Embolic protection device, folding method and forming device

Abstract

Embolic protection device for insertion into an aortic arch, with a filter unit, a frame and a feed unit, wherein the filter unit is arranged at the frame and the frame provides a proximal area having a proximal shape, which is arranged in an inner area of the frame and is connected to the feed unit, wherein the proximal shape has a first part and a second part, wherein the second part is formed at one end of the first part.

Claims

1. Embolic protection device (1) for insertion into an aortic arch, comprising a filter unit (3), a frame (5) with a proximal end and a distal end and a feed unit (7) located at the proximal end of the frame, wherein the filter unit (3) is arranged within the frame (5) and the frame (5) is comprised of a wire and provides a proximal area (9), comprising a proximal shape (11) and provides a distal area (2) comprising a distal shape (4), wherein the frame (5) defines a generally oval two-dimensional area, where the proximal shape (11) is arranged at the proximal end of the frame (5) and is connected to the feed unit (7), wherein the proximal shape (11) comprises a first part (13) and a second part (15), wherein the second part (15) is formed at one end of the first part (13) and the second part is connected to the feed unit, wherein the first and second parts (13, 15) form the proximal shape (11), wherein the proximal shape (11) extends over and under the generally oval two-dimensional area of the frame (5), and wherein the distal shape (4) has a constriction (12) of the wire of the frame (5) into an interior of the generally oval two-dimensional area of the frame (5).

2. Embolic protection device (1) according to claim 1, characterized in that the first part (13) of the proximal shape (11) is at a first angle (W1) to the generally oval two-dimensional area of the frame (5) and the second part (15) is at a second angle (W2) to the first part (13) of the proximal shape (11).

3. Embolic protection device (1) for insertion into an aortic arch, comprising a filter unit (3), a frame (5) with a proximal end and a distal end and a feed unit (7) located at the proximal end of the frame, wherein the filter unit (3) is arranged within the frame (5) and the frame (5) is comprised of a wire and has a proximal area (9), comprising a proximal shape (11) and a distal area (2) comprising a distal shape (4), wherein the frame (5) defines a generally oval two-dimensional area, where the proximal shape (11) is arranged at the proximal end of the frame (5) and is connected to the feed unit (7) wherein the proximal shape (11) comprises a first part (13) and a second part (15), wherein the first and second parts (13, 15) form the proximal shape (11), wherein the proximal shape (11) extends over and/or under the generally oval two-dimensional area of the frame (5), wherein the second part is formed at one end of the first part (13) and the second part is connected to the feed unit, wherein the first and second parts (13, 15) are arranged to each other such that they form a spring mechanism, and wherein the distal shape (4) has a constriction (12) of the wire of the frame (5) into an inside of the generally oval two-dimensional area of the frame (5).

4. Embolic protection device (1) according to any one of claims 1-3, characterized in that the proximal shape (11) can be set under tension via the feed unit (7).

5. Embolic protection device (1) according to claim 1, characterized in that the proximal shape (11) comprises two ends (17, 19) of the frame (5), which extend parallel to each other.

6. Embolic protection device (1) according to claim 1, characterized in that the filter unit (3) is connected to the frame (5) outside the proximal and/or distal area(s) (9, 2).

7. Forming device (31) for shaping the embolic protection device (1) according to claim 1 for insertion into a tube (38), wherein the frame (5) of the embolic protection device (1) having the filter unit (3) arranged at it, is formed from an expanded state to a stretched state, comprising a one-sided flat or round opening (35), a narrowest cross section (39)′ and an opposite round opening (37).

8. Forming device (31) according to claim 7, wherein the flat or round opening (35) of the forming device (31) is formed such that at least one of the proximal shape (11) and the distal shape (4) of the frame (5) of the embolic protection device is folded outwards.

9. Method for folding the embolic protection device by means of the forming device according to claim 7, comprising moving (S1) the frame (5) of the embolic protection device in front of the flat or round opening (35) of the forming device (31), wherein the feed unit (7) is fed through the forming device (31), retracting (S3) the proximal shape (11) into the forming device (31), wherein the proximal shape (11) is folded outwards, the distal shape (4) hooks (S4) over the outer edge of the forming device (31), and by pulling the distal shape (4) further is folded outwards, and is retracted into the forming device (31).

10. Method according to claim 9, wherein the folded proximal shape (11) transfers a prestress to the frame (5), which is substantially equal to the tension resulting from straightening the folded proximal shape (11).

