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

Research Project

Project/Area Number 23390341
Research Category

Grant-in-Aid for Scientific Research (B)

Allocation TypeSingle-year Grants
Section一般
Research Field Thoracic surgery
Research InstitutionNational 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
Project Status Completed (Fiscal Year 2013)
Budget Amount *help
¥16,640,000 (Direct Cost: ¥12,800,000、Indirect Cost: ¥3,840,000)
Fiscal Year 2013: ¥4,290,000 (Direct Cost: ¥3,300,000、Indirect Cost: ¥990,000)
Fiscal Year 2012: ¥5,590,000 (Direct Cost: ¥4,300,000、Indirect Cost: ¥1,290,000)
Fiscal Year 2011: ¥6,760,000 (Direct Cost: ¥5,200,000、Indirect Cost: ¥1,560,000)
Keywordsデバイス由来感染症 / スキンボタン / 多孔体 / ドライブライン感染症 / 補助人工心臓 / 医療機器 / 出口部感染症 / セグメント化ポリウレタン製多孔体 / カニューレ / ドライブライン
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.

Report

(4 results)
  • 2013 Annual Research Report   Final Research Report ( PDF )
  • 2012 Annual Research Report
  • 2011 Annual Research Report
  • Research Products

    (47 results)

All 2013 2012 2011

All Journal Article (18 results) (of which Peer Reviewed: 9 results) Presentation (27 results) Patent(Industrial Property Rights) (2 results)

  • [Journal Article] Development of a Novel Tissue-compatible apical inflow cannula for an implantable VAD2013

    • Author(s)
      Mizuno T, Tsukiya T, Takewa Y, Tatsumi E
    • Journal Title

      The Journal of Heart and Lung Transplantation

      Volume: 48, 32, 174

    • Related Report
      2013 Annual Research Report 2013 Final Research Report
    • Peer Reviewed
  • [Journal Article] Assessment of the cannula exit site infection in two different configuration, porous material covered vs. non-covered tube2013

    • 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

    • Related Report
      2013 Final Research Report
  • [Journal Article] Pathological changes in cardio-pulmonary tissue of the goat following prolonged venoarterial ECMO2013

    • Author(s)
      Mizuno T, Katagiri N, Tsukiya T, Takewa Y, Tatsumi E
    • Journal Title

      人工臓器

      Volume: 42

    • Related Report
      2013 Annual Research Report
  • [Journal Article] Development and animal test of the novel infection-resistant skin-button for long-term VAD support2012

    • 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

    • Related Report
      2013 Final Research Report
    • Peer Reviewed
  • [Journal Article] Development and animal test of a novel infection-resistant skin-button for long-term VAD support2012

    • Author(s)
      Mizuno T, Tsukiya T, Takewa Y, Taenaka Y, Tatsumi E
    • Journal Title

      ASAIO Journal

      Volume: 7, 58, 23

    • Related Report
      2013 Final Research Report
    • 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

    • Related Report
      2013 Final Research Report
  • [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

    • Related Report
      2013 Final Research Report
  • [Journal Article] Development and animal test of the novel infection-resistant skin-button for long-term VAD support2012

    • Author(s)
      Toshihide MIZUNO
    • Journal Title

      The Journal of Heart and Lung Transplantation

      Volume: 31 Issue: 4 Pages: S198-S198

    • DOI

      10.1016/j.healun.2012.01.584

    • Related Report
      2012 Annual Research Report
    • 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
    • Journal Title

      人工臓器

      Volume: 40 Pages: 49-49

    • Related Report
      2012 Annual Research Report
  • [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
    • Journal Title

      人工臓器

      Volume: 40 Pages: 177-177

    • Related Report
      2012 Annual Research Report
  • [Journal Article] 新規開発された動圧浮上型軸流ポンプを用いた埋め込み型補助人工心臓システムの慢性動物実験による in vivo 評価2012

