WO1996035376A1 - Matiere de suture medicale - Google Patents

Matiere de suture medicale Download PDF

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Publication number
WO1996035376A1
WO1996035376A1 PCT/JP1996/001219 JP9601219W WO9635376A1 WO 1996035376 A1 WO1996035376 A1 WO 1996035376A1 JP 9601219 W JP9601219 W JP 9601219W WO 9635376 A1 WO9635376 A1 WO 9635376A1
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Prior art keywords
suture material
suture
suturing
medical
material according
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PCT/JP1996/001219
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English (en)
French (fr)
Inventor
Keiji Igaki
Masatoshi Mori
Shigeo Ohoi
Original Assignee
Kabushikikaisha Igaki Iryo Sekkei
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Application filed by Kabushikikaisha Igaki Iryo Sekkei filed Critical Kabushikikaisha Igaki Iryo Sekkei
Priority to US08/765,882 priority Critical patent/US5843096A/en
Priority to KR1019960707422A priority patent/KR100289263B1/ko
Priority to AU56588/96A priority patent/AU711168B2/en
Priority to DE69625664T priority patent/DE69625664T2/de
Priority to CA002194240A priority patent/CA2194240C/en
Priority to DK96922672T priority patent/DK0770357T3/da
Priority to EP96922672A priority patent/EP0770357B1/en
Priority to AT96922672T priority patent/ATE230582T1/de
Publication of WO1996035376A1 publication Critical patent/WO1996035376A1/ja

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063Implantable repair or support meshes, e.g. hernia meshes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L17/00Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
    • A61L17/06At least partially resorbable materials
    • A61L17/10At least partially resorbable materials containing macromolecular materials
    • A61L17/12Homopolymers or copolymers of glycolic acid or lactic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07292Reinforcements for staple line, e.g. pledgets

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Epidemiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Chemical & Material Sciences (AREA)
  • Materials Engineering (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Materials For Medical Uses (AREA)
  • Surgical Instruments (AREA)

