Embolism protection device for introducing into an aortic arch

Abstract

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 said handle and the embolic protection device and a system consisting of a handle, an embolic protection device and 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 feedback is generated, which signals to the user the final position.

Claims

1. An embolic protection device (1) for inserting into an aortic arch, (9), comprising a filtering unit (2) and a feeding unit (4), wherein the filtering unit (2) comprises a frame (3) and a filter mesh (20) and the filter mesh (20) is arranged on the frame (3), the filtering unit (2) has a proximal area (6) and a distal area (7), wherein the filtering unit (2) is designed in such a way that it can, at least partially, be positioned in the aortic arch (9).

2. The embolic protection device (1) in accordance with claim 1, characterised in that the filtering unit (2) is divided into two sections in such a way that the proximal area (6) and the distal area (7) each have their own frame (27, 28).

3. The embolic protection device (1) in accordance with claim 1, characterised in that, when the filtering unit (2) is appropriately positioned, haptic or visual feedback is generated, which signals the final position to the user.

4. The embolic protection device (1) in accordance with claim 1, characterised in that the proximal frame (27) and the distal frame (28) comprise two respective ends in the proximal area (6), which extend in parallel to one another in the interior of the frame (3) and/or are arranged standing perpendicularly to the frame, and are connected with the feeding unit (4).

5. The embolic protection device (1) in accordance with claim 1, characterised in that the distal and proximal areas (6) possess an anchorage (16), designed in such a way that the radial rigidity is increased.

6. The embolic protection device (1) in accordance with claim 1, characterised in that the frame ends along, as well as perpendicular to, the direction of flow, can be bent.

7. The embolic protection device (1) in accordance with claim 1, characterised in that the frame ends and/or the sides of the frames can be given an angle of between 5° and 85°, preferably 25° to 75°, especially preferably 60° in the direction of flow and/or perpendicularly to it.

8. The embolic protection device (1) in accordance with claim 1, characterised in that the filtering unit (2) is divided into two sections, in such a way that the proximal area (6) can be actively and/or passively collapsed, independently of the distal area (7), when the embolic protection device (1) is removed.

9. The embolic protection device (1) in accordance with claim 1, characterised in that, via a device (23) which is connected with the filter mesh (20) and/or with the proximal frame (27), the proximal area (6) can be actively collapsed in the direction of the feeder vessel (11).

10. The embolic protection device (1), in particular in accordance with claim 1, characterised in that a respective independent filter (29,30) is stretched over both frames (27, 28).

11. The embolic protection device (1), in particular in accordance with claim 1, characterised in that the filtering unit (2) is divided into two sections in such a way that the proximal area (6) and the distal area (7) each possess their own frame (27, 28), and that a single filter (31) expands over both frames.

12. A handle (5) for a medical device, in particular an embolic protection device (1), in particular in accordance with claim 1, characterised in that the handle (5) comprises a first connecting piece (36), a handle shell (37), a slide (38) and/or a second connecting piece (39).

13. The handle (5) in accordance with claim 12, characterised in that the first connecting piece (36) is designed in such a way that a connection that is to be actively secured to a catheter can be produced.

14. The handle (5) in accordance with claim 12, characterised in that the connecting piece (36) has notches (42) on the inside, into which the blades (40) of the catheter (12) can be inserted.

15. The handle (5) in accordance with claim 12, characterised in that, by means of the second connecting piece (39), a reversible clamp connection to the feeding unit (4) can be produced.

16. The handle (5) in accordance with claim 12, characterised in that the slide (38) is designed in such a way that it can exert a tractive and/or compression mechanism for loading and positioning devices.

17. The handle (5) in accordance with claim 12, characterised in that the slide (38) has a locking device for anchorage, which makes the relative position of the slide in relation to the handle shell (37) possible.

18. The handle (5) in accordance with claim 12, characterised in that the handle (5) contains a haemostatic valve.

19. The handle in accordance with claim 12, characterised in that the handle shell (37) has an interior guide tube, which can be inserted into the slide (38).

20. The system consisting of an embolic protection device (1) in accordance with claim 1 and a catheter (12).

21. The system consisting of an embolic protection device (1) in accordance with claim 1, a handle (5) in accordance with claim 12 and a catheter (12).

22. The system consisting of a handle (5) in accordance with claim 12 and a catheter (12).

23. The system consisting of an embolic protection device (1) in accordance with claim 1 and a handle (5) in accordance with claim 12.

