JPWO2019188916A1 - 医療デバイス及び処置方法 - Google Patents
医療デバイス及び処置方法 Download PDFInfo
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Abstract
Description
図1に示すように、本実施形態の医療デバイス10は、長尺なシャフト部20と、シャフト部20の先端部に設けられる拡張体21と、シャフト部20の基端部に設けられる操作部23とを有している。拡張体21には、前述の維持処置を行うための維持処置要素(エネルギー伝達要素)22が設けられる。
医療デバイス10を使用した処置方法について説明する。本実施形態の処置方法は、一例として、心不全(左心不全)に罹患した患者に対して行われる。より具体的には、図7に示すように、心臓Hの左心室の心筋が肥大化してスティッフネス(硬さ)が増すことで、左心房HLaの血圧が高まる慢性心不全に罹患した患者に対して行われる処置の方法である。
次に、第2の実施形態の医療デバイス15について説明する。本実施形態の医療デバイス15は、拡張体100以外の構成については、第1の実施形態と同じであり、共通部分については説明を省略する。図13に示すように、拡張体100は、周方向に複数の線材を有し、この線材は、基端側拡張部106と先端側拡張部107及び可動部103を有している。拡張体100は、軸方向の中央部に凹状部104を有している。凹状部104は、基端側把持部102a及び先端側把持部102bを有する把持部102と、把持部102間に設けられる可動部103とで形成されている。例えば、可動部103には、把持部102より大径状で、把持部102より曲げ強度が大きい曲がり部105が設けられている。このため、拡張体100は、把持部102が大きく開口し、可動部103が牽引シャフト33から収納シース30の外径方向に離れるように形状付けされている。
本実施形態の医療デバイス15を使用した処置方法について説明する。図15に示すように、本実施形態の処置方法は、心房中隔HAに貫通孔Hhを形成するステップ(S2−1)と、貫通孔Hhに拡張体100を配置するステップ(S2−2)と、拡張体100によって貫通孔Hhの径を拡張させるステップ(S2−3)と、拡張体100によって心房中隔HAを把持するステップ(S2−4)と、を有する。ここで、S2−1〜S2−2のステップは、第1の実施形態におけるS1−1〜S1−2のステップと同様であるので、説明を省略する。
把持部を開閉させる可動部は様々な形態とすることができる。曲がり部54における曲げ強度を小さくするための形状として、第1の実施形態では把持部51より細径状としている。この他にも、図16(a)に示すように、スリット部54aを設けることができる。また、図16(b)に示すように、切欠き部54bを設けることができる。また、図16(c)に示すように、複数の小孔部54cを設けることができる。また、図16(d)に示すように、スリット部54aと切欠き部54bを両方設けることができる。また、図16(e)に示すように、周囲より柔らかい材料で形成された軟質部54dを設けることができる。また、周囲よりも厚みを薄くした部分を設けることで、可動部を形成することができる。
拡張体は、基端側と先端側とで分離していてもよい。図19に示すように、この拡張体140は、基端側拡張部141と先端側拡張部143との2つの独立した部材を有している。基端側拡張部141は基端側把持部142を有し、先端側拡張部143は先端側把持部144を有している。基端側拡張部141と先端側拡張部143は、ワイヤ等の連結部145によって連結されている。この場合に、図中矢印で示すように、牽引シャフト33を基端側に移動させることで、先端側拡張部143は基端側に移動し、先端側把持部144と基端側把持部142との距離が小さくなる。これによって、先端側把持部144と基端側把持部142とで生体組織を把持することができる。
上述の実施形態では、拡張体21を拡張させる際に、まず先端側を拡張させ、その後に基端側を拡張させて心房中隔HAを把持する。これに対し、拡張体21の基端側を先に拡張させ、その後に先端側を拡張させて心房中隔HAを把持することもできる。この場合、図23(a)に示すように、拡張体21のうち、凹状部53のやや先端側を貫通孔Hh内に位置させた状態で、収納シース30を基端側に移動させ、拡張体21の全体を露出させる。これにより、拡張体21の凹状部53より先端側の部分は、貫通孔Hhにより拡張が抑えられ、拡張体21の凹状部53より基端側の部分は、径方向に拡張した状態となる。
