Thrombectomy device and methods of use thereof
The present disclosure provides devices and systems for performing thrombectomies and methods of use thereof.
1 . A thrombectomy device comprising a proximal end and a distal end defining a first axis and having a length therebetween, wherein the thrombectomy device comprises:
a) a single centrally located shaft along the first axis, wherein the shaft has a proximal end and a distal end, wherein the shaft is configured for complete rotation about the first axis, and wherein the shaft comprises a plurality of segments, wherein each segment is from about 0.1 mm to about 10 mm in length, wherein adjacent segments of the plurality of segments are configured to rotate or bend independently of each other; and
b) a helical lattice with a proximal end and a distal end along the first axis, wherein the proximal end of the helical lattice is attached to the distal end of the shaft and wherein the helical lattice:
i) comprises a width that extends along a second axis that is perpendicular to the first axis,
ii) comprises a first outer edge and a second outer edge forming a double helix, wherein a network of hollow lattice cells is located between the first outer edge and the second outer edge,
iii) comprises a texture located on an inner surface of the helical lattice, and
iv) is configured to convert between a compressed state and an uncompressed state about the second axis, wherein, the first outer edge and the second outer edge of the helical lattice join at the proximal end of the helical lattice.
2 . The thrombectomy device of claim 1 , wherein the thrombectomy device is sized to traverse a blood vessel.
3 . The thrombectomy device of claim 1 , wherein the helical lattice comprises about 1 to about 25 turns, wherein each turn comprises a pitch from about 1 mm to about 50 mm.
4 . The thrombectomy device of claim 1 , wherein the lattice cells are compressible, and the helical lattice is self-expanding from the compressed state to the uncompressed state.
5 . The thrombectomy device of claim 1 , wherein the lattice cells comprise a polygonal, square, rectangular, triangular, diamond, circular, elliptical, oval, oblong, lens, asteroid, deltoid, slit, or amorphous shape.
6 . The thrombectomy device of claim 1 , wherein the helical lattice comprises a thickness from about 0.01 mm to about 1 mm.
7 . The thrombectomy device of claim 1 , wherein the width of the thrombectomy device is from about 1 mm to about 30 mm when the thrombectomy device is in the uncompressed state.
8 . The thrombectomy device of claim 1 , wherein the width of the thrombectomy device is periodic along the length.
9 . The thrombectomy device of claim 1 , wherein the length of the thrombectomy device is from about 10 mm to about 600 mm.
10 . The thrombectomy device of claim 1 , wherein the adjacent segments may be rotated or bent from about 0.01° to about 45° relative to each other.
11 . The thrombectomy device of claim 1 , wherein the length of the shaft is from about 1 cm to about 200 cm and the width of the shaft is from about 1 mm to about 30 mm.
12 . The thrombectomy device of claim 1 , wherein the helical lattice further comprises a radiopaque marker and/or a coating.
13 . The thrombectomy device of claim 1 , wherein the helical lattice comprises a shape memory material, wherein optionally the shape memory material is nitinol.
14 . The thrombectomy device of claim 1 , wherein the thrombectomy device and/or the shaft is enclosed within a sheath.
15 . The thrombectomy device of claim 1 , wherein the shaft interfaces with a housing comprising a sheath, a deployment mechanism configured to retract the sheath, a rotary configured to rotate the shaft and/or the thrombectomy device, and/or an inlet port.
16 . A delivery system comprising:
(a) the thrombectomy device of claim 1 ; and
(b) a housing comprising one or more of an inlet port, a pusher, a sheath, a deployment mechanism configured to retract the sheath into the body of the housing, and a rotator configured to rotate the thrombectomy device one or more times.
17 . The delivery system of claim 16 , wherein the sheath comprises a proximal end, a distal end, and a lumen, wherein the thrombectomy device and the shaft at the proximal end of the thrombectomy device is enclosed by the lumen.
18 . The delivery system of claim 16 , wherein the inlet port is configured to transmit negative pressure through the inlet port to a distal end of the sheath, and/or receive an infusion of a therapeutic agent therethrough and to transmit the therapeutic agent to a distal end of the sheath, wherein, optionally, the therapeutic agent is one or more of heparin, tPA, nitroglycerin, and calcium channel blockers.
19 . The delivery system of claim 16 , wherein the deployment mechanism is configured to retract the sheath, thereby releasing the thrombectomy device from the lumen of the sheath, and to redeploy the sheath, thereby returning the thrombectomy device into the lumen of the sheath.
20 . The delivery system of claim 16 , wherein the rotator comprises a motor and one or more gears.
21 . A method of removing a thrombus from a blood vessel, comprising:
a) inserting the thrombectomy device of claim 1 in the compressed state into the blood vessel;
b) advancing the thrombectomy device through the blood vessel and into contact with the thrombus;
c) allowing the helical lattice of the thrombectomy device to convert to the uncompressed state; and
d) retracting the thrombectomy device, thereby removing the thrombus, or rotating the thrombectomy device about the first axis one or more times, thereby disrupting the thrombus.
22 . The method of claim 21 , wherein the thrombectomy device is enclosed in the lumen of a sheath in step a), and after step b) and prior to step c), the sheath is retracted, thereby allowing the helical lattice of the thrombectomy device to convert to the uncompressed state.
23 . The method of claim 21 , further comprising aspirating the thrombus and/or administering a therapeutic agent to the thrombus.
24 . A kit comprising the thrombectomy device of claim 1 and one or more of a catheter, a pusher, a sheath, and a housing, wherein the housing further comprises one or more of an inlet port, a sheath, a deployment mechanism configured to retract the sheath into the body of the housing, and a rotator configured to rotate the thrombectomy device.