JP7346471B2 - 陰圧創傷閉鎖デバイス - Google Patents
陰圧創傷閉鎖デバイス Download PDFInfo
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- JP7346471B2 JP7346471B2 JP2021003800A JP2021003800A JP7346471B2 JP 7346471 B2 JP7346471 B2 JP 7346471B2 JP 2021003800 A JP2021003800 A JP 2021003800A JP 2021003800 A JP2021003800 A JP 2021003800A JP 7346471 B2 JP7346471 B2 JP 7346471B2
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- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/05—Bandages or dressings; Absorbent pads specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
- A61M1/91—Suction aspects of the dressing
- A61M1/912—Connectors between dressing and drainage tube
- A61M1/913—Connectors between dressing and drainage tube having a bridging element for transferring the reduced pressure from the connector to the dressing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
- A61M1/91—Suction aspects of the dressing
- A61M1/915—Constructional details of the pressure distribution manifold
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- A—HUMAN NECESSITIES
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- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
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- A61F13/00—Bandages or dressings; Absorbent pads
- A61F2013/00361—Plasters
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Description
本出願は、2012年7月16日に出願した「NEGATIVE PRESSURE WOUND CLOSURE DEVICE」という名称の米国仮出願第61/672,225号、2013年3月1日に出願した「NEGATIVE PRESSURE WOUND CLOSURE DEVICE」という名称の米国仮出願第61/771,732号、および2013年3月13日に出願した「NEGATIVE PRESSURE WOUND CLOSURE DEVICE」という名称の米国仮出願第61/780,629号の利益を主張するものである。前述の出願の内容は、本明細書に完全に記載されているかのように、その全体が参照により本明細書に組み込まれる。前述の出願の優先権の利益は、限定するものではないが、米国特許法第119条(e)項を含む、適切な法的根拠の下で主張される。
複数の平面状支持構造物を備える安定化構造物であって、各平面状支持構造物は、第2の複数の梁と交差する第1の複数の梁を備え、複数の平面状支持構造物は互いと平行に配置される、安定化構造物と、
隣接する平面状支持構造物と接合する複数のばね要素であって、平面状支持構造物が互いに近づくように安定化構造物の圧縮を提供する複数のばね要素と
を備える。
第1の方向に延びる少なくとも1つの上部ストリップであって、それを通って部分的に延び、上部ストリップの下面に開く少なくとも1つの切欠きを備える上部ストリップと、
第2の方向に延びる少なくとも1つの下部ストリップであって、それを通って部分的に延び、下部ストリップの上面に開く少なくとも1つの切欠きを備える下部ストリップと