11. Method for unfolding the embolic protection device according to claim 1, when the embolic protection device leaves a catheter containing it, comprising pushing the embolic protection device out of the catheter, folding the distal shape (4) into the distal end of the frame (5) when the distal area (2) of the frame of the embolic protection device leaves the catheter.

12. Method according to claim 11, comprising indicating the direction of the frame (5) by a marker, when the distal area (2) leaves the catheter, wherein the distal area (2) indicates the orientation of the frame (5).

13. Method according to claim 11, characterised in that, due to the folding of the distal shape, as well as the proximal shape, a torsion is generated in the wire of the frame (5), having a preferred direction, when leaving the catheter, from the distal area (2) towards the distal shape (4).

14. Embolic protection device (1) according to claim 1, wherein the proximal shape (11) is defined by two ends (17, 19) of the frame (5).

15. Embolic protection device (1) according to claim 3, wherein the proximal shape (11) is defined by two ends (17, 19) of the frame (5).

Description

(1) Further details of the invention can be derived from the embodiment examples which are described below with the aid of the figures. Furthermore none of the stated details of the invention are limited to the embodiment examples provided, but, instead, may be represented individually, selectively together or in their entirety in other embodiment examples.

(2) It is Shown, in:

(3) FIG. 1: Embolic protection device according to the invention;

(4) FIG. 2: Top view of the frame of the embolic protection device from FIG. 1;

(5) FIG. 3: Side view of the frame from FIG. 2;

(6) FIG. 4: Perspective view of the proximal area of the frame from FIG. 2;

(7) FIG. 5A: Frame with a configuration of radiopaque markers;

(8) FIG. 5B: Frame with a further configuration of radiopaque markers;

(9) FIG. 6: Connection of an inventive proximal shape to the insertion device;

(10) FIG. 7: Illustration of an adhesive tunnel in section with frame, filter unit and sealing;

(11) FIG. 8: Top view of a frame with filter unit arranged at it;

(12) FIG. 9: Distal filter unit from FIG. 8;

(13) FIG. 10: Top view of a proximal shape with arranged filter unit;

(14) FIG. 11: Perspective view of the proximal shape from FIG. 10;

(15) FIG. 12: Top view of a distal shape with arranged filter unit;

(16) FIG. 13: Perspective view of the distal shape from FIG. 12;

(17) FIG. 14: View of a folded embolic protection device in a catheter;

(18) FIG. 15A-F: Shaping of a frame of an inventive embolic protection device from a folded state to an unfolded state;

(19) FIG. 16: Schematic view of an unfolded state of the embolic protection device after leaving a catheter;

(20) FIG. 17: Sequence of the unfolding of an embolic protection device after leaving the catheter in an aortic arch;

(21) FIG. 18: Covering of the head blood vessel outflows in the aorta due to the embolic protection device after leaving the catheter as in FIG. 17;

(22) FIG. 19: Forming device for shaping an inventive embolic protection device;

(23) FIG. 20: Perspective view of the forming device from FIG. 19;

(24) FIG. 21: Method for folding the inventive embolic protection device by means of a forming device.

(25) An embolic protection device 1 according to the invention is shown in FIG. 1. The embolic protection device 1 comprises a frame 5 to which a filter unit 3 is arranged. The frame 5 is connected to a feed unit 7. The length of the frame 5 is advantageously 50 to 100 mm. The width of the frame 5 is advantageously 15 to 45 mm. In this embodiment example, the frame 5 consists of a single continuously bent wire. However, the described characteristics and advantages of the embolic protection device also apply for other embodiment examples.

(26) Frame 5 has a two-dimensional and a three-dimensional area. The two-dimensional area, that is the plane over which the frame spans, is oval in shape, which, at the distal and proximal areas 2, 9 changes into a proximal shape 11 and a distal shape 4. The proximal shape 11 and the distal shape 4 are the three-dimensional area of the frame 5, wherein the remaining areas of the frame 5 forms the two-dimensional area, that is, the oval shape. The embolic protection device 1 is shown in its basic state.

(27) FIG. 2 shows a top view of the frame 5 of the embolic protection device 1 from FIG. 1. The proximal area 9 of the frame 5 is that which leads into the open ends 17, 19 of the frame 5, in this embodiment example the ends of the wire. The proximal area 9, and, therefore, also the proximal shape 11, is defined by the two loose ends 17, 19 of the frame 5 used or, respectively, the wire used. The proximal shape 11 has a first part 13 and a second part 15, which are formed in this embodiment by the parallel ends 17, 19. In the distal area 2, the frame 5 changes into a distal shape 4. The distal shape 4 has a constriction 12 of the wire of approximately 1-3 cm into the inside of the frame 5, or, expressed otherwise, into the inside of the oval, two-dimensional area.

