Device for vascular occlusion and methods of use thereof
The present disclosure features devices, systems, and kits for vascular occlusion and methods of use thereof.
1 . A vascular occlusion device comprising a proximal end and a distal end defining a first axis and having a length therebetween, wherein:
a) the vascular occlusion device comprises a helical lattice along the first axis, wherein the helical lattice comprises a width that extends along a second axis that is perpendicular to the first axis, a first outer edge and a second outer edge, and one or more connectors at the proximal end, wherein the one or more connectors at the proximal end comprise one or more loops or fasteners configured for reversible separation of the vascular occlusion device from a pusher in a blood vessel of a subject;
b) the helical lattice is a helical sheet comprising a double helix wherein a network of lattice cells extends between the first outer edge and the second outer edge of the double helix, wherein the double helix is symmetrical about a central axis of rotation; and
c) the helical lattice is configured to convert between a compressed state and an uncompressed state about the second axis; and
wherein, upon separation of the vascular occlusion device from the pusher in the blood vessel of the subject, the vascular occlusion device is configured to reduce blood flow in the blood vessel to less than about 4 mL/s.
2 . The vascular occlusion device of claim 1 , wherein the helical lattice comprises about 1 to about 25 turns.
3 . The vascular occlusion device of claim 2 , wherein each of the turns comprises a pitch from about 1 mm to about 30 mm.
4 . The vascular occlusion device of claim 1 , wherein the lattice cells are compressible cells comprising a polygonal, square, rectangular, triangular, diamond, circular, elliptical, oval, oblong, lens, asteroid, deltoid, slit, or amorphous shape.
5 . The vascular occlusion device of claim 1 , wherein a width of the vascular occlusion device is periodic along the length, and the width of the helical lattice is greater than the width of the vascular occlusion device at the proximal end, the distal end, or both, further wherein a maximum width of the vascular occlusion device is from about 1 mm to about 30 mm when the vascular occlusion device is in the uncompressed state.
6 . The vascular occlusion device of claim 1 , wherein the length of the vascular occlusion device is from about 10 mm to about 600 mm.
7 . The vascular occlusion device of claim 1 , wherein the helical lattice is flexible and self-expanding from the compressed state to the uncompressed state.
8 . The vascular occlusion device of claim 1 , wherein the one or more connectors comprises a lumen configured to accommodate a guidewire comprising a diameter from about 0.2 mm to about 1 mm.
9 . The vascular occlusion device of claim 1 , further comprising a radiopaque marker located on the distal end, the proximal end, the helical lattice, or combinations thereof.
10 . The vascular occlusion device of claim 1 , further comprising a coating, wherein the coating comprises a thrombogenic agent or a hydrogel.
11 . The vascular occlusion device of claim 10 , wherein the thrombogenic agent is thrombin, and the hydrogel comprises a polysaccharide, a mucopolysaccharide, a carboxy alkyl cellulose, a synthetic polymer, or a protein.
12 . The vascular occlusion device of claim 1 , further comprising a plurality of filaments attached to the helical lattice, wherein at least a portion of the filaments extend radially from the helical lattice.
13 . A delivery system comprising:
(a) the vascular occlusion device of claim 1 ;
(b) a catheter comprising a proximal end and a distal end with a length therebetween;
(c) the pusher comprising a deployment shaft comprising a proximal end and a distal end, and a deployment structure at the distal end of the deployment shaft, wherein the deployment structure is configured to reversibly attach to the one or more connectors at the proximal end of the vascular occlusion device; and
(d) a cartridge comprising a proximal opening and a distal opening and a lumen sized to house the vascular occlusion device, wherein the lumen spans the length of the cartridge from the proximal opening to the distal opening.
14 . The delivery system of claim 13 , wherein the reversible attachment between the pusher and the one or more connectors at the proximal end of the vascular occlusion device is rotational engagement.
15 . The delivery system of claim 13 , wherein the proximal end of the catheter is configured to reversibly attach to a distal end of the cartridge, thereby establishing fluid communication between the catheter and the cartridge.
16 . The delivery system of claim 15 , wherein the cartridge comprises the vascular occlusion device inside the lumen thereof, and wherein the vascular occlusion device is configured to be slidably translated from the cartridge to the catheter upon attachment of the cartridge to the catheter.
17 . The delivery system of claim 13 , further comprising a guidewire, wherein the guidewire is configured to direct the vascular occlusion device through the catheter and to a target site in a blood vessel for vascular occlusion.
18 . The delivery system of claim 13 , further comprising a deployment device, wherein the deployment device is configured to interface with the proximal end of the catheter and the proximal end of the pusher, wherein the deployment device comprises:
(a) an actuator configured such that operation of the actuator either retracts the catheter into the deployment device, or extends the catheter from a body of the deployment device;
(b) an inlet port in fluid communication with proximal end of the catheter; and
(c) a deployment release configured such that operation of the deployment release manipulates the position of the deployment structure.
19 . The delivery system of claim 18 , wherein the actuator is a rotary actuator.
20 . The delivery system of claim 13 , wherein the deployment structure is a deployment hook.
21 . A method of occluding a blood vessel, comprising:
a) inserting the vascular occlusion device of claim 1 in the compressed state into the blood vessel;
b) deploying the vascular occlusion device at a target site in the blood vessel using a pusher, whereby the vascular occlusion device converts to the uncompressed state;
c) separating the vascular occlusion device from the pusher, wherein the vascular occlusion device reduces blood flow in the blood vessel to less than 4 mL/s.
22 . The method of claim 21 , further comprising advancing the vascular occlusion device through the blood vessel after the inserting step a).
23 . The method of claim 21 , further comprising providing a cartridge comprising a proximal end, a distal end, and a lumen spanning the length therebetween, wherein the vascular occlusion device is loaded within the lumen prior to step a).
24 . The method of claim 21 , wherein, prior to step a), the method comprises inserting a catheter into the blood vessel and wherein inserting the vascular occlusion device into the blood vessel comprises inserting the vascular occlusion device into the catheter and advancing the vascular occlusion device along the length of the catheter.
25 . The method of claim 24 , further comprising attaching a distal opening of a cartridge to a proximal end of the catheter and transferring the vascular occlusion device from the cartridge into the catheter by use of a pusher comprising a deployment shaft and a deployment structure, and advancing the vascular occlusion device along the length of the catheter by use of the pusher.
26 . The method of claim 25 , further comprising deploying the vascular occlusion device by holding the vascular occlusion device in place by applying a non-moving biasing force against the vascular occlusion device with the pusher and pulling the catheter towards the pusher, wherein the vascular occlusion device is pushed out of the catheter at the target site, whereby the vascular occlusion device converts to the uncompressed state, thereby occluding blood flow in the blood vessel to less than about 4 mL/s.
27 . The method of claim 25 , further comprising reengaging the deployment structure and a proximal connector after the vascular occlusion device converts to the uncompressed state and extending the catheter along the length of the vascular occlusion device, at least partially converting the vascular occlusion device to the compressed state, and redeploying the vascular occlusion device to a different position in the vasculature of the subject.
28 . The method of claim 24 , wherein the method further comprises administering a therapeutic or diagnostic agent via the catheter, wherein the therapeutic agent is a thrombogenic agent or an anti-tumor agent.
29 . The method of claim 21 , wherein the blood vessel is a vein, an artery, a stent, an arteriole, a capillary, a splenic artery, a gastroduodenal artery, a fistula, or a graft.