JP6561044B2 - 弁搬送ツール - Google Patents
弁搬送ツール Download PDFInfo
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- JP6561044B2 JP6561044B2 JP2016512087A JP2016512087A JP6561044B2 JP 6561044 B2 JP6561044 B2 JP 6561044B2 JP 2016512087 A JP2016512087 A JP 2016512087A JP 2016512087 A JP2016512087 A JP 2016512087A JP 6561044 B2 JP6561044 B2 JP 6561044B2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/9522—Means for mounting a stent or stent-graft onto or into a placement instrument
- A61F2/9525—Means for mounting a stent or stent-graft onto or into a placement instrument using a funnel
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/243—Deployment by mechanical expansion
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2439—Expansion controlled by filaments
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2496—Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/9522—Means for mounting a stent or stent-graft onto or into a placement instrument
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
- A61F2250/0007—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting length
Description
本出願は、2013年5月3日出願の米国特許仮出願第61/819,488号、2013年5月3日出願の米国特許仮出願第61/819,492号、2013年5月3日出願の米国特許仮出願第61/819,490号、及び2014年1月23日出願の米国特許仮出願第61/930,905号の利益を主張するものであり、これらの各々は、これによりそれが本明細書に提示する開示に反しない範囲に対してその全体が引用によって本明細書に組み込まれる。
一部の実施形態において、搬送ツールは、側面装着ホルダを含む。
本明細書に説明する搬送ツールの一部の実施形態は、使いやすい。
一部の実施形態において、本明細書に説明するツールは、外科医が患者の環帯での弁の着座を可視化することを可能にする。
図1〜2を参照すると、ホルダ100と医療デバイス20とを含むシステム500が示されている。医療デバイス20は、自己拡張式フレーム24を有する。医療デバイス20は、被験者の弁に埋め込むように構成することができる。実施形態において、医療デバイス20は、無縫合外科用心臓弁のような補綴心臓弁である。ホルダ100は、収縮構成で埋込可能医療デバイスのフレーム24を保持し、かつフレームの拡張を制御するように構成される。図1A(側面図)及び2A(上面図)では、フレーム24は収縮構成にあり、図1B(側面図)及び2B(上面図)では、フレーム24は拡張構成にある。
患者の心臓弁に補綴心臓弁を搬送するように有利に使用することができるホルダ及び搬送システムの特定の実施形態を説明する前に、心臓弁デバイス構成要素及び心臓弁生体構造の概要を図10〜19に関して提供する。
