JP7186842B2 - ガイドワイヤを送出システムに結合するためのロックアセンブリ - Google Patents
ガイドワイヤを送出システムに結合するためのロックアセンブリ 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
-
- 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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
-
- 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M39/1011—Locking means for securing connection; Additional tamper safeties
-
- 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M39/105—Multi-channel connectors or couplings, e.g. for connecting multi-lumen tubes
-
- 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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- 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
-
- 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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2002/065—Y-shaped blood vessels
-
- 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M2039/1016—Unlocking means providing a secure or comfortable disconnection
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
Description
この出願は、参照によりその全体が本願に組み入れられる2015年6月30日に出願された米国仮特許出願第62/187103号の利益を主張する。
図1Aは、腹大動脈30と左右総腸骨動脈37、38との間の分岐部に位置付けられる、本明細書中に開示される配備カテーテルの任意の実施形態と共に使用され得る二股血管グラフト50の一例の概略図である。図1Aを参照すると、大動脈の腹部及びその主分岐部の概略図が示される。特に、腹大動脈30は、右腎動脈2と左腎動脈4とによって特徴付けられる。大動脈30の大終枝が左右総腸骨動脈37、38である。簡素化のために、更なる血管(例えば、第2腰動脈、精巣動脈、下腸間膜動脈、正中仙骨動脈)は図1から省かれている。拡張された二股管腔内血管プロテーゼの一つの実施形態が、動脈瘤103、104、105に跨って示されている。拡張された二股管腔内血管グラフト50は、大動脈を横切るための主分岐部52(本明細書中では主分岐セグメントとも称される)、同側腸骨動脈37に跨るための第1の分岐部54(本明細書中では第1の分岐セグメント又は同側分岐部とも称される)、及び、対側腸骨動脈38に跨るための第2の分岐部56(本明細書中では第2の分岐セグメント又は対側分岐部とも称される)を備えることができる。
拡張可能な二股グラフト50は、当業者に明らかなように、任意の様々な配備カテーテルを用いて治療部位に配備され得る。本明細書中に開示される配備カテーテルの任意の実施形態は、当該技術分野において知られる拡張可能な二股グラフトを配備するのに適した任意の配備カテーテルの材料、特徴、又は、他の詳細のいずれかを備えてもよい。配備カテーテルの更なる詳細及び付加的な実施形態は、そのそれぞれの全体が参照により本願に組み入れられる米国特許第8,236,040号明細書及び米国特許第8,523,931号明細書において見出すことができる。
ここで、前述した配備カテーテル120の実施形態に関連して、先に開示された二股管腔内グラフト50の実施形態を使用して患者の腹部大動脈瘤を治療するために配備カテーテル120を使用する典型的な手順又は方法について説明する。しかしながら、本開示の方法及び装置は、この特定の例示的な例に限定されるように解釈されるべきでない。この方法及びシステムは、カテーテル、シース、ガイドワイヤ、又は、同様の装置を可逆的に結合することを望む任意の医療処置で使用され得る。
図13Aはロックアセンブリ300の概略図である。ロックアセンブリ300は、第1の長尺部材303及び第2の長尺部材305と接続され(例えば、取り外し可能に結合され、取り外し不能に固定され、或いは、一体形成され)てもよい。ロックアセンブリ300は、3つ以上の長尺部材と接続するように構成されてもよい。第1の長尺部材303はロックアセンブリ300を貫通してもよい。ロックアセンブリ300は、第1の長尺部材303の固定部307と接続できる。ロックアセンブリ300は、第2の長尺部材305のロック部309に可逆的に結合してもよい。
先の説明は、様々な実施形態に適用されるように新規な特徴を示し、記載し、及び、指摘してきたが、開示の思想から逸脱することなく、例示された装置又はプロセスの形状及び細部において様々な省略、置換、及び、変更がなされてもよいことが理解される。また、先に説明された様々な特徴及びプロセスは、互いに独立に使用されてもよく、或いは、様々な方法で組み合わされてもよい。全ての想定し得る組み合わせ及び/又は部分組み合わせがこの開示の範囲内に入るように意図される。
1.
第1の長尺構造体を第2の長尺構造体に対して解放可能に結合するためのロックアセンブリであって、
近位端、遠位端、及び、側壁部を備えるハウジングと、
前記ロックアセンブリの長手方向軸に沿って前記ハウジングの前記近位端から前記ハウジングの前記遠位端まで延びる第1のルーメンであって、前記第1のルーメンが前記第1の長尺構造体を受けるように構成される、第1のルーメンと、
前記ハウジングの前記遠位端から延びる第2のルーメンであって、前記第2のルーメンの直径が前記第1のルーメンの直径よりも小さく、前記第2のルーメンが前記第2の長尺構造体を受けるように構成される、第2のルーメンと、
前記ハウジングを少なくとも部分的に貫通して延びる凹部であって、前記凹部が前記ハウジングの前記側壁部に少なくとも1つの開口を備える、凹部と、
を備えるロックアセンブリ。
2.
