Nitinol Wire Research Articles

Influence of Heat Treatment of Nitinol Wire on the Properties of Nitinol/Hybrid Layer for Ibuprofen Release.

The efficiency of drug delivery from coatings of metallic implants is one of the key factors. The influence of chemical and thermal treatments of nitinol wire on the corrosion properties, deposition of hydroxyapatite(HA)/poly ε-caprolactone-polyethylene glycol (PEG-b-PCL), and the amount of ibuprofen released from that bilayer were studied. The hydroxyapatite layer was electrodeposited by pulse current, while the PEG-b-PCL layer was by drop-coating. It was shown that nitinol wire, chemically treated and thermally heated at 470 °C under optimized conditions, is the most optimal substrate for the deposition of uniform and compact hybrid HA/(PEG-b-PCL) bilayer. Ibuprofen incorporated into this hybrid bilayer exhibits the maximum release into phosphate-buffered saline (PBS) solution. About 80% of ibuprofen is released within 5 h.

Animal Experimental Study of Bioabsorbable Left Atrial Appendage Occluder.

Left atrial appendage (LAA) closure can prevent stroke in high-risk patients with atrial fibrillation.A bioabsorbable LAA occluder made of degradable polymer materials, such as polydioxanone (PDO) and poly-L-lactic acid (PLA), and nitinol wire was used. Occluders were successfully implanted in 18 Chinese rural dogs, 2 of which died within 48 hours after operation due to pericardial tamponade and hemorrhage, respectively. Follow-up observation was performed after transcatheter LAA closure. New tissue was found on the surface of the occluder 2 months after operation. No adjacent structures such as the mitral valve and the left superior pulmonary vein were affected by the occluder discs. Hematoxylin and eosin (HE) staining was performed at 3 months after operation, which showed intact intimal structure on the occluder surface, and unabsorbed PDO and PLA were observed. Scanning electron microscopy showed irregular arrangement of endothelial cells. New endothelial tissue was observed to completely cover the occluder at 6 months after operation. Most PDOs were replaced by fibrous connective tissue, and scanning electron microscopy showed regularly arranged endothelial cells. Pathological examination at 12 months showed only a small remnant of PDO. The gross specimens of the liver, spleen, and kidneys and pathological examination did not indicate thromboembolism.The bioabsorbable LAA occluder made of PDO, PLA, and nitinol wire was safe and effective for the occlusion of LAA in dogs. The surface of the occluder was endothelialized half a year after operation. The absorbable materials of the occluder were degraded after 1 year.

Pulsed focused ultrasound ablation assisted by a surface modified catheter for thrombolysis: a feasibility study

Interventional procedures for the recanalization of blood vessels to treat deep vein thrombosis carry a high risk of vessel wall injuries or hemorrhaging. Focused ultrasound (FUS) has been used to non-invasively break down blood clots that occlude the vessels in both in vitro and in vivo studies. Previous studies have either used thrombolytic drugs or ultrasound contrast agents (e.g., microbubbles) in combination with FUS. Several studies have applied very high peak-negative-pressures (PNP) during FUS treatment to achieve successful thrombolysis without the use of contrast agents. In the current study, we demonstrated that cavitation activity could be significantly enhanced by placing a nitinol wire, whose surface was roughed by laser etching, in the focal region of a FUS field. We demonstrated in vitro in a mock thrombosis that the thrombolysis efficacy of a 500 kHz FUS transducer was significantly enhanced using a surface-etched nitinol wire as compared to an unetched nitinol wire, whereas FUS-alone at the same pressure level did not result in any thrombolysis. These results suggest that a surface modified nitinol catheter exposed to FUS can result in intense cavitation activities leading to enhanced thrombolysis without the use of additional pharmacological or contrast agents.

