JP7381337B2 - 成形可能なポリマー先端部を有するガイドワイヤデバイス - Google Patents
成形可能なポリマー先端部を有するガイドワイヤデバイス Download PDFInfo
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- 229920000642 polymer Polymers 0.000 title description 9
- 239000000463 material Substances 0.000 claims description 37
- 239000011248 coating agent Substances 0.000 claims description 13
- 238000000576 coating method Methods 0.000 claims description 13
- 229910001220 stainless steel Inorganic materials 0.000 claims description 8
- 239000010935 stainless steel Substances 0.000 claims description 8
- 238000005452 bending Methods 0.000 claims description 6
- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 claims description 4
- 229910001000 nickel titanium Inorganic materials 0.000 claims description 4
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- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 7
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- KDLHZDBZIXYQEI-UHFFFAOYSA-N Palladium Chemical compound [Pd] KDLHZDBZIXYQEI-UHFFFAOYSA-N 0.000 description 2
- TZCXTZWJZNENPQ-UHFFFAOYSA-L barium sulfate Chemical compound [Ba+2].[O-]S([O-])(=O)=O TZCXTZWJZNENPQ-UHFFFAOYSA-L 0.000 description 2
- 229910052797 bismuth Inorganic materials 0.000 description 2
- JCXGWMGPZLAOME-UHFFFAOYSA-N bismuth atom Chemical compound [Bi] JCXGWMGPZLAOME-UHFFFAOYSA-N 0.000 description 2
- 239000000945 filler Substances 0.000 description 2
- NIXOWILDQLNWCW-UHFFFAOYSA-M Acrylate Chemical compound [O-]C(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-M 0.000 description 1
- 229910052692 Dysprosium Inorganic materials 0.000 description 1
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- BQCADISMDOOEFD-UHFFFAOYSA-N Silver Chemical compound [Ag] BQCADISMDOOEFD-UHFFFAOYSA-N 0.000 description 1
- 239000002318 adhesion promoter Substances 0.000 description 1
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- 229910052788 barium Inorganic materials 0.000 description 1
- DSAJWYNOEDNPEQ-UHFFFAOYSA-N barium atom Chemical compound [Ba] DSAJWYNOEDNPEQ-UHFFFAOYSA-N 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
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- KBQHZAAAGSGFKK-UHFFFAOYSA-N dysprosium atom Chemical compound [Dy] KBQHZAAAGSGFKK-UHFFFAOYSA-N 0.000 description 1
- 239000013013 elastic material Substances 0.000 description 1
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- 230000014509 gene expression Effects 0.000 description 1
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
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- SYQBFIAQOQZEGI-UHFFFAOYSA-N osmium atom Chemical compound [Os] SYQBFIAQOQZEGI-UHFFFAOYSA-N 0.000 description 1
- 229910052763 palladium Inorganic materials 0.000 description 1
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- WFKWXMTUELFFGS-UHFFFAOYSA-N tungsten Chemical compound [W] WFKWXMTUELFFGS-UHFFFAOYSA-N 0.000 description 1
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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
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- A61M25/00—Catheters; Hollow probes
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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- A61L31/022—Metals or alloys