弁交換システムのためのホルダ及び搬送システムの様々な実施形態を以下に説明する。一部の実施形態において、ホルダ及び搬送システムは、多くの場合、弁搬送システム、特に無縫合人工弁を搬送するための搬送システムに関連付けられた不正確な配置又は不十分な可視化に対する解決法を提供する。
以下で提供するのは、三脚ホルダ及びラチェット式搬送システム実施形態の追加の考察である。以下に提示する一部の実施形態は、上述したものと同じか又はこれらに類似している場合がある。
多くの延長部を使用して流出レール又はタブに取り付ける1つと、プラスチックスリーブ又はバンドで流出レール及びタブを締める別のものとを含む三脚以外のホルダのバージョンを考えている。その例は、2013年5月3日出願の「外科用心臓弁及び関連の装置、システム、及び方法」という名称の米国特許仮出願第61/819,488号明細書の図A16〜A17に示されており、上述のように、この特許出願は、それが本明細書に提示する開示に反しない範囲で引用によって本明細書に組み込まれている。
例示目的のために、本明細書に説明するホルダ及び搬送システムの様々な実施形態を使用することができるMedtronic,Inc.のEnable II弁のような人工弁デバイスを埋め込むための手順にここに説明する。患者の自然リーフレットの除去及び自然環帯の創面切除の後に、外科医は、典型的には、自然環帯をサイズ決定し、適切な交換弁システムを選択する。次に、ホルダ及びコードを有する交換弁システムは、これらのパッケージから取り外されて氷浴中に置かれる。次に、ホルダ/弁は、典型的には、搬送システムシャフトに結合又は接続される。次に、人工弁は、使い捨てクリンパー又は内蔵型縫合糸のいずれかを使用してクリンピングされることになる。これに代えて、人工弁は、搬送システムに取り付ける前にクリンピングすることができる。クリンピングされた人工弁は、患者内に位置決めされて自然弁環帯のレベルまで下げることになり、温生理食塩水は、人工弁の上に噴霧されることになる。人工弁の上側流入は、張力を受けて周方向ループによりクリンピングされたままになる。人工弁は回転することになるので、タブは自然リーフレット交連と位置合わせされ、搬送システム作動要素を作動させてループにかかる張力を解除することになる。次に、外科医は、搬送システム及びホルダを外科用空洞から摺動して落として人工弁の位置決めを点検することになる。位置決めが正しくなかった場合に、外科医は、搬送システムを摺動させて人工弁に戻し、搬送システム上の作動要素を作動させ、人工弁は、張力を受けたループを通じてクリンピングされることになり、再位置決めすることができる。再位置決めが終了した後に、人工弁は、配備システムを通じてここでもまた配備されることになり、位置決めを確認することになる。人工弁配備工程を終了するために、コードは、搬送システムが外科用空洞から引っ張り出される時に切断されることになる。次に、縫合残余物は、個々に人工弁から取り出されて埋め込みを達成することになる。
一部の実施形態において、搬送システムは、少なくとも3つの機能を実施する。第1に、ホルダのアダプタ及びコードと接続することができる。第2に、軸線方向にコードを張力付与することによって人工弁の上側流入カフのような人工弁の少なくとも一部分をクリンピングすることができる。第3に、人工弁の部分が拡張すること及びホルダが摺動して弁から戻ることを可能にするコードにかかる張力を全て又は実質的に全て解除することができる。
一部の実施形態において、1つ又はそれよりも多くのコードにかかる張力を制御するための1つ又はそれよりも多くの作動要素は、搬送ツールのハンドルから離れて位置決めすることができる。そのような実施形態は、一方の手の使用が人工弁を位置付けることを可能にし、別の手の使用が1つ又はそれよりも多くのコードにかかる張力を通じて収縮又は拡張を制御することを可能にし、又は2人の人が異なる態様を実施することを可能にする。
一部の外科医は、あらゆる与えられた患者に応じてハンドルのシャフト長さに関して異なる好みを有する場合がある。従って、本明細書に説明する搬送ツールのシャフトは、あらゆる適切な長さを有することができ又は調節可能にすることができる。例えば、ロック/アンロックスイッチを使用する調節可能な長さのシャフトの実施形態は、2013年5月3日出願の「外科用心臓弁及び関連の装置、システム、及び方法」という名称の米国特許仮出願第61/819,488号明細書の図A51に示してこれに関して考察されており、上述のように、この特許出願は、それが本明細書に提示する開示に反しない範囲で引用によって本明細書に組み込まれている。