Observation and modeling of potential sub-threshold damage growth mechanism for nitinol in ultra-high cycle fatigue

Fatigue fracture of small nitinol components commonly used in medical devices is currently dominated by the initiation and/or growth of small cracks at non-metallic inclusions preceding conventional fatigue crack growth. Therefore, an understanding of the threshold and growth of small cracks is critical to inform fatigue performance of devices. In this paper, we conduct rotary bend fatigue experiments of nitinol wire to 2 billion cycles, measure the inclusion from which the crack initiated, and calculate the stress intensity threshold. Inclusion size is compared to the size of a unique feature observable with a scanning electron microscope which appears as a smooth area surrounding the inclusion and only on specimens that fractured after > 10 million cycles. The hypothesis presented is that the smooth feature around the inclusion is the growth of a small crack which continues until it reaches a size large enough to cause conventional fatigue crack growth. Relating inclusion size to that of the smooth feature creates a damage curve that can be written as a function of cycles to fracture. This damage curve may be useful to estimate the critical size of the largest allowable defect based on the design life and applied loading of the nitinol component.

Adaptive bioinspired morphing surface using temperature-responsive elastomer-SMA composites

The pursuit of "smart" materials, drawing inspiration from biological organisms, has been a significant focal point in the realm of material science and engineering. Shape memory materials, notably Shape Memory Alloys (SMAs), have emerged as promising platforms for the development of adaptive and responsive materials that undergo transformations in response to environmental stimuli. This article explores the creation of a bioinspired morphing surface that capitalizes on the innovative amalgamation of Ecoflex and Nitinol (NiTi) wires. Inspired by biological mechanisms, this morphing surface exemplifies remarkable adaptability, seamlessly transitioning from 2D to 3D shapes with precision. A detailed mechanical characterization underscores pivotal changes in material properties, showcasing a significant reaction force increase from 0.4 N to 1 N in NiTi wires at 20 °C and 50 °C. Concurrently, the embedded NiTi wire within the Ecoflex matrix exhibits a similar force increment from 0.6 N to 1.2 N, reflecting the microstructural alterations dependent on temperature. The study also elucidates the versatility and scalability of this technology, highlighting its potential for diverse applications in aerospace, robotics, medical devices, and adaptive materials. This bioinspired morphing surface offers a versatile foundation for customizable shapes and programmable transformations, paving the way for impactful advancements in a multitude of fields.

Predictors of Curve of Spee Leveling in Class II Division 1 Malocclusion Treated With Reverse Curve of Spee Archwires: An Observational Study.

Introduction Aligning and leveling is the initial stage of comprehensive fixed orthodontic treatment aimed at minimizing the depth of the curve of Spee (COS). Various techniques exist to decrease the magnitude of the curve. This study investigates the skeletal and dental factors that reduce COS in individuals with minor class II malocclusions receiving nitinol (NiTi) wires with a reverse curve of Spee (RCS). Materials and methods The data for this observational study was collected from a sample of 84 patients who had class II molar relations and were sequentially treated with RCS NiTi wires throughout the initial leveling and aligning phase. All patients with class II molar relationships underwent non-extraction procedures during the leveling phase. The COS was determined using digitalized dental models. Skeletal and dental characteristics that could impact COS were identified and quantified using digital lateral cephalograms and orthopantomograms recorded during the pre-treatment (T1) and post-leveling (T2) stages. After calibrating the radiographs and models, we acquired angular and linear data. The data was categorized based on gender, growth pattern, and initial alignment of the teeth. We analyzed the differences between the groups using an independent t-test and an ANOVA. A paired t-test was used to compare the difference in the dimensional values between (T1) and (T2) points. Following the correlation coefficient tests, the study used stepwise multiple linear regression analysis to assess the predictive value of independent factors on the COS. The results were considered statistically significant at p < 0.05. Results The COS decreased by -1.43 ± 0.68 mm, which is statistically significant (<0.001*). There is no significant difference in COS reduction between the categorical variables. Despite statistically significant differences in the parameters between pre- and post-treatment, the linear correlation between most of the variables and COS reduction ranged from very weak (<0.20) to weak (0.20-0.39). Conclusions The vertical extrusion of lower premolars and molars combined with the intrusion of lower incisors contributed to the reduction of the COS by RCS wires. There is a change in the orientation of the occlusal plane with the flattening of the COS.

