Development of a novel infection-resistant skin-button and cover materials for long-term VAD support

2013 Fiscal Year Final Research Report

• Project/Area Number: 23390341
• Research Category: Grant-in-Aid for Scientific Research (B)
• Allocation Type: Single-year Grants
• Section: 一般
• Research Field: Thoracic surgery
• Research Institution: National Cardiovascular Center Research Institute
• Principal Investigator: MIZUNO Toshihide 独立行政法人国立循環器病研究センター, 研究所, 室長 (40426515)
• Co-Investigator(Renkei-kenkyūsha): TATSUMI Eisuke 国立循環器病研究センター, 研究所, 部長 (00216996) ; TSUKIYA Tomonori 国立循環器病研究センター, 研究所, 室長 (00311449) ; TAKEWA Yoshiaki 国立循環器病研究センター, 研究所, 室長 (20332405) ; TAENAKA Yoshiyuki 国立循環器病研究センター, 副所長 (00142183)
• Project Period (FY): 2011-04-01 – 2014-03-31
• Keywords: デバイス由来感染症 / スキンボタン / 多孔体

Research Abstract

In this study, we developed a novel infection-resistant skin-button for preventing the driveline infection. Our skin-button that resembled a hemispheric button was consisted of bi-layered parts. These parts were made of the segmented polyurethane having skin-like flexibility and sufficient mechanical strength. The lower part featured tissue-compatible porous flange for implanting into the subcutaneous tissue around the driveline. Its pore size was optimized to promote tissue-ingrowth into the material, and the topmost nonporous part was used for fixing the driveline in the state of exposing from the skin. In in vivo study, three animals with newly developed skin-button demonstrated no sign of the epidermal downgrowth at all, and local bacterial infection at the exit site of the driveline was completely prevented.We conclude that the newly developed skin-button may become a useful tool for preventing device-rerated infection in prolonged VAD support.

