Embolism protection device for introducing into an aortic arch
The invention concerns an embolic protection device for inserting into an aortic arch to prevent embolisms. The invention moreover concerns a handle for such an embolic protection device, as well as a system consisting of a handle and/or embolic protection device and/or a catheter. Through the invention, an embolic protection device for inserting into an aortic arch, comprising a filtering unit and a feeding unit, is provided, wherein the filtering unit comprises a frame and a filter mesh, and the filter mesh is placed on the frame, the filtering unit has a proximal area and a distal area, wherein the filtering unit is designed in such a way that it can, at least partially, be positioned in the aortic arch, and wherein, once the filtering unit is appropriately positioned, haptic and/or visual feedback is generated, which signals to the user the final position.
1 . A method of positioning an embolic protection device in an aortic arch, the method comprising:
providing a filtering unit;
providing a feeding unit coupled to the filtering unit;
wherein the filtering unit comprises a frame forming a loop and a filter mesh arranged along the loop of the frame,
wherein the loop of the frame comprises a proximal area and a distal area, and
introducing the filtering unit at least partially into the aortic arch, wherein the filtering unit is introduced into the aortic arch from a feeder vessel; and
expanding the filtering unit into an expanded state using the feeding unit;
wherein, after the filtering unit is expanded, the proximal area of the loop and at least a portion of the filter mesh is positioned in the feeder vessel separately from the distal area positioned in the aortic arch.
2 . The method of claim 1 , further comprising generating haptic or visual feedback when the filtering unit is appropriately positioned to signal a final position to a user.
3 . The method of claim 1 , wherein the frame comprises two proximal ends extending in parallel to one another and connected to the feeding unit via an area.
4 . The method of claim 1 , wherein the proximal area comprises an anchorage, such that a radial rigidity of the frame is increased.
5 . The method of claim 1 , further comprising passively drawing the filter mesh to an aortic roof, using a support placed between the filter mesh and the feeding unit, when the filter mesh is in an expanded state.
6 . The method of claim 5 , wherein the support is a spring, a rubber component, nitinol or an elastic material.
7 . The method of claim 1 , further comprising actively drawing the filter mesh to an aortic roof using a device coupled to the filter mesh.
8 . The method of claim 7 , wherein the device is a wire, a yarn or a chain.
9 . The method of claim 1 , further comprising fixing the proximal area in the feeder vessel, the proximal area configured to adjust to the feeder vessel through a change in a direction of curvature in the frame.
10 . The method of claim 1 , further comprising returning the frame of the filtering unit to a catheter using a return device coupled to the frame.
11 . The method of claim 1 , wherein the filtering unit comprises a first frame and a second frame, such that the second frame lies in an outer area of the first frame.
12 . The method of claim 1 , wherein a circumference of the filter mesh exceeds a circumference of the frame, wherein the filter mesh is connected to the feeding unit such that a wedge is formed when the filter mesh is pulled toward the feeder vessel.
13 . The method of claim 1 , further comprising providing a handle coupled to the feeding unit, the handle comprising a first connecting piece, a handle shell, a slide, and a second connecting piece.
14 . The method of claim 13 , wherein the handle is coupled to a catheter through which the filtering unit is introduced into the aortic arch.
15 . The method of claim 14 , wherein the first connecting piece of the handle comprises notches on an inside surface of the first connecting piece that receive blades of the catheter.
16 . The method of claim 13 , wherein the second connecting piece reversibly clamps to the feeding unit.
17 . The method of claim 13 , wherein positioning the filtering unit comprises operating the slide to exert a pull and/or push force on the feeding unit.
18 . The method of claim 13 , further comprising anchoring the slide with a locking device such that a position of the slide is adjustable in relation to the handle shell.
19 . The method of claim 13 , wherein the handle further comprises a haemostatic valve.
20 . The method of claim 13 , wherein the handle shell comprises an interior guide tube insertable into the slide.
21 . The method of claim 1 , wherein the filtering unit is introduced into the aortic arch through a catheter.
22 . The method of claim 14 , further comprising actively securing the first connecting piece of the handle to the catheter.