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/18—Materials at least partially X-ray or laser opaque
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
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- A—HUMAN NECESSITIES
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- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09058—Basic structures of guide wires
- A61M2025/09083—Basic structures of guide wires having a coil around a core
- A61M2025/09091—Basic structures of guide wires having a coil around a core where a sheath surrounds the coil at the distal part
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09133—Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
-
- 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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09133—Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
- A61M2025/09141—Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque made of shape memory alloys which take a particular shape at a certain temperature
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/0915—Guide wires having features for changing the stiffness
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09166—Guide wires having radio-opaque features
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09175—Guide wires having specific characteristics at the distal tip
-
- 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
- A61M2210/00—Anatomical parts of the body
- A61M2210/12—Blood circulatory system
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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
- 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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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Vascular Medicine (AREA)
- Surgery (AREA)
- Epidemiology (AREA)
- Hematology (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Inorganic Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Physics & Mathematics (AREA)
- Optics & Photonics (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Description
[0001]本出願は、「GUIDEWIRE DEVICES HAVING SHAPEABLE POLYMER TIPS」と題される、2017年6月1日に出願された米国特許出願第15/611,344号、および「GUIDEWIRE DEVICES HAVING SHAPEABLE TIPS」と題される、2016年7月18日に出願された米国仮特許出願第62/363,760号の優先権および利益を主張するものである。上で言及したすべての出願はその全体が参照により本明細書に組み込まれる。
[0018]本開示は、有効な解剖学的ナビゲーション能力(anatomical navigation capability)を提供するガイドワイヤデバイスに関連する。ガイドワイヤを操作して標的の解剖学的ロケーションまで移動させる能力は、トルク伝達性と成形先端部を維持するための能力との間のバランスを維持しながらそれらの間のトレードオフを最適化することに依存する。ガイドワイヤデバイスが、手術者が遠位側先端部を回転させることにより先端部を脈管構造内の所望の方向に向けるのを可能にするための成形可能な先端部を有することができる。しかし、このようなガイドワイヤデバイスのトルク伝達性が不十分である場合、成形遠位側先端部の向きを制御するために手術者がねじり力を常に成形遠位側先端部まで伝達することが不可能となる。このような障害は、脈管構造の中へとさらにガイドワイヤデバイスが前進させられてより大きい摩擦抵抗を受けるときにその問題性が増大する。加えて、ガイドワイヤデバイスが成形先端部を適切に形成および維持することができない場合、先端部の向きを調節するためのガイドワイヤデバイスの能力を制限することになり、脈管構造内でのナビゲーションがより困難なものとなる。
成形可能な先端部を有するガイドワイヤデバイス
[0021]図1Aおよび1Bが、有効な成形可能な先端部を有する例示のガイドワイヤデバイス100を示す。図1Aがデバイスの側面図を示し、図1Bがデバイスの断面図を示す。ガイドワイヤデバイス100がコア102を有する。チューブ104がコア102に結合され、コア102に取り付けられるポイントから遠位側に延在する。示されるように、コア102の遠位側セクションがチューブ104の中まで延在し、チューブ104によって囲まれる。いくつかの実施形態では、コア102が1つまたは複数のテーパ状セクションを有し、その結果、コア102がチューブ104の中に嵌合されてチューブ104の中まで延在することができる。例えば、コア102の遠位側セクションが、漸進的に先細となり遠位端のところでより小さい直径となるように研削され得る。この実施例では、コア102およびチューブ104が取り付けポイント103のところで実質的に同等の外径を有し、取り付けポイント103のところでコア102およびチューブ104が互いに隣接して取り付けられる。
