JP6353445B2 - 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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- JP6353445B2 JP6353445B2 JP2015523184A JP2015523184A JP6353445B2 JP 6353445 B2 JP6353445 B2 JP 6353445B2 JP 2015523184 A JP2015523184 A JP 2015523184A JP 2015523184 A JP2015523184 A JP 2015523184A JP 6353445 B2 JP6353445 B2 JP 6353445B2
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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]
-
- 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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- 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
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- Materials For Medical Uses (AREA)
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 (26)
- 創傷に挿入するための安定化構造物であって、
複数の細長いストリップと、
前記複数の細長いストリップを接続する複数の介在部材であって、前記細長いストリップに対して枢動するように構成されており、それによって前記安定化構造物が潰れることを可能にする前記介在部材と、
を備え、
前記複数の細長いストリップは、複数の第1のストリップ、複数の第2のストリップ、及び複数の第3のストリップからなり、
前記第1のストリップと、前記第2のストリップと、の間の前記介在部材が、前記第2のストリップと、前記第3のストリップと、の間の前記介在部材から独立して枢動するように構成されており、
前記複数の細長いストリップと、前記複数の細長いストリップを接続する前記複数の介在部材とが、複数の壁によって画定された複数のセルを形成する、安定化構造物。 - 前記介在部材が、少なくとも1つの継手を介して前記細長いストリップに接続されている、請求項1に記載の安定化構造物。
- 前記継手が、ヒンジである、請求項2に記載の安定化構造物。
- 前記ヒンジが、前記安定化構造物が一方向に潰れるように構成されている、請求項3に記載の安定化構造物。
- 前記継手が、前記介在部材の動きを制限するように構成されている、請求項2から4のいずれか一項に記載の安定化構造物。
- 前記細長いストリップが、剛体である、請求項1から5のいずれか一項に記載の安定化構造物。
- 前記細長いストリップが、前記細長いストリップの長さに沿って屈曲するように構成されている、請求項1から6のいずれか一項に記載の安定化構造物。
- 前記細長いストリップが、シリコーン、ポリウレタン、硬質プラスチック、半硬質プラスチック、生体適合性材料、軟質プラスチック材料、複合材料、およびフォーム材料からなる群から選択された材料から構成されている、請求項1から7のいずれか一項に記載の安定化構造物。
- 前記介在部材が、シリコーン、ポリウレタン、硬質プラスチック、半硬質プラスチック、生体適合性材料、軟質プラスチック材料、複合材料、およびフォーム材料からなる群から選択された材料から構成されている、請求項1から8のいずれか一項に記載の安定化構造物。
- 複数の介在部材が隣り合う細長いストリップ間に備えられていて隣り合う細長いストリップの各対の間に複数のセルの列が画定されている、請求項1から9のいずれか一項に記載の安定化構造物。
- 前記セルが、ダイヤモンド形の形状になっている、請求項1から10のいずれか一項に記載の安定化構造物。
- 隣り合う細長いストリップ間の一列の前記複数のセルが、前記安定化構造物が潰れる際に一斉に潰れるように構成されている、請求項10に記載の安定化構造物。
- 第1の方向に潰れるように構成された、前記隣り合う細長いストリップ間の前記複数のセルの1または複数の列と、前記第1の方向の反対側の第2の方向に潰れるように構成された、前記隣り合う細長いストリップ間の前記複数のセルの1または複数の列とを備える、請求項10又は12に記載の安定化構造物。
- 前記安定化構造物の前記複数のセルの複数の列の全てが同じ方向に潰れるように構成されている、請求項10または12に記載の安定化構造物。
- 前記第1のストリップと前記第2のストリップとの間の介在部材が、前記第2のストリップと前記第3のストリップとの間の介在部材に対してずれている、請求項10、12、13及び14のいずれか一項に記載の安定化構造物。
- 前記安定化構造物全体を囲むフォームをさらに備える、請求項1から15のいずれか一項に記載の安定化構造物。
- 隣り合う細長いストリップ間にフォームをさらに備える、請求項1から16のいずれか一項に記載の安定化構造物。
- 前記安定化構造物が、前記安定化構造物のいずれかの方向における潰れによる寸法の変化全体の90%が1時間以内に生じるように構成されている、請求項1から17のいずれか一項に記載の安定化構造物。
- 前記安定化構造物が、前記安定化構造物のいずれかの方向における潰れによる寸法の変化全体の90%が5分以内に生じるように構成されている、請求項1から17のいずれか一項に記載の安定化構造物。
- 前記安定化構造物の上方、前記安定化構造物の下方、または前記安定化構造物の上層および下層の両方には、別個のフォーム層が設けられている、請求項1から19のいずれか一項に記載の安定化構造物。
- 前記フォーム層が、前記安定化構造物の中へ延在する指部をさらに備える、請求項20に記載の安定化構造物。
- 前記安定化構造物の周りには、フォームリボンまたはフォームリングが設けられている、請求項1から21のいずれか一項に記載の安定化構造物。
- 前記複数の細長いストリップが、略平行に配置されている、請求項1から22のいずれか一項に記載の安定化構造物。
- 前記安定化構造物が、卵形の形状になっている、請求項1から23のいずれか一項に記載の安定化構造物。
- 陰圧創傷治療で創傷を治療するための装置であって、
前記装置が、創傷の中へ挿入させるための安定化構造物を備えており、前記安定化構造物が、陰圧下で潰れるように構成されており、前記安定化構造物が、前記安定化構造物の中央の長手方向軸に沿って延在する長さと、前記安定化構造物の中央の横方向軸に沿って延在する、前記長さに直交する幅と、前記長さ及び前記幅に直交する厚さとを有し、
前記安定化構造物が、
前記安定化構造物の前記長さに延びた第1の側および第2の側であって、前記第1の側が前記第2の側の反対側にあり、前記第1の側および前記第2の側が前記中央の長手方向軸に対して湾曲していて、楕円の少なくとも一部分の形状をした前記安定化構造物の外側周辺部をもたらす、第1の側および第2の側と、
前記安定化構造物の前記長さに少なくとも部分的に延びた複数の細長いストリップであって、前記安定化構造物の前記第1の側および前記第2の側を画定する最も外側の細長いストリップ、および、前記最も外側の細長いストリップ間に位置付けられた複数の内側の細長いストリップを含む細長いストリップと、
前記複数の細長いストリップを接続する複数の介在部材であって、前記細長いストリップに対して枢動するように構成されていて前記安定化構造物が潰れることを可能にする、介在部材と、
前記安定化構造物の前記長さ及び前記幅に対して垂直な水平方向平面内に並んで設けられた複数のセルであって、各セルが、前記水平方向平面に対して垂直な垂直方向に延在する複数の壁によって画定されると共に、前記細長いストリップ又は前記介在部材のいずれかによって形成されており、各セルが上端及び下端を有していて開口が前記上端および前記下端を通って延びている、セルと、
を備えており、
前記安定化構造物が、前記複数のセルを潰すことによって、前記垂直方向よりも前記水平方向平面内により潰れるように構成されている、装置。 - 請求項1から24のいずれか一項に記載の安定化構造物または請求項25に記載の装置と、
前記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、
前記創傷と流体連通するように構成された陰圧源と
を備える陰圧創傷閉鎖システム。
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