JP2012507353A - 減圧式腹部治療システムおよび方法 - Google Patents
減圧式腹部治療システムおよび方法 Download PDFInfo
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Abstract
【選択図】図1
Description
本発明は、2008年10月29日提出の米国暫定特許出願整理番号61/109,486「Reduced-Pressure, Abdominal Treatment System and Method」、2008年10月29日提出の米国暫定特許出願整理番号61/109,390「Open-Cavity, Reduced-Pressure Wound Dressing and System」、2008年10月29日提出の米国暫定特許出願整理番号61/109,410「Reduced-Pressure, Wound-Closure System and Method」、2008年10月29日提出の米国暫定特許出願整理番号61/109,448「Reduced-Pressure, Deep-Tissue Closure System and Method」の35USC119条(e)の利益を主張するものである。これらの暫定出願のすべてはあらゆる目的において参照により本書に組み込まれる。
最初に図1を参照すると、減圧式腹部治療システム30の実施例が示されている。この減圧式腹部治療システム30は、患者の腹部開腔32や、開腹の際の組織または創傷を治療あるいは処置するのに用いられる。本書において「創傷」とは、損傷した範囲または組織をいう。減圧式腹部治療システム30は、通常の組織部位34、腹膜36などの深部組織における深部創傷、筋肉40、脂肪層42、および表皮44における表面創傷180の治療に用いることができる。腹膜36の創傷は、腹膜縁部38を有する。表皮44の表面創傷180は、表面創傷縁部182を有する。組織部位34が腹部器官46の近くに示されている。この組織部位34は、様々な人間、動物、または他の器官の肉体組織である。本実施例において、組織部位34は通常、腹部開腔32内の組織を含み、特に腹部器官46の近傍の組織を含む。
例えば減圧サブシステム58といった減圧サブシステムの実施例について以下に説明する。この減圧治療サブシステム58は、マニホルド64と、シーリング部材66(またはオーバドレープ)と、減圧接続器72とを具える。マニホルド64は腹腔32内に配置されて示されている。シーリング部材66は表皮44上の表面創傷180の上に配置され、腹腔32を覆い気密を形成している。
開腔部治療サブシステム52は、腹腔32または組織部位34の治療用である。この開腔部治療サブシステム52について、以下に詳細に説明する。
図1を参照すると、減圧式腹部治療システム30の深部組織閉塞サブシステム56は、腹膜36などの深部組織を閉塞すべく用いられ、特に腹膜縁部38を接合させるのに用いられる。深部組織閉塞デバイス54を具える深部組織閉塞サブシステム56が示されている。深部組織閉塞サブシステム56は特に、例えば腹膜36などの深部組織を含む腹腔32内での利用に適している。腹膜36の創傷は、腹膜縁部38を有して示されており、これは典型的な深部組織の損傷を規定している。これらの腹膜縁部38を近接させることにより、深部組織の創傷を閉じるか、閉塞力をかけることが望ましい。より具体的には後述するが、深部組織閉塞デバイス54はこの目的を補助する。
再び図1を参照すると、表面創傷閉塞サブシステム60が示されている。表皮44の表面創傷180、特に、表面創傷縁部182間に閉塞力を提供することが望まれる。図1、16に示すように、表面創傷閉塞サブシステム60を、この目的で用いることができる。この表面創傷閉塞サブシステム60は、表皮44に連結された矢印184で示す閉塞力を生成し、表面創傷縁部182を互いに向かって動かす。表面創傷閉塞サブシステム60は、第1の取付部材186を具え、これは第1のベース部材177と、第1のウォール188またはウォール部材を具える(図16)。密閉型収縮部材196が、例えば粘着材189といった固定具によりウォール188に固定される。第1のベース部材177は、第1の面190と第2の内側対向面191とを具える。第1のベース部材177と第1のウォール188は、多様な材料で構成することができるが、いくらか柔軟性のある材料が好ましい。例えば、第1の取付部材186は、第1のベース部材177で構成され、第1のウォール188はポリプロピレンや硬質シリコーン等で構成されてもよい。
