JP7257342B2 - 医療器具およびこれを用いた癒合促進デバイス - Google Patents
医療器具およびこれを用いた癒合促進デバイス Download PDFInfo
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- JP7257342B2 JP7257342B2 JP2019571175A JP2019571175A JP7257342B2 JP 7257342 B2 JP7257342 B2 JP 7257342B2 JP 2019571175 A JP2019571175 A JP 2019571175A JP 2019571175 A JP2019571175 A JP 2019571175A JP 7257342 B2 JP7257342 B2 JP 7257342B2
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B2017/1135—End-to-side connections, e.g. T- or Y-connections
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
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Description
上述したように、本発明の一形態は、複数の貫通孔が形成された生分解性シートを備える医療器具であって、前記貫通孔のピッチPに対する孔径Dの比の値(D/P)が0.25以上40未満である、医療器具に関する。本形態に係る医療器具によれば、吻合部(縫合部)に挟み込むという簡便な手法により、外科手術等の術後における縫合不全のリスクを低減させることが可能となる。以下では、本形態についてより詳細に説明する。
生分解性シートの構成材料について特に制限はなく、例えば、生分解性樹脂が挙げられる。生分解性樹脂としては、例えば、特表2011-528275号公報、特表2008-514719号公報、国際公報第2008-1952号、特表2004-509205号公報等に記載されるものなどの公知の生分解性(共)重合体が使用できる。具体的には、(1)脂肪族ポリエステル、ポリエステル、ポリ酸無水物、ポリオルソエステル、ポリカーボネート、ポリホスファゼン、ポリリン酸エステル、ポリビニルアルコール、ポリペプチド、多糖、タンパク質、セルロースからなる群から選択される重合体;(2)上記(1)を構成する一以上の単量体から構成される共重合体などが挙げられる。すなわち、生分解性シートは、脂肪族ポリエステル、ポリエステル、ポリ酸無水物、ポリオルソエステル、ポリカーボネート、ポリホスファゼン、ポリリン酸エステル、ポリビニルアルコール、ポリペプチド、多糖、タンパク質、セルロースからなる群から選択される重合体、ならびに前記重合体を構成する一以上の単量体から構成される共重合体からなる群より選択される少なくとも一種の生分解性樹脂を含むことが好ましい。
図1は、本発明の一実施形態に係る医療器具を構成する生分解性シートの平面図である。図2は、図1に示す2-2線に沿った断面図である。図3は、複数の貫通孔のサイズを説明するための拡大説明図である。
本発明に係る医療器具を構成する生分解性シートには、癒合を促進するための癒合強化剤が配合されていてもよい。癒合強化剤としては、胸膜癒着術で癒着作用を示す材料であれば特に制限なく用いられうる。例えば、タルク、ポビドンヨード(イソジンなど)、硬化剤(ミノサイクリン、テトラサイクリンなど)、抗がん剤(アドリアマイシン,マイトマイシンC,シスプラチンなど)、免疫賦活剤(OK-432、Broncasma Bernaなど)が挙げられる。タルク、ポビドンヨード、硬化剤および抗がん剤は、胸膜腔内に投与すると化学作用によって炎症を惹起し、回復過程において癒着を生じさせる。また、免疫賦活剤は、死菌製剤へのアレルギー反応によって胸膜からフィブリン析出を促進して、癒着を促進する。
本発明にかかる生分解性シートの製造方法について特に制限はなく、上述した特徴的なサイズを有する貫通孔が形成された生分解性樹脂等からなるシートを製造することが可能な任意の方法が採用されうる。
本発明に係る医療器具(生分解性シート)は、生体組織の癒合を促進するのに用いられる癒合促進デバイスとして用いられうる。
図4には、変形例1に係る医療器具110(生分解性シート120)を示す。
図5には、変形例2に係る医療器具210(生分解性シート220)の拡大断面図(図2に相当する断面図)を示す。