(28) In this embodiment example, the constriction 12 is a loop with a head diameter of about 1-1.8 mm and with the wire lying otherwise parallel to itself. The loop and the wire lying parallel to itself are located in the same two-dimensional plane of the frame 5.

(29) FIG. 3 shows a side view of the frame 5 from FIG. 2. The proximal shape 11 is extended with the ends of the frame 17, 19 as well as the frame in the distal shape 4 mutually parallel into the inside of the frame 5. In this case, the first part 13 of the proximal shape is at a first angle W1 to the two-dimensional plane of the frame 5 of preferably 25 to 50 degrees downwards, wherein the angle is measured from the first part 13 to the plane of the frame. After preferably a length of 0.5 to 2.5 cm of the first part 13, a second part 15 is arranged on the end of the first part 13 at a second angle W2 of preferably 110 to 145 degrees upwards from the two-dimensional plane of the frame 5, wherein the angle is measured from the second part 15 to the plane of the frame. The length of the second part 15 is 1 to 5 cm. The lengths of the first and second part 13, 15 as well as their angle to the plane of the frame 5 may be selected larger or smaller corresponding to the requirements placed on the embolic protection device.

(30) The first and second parts 13, 15 form the proximal shape 11, which is arranged in an inner area of the frame 5, wherein the proximal shape 11 extends over and under the plane of the frame 5. Due to this geometric shape of the proximal shape 11, the frame 5 is pretensioned and, at the same time, is stabilised in the longitudinal and lateral directions.

(31) It is possible that the first part 13 extends into the plane of the frame 5, that is, the angle W1 equals 0 degrees and only the second part 15 is inclined to the plane of the frame 5 by a second angle W2.

(32) The distal shape 4, comprising constriction 12, lies in the two-dimensional plane of the frame 5.

(33) FIG. 4 shows a perspective view of the proximal area 9 of the frame from FIG. 2. The proximal shape 11 comprises the first part 13, which is bent by a first angle W1 to the plane of the frame 5, the second part 15 which is bent by a second angle W2 to the plane of the frame 5 and the two ends 17, 19 of the frame 5. Both the first part 13 as well as the second part 15 of the proximal shape 11 each have two frame wires.

(34) FIGS. 5A and 5B show a frame 5 with a configuration of radiopaque markers 20. The radiopaque markers 20 are applied for radiopaque visibility on the frame 5 at prominent places. For example, the radiopaque markers 20 are applied in the area of the constriction 12 as well as on the frame in the distal area 2 so that the precise position of the tip of the frame 5 can be determined. Furthermore, radiopaque markers 20 are applied on the frame 5 outside the distal or proximal areas 2, 9. It is possible to determine in which state the folding or unfolding of the embolic protection device 1 is by the distance of the markers 20 from one another. Also, the precise position of the embolic protection device 1 in the aortic arch can be determined by means of the radiopaque markers 20.

(35) The radiopaque markers can be sleeves made of platinum/iridium, which are placed on or applied to the frame. The sleeves have a minimal greater internal diameter than the frame 5, have a wall thickness of about 50-100 μm and are attached by means of an adhesive.

(36) In FIGS. 5A, 5B only some of the possible places for the positioning of radiopaque markers are shown. Furthermore, there are various possibilities for applying radiopaque markers 20 depending on the outcome desired.

(37) FIG. 6 shows a connection of an inventive proximal shape 11 to an inventive feed device 7, wherein, in the drawing, the ends 17, 19 of the frame 5 the proximal shape 11 are shown. At the same time, the ends 17, 19 are also the end of the second part 15 of the proximal shape 11.

(38) The feed unit 7 in this embodiment example comprises a stainless steel coil and the envelope is sealed. In this embodiment example, the outer diameter of the feed unit 7 is 1.5 mm and the diameter of its open lumen is 0.8 mm. The overall length of the feed unit 7 is 150 cm. Other dimensions for the feed unit 7 are possible.

(39) The proximal shape 11 of the frame 5 is joined to the feed unit 7 by means of an adhesive unit 8, for example, polyurethane adhesive. The ends of the wire 17, 19 of the proximal shape 11 are pushed into the open inner lumen of the feed unit 7 and glued. For better visualisation, the adhesive unit 8 in the figure is cross hatched.