Description

明細書 発明の名称 医療用縫合材 技術分野 本発明は、 生体組織の切除部位等に縫い合わされる医療用縫合材 に関し、 特に自動縫合器に装着して使用される医療用縫合材に関す る 景技術 生体組織に生じた病巣の切除は、 外科的手術によるのが一般的で あるが、 患者に対する負担の軽減などを目的に、 内視鏡下での手術 等が施術されるようになってきている。
例えば、 自動縫合器を用いた切除術等は、 その一例である。 自動 縫合器は、 穿孔から生体内へ導入され、 患部を切除すると同時に切 除部位の縫合を行うものであり、 これを用いることで患部の切開が 不用となるという利点がある。 したがって、 上記自動縫合器は、 先 端に生体組織の切除部位を挟み込む縫合機構部を有し、 さらにこの 縫合機構部には、 縫合のための複数のステ一プルラインゃ生体組織 を切断するためのナイフ等の切断機構が設けられている。 もちろん、 外科的手術においても、 前記自動縫合器の使用は、 縫 合、 切開時間の短縮や、 施術の簡便化に有利である。
ところで、 肺、 気管支、 肝臓、 消化管等の脆弱な組織に対して前 述の自動縫合器で施術する場合、 ステ一プルによる縫合のみでは、 組織の断裂の皮があり、 また、 例えば肺の手術においては、 空気漏 れが発生する虞がある。 前記空気漏れは、 患者にとって致命的であ り、 これを確実に防止することが望まれる。
そこで従来、 前記自動縫合器に縫合材を装着しておき、 これを生 体組織の切除部位にステ一プルで縫い合わせるということが行われ ている。
この場合、 縫合材を自動縫合器に装着可能とし、 確実に患部に到 達させるためには、 何らかの工夫が必要であり、 例えば、 フェルト 状の縫合材に伸縮性を有するニット地を重ね、 これらを仮縫い糸で 両側縁に沿って縫い付け、 筒状にしたものが提案されている。
しかしながら、 伸縮性を有するニッ ト地を縫合用の糸により縫い 付けて自動縫合器への装着を可能とした縫合材では、 自動縫合器を 生体内に挿入して患部へ導入する際に、 挿入方向で収縮し自動縫合 器の基端側に片寄ったり、 自動縫合器の周囲で回転する、 すなわち ツイストする等の不都合が発生している。
縫合材に片寄りや回転が生ずると、 的確な処置が難しく、 特に内 視鏡下のような限られた視野での施術の際に、 大きな問題となる。 発明の開示 そこで本発明は、 このような実情に鑑みて提案されたものであつ て、 自動縫合器の挿入時に片寄りや回転による不都合が発生するこ とがなく、 例えば肺の手術に用いた場合に空気漏れを確実に防止す ることが可能な医療用縫合材を提供することを目的とする。
前述の目的を達成するために、 本発明の医療用縫合材は、 縫合用 の糸を用いてシート状をなす縫合材料が先端が閉塞された袋状に縫 い合わされてなり、 ステ一プルラインを有する自動縫合器に装着さ れる。
本発明の縫合材において、 その主体となる縫合材料には、 フェル トのような不織布や、 織布、 ニッ ト地等、 ある程度の柔軟性、 伸縮 性を有するものであれば任意の形態のものが使用でき、 その材質も 公知のものがいずれも使用できるが、 術後を考えると、 ポリグリコ ール酸のような生体吸収性高分子や、 生体組織の一部、 例えば心の う膜等の臓器保護膜を用いることが望ましい。
上述の縫合材料は、 例えば 1枚の布状のものを縫合用の糸によつ て袋状に縫い合わせてもよいし、 複数枚、 例えば 2枚の縫合材料を 袋状に縫い合わせるようにしてもよい。 後者の場合、 2枚の縫合材 料は同一の材料であってもよいし、 別の材料であってもよい。 また、 2枚の縫合材料のうちの一方は、 必ずしも縫合材料でなくともよく、 例えば通常のニッ ト地等も使用可能である。
本発明の縫合材は、 先端が閉塞された袋状に縫い合わされたもの であるため、 自動縫合器挿入の際に挿入方向に収縮することによる 片寄りが発生することはない。
また、 特に、 1枚あるいは複数枚の縫合材料を袋状に縫い合わせ た縫合材は、 全周に亘り縫合材料のみによって構成されるため、 不 用意に回転 (ツイスト) したとしても問題はない。 図面の簡単な説明 図 1は、 本発明を適用した縫合材の一例を示す概略斜視図である, 図 2は、 上記縫合材が用いられる自動縫合器の一例を示す概略斜 視図である。
図 3は、 上記自動縫合器の縫合機構部の要部概略平面図である. 図 4は、 縫合材の上記自動縫合器への装着状態を示す概略斜視図 である。
図 5は、 上記自動縫合器による縫合操作状態を示す概略斜視図で め o
図 6は、 縫合処置の終了状態を示す概略斜視図である。
図 7は、 本発明を適用した縫合材の他の例を示す概略斜視図であ ο 発明を実施するための最良の形態 以下、 本発明を適用した具体的な実施例について、 図面を参照し ながら詳細に説明する。
実施例 1
本実施例の医療用縫合材 1は、 図 1に示すように、 例えば吸収性 ポリグリコール酸のフェルト (例えば、 グンゼ株式会社製、 商品名 ネオベール等) よりなる 1枚の主縫合材 2を、 縫合用の糸を用いて 先端が閉塞された袋状に縫い合わせてなるものであり、 極めてシン プルな構成を有するものである。
ここで、 主縫合材 2には、 前記吸収性ポリグリコール酸のような 生体吸収性高分子の他、 従来縫合材として用いられているものがい ずれも使用可能である。 例えば、 心のう膜等の臓器保護膜のような 生体組織の一部を使用することも可能である。
