JP7136806B2 - 新生腱索の経血管的埋め込み方法及び装置 - Google Patents
新生腱索の経血管的埋め込み方法及び装置 Download PDFInfo
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- JP7136806B2 JP7136806B2 JP2019556554A JP2019556554A JP7136806B2 JP 7136806 B2 JP7136806 B2 JP 7136806B2 JP 2019556554 A JP2019556554 A JP 2019556554A JP 2019556554 A JP2019556554 A JP 2019556554A JP 7136806 B2 JP7136806 B2 JP 7136806B2
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- 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
- A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
- A61B2017/0488—Instruments for applying suture clamps, clips or locks
-
- 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
- A61B2017/0496—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials for tensioning sutures
-
- 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
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B2017/06052—Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
- A61B2018/00351—Heart
- A61B2018/00369—Heart valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
- A61B2018/0212—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques using an instrument inserted into a body lumen, e.g. 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
- 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
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
- A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
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Description
1.給送カテーテル100の経静脈、経大腿への侵入
2.右心房10へのカテーテル100の前進
3.カテーテル100の左心房14への経中隔前進12
4.ストレインリリーフアンカ18の位置決め及び給送のための僧帽弁輪16へのカテーテル100の前進
5.僧帽弁弁尖の把持ツールの位置決め
6.僧帽弁輪16に対するストレインリリーフアンカ18の取り付け
7.既存のコード17の間における僧帽弁25に亘る置換コード22の前進
8.コード22の左心室の心尖部20への前進及び心尖部20への遠位の取り付け
9.僧帽弁弁尖の動きを監視しながらコード22に張力を付与すること
1.給送カテーテル100の経大腿への進入
2.右心房10へのカテーテル100の前進
3.カテーテル100の左心房14への経中隔前進12
4.僧帽弁24を通した左心室の心尖部20への給送カテーテル100の前進
5.遠位心室アンカ(例えば、回転アンカ32)の心尖部20への給送
6.下方心尖部アンカ30を露出させるような給送カテーテル100の引き抜き
7.新たなコード縫合部線22又は複数の線22を露出させるように給送カテーテル100を近位に引っ張ること
8.各々の新たなコード22に亘って、僧帽弁弁尖ストレインリリーフは僧帽弁弁尖を通して、弁尖の心室側に供給され得る
9.縫合部の位置をストレインリリーフアンカの位置にロックするような縫合部尾部28に亘る縫合部ロック26の前進
10.僧帽弁弁尖アンカにおける縫合部尾部の切断
11.カテーテルハンドルから僧帽弁弁尖アンカへの縫合部尾部に亘る縫合部ロック26の前進
12.カテーテルハンドルの外側の最も遠位の縫合部尾部から加えられる張力をロックする、カテーテルハンドルから遠位心尖部アンカへの縫合部尾部に亘る縫合部ロック26の前進
13.遠位心尖部アンカにおける縫合部尾部の切断
上記方法のいくつかのステップは任意選択的なものであってもよい。適切な箇所に付加的なステップを含んでもよい。さらに、実行可能な任意の順序にステップを再配置してもよい。
当該実施例は、図23に示した実施例と類似していてもよい。
・原発性又は変性による僧帽弁逆流症と診断されていること。
・二次的又は機能的僧帽弁逆流症と診断されていること。
・粘液腫性僧帽弁逆流症と診断されていること。
・動揺弁尖(flail leaflet)、腱索裂傷又は弁尖逸脱症と診断されていること。
・僧帽弁逆流症のグレードが1以上、2以上、3以上、4以上であること。
・A2弁尖~P2弁尖の直径がP2+A2弁尖の総長さより少なくとも5,10,15,20,30,50mm小さいこと。
また、耐久性のある修復を行うため、修復後に適切な冗長な接合を保証する同様の数学的関係を用いてもよい。
・A2~P2弁尖の直径が、10~50mm、好ましくは24~36mm、又は最も好ましくは26~33mmであること。
・アクセス血管径が少なくとも直径2~10mmであること。
好ましくは、患者は、以下の第2の群の特徴のうち少なくとも1つ、3つ又は5つの特徴を有する:
・少なくとも1人、好ましくは2人の心臓外科医を含む心臓チームによって評価され、従来の開胸手術による修復に適した候補者ではないと決定されていること。
・STSが予測した手術死亡率(胸部外科学会のスコア、STSスコア)が2~20以上であること。
・患者は開胸手術による修復を提示され拒否した。
・年齢が、18~90歳、好ましくは35~85歳、より好ましくは40~85歳であること。
・患者が輸血を受けないこと。
・以前に開胸手術が行われていること。
・駆出率が少なくとも10~60パーセントであること。
装置の実施例について、患者は実質的に以下の要件(第3の群)を有していないことが好ましい:
・中等度又は重度のCOPD
・凝固亢進性疾患
・全身性変性膠原病(すなわち、マルファン症候群)
・アンカ領域に影響を与える以前の中隔梗塞
・心室中隔欠損
・造影剤に対する既知のアレルギー
・以前の僧帽弁置換
・左心室流出路の閉塞又は制限を引き起こす収縮期前尖運動がないこと
・僧帽弁勾配
・逆流ジェットの出現
・逆流ジェストの速度
・逆流ジェットの長さ
・MRグレード
・少なくとも3,5,9,12又は15mmの最小弁尖接合距離が接合線に亘って実現すること
・弁尖逸脱の程度又は僧帽弁弁尖の一部が僧帽弁平面より上方に移動する高さの測定値
・心房、心室又は心耳内における「スモーク」又はうっ血(ステイシス)の領域
・左心室と右心室との間、特に、アンチョ(ancho)の位置又は他の中隔セクションにおける閉鎖
・血圧
・心拍出量
・ACT 実際の凝固時間
・EKG心電図
・心臓酵素ckmb及びトロポニン
・冠状動脈の開存性
・アンカ又は経心室アクセスからの潜在的な心室シャント(短絡)の透視評価。
・心室アンカの透視図
・給送システムの透視位置
・心房圧又は楔入圧
・患者の血液中の酸素含有量
Claims (17)
- 近位端部及び遠位端部を有するカテーテルと、
前記カテーテル内に挿入されるように構成され、心室アンカ及びドライバを有する心室アンカ給送サブシステムと、
前記カテーテル内に挿入されるように構成され、前記カテーテルを通って近位方向に延びる縫合糸及び半径方向に拡大可能な弁尖アンカを有する弁尖アンカ給送サブシステムと、
を有し、
前記ドライバは、前記カテーテルを通って近位方向に延びる前記心室アンカを展開させるように構成されており、
前記半径方向に拡大可能な弁尖アンカは、2つのシート状の材料の間に挿入された縫合糸を含み、かつ前記縫合糸の近位方向への後退により半径方向に拡大した構成に変形可能である、ことを特徴とする新生腱索展開システム。 - 前記半径方向に拡大可能な弁尖アンカは綿撒糸を含む、ことを特徴とする請求項1に記載の新生腱索展開システム。
- 前記綿撒糸は、前記縫合糸の近位への後退により、細長いストリップ状の構成から、半径方向に拡大され軸方向に縮小された構成に変形可能である、ことを特徴とする請求項2に記載の新生腱索展開システム。
- 前記半径方向に拡大可能な弁尖アンカは、弁尖を通って前進可能な第1の縮小断面から、前記弁尖の一方の側に接触する第2の拡大断面へと拡大可能である、ことを特徴とする請求項1~3のいずれかに記載の新生腱索展開システム。
- 縫合糸ロック給送サブシステムをさらに備え、
前記縫合糸ロック給送サブシステムは、前記弁尖アンカ給送サブシステムの前記縫合糸及び前記心室アンカ給送サブシステムの心室アンカ縫合糸に亘って進むように構成された縫合糸ロックを有する、ことを特徴とする請求項1~4のいずれかに記載の新生腱索展開システム。 - 前記縫合糸ロックは、前記縫合糸の長さを固定するためロックするように構成されている、ことを特徴とする請求項5に記載の新生腱索展開システム。
- 前記心室アンカ給送サブシステム及び前記弁尖アンカ給送サブシステムは、前記カテーテルを同時に又は連続的に占有するように構成されている、ことを特徴とする請求項1~6のいずれかに記載の新生腱索展開システム。
- 前記心室アンカ給送サブシステム、前記弁尖アンカ給送サブシステム及び前記縫合糸ロック給送サブシステムのいくつか又は全ては、前記カテーテルを同時に又は連続的に占有するように構成されている、ことを特徴とする請求項5又は6に記載の新生腱索展開システム。
- 前記心室アンカを遠位方向に展開するように構成され、かつ前記半径方向に拡大可能な弁尖アンカを近位方向に展開するように構成されている、ことを特徴とする請求項1~8のいずれかに記載の新生腱索展開システム。
- 前記半径方向に拡大可能な弁尖アンカは、前記心室アンカ及び前記ドライバが前記カテーテルから取り除かれた後、連続して前記カテーテルに挿入される、ことを特徴とする請求項1~9のいずれかに記載の新生腱索展開システム。
- 前記半径方向に拡大可能な弁尖アンカ、前記心室アンカ及び前記ドライバは、前記カテーテル内に予め配置される、ことを特徴とする請求項1~10のいずれかに記載の新生腱索展開システム。
- 前記弁尖アンカ給送サブシステムは、前記カテーテルの前記遠位端部を通って前進するように構成された組織貫通要素をさらに有する、ことを特徴とする請求項1~11のいずれかに記載の新生腱索展開システム。
- 前記弁尖アンカ給送サブシステムは、組織貫通ガイド要素を有し、
前記組織貫通要素は、前記組織貫通ガイド要素から前進するように構成されている、ことを特徴とする請求項12に記載の新生腱索展開システム。 - 前記組織貫通要素は、弁尖を通って前進し、前記弁尖アンカを前記組織貫通要素から展開させるように構成されている、ことを特徴とする請求項12又は13に記載の新生腱索展開システム。
- 前記心室アンカはブレード部分を有する、ことを特徴とする請求項1~14のいずれかに記載の新生腱索展開システム。
- 前記心室アンカは機械的に拡張可能である、ことを特徴とする請求項1~14のいずれかに記載の新生腱索展開システム。
- 前記心室アンカは、とげのあるステント状構造体を有する、ことを特徴とする請求項1~14のいずれかに記載の新生腱索展開システム。
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US15/638,176 | 2017-06-29 | ||
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