JPWO2020190620A5 - - Google Patents
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- JPWO2020190620A5 JPWO2020190620A5 JP2021555222A JP2021555222A JPWO2020190620A5 JP WO2020190620 A5 JPWO2020190620 A5 JP WO2020190620A5 JP 2021555222 A JP2021555222 A JP 2021555222A JP 2021555222 A JP2021555222 A JP 2021555222A JP WO2020190620 A5 JPWO2020190620 A5 JP WO2020190620A5
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- shell
- proximal portion
- expanding
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- 230000003204 osmotic effect Effects 0.000 claims description 16
- 230000003014 reinforcing effect Effects 0.000 claims description 14
- 201000008450 Intracranial aneurysm Diseases 0.000 claims description 12
- 208000021138 brain aneurysm Diseases 0.000 claims description 12
- 239000000017 hydrogel Substances 0.000 claims description 9
- 239000000463 material Substances 0.000 claims description 4
- 239000011148 porous material Substances 0.000 claims description 3
- 238000000034 method Methods 0.000 description 23
- 239000007943 implant Substances 0.000 description 12
- 206010002329 Aneurysm Diseases 0.000 description 3
- 210000001627 cerebral artery Anatomy 0.000 description 3
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 230000002708 enhancing effect Effects 0.000 description 1
Description
前述の発明は、明確性および理解の目的のために、ある程度詳細に、例証および実施例として、説明されているが、依然として、添付の請求項の範囲内に該当するであろう、ある変更および修正が、実践されてもよいことが明白となるであろう。
(付記)
(付記1)
患者の脳動脈瘤の治療のためのデバイスであって、
弾力性自己拡張浸透性シェルであって、前記弾力性自己拡張浸透性シェルは、カテーテル管腔内での送達のために構成される半径方向に拘束された伸長状態と、前記半径方向に拘束された状態に対して縦方向に短縮された構成を伴う拡張状態と、ともに織り合わされ、メッシュを形成し、前記浸透性シェルの空洞を画定する複数の伸長フィラメントとを含む、弾力性自己拡張浸透性シェル
を備え、
前記拡張状態は、近位部分および遠位部分を有し、前記近位部分は、前記メッシュに結合される少なくとも1つのコイルを含む、デバイス。
(付記2)
前記少なくとも1つのコイルは、前記複数のフィラメントのうちのフィラメントの少なくとも一部を中心として配置されるかまたはそれに結合される、付記1に記載のデバイス。
(付記3)
前記少なくとも1つのコイルは、螺旋形状を有する、付記1に記載のデバイス。
(付記4)
前記少なくとも1つのコイルは、ヒドロゲルを含む、付記1に記載のデバイス。
(付記5)
前記少なくとも1つのコイルは、約2~約10、約3~約12、約4~約8、約5~約10、約5~約15、約2~約30、および約2~約25から成る群から選択されるいくつかのコイルを備える、付記1に記載のデバイス。
(付記6)
前記近位部分は、前記浸透性シェルの遠位部分より高い半径方向剛性を有する、付記1に記載のデバイス。
