JPWO2017184153A5 - - Google Patents
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- JPWO2017184153A5 JPWO2017184153A5 JP2018555257A JP2018555257A JPWO2017184153A5 JP WO2017184153 A5 JPWO2017184153 A5 JP WO2017184153A5 JP 2018555257 A JP2018555257 A JP 2018555257A JP 2018555257 A JP2018555257 A JP 2018555257A JP WO2017184153 A5 JPWO2017184153 A5 JP WO2017184153A5
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ある例では、ベースグラフトは、結晶溶融温度を有する延伸ＰＴＦＥを含み、およびさらに被制御拡張エレメントは、結晶溶融温度未満の温度でステント－グラフト構成部分に連結されている。また、被制御拡張エレメントが滑走界面においてステント－グラフトと異なる速度で縦寸法において変化（例えば、放射状の拡張の間の縦方向への収縮）できるように、被制御拡張エレメントは、任意選択的にステント－グラフト構成部分に連結されている。例えば、ステント－グラフトと被制御拡張エレメントとの間の界面の１つまたは２つ以上の部分は、内部人工器官の拡張の間に縦方向の収縮差を防ぐであろう様式で結合またはそうでなければ取り付けられていない。 In one example, the base graft comprises stretched PTFE having a crystal melting temperature, and further the controlled expansion element is coupled to the stent-graft component at a temperature below the crystal melting temperature. Also, the controlled expansion element is optional so that the controlled expansion element can change in longitudinal dimensions (eg, longitudinal contraction during radial expansion) at a different rate than the stent-graft at the gliding interface. It is connected to the stent-graft component. For example, one or more parts of the interface between the stent-graft and the controlled expansion element are coupled or so in a manner that will prevent longitudinal contraction differences during expansion of the internal prosthesis. If not, it is not installed.
設定工程は被制御拡張エレメント２０を内部人工器官１０の外側表面にならうようにし、これは熱および／または接着剤結合の使用なしで内部人工器官１０のその後の加工、配置、および移植を通して、被制御拡張エレメント２０を定位置に保持することを助けると考えられる。いくつかの態様において、被制御拡張エレメント２０とステント－グラフト１２、１８との間の界面の少なくとも一部に沿って熱および／または接着剤結合または他の取付具がないことは、滑走界面を画定し、これは、膨らんだ場合に被制御拡張エレメント２０がステント－グラフト１２、１８の表面上を滑るのを可能にすることを助け、したがって被制御拡張エレメント２０の縮小量を制限することは、ステント－グラフト１２、１８につたわる（ｔｒａｎｓｌａｔｅ ｔｏ）。いくつかの態様により、例えば、ステントグラフト１２、１８と被制御拡張エレメント２０との間の締りばめは、構成部分間で滑走界面を提供する。別の言葉でいうと、内部人工器官１０の直径の拡張の間に、被制御拡張エレメント２０とステント－グラフト１２、１８との間の滑走界面は、被制御拡張エレメント２０の少なくとも一部が滑走界面においてステント－グラフト１２、１８と異なる速度で、縦寸法において変化すること（例えば、放射状拡張の間の収縮）を可能にする。 The setting process follows the outer surface of the controlled expansion element 20 through subsequent processing, placement, and implantation of the internal organ 10 without the use of heat and / or adhesive binding. It is believed to help hold the controlled expansion element 20 in place. In some embodiments, the absence of thermal and / or adhesive binding or other fittings along at least part of the interface between the controlled expansion element 20 and the stent-grafts 12, 18 provides a gliding interface. Demarcated, which helps allow the controlled expansion element 20 to slide on the surface of the stent-grafts 12, 18 when inflated, thus limiting the amount of reduction of the controlled expansion element 20. , Stent-grafts 12, 18 (translate to). In some embodiments, for example, the clamp between the stent grafts 12 and 18 and the controlled expansion element 20 provides a gliding interface in the component minutes. In other words, during the expansion of the diameter of the internal prosthesis 10, the sliding interface between the controlled expansion element 20 and the stent-grafts 12 and 18 is such that at least part of the controlled expansion element 20 slides. Allows changes in longitudinal dimensions (eg, contraction during radial expansion) at a different rate than stent-grafts 12, 18 at the interface.
