JPWO2020225698A5 - - Google Patents
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- JPWO2020225698A5 JPWO2020225698A5 JP2021565133A JP2021565133A JPWO2020225698A5 JP WO2020225698 A5 JPWO2020225698 A5 JP WO2020225698A5 JP 2021565133 A JP2021565133 A JP 2021565133A JP 2021565133 A JP2021565133 A JP 2021565133A JP WO2020225698 A5 JPWO2020225698 A5 JP WO2020225698A5
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Claims (21)
支持構造(2)を備え、
前記支持構造(2)は、管腔(4)を区切る中心支持構造部分(3)を有し、
前記支持構造(2)は、第1固定部分(5)と反対側の第2固定部分(6)と、を有し、
前記支持構造(2)は、患者の血管系を通して挿入するための圧縮されたチューブ構成と、前記第1および第2固定部分(5、6)が前記中心支持構造部分(3)から外側に向かって半径方向に伸びてその間の仕切り(7)を圧縮し、前記仕切り(7)に存在する欠損または穴または開口部を通って、前記仕切り(7)の両側に前記支持構造(2)を配置する拡張構成と、との間で伸縮するよう構成され、
前記通過可能な隔壁閉塞デバイス(1)は、さらに少なくとも1つの隔壁(8)を備え、
前記隔壁(8)は、前記支持構造(2)により支持され、前記隔壁(8)が弛緩構成である場合に、前記管腔(4)の大部分を閉塞するよう配置され、
前記隔壁(8)は、前記仕切り(7)で区切られた第1区画(9、10)に挿入された医療機器が、前記隔壁(8)を通過して、前記管腔(4)を通り、前記仕切り(7)で区切られた第2区画(10、9)に入ることができるよう構成され、
前記隔壁(8)は、複数の閉塞ブリッジ(21)を有し、
それぞれの前記複数の閉塞ブリッジ(21)は、対向する細長い本体端部(51、52)と、対向する長手方向端部(22)と、を有する細長い本体(50)を有し、
任意の閉塞ブリッジ(21)の前記長手方向端部(22)の少なくとも一部と、さらなる閉塞ブリッジ(21)の前記長手方向端部(22)の少なくとも一部とは、前記隔壁(8)への少なくともスリットまたは切込み(27)を画定し、
それぞれの閉塞ブリッジ(21)の前記対向する端部(51、52)の両方は、前記支持構造(2)により、直接的にまたは間接的に接続される、または支持され、
弛緩構成の場合に、前記隔壁(8)は、平面形状であり、前記閉塞ブリッジ(21)は、前記支持構造(2)に引っ張られ、
前記隔壁(8)の弛緩構成において、前記複数の閉塞ブリッジ(21)のそれぞれの閉塞ブリッジ(21)は、前記複数の閉塞ブリッジ(21)の少なくとも前記さらなる閉塞ブリッジ(21)の近くに配置され、
前記隔壁(8)は、弾性膜であり、
前記閉塞ブリッジ(21)は、前記医療機器が前記隔壁(8)を通過できるよう離れて延びるよう構成される、
通過可能な隔壁閉塞デバイス(1)。 A passable septum occlusion device (1), comprising:
comprising a support structure (2);
said support structure (2) having a central support structure portion (3) delimiting a lumen (4);
The support structure (2) has a first fixed portion (5) and an opposite second fixed portion (6),
Said support structure (2) comprises a compressed tube configuration for insertion through a patient's vasculature and said first and second fixation portions (5,6) extend outwardly from said central support structure portion (3). to radially extend to compress the partition (7) therebetween and locate said support structure (2) on either side of said partition (7) through defects or holes or openings present in said partition (7). and configured to stretch between and
said passable septum occlusion device (1) further comprising at least one septum (8);
said septum (8) is supported by said support structure (2) and arranged to occlude a majority of said lumen (4) when said septum (8) is in a relaxed configuration;
The septum (8) allows a medical device inserted into the first compartment (9, 10) separated by the partition (7) to pass through the septum (8) and through the lumen (4). , configured to enter a second compartment (10, 9) separated by the partition (7),
said septum (8) having a plurality of closing bridges (21),
each of said plurality of occlusion bridges (21) has an elongated body (50) having opposite elongated body ends ( 51, 52) and opposite longitudinal ends (22);
At least a portion of said longitudinal ends (22) of any occluding bridge (21) and at least a portion of said longitudinal ends (22) of further occluding bridges (21) are connected to said septum (8). ) defining at least a slit or cut (27) into
both said opposite ends (51, 52) of each occlusion bridge (21) are directly or indirectly connected or supported by said support structure (2);
in the relaxed configuration, said septum (8) is planar and said occlusion bridge (21) is pulled onto said support structure (2);
In the relaxed configuration of said septum (8), each occlusion bridge (21) of said plurality of occlusion bridges (21) is positioned near at least said further occlusion bridge (21) of said plurality of occlusion bridges (21). ,
The partition (8) is an elastic membrane,
said occlusion bridge (21) is configured to extend apart to allow said medical device to pass through said septum (8);
A passable septum occlusion device (1).