24. The method for using an embolic protection device in accordance with claim 1.

25. The method for using a handle (5) in accordance with claim 12.

26. The method for using a system consisting of an embolic protection device in accordance with claim 1 and/or a handle (5) in accordance with claim 12 and/or a catheter (12).

Description

[0108] The following are shown:

[0109] FIG. 1: View from above of the frame of the embolic protection device with a tapered tip;

[0110] FIG. 2: View from above of the frame of the embolic protection device with separation into an aortic section and a vascular section;

[0111] FIG. 3: Cross-section through the aortic arch with a positioned embolic protection device with the frame from FIG. 2;

[0112] FIG. 4: View from above of the frame of the embolic protection device with a radially stabilising anchorage;

[0113] FIG. 5: Configuration of the passive filter mesh support in a) lateral view; b) frontal view; and c) perspective view, slanted from the front and the top;

[0114] FIG. 6: Examples of passive filter mesh support a)-c) as a lateral view;

[0115] FIG. 7: Configuration of the passive filter mesh support as a lateral view;

[0116] FIG. 8A: Configuration of the active filter mesh support as a lateral view;

[0117] FIG. 8B: Configuration of the active filter mesh support, perspective view, slanted from the front and the top;

[0118] FIG. 8C: Detailed representation of the connection of the frame to the feeding unit

[0119] FIG. 9: Frame of the embolic protection device for complete positioning in the aortic arch, with ends pointing in the direction of flow, in a) view from above, b) lateral view; and c) in the folded state in the catheter

[0120] FIG. 10: Cross-section through the aortic arch with a positioned embolic protection device from FIG. 9;

[0121] FIG. 11: Frame of the embolic protection device with submerged proximal filtering level a) perspective view of the frame obliquely from the rear above, b) frontal view, c) lateral view, d) view from above

[0122] FIG. 12: View from above of the filtering unit with double (first and second) frames

[0123] FIG. 13: Perspective lateral view obliquely from above of the embolic protection device with expanded funnel shape.

[0124] FIG. 14: View from above of the embolic protection device with frame divided into two sections and separated filters

[0125] FIG. 15: View from above of the embolic protection device with frame divided into two sections and integral filter

[0126] FIG. 16A: Lateral view of the embolic protection device with filter divided into two sections and active retraction of the proximal area

[0127] FIG. 16B: Frontal view of the embolic protection device with filter divided into two sections and active retraction of the proximal area

[0128] FIG. 16C: View of the embolic protection device in the folded state when inserting and removing it

[0129] FIG. 17A: Lateral view of the embolic protection device with filter divided into two sections in the unfolded state

[0130] FIGS. 17B and 17C: Lateral view of the positioning of the embolic protection-device in the catheter upon insertion FIG. 17B and removal FIG. 17C

[0131] FIG. 18A: Lateral view of the handle with extended slide

[0132] FIG. 18B: Perspective representation obliquely from the front of the first connecting piece of the handle;

[0133] FIG. 19: Cross-section through the lateral view of the second connecting piece of the handle;

[0134] FIG. 20: Cross-section through the lateral view of the first connecting piece of the handle;

[0135] FIG. 21: Cross-section through the frontal view of the first connecting piece of the handle.

[0136] FIG. 22: Lateral view of the handle

[0137] FIG. 1 shows the view from above of the frame 3 of the embolic protection device 1, which comprises a distal area 7 and a proximal area 6, With this embodiment, the frame 3 is formed with a tapering distal tip 17. This leads to a streamlined cross-sectional distribution, designated by the arrows 13, being achieved, in order to implement the gradual rise in the contact pressure on the aortic arch 9. That leads to a reduction in the contact surface in the bloodstream when the device is positioned. It also leads to an improved adaptation of the geometry of the distal tip 17 on the aortic arch.

[0138] FIG. 2 likewise shows a view from above of the frame 3 of the embolic protection-device 1 including separation into an aortic section 8 and a vascular section 10. Said separation is implemented through a powerful modification of the direction of curvature being formed in the filter frame geometry on the frame 3 at Position 15. This results in the frame being separated into an aortic section 8 in the distal area 7 and a vascular section 10 in the proximal area 6, in such a way that when the vascular section 10 is drawn into the feeder vessel 11, the geometry of the aortic section remains unaffected.