人工弁を適正に埋込んだ後にコードを切断する1つの方法は、ユーザにハサミを取らせてコードを切断することである。別の方法は、コードを自動的に切断させることである。これは、搬送システムハンドルで、シャフトで、ホルダ内で、その他で行うことができる。本明細書で考えているアイデアの一部は、鋭いディスクの回転、鋭い刃先の軸線方向移動を含み、又は多くの外科用弁に対して行われるようにホルダ上に隆起切断点を有することである。1つのバージョンでは、コードの一端(2つのアームがホルダ、シャフト又は搬送システムを通じて与えられる実施形態において)は、ホルダシャフト、又は搬送システム、その他に固定されたままになり、コードを搬送システムハンドルで引っ張り出すことを可能にする。第2の企図は、搬送システムが取り外された後に弁の回りにコードを残すことになり、コードの各々を個々に引っ張り出すことを可能にする。第3の企図は、コードの各々に搬送システムによって区分的に弁から自動的に引っ張らせることになる。
この節で提供する考察は、一般的に、人工弁の縦軸線から延長部がオフセットされたホルダに関する。しかし、この節で提示する考察の一部は、本明細書に説明するあらゆるホルダ又は搬送システムに適用することができることは理解されるであろう(例えば、クリンプ制限器、迅速接続、ハンドル及び作動要素構成、埋め込み手順、その他に関する以下の考察)。
この節に説明する搬送システムの実施形態は、14mmよりも大きくない直径まで弁を縮小することができる。弁は、ネジ付きホルダを通じて搬送ツールに接続されるが、スナップ式及び/又は他の機構も考えている。次に、クラムシェル漏斗は、搬送ツールのシースの端部上に組み立てられ、シースは、人工弁(弁が固定される)の上を前進する。これは、ラック上のサムホイールを通じて達成される。そのようなホイール/つまみの様々な歯車比及び向きにより、原型が製造されている。スカートをシースの中に引き込む前に、シースをスピンしてシース交連マーカを弁スカートの交連マーカと位置合わせすることができる。弁を完全に覆った後に、漏斗を搬送ツールから引っ張って取る。弁は、装填する前に冷やすことができるが、弁に応じてそれは必須ではない。
クリンピング
弁の初期クリンプの目的は、大動脈弁のような自然弁に至るまで容易に並進し、依然としてユーザ可視化を可能にするほど十分に小さい直径にその全体の弁を縮小することである。この臨海クリンプ直径は、典型的には、自然弁環帯サイズよりも小さい4mmである。従って19mmの場合に、弁は、約15mmまで最小にクリンピングされなければならない。弁が「ニチノール」で形成された構成要素を有する場合に、弁は、クリンピング前に冷やすべきであるので、弁は、小径形状を保持することができる。弁のクリンピングは、弁が取り付けられ又は搬送システムから脱離される間に行うことができる。弁が搬送システムに取り付けられる場合に、例えば、漏斗を人工弁にわたって簡単に引っ張ることができるので、クリンピング漏斗を通じて弁を押すガイドは必要ないが、ガイドは、クリンピングを均一に保つという目的に機能する。
1)個別の無菌食塩水浴3X中で弁を濯ぎ(30秒各々)、
2)約5℃無菌食塩水氷浴中で弁を冷やし(30秒)、
3)スネアで収集縫合糸を集め、搬送システムハンドルの後側を通じて収集縫合糸を引っ張り、
4)弁を円錐低減器に置き、弁タブを低減器スロットと位置合わせし、
5)弁ドライバを円錐低減器に置き、3つのドライバ突起を低減器スロットと位置合わせさし、
6)過剰の収集縫合糸を集め(実施形態において、弁を収集縫合糸によって円錐低減器の中に引き込まないことが重要であると考えられる)、
7)弁ドライバが完全に進むまで弁を進め、
8)過剰の収集縫合糸を集め、搬送システムハンドル上のロックボタンを押し、
9)弁ドライバを円錐低減器から取り外し、
10)円錐低減器のドアを開き、搬送システム円錐に弁を有する搬送システムを取り外し、
11)搬送システム円錐に弁を手動で着座させ、かつ
12)搬送システムハンドル上のアンロックボタンを押し、過剰の収集縫合糸を集め、終了する時に搬送システムハンドル上のロックボタンを押す。