Effect of heat treatment conditions on the phase transformation characteristics of nitinol

Nitinol is the most widely used shape memory alloy in medical applications. In this study, the effect of different heat treatment conditions on the phase transformation characteristics of medical-grade nitinol was investigated. Nickel-rich nitinol wires containing 50.6% nickel with a diameter of 120 μm were used in the experimental studies. The nitinol wires were heat treated for 10 minutes at heat treatment temperatures between 540 and 570 °C. Then, nitinol wires were heat treated at a heat treatment temperature of 550 °C between 8 and 14 minutes. The austenitic and martensitic transition temperatures of these samples were measured using differential scanning calorimetry (DSC). In the experiments with 10 minutes of heat treatment time, transition temperatures decreased, and hysteresis increased with the increase in heat treatment temperature. This is related to the amount of precipitates in the structure. In the experiments carried out at 550 °C, transition temperatures decreased, and hysteresis increased with increasing heat treatment time. Experimental studies showed that the austenite finish (Af) temperature of all nitinol wire samples was below 37 °C, and they will exhibit superelasticity in the human body.

Investigating the potential of catheter-assisted pulsed focused ultrasound ablation for atherosclerotic plaques.

Atherosclerosis is a condition in which an adhesive substance called plaque accumulates over time inside the arteries. Plaque buildup results in the constriction of arteries, causing a shortage of blood supply to tissues and organs. Removing atherosclerotic plaques controls the development of acute ischemic stroke and heart diseases. It remains imperative for positive patient outcomes. This study sought to develop a minimally invasive technique for removing arterial plaques by applying focused ultrasound (FUS) energy on the metal surface of a nitinol catheter wire to induce inertial cavitation. The induced cavitation can deplete plaque mechanically inside the arteries, leading towards improved recanalization of blood vessels. The enhanced cavitation effect induced by combining FUS with a metal catheter was first verified by exposing agar phantom gels with or without a 0.9-mm diameter nitinol wire to an acoustic field produced by a 0.5-MHz FUS transducer. The phenomenon was further confirmed in pork belly fat samples with or without a 3-mm diameter nitinol catheter wire. Cavitation was monitored by detecting the peaks of emitted ultrasound signals from the samples using a passive cavitation detector (PCD). Cavitation threshold values were determined by observing the jump in the peak amplitude of signals received by the PCD when the applied FUS peak negative pressure (PNP) increased. To simulate arterial plaque removal, FUS with or without a catheter was used to remove tissues from pork belly fat samples and the lipid cores of human atherosclerotic plaque samples using 2500-cycle FUS bursts at 10% duty cycle and a burst repetition rate of 20Hz. Treatment outcomes were quantified by subtracting the weight of samples before treatment from the weight of samples after treatment. All measurements were repeated 5 times (n=5) unless otherwise indicated, and paired t-tests were used to compare the means of two groups. A p-value of <0.05 will be considered significant. Our results showed that with a nitinol wire, the cavitation threshold in agar phantoms was reduced to 2.6MPa from 4.3MPa PNP when there was no nitinol wire in the focal region of FUS. For pork belly fat samples, cavitation threshold values were 1.0 and 2.0MPa PNP, with and without a catheter wire, respectively. Pork belly fat tissues and lipid cores of atherosclerotic plaques were depleted at the interface between a catheter and the samples at 2 and 4MPa FUS PNP, respectively. The results showed that with a catheter wire in the focal region of a 3-min FUS treatment session, 24.7 and 25.6mg of lipid tissues were removed from pork belly fat and human atherosclerotic samples, respectively. In contrast, the FUS-only group showed no reduction in sample weight. The differences between FUS-only and FUS-plus-catheter groups were statistically significant (p<0.001 for the treatment on pork belly samples, and p<0.01 for the treatment on human atherosclerotic samples). This study demonstrated the feasibility of catheter-assisted FUS therapy for removing atherosclerotic plaques.