[0139] In FIG. 3, a cross-section through the aortic arch 9 with a positioned embolic protection device 1 with the frame 3 from the embodiment from FIG. 2 can be seen. The figure shows how the aortic section 8 is positioned in the distal area 7 of the frame 3 in the aortic arch, and the vascular section 10 is fixed, in the feeder vessel 11, in the proximal area 6 of the frame 3. The proximal area 6 of the frame 3 is connected with the feeding unit 4, via which the filtering unit 2 is positioned. The retraction of the vascular section 10 into the feeder vessel H serves to reduce any possible interactions with devices that are used in the aortic arch 9.

[0140] The arrow shows the position of the reduced interaction with devices in the aortic arch 9 through the vascular section 10 retracted into the feeder vessel 11, The proximal area 6 is designed for good anatomical adaptation.

[0141] A further advantageous embodiment is shown in the example of FIG. 4, of a view from above of the frame 3 of the embolic protection device 1 with a radially stabilising anchorage. Here the two loose ends of the frame 18 and 19 are shown, which are connected at the far end of the proximal area. 6 by an anchorage 16. This leads to a radially stabilising frame geometry, in order to enable haptic feedback when the filtering unit 2 is positioned correctly in the aortic arch 9, as well as a stable position during the period of application.

[0142] The area of radial stability 41 can be found at the proximal end. In this embodiment, the design of the proximal and the distal frame geometry is identical, in order to generate a synchronous distribution of force.

[0143] FIG. 5 shows the configuration of the passive filter mesh support 21 in a) lateral view; b) frontal view; and c) perspective view, obliquely from the front and the top. The passive support 21 is placed at the ends of the frame 18 and 19, which is connected to the feeding unit 4. On the other side, the support 21 is connected with the filter mesh 20 and, in the expanded state, passively draws the filter material towards the roof of the aortic arch 22 (not shown). Besides better covering of the branched vessels, in order to prevent macroscopic particles from entering these vessel branches, a more stable position of the embolic protection device 1 is also implemented.

[0144] In FIG. 6, some examples of such a support 21 are shown, in a lateral view. In that respect, in a), the lateral view of a fiat spring element is shown, as in b), and in c) a coil spring. Other materials for the support may be silicones, rubber or other elastic synthetics, as well as moulded nitinol geometries.

[0145] In FIG. 7, the configuration of the support 21 based on a flexible material, in a lateral view at the ends 18 or 19 and on the filter mesh 20 is shown. The anchorage on the filter mesh 20 leads directly to the branched vessels being better covered, as the filter mesh 20 is more elastic than the frame 3, and can develop a certain additional tension to the frame 3.

[0146] In FIG. 8A, the configuration. of the active filter mesh support in the form of a device 23, from a lateral view, is shown. The device 23 is likewise connected with the filter mesh 20, is, however, actively operated by the user. It is likewise, like the feeding unit 4, arranged in the catheter 12. When it is actively pulled in the direction of the arrow, the filter mesh 20, and thus also the frame 3. is drawn towards the roof of the aortic arch 22.

[0147] In FIG. 8B, the configuration of the device 23 is shown in perspective, obliquely from the front and obliquely from above. It is apparent in both figures that the device 23 is not connected with the feeding unit 4 here, but is being conducted, independently, to the user, and, from there, can be independently operated by the feeding unit 4.

[0148] FIG. 8C shows a section of the connection of the frame ends with the feeding unit.

[0149] FIG. 9 shows the frame 3 of the embolic protection device 1 for the execution of the complete configuration of ends 18 and 19 in the aortic arch 9 pointing in the direction of flow in a) view from above, b) lateral view; and c) in a retracted state.

[0150] The ends 18 and 19 are bent, in the relaxed state, toward the proximal filtering level 25, so that, as shown in FIG. 9b), an acute angle W5 emerges between the distal filtering level 24 and where the ends 18 and 19 meet the frame. In other words, the ends 18 and 19 of the proximal area 6 define an arcuate shape, so that the first part, a, of the arcuate shape is formed in the direction of the distal area 7 and the second part, b, in the direction of the proximal area 6.

[0151] In other words, in the relaxed state (outside the body) the ends 18 and 19 of the proximal area 6 define an arcuate shape (FIG. 9b). Said arcuate shape can be divided into a Part a and a Part b, wherein Part a of the arcuate shape is formed in the direction of the distal area 7 and the second part, Part b, in the direction of the proximal area 6, forming an acute angle W5 to one another.

