JPWO2020102679A5 - - Google Patents

Claims (34)

An expandable filter comprising a plurality of pores, the plurality of pores sized to allow for limited obstruction blood flow and to capture emboli larger than the pore diameter. , an extensible filter, and
an introducer sheath having a sheath diameter configured to accommodate at least the filter when unexpanded;
a tear away (TA) sleeve having a sleeve diameter configured to accommodate said introducer sheath, including at least a filter, when unexpanded;
The TA sleeve is torn or otherwise torn from the proximal end along at least a portion of its length as the TA sleeve is pulled or otherwise guided proximally prior to expansion of the filter. configured to separate into
An embolic protection system (EPS) wherein the filter expands when exposed distally by retracting the introducer sheath proximally, thereby causing the introducer sheath to fold proximally over itself. ). The embolism protection system (EPS) of claim 1, wherein at least the expanded filter is configured to be recaptured after expansion by a distal end of an introducer sheath as the introducer sheath moves distally. . 3. The embolism protection system (EPS) of claim 2, wherein the introducer sheath proximally folds over itself like an accordion. The embolism protection system (EPS) of claim 1, further comprising an expandable inner body having a body diameter and a distal section. 4. The embolism protection system (EPS) of any one of claims 1-3, further comprising an expandable inner body having a body diameter and a distal section. 6. The embolism protection system (EPS) of claim 4 or 5, wherein the filter is positioned on or adjacent to at least the distal section of the inner body. 3. The embolism protection system (EPS) of claim 1, further comprising radiopaque markers disposed on at least one or more areas of said filter. 8. The embolism protection system (EPS ). 8. The embolic protection of any one of claims 4-7, further comprising radiopaque markers disposed on one or more areas of at least one of the filter and inner body distal section. System (EPS). 10. The embolism protection system (EPS ). 11. The embolism protection system of any one of claims 4-6, 9 and 10, wherein the sheath diameter is configured to accommodate the inner body and filter, including the distal portion, when unexpanded. EPS). 2. The introducer sheath of claim 1, wherein the introducer sheath includes at least one of a wall having a thickness of about 0.025-0.250 mm, an introducer hub disposed on its proximal end, and a flush port. Embolic protection system (EPS) as described. The embolism protection system (EPS) of claim 1, wherein said pores are about 0.1 mm to 1.0 mm in size. The introducer sheath includes at least one of a wall having a thickness of about 0.025-0.250 mm, an introducer hub disposed on a proximal end thereof, a flush port, and the pores are The embolism protection system (EPS) according to any one of claims 1 to 11, having a size of about 0.1 mm to 1.0 mm. 14. The embolism of any one of claims 4-6 and 9-13, wherein the sleeve diameter of the TA sleeve is configured to accommodate the introducer sheath enclosing an inner body and filter when unexpanded. Protection system (EPS). The embolism protection system (EPS) of claim 1, further comprising a dilator having a dilator diameter configured to fit within the introducer sheath. 9. The embolism protection system (EPS) of any one of claims 1, 7 and 8, further comprising a dilator having a dilator diameter configured to fit within the introducer sheath. 18. The embolism protection system (EPS) of claim 17, wherein the dilator includes at least one of a conical distal tip and a proximal dilator hub. 16. The embolism protection system of any one of claims 4-6 and 9-15, further comprising a dilator having a dilator diameter configured to fit within said introducer sheath and within a body diameter (EPS ). 20. The embolism protection system (EPS) of Claim 19, wherein the dilator includes at least one of a conical distal tip and a proximal dilator hub. The embolism protection system (EPS) of Claim 1, wherein said TA sleeve includes at least one pull tab at a proximal end. 3. The embolism protection system (EPS) of Claim 1, wherein the TA sleeve includes at least two pull tabs at the proximal end. 22. The embolism protection system of any one of claims 1-21, wherein the TA sleeve includes at least one pull tab at the proximal end or at least two pull tabs at the proximal end (EPS ). The TA extends its length at least initially from the proximal end via the at least one pull tab as the TA sleeve is pulled or otherwise directed proximally prior to expansion of the filter. 24. An embolism protection system (EPS) according to claim 22 or 23, adapted to tear or otherwise separate along at least a portion of the . At least a portion of the filter and/or inner body distal section is configured to expand to a size such that it exerts a force against the inner wall of a blood vessel in which the filter and/or inner body distal section is positioned. 25. The embolism protection system (EPS) of any one of claims 4-6, 9-15, 19, and 20-24, wherein the The embolism protection system (EPS) of claim 1, wherein the length of the introducer sheath is configured to expand. The embolism protection system (EPS) of Claim 1, wherein at least a portion of the length of the introducer sheath is configured to expand. 27. Any one of claims 1-26, wherein at least a portion of the length of the introducer sheath is configured to expand, or the entire length of the introducer sheath is configured to expand. Embolic protection system (EPS) as described. The embolism protection system (EPS) according to any one of claims 26-28, wherein said expansion is between about 10 cm and 30 cm. The embolism protection system (EPS) of claim 1, further comprising a first housing configured to substantially enclose and/or seal the proximal end of the TA sleeve. 30. The embolism protection system of any one of claims 1-29, further comprising a first housing configured to substantially enclose and/or seal the proximal end of the TA sleeve (EPS). ). 31. The embolism protection system (EPS) of claim 30, wherein said first housing comprises a guide lumen. 31. The embolism protection system (EPS) of claim 30, further comprising a second housing for enclosing and/or sealing said first housing. 34. The embolism protection system (EPS) of Claim 33, wherein the second housing comprises a guide lumen.