切欠部パターン
[0042]図3から8が、本明細書で説明されるガイドワイヤデバイスの実施形態うちの1つまたは複数の実施形態で利用され得るチューブ切欠部パターンの例示の実施形態を示す。例えば、図1および2に示される実施形態のチューブ104が、図3から8に示される構成のうちの1つまたは複数の構成に従って切削され得る。
先端部の変形形態
[0053]図9から11が、本明細書で説明される実施形態のうちの1つまたは複数の実施形態と共に利用され得る種々の遠位側先端部の構成の実施形態を示す。図9が連続的な直径の先端部構成を示す。ここでは、テーパ状のコア902を囲むコイル918が実質的に連続的な直径を有する。図10が段のある先端部構成を示し、ここでは、コア1002の上に位置決めされる外側コイル1018が実質的に連続的な直径を有する。より小さい直径の内側コイル1014が、先端部の階段状に変化する直径を提供するように、外側コイル1018よりさらに遠位側に延在するように位置決めされる。図11がテーパ状の先端部構成を示しており、ここでは、コイル1118がコア1102の少なくとも一部分のテーパ部分に適合するように先細となる。図9から11に示される先端部の実施形態が、本明細書で説明されるガイドワイヤデバイスの実施形態のうちの任意の実施形態と組み合わされ得る。例えば、所望の先端部構成が、所与のガイドワイヤの用途のための所望の成形可能性特性および/または可撓性特性を提供するように選択され得る。
Claims (19)
- 成形可能な先端部を有するガイドワイヤデバイスであって、前記ガイドワイヤデバイスが、
近位側セクションおよび遠位側セクションを有するコアであって、前記遠位側セクションが前記近位側セクションより小さい直径を有し、前記遠位側セクションに、成形可能な先端部を形成する、コアと、
前記コアに結合され、近位端と遠位端とを有するチューブ構造であって、前記チューブ構造の長さは、前記コアの前記遠位側セクションが前記チューブ構造の中を通過し、前記成形可能な先端部が前記チューブ構造を越えて遠位側に位置するような長さである、チューブ構造と、
前記成形可能な先端部の少なくとも一部分を包囲するポリマー被覆物と
を備え、
前記コアの前記遠位側セクションは、前記コアの前記近位側セクションから先細にテーパして、前記コアがテーパ部分を有し、
前記チューブ構造の近位端が、前記コアの前記テーパ部分の近位端に取り付けられ、前記コアの前記テーパ部分の近位端と一致している、
ガイドワイヤデバイス。 - 前記チューブ構造の近位端が、前記コアの前記テーパ部分の近位端に取り付けられた地点において、前記チューブ構造の近位端と前記テーパ部分の近位端とが同じ外径を有する、請求項1に記載のガイドワイヤデバイス。
- 前記成形可能な先端部が、0.5cmから5cm、または1cmから3cmの距離で前記チューブ構造を越えて遠位側へと延在する、請求項1に記載のガイドワイヤデバイス。
- 部分的に前記チューブ構造内に配設され、部分的に前記チューブ構造を越えて遠位側へと延在するコイルをさらに備える、請求項1に記載のガイドワイヤデバイス。
- 前記チューブ構造を越えて遠位側へと延在する前記コイルの前記一部分が前記ポリマー被覆物によって包囲される、請求項4に記載のガイドワイヤデバイス。
- 前記チューブ構造内に配設される前記コイルの前記一部分が前記コアを包囲し、前記コアの外側表面と前記チューブ構造の内側表面との間に位置決めされる、請求項4に記載のガイドワイヤデバイス。
- 前記コイルが前記コアと前記チューブ構造との間の空間の中を満たすようにサイズおよび形状を構成され、その結果、前記チューブ構造の湾曲時に前記チューブ構造の湾曲部分が前記コアの一致する部分の湾曲部分に位置合わせされる、請求項4に記載のガイドワイヤデバイス。
- 前記コイルがX線不透過材料から形成される、請求項4に記載のガイドワイヤデバイス。
- 前記チューブ構造がニチノールから形成される、請求項1に記載のガイドワイヤデバイス。
- 前記コアがステンレス鋼から形成される、請求項1に記載のガイドワイヤデバイス。
- 前記ポリマー被覆物がX線不透過材料を含む、請求項1に記載のガイドワイヤデバイス。
- 前記チューブ構造の遠位端に結合されて前記チューブ構造から遠位側へ延在する編組材料をさらに備える、請求項1に記載のガイドワイヤデバイス。
- 前記編組材料が前記ポリマー被覆物内に埋設される、請求項12に記載のガイドワイヤデバイス。
- 前記チューブ構造が、円周方向に延在する複数のリングを結合する軸方向に延在する複数のビームを画定する複数の窓を有する、請求項1に記載のガイドワイヤデバイス。
- 前記複数の窓が、ワンビーム切欠部パターン、ツービーム切欠部パターン、またはスリービーム切欠部パターン、のうちの1つまたは複数の切欠部パターンとなるように構成される、請求項14に記載のガイドワイヤデバイス。
- 前記窓が、前記チューブ構造の長さ方向に沿う連続する各セグメントを1つ前のセグメントから円周方向に回転させるような回転方向のオフセットを有する切欠部パターンを画定する、請求項14に記載のガイドワイヤデバイス。
- 前記窓が、前記チューブ構造の遠位端に向かって増大する深さを有する切欠部を有する、および/または前記チューブ構造の遠位端に向かって縮小する連続する切欠部の間の間隔を有する、切欠部パターンを画定する、請求項14に記載のガイドワイヤデバイス。
- 成形可能な先端部を有するガイドワイヤデバイスであって、前記ガイドワイヤデバイスが、
近位側セクションおよび遠位側セクションを有するコアであって、前記遠位側セクションが前記近位側セクションより小さい直径を有し、前記遠位側セクションに、成形可能な先端部を形成する、コアと、
前記コアに結合され、近位端と遠位端とを有するチューブ構造であって、前記チューブ構造の長さは、前記コアの前記遠位側セクションが前記チューブ構造の中を通過し、前記成形可能な先端部が前記チューブ構造を遠位側に越えて位置するような長さであり、前記チューブ構造が、軸方向に延在する複数のビームと、円周方向に延在する複数のリングとを画定する複数の窓を有する、チューブ構造と、
前記コアの前記遠位側セクションの少なくとも一部分を包囲するコイルであって、前記コイルの一部分が、前記コアの外側表面と前記チューブ構造の内側表面との間に配設され、前記コイルの一部分が、前記成形可能な先端部の少なくとも一部分を包囲するように前記チューブ構造を越えて遠位側へと延在する、コイルと、
前記チューブ構造の遠位端に結合され、前記チューブ構造から遠位側へと延在するポリマー被覆物であって、前記ポリマー被覆物が、前記チューブ構造を越えて遠位側へと延在する前記コイルの前記一部分を包囲する、ポリマー被覆物と、
を備え、
前記コアの前記遠位側セクションは、前記コアの前記近位側セクションから先細にテーパして、前記コアがテーパ部分を有し、
前記チューブ構造の近位端が、前記コアの前記テーパ部分の近位端に取り付けられ、前記コアの前記テーパ部分の近位端と一致している、
ガイドワイヤデバイス。 - 前記ポリマー被覆物内に埋設されて前記チューブ構造の前記遠位端に取り付けられる編組材料をさらに備える、請求項18に記載のガイドワイヤデバイス。
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