IPC분류정보
국가/구분 |
United States(US) Patent
등록
|
국제특허분류(IPC7판) |
|
출원번호 |
US-0786023
(2007-04-09)
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등록번호 |
US-8715340
(2014-05-06)
|
우선권정보 |
SG-SG200401735-6 (2004-03-31); SG-SG200508026-2 (2005-12-13) |
발명자
/ 주소 |
- Rudakov, Leon
- Hong, Tsui Ying Rachel
- O'Connor, Michael
|
출원인 / 주소 |
|
대리인 / 주소 |
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인용정보 |
피인용 횟수 :
6 인용 특허 :
112 |
초록
▼
Embodiments of a uniformly porous membrane covering an endoprosthetic device, for example, a stent used to treat an aneurysm, are described. Some embodiments have a pore size and spacing that provides a material ratio of between 70-80% in the deployed state. Material ratio is the proportion of the t
Embodiments of a uniformly porous membrane covering an endoprosthetic device, for example, a stent used to treat an aneurysm, are described. Some embodiments have a pore size and spacing that provides a material ratio of between 70-80% in the deployed state. Material ratio is the proportion of the total porous segment of the membrane that corresponds to membrane material, the remainder being pores. In some embodiments, pore size ranges from about 10-100 μm. In some embodiments, pores are equidistantly spaced with pore spacing in a range of about 40-100 μm. The combination of pore size and spacing are effective to provide a membrane that substantially prevents flow to the aneurysm, while maintaining flow to perforator vessels. In some embodiments the membrane includes permanently attached agents that promote attachment of endothelial cells or progenitors and healing of the aneurysm, or reduce immune responses detrimental to the healing process.
대표청구항
▼
1. An endovascular device for insertion into a body vessel to treat an aneurysmal portion of the body vessel, the endovascular device comprising: an expandable member, expandable from a first position to a second position, said expandable member being expandable radially outwardly to the second posi
1. An endovascular device for insertion into a body vessel to treat an aneurysmal portion of the body vessel, the endovascular device comprising: an expandable member, expandable from a first position to a second position, said expandable member being expandable radially outwardly to the second position such that an outer surface of said expandable member is configured to engage an inner surface of the vessel so as to maintain a fluid pathway in said vessel through a lumen in the expandable member, the expandable member comprising a plurality of struts that define a wall having an exterior surface and an interior surface;a membrane, comprising an expandable polymer film, covering at least a portion of an outer surface of said expandable member, the membrane extending continuously around and between each of the plurality of struts and having a portion extending (i) continuously from a first of the plurality of struts to a strut adjacent to the first strut, and (ii) entirely between the exterior surface and the interior surface;wherein the portion of the membrane contacts the first of the plurality of struts and the adjacent strut and resides entirely within a space bounded by the first of the plurality of struts, the adjacent strut, the exterior surface, and the interior surface; anda plurality of pores in a porous section of the membrane, the porous section (a) extending from a proximal end to a distal end of the expandable polymer film, and (b) having a substantially uniform porosity over a length extending from a proximal end to a distal end of the porous section, porosity being determined by a pore spacing and a pore size, the pore spacing being a distance between adjacent pores of the plurality of pores, and the pore spacing being less than about 100 μm in the first position;wherein the ratio of (a) the area of only membrane material at an outer surface of the porous section, to (b) a total area of the outer surface, including the area of the pores, defines a material ratio of 70% to 80% in the second position;wherein, when the expandable member is positioned in the body vessel, the substantially uniform porosity of the membrane permits a flow of blood from within the lumen of the expandable member, through at least one of the pores, and into at least one branch vessel that branches off of the body vessel; andwherein, when the expandable member is positioned in the body vessel, the substantially uniform porosity of the membrane reduces blood flow to the aneurysmal portion of the vessel, promoting thrombosis at or in the aneurysmal portion. 