[0152] The ends 18 and 19 are, when inserted into the catheter 12 (FIG. 9c) arranged in the catheter in parallel to the proximal filtering level 25 and the distal filtering level 24.

[0153] When the catheter 12 is left by thrust by means of the feeding unit 4, the frame takes on its final form, and can be positioned by being pulled by the feeding unit 4 in the aortic arch 9, so that Part a of the proximal area 6 is placed behind the feeder vessel 11, and Part b lies in the actual feeder vessel. When the feeding unit 4 is retracted, a haptic signal is generated in this way, which signals the final position to the user.

[0154] In FIG. 10, the embolic protection device from FIG. 9 is shown in the final position as a cross-section through the aortic arch 9, In the unfolded state, the ends 18 and 19 of the frame 3 are arranged in relation to the proximal filtering level 25 at an obtuse angle W3.

[0155] By drawing the frame 3 towards the roof of the aortic arch 22, a filtering surface extending in the direction of flow is formed, which causes the cerebral vessels to be covered. Thus, the interaction to the TAVI procedure is also reduced by the improved contact pressure of the proximal area 6 in relation to the roof of the aortic arch 22.

[0156] FIG. 11 shows a further embodiment of the invention and its frame geometry. Shown are the frame 3 of the embolic protection device 1 in a) a perspective view of the frame 3 obliquely from the rear above, b) frontal view, c) lateral view and d) view from above.

[0157] It is recognisable that the ends 18 and 19 of the frame 3 in the unfolded state are arranged at an acute angle W1 to the distal filtering level 24, especially preferably to the proximal filtering level 25 (shown in the figure), so that, by drawing the frame 3 towards the roof of the aortic arch 22, the latter is moulded in such a way that the width of the end of the proximal area 6 is increased.

[0158] This widening, after the positioning on the aortic arch 9 (see Arrow E in FIG. 11d), is implemented by the proximal frame from the filtering level (shown by the angle W4 in FIG. 11c) being submerged, and results in a frame torsion which, in turn, leads to the distal area being elevated (likewise shown by the rotation arrow T in Fig. c).

[0159] Due to this elevation of the distal area it can be positioned in a more stable manner. In addition, due to the increase in the width it is made possible for the cerebral vessels to be covered better, and haptic feedback is generated which signals the final position to the user.

[0160] A view from above of a filtering unit 2 with a double frame 3 is shown in FIG. 12. A second frame 32 can be found outside a first frame 33. The distal end of both frames (32, 33) is connected with the filter mesh 20. The proximal end of the first frame 33 is not connected with the filter mesh 20, so that, through the proximal end of the first frame 33 being actively retracted, using a device 23, at the proximal end in the direction of the feeder vessel 11, a wedge created from the filter mesh 20 emerges, which minimises the interaction with devices in the aortic arch 9.

[0161] In addition, the second frame 32 is drawn towards the roof of the aortic arch 22, and thus an improved adaptation to the aortic arch 9 is achieved.

[0162] FIG. 13 shows a perspective lateral view obliquely from above of the embolic protection device 1 with a stretched funnel shape for an embodiment with a filter mesh 20, the circumference of which exceeds the circumference of the frame 3, and is thus not clamped. Said filter mesh 20 is connected with the feeding unit 4, so that, when the filter mesh 20 is pulled in the direction of the feeder vessel 11, a funnel 34 is formed. As a result, the frame 3 is likewise pulled to the aortic arch wall, which ensures that the vessel branches are very well covered.

[0163] The frame is connected with a return device 35, with which the frame can be returned into the catheter 12.

[0164] The frame 3 itself is not otherwise equipped with any further stabilising device in relation to the feeding unit 4.

[0165] FIG. 14 shows a filtering unit 2 of an embolic protection device 1 including a frame divided into two sections and a filter divided into two sections. In the view from above of the embolic protection device including a filter divided into two sections shown, it can be seen that the frame 3 is divided into a distal frame 28 and a proximal frame 27 with a distal filter 30 and a proximal filter 29.

[0166] Through the division of the frame, the existence of four ends emerges (designated with dots that run parallel to one another and/or protrude from the frame plane at a perpendicular angle (in their extension, not shown), so that four wires in total are connected with the feeding unit.

[0167] Said filtering unit 2 is preferably placed centrally in front of the ostium of the feeder-vessel 11. An improved contact-pressure of the frame 3 against the aortic arch wall, both proximally and distally, is implemented by the division into two sections.