主に図1を参照すると、開口した腹腔32の治療アプローチによると、医療提供者は最初に、開口部治療サブシステム52の部品としての開腔部治療デバイス50を入れる。この開腔部治療デバイス50は、最初に、特定のアプリケーションに合致するよう寸法調整されている。例えば、図6では、開腔部治療デバイス202は、適切なサイズとなるよう、目に見える印214に沿って操作領域212を通ってカットされる。再び図1を参照すると、開腔部治療デバイス50が適切なサイズとなったら、開腔部治療デバイス50は腹腔32内の腹部器官46の上に配置される。開腔部治療デバイス50のカプセル化された脚部材90が曲げられ、結腸傍溝92、94、骨盤腔、患者の肝臓の裏などの所望位置に入れられる。
Claims (43)
- 腹部治療システムであって、
複数のカプセル化された脚部材を具え、患者の腹部器官の近くに減圧治療を施すための開腔部治療デバイスと、
収縮マトリクスを具え、患者の腹膜の深部組織創傷に閉塞力をかける深部組織閉塞デバイスと、
前記患者の腹腔内に減圧治療を施すための減圧治療サブシステムとを具えることを特徴とする腹部治療システム。 - 請求項1のシステムにおいて、さらに、患者の表皮の表面創傷に閉塞力をかける表面創傷閉塞サブシステムを具えることを特徴とする腹部治療システム。
- 請求項1のシステムにおいて、さらに、
患者表皮の表面創傷に閉塞力をかける表面創傷閉塞サブシステムと、
前記開腔部治療デバイス、前記深部組織閉塞デバイス、前記減圧治療サブシステム、および前記表面創傷閉塞サブシステムに使用する減圧を生成可能な減圧供給サブシステムとを具えることを特徴とする腹部治療システム。 - 請求項1のシステムにおいて、前記収縮マトリクスが複数のセルを具え、当該複数のセルは減圧下にないときに第1の体積(V1)を有し、減圧下にあるときに第2の体積(V2)を有し、V1>V2であることを特徴とする腹部治療システム。
- 請求項1のシステムにおいて、前記収縮マトリクスは複数のセルを具え、当該複数のセルは柔軟な側壁を具え、当該柔軟な側壁は減圧下において互いに近づくよう動くことを特徴とする腹部治療システム。
- 請求項1のシステムにおいて、前記収縮マトリクスは複数のセルを具え、当該複数のセルは、深部組織に液通する第1の開口部と、減圧をうける第2の複数の開口部とを具えることを特徴とする腹部治療システム。
- 請求項1のシステムにおいて、さらに、
患者表皮の表面創傷に閉塞力を提供する表面創傷閉塞サブシステムと、
前記開腔部治療デバイス、前記深部組織閉塞デバイス、前記減圧治療サブシステム、および前記表面創傷閉塞サブシステムに使用する減圧を生成可能な減圧供給サブシステムとを具え、
前記複数のカプセル化された脚部材が非接着性ドレープに結合されており、前記複数のカプセル化された脚部材がそれぞれ、脚部マニホルド部材を有する内側部分を有するとともに、当該内側部分に流体が流れ込むのを可能にする有窓部が形成されていることを特徴とする腹部治療システム。 - 請求項3のシステムにおいて、前記深部組織閉塞デバイスが、第1の面と第2の内側対向面とを有する収縮マトリクスを具え、前記第1の面は複数の開口部が形成され、前記第2の内側対向面は複数のセルが形成されており、前記収縮マトリクスは前記患者の腹膜に近接配置され、減圧下で収縮しうることを特徴とする腹部治療システム。
- 請求項3のシステムにおいて、前記減圧治療サブシステムは、
前記患者の腹腔内に配置され前記患者の腹腔内に減圧を集配しうるマニホルドと、
前記患者の表皮の一部に配置され前記患者の腹腔の上に気密を形成しうる密閉部材と、
減圧送達導管と、