(付記7)
前記近位部分は、前記浸透性シェルの遠位部分の半径方向剛性より1.5~3倍高い半径方向剛性を有する、付記1に記載のデバイス。
(付記8)
患者の脳動脈瘤の治療のためのデバイスであって、
弾力性自己拡張浸透性シェルであって、前記弾力性自己拡張浸透性シェルは、カテーテル管腔内での送達のために構成される半径方向に拘束された伸長状態と、前記半径方向に拘束された状態に対して縦方向に短縮された構成を伴う拡張状態と、ともに織り合わされ、メッシュを形成し、前記浸透性シェルの空洞を画定する複数の伸長フィラメントとを含む、弾力性自己拡張浸透性シェル
を備え、
前記拡張状態は、近位部分および遠位部分を有し、前記近位部分は、前記デバイスの近位剛性を増強させるための1つ以上の補剛要素を含む、デバイス。
(付記9)
前記1つ以上の補剛要素は、前記複数のフィラメントのうちのフィラメントの少なくとも一部を中心として配置されるかまたはそれに結合される、付記8に記載のデバイス。
(付記10)
前記1つ以上の補剛要素は、螺旋形状を有する、付記8に記載のデバイス。
(付記11)
前記1つ以上の補剛要素は、ヒドロゲルを含む、付記8に記載のデバイス。
(付記12)
前記1つ以上の補剛要素は、約2~約10、約3~約12、約4~約8、約5~約10、約5~約15、約2~約30、および約2~約25から成る群から選択されるいくつかの補剛要素を備える、付記8に記載のデバイス。
(付記13)
前記近位部分は、前記浸透性シェルの遠位部分より高い半径方向剛性を有する、付記8に記載のデバイス。
(付記14)
前記近位部分は、前記浸透性シェルの遠位部分の半径方向剛性より1.5~3倍高い半径方向剛性を有する、付記8に記載のデバイス。
(付記15)
患者の脳動脈瘤の治療のためのデバイスであって、
弾力性自己拡張メッシュであって、前記弾力性自己拡張メッシュは、カテーテル管腔内での送達のために構成される半径方向に拘束された伸長状態と、前記半径方向に拘束された状態に対して縦方向に短縮された構成を伴う拡張状態とを含む、弾力性自己拡張メッシュ
を備え、
前記メッシュは、その中に空洞を画定する複数の相互織り合わされた伸長フィラメントから形成され、前記メッシュは、複数の細孔と、近位部分および遠位部分とを有し、
前記メッシュの近位部分は、前記メッシュの近位多孔率が、前記メッシュの遠位多孔率未満であるように、1つ以上の補強要素を含む、デバイス。
(付記16)
前記1つ以上の補強要素は、前記複数のフィラメントのうちのフィラメントの少なくとも一部を中心として配置されるかまたはそれに結合される、付記15に記載のデバイス。
(付記17)
前記1つ以上の補強要素は、螺旋形状を有する、付記15に記載のデバイス。
(付記18)
前記1つ以上の補強要素は、ヒドロゲルを含む、付記15に記載のデバイス。
(付記19)
前記1つ以上の補強要素は、約2~約10、約3~約12、約4~約8、約5~約10、約5~約15、約2~約30、および約2~約25から成る群から選択されるいくつかの補強要素を備える、付記15に記載のデバイス。
(付記20)
前記近位部分は、前記浸透性シェルの遠位部分より高い半径方向剛性を有する、付記15に記載のデバイス。
(付記21)
内部空洞と、頸部とを有する脳動脈瘤を治療するための方法であって、
マイクロカテーテル内のインプラントを脳動脈内の着目領域まで前進させるステップであって、前記インプラントは、弾力性自己拡張浸透性シェルを備え、前記弾力性自己拡張浸透性シェルは、カテーテル管腔内での送達のために構成される半径方向に拘束された伸長状態と、前記半径方向に拘束された状態に対して縦方向に短縮された構成を伴う拡張状態と、ともに織り合わされ、メッシュを形成し、前記浸透性シェルの空洞を画定する複数の伸長フィラメントとを含み、前記拡張状態は、近位部分および遠位部分を有し、前記近位部分は、前記メッシュに結合される少なくとも1つのコイルを含む、ステップと、
前記インプラントを前記脳動脈瘤内で展開するステップであって、前記浸透性シェルは、前記拡張状態に、前記動脈瘤の内部空洞内で拡張する、ステップと、
前記インプラントを展開後、前記マイクロカテーテルを前記着目領域から抜去するステップと
を含む、方法。
(付記22)
前記少なくとも1つのコイルは、前記複数のフィラメントのうちのフィラメントの少なくとも一部を中心として配置されるかまたはそれに結合される、付記21に記載の方法。
(付記23)
前記少なくとも1つのコイルは、螺旋形状を有する、付記21に記載の方法。
(付記24)
前記少なくとも1つのコイルは、ヒドロゲルを含む、付記21に記載の方法。
(付記25)