を備え、
少なくとも1つの上部ストリップおよび少なくとも1つの下部ストリップは、上部ストリップ上の切欠きを下部ストリップ上の切欠きの上に設置することによって互いに移動可能にインターロックされるように構成され、
少なくとも1つの上部ストリップおよび少なくとも1つの下部ストリップは、依然として移動可能にインターロックされたままであり、第1の平面に垂直な第3の方向に沿って実質的に潰れないながらも、第1の方向および第2の方向によって画定される第1の平面に沿って優先的に潰れるように構成される。
第1の方向に延びる少なくとも1つの上部ストリップと、
第2の方向に延びる少なくとも1つの下部ストリップと
を備え、
少なくとも1つの上部ストリップおよび少なくとも1つの下部ストリップは、インターロック機構を使用して移動可能にインターロックされるように構成され、
少なくとも1つの上部ストリップおよび少なくとも1つの下部ストリップは、依然として移動可能にインターロックされたままであり、第1の平面に垂直な第3の方向に沿って実質的に潰れないながらも、第1の方向および第2の方向によって画定される第1の平面に沿って優先的に潰れるように構成される。
本項または本明細書の別の場所で説明するような創傷閉鎖デバイスまたは安定化構造物を創傷の中に設置すること、
創傷を液密ドレープで密封すること、
創傷を陰圧源に流体的に接続すること、および
陰圧源を介して創傷に陰圧を加えること
を含む、創傷を閉鎖する方法を提供する。
本項または本明細書の別の場所で説明するなどの安定化構造物と、
この安定化構造物の上に設置され、創傷を囲む皮膚の領域に対して実質的に液密のシールを形成するような大きさおよび構成にされたドレープと、
創傷と流体連通する陰圧源と
を備えることができる。
創傷閉鎖デバイスを創傷内に設置することであって、創傷閉鎖デバイスは、1つまたは複数のインサートを除去可能に受け入れるように構成され、創傷閉鎖デバイスは陰圧下で潰れるように構成される、設置すること、
創傷を液密ドレープで密封すること、
創傷を陰圧源に流体的に接続すること、
陰圧源を介して創傷に陰圧を加えること、および
安定化構造物から1つまたは複数のインサートを除去することおよび/または安定化構造物に1つもしくは複数のインサートを挿入して創傷閉鎖デバイスの潰れを動的に制御すること
を含むことができる。
図3A~図3Dは、安定化構造物1701を備える創傷閉鎖デバイスの一実施形態の様々な図を示す。ここで、安定化構造物1701は、第2の組の交差する梁1705にしっかりと、またはややしっかりと取り付けられたまたは結合された第1の組の梁1703を備える。これらの梁1703、1705は、好ましくは平面内で実質的に剛性である平面状支持構造物1702を形成する。梁1703、1705は、互いに対して直角をなしてよい(が、他の構成たとえばハニカムが可能である)。2つ以上の平面状支持構造物1702を接合して安定化構造物1701を形成してよく、各平面状支持構造物1702は、好ましくは、以下でさらに詳細に説明するように、ばね要素1711および1713によって他の平面状支持構造物1702から分離される。安定化構造物において使用される平面状支持構造物1702の数は、創傷の大きさに関連して調整されてよい。たとえば、互いに対して平行または実質的に平行に配置された2つ、3つ、4つ、5つ、またはそれ以上の平面状支持構造物1702があり得る。ばね要素1711、1713は、好ましくは、平面状支持構造物1702を互いに近づけるように一方向における安定化構造物1701の圧縮を可能にするように配置される。好ましい一実施形態では、安定化構造物1701は、その元の大きさの40%以下、好ましくはその元の大きさの30%以下、より好ましくはその元の大きさの20%以下、さらにより好ましくはその元の大きさの10%以下に潰れてよい。いくつかの実施形態では、安定化構造物1701は、その元の大きさの5%以下に潰れてよい。
図8A~図8Eは、安定化構造物1100を備える創傷閉鎖デバイスの追加実施形態を示す。図8Aは、安定化構造物1100の一実施形態の斜視図を示す。ここで、安定化構造物1100は、好ましくは、実質的に潰されない構成であるとき互いにほぼ直交する方向に延びる(以下で図8Bに関してより詳細に説明する)2つ以上のインターロッキングストリップからなる。この安定化構造物は、好ましくは、依然として比較的剛性かつ第1の方向または第1の平面に垂直な方向に潰れ抵抗性でありながらも、一方向に、または第1の平面に沿って、潰れるように構成される。