請求項1に記載の通過可能な隔壁閉塞デバイス(1)。 In the relaxed configuration of said septum (8) each said opposite longitudinal end (22) defines an elongated narrow opening or elongated slit (27) at the end of an adjacent occlusion bridge (21). ,
Passable septum occlusion device (1) according to claim 1.
請求項1または2に記載の通過可能な隔壁閉塞デバイス(1)。 in the relaxed configuration of said septum (8) each of said plurality of occlusion bridges (21) of each septum of said at least one septum (8) lies in a single plane;
Passable septum occlusion device (1) according to claim 1 or 2.
請求項1から3のいずれか1項に記載の通過可能な隔壁閉塞デバイス(1)。 In the relaxed configuration of said bulkhead (8) each said closure bridge (21) has at least part of its longitudinal end (22) facing at least part of the longitudinal direction of said further closure bridge (21). is positioned at least near said further occluding bridge (21) so as to
A passable septum occlusion device (1) according to any one of claims 1 to 3 .
請求項1から4のいずれか1項に記載の通過可能な隔壁閉塞デバイス(1)。 In the relaxed configuration of the septum (8), each of the opposed longitudinal ends (22) is such that the total length of the elongated body (50) of the occlusion bridge (21) spans most of the lumen (4). arranged to be occluded,
Passable septum occlusion device (1) according to any one of claims 1 to 4 .
請求項1から5のいずれか1項に記載の通過可能な隔壁閉塞デバイス(1)。 In the relaxed configuration of said septum (8), said slit or notch (27) is a longitudinal extension of said elongate body (50) of said respective occlusion bridge (21) defining said slit or notch (27). having a longitudinal extension equal to the entirety of
Passable septum occlusion device (1) according to any one of claims 1 to 5 .
請求項1から6のいずれか1項に記載の通過可能な隔壁閉塞デバイス(1)。 both said opposite ends (51, 52) of each closing bridge (21) are directly or indirectly connected or supported by said central support structure portion (3) of said support structure (2); to be
A passable septum occlusion device (1) according to any one of claims 1 to 6 .
または、
前記隔壁(8)は、シリコーン、または医療用エラストマ、またはポリウレタン、または生体内分解性材料、または生体吸収性材料により形成され、前記隔壁(8)は、少なくとも150%の変形が可能な弾性材料により形成される、
請求項1から7のいずれか1項に記載の通過可能な隔壁閉塞デバイス(1)。 said partition (8) is made of an elastic material that is deformable in the range of at least 10% or 20%;
or,
Said septum (8) is made of silicone , or medical elastomer, or polyurethane, or biodegradable material, or bioabsorbable material, and said septum (8) is an elastic material capable of deformation of at least 150%. formed by material,
Passable septum occlusion device (1) according to any one of claims 1 to 7 .
請求項1から8のいずれか1項に記載の通過可能な隔壁閉塞デバイス(1)。 said occlusion bridges (21) of said septum (8) are separated from each other at an occlusion bridge extension or central portion (29) of said occlusion bridge (27) but are integrally joined;
Passable septum occlusion device (1) according to any one of claims 1 to 8 .
