JP2021500129A - カテーテルアセンブリ - Google Patents
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- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
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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
- A61F2/2433—Deployment by mechanical expansion using balloon catheter
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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
- A61F2/2436—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
- A61F2/02—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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2466—Delivery devices 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00243—Type of minimally invasive operation cardiac
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- Prostheses (AREA)
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Abstract
Description
本願は、2017年10月18日に出願された米国特許仮出願第62/573,883号に基づく利益を主張するものである。前述の出願は、参照によりその全体が本明細書に組み込まれる。
本開示の実施形態は、心臓の天然弁輪/天然弁(例えば肺動脈弁輪/肺動脈弁、僧房弁輪/僧帽弁、および三尖弁輪/三尖弁など)のいずれかにプロテーゼデバイスを送達および植込みするように構成されることが可能であり、任意の様々な送達アプローチ(例えば逆行性アプローチ、順行性アプローチ、経中隔アプローチ、経心室アプローチ、経心房アプローチ、経血管アプローチ等)または他の器官と共に使用することが可能である。
12 送達装置
12b 送達装置
14 第1のシャフト
14d 遠位端部、遠位端部部分
14p 近位端部
16 外方シース
16p 近位端部
18 第2のシャフト、内方シャフト
18d 遠位端部
18p 近位端部
20 コネクタアセンブリ
22 ノーズコーン
24 長手方向軸
26 第1のコネクタ部分
28 第2のコネクタ部分
28b 第2のコネクタ部分
30 ピン
30' ピン
30'' ピン
32 凹部
34 ボス、径方向延在ボス、ピン、径方向延在ピン
36 フランジ
38 切欠部
40 スロット
40' スロット
40'' スロット
42 近位端部部分
44 遠位端部部分
46 中間部分
48 側壁部、壁部
50 近位ルーメン
52 遠位ルーメン
54 遠位端部部分
56 近位端部部分
58 側壁部
60 遠位ルーメン
62 近位ルーメン、軸方向ボア
64 凹部
64' 凹部
64'' 凹部
68 ハンドル
70 第1のノブ
72 第2のノブ
74 第3のノブ
76 ガイドワイヤ
78 デバイス保持部分
80 人工心臓弁
82 傾斜軸
84 保持アーム
86 アパーチャ
88 中心軸
100 コネクタアセンブリ
102 第1のコネクタ部分
104 第2のコネクタ部分
106 近位端部部分
108 遠位ルーメン
200 コネクタアセンブリ
202 第1のシャフトセグメント
204 第2のシャフトセグメント
206 第1のコネクタ部分
208 第2のコネクタ部分
D1 断面直径、最大断面寸法、寸法
D2 直径
D3 直径
Claims (20)
- シャフトと、