前記凹部内にエラストマー部材を更に備え、前記エラストマー部材は、前記第2の長尺構造体が前記第2のルーメンを通じて延びるときに前記第2の長尺構造体を保持するように構成される形態1に記載のロックアセンブリ。
3.
前記エラストマー部材の外面の少なくとも一部が前記ハウジングの前記側壁部の外面と略同一平面内にある形態2に記載のロックアセンブリ。
4.
前記エラストマー部材が前記第2のルーメンと少なくとも部分的に位置合わせされる開口を備える形態2又は3に記載のロックアセンブリ。
5.
前記開口が前記第2のルーメンの直径よりも小さい直径を備える形態4に記載のロックアセンブリ。
6.
前記エラストマー部材がシリコーンを備える形態2~5のいずれかに記載のロックアセンブリ。
7.
前記ハウジングの近位部がテーパ状を成す上記いずれかに記載のロックアセンブリ。
8.
前記ハウジングの遠位部の外周の少なくとも一部に沿って延びる突出部を更に備える上記いずれかに記載のロックアセンブリ。
9.
前記第2のルーメンが前記第1のルーメンと前記突出部との間に位置付けられる形態8に記載のロックアセンブリ。
10.
前記第2のルーメンは、近位部、遠位部、及び、前記近位部と前記遠位部との間の中間部を備え、前記中間部の直径が前記近位部及び前記遠位部の直径よりも小さい上記いずれかに記載のロックアセンブリ。
11.
対側ガイドワイヤを同側カテーテルに結合するためのロックアセンブリであって、
前記同側カテーテルと係合するように構成される固定部と、
少なくとも0.1lbfの垂直力が前記対側ガイドワイヤに印加されなければ前記対側ガイドワイヤが押し進められる又は引き込まれるときに前記対側ガイドワイヤの遠位部を保持するように構成されるインターロック部と、
を備えるロックアセンブリ。
12.
前記インターロック部がルーメンを備え、前記ルーメンは、前記対側ガイドワイヤが引き込まれるときに前記対側ガイドワイヤを保持するように形成される形態11に記載のロックアセンブリ。
13.
前記ルーメンは、遠位部、近位部、及び、前記遠位部と前記近位部との間の中間部を備え、前記中間部の直径が前記遠位部の直径及び前記近位部の直径よりも小さい形態12に記載のロックアセンブリ。
14.
前記ガイドワイヤが押し進められるときに前記ガイドワイヤを摩擦的に保持するように構成される保持部材を更に備える形態11~13のいずれかに記載のロックアセンブリ。
15.
前記保持部材がエラストマー材料を備える形態14に記載のロックアセンブリ。
16.
前記保持部材は、前記対側ガイドワイヤを受けるように構成される開口を備える形態14又は15に記載のロックアセンブリ。
17.
前記インターロック部は、該インターロック部内の前記ガイドワイヤの遠位部から約60度以下の角度で力が前記対側ガイドワイヤの中間部に対して印加されるときに前記対側ガイドワイヤを解放するように構成される形態11~16のいずれかに記載のロックアセンブリ。
18.
第1の長尺部材を第2の長尺部材に対して可逆的に固定するためのシステムであって、
第1の長尺部材と、
近位部及び遠位部を備える第2の長尺部材と、
前記第1の長尺部材に固定されるロックアセンブリと、
を備え、
前記ロックアセンブリは、
近位端及び遠位端を備えるハウジングと、
前記ハウジングの前記遠位端から前記ハウジングの少なくとも一部を貫いて延びるルーメンであって、前記第2のルーメンが前記ロックアセンブリの遠位側から前記第2の長尺部材を受けるように構成される、ルーメンと、
前記ハウジングを少なくとも部分的に貫いて延びる凹部と、
前記凹部内のエラストマー部材であって、前記エラストマー部材は、前記第2の長尺部材が前記第2のルーメンを通じて延びるときに前記第2の長尺部材の前記遠位部を保持するように構成される、エラストマー部材と、
を備える、システム。
19.
前記第2の長尺部材が第1の領域及び第2の領域を備え、前記第1の領域が第1の剛性を有し、前記第2の領域が第2の剛性を有し、前記第1の剛性が前記第2の剛性よりも大きい形態18に記載のシステム。
20.
前記第1の領域が前記第2の領域よりも遠位側にある形態19に記載のシステム。
21.
前記第1の領域が前記第2の長尺部材の遠位端にある形態19に記載のシステム。
22.
前記第2の長尺部材に沿って押し進められて前記第2の長尺部材を前記凹部から離脱させるように構成されるシースを更に備える形態18又は19に記載のシステム。
23.
前記第2の長尺部材がガイドワイヤである形態18~22のいずれかに記載のシステム。
24.
前記第1の長尺部材がカテーテルである形態18~23のいずれかに記載のシステム。
25.
前記第2のルーメンは、近位部、遠位部、及び、前記近位部と前記遠位部との間の中間部を備え、前記中間部の直径が前記遠位部の直径及び前記近位部の直径よりも小さい形態18~24のいずれかに記載のシステム。
26.