1)10秒の間温生理食塩水浴(約37℃)中に弁を置き、弁を拡張させ、
2)円錐低減器に搬送システムの搬送円錐を置き、ドアを閉じ、かつラッチが係合することを確認し、
3)約5℃無菌食塩水氷浴中で弁を冷やし(30秒)、
4)スネアで収集縫合糸を集め、搬送システムハンドルの後側を通じて収集縫合糸を引っ張り、
5)弁を円錐低減器に置き、弁タブを低減器スロットと位置合わせし、
6)弁ドライバを円錐低減器に置き、3つのドライバ突起を低減器スロットと位置合わせし、
7)過剰の収集縫合糸を集め(実施形態において、弁を収集縫合糸によって円錐低減器の中に引き込まないことが重要である場合がある)、
8)弁ドライバが完全に進むまで弁を進め、
9)過剰の収集縫合糸を集め、搬送システムハンドル上のロックボタンを押し、
10)弁ドライバを円錐低減器から取り外し、
11)円錐低減器のドアを開き、搬送システム円錐において弁を有する搬送システムを取り外し、
12)搬送システム円錐に弁を手動で着座させ、かつ
13)搬送システムハンドル上のアンロックボタンを押し、過剰の収集縫合糸を集め、終了する時に搬送システムハンドル上のロックボタンを押す。
無縫合大動脈弁埋め込み手順のために正確な弁サイズ決定を容易にする様々な大動脈弁サイザーの器具が本明細書に開示されている。
削除の工程によって外科医が補綴具サイズを選択することを可能にする図49の続行/中止サイザー1040が考えられている。サイザーは、サイザーよりも小さい直径の遠位端部分とサイザーのサイズの近位端部分とを有する。例示によって及びサイズ23mmのサイザーに対して、サイザーの遠位端は、22mmの直径を有することができ、近位端は、23mmの直径を有することができる。同様に、25mmのサイザーに対して、サイザーの遠位端は24mmの直径を有することができ、近位端は26mmの直径を有することができる。
人工弁を搬送するのに使用することができる搬送システムの一部の追加の実施形態を以下に提供する。
本明細書に使用する全ての科学的及び技術的用語は、別に定めない限り、一般的に当業技術に使用する意味を有する。本明細書で提供する定義は、本明細書で頻繁に使用する特定の用語の理解を容易にするためであり、本発明の開示の範囲を制限するようにはなっていない。
デバイス、システム、及び方法のいくつかの実施形態を本明細書に説明している。上述の一部の実施形態の一部の態様の要約を以下に提示する。
Claims (22)
- システムであって、
被験者の弁を交換するための医療デバイスであって、前記埋込可能医療デバイスが自己拡張式フレームを有する前記医療デバイスと、
収縮構成に前記埋込可能医療デバイスの前記自己拡張式フレームを保持し、かつ前記自己拡張式フレームの拡張を制御するように構成されたホルダと、を含み、
前記ホルダは、制御可能に収縮可能かつ拡張可能な第1のループを含み、前記第1のループは、前記第1のループの収縮又は拡張が前記自己拡張式フレームの収縮又は拡張を制御するように前記自己拡張式フレームの少なくとも一部分の回りに円周方向に配置され、 前記自己拡張式フレームは、流入領域を含み、
前記流入領域は、上側部分及び下側部分を含み、
前記第1のループは、前記第1のループの収縮又は拡張が前記自己拡張式フレームの前記流入領域の前記上側部分の収縮又は拡張を制御するように、前記自己拡張式フレームの前記流入領域の前記上側部分の少なくとも一部分の回りに配置され、
前記ホルダは、制御可能に収縮可能かつ拡張可能な第2のループを含み、
前記第2のループは、前記第2のループの収縮又は拡張が前記自己拡張式フレームの前記流入領域の前記下側部分の収縮又は拡張を制御するように、前記自己拡張式フレームの前記流入領域の前記下側部分の少なくとも一部分の回りに配置され、
前記自己拡張式フレームは、流出領域を含み、
前記ホルダは、制御可能に収縮可能かつ拡張可能な第3のループを含み、
前記第3のループは、前記第3のループの収縮又は拡張が前記自己拡張式フレームの前記流出領域の少なくとも一部分の収縮又は拡張を制御するように、前記自己拡張式フレームの前記流出領域の少なくとも一部分の回りに配置され、
前記第1のループは、第1のコードの一部分であり、前記第2のループは、第2のコードの一部分であり、前記第3のループは、第3のコードの一部分であり、
