EMBOLIC PROTECTION DEVICES AND RELATED SYSTEMS AND METHODS
According to one aspect of the disclosure, an embolic protection device is provided comprising an elongate element having a deflector at its distal end. The embolic protection device is generally configured to redirect and/or funnel embolic debris and permit at least a portion of the blood, no longer containing the redirected and/or funneled embolic debris, to perfuse the surrounding vasculature and/or tissue.
1 . An embolic protection device configured for retrograde vascular delivery comprising:
an elongate element having a proximal opening, a distal opening, and a lumen extending therethrough; and
a deflector at the distal opening of the elongate element comprising a structural support element and deflector material covering the structural support element, the deflector configured to redirect embolic debris into the lumen.
2 . The embolic protection device of claim 1 , wherein the deflector material comprises a plurality of pores.
3 . The embolic protection device of claim 1 , wherein the deflector material comprises a plurality of pores, wherein a first portion of the deflector comprises a plurality of first pores having a smaller average pore size and wherein a second portion of the deflector comprises a plurality of second pores having a larger average pore size.
4 . The embolic protection device of claim 1 , wherein the deflector material comprises a plurality of pores, wherein a distal portion of the deflector comprises a plurality of first pores having a smaller average pore size and wherein a proximal portion of the deflector comprises a plurality of second pores having a larger average pore size.
5 . The embolic protection device of claim 3 , the deflector further comprising a radio-opaque band between the first portion of the deflector and the second portion of the deflector.
6 . The embolic protection device of claim 4 , the deflector further comprising a radio-opaque band between the proximal portion of the deflector and the distal portion of the deflector.
7 . An embolic protection device configured for retrograde vascular delivery comprising:
an elongate element having a proximal opening, a distal opening, and a lumen extending therethrough; and
a deflector at the distal opening of the elongate element configured to redirect embolic debris into the lumen,
wherein the elongate element comprises at least one window having a greater porosity than an adjacent portion of the elongate element, the at least one window further comprising a one-way valve configured to permit perfusion external to the elongate element.
8 . An embolic protection device configured for retrograde vascular delivery comprising:
an elongate element having a proximal opening, a distal opening, and a lumen extending therethrough; and
a deflector at the distal opening of the elongate element comprising a structural support element and deflector material covering the structural support element, the deflector configured to redirect embolic debris into the lumen, wherein the deflector material comprises a plurality of pores,
wherein the deflector is configured to be deconstructed in situ by applying tension to the structural support element.
9 . A multi-stage embolic protection system configured for retrograde vascular delivery comprising:
an elongate element having a proximal opening, a distal opening, and a lumen extending therethrough;
a deflector at the distal opening of the elongate element comprising a structural support element and deflector material covering the structural support element, the deflector configured to redirect embolic debris into the lumen, wherein the deflector material comprises a plurality of pores;
a guide element extending through the lumen and the deflector and having a constraining element at its distal end; and
a guidewire extending through the guide element,
wherein after a first stage deployment, a distal end of the deflector is radially restrained by the constraining element; and
wherein during a second stage deployment, advancement of the guide element releases the constraining element from the distal end of the deflector.
10 . A multi-stage embolic protection system configured for retrograde vascular delivery comprising:
an elongate element having a proximal opening, a distal opening, and a lumen extending therethrough;
a deflector at the distal opening of the elongate element comprising a structural support element and deflector material covering the structural support element, the deflector configured to redirect embolic debris into the lumen, wherein the deflector material comprises a plurality of pores;
a guide element extending through the lumen and the deflector; and
a constraining element,
wherein a first stage deployment comprises a proximal portion of the deflector being deployed while a distal end of the deflector is radially restrained by the constraining element; and
wherein a second stage deployment comprises the proximal portion and the distal end being deployed.
