the first limiting block (31) and the second limiting block (30) are fitted onto the outer tube (4); The push rod (34) is moved, and the first limiting block (31) and the second limiting block (30) can move axially along the outer tube (4) in sync with the push rod (34) and the scoring structure, so that the scoring structure can enter the scoring structure receiving cavity (2) or cover the balloon (1).

2. The balloon dilation catheter as described in claim 1, characterized in that, The etched structure includes etched wires (3) and a thin film (33), the thin film (33) is a cavity structure, and the etched wires (3) are disposed on the thin film (33).

3. The balloon dilation catheter as described in claim 2, characterized in that, The film (33) is in the form of a membrane or a mesh, and micropores capable of containing drugs are provided on the film (33).

4. The balloon dilation catheter as described in claim 1 or 2, characterized in that, The push rod (34) starts from the position of the second limiting block (30) and moves towards the balloon (1), adhering closely to the surface of the outer tube (4); the push rod (34) is pulled until the first limiting block (31) engages with the inner wall of the near end of the grooved structure receiving cavity (2), and the grooved structure is housed in the grooved structure receiving cavity (2); the push rod (34) is pushed, and the grooved structure opens along the surface of the balloon (1) until the second limiting block (30) engages with the outer wall of the near end of the grooved structure receiving cavity (2), and the grooved structure completes the covering of the balloon (1).

5. The balloon dilation catheter as described in claim 2, characterized in that, The scoring wire (3) is parallel to the axis of the outer tube (4), and at least one scoring wire (3) is provided. When the number of scoring wires (3) is at least two, the scoring wires (3) are uniformly arranged in the circumferential direction on the outer surface of the balloon (1).

6. The balloon dilation catheter as described in claim 5, characterized in that, The distal end of the etched wire (3) is designed as a sphere, which makes smooth contact with the surface of the balloon (1).

7. The balloon dilation catheter as described in claim 1, characterized in that, The outer tube (4) is sleeved on the outside of the inner tube (5). The proximal end of the outer tube (4) is sealed to the catheter seat (6). The distal end of the outer tube (4) is connected to the proximal end of the balloon (1). The distal end of the balloon (1) is sealed to the outer wall of the inner tube (5). The inner wall of the outer tube (4) and the outer wall of the inner tube (5) form a balloon inflation cavity, which communicates with the inner cavity of the balloon (1).

8. The balloon dilation catheter as described in claim 7, characterized in that, It also includes a radiopaque ring (7), at least one of the radiopaque rings (7) being disposed on the inner tube (5) located in the balloon (1).

9. The balloon dilation catheter according to claim 8, characterized in that, The catheter seat (6) is provided with an air inlet (8) and a guidewire inlet (9). The air inlet (8) is connected to the inner cavity of the balloon (1) through the balloon inflation chamber, which can inflate or deflate the balloon (1). The inner cavity of the inner tube (5) is the guidewire cavity, which is connected to the guidewire inlet (9).

10. The balloon dilation catheter as described in claim 1, characterized in that, The balloon (1) includes a guide section, an expansion section and a connecting section from the distal end to the proximal end. The expansion section is smoothly connected to the guide section and the connecting section respectively. The connecting section is connected to the distal end of the outer tube (4). The outer diameter of the expansion section is larger than the outer diameter of the guide section and the connecting section.

Images