High-safety segmented hinged medical stent structure and preparation process thereof

Abstract

This invention discloses a high-safety segmented articulated medical stent structure and its manufacturing process, belonging to the field of vascular interventional devices. The invention uses medical alloy wire to form a closed ring, which is then stamped into a multi-peaked ring shape with circular corrugations or triangular patterns using a mold. After the peaks of the multi-peaked ring are aligned, they are assembled into a flexible stent body using laser micro-spot welding. Fixed rings can be selectively added to both ends to enhance end rigidity. After the stent is integrally formed, it is uniformly polished and then subjected to shape-memory heat treatment to impart a shape memory effect. After sterilization, the outer diameter is compressed by external force and fitted onto the balloon surface. This invention adopts a segmented assembly structure with a smooth, burr-free outer wall, avoiding the drawbacks of traditional laser cutting that easily damages blood vessels. It relies on precise balloon inflation for diameter expansion, combined with shape memory to maintain shape and resist shrinkage. The process is reasonable, suitable for clinical use, has high material utilization, and is easy to mass-produce, reducing manufacturing costs and the burden on patients.

Description

Technical Field

[0001] This invention relates to the field of medical vascular interventional device technology, specifically to a high-safety segmented articulated medical stent structure and its manufacturing process. Background Technology

[0002] Currently, the mainstream clinical vascular stents are generally formed using laser-cut precision metal tubing. This process has several inherent technical drawbacks that cannot be avoided: 1. Safety hazards are difficult to eradicate Laser cutting creates numerous sectional cuts, microscopic serrations, and sharp edges on the stent surface. Subsequent polishing processes can only remove visible burrs; the microscopic sharp structures cannot be completely eliminated. After the stent is implanted in a blood vessel, it rubs against the inner wall of the vessel with the continuous pulsation of the heartbeat, which can easily cause damage to the vascular intima, significantly increasing the probability of postoperative thrombosis and vascular inflammation.

[0003] 2. High processing difficulty, low yield, large waste, and high cost. Laser cutting places extremely high demands on pipe precision, equipment stability, and process control. Even slight fluctuations can lead to defects in the support structure, making it difficult to maintain a stable production yield. The pipe cutting process uses whole round pipes as raw materials, and the hollow structure results in a large amount of metal being directly cut off as waste, with a material utilization rate of less than 30%. This leads to a significant waste of precious metal raw materials and keeps the overall cost high.

[0004] 3. Insufficient structural flexibility and adaptability Traditional integrated cutting stents are not very flexible and have difficulty conforming to the natural physiological curvature of blood vessels. After expansion, they are prone to problems such as retraction and poor apposition, which affect the treatment effect.

[0005] Existing laser-cut supports have significant shortcomings in terms of safety, economy, mass production capacity, and structural performance. The industry urgently needs new technical solutions to overcome existing technical bottlenecks. Summary of the Invention

[0007] Purpose of the invention To address the shortcomings of existing laser-cut stents, such as easy damage to blood vessels, insufficient flexibility, poor shaping accuracy, high cost, and unreasonable processes, this invention provides a high-safety segmented articulated medical stent structure and its manufacturing process. It adopts a segmented multi-peak ring-shaped assembly structure and optimizes the entire process of molding, polishing, heat treatment shaping, and post-processing to improve safety and clinical suitability.

[0008] Technical solution This invention uses medical alloy wire to first form a closed ring, which is then stamped with a mold to form a multi-peaked ring with circular ripples or triangular patterns; multiple sets of multi-peaked rings are aligned and assembled into a flexible support body by laser micro-spot welding at the peak positions; fixed-specification rings can be selectively added to both ends of the support to enhance the rigidity of the ends.

[0009] After the whole thing is formed, it is polished and ground, and then heat-treated to give it a shape memory effect. After sterilization and disinfection, the tube diameter is compressed by external force and then fitted onto the surface of the balloon to make the finished product.

[0010] During clinical implantation, the balloon is inflated to precisely expand to match the diameter of the blood vessel. After the balloon is removed, the alloy shape memory is used to maintain the shape and prevent retraction and collapse.

[0011] Beneficial effects 1. Enhanced safety: Abandoning laser cutting technology, there are no burrs or micro-serrations on the cut surface. The outer wall is smooth after overall polishing, which completely avoids blood vessel abrasion and reduces the risk of postoperative thrombosis and inflammation.

[0012] 2. High material utilization rate: It is formed directly from metal wire, eliminating waste from pipe cutting, which greatly improves material utilization and significantly reduces raw material costs.

[0013] 3. Stable process and easy mass production: The core processes are mold stamping and micro-spot welding, with controllable yield and stable cycle time, solving the bottleneck of difficult large-scale mass production of traditional processes.