第1のコネクタ部分および第2のコネクタ部分を備えるコネクタアセンブリであって、前記第1のコネクタ部分は、前記シャフトの遠位端部に対して固定的に結合され、前記第2のコネクタ部分上の少なくとも1つのスロット内に保持された少なくとも1つの径方向延在ピンにより前記第2のコネクタ部分に対して回転可能に結合され、前記少なくとも1つのスロットは、前記シャフトの長手方向軸を中心とする前記第1のコネクタ部分に対する前記第2のコネクタ部分の限定された回転を可能にする過大周方向寸法を有する、コネクタアセンブリと
を備える、カテーテルアセンブリ。 - 前記少なくとも1つのスロットは、前記シャフトの前記長手方向軸に対する前記第2のコネクタ部分の限定された傾斜を可能にするようにサイズ設定される、請求項1に記載のカテーテルアセンブリ。
- 前記少なくとも1つのスロットは、前記第2のコネクタ部分に対する前記第1のコネクタ部分の限定された軸方向移動を可能にする、前記長手方向軸に沿った方向への過大幅を有する、請求項1または2に記載のカテーテルアセンブリ。
- 前記少なくとも1つのスロットは、第1のスロットおよび第2のスロットを備え、前記少なくとも1つのピンは、前記第1のスロットおよび前記第2のスロットのそれぞれの中に配設された第1のピンおよび第2のピンを備える、請求項1から3のいずれか一項に記載のカテーテルアセンブリ。
- 各スロットが、180度未満の弧長を前記長手方向軸周囲に有する、請求項4に記載のカテーテルアセンブリ。
- 前記第1のコネクタ部分は、前記第2のコネクタ部分の軸方向ボア内に延在する遠位端部部分を備え、前記少なくとも1つのピンは、前記遠位端部部分から前記第2のコネクタ部分の前記少なくとも1つのスロット内へと径方向外方に延在する、請求項1から5のいずれか一項に記載のカテーテルアセンブリ。
- 前記第2のコネクタ部分は、植込み可能医用デバイスの対応する保持アームとの解除可能装着部を形成するように構成された1つまたは複数の装着特徴部を備える、請求項1から6のいずれか一項に記載のカテーテルアセンブリ。
- 前記1つまたは複数の装着特徴部は、前記植込み可能医用デバイスの前記1つまたは複数の保持アームを受けるように構成された1つまたは複数の凹部を備える、請求項7に記載のカテーテルアセンブリ。
- 外方シースをさらに備え、前記外方シースは、前記保持アームが前記第2のコネクタ部分の前記装着特徴部と係合状態にある場合に、前記シース内に径方向圧縮状態において前記植込み可能医用デバイスを保持するために、前記コネクタアセンブリおよび前記植込み可能医用デバイスを覆って延在するように構成される、請求項7または8に記載のカテーテルアセンブリ。
- 前記第2のコネクタ部分に対して連結された近位端部を有する別のシャフトをさらに備える、請求項1から9のいずれか一項に記載のカテーテルアセンブリ。
- 患者の脈管を経由して植込み可能デバイスを送達するための送達装置であって、
外方シースと、
前記外方シースを貫通して延在するシャフトと、
第1のコネクタ部分および第2のコネクタ部分を備えるコネクタアセンブリであって、前記第1のコネクタ部分は、前記シャフトの遠位端部に対して固定的に結合され、前記第2のコネクタ部分は、前記第2のコネクタ部分が前記シャフトの長手方向軸を中心として前記第1のコネクタ部分に対して回転することが可能となり、前記シャフトの前記長手方向軸に対して傾斜することが可能となるように、前記第1のコネクタ部分に対して結合される、コネクタアセンブリと
を備え、
前記第2のコネクタ部分は、径方向に拡張可能な植込み可能医用デバイスの対応する保持アームとの解除可能装着部を形成するように構成された1つまたは複数の装着特徴部を備え、
前記外方シースは、前記植込み可能医用デバイスの前記保持アームが前記第2のコネクタ部分の前記装着特徴部と係合状態におかれる場合に、前記シース内に径方向圧縮状態において前記植込み可能医用デバイスを保持するために前記コネクタアセンブリおよび前記植込み可能医用デバイスを覆って延在するように構成される、送達装置。 - 前記第2のコネクタ部分は、前記第2のコネクタ部分が前記長手方向軸に対して平行な方向における限定量だけ前記第1のコネクタ部分に対して軸方向に移動し得るように、前記第1のコネクタ部分に対して結合される、請求項11に記載の送達装置。
- 前記第2のコネクタ部分は、前記第2のコネクタ部分上の少なくとも1つのスロット内に保持された少なくとも1つの径方向延在ピンにより前記第1のコネクタ部分に対して結合される、請求項11または12に記載の送達装置。
- 前記第2のコネクタ部分は、前記第1のコネクタ部分上の少なくとも1つのスロット内に保持された少なくとも1つの径方向延在ピンにより前記第1のコネクタ部分に対して結合される、請求項11または12に記載の送達装置。