図21Aは、創傷内へと設置され得るまたは挿入され得る安定化構造物2100を備える創傷閉鎖デバイスの一実施形態の写真である。ここで、このデバイスは、略平面状構成で並んで設けられた複数のセル2102を備える。好ましくは、安定化構造物2100は、平面2101に垂直な方向に大きく潰れることなく、デバイスの幅によって画定された平面2101に沿った方向に潰れるように構成される。すなわち、図で見ると、安定化構造物2100は水平方向に潰れるが、垂直方向に圧縮されない。いくつかの実施形態では、安定化構造物は、組織の動きに関連して潰れる。ここで、セル2102は、好ましくは、両端で平面2101に垂直な方向に開いている。
図28Aは、創傷3405の軸に沿った張力の印加による、前に説明したまたは以下で説明する本項または本明細書の別の場所で説明する安定化構造物のいずれかを使用した創傷の閉鎖のための方法の一実施形態を示す。この例では、創傷を上から見たとき、張力が、一般的に矢印3407によって表されている創傷の長手方向軸に沿って加えられる。長手方向軸に沿った張力は長手方向軸に沿った創傷の収縮を防止するが、長手方向軸に沿った張力は、創傷の横方向辺縁を互いに引っ張らせ、創傷閉鎖を促進することができる。いくつかの実施形態では、さらなる内向き張力を創傷の横方向辺縁に加え、それによって、さらなる創傷閉鎖力を提供することができる。
図36A~図36Fは、図29A~図32に関して上記で説明した実施形態に類似した安定化構造物4200の実施形態を示す。安定化構造物は、並列に配置された複数の細長いストリップ4202を備えてよく、ストリップ4202の長手方向長さは、創傷内に設置されたとき、創傷の長手方向軸と位置合わせすることができる。安定化構造物は、継手4206を介して細長いストリップ4202に接続された複数の介在部材4204をさらに備えることができる。特定の実施形態では、安定化構造物4200は、陰圧の印加を用いてまたは用いずに、本項または本明細書の別の場所で説明する任意の形で潰れることができる。たとえば、安定化構造物は、一平面内で、別の平面内よりも著しく大きく潰れてよい。いくつかの実施形態では、安定化構造物は、シリコーンなどの軟質プラスチック、ポリウレタン、ポリ塩化ビニルなどの硬質プラスチック、半硬質プラスチック、半軟質プラスチック、生体適合性材料、複合材料、金属、およびフォームを含む、本項または本明細書の別の場所で説明する任意の材料からなることができる。
101 創傷
102 創傷充填物
104 ドレープ
106 アパーチャ
108 コンジット
110 ポンプ
1000 安定化構造物
1100 安定化構造物、構造物、デバイス
1102 下部ストリップ、インターロッキングストリップ、インターロッキング下部ストリップ
1104 上部ストリップ、インターロッキングストリップ、インターロッキング上部ストリップ
1106 切欠き
1108 切欠き
1109 空間、アパーチャ
1110 多孔性創傷充填材料、多孔性材料
1120 長手方向ストリップ、長手方向交差ストリップ
1122 潰すことが可能な交差ストリップ交差ストリップ
1124 角度付き交差ストリップ
1126 長手方向ストリップ
1127 セル
1128 長手方向ストリップ
1129 セル
1130 垂直方向セグメント
1131 セル
1132 テーパ、テーパ付き部分
1140 創傷
1145 ドレープ
1148 多孔性創傷充填材
1150 流体コネクタ
1190 皮下脂肪層
1192 筋組織層
1201 安定化構造物、構造物
1202 平面状支持構造物
1203 梁
1207 離隔器
1211 ばね要素
1213 ばね要素
1301 創傷閉鎖デバイス
1303 スロット
1305 セル、穴
1701 安定化構造物、構造物
1702 平面状支持構造物
1703 梁
1705 梁
1707 離隔器
1708 離隔器
1711 ばね要素
1713 ばね要素
2100 安定化構造物、インサート
2101 平面
2102 セル
2104 壁
2105 穴
2106 可撓性継手、継手
2108 空洞
2109 切欠き
2110 インサート
2111 インサート
2112 インサート
2113 インサート
2114 インサート
2115 インサート
2201 切欠き
2203 水平方向リップ
2205 アパーチャ
2207 チャネル、水平方向チャネル
3001 安定化構造物、構造物
3002 上部ストリップ、ストリップ
3004 下部ストリップ、ストリップ
3006 インターロック機構
3010 留め具
3011 リップ、フック
3012 突出部
3013 拡大された端
3014 安定化柱
3020 カップ形部材
3021 スリット
3022 フック
3201 安定化構造物
3301 安定化構造物
3400 安定化構造物
3402 ストリップ
3404 ストラット
3405 創傷
3406 フォーム
3407 矢印
3408 線
3410 線