Unlocking Versatility: Magnetic-Actuated Deployable Suction Gripper for Complex Surface Handling.

Suction grippers offer a distinct advantage in their ability to handle a wide range of items. However, attaching these grippers to irregular and rough surfaces presents an ongoing challenge. To address this obstacle, this study explores the integration of magnetic intelligence into a soft suction gripper design, enabling fast external magnetic actuation of the attachment process. Additionally, miniaturization options are enhanced by implementing a compliant deploying mechanism. The resulting design is the first-of-its-kind magnetically-actuated deployable suction gripper featuring a thin magnetic membrane (Ø 50 mm) composed of carbonyl iron particles embedded in a silicone matrix. This membrane is supported by a frame made of superelastic nitinol wires that facilitate deployment. During experiments, the proof-of-principle prototype demonstrates successful attachment on a diverse range of curved surfaces in both dry and wet environments. The gripper achieves attachment on curved surfaces with radii of 50-75 mm, exerting a maximum attachment force of 2.89 ± 0.54 N. The current gripper design achieves a folding percentage of 75%, enabling it to fit into a Ø 12.5 mm tube and access hard-to-reach areas while maintaining sufficient surface area for attachment forces. The proposed prototype serves as a foundational steppingstone for further research in the development of reliable and effective magnetically-actuated suction grippers across various configurations. By addressing the limitations of attachment to irregular surfaces and exploring possibilities for miniaturization and precise control, this study opens new avenues for the practical application of suction grippers in diverse industries and scenarios.

Casting and comprehensive analysis of nitinol-based self-healing metal matrix composite of A356 alloy prepared via clamp technique

The present research explores the development and casting of a self-healing metal matrix composite using A356 alloy reinforced with Nitinol wire through the Clamp technique. The matrix provided a high-strength base, while Nitinol wire acted as a shape memory alloy reinforcement. The clamp technique ensured proper integration and alignment between the matrix and the reinforcement. Semi-solid metal processing enhances the mechanical properties of the base alloy and the wire integration as reinforcement. Mechanical properties of the composite including tensile strength and impact resistance were evaluated. The self-healing capability of the composite was evident through its significant recovery i.e. 61.53% of the deformed surface after thermal loading cycles. Additionally, the self-healing behavior of the composite was examined through cyclic thermal loading. This could provide valuable insight into the design and fabrication of self-healing metal matrix composite.

Microstructural characterization and analysis of nitinol-based self-healing metals matrix composite of A356 alloy produced by high-pressure die casting

A self-healing non-ferrous metal-matrix composite is prepared by the high-pressure die-casting process. It includes casting set-up, sample preparation of metal matrix composite (MMC), microstructural characterization, and analysis of its ability to close the crack. Aluminum alloy (A356) is deployed as a matrix material in the MMC. Nitinol is a smart alloy produced by a combination of Nickel and Titanium in equal mass proportion. Apart from excellent mechanical properties it also exhibits super-elasticity and shape-memory effect. The wire of the Nitinol is integrated as reinforcement within the matrix of A356 alloy through a high-pressure die-casting process. The recovery percentage of the metal matrix composite and microstructural evaluation are reported. The deployment of shape memory wire provides the ability to recover the matrix material even from plastic strain by just heating the sample slightly above the activation temperature of the Nitinol wire. Microstructural evaluation indicates fair integration of the reinforcement within the matrix material. Gaining the ability for 30.27% angular restoration and 19.37% crack closer is a very positive sign for designing self-healing metallic materials.