[0168] FIG. 15 shows a view from above of the embolic protection device with frame 27, 28 divided into two sections, but a single filter 31. Said filtering unit 2 is likewise preferably placed centrally in front of the ostium of the feeder vessel 11. An improved contact pressure against the aortic arch wall, both proximally and distally, is implemented by the division of the frame 3.

[0169] An active device 23 is configured for removing the filtering unit (FIG. 16A), which is routed through the catheter 12 to the user. Upon removal, the proximal area 6 is actively folded in the direction of the feeder vessel 11 by the device 23, and the entire filtering unit 2 can then be removed from the vessel.

[0170] FIG. 16B represents the frontal view of the filtering unit 2 and indicates a potential bending of the filter frames perpendicularly in relation to the direction of flow, which, by drawing towards the aortic roof, causes, inter alia, a widening of the filtering surface and/or an improvement of the abutment against the aortic roof, and thus leads to an increase in the dimensionally stable position and haptic and/or visual feedback.

[0171] FIG. 16C shows the embolic protection device in the folded state, upon both insertion and removal, into and from, respectively, the aortic arch 9.

[0172] FIG. 17A shows a lateral view of the device upon unfolding, after leaving the catheter 12. The proximal frame 27 and the distal frame 28 are folded out and can be positioned in the aortic arch 9

[0173] FIG. 17B shows the filtering unit 2 in the catheter 12 connected with the feeding unit 4 upon being inserted into the aortic arch 9. In this respect, the proximal frame 27 is folded back, so that the proximal frame 27 and the distal frame 28 are arranged sequentially.

[0174] FIG. 17C shows the configuration of the filtering unit 2 in the sluice upon being removed from the aortic arch 9. In this case, the proximal and distal sections are situated parallel to one another.

[0175] In FIG. 18A, the lateral view of the handle 5 with extended slide between the handle shell 37 and the second connecting piece is shown.

[0176] FIG. 18B shows a perspective representation obliquely from the front of the first connecting piece 36 of the handle 5. Notches 42, with which a connection with the blades 40 of the catheter 12 that is to be actively secured can be produced, can be discerned.

[0177] In FIG. 19, a cross-section through the lateral view of the second connecting piece 39 of the handle is shown, which includes at least one device for producing reversible connections 43 with the feeding unit 4.

[0178] FIG. 20 shows a cross-section through the lateral view of the first connecting piece 36 of the handle 5. The notches 42 on the inside, that interlock with the blades 40 of the catheter 12 are shown, and the catheter 12 is thus fixed in such a way that it cannot rotate.

[0179] FIG. 21 shows a cross-section through the frontal view of the first connecting piece 36 of the handle 5 with the catheter 12 inserted, and the blades 40 that interlock with the notches 42.

[0180] FIG. 22 shows the lateral view of the handle 5 for a medical device, but in particular for the embolic protection device 1, with a first connecting piece 36, a handle shell 37 and a second connecting piece 39.

[0181] The feeding unit, and thus the embolic protection device (1) can be brought into a particular position by means of the slide, so that an advantageous positioning of the filtering unit (2) can be achieved by the feeding unit (4), which runs through the handle (5).

[0182] The invention concerns an embolic protection device (1) for inserting into an aortic arch, (9), comprising a filtering unit (2) and a feeding unit (4), wherein

[0183] the filtering unit (2) comprises a frame (3) and a filter mesh (20) and the filter mesh (20) is arranged on the frame (3).

[0184] the filtering unit (2) has a proximal area (6) and a distal area (7),

[0185] wherein the filtering unit (2) is designed in such a way that it can, at least partially, be positioned in the aortic arch (9).

[0186] In an enhancement of the embolic protection device (1), the latter is characterised in that, when the filtering unit (2) is appropriately positioned, haptic and/or visual feedback is generated, which signals the final position to the user.

[0187] In one enhancement of the embolic protection device (1), the frame (3) comprises two ends (18) and (19) in the proximal area (6), which extend in parallel to one another in the interior of the frame (3) and are connected with the feeding unit (4).

[0188] In one enhancement of the embolic protection device (1), the latter is characterised in that the proximal area (6) has an anchorage (16), designed in such a way that the radial rigidity is increased.

[0189] In one enhancement of the embolic protection device (1), the distal area (7) is designed to be tapered towards the tip (17), and thus has a streamlined cross-sectional distribution.