前記少なくとも1つのコイルは、約2~約10、約3~約12、約4~約8、約5~約10、約5~約15、約2~約30、および約2~約25から成る群から選択されるいくつかのコイルを備える、付記21に記載の方法。
(付記26)
前記近位部分は、前記浸透性シェルの遠位部分より高い半径方向剛性を有する、付記21に記載の方法。
(付記27)
前記近位部分は、前記浸透性シェルの遠位部分の半径方向剛性より1.5~3倍高い半径方向剛性を有する、付記21に記載の方法。
(付記28)
内部空洞と、頸部とを有する脳動脈瘤を治療するための方法であって、
マイクロカテーテル内のインプラントを脳動脈内の着目領域まで前進させるステップであって、前記インプラントは、弾力性自己拡張浸透性シェルを備え、前記弾力性自己拡張浸透性シェルは、カテーテル管腔内での送達のために構成される半径方向に拘束された伸長状態と、前記半径方向に拘束された状態に対して縦方向に短縮された構成を伴う拡張状態と、ともに織り合わされ、メッシュを形成し、前記浸透性シェルの空洞を画定する複数の伸長フィラメントとを含み、前記拡張状態は、近位部分および遠位部分を有し、前記近位部分は、デバイスの近位剛性を増強させるための1つ以上の補剛要素を含む、ステップと、
前記インプラントを前記脳動脈瘤内で展開するステップであって、前記浸透性シェルは、前記拡張状態に、前記動脈瘤の内部空洞内で拡張する、ステップと、
前記インプラントを展開後、前記マイクロカテーテルを前記着目領域から抜去するステップと
を含む、方法。
(付記29)
前記1つ以上の補剛要素は、前記複数のフィラメントのうちのフィラメントの少なくとも一部を中心として配置されるかまたはそれに結合される、付記28に記載の方法。
(付記30)
前記1つ以上の補剛要素は、螺旋形状を有する、付記28に記載の方法。
(付記31)
前記1つ以上の補剛要素は、ヒドロゲルを含む、付記28に記載の方法。
(付記32)
前記1つ以上の補剛要素は、約2~約10、約3~約12、約4~約8、約5~約10、約5~約15、約2~約30、および約2~約25から成る群から選択されるいくつかの補剛要素を備える、付記28に記載の方法。
(付記33)
前記近位部分は、前記浸透性シェルの遠位部分より高い半径方向剛性を有する、付記28に記載の方法。
(付記34)
前記近位部分は、前記浸透性シェルの遠位部分の半径方向剛性より1.5~3倍高い半径方向剛性を有する、付記28に記載の方法。
(付記35)
内部空洞と、頸部とを有する脳動脈瘤を治療するための方法であって、
マイクロカテーテル内のインプラントを脳動脈内の着目領域まで前進させるステップであって、前記インプラントは、弾力性自己拡張メッシュを備え、前記弾力性自己拡張メッ
シュは、カテーテル管腔内での送達のために構成される半径方向に拘束された伸長状態と、前記半径方向に拘束された状態に対して縦方向に短縮された構成を伴う拡張状態とを含み、前記メッシュは、その中に空洞を画定する複数の相互織り合わされた伸長フィラメントから形成され、前記メッシュは、複数の細孔と、近位部分および遠位部分とを有し、前記メッシュの近位部分は、前記メッシュの近位多孔率が、前記メッシュの遠位多孔率未満であるように、1つ以上の補強要素を含む、ステップと、
前記インプラントを前記脳動脈瘤内で展開するステップであって、前記メッシュは、前記拡張状態に、前記動脈瘤の内部空洞内で拡張する、ステップと、
前記インプラントを展開後、前記マイクロカテーテルを前記着目領域から抜去するステップと
を含む、方法。
(付記36)
前記1つ以上の補強要素は、前記複数のフィラメントのうちのフィラメントの少なくとも一部を中心として配置されるかまたはそれに結合される、付記35に記載の方法。
(付記37)
前記1つ以上の補強要素は、螺旋形状を有する、付記35に記載の方法。
(付記38)
前記1つ以上の補強要素は、ヒドロゲルを含む、付記35に記載の方法。
(付記39)
前記1つ以上の補強要素は、約2~約10、約3~約12、約4~約8、約5~約10、約5~約15、約2~約30、および約2~約25から成る群から選択されるいくつかの補強要素を備える、付記35に記載の方法。
(付記40)
前記近位部分は、前記浸透性シェルの遠位部分より高い半径方向剛性を有する、付記35に記載の方法。
Although the foregoing invention has been described in some detail, by way of illustration and example, for purposes of clarity and understanding, certain modifications and It will be apparent that modifications may be practiced.