3412 線
3500 安定化構造物
3502 ストリップ、第2のストリップ
3504 介在部材
3506 継手
3508 セル
3600 安定化構造物、構造物
3602 ストリップ
3604 介在部材、バー
3606 継手、ピン
3608 ストッパ
3700 安定化構造物、構造物
3702 ストリップ
3704 介在部材
3706 継手
3708 線
3800 安定化構造物
3802 長手方向ストリップ
3804 交差ストリップ
3806 可撓性セル
3900 ストリップ
3902 第1のストリップ
3904 開口
3906 第2のストリップ
3908 切欠き
3910 中央部分
4000 安定化構造物
4002 長手方向ストリップ
4004 セル
4006 ロール
4100 安定化構造物
4102 セル
4104 同心リング
4200 安定化構造物、安定化デバイス、構造物
4202 ストリップ
4204 介在部材
4206 継手
4210 セル
4212 屈曲セグメント
4214 支持セグメント、支持部材、材料、インサート
4216 スリーブ、第1の材料、インサート
4218 インサート
4220 切欠き
4224 開口
4400 安定化構造物
4402 ストリップ
4404 介在部材
4416 開口
4500 安定化構造物
4502 ストリップ
4504 介在部材
4506 窓
4508 間隙
4510 バー
4600 フォーム層
4602 指部
4700 安定化構造物
4800 フォームインサート、インサート、リング
4802 組織アンカー、組織アンカー層
4804 リップ
4900 創傷閉鎖デバイス
4902 安定化構造物
4904 フォーム層
4906 リング
Claims (15)
- 幅、長さ、および厚さを有し、卵形の多孔性フォーム材料を有する創傷充填材料であって、中心長手方向軸と、前記多孔性フォーム材料の厚さを貫通して前記創傷充填材料の上面と下面の間に延びる複数のセルとを有し、創傷に陰圧を加えると前記創傷充填材料が優先的に前記中心長手方向軸に直交する幅方向に潰れて、前記多孔性フォーム材料を通して流体を輸送する、創傷充填材料を有し、
前記複数のセルは、前記卵形の多孔性フォーム材料の前記中心長手方向軸の両側で長手方向に長い形状であり、前記複数のセルは、前記中心長手方向軸について対称である、創傷閉鎖デバイス。 - 前記複数のセルは、前記中心長手方向軸の方向に延びる複数のスロットを有する、請求項1に記載の創傷閉鎖デバイス。
- 前記複数のセルは、前記創傷充填材料の厚さを貫通して延びる穴を有する、請求項1に記載の創傷閉鎖デバイス。
- 前記穴はダイヤモンド形である、請求項3に記載の創傷閉鎖デバイス。
- 前記創傷充填材料は、前記多孔性フォーム材料のインターロッキングストリップを有する安定化構造物を有する、請求項1に記載の創傷閉鎖デバイス。
- 前記多孔性フォーム材料は幅方向に比べて厚さ方向の剛性が高い、請求項1に記載の創傷閉鎖デバイス。
- 前記複数のセルは、負圧を加えると幅方向に潰れる形状および大きさを有し、前記複数のセルの大きさは、前記創傷内に配置されると元の幅寸法から40%と等しいまたはこれより小さく潰れる、請求項1に記載の創傷閉鎖デバイス。
- 液密シールを形成するために前記創傷充填材料の上に設置されたドレープをさらに有する、請求項1に記載の創傷閉鎖デバイス。
- 前記ドレープのアパーチャが陰圧源と流体的に接続するように構成される、請求項8に記載の創傷閉鎖デバイス。
- 前記ドレープの前記アパーチャとポンプを含む前記陰圧源との間の流体的な接続を提供するコンジットをさらに有する、請求項9に記載の創傷閉鎖デバイス。
- 前記複数のセルのうちの1または複数のセル内にフォームインサートをさらに有する、請求項1に記載の創傷閉鎖デバイス。
- 前記ドレープは、前記創傷充填材料が幅方向に優先的に潰れるように長さ方向に整列したひだまたは折り畳み部分を有する、請求項8に記載の創傷閉鎖デバイス。
- 前記卵形の多孔性フォーム材料は、安定化構造物を定義するために相互に接続する上部および下部ストリップを有する、請求項1に記載の創傷閉鎖デバイス。
- 前記創傷充填材料は、垂直方向の剛性が高く、潰れなしで3psiの印加圧力を支持する、加熱および圧縮されたポリウレタンフォームを有する、請求項1に記載の創傷閉鎖デバイス。
- 前記複数のセルは、異なるサイズを有し、長さおよび幅の寸法によって定義される平面内で正方形、ダイヤモンド、長方形、卵形または平行六面体の形状を有し得、前記創傷充填材料は創傷口の対辺の間に広がる平面内に配置される、請求項1に記載の創傷閉鎖デバイス。
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