または、
少なくとも1つの前記閉塞ブリッジ(21)は、長手方向の延長部を有し、正方形または長方形形状の前記長手方向と直交する方向に評価された閉塞ブリッジセクション(23)を備える、
または、
少なくとも1つの前記閉塞ブリッジ(21)は、長手方向の延長部を有し、セクションの中心からそのセクション端部(24)までを通過するテーパー形状の前記長手方向と直交する方向に評価された閉塞ブリッジセクション(23)を備える、
または、
少なくとも1つの前記閉塞ブリッジ(21)は、長手方向の延長部を有し、第1セクションベース側面(25)からセクション端部(24)までを通過するテーパー形状の前記長手方向と直交する方向に評価された閉塞ブリッジセクション(23)を備える、
または、
少なくとも1つの前記閉塞ブリッジ(21)は、長手方向の延長部を有し、第1セクションベース側面(25)からより小さいセクション側面(26)までを通過するテーパー形状の前記長手方向と直交する方向に評価された閉塞ブリッジセクション(23)を備える、
または、
少なくとも1つの前記閉塞ブリッジ(21)は、長手方向の延長部を有し、楕円形、または三角形、またはひし形、または台形形状の前記長手方向と直交する方向に評価された閉塞ブリッジセクション(23)を備える、
請求項1から9のいずれか1項に記載の通過可能な隔壁閉塞デバイス(1)。 at least one said occlusion bridge (21) comprises a occlusion bridge section (23) having a longitudinal extension and measured perpendicular to said longitudinal direction of circular shape;
or,
at least one said occluding bridge (21) has a longitudinal extension and comprises a occluding bridge section (23) rated perpendicular to said longitudinal direction of square or rectangular shape;
or,
At least one said closing bridge (21) had a longitudinal extension and was measured perpendicular to said longitudinal direction with a tapered shape passing from the center of the section to its section end (24). comprising a closed bridge section (23),
or,
At least one of said closure bridges (21) has a longitudinal extension and is tapered transversely to said longitudinal direction passing from a first section base side (25) to a section end (24). comprising a rated occlusion bridge section (23),
or,
At least one said closing bridge (21) has a longitudinal extension and is tapered transversely to said longitudinal direction passing from a first section base side (25) to a smaller section side (26). with a closed bridge section (23) rated to
or,
At least one said closing bridge (21) has a longitudinal extension and a closing bridge section (23) rated perpendicular to said longitudinal direction of elliptical, or triangular, or rhombic, or trapezoidal shape comprising a
Passable septum occlusion device (1) according to any one of claims 1 to 9 .
前記一対の隔壁(28)の前記隔壁(8)は、互いに対向して配置され、前記一対の隔壁(28)の第1隔壁(8)の前記複数の閉塞ブリッジ(21)は、前記一対の隔壁(28)の第2隔壁(8)の前記複数の隔壁閉塞ブリッジ(21)に対してオフセットされて、前記第1隔壁(8)の前記複数の閉塞ブリッジを少なくとも部分的に、前記第2隔壁(8)の前記複数の細長いスリットまたは切込み(27)に重なる、
請求項1から10のいずれか1項に記載の通過可能な隔壁閉塞デバイス(1)。 said device comprising a pair of septums (28), each said septum (8) of said pair of septa (28) comprising a plurality of occlusive bridges (21);
The partitions (8) of the pair of partitions (28) are arranged opposite each other, and the plurality of closing bridges (21) of the first partitions (8) of the pair of partitions (28) are arranged in the pair of offset with respect to said plurality of septum occlusion bridges (21) of said second septum (8) of septum (28) to at least partially offset said plurality of occlusion bridges (21) of said first septum (8); overlying said plurality of elongated slits or cuts (27) in the septum (8);
A passable septum occlusion device (1) according to any one of claims 1 to 10 .
前記第1隔壁(8)の前記複数の閉塞ブリッジ(21)の前記閉塞ブリッジセクション(23)のテーパー形状は、前記第2隔壁(8)に向かって次第に細くなる、 the tapered shape of the closure bridge section (23) of the plurality of closure bridges (21) of the first bulkhead (8) tapers towards the second bulkhead (8);
請求項11に記載の通過可能な隔壁閉塞デバイス(1)。 Passable septum occlusion device (1) according to claim 11.
請求項11または12に記載の通過可能な隔壁閉塞デバイス(1)。 Passable septum occlusion device (1) according to claim 11 or 12.