(Appendix)
(Appendix 1)
A device for treatment of a brain aneurysm in a patient, comprising:
A resilient self-expanding osmotic shell, said resilient self-expanding osmotic shell having a radially constrained stretched state configured for delivery within a catheter lumen and said radially constrained a resilient self-expanding osmotic material comprising an expanded state with a longitudinally shortened configuration relative to the collapsed state and a plurality of elongated filaments woven together to form a mesh and defining a cavity of the osmotic shell. shell
with
The device, wherein the expanded state has a proximal portion and a distal portion, the proximal portion including at least one coil coupled to the mesh.
(Appendix 2)
Clause 1. The device of Clause 1, wherein the at least one coil is centered about or coupled to at least a portion of a filament of the plurality of filaments.
(Appendix 3)
10. The device of clause 1, wherein the at least one coil has a helical shape.
(Appendix 4)
Clause 1. The device of Clause 1, wherein the at least one coil comprises a hydrogel.
(Appendix 5)
The at least one coil has a 1. The device of clause 1, comprising a number of coils selected from the group consisting of:
(Appendix 6)
Clause 1. The device of Clause 1, wherein the proximal portion has a higher radial stiffness than the distal portion of the permeable shell.
(Appendix 7)
2. The device of paragraph 1, wherein the proximal portion has a radial stiffness 1.5 to 3 times higher than the radial stiffness of the distal portion of the permeable shell.
(Appendix 8)
A device for treatment of a brain aneurysm in a patient, comprising:
A resilient self-expanding osmotic shell, said resilient self-expanding osmotic shell having a radially constrained stretched state configured for delivery within a catheter lumen and said radially constrained a resilient self-expanding osmotic material comprising an expanded state with a longitudinally shortened configuration relative to the collapsed state and a plurality of elongated filaments woven together to form a mesh and defining a cavity of the osmotic shell. shell
with
The device, wherein the expanded state has a proximal portion and a distal portion, the proximal portion including one or more stiffening elements for increasing proximal stiffness of the device.
(Appendix 9)
9. The device of clause 8, wherein the one or more stiffening elements are centered about or coupled to at least some of the filaments of the plurality of filaments.
(Appendix 10)
9. The device of clause 8, wherein the one or more stiffening elements have a helical shape.
(Appendix 11)
9. The device of clause 8, wherein the one or more stiffening elements comprise hydrogel.
(Appendix 12)
The one or more stiffening elements are from about 2 to about 10, from about 3 to about 12, from about 4 to about 8, from about 5 to about 10, from about 5 to about 15, from about 2 to about 30, and from about 2 to about 10 9. The device of clause 8, comprising a number of stiffening elements selected from the group consisting of about 25.
(Appendix 13)
9. The device of paragraph 8, wherein the proximal portion has a higher radial stiffness than the distal portion of the permeable shell.
(Appendix 14)
9. The device of paragraph 8, wherein the proximal portion has a radial stiffness 1.5 to 3 times higher than the radial stiffness of the distal portion of the permeable shell.
(Appendix 15)
A device for treatment of a brain aneurysm in a patient, comprising:
A resilient self-expanding mesh, said resilient self-expanding mesh having a radially constrained stretched state configured for delivery within a catheter lumen, and against said radially constrained state. elastic self-expanding mesh
with
said mesh is formed from a plurality of interwoven elongated filaments defining cavities therein, said mesh having a plurality of pores and proximal and distal portions;
A device wherein a proximal portion of the mesh includes one or more reinforcing elements such that a proximal porosity of the mesh is less than a distal porosity of the mesh.
(Appendix 16)
16. The device of Clause 15, wherein the one or more reinforcing elements are centered about or coupled to at least some of the filaments of the plurality of filaments.
(Appendix 17)
16. The device of clause 15, wherein the one or more stiffening elements have a helical shape.
(Appendix 18)
16. The device of Clause 15, wherein the one or more reinforcing elements comprise a hydrogel.
(Appendix 19)
The one or more reinforcing elements are from about 2 to about 10, from about 3 to about 12, from about 4 to about 8, from about 5 to about 10, from about 5 to about 15, from about 2 to about 30, and from about 2 to about 16. The device of clause 15, comprising a number of stiffening elements selected from the group consisting of 25.
(Appendix 20)
16. The device of paragraph 15, wherein the proximal portion has a higher radial stiffness than the distal portion of the permeable shell.