[0014] 4. Reduced overall costs: High utilization rate + low-threshold process + high yield rate reduce manufacturing costs in multiple dimensions, which can directly alleviate the economic burden on patients.

[0015] 5. Excellent flexibility and adaptability: The segmented hinged structure has excellent flexibility and conforms to the physiological curvature of blood vessels; combined with the shape memory effect, it has excellent anti-retraction and wall adhesion, resulting in more stable treatment effects. Detailed Implementation

[0016] The basic unit of this invention is a closed ring made of medical alloy wire, which is stamped into a multi-peak ring shape in one go by a special mold. The ring shape can adopt a continuous smooth circular wave or triangular wave structure without sharp bends. The number of peaks in the multi-peak ring shape is multiple, preferably six evenly distributed around the circumference, with a smooth transition.

[0017] Several multi-peaked rings are aligned with their peaks in sequence and connected at the peak positions using laser micro-spot welding to assemble a flexible support body of the required length. According to usage requirements, fixed rings with corresponding inner diameters can be added to the beginning and end of the support to improve the radial support and rigid shaping effect at the ends.

[0018] After the entire bracket is assembled and the optional end ring is assembled, it is uniformly polished and ground to completely remove interface traces, weld protrusions and surface burrs; then, the bracket is subjected to shaping heat treatment to obtain stable shape memory and preset standard working pipe diameter shape.

[0019] After medical sterilization, the stent is radially compressed to reduce its outer diameter using external force and then fitted and fixed onto the surface of a balloon, forming a pre-assembled component suitable for interventional delivery. In clinical use, a balloon with the stent attached is inserted into the target location in the blood vessel. Inflation of the balloon precisely expands the stent to fit the appropriate vessel diameter. After the balloon is released and withdrawn, the stent maintains its stable support shape due to its shape memory, preventing retraction and collapse, and exhibiting excellent biocompatibility and adherence to the vessel wall. Attached Figure Description

[0020] The accompanying drawings illustrate the structural composition of the invention: it includes a single-group multi-peak circular structure and two circular outline forms: circular ripples and triangular patterns.

[0021] Figure 1 This is a schematic diagram of the four-peak component structure; Figure 2 This is a schematic diagram of the six-peak component structure.

Claims

1. A high-safety segmented articulated medical stent structure, characterized in that: A closed ring is made of medical alloy wire, and the closed ring is formed into a multi-peak ring shape by die stamping; the ring outline is a continuous and smooth circular wave or triangular pattern structure without sharp bends.

2. The high-safety segmented articulated medical stent structure according to claim 1, characterized in that: Several multi-peak ring shapes are aligned one after another, and fixed at the peak positions by laser micro-spot welding to form a flexible support body of a set length.

3. The high-safety segmented articulated medical stent structure according to claim 2, characterized in that: After the flexible support body is formed, fixed-size rings that match the inner diameter of the support can be selectively installed at both ends to enhance the rigidity of the support ends and provide radial shaping and support.

4. The high-safety segmented articulated medical stent structure according to claim 1, characterized in that: The number of peaks in the multi-peak circular shape is set to multiple, preferably six evenly distributed around the circumference; the waveform is a smoothly transitioning circular ripple or triangular pattern structure without sharp corners.

5. The high-safety segmented articulated medical stent structure according to claim 2, characterized in that: Laser micro-spot welding produces weld points flush with the outer wall of the stent, without any protruding edges, thus avoiding scratching the inner wall of the blood vessel after implantation.

6. A manufacturing process for a high-safety segmented articulated medical stent, characterized in that... Includes the following steps: The first step is to cut the medical alloy wire to a fixed length, and then weld the two ends of the wire together to form a closed circular ring blank. The second step is to use a special mold to directly press the closed ring into a multi-peak ring shape, with the ring outline being a circular wave or triangular pattern structure. The third step is to align the peaks of multiple multi-peak ring-shaped components one by one, and then use laser micro-spot welding at the peak positions to assemble them into a flexible support body of a set length. The fourth step is to install fixed rings at both ends of the main body of the bracket as needed; The fifth step is to polish and grind the entire support structure after it has been formed to remove weld marks, surface burrs and sharp edges. The sixth step is to perform a shaping heat treatment on the bracket to create a shape memory effect, pre-setting and memorizing the standard expansion shape and tube diameter; Step 7: Perform sterilization and disinfection according to relevant medical device standards; Step 8: After disinfection, the stent is radially compressed to reduce its outer diameter using external force; The ninth step is to fix the compressed stent assembly onto the surface of the balloon to form a complete interventional delivery component.

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