(40) For additional stability, the ends of the wire 17, 19, that is, the second part 15 of the proximal shape 11, are secured by means of wrapped stainless steel wire 6. In this case, the ends of the wire 10 of the wrapped stainless steel wire 6 lie parallel to the ends 17, 19 of the frame 5, glued in the feed unit 7. The transition of the proximal shape 11 to the feed unit 7, as well as the wrapped stainless steel wire 6 are also coated with polyurethane in order to ensure a smooth surface as well as an even transition.

(41) FIG. 7 shows an enlarged view of the connection of frame 5 and filter unit 3, shown in section. The connection is executed as an enveloping polymer shape around frame 5. The polymer shape forms an adhesive tunnel 41 in which the frame 5 is arranged on the filter unit 3. At the outer edge of the filter unit 3, the sealing 42 is shown in this figure.

(42) FIG. 8 shows a top view over a frame 5 with a filter unit 3 arranged on it. The length of the frame 5 is advantageously 50 to 100 mm. The width of the frame 5 is advantageously 15 to 45 mm. The filter unit 3 in this embodiment example is secured to the frame 5 by means of an adhesive or by an adhesive based on polyurethane. The gluing runs continuously on the outer part of frame 5. The parts of the frame 5 in the proximal and distal areas, which, in the basic state, are folded inwards, are not glued to the filter unit 3. The filter unit 3 is glued from the lower side on to the frame 5 so that the surface of the filter unit 3 completely faces the central blood flow when frame 5 is positioned in its placement position in the aortic arch.

(43) The frame 5, in this embodiment example made of nitinol, is glued in a prestressed manner to the filter unit 3 to achieve a better stretching force on the frame 5. In doing so, the width of the frame 5 is reduced from 35-45 mm to 25-35 mm.

(44) The filter unit 3 projects with a protrusion 14 of about 1 mm over the frame 5 on its upper side and is turned over or flipped over in the distal and proximal areas 2, 9 of the frame 5 from the underside over the frame 5 to the upper side. The protrusion 14 of the attached filter unit 3 over the outer edge of the frame 5 has the additional function of a flexible sealing lip against the aorta wall when the embolic protection device 1 lies in the placement position in the aortic arch.

(45) The flipped area of the filter unit 3 comprises a proximal filter unit 21 and a distal filter unit 22. The proximal and distal filter units 21, 22 are not glued to the frame which helps the desired deformation whenever it is pushed through a catheter. The proximal filter unit 21 together with the second part 15 of the proximal shape 11 is secured under the wrapped stainless steel wire 6 and is sealed in this area, as shown also in FIG. 7.

(46) The distal filter unit 22 is secured at the constriction 12 of the distal shape 4. The distal filter unit 22 extends further over the constriction 12 towards the inside of the frame 5 by about 2-5 mm and is also flexibly sealed.

(47) The fibres of the filter unit 3 are aligned such that they are aligned at an angle of 45° to the centre line of the frame 5 from the start to the end. This allows the filter unit 3 to extend better in the longitudinal direction while providing stability in the lateral direction. The outer edge of the protrusions 14 and 21 and 22 are also sealed.

(48) FIG. 9 shows an end area of the distal filter unit 22 of the filter unit 3 from FIG. 8. The distal filter unit 22 is cut short such that it extends not only about 2 mm over the constriction 12, but becomes wider again beyond the constriction 12 and assumes the shape of a flag 23.

(49) This flag 23 curls inwards. In doing so, the ends of the thread used for securing are trapped inside the flag 23. Glue secures the distal filter unit 23 from rolling up. The diameter of the curled distal filter unit 22 is less than 1.6 mm. Besides securing the distal filter unit 23, an additional protective pad is formed therefore between frame 5 and the aorta wall to avoid injuries.

(50) FIG. 10 shows a top view over a proximal shape 11 with an arranged filter unit 3. The proximal filter unit 21 is flipped over the frame 5 to the upper side. In this embodiment example, both the first part 13 of the proximal shape 11 as well as the second part 15 of the proximal shape 11 are wrapped with a stainless steel wire 6 (For better visualisation of the stainless steel wire, the first and second parts 13, 15 of the proximal shape are not shown). The first part 13 is bent at a first angle W1 to the plane of the frame 5 and the second part 15 is bent at a second angle W2 to the plane of the frame 5.