2. The device of claim 1, wherein the porosity of the porous section is selected such that it enables enhanced endothelial cell migration and tissue in-growth for endothelialization while substantially preventing blood circulation to the diseased, damaged or weakened portion of the vessel wall. 3. The device of claim 1, wherein the pore size is between about 20 μm and 100 μm. 4. The device of claim 1, wherein the pore size is between about 0.025 mm and 0.05 mm. 5. The device of claim 1, wherein the pore spacing does not exceed 75 μm. 6. The device of claim 1, wherein the material ratio in the second position is 75%. 7. The device of claim 1, wherein a diameter of the device in the second position is between about 2.5 mm and about 4.5 mm. 8. The device of claim 1, wherein a thickness of the membrane is between 0.001 inch and 0.005 inch. 9. The device of claim 8, wherein the thickness of the membrane is measured in the first position. 10. The device of claim 1, wherein a thickness of the membrane is between 0.001 inch and 0.002 inch. 11. The device of claim 10, wherein the thickness of the membrane is measured in the second position. 12. The device of claim 1, wherein the membrane comprises at least one therapeutic agent. 13. The device of claim 12, wherein the at least one therapeutic agent comprises at least one of heparin, phosporylcholine, albumin, dexamethasone, paclitaxel, and vascular endothelial growth factor (VEGF). 14. The device according to claim 1, wherein each pore has a diameter between 20 μm and 30 μm, and a distance between adjacent pores does not exceed 75 μm. 15. The device of claim 1, wherein the aneurysmal portion of the vessel is located at or near at least one of an intracranial aneurysm, a saccular aneurysm, a wide-neck aneurysm, a fusiform aneurysm, and a caroticocavernous fistula. 16. The device of claim 1, wherein the pore size is in a range between 0.025 mm and 0.05 mm, and pore spacing does not exceed 75 μm. 17. The device claim 1, wherein the pore size is between 20 μm and 30 μm. 18. The device of claim 1, wherein the porous section extends from a proximal end to a distal end of the membrane. 19. The device of claim 1, wherein the porous section extends from a proximal end to a distal end of the expandable member. 20. A method of treating a body vessel having an aneurysmal portion, the method comprising the steps of: providing an endovascular device, comprising:an expandable member, expandable from a first position to a second position, said expandable member being expandable radially outwardly to the second position such that an outer surface of said expandable member is configured to engage an inner surface of the body vessel so as to maintain a fluid pathway in said body vessel through a lumen in the expandable member, the expandable member comprising a plurality of struts that define a wall having an exterior surface and an interior surface;a membrane, comprising an expandable polymer film, covering at least a portion of an outer surface of said expandable member; the membrane comprising a plurality of pores in a porous section of the membrane, the porous section (a) extending from a proximal end to a distal end of the expandable polymer film, and (b) having a substantially uniform porosity over a length extending from a proximal end to a distal end of the porous section, porosity being determined by a pore spacing and a pore size, the pore spacing being a distance between adjacent pores of the plurality of pores, and the pore spacing being less than about 100 μm in the first position, the membrane extending continuously around and between each of the plurality of struts and having a portion extending (i) continuously from a first of the plurality of struts to a strut adjacent to the first strut, and (ii) entirely between the exterior surface and the interior surface;wherein the portion of the membrane contacts the first of the plurality of struts and the adjacent strut and resides entirely within a space bounded by the first of the plurality of struts, the adjacent strut, the exterior surface, and the interior surface;wherein the ratio of (a) the area of only membrane material at an outer surface of the porous section, to (b) a total area of the outer surface, including the area of the pores, defines a material ratio of 85% to 96% in the first position;wherein, when the expandable member is positioned in the body vessel, the substantially uniform porosity of the membrane permits a flow of blood from within the lumen of the expandable member, through at least one of the pores, and into at least one branch vessel that branches off of the body vessel; andwherein, when the expandable member is positioned in the body vessel, the substantially uniform porosity of the membrane reduces blood flow to the aneurysmal portion of the body vessel, promoting thrombosis at or in the aneurysmal portion; and positioning the expandable member in the body vessel. 21. The method of claim 20, wherein the porosity of the membrane is selected such that it enhances endothelial cell migration and tissue in-growth. 