前記ホルダは、第1の開口部と、第2の開口部と、前記第1及び第2の開口部の間の導管とを有する第1の延長部材を含み、
前記ホルダは、第1の開口部と、第2の開口部と、前記第1及び第2の開口部の間の導管とを有する第2の延長部材を含み、
前記第1のコードの一部分が、前記第1の延長部材の前記導管を通って延び、
前記第2及び第3のコードの一部分が、前記第2の延長部材の前記導管を通って延び、
前記ホルダは、シャフトと協働的に嵌合するように構成されたアダプタを含み、前記アダプタは、前記アダプタを通って延びる第1及び第2の内腔を含み、
前記第1のコードの一部分が、前記第1のコードの端部が前記アダプタを超えて延びるように前記第1の内腔を通って延び、前記第2のコードの一部分が、前記第2のコードの端部が前記アダプタを超えて延びるように前記第2の内腔を通って延び、
更に、前記シャフトを含み、
前記シャフトは、前記シャフトを通る1つ又はそれよりも多くの内腔を形成し、
前記シャフトは、前記ホルダの前記アダプタに結合するように構成され、
前記第1のコードの一部分が、前記第1のコードの端部が前記シャフトを超えて延びるように前記シャフトの前記1つ又はそれよりも多くの内腔のうちの1つを通って延び、
前記第2のコードの一部分が、前記第2のコードの端部が前記アダプタを超えて延びるように前記シャフトの前記1つ又はそれよりも多くの内腔のうちの1つを通って延び、
前記第1及び第2のコードの前記部分は、前記シャフトの同じ内腔又は異なる内腔を通って延び、
前記アダプタは、前記第1の延長部材及び前記第2の延長部材の相対位置を保持し、
前記自己拡張式フレームは、縦軸線を有し、
前記ホルダは、前記第1及び第2の延長部材が、前記ホルダが前記自己拡張式フレームを収縮するか又は前記自己拡張式フレームを収縮構成に保持する時に前記自己拡張式フレームの前記縦軸線からオフセットされ、かつ前記自己拡張式フレームの前記縦軸線に実質的に平行であるように構成される、
前記第1及び第2の延長部材は、前記ホルダが前記自己拡張式フレームを収縮するか又は前記自己拡張式フレームを収縮構成に保持する時に前記自己拡張式フレームに対して外部に位置決めされる
ことを特徴とするシステム。 - 前記第1及び第2のループは、独立に制御可能に収縮可能かつ拡張可能である、
ことを特徴とする請求項1に記載のシステム。 - 前記第1のループは、前記第2及び第3のループに対して独立に制御可能に収縮可能かつ拡張可能である、
ことを特徴とする請求項1に記載のシステム。 - 前記第2及び第3のループは、互いに制御可能に収縮可能かつ拡張可能である、
ことを特徴とする請求項3に記載のシステム。 - 前記第1のコードは、前記第1のループを形成する縫合糸と前記縫合糸の端部に取り付けられたテザーとを含み、
前記第2のコードは、前記第2のループを形成する縫合糸と前記縫合糸の端部に取り付けられたテザーとを含み、
前記第3のコードは、前記第3のループを形成する縫合糸と前記縫合糸の端部に取り付けられたテザーとを含む、
ことを特徴とする請求項1に記載のシステム。 - 前記シャフトに作動可能に結合されたか又は作動可能に結合可能なハンドルを更に含む、
ことを特徴とする請求項1に記載のシステム。 - 前記ハンドルは、前記第1のループの収縮及び拡張が第1の作動要素を通じて制御可能であるように前記第1のコードの前記端部に作動可能に結合可能な第1の作動要素を含む、
ことを特徴とする請求項6に記載のシステム。 - 前記ハンドルは、前記第2のループの収縮及び拡張が第2の作動要素を通じて制御可能であるように前記第2のコードの前記端部に作動可能に結合可能な第2の作動要素を含む、
ことを特徴とする請求項7に記載のシステム。 - 前記第2の作動要素は、前記第3のループの収縮及び拡張が前記第2の作動要素を通じて制御可能であるように前記第3のコードの前記端部と作動可能に結合可能である、
ことを特徴とする請求項8に記載のシステム。 - 前記ハンドルに繋がれた制御ユニットを更に含み、
前記制御ユニットは、前記第2のループの収縮及び拡張が前記制御ユニットの作動要素を通じて制御可能であるように前記第2のコードの前記端部に作動可能に結合可能な作動要素を含む、
ことを特徴とする請求項7に記載のシステム。 - 前記ハンドルに作動可能に結合された制御ユニットを更に含み、