本発明の範囲から離れることなく、記載された例示的な態様に種々の改変および追加をなすことができる。例えば、上記の態様は、特定の特徴をいうが、本発明の範囲はまた、上記の特徴のすべてを含まない異なる組み合わせの特徴および態様を有する態様を含む。
（態様）
（態様１）
ステントと前記ステントに固定されたベースグラフトとを含むステント－グラフトと、
連続した壁を有する被制御拡張エレメントと、
を含む、
直径を調節可能な内部人工器官であって、
前記ベースグラフトは第１終端および第２終端を有し、ならびに前記ステント－グラフトは自己拡張性でありおよび自己拡張力を有し、前記ステント－グラフトは最大直径拡張限界を有し、
前記被制御拡張エレメントは、初期直径拡張限界を有し、および前記ステント－グラフトの前記自己拡張力に加えて拡張力下で配置された場合に前記初期直径拡張限界と前記最大直径拡張限界との間の直径の範囲内の調節された直径に調節可能であり、前記拡張力を除いた後で前記被制御拡張エレメントは生理的条件下で前記調節された直径を維持するように構成されており、および前記ステント－グラフトは、前記調節された直径のための前記直径の範囲を前記最大直径拡張限界に制限するように構成されている、内部人工器官。
（態様２）
前記内部人工器官の直径の拡張の間に、前記被制御拡張エレメントと前記ステント－グラフトとの間の滑走界面は、前記被制御拡張エレメントの少なくとも一部が前記滑走界面で前記ステント－グラフトと異なる速度で縦寸法を変化させることを可能にするように、前記被制御拡張エレメントは、前記ステント－グラフトで前記滑走界面を画定している、態様１に記載の内部人工器官。
（態様３）
前記内部人工器官は生体体液を運ぶように構成された内側管腔を有し、およびさらに前記ベースグラフトは前記内部人工器官の前記内側管腔を画定している、態様１に記載の内部人工器官。
（態様４）
前記初期直径拡張限界において前記被制御拡張エレメントは直径で１つまたは２つ以上のテーパーを画定する、態様１に記載の内部人工器官。
（態様５）
前記被制御拡張エレメントは、第１終端部と、第２終端部と、前記第１終端部と前記第２終端部との間の中央部とを有し、およびさらに前記初期直径拡張限界において前記被制御拡張エレメントは、第１の直径へ外側に向かってテーパーしている前記第１終端部と、第２の直径へ外側に向かってテーパーしている前記第２終端部と、前記第１の直径および第２の直径より小さい直径を有する前記中央部と含む、態様１に記載の内部人工器官。
（態様６）
前記被制御拡張エレメントは、前記拡張力の適用で変形し、および生理的条件で前記調節された直径を維持するように構成された制御された拡張材料のスリーブを含む、態様１に記載の内部人工器官。
（態様７）
前記ベースグラフトは長さを有し、および前記ステント－グラフトは、裏地のついた領域および裏地のついていない領域を含み、前記裏地のついた領域は前記グラフトの前記長さに相当し、および前記裏地のついていない領域は覆いのないままである、態様１に記載の内部人工器官。
（態様８）
前記ステントは鎖リンクパターンを画定する区間を含み、前記区間は前記ステント－グラフトの前記裏地のついていない領域に相当する、態様８に記載の内部人工器官。
（態様９）
態様１～８のいずれか一項に記載の前記内部人工器官を用いて肝臓内門脈体静脈シャントを形成する方法であって、
送達直径寸法で患者の肝臓内に前記内部人工器官を配置することと、
前記内部人工器官がｉｎ ｓｉｔｕで前記初期直径拡張限界に自己拡張し、および前記患者の前記肝臓に固定されて肝臓内門脈体静脈シャントを形成するように、前記内部人工器官を配置することと、
前記被制御拡張エレメントの少なくとも一部が前記ステント－グラフトの前記最大直径拡張限界未満の調節された直径に選択的に拡大し、および前記調節された直径が生理的条件下で維持されるように、前記内部人工器官を配置した後で前記内部人工器官に内部圧力を掛けることと、
を含む、方法。
（態様１０）
肝臓内門脈体静脈シャントを形成する方法であって、