- 前記少なくとも1つのスロットは、前記シャフトの前記長手方向軸を中心とする前記第1のコネクタ部分に対する前記第2のコネクタ部分の限定された回転を可能にする過大周方向寸法を有する、請求項13または14に記載の送達装置。
- 前記少なくとも1つのスロットは、前記シャフトの前記長手方向軸に対する前記第2のコネクタ部分の限定された傾斜を可能にするようにサイズ設定される、請求項11から15のいずれか一項に記載の送達装置。
- 前記少なくとも1つのスロットは、前記第2のコネクタ部分に対する前記第1のコネクタ部分の限定された軸方向移動を可能にする、前記長手方向軸に沿った方向への過大幅を有する、請求項11から16のいずれか一項に記載の送達装置。
- 前記少なくとも1つのスロットは、第1のスロットおよび第2のスロットを備え、前記少なくとも1つのピンは、前記第1のスロットおよび前記第2のスロットのそれぞれの中に配設された第1のピンおよび第2のピンを備え、前記第1のスロットは、前記長手方向軸に対して前記第2のスロットの対向側に位置する、請求項11から17のいずれか一項に記載の送達装置。
- 前記第2のコネクタ部分の前記装着特徴部は、前記植込み可能デバイスの1つまたは複数の保持アームを受けるように構成された1つまたは複数の凹部を備える、請求項11から18のいずれか一項に記載の送達装置。
- 外方シースと、
前記外方シースを貫通して延在する第1のシャフトと、
前記第1のシャフトを貫通して延在する第2のシャフトと、
前記第2のシャフトの遠位端部部分上に取り付けられたノーズコーンと、
近位コネクタ部分および遠位コネクタ部分を備えるコネクタアセンブリであって、前記近位コネクタ部分は、前記第1のシャフトの遠位端部に対して固定的に結合され、前記遠位コネクタ部分は、前記遠位コネクタ部分中のスロット内に保持された少なくとも1つのピンにより前記近位コネクタ部分に対して回転可能に結合され、前記スロットは、前記第1のシャフトの長手方向軸を中心とする前記近位コネクタ部分に対する前記遠位コネクタ部分の限定された回転と、前記長手方向軸に対する前記遠位コネクタ部分の限定された傾斜と、前記長手方向軸に対して平行な方向における前記近位コネクタ部分に対する前記遠位コネクタ部分の限定された軸方向移動とを可能にする過大周方向寸法を有し、前記遠位コネクタ部分は、1つまたは複数の装着特徴部を備える、コネクタアセンブリと、
前記シース内に径方向圧縮状態に保持された、および前記遠位コネクタ部分の各装着特徴部に係合する1つまたは複数の保持アームを有する、径方向に拡張および圧縮可能な人工心臓弁と
を備える、アセンブリ。
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CN111225634B (zh) | 2022-06-24 |
CA3078928A1 (en) | 2019-04-25 |
US20200229923A1 (en) | 2020-07-23 |
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IL273562B2 (en) | 2024-01-01 |
AU2018351966A1 (en) | 2020-04-16 |
AU2018351966B2 (en) | 2021-04-01 |
CN115177404A (zh) | 2022-10-14 |
IL273562A (en) | 2020-05-31 |
JP7237955B2 (ja) | 2023-03-13 |
JP2023078178A (ja) | 2023-06-06 |
EP3697344A1 (en) | 2020-08-26 |
KR20200074148A (ko) | 2020-06-24 |
AU2021204636B2 (en) | 2023-07-06 |
AU2021204636A1 (en) | 2021-07-29 |
CN111225634A (zh) | 2020-06-02 |
SG11202002918YA (en) | 2020-05-28 |
WO2019079019A1 (en) | 2019-04-25 |
US11857416B2 (en) | 2024-01-02 |
US20240081993A1 (en) | 2024-03-14 |
IL305364A (en) | 2023-10-01 |
AU2023241363A1 (en) | 2023-10-26 |
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