(51) FIG. 11 shows a perspective view of the proximal shape 11 from FIG. 10.

(52) FIG. 12 shows a top view over a distal shape 4 with arranged filter unit 3, in particular a distal filter unit 22. The distal filter unit 22 is secured by means of a thread 43, which in other embodiments can be yarn or wire, at the constriction 12 of the distal shape 4 and projects into the inside of the frame 5.

(53) FIG. 13 shows a top view over a proximal shape 11 with arranged filter unit 3. The flag 23 is rolled in, wherein a thread is used to secure it, as described for FIG. 9 and is not repeated here.

(54) FIG. 14 shows a folded embolic protection device 1 in a catheter 25. The embolic protection device 1 is shown in a folded state. Due to mechanical shaping, the basic state of the embolic protection device, as shown, for example, in FIGS. 1 to 13, is changed to the folded state. The reversibly deformable material of the frame 5, for example, a superelastic nitinol wire, can be deformed such that the embolic protection device 1 can be pushed into a catheter 25. In doing so, the embolic protection device 1 extends lengthwise in its orientation. The distal shape 4 as well as the proximal shape 11 are folded into an outer area of the frame 5.

(55) By folding the distal shape 4 and the proximal shape 11, the frame 5 transforms into a straight or extended shape. The change in length thus brought about depends on the reduction in the width of frame 5. The folded frame 5, i.e. the two sides of the frame outside the distal shape 4 and/or proximal shape 11, lie in this case parallel to each other in the catheter 25. The filter unit 3 can follow this mechanical deformation and is located in the intermediate space between catheter 25 and frame 5. In this extended shape, the embolic protection device can be pushed into a catheter with an inner diameter of, for example, 1.7 mm.

(56) FIG. 15A-F shows shaping of a frame 5 of an inventive embolic protection device 1 from a folded state to an unfolded state.

(57) When positioning the embolic protection device from a catheter 25, for example, in the aortic arch, the embolic protection device 1, in particular the frame 5 with the filter unit 3 arranged at it, is pushed out of the catheter 25. This is shown in FIGS. 15A-F.

(58) The frame 5, which is formed from reversibly deformabable material, tries to revert to its original basic state, as shown, for example, in FIG. 1. The filter unit 3 arranged on frame 5 follows the reshaping. By feeding the folded distal shape 4 located in catheter 25 forward, on leaving catheter 25 with a feed of about 1-2 cm, up to a half of said shape folds back in the direction of the originally provided setting, as in FIG. 15A. In doing so, the direction of the distal shape 4 specifies in which position the embolic protection device 1 is located inside catheter 25. Radiopaque markers, which can be applied to the distal shape 4, enable the position of the distal shape 4 to be determined. In this case, the pointing direction of the distal shape 4 specifies the upper side of the embolic protection device 1. By rotating catheter 25, the placement position, for example, in the aortic arch, can be adjusted.

(59) Since the constriction 12 in the distal area of the embolic protection device 1, that is, the distal shape 4 immediately after leaving catheter 25, unfolds, as in FIGS. 15A-B, the risk of possible damage to the wall of the blood vessel by feeding the embolic protection device 1 further is minimised. In addition, the frame 5 is wrapped on the distal shape 4 with atraumatic material which protrudes about 1-2 mm and, as a result, also counteracts any possible injuries.

(60) As the forward feed into the aortic arch continues, the frame 5 unfolds further until it is completely unfolded. This can be seen, for example, in FIGS. 15C-F. Here, FIG. 15D shows the same unfolded state as in FIG. 15C as seen from the side, wherein FIG. 15C shows the unfolded state as seen from above. Now almost completely unfolded, the distal shape 4 and the unfolded frame 5, as well as the unfolded filter unit 3 are shown.

(61) In the completely unfolded state, frame 5 is unfolded and the filter unit 3 is stretched out by frame 5. FIG. 15E shows the completely unfolded frame or unfolded embolic protection device 1 as seen from above and in FIG. 15F as seen from the side. The effect of the spring mechanism by the proximal shape 11 is evident from the transition from FIG. 15C to FIG. 15E or FIG. 15D to FIG. 15F.

(62) FIG. 16 shows schematically an unfolded state of the embolic protection device 1 after leaving a catheter 25. Due to the special geometry of the proximal shape 11 up to the transition to the feed unit 3, a prestress is created on frame 5 to the same extent as the pre-bent proximal shape 11 is straightened. The figure shows two different conditions of the unfolded state. The position of the filter unit is the same in both illustrations. The position of the first and second parts 13, 15, which are connected to the feed unit (not shown), is shown both in the unstressed as well as the stressed state. As a result, a spring function is provided which will be explained more precisely below.