前記主縫合材 2は、 後述の自動縫合器の装着部位の長さとほぼ等 しい長さを有し、 2つ折りにして、 幅方向一側縁に沿って縫合用の 糸である縫い糸 3によって縫い合わされている。
前記縫い糸 3は、 抜取り易さを考慮すると、 いわゆるモノフイラ メントがよく、 その材質は任意である。 例えば、 生体吸収性ポリマ —の糸や、 滑り性の良好なポリアミ ド糸 (商品名 ·ナイロン糸) 等 が好適である。
上述の構成を有する医療用縫合材は、 自動縫合器に装着して使用 される。 そこで次に、 自動縫合器の構造、 並びに本実施例の医療用 縫合材の使用方法について説明する。
自動縫合器は、 図 2に示すように、 シャフ ト 1 1の先端に開閉自 在な縫合部 1 2を有してなるものであって、 基端部には把持 ·操作 するための操作部 1 3が設けられている。
前記縫合部 1 2は、 図 3に示すように、 ステ一プルが収容された カートリッジゃナイプブレードが装填される縫合機構部 1 2 a及び 生体組織を挟み込むための顎部 1 2 bとからなり、 縫合機構部 1 2 aの挟み込み面には、 複数 (本例では、 3列 X 3列 = 6列) のステ 一プルライン 1 4やナイフの走査ライン 1 5が臨んでいる。
この自動縫合器は、 サージボートと称されるアタッチメントを介 して生体内に導入される。 すなわち、 まず、 生体に設けた穿孔にサ ージボートを装着し、 このサージボートを通して自動縫合器のシャ フト 1 1を生体内へと挿入する。 これによつて、 生体に設けた穿孔 の密閉が保たれる。
先の医療用縫合材 1は、 前記自動縫合器の縫合部 1 2に装着して 使用される。 図 4は、 縫合材 1を自動縫合器の縫合部 1 2に装着し た状態を示すもので、 縫合機構部 1 2 a及び顎部 1 2 bにそれぞれ 縫合材 1が取り付けられる。
縫合材 1の縫合部 1 2への装着は、 袋状の縫合材 1を縫合部 1 2 に被せることで円滑に行うことができる。
この状態で、 先に述べたようにサージボートを介して自動縫合器 を生体内へと挿入し、 患部へと到達させる. このとき、 自動縫合器 に装着される縫合材 1は、 袋状のものを閉塞された部分より押し込 む形になっているので、 収縮による片寄りゃヅイストが発生するこ とはない。
縫合部 1 2を息部へ導入した後、 図 5に示すように、 生体組織 2 0の切除部位を縫合機構部 1 2 a及び顎部 1 2 bによって挟み込む。 これによつて、 前記切除部位は主縫合材 2で覆われることになる。 次に、 自動縫合器の操作部 1 3に設けられた操作レバ一 1 3 aを 操作し、 前記ステーブルライン 1 3からステ一プルを打針する。
これによつて、 生体組織 2 0の切除部位に沿ってステ一プルが打 針され、 縫合処置が施されるが、 このとき、 同時に縫合部 1 2に装 着された縫合材 1の主縫合材 2が生体組織 2 0の切除部位に押し当 てられ、 前記ステ一プルによって縫合される。
前記主縫合材 2は、 縫合の際の補強材として機能し、 生体組織 2 0の切断部分をこの主縫合材 2を介して縫合することで、 組織の断 裂が防止され、 例えば巨大肺のう胞の切除術等においては、 空気漏 れが防止される。
次いで、 縫合機構部 1 2 aに設けられたナイフを走査ライ ン 1 5 に沿って走査し、 生体組織 2 0及び主縫合材 2を切断する。
以上によって縫合処置が完了するが、 本例の縫合材 1を用いるこ とによって、 縫合操作を円滑に進めることができ、 しかも確実に縫 合部位の補強、 空気漏れの防止を行うことができる。 図 6は、 縫合 終了状態を示すものであり、 生体組織 2 0の縫合部位には、 主縫合 材 2が縫い合わされ、 縫合状態が極めて安定なものとなっている。 実施例 2
本実施例の縫合材 2 1は、 図 7に示すように、 2枚の縫合材料 2 2 , 2 3を先端が閉塞する袋状に縫い合わせてなるものである。 各縫合材料 2 2、 2 3は、 いずれも先端に向かって次第に幅狭と なるような形状とされており、 縫い糸 2 4、 2 5により両側縁に沿 つて縫い合わされている。 また、 これら縫い糸 2 4、 2 5は、 前記 縫合材料 2 2、 2 3の形状により、 縫合材料 2 2、 2 3の先端部に おいて交差され、 袋状の縫い合わせを確実なものとしている。
ここで、 縫合材料 2 2、 2 3は、 同一材料であってもよいし、 別 の材料であってもよい。 具体的に本例では、 第 1の縫合材料 2 2を 吸収性ポリグリコール酸のフェルト (例えば、 グンゼ株式会社製、 商品名ネオベール等) により構成し、 第 2の縫合材料 2 3を別の材 料により構成した。
このように、 別の材料で構成することにより、 コストを削減する ことができ、 製造上有利である。
なお、 本例の縫合材も、 先の実施例 1の縫合材と同様、 自動縫合 器に装着して使用されるものであり、 その使用方法は実施例 1のも のと同様である。
以上、 本発明の具体的な実施例について説明してきたが、 本発明 がこの実施例に限られるものではなく、 材質、 形状等において種々 の変形か可能であることは言うまでもない。 産業上の利用可能性 本発明の縫合材においては、 自動縫合器挿入時に発生する縮みに よる片寄りを防止することができる。 また、 ツイス トが発生したと しても、 常に縫合材料が患部に当接される。
したがって、 本発明の縫合材を用いることによって、 縫合部位の 補強を確実に行うことができ、 組織の断裂や空気漏れを抑えること が可能である。