送達直径寸法で内部人工器官を患者の肝臓内に配置することであって、前記内部人工器官は自己拡張性ステント－グラフトおよび被制御拡張エレメントを含むことと、
前記内部人工器官が、自己拡張しおよび前記患者の前記肝臓に固定されて肝臓内門脈体静脈シャントを形成するように、前記内部人工器官を配置することであって、初期の配置された直径寸法が生理学的条件下で維持されるように、前記被制御拡張エレメントは、前記内部人工器官の直径被制御部分の拡張を前記初期の配置された直径寸法に制限することと、
前記被制御拡張エレメントの少なくとも一部が機械的に変化されおよび前記内部人工器官の前記直径被制御部分の直径寸法が拡大された直径寸法に選択的に拡大し、および生理学的条件下で前記拡大された直径寸法に維持されるように、前記内部人工器官を配置した後で前記内部人工器官に内部圧力を掛けることと、
を含む、方法。
（態様１１）
前記内部圧力は、膨らませることができるバルーンによって掛けられる、態様１０に記載の方法。
（態様１２）
内部人工器官の性能を評価し、そして次に前記内部人工器官の前記直径寸法をｉｎ ｓｉｔｕでさらに拡大させることをさらに含む、態様１０に記載の方法。
（態様１３）
前記内部人工器官の前記部分を選択的に拡大させることは、血液が前記内部人工器官を通って流れることの増加となる、態様１０に記載の方法。
（態様１４）
前記内部人工器官を配置した後で少なくとも１つの圧力測定を行って、門脈と全身の静脈循環との間の圧力勾配を決定することをさらに含む、態様１０～１３のいずれか一項に記載の方法。
（態様１５）
前記内部人工器官の前記直径被制御部分を選択的に拡張した後で少なくとも１つの圧力測定を行って患者の門脈と全身の静脈循環との間の圧力勾配を決定することと、前記内部人工器官の前記直径被制御部分を機械的に変化させて前記直径被制御部分を選択的にさらに拡張することと、をさらに含む、態様１０～１３のいずれか一項に記載の方法。
（態様１６）
前記内部圧力は前記内部人工器官の前記直径被制御部分に適用されて、前記被制御拡張エレメントを変形させる、態様１０～１３のいずれか一項に記載の方法。
（態様１７）
前記内部人工器官の前記直径被制御部分は、前記ステント－グラフトの全長未満で延びている、態様１０～１３のいずれか一項に記載の方法。
（態様１８）
門脈圧亢進症を治療するための方法であって、
ステントと、第１グラフト部分と、前記第１グラフト部分の少なくとも一部に沿って延びている第２グラフト部分と、を含む内部人工器官を提供することであって、前記内部人工器官は管腔内に挿入されるための送達拘束部によって第１の直径寸法に拘束され、および前記送達拘束部が解放された場合に、第２の拡大された直径寸法に自己拡張するように構成されており、前記第２グラフト部分は、制限された直径への自己拡張によるさらなる直径の拡大を制限されている前記内部人工器官の直径被制御部分を画定していることと、
門脈および肝静脈中に前記内部人工器官を配置することと、
前記送達拘束部を解放することおよび前記内部人工器官を自己拡張可能にすることにより前記内部人工器官を前記第２の拡大された直径寸法に配置することであって、前記直径被制御部分は、生理学的条件下で前記制限された直径を維持することと、
前記内部人工器官の前記直径被制御部分に膨張力を掛けることによって、前記内部人工器官の前記直径被制御部分の少なくとも一部を調節された直径に直径方向で拡張させることを含む、ｉｎ ｓｉｔｕで前記内部人工器官の直径の調節を行うことであって、前記内部人工器官の前記直径被制御部分は、生理学的条件下で前記調節された直径を維持することと、を含む、方法。
（態様１９）
前記内部人工器官の前記直径被制御部分を直径方向で拡張させることは、門脈と全身の静脈循環との間の圧力勾配を低下させる、態様１８に記載の方法。
（態様２０）
前記内部人工器官の前記直径被制御部分を直径方向で拡張させることは、前記第２グラフト部分を変形させる、態様１８に記載の方法。
（態様２１）