Research Products

• [Journal Article] Development of a Novel Tissue-compatible apical inflow cannula for an implantable VAD (2013)
  • Author(s): Mizuno T, Tsukiya T, Takewa Y, Tatsumi E
  • Journal Title: The Journal of Heart and Lung Transplantation Volume: 48, 32, 174
  • Peer Reviewed
• [Journal Article] Assessment of the cannula exit site infection in two different configuration, porous material covered vs. non-covered tube (2013)
  • Author(s): Atsuta Y, Mizuno T, Takewa Y, Tsukiya T, Yanagisono Y, Kobara D, Taenaka Y, Tatsumi E
  • Journal Title: 人工臓器 Volume: 2, 42, S242
• [Journal Article] Development and animal test of the novel infection-resistant skin-button for long-term VAD support (2012)
  • Author(s): Mizuno T, Nemoto Y, Tsukiya T, Takewa Y, Tatsumi E
  • Journal Title: The Journal of Heart and Lung Transplantation Volume: 4S, 31, S198
  • Peer Reviewed
• [Journal Article] Development and animal test of a novel infection-resistant skin-button for long-term VAD support (2012)
  • Author(s): Mizuno T, Tsukiya T, Takewa Y, Taenaka Y, Tatsumi E
  • Journal Title: ASAIO Journal Volume: 7, 58, 23
  • Peer Reviewed
• [Journal Article] 人工心臓使用時のデバイス由来感染症防止に有用なスキンボタン・デバイス被覆材の開発 (2012)
  • Author(s): 水野敏秀, 根本泰, 熱田祐一, 柳園宜紀, 小原大輔, 築谷朋典, 武輪能明, 妙中義之, 巽英介
  • Journal Title: 人工臓器 Volume: 2, 41, 49
• [Journal Article] ニプロ社製LVAS施行時における出口部感染防止に優れたセグメント化ポリウレタン製多孔体スキンカフの開発 (2012)
  • Author(s): 熱田祐一, 水野敏秀, 武輪能明, 築谷朋典, 角田幸秀, 片桐伸将, 大沼健太郎, 住倉博仁, 藤井豊, 岸本祐一郎, 荒川衛, 東郷好美, 妙中義之, 巽英介, 柳園宜紀, 小原大輔
  • Journal Title: 人工臓器 Volume: 2, 40, 177
• [Journal Article] Development of a novel skin-button for preventing the driveline infection of an implantable VAD system (2011)
  • Author(s): Mizuno T, Tsukiya T, Nemoto Y, Takewa Y, Taenaka Y, Tatsumi E
  • Journal Title: ASAIO Journal Volume: 2, 57, 77
  • Peer Reviewed
• [Journal Article] Development and long -term in vivo testing of a novel skin-button system for preventing driveline infection of an implantable VAD system (2011)
  • Author(s): Mizuno T, Nemoto Y, Tsukiya T, Takewa Y, Taenaka Y, Tatsumi E
  • Journal Title: J Artif Organs Volume: 14 Pages: 371-374
  • Peer Reviewed
• [Journal Article] Challenges in research and development, productization, and clinical application of advanced medical devices in Japan (2011)
  • Author(s): Tatsumi E
  • Journal Title: Japan Medical Association Journal Volume: 5, 54 Pages: 331-334
  • Peer Reviewed
• [Journal Article] Initial in vivo evaluation of the newly developed axial flow turbo pump with hydrodynamic bearings (2011)
  • Author(s): Tanaka H, Tsukiya T, Tatsumi E, Mizuno T, Hidaka T, Okubo T, Osada T, Miyamoto S, Taenaka Y
  • Journal Title: J Artif Organs Volume: 14 Pages: 31-38
  • Peer Reviewed
• [Presentation] Assessment of the cannula exit site infection in two different configuration, porous material covered vs. non-covered tube (2013)
  • Author(s): Atsuta Y, Mizuno T, Takewa Y, Tsukiya T, Yanagisono Y, Kobara, Taenaka Y, Tatsumi E
  • Organizer: 日本人工臓器学会大会(51), International Federation for Artificial Organs (5)
  • Place of Presentation: 横浜市
  • Year and Date: 20130927-29
• [Presentation] In vivo evaluation of the percutaneous site of VAD system (2013)
  • Author(s): Atsuta Y, Mizuno T, Takewa Y, Tsukiya T, Kakuta Y, Katagiri N, Ohnuma K, Sumikura H, Fujii Y, Arakawa M, Togo K, Kishimoto S, Tatsumi E
  • Organizer: American Society for Artificial Internal Organs (59)
  • Place of Presentation: Chicago
  • Year and Date: 20130612-15
• [Presentation] 送脱血カニューレおよびドライブライン出口部周囲における皮膚性状の経時的変化と細菌感染の関連に関する検討 (2013)
  • Author(s): 熱田祐一, 水野敏秀, 武輪能明, 築谷朋典, 角田幸秀, 片桐伸将, 大沼健太郎, 住倉博仁, 藤井豊, 岸本祐一郎, 荒川衛, 東郷好美, 巽英介
  • Organizer: 人工心臓と補助循環懇話会学術集会(41)