前記密閉部材に結合され前記減圧送達導管と流体接続するための減圧接続器であって、前記減圧送達導管から前記マニホルドに減圧を送達可能な減圧接続器とを具えることを特徴とする腹部治療システム。 - 請求項3のシステムにおいて、前記表面創傷閉塞サブシステムは、
前記表面創傷の縁部に近い患者の表皮の第1の部分に脱着可能に取り付ける第1の取付部材と、
前記表面創傷の縁部に近い患者の表皮の第2の部分に脱着可能に取り付ける第2の取付部材であって、前記第1の取付部材とは離れている第2の取付部材と、
前記第1の取付部材と第2の取付部材に連結され減圧下に置かれると収縮しうる密閉型収縮部材とを具え、
前記密閉型収縮部材に減圧が供給されると、前記第1の取付部材と第2の取付部材間に閉塞力が発生することを特徴とする腹部治療システム。 - 請求項8のシステムにおいて、前記収縮マトリクスは、減圧源から減圧をかけられたときに、前記収縮マトリクスの第1の面に隣接する患者の腹膜へのグリップ力を生成するとともに、非収縮状態から収縮状態へと遷移しうることを特徴とする腹部治療システム。
- 請求項8のシステムにおいて、前記収縮マトリクスは、減圧源から減圧をかけられたときに、前記収縮マトリクスの第1の面に隣接する患者の腹膜へのグリップ力を生成するとともに、前記深部組織創傷の閉塞力を生成しうることを特徴とする腹部治療システム。
- 請求項8のシステムにおいて、前記収縮マトリクスは、ハニカムマトリクスで形成されていることを特徴とする腹部治療システム。
- 請求項8のシステムにおいて、前記深部組織閉塞デバイスが、
第1の面と第2の内側対向面とを有する収縮マトリクスを具え、前記第1の面は複数の開口部が形成され、前記第2の内側対向面は複数のセルおよび複数のセル間開口部が形成されており、前記収縮マトリクスは前記深部組織創傷に近接配置されることを特徴とする腹部治療システム。 - 請求項14のシステムにおいて、前記収縮マトリクスは、減圧源から減圧をかけられたときに、前記収縮マトリクスの第1の面に隣接する患者の腹膜へのグリップ力を生成するとともに、非収縮状態から収縮状態へと遷移しうることを特徴とする腹部治療システム。
- 請求項15のシステムにおいて、前記収縮マトリクスは、減圧源から減圧をかけられたときに、前記収縮マトリクスの第1の面に隣接する患者の腹膜へのグリップ力を生成するとともに、前記深部組織創傷の閉塞力を生成しうることを特徴とする腹部治療システム。
- 請求項11のシステムにおいて、前記収縮マトリクスは、ハニカムマトリクスで形成されていることを特徴とする腹部治療システム。
- 請求項1のシステムにおいて、前記複数のカプセル化された脚部材の各々が、
有窓部が形成された第1のカプセル化された脚部材と、
有窓部が形成された第2のカプセル化された脚部材と、
第1の面、第2の内側対向面、第1の横方向縁部、および第2の横方向縁部を具える脚部マニホルド部材とを具え、
前記第1のカプセル化された脚部材は前記脚部マニホルド部材の第1の面に近接配置され、前記第2のカプセル化された脚部材は前記脚部マニホルド部材の第2の内側対向面に近接配置され、前記第1のカプセル化された脚部材と第2のカプセル化された脚部材は前記脚部マニホルド部材の第1の横方向縁部および第2の横方向縁部の近くで連結されることを特徴とする腹部治療システム。 - 請求項1のシステムにおいて、前記複数のカプセル化された脚部材の各々が、複数の脚部モジュールが形成されたカプセル化された脚部材を含むことを特徴とする腹部治療システム。
- 請求項7のシステムにおいて、前記非接着性ドレープがさらに、サイズ目盛りを示す目に見える印を具えることを特徴とする腹部治療システム。
- 請求項7のシステムにおいて、前記中央連結部材が、
有窓部が形成され周辺縁部を有する第1の連結カプセル化部材と、
有窓部が形成され周辺縁部を有する第2の連結カプセル化部材とを具え、
前記第1の連結カプセル化部材の周辺縁部は、前記第2の連結カプセル化部材の周辺縁部に、前記連結マニホルド部材を囲む脚部結合領域以外は連結されていることを特徴とする腹部治療システム。 - 請求項7のシステムにおいて、前記複数のカプセル化された脚部材の各々が、