少なくとも１つの圧力測定を行い、そして次にさらに前記内部人工器官の前記直径被制御部分を第２の拡大された直径に直径方向で拡張させること、をさらに含む、態様１８に記載の方法。
（態様２２）
前記内部人工器官の前記直径被制御部分を前記調節された直径より大きいさらに拡大された直径に直径方向で拡張させることをさらに含む、態様１８に記載の方法。
（態様２３）
前記内部人工器官の前記直径被制御部分を前記ステントおよび前記第１グラフト部分によって画定された最大直径拡張限界に直径方向で拡張させることをさらに含む、態様１８に記載の方法。
（態様２４）
前記内部人工器官の複数の直径の調節をｉｎ ｓｉｔｕで行うことをさらに含む、態様１８に記載の方法。
（態様２５）
前記内部人工器官は、裏地のついていない領域を含み、前記方法は前記門脈中に前記裏地のついていない領域を配置することをさらに含む、態様１８に記載の方法。
（態様２６）
門脈圧亢進症を治療するための方法であって、
シャントの形成の少なくとも２４時間後に、少なくとも１つの圧力測定を行って、門脈と全身の静脈循環との間の内部人工器官によって形成された前記シャントから生じる圧力勾配を決定することであって、前記内部人工器官は、
少なくとも第１セグメントおよび第２セグメントを有する自己拡張性ステントと、
前記第１セグメント上のグラフト構成部分と、
を含み、機械的に調節できる被制御拡張エレメントによって前記グラフト構成部分の少なくとも一部は初期配置直径に維持されていることと、
前記被制御拡張エレメントによって前記初期配置直径に維持されている前記グラフト構成部分の少なくとも一部が前記被制御拡張エレメントによって拡大された直径に拡大されおよび維持されて前記圧力勾配を低下させるように、膨張力で前記被制御拡張エレメントを機械的に調節することによって前記被制御拡張エレメントの直径方向で拡張させることと、を含む、方法。
（態様２７）
前記被制御拡張エレメントを直径方向で拡張させた後に少なくとも１つの圧力測定を行うこと、そして次に前記被制御拡張エレメントによって前記拡大された直径で維持されている前記グラフト構成部分の少なくとも一部が前記被制御拡張エレメントを前記圧力勾配に低下させることによってさらに拡大された直径にさらに拡大されおよび維持されるように、前記被制御拡張エレメントをさらに直径方向で拡張させることをさらに含む、態様２６に記載の方法。
Various modifications and additions can be made to the exemplary embodiments described without leaving the scope of the invention. For example, although the above embodiments refer to specific features, the scope of the invention also includes embodiments having different combinations of features and embodiments that do not include all of the above features.
(Aspect)
(Aspect 1)
A stent-graft, including a stent and a base graft immobilized on the stent, and
A controlled expansion element with a continuous wall,
including,
An internal artificial organ with adjustable diameter
The base graft has first and second terminations, and the stent-graft is self-expandable and self-expanding, and the stent-graft has a maximum diameter expansion limit.