    • Author(s)
      水野敏秀
    • Journal Title

      人工臓器

      Volume: 40 Pages: 179-179

    • Related Report
      2012 Annual Research Report
  • [Journal Article] Development of a novel skin-button for preventing the driveline infection of an implantable VAD system2011

    • Author(s)
      Mizuno T, Tsukiya T, Nemoto Y, Takewa Y, Taenaka Y, Tatsumi E
    • Journal Title

      ASAIO Journal

      Volume: 2, 57, 77

    • Related Report
      2013 Final Research Report
    • 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 system2011

    • Author(s)
      Mizuno T, Nemoto Y, Tsukiya T, Takewa Y, Taenaka Y, Tatsumi E
    • Journal Title

      J Artif Organs

      Volume: 14 Pages: 371-374

    • NAID

      10030339521

    • Related Report
      2013 Final Research Report
    • Peer Reviewed
  • [Journal Article] Challenges in research and development, productization, and clinical application of advanced medical devices in Japan2011

    • Author(s)
      Tatsumi E
    • Journal Title

      Japan Medical Association Journal

      Volume: 5, 54 Pages: 331-334

    • Related Report
      2013 Final Research Report
    • Peer Reviewed
  • [Journal Article] Initial in vivo evaluation of the newly developed axial flow turbo pump with hydrodynamic bearings2011

    • 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

    • NAID

      10029565662

    • Related Report
      2013 Final Research Report
    • Peer Reviewed
  • [Journal Article] Development of a novel skin-button for preventing the driveline infection of an implantable VAD system2011

    • Author(s)
      Toshihide MIZUNO
    • Journal Title

      ASAIO Journal

      Volume: 57 Pages: 77-77

    • Related Report
      2011 Annual Research Report
  • [Journal Article] Development and in vivo test of a new VAD system with hydrodynamically-levitated axial flow turbo pump2011

    • Author(s)
      Toshihide MIZUNO
    • Journal Title

      ASAIO Journal

      Volume: 57 Pages: 78-78

    • Related Report
      2011 Annual Research Report
  • [Journal Article] Development and long-term in vivo testing of a novel skin-button system for preventing driveline infection of an implantable VAD system2011

    • Author(s)
      Toshihide MIZUNO
    • Journal Title

      J Artif Organs

      Volume: 14 Pages: 371-374

    • NAID

      10030339521

    • Related Report
      2011 Annual Research Report
    • Peer Reviewed
  • [Presentation] In vivo evaluation of the percutaneous site of VAD system2013

    • 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
    • Related Report
      2013 Final Research Report
  • [Presentation] Assessment of the cannula exit site infection in two different configuration, porous material covered vs. non-covered tube2013

    • 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
    • Related Report
      2013 Final Research Report
  • [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
    • Related Report
      2013 Final Research Report
  • [Presentation] Development of a tissue-compatible apical inflow cannula for an implantable VAD2013

    • Author(s)
      Mizuno T, Tsukiya T, Takewa Y, Tatsumi E
    • Organizer
      International Society for Heart and Lung Transplantation Annual Meeting and Scientific Sessions (33)
    • Place of Presentation
      Montreal
    • Related Report
      2013 Annual Research Report
  • [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
    • Organizer
      人工心臓と補助循環懇話会学術集会 (41)
    • Place of Presentation
      山ノ内町
    • Related Report
      2012 Annual Research Report
  • [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
    • Related Report
      2013 Final Research Report
  • [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
    • Related Report
      2013 Final Research Report
  • [Presentation] Development and animal test of the novel infection-resistant skin-button for long-term VAD support, International Society for Heart and Lung Transplantation2012

    • Author(s)
      Mizuno T, Nemoto Y, Tsukiya T, Takewa Y, Taenaka Y, Tatsumi E
    • Organizer
      Annual Meeting & Scientific Sessions(32)
    • Place of Presentation
      Prague
    • Related Report
      2013 Final Research Report
  • [Presentation] Development and animal test of a novel infection-resistant skin-button for long-term VAD support2012