[0190] In a—likewise independently inventive—enhancement of the embolic protection device (1), a support (21) is configured between the filter mesh (20) and the feeding unit (4), through which the filter mesh (20) is passively drawn to the aortic roof (22) in the expanded state.

[0191] In one enhancement of the embolic protection device (1), the support (21) is a spring.

[0192] In a—likewise independently inventive—enhancement of the embolic protection device (1), the filter mesh (20) is connected with a device (23), so that the filter mesh (20) can be actively drawn via the device (23) to the aortic roof (22).

[0193] In one enhancement of the embolic protection device (1), the device (23) is a wire or a yarn.

[0194] In one enhancement of the embolic protection device (1), the proximal area. (6) can be configured separately from the distal area (7) in the feeder vessel (11), and the distal area (7) separately from the proximal area (6) in the aortic arch (9).

[0195] In an enhancement of the embolic protection device (1), the proximal area (6) can be adjusted to the feeder vessel (11) through a change in the direction of curvature in the frame geometry, and can be fixed therein.

[0196] In one—likewise independently inventive—enhancement of the embolic protection device (1), the entire filtering unit (2) can be arranged in the aortic arch (9) and, when the filtering unit (2) is appropriately positioned in the aortic arch (9), the proximal area (6) is formed distally of the feeder vessel (11).

[0197] In one enhancement of the embolic protection device (1), the ends (18, 19) of the frame (3) in the unfolded state are arranged at an acute angle W1 to the distal filtering level (24), so that, by drawing the frame (3) towards the roof of the aortic arch (22), the latter is moulded in such a way that the width of the end of the proximal area (6) is increased.

[0198] In one enhancement of the embolic protection device (1), the ends (18, 19) of the frame (3) are, in the unfolded state, configured at an acute angle W3 to the proximal filtering level (25), so that, by drawing the frame (3) towards the roof of the aortic arch (22), a proximal filtering surface (26) extending in the direction of flow is formed.

[0199] In one enhancement of the embolic protection device (1), the filtering unit (2) is divided into two sections, in such a way that the proximal area (6) can be actively and/or passively collapsed, independently of the distal area. (7), when the embolic protection device (1) is removed.

[0200] In one enhancement of the embolic protection device (1), the filtering unit (2) is divided into two sections in such a way that the proximal area (6) protrudes from the filtering level, so that, by re-shaping the proximal area (6) when positioning the device, a torsion is transmitted to the distal area (7), which increases the contact pressure on the roof of the aortic arch (22).

[0201] In one enhancement of the embolic protection device (1), the filtering unit (2) is divided into two sections in such a way that the proximal area (6) protrudes from the filtering level, so that the proximal area (6) is widened when the device is positioned.

[0202] In one enhancement of the embolic protection device (1), the filtering unit (2) is divided into two sections in such a way that the ends (18, 19) of the proximal area (6) define an arcuate shape, in such a way that the first part (a) of the arcuate shape is formed in the direction of the distal area (7) and the second part (b) in the direction of the proximal area (6).

[0203] In a—likewise independently inventive—enhancement of the embolic protection device (1), the filtering unit (2) is divided into two sections in such a way that the proximal area (6) and the distal area (7) each possess their own frame (27. 28), over which a respective independent filter (29, 30) expands.

[0204] In one enhancement of the embolic protection device (1), the second part (b) is connected with the filter mesh (20) and/or with the proximal frame (27) via a device (23), and the proximal area (6) can be actively collapsed in the direction of the feeder vessel (11) via said device (23).

[0205] In one—likewise independently inventive—enhancement of the embolic protection device (1), the filtering unit (2) is divided into two sections in such a way that the proximal area (6) and the distal area (7) each possess their own frame (27, 28), and that a single filter (31) expands over both frames.

[0206] In one enhancement of the embolic protection device (1), a support (21) is placed between the filter mesh (20) and/or the frame (3) of the proximal area (6), through which the proximal frame (27) can be passively collapsed in the direction of the feeder vessel (11).

[0207] In one—likewise independently inventive—enhancement of the embolic protection device (1), the filtering unit (2) is divided into two sections in such a way that a second frame (32) lies in the outer area of the first frame (33) and the second frame (32) is connected with the filter mesh (20) only in the distal area (7) of the first frame (33), and the proximal end (6) of the first frame (33) can be pulled in the direction of the feeder vessel (11), wherein the second frame (32) is drawn to the roof of the aortic arch (22) and a funnel (34) emerges.