前記制御ユニットは、前記第1のループの収縮及び拡張が第1の作動要素を通じて制御可能であるように前記第1のコードの前記端部に作動可能に結合可能な第1の作動要素を含む、
ことを特徴とする請求項6に記載のシステム。 - 前記制御ユニットは、前記第2のループの収縮及び拡張が第2の作動要素を通じて制御可能であるように前記第2のコードの前記端部に作動可能に結合可能な第2の作動要素を含む、
ことを特徴とする請求項11に記載のシステム。 - 前記第2の作動要素は、前記第3のループの収縮及び拡張が前記第2の作動要素を通じて制御可能であるように前記第3のコードの前記端部と作動可能に結合可能である、
ことを特徴とする請求項12に記載のシステム。 - 被験者の弁に自己拡張式フレームを有する医療デバイスを埋め込むための搬送システムであって、
前記埋込可能医療デバイスの前記自己拡張式フレームを収縮構成に保持し、かつ前記自己拡張式フレームの拡張を制御するように構成されたホルダであって、第1のループの収縮又は拡張が前記自己拡張式フレームの収縮又は拡張を制御するように、前記自己拡張式フレームの少なくとも一部分の回りに円周方向に配置されるように構成された第1の制御可能に収縮可能かつ拡張可能なループを含む前記ホルダ、
を含み、
前記自己拡張式フレームは、流入領域を含み、
前記流入領域は、上側部分及び下側部分を含み、
前記第1のループは、前記第1のループの収縮又は拡張が前記自己拡張式フレームの前記流入領域の前記上側部分の収縮又は拡張を制御するように、前記自己拡張式フレームの前記流入領域の前記上側部分の少なくとも一部分の回りに配置され、
前記ホルダは、第2の制御可能に収縮可能かつ拡張可能なループを含み、
前記第2のループは、前記第2のループの収縮又は拡張が前記自己拡張式フレームの前記流入領域の前記下側部分の収縮又は拡張を制御するように、前記自己拡張式フレームの前記流入領域の前記下側部分の少なくとも一部分の回りに配置され、
前記自己拡張式フレームは、流出領域を含み、
前記ホルダは、第3の制御可能に収縮可能かつ拡張可能なループを含み、
前記第3のループは、前記第3のループの収縮又は拡張が前記自己拡張式フレームの前記流出領域の少なくとも一部分の収縮又は拡張を制御するように、前記自己拡張式フレームの前記流出領域の少なくとも一部分の回りに配置され、
前記第1のループは、第1のコードの一部分であり、前記第2のループは、第2のコードの一部分であり、
前記ホルダは、第1の開口部と、第2の開口部と、前記第1及び第2の開口部の間の導管とを有する第1の延長部材を含み、
前記ホルダは、第1の開口部と、第2の開口部と、前記第1及び第2の開口部の間の導管とを有する第2の延長部材を含み、
前記第1のコードの一部分が、前記第1の延長部材の前記導管を通って延び、前記第2のコードの一部分が、前記第2の延長部材の前記導管を通って延び、
前記ホルダは、シャフトと協働的に嵌合するように構成されたアダプタを含み、前記アダプタは、前記アダプタを通って延びる第1及び第2の内腔を含み、
前記第1のコードの一部分が、前記第1のコードの端部が前記アダプタを超えて延びるように前記第1の内腔を通って延び、前記第2のコードの一部分が、前記第2のコードの端部が前記アダプタを超えて延びるように前記第2の内腔を通って延び、
更に、前記シャフトを含み、
前記シャフトは、前記シャフトを通る1つ又はそれよりも多くの内腔を形成し、
前記シャフトは、前記ホルダの前記アダプタに結合するように構成され、
前記第1のコードの一部分が、前記第1のコードの端部が前記シャフトを超えて延びるように前記シャフトの前記1つ又はそれよりも多くの内腔のうちの1つを通って延び、
前記第2のコードの一部分が、前記第2のコードの端部が前記アダプタを超えて延びるように前記シャフトの1つ又はそれよりも多くの内腔のうちの1つを通って延び、
前記第1及び第2のコードの前記部分は、前記シャフトの同じ内腔又は異なる内腔を通って延び、
前記アダプタは、前記第1の延長部材及び前記第2の延長部材の相対位置を保持し、
前記第1及び第2の延長部材は、前記ホルダが前記自己拡張式フレームを収縮するか又は前記自己拡張式フレームを収縮構成に保持する時に前記自己拡張式フレームの縦軸線からオフセットされるように構成され、かつ前記自己拡張式フレームの前記縦軸線と実質的に平行であるように構成される、