(63) As soon as the embolic protection device 1 is correctly positioned, for example, in the aortic arch, the transferred tension of the proximal shape 11 presses the distal shape 4 to the aorta wall, thus providing a stable restraint against the blood flow—in FIG. 16 this is indicated schematically by the thick, short arrow on the distal shape 4. The proximal shape 11 moves in a direction which is indicated by the thin, curved arrow. Without the resistance of the aorta wall, frame 5 would follow the indicated folding direction—in FIG. 16 the thin, curved arrow—as shown, for example, in FIG. 15E-F. As shown in FIG. 16, the proximal shape 11 changes into a shape in which the first part 13 is at a first angle W1 of 25 to 50 degrees over the plane of the frame, measured from the plane to the first part 13 and the second part 15 is at an angle W2 of 30 to 110 degrees over the plane of the frame, measured from the second part 15 to the plane. The numbers of degrees given for the angle are dependent on the aorta geometry and are only by way of example.

(64) FIG. 17 shows a schematic sequence of the unfolding of an embolic protection device 1 after leaving a catheter 25 in an aortic arch. In Figure part (a), the introduction of the catheter 25 through the left subclavian artery is shown, wherein the distal shape 4 of the embolic protection device 1 is at least partly folded back. Figure parts (b) to (d) show the further forward feed and the unfolding of the embolic protection device 1, wherein, in Figure part (d), the proximal shape 11 has also left the catheter. Figure part (e) shows the completely unfolded embolic protection device 1 in the placement state. In this process, the proximal area 9 of the frame 5 protrudes out over the area the ostium of the left subclavian artery, by means of which coverage over the entry way by the embolic protection device 1 is also achieved. At the same time, this protrusion offers a haptic feedback when positioning the embolic protection device: by pulling on the feed unit 7, a slight resistance can be felt as soon as the protrusion of the embolic protection device 1, or rather of the frame 5, is located correctly in front of the ostium 27. The intended position is achieved via the left subclavian artery in the aortic arch with the distal area 2 of the frame 5 towards the heart valve.

(65) As an alternative entry way, the right subclavian artery can also be used. The sequence is similar to that shown in FIG. 16, but carried out in a mirrored manner. In this case, the distal area 2 of frame 5 points towards the descending aorta (descendens).

(66) FIG. 18 shows the covering of the head blood vessel outflows 29 in the aorta by the embolic protection device 1 after leaving catheter 25 as in FIG. 17. Due to the special geometry of the frame 5, the embolic protection device 1 flexibly adapts to the anatomical conditions in the aortic arch independently of the entry way and offers a complete covering across all head blood vessels 29.

(67) In the placement position in the aortic arch, the geometry of the frame 5 of the embolic protection device 1 flexibly adapts to the aorta wall and lies in a slight bow, following the bend in the aorta, in front of the head blood vessel outflows—as in FIG. 17(e) also. On leaving catheter 25, both the distal shape 4 as well as the proximal shape 11 fold back towards their original shape, that is, towards the inner area of frame 5, thus enabling an atraumatic positioning of the frame 5 to be made on the aorta wall. The folding avoids transitions with sharp edges or corners. Additional stabilisation of the frame 5 is achieved by the physiological conditions in the aorta, since the blood flow also presses the frame 5 of the embolic protection device 1 into its placement position.

(68) FIG. 19 shows various views of a forming device 31 for shaping an inventive embolic protection device 1. In order to facilitate the shaping of the embolic protection device from an unfolded state in the basic state to a stretched state, the embolic protection device is retracted into the distal subsection 33 of the forming device 31. The distal subsection 33 of the forming device 31 has a flat funnel with a flat opening 35 about 25-40 mm wide and an opening height of about 3-10 mm. Along the length of the distal subsection 33 of the forming device 31 measuring about 60-80 mm, the opening area of the front face tapers to a narrow, circular cross section 39, with a diameter of approximately 1.7 mm. The proximal subsection 40 of the forming device 31 enlarges from the narrow cross section 39 to the round opening 37 with a diameter of about 1.8 to 5 mm diameter over a length of 20 to 40 mm. Thus, the overall length of the forming device 31 is 80 to 120 mm.

(69) FIG. 20 shows a perspective view of the forming device 31 from FIG. 19.