The controlled expansion element has an initial diameter expansion limit, and when placed under the expansion force in addition to the self-expansion force of the stent-graft, the initial diameter expansion limit and the maximum diameter expansion limit. It is adjustable to an adjusted diameter within the range of diameters between, and after removing the expanding force, the controlled expansion element is configured to maintain the adjusted diameter under physiological conditions. , And the stent-graft is an internal prosthesis configured to limit the range of diameter for the adjusted diameter to the maximum diameter expansion limit.
(Aspect 2)
During the expansion of the diameter of the internal prosthesis, the gliding interface between the controlled expansion element and the stent-graft is such that at least a portion of the controlled expansion element differs from the stent-graft at the gliding interface. The internal prosthesis of aspect 1, wherein the controlled expansion element defines the gliding interface with the stent-graft so that the longitudinal dimension can be varied at a rate .
(Aspect 3)
The internal prosthesis according to aspect 1, wherein the internal prosthesis has an medial lumen configured to carry body fluids, and further the base graft defines the medial lumen of the internal prosthesis. ..
(Aspect 4)
The internal prosthesis according to aspect 1, wherein at the initial diameter expansion limit, the controlled expansion element defines one or more tapers in diameter.
(Aspect 5)
The controlled expansion element has a first termination, a second termination, and a central portion between the first termination and the second termination, and further at the initial diameter expansion limit. The controlled expansion element has the first termination that tapers outward to a first diameter, the second termination that tapers outward to a second diameter, and the first. The internal artificial organ according to aspect 1, comprising the central portion having a diameter and a diameter smaller than the second diameter.
(Aspect 6)
The interior of aspect 1, wherein the controlled expansion element comprises a sleeve of a controlled expansion material that is deformed by the application of the expansion force and is configured to maintain the adjusted diameter under physiological conditions. Artificial organ.
(Aspect 7)
The base graft has a length, and the stent-graft includes a lined area and an unlined area, the lined area corresponding to the length of the graft, and said. The internal prosthesis according to aspect 1, wherein the unlined area remains uncovered.
(Aspect 8)
8. The internal prosthesis of aspect 8, wherein the stent comprises a section defining a chain link pattern, wherein the section corresponds to the unlined region of the stent-graft.
(Aspect 9)
A method for forming an intrahepatic portal vein venous shunt using the internal artificial organ according to any one of aspects 1 to 8.
Placing the internal prosthesis within the patient's liver in the delivery diameter dimension and
With the placement of the internal prosthesis such that the internal prosthesis self-expands to the initial diameter dilation limit in situ and is anchored to the liver of the patient to form an intrahepatic portal vein venous shunt. ,
At least a portion of the controlled expansion element selectively expands to an adjusted diameter below the maximum diameter expansion limit of the stent-graft, and the adjusted diameter is maintained under physiological conditions. After placing the internal prosthesis, applying internal pressure to the internal prosthesis,
Including, how.
(Aspect 10)
A method of forming an intrahepatic portal vein shunt,
To place the internal prosthesis in the patient's liver in the delivery diameter dimension, said internal prosthesis comprising a self-expandable stent-graft and a controlled dilation element.
By arranging the internal prosthesis such that the internal prosthesis self-expands and is anchored to the liver of the patient to form an intrahepatic portal vein venous shunt, the initial arranged diameter. The controlled expansion element limits the expansion of the diameter controlled portion of the internal prosthesis to the initially placed diameter dimension so that the dimensions are maintained under physiological conditions.
At least a portion of the controlled expansion element is mechanically altered and the diameter dimension of the diameter controlled portion of the internal prosthesis selectively expands to an expanded diameter dimension, and said expansion under physiological conditions. After placing the internal prosthesis, applying internal pressure to the internal prosthesis so that it is maintained at the desired diameter dimension,
Including, how.
(Aspect 11)
10. The method of aspect 10, wherein the internal pressure is applied by a balloon that can be inflated.
(Aspect 12)
10. The method of aspect 10, comprising assessing the performance of the internal prosthesis and then further expanding the diameter dimension of the internal prosthesis in situ.
(Aspect 13)
10. The method of aspect 10, wherein selectively enlarging the portion of the internal prosthesis results in increased flow of blood through the internal prosthesis.