22. The method of claim 20, wherein the pore size is between 20 μm and 100 μm. 23. The method of claim 20, wherein the pore size is between 0.025 mm and 0.05 mm. 24. The method of claim 20, wherein the pore spacing does not exceed 75 μm. 25. The method of claim 20, wherein a diameter of the expandable member in the second position is between 2.5 mm and 4 mm. 26. The method of claim 20, wherein a thickness of the membrane is between 0.001 inch and 0.005 inch in the first position. 27. The method of claim 20, wherein a thickness of the membrane is between 0.001 inch and 0.002 inch in the second position. 28. The method of claim 20, wherein the membrane further comprises at least one therapeutic agent. 29. The method of claim 28, wherein the at least one therapeutic agent comprises at least one of heparin, phosporylcholine, albumin, dexamethasone, paclitaxel, and vascular endothelial growth factor (VEGF). 30. The method of claim 20, wherein the porous section extends from a proximal end to a distal end of the membrane. 31. The method of claim 20, wherein the porous section extends from a proximal end to a distal end of the expandable member. 32. An endovascular device for insertion into a body vessel to treat an aneurysmal portion of the body vessel, the endovascular device comprising: an expandable stent having a plurality of struts that define a stent wall having an exterior surface and an interior surface, the expandable stent being expandable radially outwardly from a first position to a second position such that the stent is configured to engage an inner surface of the vessel so as to maintain a fluid pathway in said vessel through a lumen in the expandable stent;a porous membrane extending continuously around and between each of the plurality of struts and having a portion extending (i) continuously from a first of the plurality of struts to an adjacent strut, and (ii) entirely between the exterior surface and the interior surface of the stent wall, the porous membrane comprising an expandable polymer film and having a plurality of pores over a length extending from a proximal end to a distal end of the membrane such that the porous membrane has a substantially uniform porosity, each of the pores having a cross-sectional dimension of 10 μm to 50 μm in the first position, and the plurality of pores having borders of 60 μm to 75 μm in the first position;wherein the portion of the membrane contacts the first of the plurality of struts and the adjacent strut and resides entirely within an enclosed space bounded by the first of the plurality of struts, the adjacent strut, the exterior surface, and the interior surface;wherein, when the expandable stent is positioned in the body vessel, the substantially uniform porosity of the membrane permits blood flow from within the lumen of the expandable stent, through at least one of the pores, and into at least one branch vessel that branches off of the body vessel such that the device does not inhibit the important blood supply functions of the at least one branch vessel while reducing blood flow to the aneurismal portion of the vessel such that thrombosis at or in the aneurysmal portion is promoted. 33. The device of claim 32, wherein the porosity is selected such that it enables enhanced endothelial cell migration and tissue in-growth for endothelialization while substantially preventing blood circulation to the diseased, damaged or weakened portion of the vessel wall. 34. The device of claim 32, wherein the pore size is between about 20 μm and 30 μm. 35. The device of claim 32, wherein a proportion of a total area of an outer surface of the membrane to a total area of the pores defines a material ratio of the membrane. 36. The device of claim 35, wherein the material ratio of the membrane in the second position is 70% to 80%. 37. The device of claim 35, wherein, in the first position, the cross-sectional dimension of each of the pores is 30 μm to 40 μm, and the borders between adjacent pores are 60 μm to 70 μm. 38. The device of claim 37, wherein, in the first position, the cross-sectional dimension of each of the pores is 30 μm, and the borders between adjacent pores are 70 μm. 39. The device of claim 35, wherein, in the first position, the cross-sectional dimension of each of the pores is 20 μm, and the borders between adjacent pores are 75 μm. 40. The device of claim 32, wherein a thickness of the membrane is between 0.001 inch and 0.005 inch. 41. The device of claim 32, wherein a thickness of the membrane is between 0.001 inch and 0.002 inch. 42. The device of claim 32, wherein the membrane comprises at least one therapeutic agent. 43. The device of claim 42, wherein the at least one therapeutic agent comprises at least one of heparin, phosporylcholine, albumin, dexamethasone, paclitaxel, and vascular endothelial growth factor (VEGF).
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