Transient characterisation and analysis of shape memory alloy wire bundles for the actuation of finger joints in prosthesis design

Most current lower arm/hand prosthesis designs incorporate relatively bulky, heavy dc motors that produce substantial noise when performing actuation which rendersthem uncomfortable for the end-user. The engineering challenge is to produce more effective powered upper limb prosthetic solutions. Identification, characterisation and testing of actuation methods with better force to weight ratios are essential pre-requisites for this. The main aim of this work is to carry out a comprehensive study to establish conclusively the feasibility of employing Shape Memory Alloys (SMA’s) in the actuation of prosthetic finger designs. A comprehensive review of existing literature has been undertaken in order to establish the maximum grip forces at each phalanx of the human hand under different loading conditions. An experiment was developed in conjunction with this review to estimate the time response of the hand during a gripping/releasing action. These results, in combination with physical dimensions, will be used to drive the design of a prosthetic limb.&#x0D; A test rig has been developed which can facilitate complete transient and steady-state characterisation of a range of SMA wire diameters and bundle configurations. Anumber of different configurations were tested, each configuration having a different combination of 150 μm and 300 μm diameter nitinol wires. A data acquisition systemwas used to capture and retain data pertaining to the full characterisation of the bundles and in particular the strain and force capabilities of the various arrangements. A direct comparison is made between the actuator capabilities and the requirements of a working limb for basic gripping actions. This work will contribute to the development of an improved powered prosthetic solution.

Early Choriocapillaris Loss in a Porcine Model of RPE Cell Debridement Precedes Pathology That Simulates Advanced Macular Degeneration.

No large-mammal surgical models exist for geographic atrophy (GA), choroidal neovascularization (CNV), and pachychoroidal vascular remodeling. Our goal was to develop a porcine RPE debridement model of advanced macular degeneration to study photoreceptor cell loss and choroidal remodeling. Seven 2-month-old female domestic pigs were used for this study. After 25G vitrectomy, the area centralis was detached via subretinal bleb. A nitinol wire (Finesse Flex Loop) was used to debride RPE cells across a 3- to 5-mm diameter region. Fluid-air exchange was performed, and 20% SF6 gas injected. Animals underwent fundus photography, fluorescein angiography, optical coherence tomography (OCT), and OCT-angiography (OCTA) at 2 weeks, 1month, 2months, 3months, and 6 months postoperatively. Retinal histology was obtained at euthanasia, 2months (n = 3), 3months (n = 2), or 6months (n = 2) after surgery. RPE debridement resulted in GA with rapid loss of choriocapillaris, progressive loss of photoreceptors, and pachychoroidal changes in Sattler's and Haller's layers in all seven eyes undergoing debridement within 2 months. OCT and histological findings included subretinal disciform scar with overlying outer retinal atrophy; outer retinal tubulations and subretinal hyper-reflective material. OCTA revealed type 2 CNV (n = 4) at the edges of the debridement zone by 2 months, but there was no significant exudation noted at any time point. Surgical debridement of the RPE results in GA, CNV, and pachychoroid and reproduced all forms of advanced macular degeneration. This surgical model may be useful in examining the role of RPE and other cell replacement in treating advanced macular disease.

Use of Self-Expanding Nitinol Stent Constructed From 2 Layers of Tubular Braided Nitinol Wire Mesh in Complex Femoropopliteal Revascularization

Use of Self-Expanding Nitinol Stent Constructed From 2 Layers of Tubular Braided Nitinol Wire Mesh in Complex Femoropopliteal Revascularization

Buccal corridor and gummy smile treatment with MARPE and gingivoplasty: A 2-year follow-up case report

The advent of Mini-screws assisted rapid palatal expansion (MARPE) has introduced a simpler in-office procedure that enables the translation of the alveolar process in adults. This case report showed the combination of MARPE, orthodontic treatment, and gingivoplasty to correct malocclusion and enhance smile aesthetics. A 20-year-old woman expressed concerns about excessive buccal corridors and a gummy smile. She exhibited skeletal class I malocclusion, with buccal corridors exceeding 4 mm, a gummy smile, and lingual tipping of the lower posterior segments. The treatment plan involved utilizing the MARPE appliance, a Nitinol wire, gingivoplasty to address the gummy smile. Retention evaluations demonstrated the stability of MARPE in transversal skeletal discrepancies. There was notable improvement in incisor inclination and soft tissue profile, particularly evident in the E-line and nasolabial angle. Cephalometric analysis confirmed these changes, showing a decrease of 5.9 degrees in the inclination of the maxillary incisors. After a 2-year follow-up, the results remain stable, and the patient expresses satisfaction with the outcome. MARPE can be considered as an effective tool for managing buccal corridors, complemented by fixed orthodontic treatment employing labial appliances and gingivoplasty to correct malocclusion and enhance smile aesthetics. The treatment showed positive long-term outcomes.