[0208] In one enhancement of the embolic protection device (1), the frame (3) of the filtering unit (2) is connected with a return device (35), through which the frame can be returned into the catheter (12), and the circumference of the filter mesh (20) exceeds the circumference of the frame (3). wherein the filter mesh (20) is connected with the feeding unit (4), so that, when the filter mesh (20) is pulled in the direction of the feeder vessel (11), a funnel (34) is formed.

[0209] A—likewise independently inventive—enhancement concerns a handle (5) for an embolic protection device(1) wherein the handle (5) comprises a first connecting piece (36), a handle shell (37), a slide (38) and/or a second connecting piece (39), wherein the first connecting piece (36) is designed as a connection that is to be actively secured and/or the second connecting piece (39) is designed as a reversible clamping connection.

[0210] In one enhancement of the handle (5), the first connecting piece (36) is designed in such a way that a connection that is to be actively secured to a catheter can be produced.

[0211] In one enhancement of the handle (5), the connecting piece (36) has notches (42) on the inside, into which the blades (40) of the catheter (12) can be inserted.

[0212] In one enhancement of the handle (5), a reversible clamp connection to the feeding unit (4) can be produced by means of the second connecting piece (39).

[0213] In one enhancement of the handle (5,) the slide (38) is designed in such a way that it can exert a tractive and/or compressive mechanism for loading and positioning devices.

[0214] In one enhancement of the handle (5), the slide (38) has a locking device for anchoring, which enables the position of the slide to be adjusted in relation to the handle shell (37).

[0215] In one enhancement of the handle (5), the handle (5) includes a haemostatic valve.

[0216] In one enhancement of the handle, the handle shell (37) has an interior guide, which can be inserted into the slide (38).

[0217] One—likewise independently inventive—enhancement concerns a system consisting of an embolic protection device (1) and a catheter (12).

[0218] In one enhancement of the [word missing], the embolic protection device (1) is designed in such a way that it can be passed through the catheter (12).

[0219] In one enhancement of the system, the latter contains an embolic protection device (1), a handle (5) and a catheter (12).

[0220] In one enhancement of the system, the catheter (12) can be fixed in the handle (5), and the embolic protection device (1) can be passed through the catheter (12) and can be connected with the handle (5) via the feeding unit (4).

[0221] A—likewise independently inventive—enhancement concerns a method of using an embolic protection device (1).

[0222] A—likewise independently inventive—enhancement concerns a method of using a handle (5).

[0223] A—likewise independently inventive—enhancement concerns a method of using a system consisting of an embolic protection device (1) and/or a handle (5) and/or a catheter (12).

LIST OF REFERENCE SIGNS

[0224] 1 Embolic protection device

[0225] 2 Filtering unit

[0226] 3 Frame

[0227] 4 Feeding unit

[0228] 5 Handle

[0229] 6 Proximal area

[0230] 7 Distal area

[0231] 8 Aortic section

[0232] 9 Aortic arch

[0233] 10 Vascular section

[0234] 11 Feeder vessel

[0235] 12 Catheter

[0236] 13 Arrows to designate the streamlined cross-sectional distribution

[0237] 14 Position of the reduced interaction with devices in the aortic arch

[0238] 15 Position for changing the direction of curvature

[0239] 16 Anchorage

[0240] 17 Distal tip

[0241] 18 End of the frame

[0242] 19 End of the frame

[0243] 20 Filter mesh

[0244] 21 Support

[0245] 22 Roof of the aortic arch

[0246] 23 Device

[0247] 24 Distal filtering level

[0248] 25 Proximal filtering level

[0249] 26 Proximal filtering surface

[0250] 27 Proximal frame

[0251] 28 Distal frame

[0252] 29 Proximal filter

[0253] 30 Distal filter

[0254] 31 Individual filter

[0255] 32 Second frame

[0256] 33 First frame

[0257] 34 Funnel

[0258] 35 Return device

[0259] 36 First connecting piece

[0260] 37 Handle shell

[0261] 38 Slide

[0262] 39 Second connecting piece

[0263] 40 Blades

[0264] 41 Area of radial stability

[0265] 42 Notches

[0266] 43 Device for producing reversible connections

[0267] First part, arcuate shape a)

[0268] Second part, arcuate shape b)

[0269] W1 Angle

[0270] W2 Angle

[0271] W3 Angle

[0272] W4 Angle

[0273] W5 Angle

[0274] W6 Angle

[0275] T Torsion

[0276] E Increase in the width