Recent developments in next-generation occlusion devices

Lin, Cheng Ting; Liu, Liwu; Liu, Yanju; Leng, Jinsong

doi:10.1016/j.actbio.2021.04.050

Cited by 23 publications

(14 citation statements)

References 128 publications

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“…Once the defect is completely endothelialized and covered by newly formed autologous tissue, the task of the occluder is completed. Several studies have shown that 1-3 months are required for the fibrogranulation tissue to completely wrap around the interlay membrane, while endothelialization of the umbrella disc, particularly the raised section in the middle, requires 3-6 months (30,31). Therefore, the occluder need not be present 6 months beyond the procedure.…”

Section: Discussionmentioning

confidence: 99%

“…The umbrella disc material is derived from non-degradable stainless steel, cobalt alloy, and nickel-titanium alloy to degradable polylactic acid (PLA), PDO, polycaprolactone (PCL), etc. The material used for the interlayer membrane evolved from non-degradable PET, polytetrafluoroethylene (PTFE), and expanded PTFE (ePTFE) to biodegradable porcine intestinal collagen and PLA (31). Research and development of degradable occluders have been conducted worldwide for over 10 years, and more than 10-20 types of occluders have been developed successively.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Echocardiographic characteristics of transcatheter closure of patent foramen ovale with mallow biodegradable occluder: A single-center, phase III clinical study

Song

Shi

Zheng

et al. 2022

Front. Cardiovasc. Med.

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BackgroundTranscatheter occlusion of patent foramen ovale (PFO) has become a recognized treatment option for high-risk PFO-related diseases. However, traditional metal occluders have some disadvantages, such as permanent retention in the body, abrasion of tissues, and obstruction of access to the left side of the heart for interventional procedures. With biodegradable occluders that release non-toxic degradation products and are absorbable by the body, the risk of long-term complications could be greatly reduced. The experimental results of using a PFO-degradable occluder in beagle dogs in early stages, independently developed by Shanghai Mallow Medical Instrument Co., Ltd., showed that the occluding umbrella disc network was degraded 6 months after occlusion. The occluder also showed good memory, biocompatibility, and mechanical properties.MethodsAs one of the multi-center research units, this prospective Phase III clinical trial study included 16 patients with PFO-related complications who were treated with a degradable occluder. The follow-up period lasted for 12 months to analyze the echocardiographic characteristics and procedural feasibility.ResultsThe immediate success rate of the procedure was 100% with no serious complications. Postoperative color Doppler transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE) at 12 months showed that one patient with atrial septal aneurysm (ASA) had a residual shunt at the edge of the occluder, and contrast transcranial Doppler (cTCD) showed that all patients were grade I or 0 right-to-left shunts (RLS), indicating that the occlusion success rate was 100%. The occluder gradually degraded after the procedure, particularly when the umbrella disc structure became vague, and the size of the occluder decreased significantly 6 months after occlusion.ConclusionsPFO closure with a Mallow degradable occluder has a high plugging success rate, is safe and effective, and has no serious complications. However, for PFO closure with special anatomical features, further research with a larger sample size is required. TTE can dynamically, conveniently, and accurately observe the entire degradation process of the occluder.Clinical Trial RegistrationChiCTR1900024036.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Echocardiographic characteristics of transcatheter closure of patent foramen ovale with mallow biodegradable occluder: A single-center, phase III clinical study

Song

Shi

Zheng

et al. 2022

Front. Cardiovasc. Med.

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“…A commercially available occluder (Shanghai Shape Memory Alloy Company, Shanghai, China) for the closure of ventricular septal defects (VSD) was selected as the basic design as shown in Figure 1 a, which consists of interlaced wires that slide and rotate as they deform. It is a self-expanding and self-centering occlusion device, prepared by weaving and thermoforming technology using 72 nitinol monofilaments with a diameter of 0.11 mm [ 13 ]. The most important part of the occluder device is the double-disc structure, the left and right circular discs, which are linked together by a short connecting waist, as shown in Figure 1 b [ 14 ].…”

Section: Methodsmentioning

confidence: 99%

A Finite Element Investigation on Material and Design Parameters of Ventricular Septal Defect Occluder Devices