11 ガイドワイヤ
20 シャフト部
21 拡張体
22 維持処置要素
23 操作部
30 収納シース
31 アウターシャフト
32 インナーシャフト
33 牽引シャフト
35 先端部材
40 筐体
41 操作ダイヤル
42 変換機構
51 把持部
52 可動部
53 凹状部
54 曲がり部
56 基端側拡張部
57 先端側拡張部
100 拡張体
102 把持部
103 可動部
104 凹状部
105 曲がり部
106 基端側拡張部
107 先端側拡張部
110 拡張体
111 把持部
112 可動部
115 拡張体
116 把持部
117 可動部
118 ヒンジ部
120 拡張体
121 把持部
122 平行移動部
123 延出部
124 スライド保持部
125 拡張体
126 平行移動部
127 把持部
128 弾性体
130 拡張体
131 平行移動部
132 把持部
133 移動用バルーン
140 拡張体
141 基端側拡張部
142 基端側把持部
143 先端側拡張部
144 先端側把持部
145 連結部
150 バルーン
151 高コンプライアンス部
152 低コンプライアンス部
153 把持部
160 バルーン
161 基端側拡張部
162 基端側把持部
163 先端側拡張部
164 先端側把持部
170 基端側拡張部
171 基端側把持部
172 バルーン
173 高コンプライアンス部
174 低コンプライアンス部
175 先端側把持部
200 穿刺デバイス
210 イントロデューサ
211 ガイディングシース
212 ダイレータ
220 血行動態確認用デバイス
Claims (12)
- 長尺なシャフト部と、
前記シャフト部の先端部に設けられ径方向に拡縮可能な拡張体と、を有し、
前記拡張体は、生体組織を把持する基端側把持部及び先端側把持部を有する把持部と、該把持部を把持方向に開閉させる可動部と、を有する医療デバイス。 - 前記可動部は両側の前記把持部の間に設けられ、前記把持部を扇状に開閉させる請求項1に記載の医療デバイス。
- 前記可動部は、前記把持部と曲げ強度が異なる曲がり部である請求項2に記載の医療デバイス。
- 前記可動部は、前記把持部を互いに回動可能とする回転軸部を有する請求項2に記載の医療デバイス。
- 前記可動部は、対向する前記把持部の少なくとも一方を軸方向に沿って移動させる平行移動部を有する請求項1に記載の医療デバイス。
- 前記シャフト部は、前記拡張体に接続され、前記拡張体の先端部を前記拡張体の基端部に対して軸方向に移動させる牽引シャフトを有する請求項1〜5のいずれか1項に記載の医療デバイス。
- 前記牽引シャフトにより前記拡張体の先端部が基端部側に移動することで、前記把持部が拡張方向に移動する請求項6に記載の医療デバイス。
- 前記牽引シャフトにより前記拡張体の先端部が基端部側に移動することで、前記把持部が把持方向に閉じる請求項6に記載の医療デバイス。
- 前記把持部を開いた状態に維持する規制要素を有し、該規制要素を解除することで、前記把持部が把持方向に閉じる請求項1〜8のいずれか1項に記載の医療デバイス。
- 前記把持部は、生体組織に対して維持処置を行う維持処置要素を有する請求項1〜9のいずれか1項に記載の医療デバイス。
- 径方向に拡縮可能な拡張体を有する医療デバイスを用いて、生体組織の貫通孔を拡張させる処置方法であって、
前記拡張体が有する把持部を生体組織の貫通孔に位置決めするステップと、
前記把持部により生体組織を前記貫通孔の両側から把持するステップと、
前記拡張体を拡張させて前記貫通孔の径を大きくするステップと、
前記把持部が有する維持処置要素により維持処置を行うステップと、
を有する処置方法。 - 前記把持部により生体組織を把持するステップは、前記拡張体を拡張させて前記貫通孔の径を大きくするステップの前、または後、あるいは同時に行われる請求項11に記載の処置方法。
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