前記凹部は、前記ハウジングの側壁に少なくとも1つの開口を備える形態18~25のいずれかに記載のシステム。
27.
前記エラストマー部材は、前記第2のルーメンと少なくとも部分的に位置合わせされる開口を備える形態18~26のいずれかに記載のシステム。
28.
前記開口は、前記第2のルーメンの直径よりも小さい直径を備える形態27に記載のロックアセンブリ。
29.
前記エラストマー部材がシリコーンを備える形態18~28のいずれかに記載のロックアセンブリ。
30.
前記ハウジングの遠位部の外周の少なくとも一部に沿って延びる突出部を更に備える形態18~29のいずれかに記載のロックアセンブリ。
31.
対側ガイドワイヤを同側カテーテルから解放するための方法であって、
送出システムをロック形態で押し進めるステップであって、前記送出システムが前記同側カテーテルに固定されるロックアセンブリを備え、前記ロックアセンブリは、前記送出システムがロック形態にあるときに前記ガイドワイヤを保持するように構成されるインターロック部を備え、前記ガイドワイヤの遠位端は、前記送出システムがロック形態にあるときに前記ガイドワイヤが屈曲部を備えるように前記ロックアセンブリの遠位側から前記インターロック部内へ導入され、前記屈曲部は、前記ガイドワイヤの近位部と前記ガイドワイヤの遠位部との間に位置付けられる、ステップと、
解放カテーテルを前記ガイドワイヤに沿って押し進めることによって前記送出システムを前記ロック形態からロック解除形態へと解放するステップと、
を備える方法。
32.
前記ロック形態において、前記インターロック部は、前記ガイドワイヤが引き込まれるときに前記ガイドワイヤを保持するように構成される形態31に記載の方法。
33.
前記解放カテーテルを押し進める前に、前記インターロック部は、前記ガイドワイヤが押し進められるときに前記ガイドワイヤを保持するように構成される形態31又は32に記載の方法。
34.
前記送出システムを解放する前記ステップは、前記ロックアセンブリの長手方向軸から約60度以下の角度で力を前記ガイドワイヤに印加するステップを備える形態31~33のいずれかに記載の方法。
Claims (12)
- ロックアセンブリであって、
前記ロックアセンブリの近位端から前記ロックアセンブリの遠位端まで延びる第1のルーメンであって、前記第1のルーメンが第1の長尺部材を受けるように構成される、第1のルーメンと、
前記ロックアセンブリの前記遠位端から延びる第2のルーメンであって、前記第2のルーメンが第2の長尺部材を受けるように構成される、第2のルーメンと、
前記第2の長尺部材が前記第2のルーメンを通じて延びるときに前記第2の長尺部材を保持するように構成されるエラストマー部材と、
を備えるロックアセンブリ。 - 前記第1のルーメンおよび前記第2のルーメンが、側壁を備えるハウジングによって少なくとも部分的に囲まれている、請求項1に記載のロックアセンブリ。
- 前記ハウジングが、前記エラストマー部材を受けるように構成される凹部を更に備える、請求項2に記載のロックアセンブリ。
- 前記第2の長尺部材に沿って押し進められて前記第2の長尺部材を前記第2のルーメンから離脱させるように構成されるシースを更に備える、請求項3に記載のロックアセンブリ。
- 前記第2のルーメンが、前記第2のルーメンの直径よりも小さい直径を有する保持部を備える、請求項3に記載のロックアセンブリ。
- 前記エラストマー部材は、前記エラストマー部材が前記凹部にあるときに前記第2のルーメンと位置が合うように構成される開口を備え、ここで、前記開口の少なくとも一部は、前記第2のルーメンよりも小さい直径を有し、前記開口は、前記第2の長尺部材を受け入れるために広がるように構成される、請求項3に記載のロックアセンブリ。
- 前記エラストマー部材が、前記第1のルーメンと位置が合う通路を更に備える、請求項6に記載のロックアセンブリ。
- 前記開口は、前記第2の長尺部材が前記開口に挿入されたときに、前記第2の長尺部材を前記開口の中間部に送り込む傾斜壁を備える、請求項7に記載のロックアセンブリ。
- 前記開口は、前記第2の長尺部材が前記第2のルーメンに挿入されたときに前記エラストマー部材と前記第2の長尺部材との間に摩擦をもたらすように構成される、請求項6に記載のロックアセンブリ。
- 前記摩擦は、前記ロックアセンブリに対して、前記第2の長尺部材の遠位方向への動きに抵抗する、請求項9に記載のロックアセンブリ。
- 前記摩擦は、前記第2の長尺部材が前記遠位方向に十分な張力を受けるまで、前記遠位方向への動きに抵抗する、請求項10に記載のロックアセンブリ。
- 前記遠位端から延びる突出部を更に備え、前記第2の長尺部材が前記突出部の半径よりも鋭く曲がるのを防ぐように構成される、請求項1に記載のロックアセンブリ。
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