Impact Resistance Enhancement of GLARE Composite Laminates Reinforced with Shape Memory Alloy Wires

This study investigates the impact resistance of Glass Laminate Aluminum Reinforced Epoxy (GLARE) composite laminates by incorporating shape memory alloy (SMA) wires. The influence of varying percentages of pre-strain (0%, 1%, 3%, and 5%) on the SMA wires embedded in the GLARE composites was examined. Laminate composites were made by hand lay-up method using 1100 series aluminum, glass laminate, epoxy resin, and nitinol wire. Impact testing was carried out using the Charpy (un-notched) method. The results demonstrate that the presence of SMA wires significantly enhances the impact resistance of the laminates. The energy absorption capacity of the laminates was found to increase with increasing pre-strain percentage. The highest impact resistance was observed in the specimens with 3% pre-strain, which exhibited a 35.2% increase in energy absorption compared to the specimens without SMA wires. However, a further increase in pre-strain to 5% resulted in a 21.5% decrease in energy absorption due to the higher fraction of stress-induced martensite, limiting the shape memory effect. Additionally, the damage analysis revealed that the absence of SMA wires led to severe debonding and delamination in the GLARE laminates. Conversely, specimens with 3% pre-strain exhibited the least damage, with limited debonding observed only in the front interface of the aluminum and epoxy-laminated fiberglass layers. The higher damage resistance of these specimens is attributed to their optimal energy absorption capability. Based on the findings, it is recommended to further investigate alternative shape memory alloy materials to determine their impact resistance enhancement potential compared to the current SMA wires. Additionally, conducting experiments with pre-strain percentages in the range of 3-5% would provide a better understanding of the maximum achievable performance. Furthermore, microscale observations should be conducted to gain more detailed insights into the damage mechanisms of the tested specimens.

Fatigue and fracture of small cracks in superelastic Nitinol

The present study develops a hybrid total life and damage-tolerant fatigue methodology for the determination of a small crack growth threshold in Nitinol. Axial tension–tension/Mode I fatigue testing was performed on superelastic Nitinol wire specimens with starter cracks milled into the specimens using focused ion beam (FIB). Fatigue testing was performed in displacement control at various strain amplitudes, typical for Nitinol fatigue characterization given its superelastic behavior. The simplistic geometry of the test specimen and axial loading conditions also allowed for the calculation of stress amplitude and initial stress intensity factor range. A logistic regression analysis was used to determine strain/stress-based fatigue limits. The small crack growth threshold for superelastic Nitinol was obtained for the first time from physically small cracks with sizes comparable to native inclusions. Lastly, a fractographic analysis was performed to examine crack initiation and propagation from the FIB-milled starter cracks and to identify relevant fractographic features. While the proposed methodology is centered around the use case of Nitinol medical devices, it could be adapted for other materials and applications where small crack initiation and propagation play an important role in fatigue lifetime prediction.

The Influence of Variable Stiffness of the Shape Memory Alloys Carbon Composite Structure on Mechanical Vibration.

The purpose of this study is to investigate the dynamic properties of new structures formed by combining carbon fiber and epoxy resin-based composite materials with SMA (shape memory alloy) "smart materials" in the form of NiTiNol wire. Such a combination will have an impact on the dynamics of the structure, especially in terms of stiffness controllability. Key mechanical parameters such as natural frequency and stiffness, as well as the effect of temperature, were determined through experimental studies.

