JP7404251B2 - 中間優先曲げ区分を有する微細加工カテーテル - Google Patents
中間優先曲げ区分を有する微細加工カテーテル Download PDFInfo
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- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
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- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
- A61M25/0051—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids made from fenestrated or weakened tubing layer
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- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
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- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
- A61M25/0013—Weakening parts of a catheter tubing, e.g. by making cuts in the tube or reducing thickness of a layer at one point to adjust the flexibility
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- A61M25/00—Catheters; Hollow probes
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- A—HUMAN NECESSITIES
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- A61M25/00—Catheters; Hollow probes
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- A61M25/0043—Catheters; Hollow probes characterised by structural features
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- A61M25/0052—Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
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Description
[0001]本願は、どちらも「中間優先曲げ区分を有する微細加工カテーテル」(“Microfabricated Catheter having an Intermediate Preferred Bending Section”)と題された2019年2月20日出願の米国特許出願第16/281,046号及び2018年2月22日出願の米国仮特許出願第62/633,939号に対する優先権及びそれら出願の恩典を主張し、それら出願の全体をここに参考文献として援用する。
[0018]本開示は、大動脈起始部における効果的な位置決め及び目標とされる冠状動脈への効果的なアクセスを提供する特徴を有する介入的カテーテルデバイスに関する。実施形態の多くは大動脈起始部近傍に位置決めされるという特定の文脈で説明されるが、記載のデバイスはその様な用途のみに限定されないことを理解しておきたい。したがって、本明細書に記載のカテーテルデバイスは、デバイスの位置決め便益が好都合である他の用途に利用されることができる。
[0022]図1A及び図1Bは、大動脈起始部に到達するための実施可能な経血管進入法を描いている。図1Aは、カテーテル50が橈骨動脈18(典型的には右橈骨動脈)の中へ挿入され、対応する鎖骨下動脈の中へ通され、次いで大動脈弓12の中へ通されるという経橈骨動脈進入法を示している。大動脈弓12から、カテーテル50の遠位先端は更に上行大動脈14の中へ方向決めされ、大動脈起始部16へ向かわされる。図1Bは、カテーテル50が大腿動脈20の中へ挿入され、次いで逆行的に下行大動脈22の中へ通され、更に動脈弓12を周って大動脈起始部16に向けて方向決めされるという経大腿動脈進入法を描いている。これらは最も一般的な進入法であるが、他の進入法が利用されることもできる(例えば、経上腕動脈進入法)。利用される特定の進入法は、医師の選好、患者の解剖学的構造、処置上の必要性、などに依存するであろう。ここに説明されているカテーテルの実施形態は、大動脈起始部16への何れのその様な進入法についても利用できるであろう。