(Appendix 21)
A method for treating a brain aneurysm having an internal cavity and a neck, comprising:
Advancing an implant in a microcatheter to a region of interest within a cerebral artery, said implant comprising a resilient self-expanding permeable shell, said resilient self-expanding permeable shell extending within the catheter lumen. a radially constrained extended state configured for delivery and an expanded state with a longitudinally shortened configuration relative to said radially constrained state are interwoven together to form a mesh; and a plurality of elongated filaments defining cavities of the permeable shell, the expanded state having a proximal portion and a distal portion, the proximal portion having at least one coil coupled to the mesh. including a step;
deploying the implant within the brain aneurysm, wherein the permeable shell expands to the expanded state within an internal cavity of the aneurysm;
withdrawing the microcatheter from the region of interest after deploying the implant;
A method, including
(Appendix 22)
22. The method of Claim 21, wherein the at least one coil is centered about or coupled to at least a portion of a filament of the plurality of filaments.
(Appendix 23)
22. The method of clause 21, wherein the at least one coil has a helical shape.
(Appendix 24)
22. The method of Clause 21, wherein the at least one coil comprises a hydrogel.
(Appendix 25)
The at least one coil has a 22. The method of clause 21, comprising a number of coils selected from the group consisting of:
(Appendix 26)
22. The method of paragraph 21, wherein the proximal portion has a higher radial stiffness than the distal portion of the permeable shell.
(Appendix 27)
22. The method of paragraph 21, wherein the proximal portion has a radial stiffness 1.5 to 3 times greater than the radial stiffness of the distal portion of the permeable shell.
(Appendix 28)
A method for treating a brain aneurysm having an internal cavity and a neck, comprising:
Advancing an implant in a microcatheter to a region of interest within a cerebral artery, said implant comprising a resilient self-expanding permeable shell, said resilient self-expanding permeable shell extending within the catheter lumen. a radially constrained extended state configured for delivery and an expanded state with a longitudinally shortened configuration relative to said radially constrained state are interwoven together to form a mesh; and a plurality of elongated filaments defining a cavity of the permeable shell, the expanded state having a proximal portion and a distal portion, the proximal portion comprising one filament for enhancing proximal stiffness of the device. a step comprising one or more stiffening elements;
deploying the implant within the brain aneurysm, wherein the permeable shell expands to the expanded state within an internal cavity of the aneurysm;
withdrawing the microcatheter from the region of interest after deploying the implant;
A method, including
(Appendix 29)
29. The method of clause 28, wherein the one or more stiffening elements are centered about or coupled to at least some of the filaments of the plurality of filaments.
(Appendix 30)
29. The method of clause 28, wherein the one or more stiffening elements have a helical shape.
(Appendix 31)
29. The method of clause 28, wherein the one or more stiffening elements comprise hydrogel.
(Appendix 32)
The one or more stiffening elements are from about 2 to about 10, from about 3 to about 12, from about 4 to about 8, from about 5 to about 10, from about 5 to about 15, from about 2 to about 30, and from about 2 to about 10 29. The method of clause 28, comprising a number of stiffening elements selected from the group consisting of about 25.
(Appendix 33)
29. The method of paragraph 28, wherein the proximal portion has a higher radial stiffness than the distal portion of the permeable shell.
(Appendix 34)
29. The method of paragraph 28, wherein the proximal portion has a radial stiffness 1.5 to 3 times greater than the radial stiffness of the distal portion of the permeable shell.
(Appendix 35)
A method for treating a brain aneurysm having an internal cavity and a neck, comprising:
Advancing an implant in a microcatheter to a region of interest in a cerebral artery, said implant comprising a resilient self-expanding mesh, said resilient self-expanding mesh
The shoe has a radially constrained extended state configured for delivery within the catheter lumen and an expanded state with a longitudinally shortened configuration relative to said radially constrained state. wherein said mesh is formed from a plurality of interwoven elongated filaments defining cavities therein, said mesh having a plurality of pores and proximal and distal portions; a proximal portion includes one or more reinforcing elements such that the proximal porosity of the mesh is less than the distal porosity of the mesh;
deploying the implant within the brain aneurysm, wherein the mesh expands to the expanded state within an internal cavity of the aneurysm;
withdrawing the microcatheter from the region of interest after deploying the implant;
A method, including
(Appendix 36)
36. The method of Clause 35, wherein the one or more reinforcing elements are centered about or coupled to at least some of the filaments of the plurality of filaments.