11 . A method for embolic protection in the aortic arch comprising the steps of:
providing a device comprising:
an elongate element having a proximal opening, a distal opening, and a lumen extending therethrough;
a deflector at the distal opening of the elongate element comprising a structural support element and deflector material covering the structural support element, the deflector configured to redirect embolic debris into the lumen, wherein the deflector material comprises a plurality of pores; and
a guidewire;
advancing the device to the aortic arch of a patient's vasculature;
deploying a proximal portion of the deflector, wherein a distal end of the deflector is positioned between the aortic valve and the brachiocephalic artery, and wherein the distal end of the deflector is radially restrained;
advancing the guidewire across the aortic valve;
releasing the distal end of the deflector;
performing a therapeutic interventional procedure;
aspirating embolic debris from the proximal opening of the elongate element;
partially withdrawing the device from the patient's vasculature, wherein the distal end of the deflector is positioned proximal to the left subclavian artery;
deconstructing the deflector in situ by applying tension to a structural support element; and
completely withdrawing the device from the patient's vasculature.
12 . An embolic protection device comprising:
an elongate element having a proximal end, a distal end, and a lumen extending therethrough; and
a deflector at the distal opening of the elongate element,
wherein the elongate element and the deflector are impermeable to embolic debris greater than about 100 μm; and
wherein at least one of the elongate element and the deflector is configured to permit antegrade and retrograde perfusion of blood therethrough.
13 . The embolic protection device of claim 12 , wherein the deflector is configured to redirect and/or funnel embolic debris greater than about 100 μm into the elongate element.
14 . The embolic protection device of claim 14 , wherein the deflector is configured to not capture or retain embolic debris.
15 . The embolic protection device of claim 12 , wherein the deflector has a generally frustoconical and/or cylindrical shape.
16 . The embolic protection device of claim 15 , wherein the deflector is selectively diametrically adjustable.
17 . The embolic protection device of claim 12 , wherein the deflector is blood-permeable and the elongate element is blood-impermeable.
18 . The embolic protection device of claim 17 , wherein the deflector comprises a perforated material and a structural support element.
19 . The embolic protection device of claim 18 , wherein the perforated material comprises an ePTFE.
20 . The embolic protection device of claim 18 , wherein the structural support element comprises a shape-memory helical stent element.
21 . The embolic protection device of claim 12 , wherein the deflector is blood-impermeable and the elongate element is blood-permeable.
22 . The embolic protection device of claim 12 , wherein the deflector comprises a radiopaque element.
23 . The embolic protection device of claim 22 , wherein the elongate element comprises a plurality of blood-permeable windows.
24 . The embolic protection device of claim 12 , wherein the elongate element comprises a separate lumen for delivering a blood contrast agent.
25 . The embolic protection device of claim 12 , wherein the deflector comprises a therapeutic agent.
26 . The embolic protection device of claim 25 , wherein the therapeutic agent comprises heparin.
27 . The embolic protection device of claim 12 , wherein the elongate element comprises a tension line to cause bending of the elongate element.
28 . The embolic protection device of claim 27 , wherein bending of the elongate element is controlled remotely by an operator thereby reducing the dependence on the vessel wall for alignment.
29 . A method for embolic protection comprising:
delivering an embolic protection device to a treatment site, wherein a deflector at a distal end of an elongate element of the embolic protection device is restrained by a sheath in a radially collapsed delivery configuration;
removing the sheath from the deflector and thereby deploying the deflector into a radially expanded funneling configuration;
inserting a secondary endovascular device through a working lumen extending through the elongate element;
aspirating embolic debris redirected and/or funneled by the embolic protection device;
removing the secondary endovascular device; and
removing the embolic protection device.
30 . The method for embolic protection of claim 29 wherein the step of deploying the deflector further comprises a first stage deployment and a second stage deployment.
31 . The method for embolic protection of claim 30 further comprising maintaining a distal opening of the deflector in a radially collapsed configuration during the first stage deployment.
32 . The method for embolic protection of claim 30 further comprising deploying the distal opening of the deflector from the radially collapsed configuration during the second stage deployment.
33 . The method for embolic protection of claim 29 further comprising deconstructing the deflector in situ by applying tension to a structural support element.
34 . The method for embolic protection of claim 29 further comprising recapturing the deflector with an over-sheath.
35 . The method for embolic protection of claim 29 , wherein the deflector comprises a therapeutic agent.
36 . The method for embolic protection of claim 35 , wherein the therapeutic agent comprises heparin.