[0026]図3は、大動脈起始部に効果的に位置決めすることのできるカテーテル100の或る例示としての実施形態を描いている。描かれているカテーテル100は、近位区分102、中間区分104、及び遠位区分110を含んでいる。近位区分102は更に編上げ領域114と微細加工領域112へ分けられる。カテーテルに機械加工による段下げ部(machined-down step)(図示せず)を含み、段下げ部にて編上げをエポキシ又は他の適切な接着剤を使用してカテーテルへ結着させることによって、編上げ領域114が微細加工領域112へ結着されていてもよい。図示の様に、中間区分は更に近位側中間区分106と遠位側中間区分108へ分けられる。近位区分102の微細加工領域112は、デバイスの効果的なトルク性能及び押し出し性能にとって十分な強度を維持しながらも可撓性を提供する特徴を含んでいる。
A.桁構成(Beam Configuration)
[0036]以下に説明されている様々なパターンは、カテーテル100の異なる微細加工区分に利用されることができる。例えば、遠位区分110及び/又は近位区分102の微細加工領域112は、以下に説明されている微細加工特徴の1つ又はそれ以上を含んでいるのが望ましい。
[0047]幾つかの実施形態は、非螺旋及び非直線カットパターンから得られる分散型桁配列を有する区分を含むことができる。この型式のパターンは、優先される曲げ方向を効果的に排除する又は最小限にする。図6は、分散型パターンの1つの実施例を従来式螺旋パターンとグラフで比較している。図示されている様に、螺旋カットパターンは、セグメントからセグメントへの一定した回転オフセットを細長部材の長さに沿って適用している。分散型カットパターンは、螺旋パターンに頼ることなく曲げ軸を効果的に分散させる回転オフセットを適用している。
[0060]図7は、そうでなければ螺旋パターンになったはずのものを一連の意図的に設計された不完全さで以て故意に乱れさせることによって形成された非螺旋カットパターンの別の実施形態をグラフで描いている。この型式のカットパターンは、ここでは「不完全ランプ」パターンと呼称されている。不完全ランプパターンの故意の逸れは、有益なことに、真の螺旋状の配列に付きものの優先的捩じれ及び湾曲の名残を低減又は防止するように機能する。示されている様に、セグメントは、3つの連続した桁対又はセグメントがどれも同じ回転オフセットにしたがって離間されないように配列されている。別の言い方をすれば、3つの桁対又はセグメントで、円筒状細長部材を平面へ展開した場合に直線を形成するように配列されているものはないということだ。
[0065]図8は、ここでは「鋸歯」パターンと呼称されている非螺旋カットパターンの別の実施形態を描いている。ここに説明されている他の非螺旋カットパターンと同じく、鋸歯カットパターンは、優先される曲げ軸を回避すると共に螺旋パターンにつきものの優先される湾曲方向を制限することができるのが有益である。螺旋パターンとは対照的に、鋸歯カットパターンは回転オフセットの方向を周期的に逆転させることができる。
[0070]図9は、回転オフセット制限が適用されていない場合に生じ得る望ましからざる離間アーチファクトの一例を描いている。図9は、第1のセグメント750aと第2のセグメント750bを有する細長部材700の一区分を描いている。第1のセグメント750aは桁730aの第1の対(この図では一方の桁しか見えない)と、第1の対から90度だけオフセットされている桁730b及び730cの第2の対と、を含んでいる。第2のセグメント750bは、桁730d及び730eの第1の対と、第1の対から90度だけオフセットされている桁730f及び730gの第2の対と、を含んでいる。対内の各桁はその対応する桁から180度だけ周方向に離間されている。第2のセグメント750bは第1のセグメント750aから45度だけオフセットされており、それにより桁730d及び730eの第1の対は桁730aの第1の対から45度だけ外れた位置に置かれ、桁730f及び730gの第2の対は桁730b及び730cの第2の対から45度だけ外れた位置に置かれている。
[0073]図11Aから図11Cは、デバイスの1つ又はそれ以上の区分に含むことのできる「螺旋」カットパターンの諸実施形態を描いている。図11Aに示されている様に、デバイスの一区分170は、結果として得られる螺旋状に向きの付けられたコイル部材174の外側本体を提供するようにカットされていて、得られるコイルのピッチが開窓の大きさを画定する。典型的には、螺旋カットパターンは、1本桁パターンよりも低いトルク性能と高い可撓性をもたらすことができる。そういうものとして、殆どの用途では、螺旋区分は、トルク性能関連がとりわけ重要とされるデバイスのより近位の区分では有益性が低いが、可撓性関連がより重要になるより遠位の区分、特にデバイスの遠位端又は遠位端近傍では有益である。
14 上行大動脈
16 大動脈起始部
18 橈骨動脈
20 大腿動脈
22 下行大動脈
24 右冠状動脈
26 大動脈壁の冠状動脈に対向する点
50 カテーテル
52 遠位先端
54 曲がり
56 垂れ又は跳ねの運動の方向
100 カテーテル
102 近位区分
104 中間区分
106 近位側中間区分
108 遠位側中間区分
110 遠位区分
112 微細加工領域
114 編上げ領域
116 無外傷性遠位先端
170 区分
172 ブリッジ
174 コイル部材
180 螺旋カットパターン
184 コイル部材
190 区分
191 コイル部材間寸法
192 コイル部材
193 近位のコイル部材間寸法