(Aspect 14)
13. A section according to any one of embodiments 10-13, further comprising making at least one pressure measurement after placing the internal prosthesis to determine a pressure gradient between the portal vein and systemic venous circulation. the method of.
(Aspect 15)
After selectively expanding the diameter controlled portion of the internal prosthesis, at least one pressure measurement is performed to determine the pressure gradient between the patient's portal vein and systemic venous circulation, and the internal prosthesis. The method according to any one of aspects 10 to 13, further comprising mechanically varying the diameter controlled portion of the organ to selectively further expand the diameter controlled portion.
(Aspect 16)
13. The method of any one of embodiments 10-13, wherein the internal pressure is applied to the diameter controlled portion of the internal artificial organ to deform the controlled expansion element.
(Aspect 17)
The method of any one of aspects 10-13, wherein the diameter controlled portion of the internal prosthesis extends below the full length of the stent-graft.
(Aspect 18)
A method for treating portal hypertension,
To provide an internal prosthesis comprising a stent, a first graft portion, and a second graft portion extending along at least a portion of the first graft portion, wherein the internal prosthesis is a lumen. It is constrained to a first diameter dimension by a delivery restraint for insertion into, and is configured to self-expand to a second enlarged diameter dimension when the delivery restraint is released. The second graft portion defines a diameter controlled portion of the internal prosthesis that is restricted from further diameter expansion due to self-expansion to a restricted diameter.
Placing the internal prosthesis in the portal vein and hepatic vein,
By releasing the delivery restraint and making the internal prosthesis self-expandable, the internal prosthesis is placed in the second enlarged diameter dimension, the diameter controlled portion. Maintaining the restricted diameter under physiological conditions and
In situ, comprising applying an expansion force to the diameter controlled portion of the internal organ to diametrically expand at least a portion of the diameter controlled portion of the internal organ to a regulated diameter. A method comprising adjusting the diameter of the internal artificial organ, wherein the diameter controlled portion of the internal artificial organ maintains the adjusted diameter under physiological conditions.
(Aspect 19)
18. The method of aspect 18, wherein expanding the diameter controlled portion of the internal prosthesis in the diametrical direction reduces the pressure gradient between the portal vein and systemic venous circulation.
(Aspect 20)
18. The method of aspect 18, wherein expanding the diameter controlled portion of the internal prosthesis in the diametrical direction deforms the second graft portion.
(Aspect 21)
18. The method of aspect 18, further comprising making at least one pressure measurement and then diametrically expanding the diameter controlled portion of the internal prosthesis to a second enlarged diameter.
(Aspect 22)
18. The method of aspect 18, further comprising expanding the diameter controlled portion of the internal prosthesis in the diametrical direction to a further expanded diameter greater than the regulated diameter.
(Aspect 23)
18. The method of aspect 18, further comprising expanding the diameter controlled portion of the internal prosthesis in the radial direction to the maximum diameter expansion limit defined by the stent and the first graft portion.
(Aspect 24)
18. The method of aspect 18, further comprising adjusting a plurality of diameters of the internal prosthesis in situ.
(Aspect 25)
18. The method of aspect 18, wherein the internal prosthesis comprises an unlined area, wherein the method further comprises placing the unlined area in the portal vein.
(Aspect 26)
A method for treating portal hypertension,
At least 24 hours after the formation of the shunt, at least one pressure measurement is performed to determine the pressure gradient resulting from the shunt formed by the internal prosthesis between the portal vein and the systemic venous circulation. The internal artificial organ is
With a self-expandable stent having at least the first and second segments,
The graft component on the first segment and
At least a portion of the graft component is maintained at the initial placement diameter by a mechanically adjustable controlled expansion element.
At least a portion of the graft component maintained at the initial placement diameter by the controlled expansion element is expanded and maintained at the diameter expanded by the controlled expansion element to reduce the pressure gradient. A method comprising expanding in the radial direction of the controlled expansion element by mechanically adjusting the controlled expansion element with an expansion force.