Claims

請求の範囲
1 . ステーブルラインを有する自動縫合器に装着されて用いられる 医療用縫合材であり、
シート状をなす縫合材が、 縫合用の糸によって先端が閉塞された 袋状に縫い合わされてなる医療用縫合材。
2 . 1枚のシート状をなす縫合材料が縫合用の糸によって袋状に縫 い合わされていることを特徴とする請求の範囲第 1項記載の医療用 臉もお ο
3 . 複数枚の縫合材料が縫合用の糸によって袋状に縫い合わされて いることを特徴とする請求の範囲第 1項記載の医療用縫合材。
4 . 上記縫合材料と他の材料が袋状に縫合用の糸によって縫い合わ されていることを特徴とする請求の範囲第 1項記載の医療用縫合材£
5 . 上記縫合材料が不織布、 織布、 ニッ トから選ばれる少なくとも 1種よりなることを特徴とする請求の範囲第 1項記載の医療用縫合 材。
6 . 上記縫合材料が合成高分子よりなることを特徴とする請求の範 囲第 5項記載の医療用縫合材。
7 . 上記合成高分子が生体吸収性高分子であることを特徴とする請 求の範囲 6項記載の医療用縫合材。
8, 上記生体吸収性高分子がポリグリコール酸であることを特徴と する請求の範囲第 7項記載の医療用縫合材。
9 . 上記縫合材料が生体組織の一部よりなるこどを特徴とする請求 の範囲第 1項記載の医療用縫合材。
1 0 . 上記生体組織が臓器保護膜であることを特徴とする請求の範 囲第 9項記載の医療用縫合材。
1 1 . 上記生体組織が心のう膜であることを特徴とする請求の範囲 第 1 0項記載の医療用縫合材。
PCT/JP1996/001219 1995-05-08 1996-05-08 Matiere de suture medicale WO1996035376A1 (fr)

Priority Applications (8)

Application Number Priority Date Filing Date Title
US08/765,882 US5843096A (en) 1995-05-08 1996-05-08 Medical suturing material
KR1019960707422A KR100289263B1 (ko) 1995-05-08 1996-05-08 의료용 봉합재
AU56588/96A AU711168B2 (en) 1995-05-08 1996-05-08 Medical suturing material
DE69625664T DE69625664T2 (de) 1995-05-08 1996-05-08 Medizinisches nähmaterial
CA002194240A CA2194240C (en) 1995-05-08 1996-05-08 Medical suturing material
DK96922672T DK0770357T3 (da) 1995-05-08 1996-05-08 Medicinsk suturmateriale
EP96922672A EP0770357B1 (en) 1995-05-08 1996-05-08 Medical suture material
AT96922672T ATE230582T1 (de) 1995-05-08 1996-05-08 Medizinisches nähmaterial

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JPH0733342U (ja) * 1993-11-29 1995-06-20 グンゼ株式会社 縫合補綴材
JPH0847526A (ja) * 1994-06-03 1996-02-20 Gunze Ltd 縫合補綴材

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EP0770357A4 (en) 1998-02-11
DE69625664T2 (de) 2003-10-16
DE69625664D1 (de) 2003-02-13
ES2185784T3 (es) 2003-05-01
EP0770357B1 (en) 2003-01-08
US5843096A (en) 1998-12-01
CA2194240A1 (en) 1996-11-14
AU711168B2 (en) 1999-10-07
AU5658896A (en) 1996-11-29
JP3795100B2 (ja) 2006-07-12
CA2194240C (en) 2007-07-17
JPH0924050A (ja) 1997-01-28
ATE230582T1 (de) 2003-01-15
KR100289263B1 (ko) 2001-05-02
DK0770357T3 (da) 2003-05-05
EP0770357A1 (en) 1997-05-02

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