194 コイル部材
195 カット幅
300 細長区分
302 軸方向に延びる桁
304 周方向に延びる輪
400 細長区分
402 桁
404 輪
500 細長区分
502 桁
504 輪
600 細長区分
602 桁
604 輪
700 細長部材
730a、730b、730c、730d、730e、730f、730g 桁
750a、750b セグメント
800 細長部材
830a、830b、830c、830d、830e、830f、830g 桁
850a、850b セグメント
900 細長部材
902 桁
904 輪
Claims (14)
- 介入的デバイスであって、当該介入的デバイスは、
近位端と遠位端の間を延びている細長部材を備えており、前記細長部材は、
微細加工領域の可撓性を高めるためのカット配列を有する前記微細加工領域を含んでいる、近位区分と、
遠位区分であって、当該遠位区分の可撓性を高めるためのカット配列を有する遠位区分の微細加工領域を含み、前記遠位区分の微細加工領域は、前記近位区分の前記微細加工領域よりも大きい可撓性を有している、遠位区分と、
前記近位区分から遠位方向に延びる近位側中間区分及び前記遠位区分から近位方向に延びる遠位側中間区分を有し、前記近位区分と前記遠位区分との間に位置する中間区分と、を含み、
前記近位側中間区分は、結果として得られる背骨を残すように、また1つの平面内で優先的屈曲させられるように、同じ側に配置されるカットを有する微細加工カット配列を含み、
前記遠位側中間区分は、前記近位側中間区分、前記近位区分の前記微細加工領域及び前記遠位区分の各々より剛性である、
介入的デバイス。 - 前記近位区分は編上げ領域を含んでいる、請求項1に記載のデバイス。
- 前記編上げ領域は前記微細加工領域の近位にある、請求項2に記載のデバイス。
- 前記微細加工領域のカット間の長手方向離間間隔は、前記中間区分に向かって漸進的に狭くなってゆく、請求項2または3に記載のデバイス。
- 前記遠位側中間区分は微細加工カットを省略している、請求項1から請求項4の何れか一項に記載のデバイス。
- 少なくとも前記遠位区分及び前記中間区分はストック材料の単一一体部片から形成されている、請求項1から請求項5の何れか一項に記載のデバイス。
- 前記ストック材料の単一一体部片は、更に、前記中間区分から近位方向に延びる前記近位区分の微細加工領域を含んでいる、請求項6に記載のデバイス。
- 外側のラミネート及び/又は内側のライナー、を更に備えている請求項1から請求項7の何れか一項に記載のデバイス。
- 前記外側のラミネート及び/又は前記内側のライナーは、無外傷性遠位先端を形成するように遠位方向に前記遠位区分を越えて延びている、請求項8に記載のデバイス。
- 前記中間区分は、大動脈起始部に設置するための大きさ及び形状に構成されていて、前記近位側中間区分は前記大動脈起始部の一方の壁にて曲がりを提供し、前記遠位側中間区分は前記大動脈起始部を横断して反対側の壁に向かって延びる、請求項1から請求項9の何れか一項に記載のデバイス。
- 大動脈起始部へ及び冠状動脈へ送られるように構成された介入的デバイスであって、当該介入的デバイスは、
近位端と遠位端の間を延びている細長部材を備えており、前記細長部材は、
微細加工領域及び前記微細加工領域の近位の編上げ領域を含む近位区分と、
長さを有する遠位端(116)と、長さを有する微細加工領域とを有する遠位区分であって、前記遠位端は前記微細加工領域の遠位に位置し、前記微細加工領域の前記長さが前記遠位端の前記長さより長い、前記遠位区分と、
前記近位区分から遠位方向に延びる近位側中間区分及び前記遠位区分から近位方向に延びる遠位側中間区分を有する中間区分と、を含み、
前記近位側中間区分は、結果として得られる背骨を残すように及び1つの平面内の優先的屈曲を可能にさせるように片側に配列されたカットを有する微細加工カット配列を含み、
前記遠位側中間区分は前記近位側中間区分及び前記遠位区分より剛性であり、
前記遠位側中間区分は2から4cmの長さを有し、前記遠位区分は1から3cmの長さを有する、
介入的デバイス。 - 少なくとも前記遠位区分及び前記中間区分はストック材料の単一一体部片から形成されている、請求項11に記載のデバイス。
- 前記ストック材料の単一一体部片は、更に、前記中間区分から近位方向に延びる前記近位区分の微細加工領域を含んでいる、請求項12に記載のデバイス。
- 前記近位側中間区分は1から3cmの長さを有する、請求項11に記載のデバイス。
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CA3089737A1 (en) | 2019-08-29 |
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JP2021514700A (ja) | 2021-06-17 |
KR20200123429A (ko) | 2020-10-29 |
CN111902183B (zh) | 2022-09-13 |
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CN111902183A (zh) | 2020-11-06 |
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