(70) FIG. 21 shows individual steps of the method for folding the inventive embolic protection device by means of a forming device 31, wherein the folded embolic protection device 1 is pushed into a substantially round tube 38, e.g. a commercially obtainable introducer sheath or a commercially obtainable catheter (with an internal diameter of 1.8 to 2.5 mm) 38. In a step S1, the frame 5 of the embolic protection device 1, with the feed unit 7 leading, is moved in front of the flat opening 35 of the forming device 31. In this process, the proximal end of the feed unit 7 is guided through the distal end of the forming device 31. The substantially circular tube 38 is pushed with its distal end on to the feed unit 7 proximally up to the front of the round opening 37 of the forming device 31, wherein the feed unit 7 protrudes out of this tube 38.

(71) In a step S2, the tube 38 and the forming device 31 are connected together in the widened or conical round opening 37 of the forming device 31, for example, by a plug connection. By pulling on the feed unit 7, the embolic protection device 1 is straightened out.

(72) By further pulling on the feed unit 7, in a step S3 the proximal shape 11 is folded on the outer edge of the distal subsection 33 of the forming device 31, so that it is stretched out as it is pulled through by the forming device 31.

(73) Further pulling on the feed unit 7 in step S4 causes the distal shape 4 to be pushed over the outer edge of the distal subsection 33 of the forming device 31, wherein the distal shape 4 hooks on to the edge and is folded outwards. This is also emphasized in the side view of the figure.

(74) In a step S5, the embolic protection device 1 is completely stretched out by retracting through the forming device 31. By pulling further on the feed unit 7, the sides of the frame 5 are pushed inwards until the entire frame, elongated, is pulled into the tube 38. The embolic protection device 1 remains in this tube 38. The forming device 31 can now be removed from the tube 38.

(75) In summary, it is maintained that, by means of the described methods, an inventive embolic protection device (1) is specified for insertion into an aortic arch, comprising a filter unit (3), a frame (5) and a feed unit (7), wherein the filter unit (3) is arranged on the frame (5) and the frame (5) has a proximal area (9), which comprises a proximal shape (11), which is arranged in an inner area of the frame (5) and is connected to the feed unit (7), wherein the proximal shape (11) comprises a first part (13) and a second part (15), wherein the second part (15) is formed at one end of the first part (13).

(76) In a further development of the embolic protection device (1), the first part (13) of the proximal shape (11) is at a first angle (W1) to the plane of the frame (5) and the second part (15) is at a second angle (W2) to the first part (13) of the proximal shape (11).

(77) According to the invention, an embolic protection device (1) is provided for insertion into an aortic arch, comprising a filter unit (3), a frame (5) and a feed unit (7), wherein the filter unit (3) is arranged on the frame (5) and the frame (5) has a proximal area (9), which comprises a proximal shape (11), which is arranged in an inner area of the frame (5) and is connected to the feed unit (7), wherein the proximal shape (11) comprises a first part (13) and a second part (15), wherein the first and second parts (13, 15) are arranged together such that they form a spring mechanism.

(78) In a further development of the embolic protection device (1), the proximal shape (11) can be set under tension by the feed unit (7).

(79) In a further development of the embolic protection device (1), the proximal shape (11) comprises two ends (17, 19) of the frame (5), which extend parallel to each other in the inner area of the frame (5).

(80) In a further development of the embolic protection device (1), the proximal shape (11) is connected to the feed unit (7), wherein the two ends (17, 19) of the frame (5) are wrapped by a wire (6), whose ends (10) are arranged parallel to the ends (17, 19) of the frame (5).

(81) In a further development of the embolic protection device (1), the frame (5) has a distal area (2) which comprises a distal shape (4), which is arranged in an inner area of the frame (5).

(82) In a further development of the embolic protection device (1), the distal shape (4) has a constriction (12) towards the inside of the frame (5).

(83) In a further development of the embolic protection device (1), the connection of frame (5) and filter unit (3) is carried out by means of an adhesive tunnel or an adhesive tunnel connection.

(84) In a further development of the embolic protection device (1), the filter unit (3) is connected with the frame (5) outside the proximal and/or distal area(s) (9, 2).

(85) In a further development of the embolic protection device (1), the filter unit (3) is connected to the frame (5) in the distal area (2) substantially up to the start of the distal shape (4).

(86) In a further development of the embolic protection device (1), the filter unit (3) is connected to the frame (5) in the proximal area (2) substantially up to the first part (13) of the proximal shape (11).