    • 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
    • Related Report
      2013 Final Research Report
  • [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
    • Related Report
      2013 Final Research Report
  • [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
    • Related Report
      2013 Final Research Report
  • [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
    • Organizer
      日本人工臓器学会大会
    • Place of Presentation
      福岡市
    • Related Report
      2012 Annual Research Report
  • [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
    • Organizer
      日本人工臓器学会大会
    • Place of Presentation
      福岡市
    • Related Report
      2012 Annual Research Report
  • [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
    • Organizer
      日本定常流ポンプ研究会
    • Place of Presentation
      福岡市
    • Related Report
      2012 Annual Research Report
  • [Presentation] Development and animal test of the novel infection-resistant skin-button for long-term VAD support2012

    • Author(s)
      Toshihide MIZUNO
    • Organizer
      International Society for Heart and Lung Transplantation Annual Meeting and Scientific Sessions
    • Place of Presentation
      Prague
    • Related Report
      2012 Annual Research Report
  • [Presentation] Development and in vivo evaluation of a novel tissue-compatible inflow cannula for an implantable VAD2012

    • Author(s)
      Toshihide MIZUNO
    • Organizer
      International Society for Rotary Blood Pumps (20)
    • Place of Presentation
      Istanbul
    • Related Report
      2012 Annual Research Report
  • [Presentation] Development and animal test of the novel infection-resistant skin-button for long-term VAD support2012

    • Author(s)
      Toshihide MIZUNO
    • Organizer
      American Society for Artificial Internal Organs (58)
    • Place of Presentation
      SanFrancisco
    • Related Report
      2012 Annual Research Report
  • [Presentation] Development of a novel skin-button for preventing the driveline infection of an implantable VAD system2011

    • 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
    • Related Report
      2013 Final Research Report
  • [Presentation] Development and in vivo test of a new VAD system with hydrodynamically-levitated axial flow turbo pump2011

    • 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
    • Related Report
      2013 Final Research Report
  • [Presentation] Development and in vivo evaluation of novel infection-resistant skin-button for an implantable axial flow VAD system2011

    • 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
    • Related Report
      2013 Final Research Report
  • [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
    • Related Report
      2013 Final Research Report
  • [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
    • Related Report
      2013 Final Research Report
  • [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
    • Organizer
      日本人工臓器学会大会(49)
    • Place of Presentation
      東京都千代田区
    • Related Report
      2011 Annual Research Report
  • [Presentation] Wedge Thrombus防止に有用な組織親和性に優れた新規ポリエステルベロア装着脱血カニューレの開発2011

    • Author(s)
      水野敏秀
    • Organizer
      日本人工臓器学会大会(49)
    • Place of Presentation
      東京都千代田区
    • Related Report
      2011 Annual Research Report
  • [Presentation] Development of a novel skin-button for preventing the driveline infection of an implantable VAD system2011

    • Author(s)
      Toshihide MIZUNO
    • Organizer
      American Society for Artificial Internal Organs (57)
    • Place of Presentation
      Washington DC, USA
    • Related Report
      2011 Annual Research Report
  • [Presentation] Development and in vivo test of a new VAD system with hydrodynamically-levitated axial flow turbo pump2011

    • Author(s)
      Toshihide MIZUNO
    • Organizer
      American Society for Artificial Internal Organs (57)
    • Place of Presentation
      Washington DC, USA
    • Related Report
      2011 Annual Research Report
  • [Presentation] Development and in vivo evaluation of novel infection-resistant skin-button for an implantable axial flow VAD system2011

    • Author(s)
      Toshihide MIZUNO
    • Organizer
      Congress of the International Society for Rotary Blood Pumps (19)
    • Place of Presentation
      Louisville, USA
    • Related Report
      2011 Annual Research Report
  • [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
    • Filing Date
      2011-07-15
    • Related Report
      2013 Final Research Report
  • [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
    • Filing Date
      2011-05-20
    • Related Report
      2013 Final Research Report

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Published: 2011-04-06   Modified: 2019-07-29  

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