(Aspect 27)
At least one pressure measurement is made after expanding the controlled expansion element in the radial direction, and then at least a portion of the graft component maintained at the expanded diameter by the controlled expansion element. 26 further comprises expanding the controlled expansion element further diametrically so that it is further expanded and maintained to a further expanded diameter by reducing the controlled expansion element to the pressure gradient. The method described.
Claims (17)
連続した壁を有する被制御拡張エレメントと、
を含む、
直径を調節可能な内部人工器官であって、
前記ベースグラフトは第１終端および第２終端を有し、ならびに前記ステント－グラフトは自己拡張性でありおよび自己拡張力を有し、前記ステント－グラフトは最大直径拡張限界を有し、
前記被制御拡張エレメントは、初期直径拡張限界を有し、および前記ステント－グラフトの前記自己拡張力に加えて拡張力下で配置された場合に前記初期直径拡張限界と前記最大直径拡張限界との間の直径の範囲内の調節された直径に調節可能であり、前記拡張力を除いた後で前記被制御拡張エレメントは生理的条件下で前記調節された直径を維持するように構成されており、および前記ステント－グラフトは、前記調節可能な直径の範囲の上限を前記最大直径拡張限界に制限するように構成されており、
前記内部人工器官の直径の拡張の間に、前記被制御拡張エレメントと前記ステント－グラフトとの間の滑走界面は、前記被制御拡張エレメントの少なくとも一部の縦寸法の変化の速度が前記滑走界面で前記ステント－グラフトの縦寸法の変化の速度と異なるように、前記被制御拡張エレメントは、前記ステント－グラフトで前記滑走界面を画定している、内部人工器官。 A stent-graft, including a stent and a base graft immobilized on the stent, and
A controlled expansion element with a continuous wall,
including,
An internal artificial organ with adjustable diameter
The base graft has first and second terminations, and the stent-graft is self-expandable and self-expanding, and the stent-graft has a maximum diameter expansion limit.
The controlled expansion element has an initial diameter expansion limit, and when placed under the expansion force in addition to the self-expansion force of the stent-graft, the initial diameter expansion limit and the maximum diameter expansion limit. It is adjustable to an adjusted diameter within the range of diameters between, and after removing the expanding force, the controlled expansion element is configured to maintain the adjusted diameter under physiological conditions. , And the stent-graft is configured to limit the upper limit of the adjustable diameter range to the maximum diameter expansion limit.
During the expansion of the diameter of the internal prosthesis, the gliding interface between the controlled expansion element and the stent-graft is such that the rate of change in the longitudinal dimension of at least a portion of the controlled expansion element is the gliding interface. The controlled expansion element is an internal prosthesis that defines the gliding interface at the stent-graft so that it differs from the rate of change in the longitudinal dimension of the stent-graft.
ステントをベースグラフトに固定してステント－グラフトを形成させることと、
前記ステント－グラフトに沿って被制御拡張エレメントを配置することと、
前記被制御拡張エレメントを前記ステント－グラフトに連結することと、
を含み、
前記ステント－グラフトは自己拡張性でありおよび自己拡張力を有し、前記ステント－グラフトは最大直径拡張限界を有し、
前記被制御拡張エレメントは、初期直径拡張限界を有し、および前記ステント－グラフトの前記自己拡張力に加えて拡張力下で配置された場合に前記初期直径拡張限界と前記最大直径拡張限界との間の直径の範囲内の調節された直径に調節可能であり、前記拡張力を除いた後で前記被制御拡張エレメントは生理的条件下で前記調節された直径を維持するように構成されており、
前記ステント－グラフトは、前記調節可能な直径の範囲の上限を前記最大直径拡張限界に制限するように構成されており、
前記内部人工器官の直径の拡張の間に、前記被制御拡張エレメントと前記ステント－グラフトとの間の滑走界面は、前記被制御拡張エレメントの少なくとも一部の縦寸法の変化の速度が前記滑走界面で前記ステント－グラフトの縦寸法の変化の速度と異なるように、前記被制御拡張エレメントは、前記ステント－グラフトで前記滑走界面を画定している、方法。 A method of manufacturing internal artificial organs
Fixing the stent to the base graft to form a stent-graft,
Placing a controlled expansion element along the stent-graft and
Connecting the controlled expansion element to the stent-graft and
Including
The stent-graft is self-expandable and has self-expanding power, and the stent-graft has a maximum diameter expansion limit.