前記第1及び第2の延長部材は、前記ホルダが前記自己拡張式フレームを収縮するか又は前記自己拡張式フレームを収縮構成に保持する時に前記自己拡張式フレームに対して外部に位置決めされることを特徴とする搬送システム。 - 前記第1及び第2のループは、独立に制御可能に収縮可能かつ拡張可能である、
ことを特徴とする請求項14に記載のシステム。 - 前記ホルダは、第1及び第2の延長部材が、前記自己拡張式フレームが拡張される時に前記自己拡張式フレームの縦軸線に対してある角度で前記自己拡張式フレームの中心開口部の中に延びるように構成されるように構成される、
ことを特徴とする請求項14に記載のシステム。 - 前記シャフトに作動可能に結合されたか又は作動可能に結合可能なハンドルを更に含む、
ことを特徴とする請求項14に記載のシステム。 - 前記ハンドルは、前記第1のループの収縮及び拡張が第1の作動要素を通じて制御可能であるように前記第1のコードの前記端部に作動可能に結合可能な第1の作動要素を含む、
ことを特徴とする請求項17に記載のシステム。 - 前記ハンドルは、前記第2のループの収縮及び拡張が第2の作動要素を通じて制御可能であるように前記第2のコードの前記端部に作動可能に結合可能な第2の作動要素を含む、
ことを特徴とする請求項18に記載のシステム。 - 前記ハンドルに作動可能に結合された制御ユニットを更に含み、
前記制御ユニットは、前記第1のループの収縮及び拡張が第1の作動要素を通じて制御可能であるように前記第1のコードの前記端部に作動可能に結合可能な第1の作動要素を含む、
ことを特徴とする請求項17に記載のシステム。 - 前記ホルダは、第1の開口部と、第2の開口部と、前記第1及び第2の開口部の間の導管とを有する延長部材を更に含み、
前記第1のループは、第1のコードの一部であり、前記第1のコードの一部分が、前記延長部材の前記導管を通って延び、
前記ホルダは、前記延長部材が、前記ホルダが前記自己拡張式フレームを収縮するか又は前記自己拡張式フレームを収縮構成に保持する時に前記自己拡張式フレームの縦軸線からオフセットされ、かつ前記自己拡張式フレームの前記縦軸線に実質的に平行であるように構成される、
ことを特徴とする請求項14に記載のシステム。 - 前記ホルダは、前記延長部材が、前記ホルダが前記自己拡張式フレームを収縮するか又は前記自己拡張式フレームを収縮構成に保持する時に前記自己拡張式フレームに対して外部に位置決めされるように構成される、ことを特徴とする請求項21に記載のシステム。
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2014
- 2014-05-02 WO PCT/US2014/036688 patent/WO2014179763A1/en active Application Filing
- 2014-05-02 EP EP14733410.6A patent/EP2991586A1/en active Pending
- 2014-05-02 US US14/268,375 patent/US9629718B2/en active Active
- 2014-05-02 JP JP2016512087A patent/JP6561044B2/ja not_active Expired - Fee Related
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WO2014179763A1 (en) | 2014-11-06 |
US10568739B2 (en) | 2020-02-25 |
US20240000567A1 (en) | 2024-01-04 |
JP2016517749A (ja) | 2016-06-20 |
US20200170787A1 (en) | 2020-06-04 |
EP2991586A1 (en) | 2016-03-09 |
US11793637B2 (en) | 2023-10-24 |
US20140330368A1 (en) | 2014-11-06 |
US9629718B2 (en) | 2017-04-25 |
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