Flow Diverter Performance Comparison of Different Wire Materials for Effective Intracranial Aneurysm Treatment.

A flow diverter (FD) is an effective method for treating wide-necked intracranial aneurysms by inducing hemodynamic changes in aneurysms. However, the procedural technique remains challenging, and it is often not performed properly in many cases of deployment or placements. In this study, three types of FDs that changed the material of the wire were prepared within the same structure. Differences in physical properties, such as before and after delivery loading stent size, radial force, and radiopacity, were evaluated. The performances in terms of deployment and trackability force were also evaluated in a simulated model using these FDs. Furthermore, changes of deployment patterns when these FDs were applied to a 3D-printed aneurysm model were determined. The NiTi FD using only nitinol (NiTi) wire showed 100% size recovery and 42% to 45% metal coverage after loading. The low trackability force (10.9 to 22.9 gf) allows smooth movement within the delivery system. However, NiTi FD cannot be used in actual surgeries due to difficulties in X-ray identification. NiTi-Pt/W FD, a combination of NiTi wire and platinum/tungsten (Pt/W) wire, had the highest radiopacity and compression force (6.03 ± 0.29 gf) among the three FDs. However, it suffered from high trackability force (22.4 to 39.9 gf) and the end part braiding mesh tended to loosen easily, so the procedure became more challenging. The NiTi(Pt) FD using a platinum core nitinol (NiTi(Pt)) wire had similar trackability force (11.3 to 22.1 gf) to NiTi FD and uniform deployment, enhancing procedural convenience. However, concerns about low expansion force (1.79 ± 0.30 gf) and the potential for migration remained. This comparative analysis contributes to a comprehensive understanding of how different wire materials influence the performance of FDs. While this study is still in its early stages and requires further research, its development has the potential to guide clinicians and researchers in optimizing the selection and development of FDs for the effective treatment of intracranial aneurysms.

Experimental study of the bilateral asymmetric single-rivet occluder device for transcatheter patent foramen ovale closure with reserved interatrial septal puncture area.

To evaluate a noval bilateral asymmetric single-rivet occluder with reserved interatrial septal puncture area for treating patent foramen ovale (PFO). The study established a pig model of patent foramen ovale (PFO) by puncturing the oval fossa and then performing high-pressure balloon dilation. A specially designed bilateral asymmetric occluder for the reserved interatrial septal puncture area was then. used to close the PFO through catheter-based intervention. The pigs were kept for 3 months before undergoing a second catheter-based intervention, involving interatrial septal puncture using a newly developed occluder in the reserved interatrial septal puncture area. During 6 months, the experimental pigs underwent assessment using digital subtraction angiography (DSA), echocardiography, and histological evaluation. A patent foramen ovale (PFO) model was successfully established in 6 pigs using the puncture atrial septum high-pressure balloon dilation method. The diameter of the unclosed PFO was measured (3.56 ± 0.25 mm). Using the newly developed occluder device, all 6 pigs with unclosed PFO underwent successful catheter-based closure surgeries, with intraoperative and postoperative transesophageal echocardiography showing excellent device positioning and complete closure without residual shunting. After 3 months of implantation, the catheter-based interatrial septal puncture was performed through the reserved interatrial septal puncture area, and all procedures were successful. Immediately following euthanasia, a histological examination revealed intact and undamaged occluder devices with visible puncture holes in the reserved interatrial septal puncture area. No fracture of the nitinol wire was observed, and the surface of the occluder device showed coverage of endothelial and connective tissues. Utilizing a bilateral asymmetric single-rivet occluder device implanted through the reserved interatrial septal puncture area has proven effective in closing PFO. After implantation, the occluder device allows subsequent interatrial septal puncture procedures through the reserved area. The novel occluder device demonstrated excellent closure performance, biocompatibility, and puncturability in the experiment. This indicates the feasibility of conducting further catheter-based interventions on the interatrial septum.