有窓部が形成された第1のカプセル化された脚部材と、
有窓部が形成された第2のカプセル化された脚部材とを具え、
前記脚部マニホルド部材が、第1の面、第2の内側対向面、第1の横方向縁部、および第2の横方向縁部を具え、
前記第1のカプセル化された脚部材は前記脚部マニホルド部材の第1の面に近接配置され、前記第2のカプセル化された脚部材は前記脚部マニホルド部材の第2の内側対向面に近接配置され、前記第1のカプセル化された脚部材と第2のカプセル化された脚部材は前記脚部マニホルド部材の第1の横方向縁部および第2の横方向縁部の近くで連結され、
前記中央連結部材が、
有窓部が形成され周辺縁部を有する第1の連結カプセル化部材と、
有窓部が形成され周辺縁部を有する第2の連結カプセル化部材とを具え、
前記第1の連結カプセル化部材の周辺縁部は、前記第2の連結カプセル化部材の周辺縁部に、前記連結マニホルド部材を囲む脚部結合領域以外は連結されていることを特徴とする腹部治療システム。 - 請求項10のシステムがさらに、
前記患者表皮において前記表面創傷の縁部に近い第3の部分に脱着可能に取り付けられる第3の取付部材を具え、
前記第2の取付部材は前記第1および第2の取付部材から離されており、前記第3の取付部材は前記密閉型収縮部材に連結されていることを特徴とする腹部治療システム。 - 請求項23のシステムがさらに、
前記患者表皮において前記表面創傷の縁部に近い第4の部分に脱着可能に取り付けられる第4の取付部材を具え、
前記第4の取付部材は前記第1、第2、および第3の取付部材から離されており、前記第4の取付部材は前記密閉型収縮部材に連結されていることを特徴とする腹部治療システム。 - 請求項10のシステムにおいて、
前記第1の取付部材は第1のベース部材と第1の粘着材を具え、前記第2の取付部材は第2のベース部材と第2の粘着材を具えることを特徴とする腹部治療システム。 - 請求項10のシステムにおいて、前記密閉型収縮部材が、
第1の面と第2の内側対向面と周辺縁部とを有する収縮マニホルド材と、
前記収縮マニホルド材の第1の面に対向して配置された第1の密閉部材と、
前記収縮マニホルド材の第2の内側対向面に対向して配置された第2の密閉部材と、
前記収縮マニホルド材の周辺縁部に対向して配置された周辺部密閉デバイスとを具え、
前記第1の密閉部材、第2の密閉部材、および周辺部密閉デバイスが、前記収縮マトリクス材を気密しうることを特徴とする腹部治療システム。 - 請求項26のシステムにおいて、前記周辺部密閉デバイスは、第3の密閉層を具えることを特徴とする腹部治療システム。
- 請求項26のシステムにおいて、前記周辺部密閉デバイスが、外側壁を具えることを特徴とする腹部治療システム。
- 請求項10のシステムにおいて、前記第1の取付部材が、
第1の面と第2の内側対向面とを有する第1のベース部材と、
前記第1のベース部材に結合される第1の外側壁と、
前記第2の内側対向面に結合された第1の粘着材とを具えることを特徴とする腹部治療システム。 - 請求項9のシステムにおいて、前記表面創傷閉塞サブシステムが、
密閉型収縮部材と、
複数の取付ベース部材であって、各々が、ベースと、第1の端部および第2の端部を有する第1のウォールとを具え、前記第1のウォールの第1の端部は第1の可動連結部材を具え、前記第2の端部が第2の可動連結部材を具え、各取付ベース部材は前記患者表皮の一部に脱着可能に取り付けられるとともに前記密閉型収縮部材に結合された、複数の取付ベース部材と、
複数の連結部材であって、各々が、第1の端部および第2の端部を有する第2のウォールを具え、前記第2のウォールの第1の端部は第3の可動連結部材を具え、前記第2のウォールの第2の端部は第4の可動部材を具え、各連結部材は前記密閉型収縮部材に連結されるとともに、前記複数の取付ベース部材の1つに可動に連結された、複数の連結部材と、
前記密閉型収縮部材に流体結合され、当該密閉型収縮部材に減圧を送達可能な減圧接続器とを具え、
前記複数の取付ベース部材と複数の連結部材が、内側空間を規定する周囲ウォールを形成すべく結合しており、前記密閉型収縮部材は前記内部空間に配置され、