請求項1から13のいずれか1項に記載の通過可能な隔壁閉塞デバイス(1)。 said bulkhead (8) comprises a bulkhead reinforcing structure (30), said bulkhead reinforcing structure (30) comprising bulkhead ribs (31) adapted to form a supporting scaffold ;
Passable septum occlusion device (1) according to any one of claims 1 to 13 .
または、or,
前記隔壁強化構造(30)は、円周方向に延びる少なくとも1つのリブ(33)を備える、 said bulkhead reinforcing structure (30) comprises at least one circumferentially extending rib (33);
または、or,
前記隔壁強化構造(30)は、少なくとも1つの半径方向に延びるリブ(34)を備える Said bulkhead reinforcement structure (30) comprises at least one radially extending rib (34).
または、or,
前記隔壁強化構造(30)は、円の弦に沿って延びる少なくとも1つのリブ(35)を備える、said bulkhead reinforcing structure (30) comprises at least one rib (35) extending along a chord of a circle;
請求項14に記載の通過可能な隔壁閉塞デバイス(1)。 Passable septum occlusion device (1) according to claim 14.
それぞれの閉塞ブリッジ端部(51、52)は、前記隔壁外部環状連続部分(12)に接続されている、
または、
前記隔壁(8)は、前記支持構造(2)に直接的にまたは間接的に接続された隔壁外部環状連続部分(12)を備え、
それぞれの閉塞ブリッジ端部(51、52)は、前記隔壁外部環状連続部分(12)と一体的である、
請求項1から15のいずれか1項に記載の通過可能な隔壁閉塞デバイス(1)。 said bulkhead (8) comprises a bulkhead outer annular continuation (12) directly or indirectly connected to said support structure (2);
each closing bridge end (51, 52) is connected to said septum outer annular continuation (12) ;
or
said bulkhead (8) comprises a bulkhead outer annular continuation (12) directly or indirectly connected to said support structure (2);
each closing bridge end (51, 52) is integral with said septum outer annular continuation (12);
Passable septum occlusion device (1) according to any one of claims 1 to 15 .
または、
前記隔壁(8)は、前記隔壁(8)を形成する弾性を有する中空チューブまたはワイヤまたは糸ストレッチ(41)を形成するように折りたたまれた単一の弾性を有する中空チューブまたはワイヤまたは糸(40)を備える、
請求項1から16のいずれか1項に記載の通過可能な隔壁閉塞デバイス(1)。 said septum (8) comprises a plurality of elastic hollow tubes or wires or threads (42) comprising elastic hollow tube or wire or thread stretches (41) forming said septum (8) ;
or
Said septum (8) comprises a single elastic hollow tube or wire or thread (40) folded to form a stretch of elastic hollow tube or wire or thread (41) forming said septum (8). ) ,
A passable septum occlusion device (1) according to any one of claims 1 to 16 .
または、or,
前記隔壁(8)は、互いに並んで配置された、複数の弾性を有する中空チューブまたはワイヤまたは糸ストレッチ(41)を備える、 said septum (8) comprises a plurality of elastic hollow tubes or wire or thread stretches (41) arranged alongside each other;
または、or,
前記隔壁(8)は、互いに隣接した、複数の弾性を有する中空チューブまたはワイヤまたは糸ストレッチ(41)を備える、 said septum (8) comprises a plurality of elastic hollow tubes or wire or thread stretches (41) adjacent to each other;
または、or,
前記隔壁(8)は、複数の半径方向に配置された弾性を有する中空チューブまたはワイヤまたは糸ストレッチ(41)を備える、 said septum (8) comprises a plurality of radially arranged elastic hollow tubes or wire or thread stretches (41),
および、and,
前記隔壁(8)は、互いに平行な第1の複数の弾性を有する中空チューブまたはワイヤまたは糸ストレッチ(41)と、互いに平行であるが前記第1の複数の弾性を有する中空チューブまたはワイヤまたは糸ストレッチ(41)に対して垂直な第2の複数の弾性を有する中空チューブまたはワイヤまたは糸ストレッチ(41)と、を備える、 Said partition (8) comprises a first plurality of elastic hollow tubes or wires or thread stretches (41) parallel to each other and said first plurality of elastic hollow tubes or wires or threads parallel to each other. a second plurality of elastic hollow tube or wire or thread stretches (41) perpendicular to the stretches (41);
または、or,
前記隔壁(8)は、互いに平行な第1の複数の弾性を有する中空チューブまたはワイヤまたは糸ストレッチ(41)と、互いに平行であるが前記第1の複数の弾性を有する糸ストレッチ(41)に対して傾斜した少なくとも第2の複数の弾性を有する中空チューブまたはワイヤまたは糸ストレッチ(41)と、を備える、 Said septum (8) comprises a first plurality of elastic hollow tube or wire or thread stretches (41) parallel to each other and said first plurality of elastic thread stretches (41) parallel to each other. at least a second plurality of elastic hollow tubes or wire or thread stretches (41) inclined relative to
請求項17に記載の通過可能な隔壁閉塞デバイス(1)。 Passable septum occlusion device (1) according to claim 17.