(87) In a further development of the embolic protection device (1), is the filter unit (3) is connected flexibly to the frame (5) in the distal and proximal areas (2, 9).

(88) In a further development of the embolic protection device (1), the frame (5) is connected to the filter unit (3) with prestress in the lateral direction.

(89) In a further development of the embolic protection device (1), the filter unit (3) has a protrusion (14) over the frame (5).

(90) In a further development of the embolic protection device (1), the protrusion (14) is sealed.

(91) In a further development of the embolic protection device (1), the protrusion (14) is formed as a sealing lip.

(92) In a further development of the embolic protection device (1), in the proximal and/or distal area(s) (9, 2) of the frame (5) the filter unit (3) is flipped over the frame (5) from the lower side to the upper side.

(93) In a further development of the embolic protection device (1), the filter unit (3) is secured by means of a thread, wire or yarn to the distal shape (4).

(94) In a further development of the embolic protection device (1), the securing of the filter unit (3) by means of a thread, wire or yarn to the distal shape (4) is sealed.

(95) In a further development of the embolic protection device (1), the filter unit (3) is secured by means of gluing to the distal shape (4).

(96) In a further development of the embolic protection device (1), the filter unit (3) is secured by means of a coil in the proximal area (9).

(97) In a further development of the embolic protection device (1), the filter unit (3) has a fibre material, wherein the fibres are aligned such that they make an angle of substantially 45 degrees to a longitudinal axis of the frame (5).

(98) In a further development of the embolic protection device (1), the frame (5) has a basic state in the form of an oval shape.

(99) According to the invention, a forming device (31) is specified for reshaping the embolic protection device (1) for insertion into a tube, wherein a frame (5), with a filter unit (3) arranged on it, of the embolic protection device (1) is deformed from an expanded state to a stretched state, comprising on one side a flat or round opening (35), a narrowest cross section (39) and a round opening (37) at the opposite end.

(100) In a further development of the forming device, the flat or round opening (35) of the forming device (31) is formed such that the proximal shape (11) and/or the distal shape (4) of the frame (5) of the embolic protection device is folded outwards.

(101) According to the invention, a method is specified for folding the embolic protection device by means of the forming device, comprising pushing (S1) the frame (5) of the embolic protection device in front of the flat or round opening (35) of the forming device (31), wherein the feed unit (7) is fed through the forming device (31), drawing (S3) the proximal shape (11) into the forming device (31), wherein the proximal shape (11) is folded outwards, the distal shape (4) hooks (S4) over the outer edge of the forming device (31), and by pulling the distal shape (4) folded outwards further, it is drawn into the forming device (31).

(102) In a further development of the method, due to the frame (5) being pulled into the forming device (31), the frame (5) is stretched out lengthwise.

(103) In a further development of the method, wherein the folded proximal shape (11) transfers a prestress to the frame (5), which is substantially equal to the tension resulting from it, the curved proximal shape (11) is straightened.

(104) According to the invention, a method for unfolding the embolic protection device is specified when the embolic protection device leaves a catheter containing it, comprising pushing the embolic protection device out of the catheter, folding the distal shape (4) back into an inner area of the frame (5), when a distal area (2) of the frame of the embolic protection device leaves the catheter.

(105) A further development of the method comprises indicating the direction of the frame (5) by means of one or a multiplicity of markers, when the distal area (2) leaves the catheter, wherein the distal area (2) specifies the orientation of the frame (5).

(106) A further development of the method wherein, due to the prebending of the distal shape as well as the proximal shape, torsion is generated in the wire of the frame (5), the preferred direction of which, when leaving the catheter, is towards the curved tip of the distal shape.

REFERENCE LIST

(107) 1 Embolic protection device 2 Distal area 3 Filter unit 4 Distal shape 5 Frame 6 Stainless steel wire 7 Feed unit 8 Adhesive unit 9 Proximal area 10 Ends of the wire 11 Proximal shape 12 Constriction 13 First part 14 Protrusion 15 Second part 17, 19 Ends of the frame 20 Marker 21 Proximal filter unit 22 Distal filter unit 23 Flag 25 Catheter 27 Ostium 29 Head blood vessel outflows 31 Forming device 33 Distal subsection 35 Flat opening 37 Round opening 38 Tube 39 Very narrow cross section 40 Proximal subsection 41 Adhesive tunnel 42 Sealing 43 Thread S1-S5 Method steps W1 First angle W2 Second angle