The controlled expansion element has an initial diameter expansion limit, and when placed under the expansion force in addition to the self-expansion force of the stent-graft, the initial diameter expansion limit and the maximum diameter expansion limit. It is adjustable to an adjusted diameter within the range of diameters between, and after removing the expanding force, the controlled expansion element is configured to maintain the adjusted diameter under physiological conditions. ,
The stent-graft is configured to limit the upper limit of the adjustable diameter range to the maximum diameter expansion limit.
During the expansion of the diameter of the internal prosthesis, the gliding interface between the controlled expansion element and the stent-graft is such that the rate of change in the longitudinal dimension of at least a portion of the controlled expansion element is the gliding interface. The method in which the controlled expansion element defines the gliding interface with the stent-graft so as to be different from the rate of change in the longitudinal dimension of the stent-graft.
自己拡張性であるステントをベースグラフトに固定してステント－グラフトを形成させることと、
前記ステント－グラフトの一部の周りに連続した壁を有する被制御拡張エレメントを配置することと、
前記ステント－グラフトに前記被制御拡張エレメントを連結することと、
を含み、
前記ステント－グラフトは自己拡張性でありおよび自己拡張力を有し、前記ステント－グラフトは最大直径拡張限界を有し、
前記被制御拡張エレメントは、初期直径拡張限界を有し、および前記ステント－グラフトの前記自己拡張力に加えて拡張力下で配置された場合に前記初期直径拡張限界と前記最大直径拡張限界との間の直径の範囲内の調節された直径に調節可能であり、前記拡張力を除いた後で前記被制御拡張エレメントは生理的条件下で前記調節された直径を維持するように構成されており、
前記ステント－グラフトは、前記調節可能な直径の範囲の上限を前記最大直径拡張限界に制限するように構成されており、
前記内部人工器官の直径の拡張の間に、前記被制御拡張エレメントと前記ステント－グラフトとの間の滑走界面は、前記被制御拡張エレメントの少なくとも一部の縦寸法の変化の速度が前記滑走界面で前記ステント－グラフトの縦寸法の変化の速度と異なるように、前記被制御拡張エレメントは、前記ステント－グラフトで前記滑走界面を画定している、方法。 A method for producing internal artificial organs with adjustable diameters,
Fixing a self-expanding stent to the base graft to form a stent-graft,
Placing a controlled expansion element with a continuous wall around a portion of the stent-graft and
Connecting the controlled expansion element to the stent-graft and
Including
The stent-graft is self-expandable and has self-expanding power, and the stent-graft has a maximum diameter expansion limit.
The controlled expansion element has an initial diameter expansion limit, and when placed under the expansion force in addition to the self-expansion force of the stent-graft, the initial diameter expansion limit and the maximum diameter expansion limit. It is adjustable to an adjusted diameter within the range of diameters between, and after removing the expanding force, the controlled expansion element is configured to maintain the adjusted diameter under physiological conditions. ,
The stent-graft is configured to limit the upper limit of the adjustable diameter range to the maximum diameter expansion limit.
During the expansion of the diameter of the internal prosthesis, the gliding interface between the controlled expansion element and the stent-graft is such that the rate of change in the longitudinal dimension of at least a portion of the controlled expansion element is the gliding interface. The method in which the controlled expansion element defines the gliding interface with the stent-graft so as to be different from the rate of change in the longitudinal dimension of the stent-graft.
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