前記減圧接続器に減圧が送達された場合に、前記取付ベース部材を内側に引っ張って前記表面創傷に閉塞力を発生させる力が生じることを特徴とする腹部治療システム。 - 請求項30のシステムにおいて、前記複数の取付ベース部材は、前記密閉型収縮部材に連結されていることを特徴とする腹部治療システム。
- 請求項30のシステムにおいて、前記複数の取付ベース部材は、前記密閉型収縮部材に連結され、前記複数の連結部材は前記密閉型収縮部材に連結されていることを特徴とする腹部治療システム。
- 請求項30のシステムにおいて、前記減圧接続器は、少なくとも1の取付ベース部材に連結された減圧接続部材を少なくとも1以上具えることを特徴とする腹部治療システム。
- 請求項6のシステムにおいて、前記表面創傷閉塞サブシステムが、
閉ループへと形成可能な柔軟ストラップと、
前記柔軟ストラップに連結される複数のモジュール式閉塞部材とを具え、当該複数のモジュール式閉塞部材がそれぞれ、
前記表面創傷の縁部近くの前記患者表皮の一部に脱着可能に取り付けられ、ベースとウォールを具える取付部材と、
第1の端部と第2の端部を有する密閉型収縮部材であって、前記第2の端部が前記取付部材に連結され、減圧下におかれると収縮しうる密閉型収縮部材と、
前記密閉型収縮部材の第1の端部に連結され、選択的に前記柔軟ストラップに結合する連結部材と、
前記密閉型収縮部材に流体接続され前記密閉型収縮部材に減圧を送達する減圧接続器とを具え、
前記複数のモジュール式閉塞部材は、前記柔軟ストラップが前記表面創傷の周りで閉ループに形成されたときに閉塞力を生成可能であり、前記取付部材は前記表面創傷に近い患者表皮に脱着可能に取り付けられ、減圧が前記密閉型収縮部材に送達されることを特徴とする腹部治療システム。 - 腹部開腔の治療方法であって、
第1の面と、第2の内側対向面とを具える開腔部治療デバイスを、前記開腔部治療デバイスの第2の内側対向面を患者の腹腔に近接させた状態で前記腹部開腔に配置するステップと、
第1の面と第2の内側対向面とを具える深部組織閉塞デバイスを、前記深部組織閉塞デバイスの第2の内側対向面を前記開腔部治療デバイスの第1の面に近接させ、前記深部組織閉塞デバイスの第1の面を前記患者の腹膜に近接させて、前記腹部開腔に配置するステップと、
前記患者の腹腔内にマニホルドを配置するステップと、
前記患者の腹腔の上に気密を形成するステップと、
前記マニホルドに第1の減圧接続器を流体結合させるステップと、
表面創傷の縁部に近い患者の表皮の第1の部分に第1の取付部材を脱着可能に取り付けるステップと、
前記表面創傷の縁部に近い患者の表皮の第2の部分に第2の取付部材を脱着可能に取り付けるステップであって、前記第1の取付部材は前記第2の取付部材と離されているステップと、
前記第1の取付部材および第2の取付部材に連結され、減圧下で収縮しうる密閉型収縮部材を提供するステップと、
前記開腔部治療デバイス、前記深部組織閉塞デバイス、前記マニホルド、および前記密閉型収縮部材に減圧を供給するステップとを具えることを特徴とする方法。 - 患者の腹腔を治療するシステムの製造方法であって、
患者の腹腔に減圧治療を施すための開腔部治療デバイスを構成するステップと、
患者の腹膜上の深部組織創傷に閉塞力をかけるための深部組織閉塞デバイスを構成するステップと、
患者の表皮上の表面創傷に閉塞力をかけるための表面創傷閉塞サブシステムを構成するステップとを具えることを特徴とする方法。 - 請求項36の方法がさらに、
減圧供給サブシステムを提供するステップと、当該減圧供給サブシステムを前記開腔部治療デバイス、前記深部組織閉塞デバイス、および前記表面創傷閉塞サブシステムに流体接続するステップを具えることを特徴とする方法。 - 請求項36の方法において、前記開腔部治療デバイスを構成するステップが、
有窓部を有する非接着式ドレープを構成するステップと、
脚部マニホルド部材を有する内側部分を有するとともに、当該内側部分に流体が流れ込むのを可能にする有窓部が形成されている、複数のカプセル化された脚部材を構成するステップと、
