Investigation of Tissue Regeneration after Transplantation of Transcatheter Atrial Septal Closure Using Bioabsorbable Material

2023 Fiscal Year Final Research Report

• Project/Area Number: 20K09129
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Review Section: Basic Section 55030:Cardiovascular surgery-related
• Research Institution: Ehime University
• Principal Investigator: Kurobe Hirotsugu 愛媛大学, 医学系研究科, 准教授 (30380083)
• Co-Investigator(Kenkyū-buntansha): 平田 陽一郎 北里大学, 医学部, 准教授 (40447397) ; 坂上 倫久 愛媛大学, 医学系研究科, 講師(特定教員) (20709266)
• Project Period (FY): 2020-04-01 – 2024-03-31
• Keywords: 生体分解性素材 / 心房中隔欠損症 / 医療デバイス

Outline of Final Research Achievements

Biodegradable atrial septal defect occluder devices were transcatheterally implanted in　sheep and pigs, and subsequently, they were sacrificed over time. The explanted organs were　evaluated using various staining techniques.
The results revealed satisfactory autologous organization at six months, one year, and one　and a half years after implantation, with no indications of rejection or incomplete treatment. It　was confirmed that the functionality of the device was intact. However, micricarcification was　observed in some tissue areas, necessitating further evaluation to mitigate potential future　issues.

Free Research Field

循環器

Academic Significance and Societal Importance of the Research Achievements

試作中の生体分解性心房中隔欠損孔閉鎖デバイスを経カテーテル的に移植する実験を米国オハイオで羊で、福島県で実施した豚で実施し、動物を犠牲死させ、摘出臓器をHE染色、von Kossa染色、Azan染色などを駆使し染色・評価した。
その結果、移植後半年、一年、一年半の自己組織化は良好で、拒絶反応や治療の不完結性を疑う所見は認めず、本デバイスの実用化に近づく結果を得た。ただし、Micricarcificationを認たものの、治療完遂性には問題ないことも確認出来た。
生体吸収性素材を用いて治療デバイス実用化目処に近づいたことは、社会貢献に寄与でき、本実験により非常に有意義な結果を得た。