Zhang

Xiong

Hu³

et al. 2022

JFB

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Background and Objective: Ventricular septal defects (VSDs) are the most common form of congenital heart defects. The incidence of VSD accounts for 40% of all congenital heart defects (CHDs). With the development of interventional therapy technology, transcatheter VSD closure was introduced as an alternative to open heart surgery. Clinical trials of VSD occluders have yielded promising results, and with the development of new material technologies, biodegradable materials have been introduced into the application of occluders. At present, the research on the mechanical properties of occluders is focused on experimental and clinical trials, and numerical simulation is still a considerable challenge due to the braided nature of the VSD occluder. Finite element analysis (FEA) has proven to be a valid and efficient method to virtually investigate and optimize the mechanical behavior of minimally invasive devices. The objective of this study is to explore the axial resistive performance through experimental and computational testing, and to present the systematic evaluation of the effect of various material and braid parameters by FEA. Methods: In this study, an experimental test was used to investigate the axial resistive force (ARF) of VSD Nitinol occluders under axial displacement loading (ADL), then the corresponding numerical simulation was developed and compared with the experimental results to verify the effectiveness. Based on the above validation, numerical simulations of VSD occluders with different materials (polydioxanone (PDO) and Nitinol with different austenite moduli) and braid parameters (wire density, wire diameter, and angle between left and right discs) provided a clear presentation of mechanical behaviors that included the maximal axial resistive force (MARF), maximal axial displacement (MAD) and initial axial stiffness (IAS), the stress distribution and the maximum principal strain distribution of the device under ADL. Results: The results showed that: (1) In the experimental testing, the axial resistive force (ARF) of the tested occluder, caused by axial displacement loading (ADL), was recorded and it increased linearly from 0 to 4.91 N before reducing. Subsequent computational testing showed that a similar performance in the ARF was experienced, albeit that the peak value of ARF was smaller. (2) The investigated design parameters of wire density, wire diameter and the angle between the left and right discs demonstrated an effective improvement (7.59%, 9.48%, 1.28%, respectively, for MARF, and 1.28%, 1.80%, 3.07%, respectively, for IAS) for the mechanical performance for Nitinol occluders. (3) The most influencing factor was the material; the performance rose by 30% as the Nitinol austenite modulus (EA) increased by 10,000 MPa. The performance of Nitinol was better than that of PDO for certain wire diameters, and the performance improved more obviously (1.80% for Nitinol and 0.64% for PDO in IAS, 9.48% for Nitinol and 2.00% for PDO in MARF) with the increase in wire diameter. (4) For all of the models, the maximum stresses under ADL were distributed at the edge of the disc on the loaded side of the occluders. Conclusions: The experimental testing presented in the study showed that the mechanical performance of the Nitinol occluder and the MARF prove that it has sufficient ability to resist falling out from its intended placement. This study also represents the first experimentally validated computational model of braided occluders, and provides a perception of the influence of geometrical and material parameters in these systems. The results could further provide meaningful suggestions for the design of biodegradable VSD closure devices and to realize a series of applications for biodegradable materials in VSD.

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“…Metode ROP lebih disukai karena menghasilkan polimer dengan nilai indeks polidispersitas (PDI) yang lebih rendah dan berat molekul yang lebih tinggi, serta sifat mekanik yang lebih baik. PCL biasanya disintesis tanpa katalis menggunakan polimerisasi pembukaan cincin, tetapi titik lelehnya yang rendah menghasilkan biaya produksi yang tinggi dan keterbatasan komersial [12][13]. Karena PCL digunakan terutama di bidang biomedis dan farmasi, maka harus diproduksi dengan hatihati untuk menghindari adanya senyawa toksik yang dapat menyebabkan efek samping pada pengguna atau organisme.…”

Section: Pendahuluanunclassified

Pembuatan Bioplastik Ramah Lingkungan Berbasis Pla-PCL Dengan Composite Catechin Dan Kitosan Sebagai Bahan Baru Pengganti Plastik Berbasis Petroleum

Suryani¹,

Rihayat²,

Fitria³

et al. 2022

J.Scien.Techno.Reaction

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ABSTRAK Kemasan aktif, juga dikenal sebagai Kemasan Cerdas dan Kemasan Cerdas, dimaksudkan untuk mendeteksi dan memperingatkan pembusukan atau kemungkinan masalah dalam makanan kemasan. Sistem ini berfungsi sebagai indikator kualitas untuk menjamin keamanan pangan dan dibagi menjadi dua jenis: langsung (kelembaban, waktu-suhu, kesegaran, kerusakan, dan biosensor) dan pasif (ketertelusuran dan pelacakan). Karena perbedaan kimia, informasi kualitatif yang diberikan oleh penanda ini berbeda. Reaksi atau perkembangan mikrobiologi sebagai akibat dari waktu dan proses. Interaksi antara metabolit yang dihasilkan oleh pertumbuhan mikroba dan bahan kimia indikator memberikan sinyal visual serta informasi tentang degradasi. Bahan polimer telah menjadi bagian dari peradaban kontemporer selama beberapa dekade, memungkinkan pengembangan bidang kegiatan baru dan penerapan bidang kerja baru. Komposisi 0,9 g Kitosan: 0,1 g Katekin dengan gugus C - H, O - H, C = O, dan C - O memberikan hasil terbaik. Tes SEM menunjukkan permukaan yang halus dengan ikatan antarmuka yang baik terbentuk antara matriks dan pengisi; namun masih terdapat residu kitosan yang tidak larut karena proses pencampuran yang tidak homogen dan penggunaan pelarut yang tidak kompatibel. Kata kunci : PLA; PCL; Kitosan; katekin; FT-IR

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Recent developments in next-generation occlusion devices

Cited by 23 publications

References 128 publications

Echocardiographic characteristics of transcatheter closure of patent foramen ovale with mallow biodegradable occluder: A single-center, phase III clinical study

Echocardiographic characteristics of transcatheter closure of patent foramen ovale with mallow biodegradable occluder: A single-center, phase III clinical study

A Finite Element Investigation on Material and Design Parameters of Ventricular Septal Defect Occluder Devices

Pembuatan Bioplastik Ramah Lingkungan Berbasis Pla-PCL Dengan Composite Catechin Dan Kitosan Sebagai Bahan Baru Pengganti Plastik Berbasis Petroleum

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