前記複数のカプセル化された脚部材を前記非接着式ドレープに結合するステップと、
連結マニホルド部材を有する中央連結部材を構成するステップと、
前記中央連結部材を前記非接着式ドレープに、および前記複数のカプセル化された脚部材に結合するステップを具え、前記脚部マニホルド部材はそれぞれ前記連結マニホルド部材と流体接続していることを特徴とする方法。 - 請求項36の方法において、前記非接着式ドレープを構成するステップが、エラストマドレープを構成するステップと、前記エラストマドレープに有窓部を形成するステップと、前記エラストマドレープに、切断して様々なサイズにするための目に見える印を設けるステップとを具えることを特徴とする方法。
- 請求項36の方法において、前記深部組織閉塞デバイスを構成するステップが、
第1の面と第2の内側対向面とを有する収縮マトリクスを構成するステップであって、前記第1の面は複数の開口部が形成され、前記第2の内側対向面は複数のセルが形成されており、さらに複数のセル間開口部が形成され、前記収縮マトリクスは前記深部組織創傷の近くに配置されるステップと、
減圧を分配可能なマニホルド部材を設けるステップと、
患者の腹腔の上に気密を提供しうる密閉部材を設けるステップとを具えることを特徴とする方法。 - 請求項36の方法において、前記表面創傷閉塞サブシステムを構成するステップが、
表面創傷の縁部近くの患者の表皮の第1の部分を脱着可能に取り付ける第1の取付部材を構成するステップと、
前記表面創傷の縁部に近い患者の表皮の第2の部分に脱着可能に取り付ける第2の取付部材であって、前記第1の取付部材とは離れている第2の取付部材を構成するステップと、
前記第1の取付部材と第2の取付部材に連結され減圧下に置かれると収縮しうる密閉型収縮部材とを構成するステップとを具えることを特徴とする方法。 - 請求項36の方法において、前記表面創傷閉塞サブシステムを構成するステップが、
密閉型収縮部材を構成するステップと、
複数の取付ベース部材を構成するステップであって、各取付ベース部材が、ベースと、第1の端部および第2の端部を有する第1のウォールとを具え、前記第1のウォールの第1の端部は第1の可動連結部材を具え、前記第1のウォールの第2の端部が第2の可動連結部材を具え、各取付ベース部材は前記患者表皮の一部に脱着可能に取り付けられるとともに前記密閉型収縮部材に結合されている、ステップと、
複数の連結部材を構成するステップであって、各連結部材が、第1の端部および第2の端部を有する第2のウォールを具え、前記第2のウォールの第1の端部は第3の可動連結部材を具え、前記第2のウォールの第2の端部は第4の可動部材を具え、各連結部材は前記複数の取付ベース部材の1つに可動に連結されている、ステップと、
前記密閉型収縮部材に減圧を送達可能な減圧接続器を、前記密閉型収縮部材に流体結合するステップとを具え、
前記複数の取付ベース部材と複数の連結部材が、内側空間を規定する周囲ウォールを形成すべく結合しており、前記密閉型収縮部材は前記内部空間に配置されていることを特徴とする方法。 - 請求項36の方法において、前記表面創傷閉塞サブシステムを構成するステップが、
閉ループへと形成可能な柔軟ストラップを構成するステップと、
前記柔軟ストラップに連結される複数のモジュール式閉塞部材を設けるステップとを具え、当該ステップが、前記複数のモジュール式閉塞部材の各々について、
前記表面創傷の縁部近くの前記患者表皮の一部に脱着可能に取り付けられ、ベースとウォールが形成された取付部材を構成するステップと、
第1の端部と第2の端部を有し、減圧下におかれると収縮しうる密閉型収縮部材を構成するステップと、
前記密閉型収縮部材の第2の端部を前記取付部材に連結するステップと、
選択的に前記柔軟ストラップに結合する連結部材を構成するステップと、
前記連結部材を前記密閉型収縮部材の第1の端部に連結するステップと、
前記密閉型収縮部材に流体接続され前記密閉型収縮部材に減圧を送達する減圧接続器を構成するステップとを具えることを特徴とする方法。
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