(Appendix 37)
36. The method of clause 35, wherein the one or more reinforcing elements have a helical shape.
(Appendix 38)
36. The method of Clause 35, wherein the one or more reinforcing elements comprise a hydrogel.
(Appendix 39)
The one or more reinforcing elements are from about 2 to about 10, from about 3 to about 12, from about 4 to about 8, from about 5 to about 10, from about 5 to about 15, from about 2 to about 30, and from about 2 to about 36. The method of clause 35, comprising a number of reinforcing elements selected from the group consisting of 25.
(Appendix 40)
36. The method of paragraph 35, wherein the proximal portion has a higher radial stiffness than the distal portion of the permeable shell.
Claims (20)
弾力性自己拡張浸透性シェルであって、前記弾力性自己拡張浸透性シェルは、カテーテル管腔内での送達のために構成される半径方向に拘束された伸長状態と、前記半径方向に拘束された状態に対して縦方向に短縮された構成を伴う拡張状態と、ともに織り合わされ、メッシュを形成し、前記浸透性シェルの空洞を画定する複数の伸長フィラメントとを含む、弾力性自己拡張浸透性シェルを備え、
前記拡張状態は、近位部分および遠位部分を有し、前記近位部分は、前記メッシュに結合される少なくとも1つのコイルを含む、デバイス。 A device for treatment of a brain aneurysm in a patient, comprising:
A resilient self-expanding osmotic shell, said resilient self-expanding osmotic shell having a radially constrained stretched state configured for delivery within a catheter lumen and said radially constrained a resilient self-expanding osmotic material comprising an expanded state with a longitudinally shortened configuration relative to the collapsed state and a plurality of elongated filaments woven together to form a mesh and defining a cavity of the osmotic shell. equipped with a shell ,
The device, wherein the expanded state has a proximal portion and a distal portion, the proximal portion including at least one coil coupled to the mesh.
弾力性自己拡張浸透性シェルであって、前記弾力性自己拡張浸透性シェルは、カテーテル管腔内での送達のために構成される半径方向に拘束された伸長状態と、前記半径方向に拘束された状態に対して縦方向に短縮された構成を伴う拡張状態と、ともに織り合わされ、メッシュを形成し、前記浸透性シェルの空洞を画定する複数の伸長フィラメントとを含む、弾力性自己拡張浸透性シェルを備え、
前記拡張状態は、近位部分および遠位部分を有し、前記近位部分は、前記デバイスの近位剛性を増強させるための1つ以上の補剛要素を含む、デバイス。 A device for treatment of a brain aneurysm in a patient, comprising:
A resilient self-expanding osmotic shell, said resilient self-expanding osmotic shell having a radially constrained stretched state configured for delivery within a catheter lumen and said radially constrained a resilient self-expanding osmotic material comprising an expanded state with a longitudinally shortened configuration relative to the collapsed state and a plurality of elongated filaments woven together to form a mesh and defining a cavity of the osmotic shell. equipped with a shell ,
The device, wherein the expanded state has a proximal portion and a distal portion, the proximal portion including one or more stiffening elements for increasing proximal stiffness of the device.
弾力性自己拡張メッシュであって、前記弾力性自己拡張メッシュは、カテーテル管腔内での送達のために構成される半径方向に拘束された伸長状態と、前記半径方向に拘束された状態に対して縦方向に短縮された構成を伴う拡張状態とを含む、弾力性自己拡張メッシュを備え、
前記メッシュは、その中に空洞を画定する複数の相互織り合わされた伸長フィラメントから形成され、前記メッシュは、複数の細孔と、近位部分および遠位部分とを有し、
前記メッシュの近位部分は、前記メッシュの近位多孔率が、前記メッシュの遠位多孔率未満であるように、1つ以上の補強要素を含む、デバイス。 A device for treatment of a brain aneurysm in a patient, comprising:
A resilient self-expanding mesh, said resilient self-expanding mesh having a radially constrained stretched state configured for delivery within a catheter lumen, and against said radially constrained state. with a resilient self-expanding mesh , including an expanded state with a longitudinally shortened configuration;
said mesh is formed from a plurality of interwoven elongated filaments defining cavities therein, said mesh having a plurality of pores and proximal and distal portions;
A device wherein a proximal portion of the mesh includes one or more reinforcing elements such that a proximal porosity of the mesh is less than a distal porosity of the mesh.
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