JP6190273B2 - 接合強化インプラント、システム、および方法 - Google Patents
接合強化インプラント、システム、および方法 Download PDFInfo
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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
- A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
-
- 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
- A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00867—Material properties shape memory effect
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0412—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from suture anchor body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
- A61B2017/0448—Additional elements on or within the anchor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0464—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
- A61B2017/048—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery for reducing heart wall tension, e.g. sutures with a pad on each extremity
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B2017/0649—Coils or spirals
-
- 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
- A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
- A61F2/2457—Chordae tendineae prostheses
-
- 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
- A61F2250/0003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Surgery (AREA)
- Vascular Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Rheumatology (AREA)
- Prostheses (AREA)
Description
本出願は、2011年1月28日に出願した「Coaptation Enhancement Implant, System, and Method」という名称の米国仮特許出願第61/437,397号および2011年5月3日に出願した米国非仮特許出願第13/099,532号からの優先権を主張するものであり、開示全体のそれぞれは、あらゆる目的で参照により本明細書に組み込まれる。
適用なし
適用なし
12 接合支援本体、弁本体
14 アンカー
100 アンカー展開カテーテル、アンカーデリバリーカテーテル
101 カテーテル本体
102 近位端
104 遠位端
106 内腔
108 第1の心房アンカー
108’ 第2のアンカー
110 アンカーデリバリー本体、アンカー結合本体、展開カテーテル、コネクタ本体、案内本体、アンカー本体、アンカー展開本体
110’ アンカー本体、アンカー展開本体、案内本体
112 近位ハンドル
114 アクチュエータ
116 電極
118 電位図コネクタ
120 弁本体デリバリーカテーテル、弁本体展開カテーテル
122 接合本体、弁本体
122a 弁本体
122x 弁本体
124 遠位端
126 内腔
128 外側展開シース
130 近位ハンドル
132 カテーテル本体
134 近位端、心房端
136 遠位端
138 側方縁、外側シース
140 心房部材、側方心房支持具
142 ループ、アパーチャ
142’ ループ、アパーチャ
150 弁本体セット
156 主要表面
158 主要表面
170 外側層、外側組織内殖層
172 流体吸収コア
174 弁本体曲線
180 インプラント
182 心室結合器、コネクタ
184 軸ストラット
190 ばね
192 テザー
196 心房テザー、心房支持テザー
198 左心耳アンカー
202 支持基部
204 代替インプラント
300 経中隔シース
301 シース
302 外側シース本体
304 近位ハンドル
306 遠位端
310 外側経中隔シース、操縦機能
320 リモートイメージングシステム
330 ガイドワイヤ
340 弁本体展開カテーテル
402 アンカー展開アセンブリ
404 アンカー展開カテーテル、アンカーカテーテル
406 近位部分
408 遠位部分
410 スロット
420 アンカー圧着および切断アセンブリ、圧着および除去カテーテル、圧着および切断カテーテル
420’ 圧着および切断アセンブリ
422 切断カテーテル
424 シャフト
426 近位ハンドル
428 遠位先端
430 側面ポート
432 クリンプ
434 切断ノブ
440 切断部材、ブレード
440’ 切断部材
444 エネルギー源
450 ハブ
452 ピン
454 ソケット
456 駆動機構
458 アンカー展開シャフト
460 非外傷性心室アンカー
462 中央シャフト
464 アーム
468 弁本体実施形態
470 フランジ
472 接合表面
474 弁本体実施形態
480 弁本体
484 リップ
488 接合表面
490 接合表面
502 接合不全
504 心室テザー
506 円弧状アンカー、支持構造
510 第1の接合ゾーン
512 第2の接合ゾーン