前記支持構造(2)および前記隔壁(8)は、一体的である、
および/または、
前記支持構造は、医療用エラストマである、
請求項1から16のいずれか1項に記載の通過可能な隔壁閉塞デバイス(1)。 the support structure (2) is integral,
said support structure (2) and said partition (8) are integral;
and/or
the support structure is a medical elastomer;
A passable septum occlusion device (1) according to any one of claims 1 to 16 .
または、
前記デバイス(1)は、波状の閉塞ブリッジ本体(50)を有する閉塞ブリッジ(21)を有する隔壁8を備え、したがって、例えば医療機器による前記隔壁自体の可能な通過によって促されたそれぞれの閉塞ブリッジ(21)が伸長し、その後、前記隔壁(8)の閉じた位置に戻ることを可能にする、
または、
前記デバイス(1)は、波状の閉塞ブリッジ端部(22)を有する閉塞ブリッジ(21)を有する隔壁(8)を備え、前記閉塞ブリッジ端部は、前記細長いスリット(27)を画定する前記閉塞ブリッジ(21)の側面部分を意味し、したがって、医療機器による前記隔壁の可能な通過によって促されたそれぞれの閉塞ブリッジが伸長することを可能にし、前記機器が取り外された後、前記閉塞ブリッジ(21)、ひいては前記隔壁(8)自体の再閉鎖を容易にする、
請求項1から19のいずれか1項に記載の通過可能な隔壁閉塞デバイス(1)。 Said device (1) comprises a septum 8 having an occluding bridge (21) with an undulating occluding bridge body (50),
or,
Said device (1) comprises a septum 8 with an occlusion bridge (21) having an undulating occlusion bridge body (50), thus each occlusion bridge prompted by a possible passage of said septum itself by e.g. allowing (21) to extend and then return to the closed position of said septum (8);
or,
Said device (1) comprises a septum (8) having an occlusion bridge (21) with an undulating occlusion bridge end (22), said occlusion bridge end defining said occlusion bridge (27) defining said elongated slit (27). means a lateral portion of a bridge (21), thus allowing the respective occluding bridge to extend, prompted by the possible passage of said septum by a medical device, after said device has been removed, said occluding bridge ( 21), thus facilitating reclosure of said septum (8) itself;
A passable septum occlusion device (1) according to any one of claims 1 to 19 .
請求項1から20のいずれか1項に記載の通過可能な隔壁閉塞デバイス(1)。 said septum (8) is obtained from a single foil with said elongated slits (27) formed by laser cutting;
A passable septum occlusion device (1) according to any one of claims 1 to 20 .
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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IT201900006534 | 2019-05-03 | ||
IT102019000006534 | 2019-05-03 | ||
PCT/IB2020/054195 WO2020225698A1 (en) | 2019-05-03 | 2020-05-04 | Crossable interseptal occluder device |
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JP2022531433A JP2022531433A (en) | 2022-07-06 |
JPWO2020225698A5 true JPWO2020225698A5 (en) | 2023-05-01 |
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Application Number | Title | Priority Date | Filing Date |
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JP2021565133A Pending JP2022531433A (en) | 2019-05-03 | 2020-05-04 | Passable bulkhead blockage device |
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US (1) | US20220211361A1 (en) |
EP (2) | EP3962368B1 (en) |
JP (1) | JP2022531433A (en) |
CN (3) | CN114007520B (en) |
WO (1) | WO2020225698A1 (en) |
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