図6には、変形例3に係る医療器具310(生分解性シート320)の拡大断面図(図2に相当する断面図)を示す。
図7には、変形例4に係る医療器具410(生分解性シート420)の概観斜視図を示す。
図8には、変形例5に係る医療器具510(生分解性シート520)の概観斜視図を示す。
図9には、変形例6に係る医療器具610(生分解性シート620)の概観斜視図を示す。
図10には、変形例7に係る医療器具710の概観斜視図を示す。
図11には、変形例8に係る医療器具810の概観斜視図を示す。
図1および図2に示すような、多数の貫通孔が形成された生分解性シート(癒合促進デバイス)を、エレクトロスピニング法により形成した生分解性樹脂シートにレーザー光を照射することにより製造した。ここで、得られた生分解性シート(癒合促進デバイス)に設けられた多数の貫通孔の孔径(D)、ピッチ(P)、孔径/ピッチ比(D/P)および厚み(T)の値を下記の表1に示す。
グレード1:わずかな鈍的操作で組織損傷なしに剥離可能な癒着
グレード2:鈍的操作で組織損傷なしに剥離可能な癒着
グレード3:鈍的操作で組織損傷を伴いながら剥離可能な癒着
グレード4:強い鈍的操作で組織損傷を伴いながら剥離可能な癒着
グレード5:強い鈍的操作でも剥離できない癒着
図1および図2に示すような、多数の貫通孔が形成された生分解性シート(癒合促進デバイス)を、2種類の製法を用いて製造した。1つ目は、樹脂溶液に癒合強化剤を溶解、または懸濁した状態でエレクトロスピニング法により形成した生分解性樹脂シートにプレス孔加工を施す方法(以下、「混練法」とも称する)により製造した。2つ目は、樹脂溶液のみでエレクトロスピニング法により形成した生分解性樹脂シートにプレス孔加工した後、癒合強化剤の溶液に浸漬し、乾燥して生分解性シートに癒合強化剤を吸着させる方法(以下、「吸着法」とも称する)により製造した。
20、120、220、320、420、520、620、720、820 生分解性シート、
21 一方の面、
23 他方の面、
25 側面(一辺)、
30 貫通孔、
31 連通孔、
230a 狭小部、
330a 幅広部、
440 中心孔、
550 スリット、
620a 生分解性シートの本体部、
660 突出部、
D 貫通孔の孔径、
P 貫通孔のピッチ、
T 生分解性シートの厚み。
Claims (11)
- 複数の貫通孔が形成された生分解性シートを備える癒合促進デバイスであって、前記生分解性シートが吻合部に挟み込まれて用いられ、
前記貫通孔のピッチPに対する孔径Dの比の値(D/P)が0.25以上40未満であり、かつ、
前記吻合部に適用されて生体反応を惹起することで生体成分の発現を誘導し、誘導された前記生体成分が、前記吻合部に挟み込まれた前記生分解性シートの前記貫通孔に、前記貫通孔を貫通して集積する、癒合促進デバイス。 - 前記孔径Dが0.1~6mmである、請求項1に記載の癒合促進デバイス。
- 前記ピッチPが0.1~0.4mmである、請求項1または2に記載の癒合促進デバイス。
- 前記生分解性シートの厚みが0.1~0.2mmである、請求項1~3のいずれか1項に記載の癒合促進デバイス。
- 前記貫通孔が前記生分解性シートの厚み方向に沿って略垂直に設けられている、請求項1~4のいずれか1項に記載の癒合促進デバイス。
- 前記貫通孔は、前記生分解性シートの厚み方向と交差する方向に一部が広がる形状を有する、請求項1~5のいずれか1項に記載の癒合促進デバイス。
- 前記生分解性シートは、平面視において円形形状を有しており、
前記平面視した際の略中心位置に、前記貫通孔よりも孔径が大きく形成された中心孔が形成されている、請求項1~6のいずれか1項に記載の癒合促進デバイス。 - 前記生分解性シートの側面と前記中心孔とに連なるスリットを有する請求項7に記載の癒合促進デバイス。
- 前記生分解性シートは、平面視において略矩形形状に形成された本体部を有しており、
前記本体部の一辺には、前記本体部から突出した突起部が形成されている、請求項1~6のいずれか1項に記載の癒合促進デバイス。 - 前記生分解性シートの構成材料は、ポリ乳酸(PLA)、ポリグリコール酸(PGA)または乳酸-グリコール酸共重合体(PLGA)である、請求項1~9のいずれか1項に記載の癒合促進デバイス。
- 前記生分解性シートに癒合強化剤が配合されてなる、請求項1~10のいずれか1項に記載の癒合促進デバイス。
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