  • Place of Presentation: 下高井戸郡山ノ内町
  • Year and Date: 20130201-02
• [Presentation] 人工心臓使用時のデバイス由来感染症防止に有用なスキンボタン・デバイス被覆材の開発 (2012)
  • Author(s): 水野敏秀, 根本泰, 熱田祐一, 柳園宜紀, 小原大輔, 築谷朋典, 武輪能明, 妙中義之, 巽英介
  • Organizer: 日本人工臓器学会大会(50)
  • Place of Presentation: 福岡市
  • Year and Date: 20121122-24
• [Presentation] Development and animal test of a novel infection-resistant skin-button for long-term VAD support (2012)
  • Author(s): Mizuno T, Tsukiya T, Takewa Y, Taenaka Y, Tatsumi E
  • Organizer: American Society for Artificial Internal Organs (58)
  • Place of Presentation: San Francisco
  • Year and Date: 20120613-16
• [Presentation] Development and animal test of the novel infection-resistant skin-button for long-term VAD support, International Society for Heart and Lung Transplantation (2012)
  • Author(s): Mizuno T, Nemoto Y, Tsukiya T, Takewa Y, Taenaka Y, Tatsumi E
  • Organizer: Annual Meeting & Scientific Sessions(32)
  • Place of Presentation: Prague
  • Year and Date: 20120418-21
• [Presentation] ニプロ社製LVAS 施行時における出口部感染防止に優れたセグメント化ポリウレタン製多孔体スキンカフの開発 (2012)
  • Author(s): 熱田祐一, 水野敏秀, 武輪能明, 築谷朋典, 角田幸秀, 片桐伸将, 大沼健太郎, 住倉博仁, 藤井豊, 岸本祐一郎, 荒川衛, 東郷好美, 妙中義之, 巽英介, 柳園宜紀, 小原大輔
  • Organizer: 日本人工臓器学会大会(50)
  • Place of Presentation: 福岡市
  • Year and Date: 20120000
• [Presentation] 10 年後のVAD治療を見据えた要素技術開発 (2012)
  • Author(s): 築谷朋典, 水野敏秀, 武輪能明, 巽英介
  • Organizer: 日本定常流ポンプ研究会2012
  • Place of Presentation: 福岡市
  • Year and Date: 2012-11-22
• [Presentation] GLP 準拠大型動物慢性動物試験の進め方FDA 提出GLP データ作成の経験を中心に早期・探索的臨床試験拠点整備事業 (2012)
  • Author(s): 水野敏秀
  • Organizer: シーズ紹介セミナー(1)
  • Place of Presentation: 吹田市
  • Year and Date: 2012-01-18
• [Presentation] ドライブライン感染防止に有用な新規スキンボタンの開発とin vivo 評価 (2011)
  • Author(s): 水野敏秀, 根本泰, 築谷朋典, 武輪能明, 妙中義之, 巽英介
  • Organizer: 日本人工臓器学会大会(49)
  • Place of Presentation: 千代田区
  • Year and Date: 20111125-27
• [Presentation] Development and in vivo evaluation of novel infection-resistant skin-button for an implantable axial flow VAD system (2011)
  • Author(s): Mizuno T, Nemoto Y, Tsukiya T, Takewa Y, Taenaka Y, Tatsumi E
  • Organizer: Congress of the International Society for Rotary Blood Pumps(19)
  • Place of Presentation: Louisville
  • Year and Date: 20110908-10
• [Presentation] Development of a novel skin-button for preventing the driveline infection of an implantable VAD system (2011)
  • Author(s): Mizuno T, Tsukiya T, Nemoto Y, Takewa Y, Taeneka Y, Tatsumi E
  • Organizer: American Society for Artificial Internal Organs(57)
  • Place of Presentation: Washington, DC
  • Year and Date: 20110610-12
• [Presentation] Development and in vivo test of a new VAD system with hydrodynamically-levitated axial flow turbo pump (2011)
  • Author(s): Mizuno T, Tsukiya T, Osada T, Yamane T, Takewa Y, Taenaka Y, Tatsumi E
  • Organizer: American Society for Artificial Internal Organs(57)
  • Place of Presentation: Washington, DC
  • Year and Date: 20110610-12
• [Presentation] より安全な長期使用を目的とした次世代型植込み型補助人工心臓システムの改良点と動物実験による評価 (2011)
  • Author(s): 水野敏秀, 築谷朋典, 武輪能明, 妙中義之, 巽英介
  • Organizer: 人工心臓と補助循環懇話会(39)
  • Place of Presentation: 米子市
  • Year and Date: 20110218-19
• [Patent(Industrial Property Rights)] カフ部材 (2011)
  • Inventor(s): 巽英介, 水野敏秀, 妙中義之, 根本泰, 岡本吉弘
  • Industrial Property Rights Holder: 独立行政法人国立循環器病研究センター, 株式会社ブリヂストン
  • Industrial Property Rights Type: 特許
  • Industrial Property Number: 特許第4779968号
  • Filing Date: 2011-07-15
• [Patent(Industrial Property Rights)] ストマ- (2011)
  • Inventor(s): 巽英介, 水野敏秀, 妙中義之, 根本泰, 岡本吉弘
  • Industrial Property Rights Holder: 独立行政法人国立循環器病研究センター, 株式会社ブリヂストン
  • Industrial Property Rights Type: 特許
  • Industrial Property Number: 特許第4743501号
  • Filing Date: 2011-05-20