900 接合デバイス、接合支援デバイス
901 アンカー接合支援本体
902 第1の主要接合表面、上流端
903 下流端、上流端
904 軸方向チャネル
905 テザー
906 中心心房アンカー
907a 側方心房アンカー
907b 側方心房アンカー
908 心室アンカー
1001 湾曲ロック、クリンプ
1201 開口
1202 弁尖
1203 場所
1204 カテーテル
1205 卵円窩
AV 僧帽弁
CA 重心
CO 開口部
CZ 三次元接合ゾーン
EG 電位図システム
FP 流路
H 心臓
LA 左心房
LAA 左心耳
LV 左心室
MR 僧帽弁逆流
MV 僧帽弁
Claims (15)
- 患者の心臓の心臓弁の接合不全を治療するための接合支援インプラントであって、
前記心臓弁が弁輪と、第1の弁尖および第2の弁尖とを有し、前記弁輪が、血流路に沿って延在する弁軸を画定し、前記第1の弁尖および第2の弁尖が、前記血流路にわたって延在する曲線を画定する接合ゾーンを有する、インプラントにおいて、
軸、ならびに対向する第1の主要接合表面および第2の主要接合表面を有する接合支援本体であって、各接合表面が第1の側方縁と第2の側方縁との間に側方に延在し、前記接合支援本体の前記軸が前記心臓弁の前記弁軸に沿って延在し、前記第1の側方縁および前記第2の側方縁が前記心臓弁の前記接合ゾーンの前記曲線に沿って延在するように心臓の内部で支持可能である、接合支援本体と、
らせん状のアンカーを中に通して受け入れるように構成されたハブと、
軸方向チャネルの内部に配設され、前記軸方向チャネルの第1の端の近くで前記接合支援本体に結合されるテザーと、
前記軸方向チャネルの第2の端の近くで前記テザーに取り付けられる湾曲ロックであって、前記テザーが、前記接合支援本体の湾曲を画定するように前記軸方向チャネルの前記第1の端と前記第2の端との間の距離を限定するためにそれによってロック可能である、湾曲ロックと、
を備え、
支持された前記接合支援インプラントの前記接合支援本体は、前記接合支援インプラントと心臓との間の係合が、前記心臓弁の前記接合ゾーンによって画定される前記曲線の方へ前記第1の側方縁と前記第2の側方縁との間で前記接合支援本体を曲げるほど十分に合致する、
インプラント。 - 前記接合支援本体は、周囲展開カテーテル内から前記接合支援本体を取り除くことによって第1の構成から第2の構成へ展開可能である、請求項1に記載のインプラント。
- 前記接合支援本体が、前記心臓の内部で前記接合支援本体を広げる、かつ/または開くことによって展開可能である、請求項2に記載のインプラント。
- 前記接合支援本体が、前記周囲展開カテーテル内での挿入時容量と、前記挿入時容量より大きい展開時容量とを有し、前記接合支援本体が、対応する前記第1の主要接合表面と前記第2の主要接合表面との間の接合支援本体の厚さを増加させるように心臓の内部で容量分析に基づいて拡張可能である、請求項2に記載のインプラント。
- 前記接合支援本体が、心臓の内部で解放されたとき前記患者の血管系の外部から導入される膨張流体を使用して前記接合支援本体を膨張させることなく容量分析に基づいて拡張するように構成される、請求項4に記載のインプラント。
- 前記接合支援本体が、コア材料を覆うように配設された組織内殖材料層を備え、前記コア材料を心臓の内部で解放すると拡張する、請求項5に記載のインプラント。
- 前記接合支援本体が、フォームまたはその他の液体吸収マトリックスを覆うePTFEの層を備える、請求項5に記載のインプラント。
- 前記接合支援本体は、軸方向の屈曲を阻止するために軸ストラットを備える、請求項1に記載のインプラント。
- 前記らせん状のアンカーが、第1の交連の近くの心臓の第1の目標場所のところにカテーテル本体の遠位端から選択的に展開可能であり、
前記接合支援本体が心臓に導入可能であり、前記第1の側方縁が第1の交連の方へ延在するように前記らせん状のアンカーを心臓内で展開した後で前記らせん状のアンカーと生体内で結合可能である、
請求項1に記載のインプラント。 - 前記らせん状のアンカーが、前記接合支援本体の上流端に固定され、前記接合支援本体の前記上流端を心臓に固定するために展開可能である、請求項1に記載のインプラント。
- 前記らせん状のアンカーが、前記接合支援本体の下流端に固定され、前記接合支援本体の前記下流端を心臓の心室組織に固定するために展開可能である、請求項1に記載のインプラント。
- 前記らせん状のアンカーが、前記接合支援本体の上流端のそれぞれの側方縁の近位に固定され、前記心臓弁のそれぞれの交連の近位で上流端を心臓に固定するために展開可能である、請求項1に記載のインプラント。
- 前記テザーがワイヤまたは縫合糸を備え、前記湾曲ロックが前記ワイヤまたは前記縫合糸の上にクリンプを備える、請求項1に記載のインプラント。
- 前記ハブが、該ハブを側方に貫通するピンを備え、前記らせん状のアンカーのらせん巻きは、前記ピンの上方及び下方を通過するように構成されている、請求項1に記載のインプラント。
- ニチノール合金フレームをさらに備える、請求項1に記載のインプラント。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201161437397P | 2011-01-28 | 2011-01-28 | |
US61/437,397 | 2011-01-28 | ||
US13/099,532 | 2011-05-03 | ||
US13/099,532 US8845717B2 (en) | 2011-01-28 | 2011-05-03 | Coaptation enhancement implant, system, and method |
PCT/US2012/021744 WO2012102928A1 (en) | 2011-01-28 | 2012-01-18 | Coaptation enhancement implant, system, and method |
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CN103338726B (zh) | 2016-05-11 |
EP2667823A4 (en) | 2016-06-22 |
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