Embolism protection device for inserting into an aortic arch

Abstract

The invention relates to an embolism protection device for introducing into an aortic arch in order to prevent embolisms. The invention additionally relates to a handle for such an embolism protection device, to a system consisting of the handle and / or the embolism protection device, and to a system consisting of the handle, the embolism protection device, and a catheter. The invention provides an embolism protection device for introducing into an aortic arch, comprising a filter unit and an introduction unit, wherein the filter unit comprises a frame and a filter fabric, and the filter fabric is arranged on the frame. The filter unit has a proximal region and a distal region, and the filter unit is designed such that the filter unit can be arranged at least partly in the aortic arch. When the filter unit is properly positioned, a haptic feedback is produced which signals the final position to the user.

Description

[0001] Embolic protection device for delivery into an aortic arch

[0002] The invention relates to an embolic protection device for delivery into an aortic arch to prevent the influx of particles or other debris into the cerebral vascular system. Furthermore, the invention relates to a handle for such an embolic protection device, as well as a system comprising this handle and a catheter, a system comprising a handle and the embolic protection device, a system comprising an embolic protection device and a catheter, and a system comprising a handle, an embolic protection device and a catheter, as well as a method for using an embolic protection device, a method for using a handle, and a method for using a system comprising an embolic protection device and / or a handle and / or a catheter.

[0003] The area of ​​application is medicine, especially cardiac surgery and interventional cardiology.

[0004] The risk of ischemic brain lesions leading to strokes is one of the most feared complications in cardiac surgery, especially in minimally invasive procedures such as transcatheter aortic valve implantation (TAVI).

[0005] During such procedures, macroscopic particles can break off, which can travel via branches of the aortic arch to the brain and trigger embolisms there.

[0006] From the state of the art, embolic protection devices are already known which can be inserted into the aortic arch as filters during cardiac surgery and interventional procedures to prevent the penetration of such particles into the vascular branches.

[0007] However, the correct positioning of the filters within the aortic arch is problematic; even small gaps can allow particles to bypass the filter, necessitating a precise fit. Furthermore, the user cannot visually determine the filter's correct position, making it difficult to estimate when the optimal final position has been reached. Additional factors, such as even the slightest twisting of the catheter with the delivery device, can further complicate accurate positioning.

[0008] The object of the invention was therefore to provide an improved embolic protection device. This object is achieved by the features of claim 1 and the further independent claims. The dependent claims relate to advantageous embodiments of the invention.

[0009] The invention provides an embolic protection device for delivery into an aortic arch, comprising a filter unit and a delivery unit, wherein the filter unit comprises a frame and a filter fabric and the filter fabric is arranged on the frame, the filter unit has a proximal region and a distal region, and wherein the filter unit is designed such that it can be arranged at least partially in the aortic arch.

[0010] The positionability of the embolic protection device is advantageous, thanks to a connection formed over a certain area to a controllable feeding unit. This connection between the frame and the feeding unit allows for positional corrections of the filter while it is deployed.

[0011] It is advantageous if the correct positioning of the filter unit provides haptic or visual feedback that signals the final position to the user.

[0012] Advantageously, this allows the user to feel when the embolic protection device is precisely positioned. The embolic protection device can be designed to provide haptic and / or visual feedback when the filter unit has reached its position in the aortic arch.

[0013] Haptic feedback is primarily generated by the high degree of anatomical adaptation of the filter unit. When the filter unit has achieved its optimal position, it responds to the user's pulling with a certain resistance, thus signaling its correct fit within the aortic arch. Alternatively or additionally, visual verification can be provided by attaching radiopaque markers.

[0014] In addition to correct positioning supported by haptic and / or visual feedback, a stable position during the placement period and minimized interaction with the respective indexing procedure are crucial for the functionality of the embolic protection device.

[0015] Increased stability of the embolic protection device can be achieved, among other things, by optimizing the fit of the filter unit with regard to its placement environment. Furthermore, the radial stiffness of the embolic protection device can be increased by reinforcement in the proximal area and internal stress (torsion) within the frame.

[0016] A further advantage for the functionality of the embolic protection device is its independence from the need to maintain a stable position during the placement of interventional equipment required for the index procedure. This is also achieved through an optimized fit. A further advantageous minimization of potential interaction is achieved by placing the proximal end of the embolic protection device within the delivery vessel. A particular advantage here is that this arrangement allows the proximal end of the embolic protection device to dip into the delivery vessel, thus creating a smooth transition without any visible edge between the embolic protection device and the aortic arch.

[0017] The delivery unit according to the invention is a device for transmitting forces to the filter unit, by which the filter unit can, among other things, be pulled or pushed through the catheter and moved in the aortic arch. Preferably, this is designed as a wire in the embolic protection device, preferably as a winding of several thin wires; other embodiments are conceivable.

[0018] Advantageously, the embolic protection device is designed such that the frame comprises two ends in the proximal region, which extend parallel to each other within the frame and are connected to the delivery unit via a section. This allows the filter unit to be guided through a catheter and moved within the aortic arch by means of the delivery unit.

[0019] In one embodiment of the invention, the proximal region of the filter unit has a fixing mechanism that increases the radial stiffness of the frame. This contributes to more stable positioning and stronger haptic feedback.

[0020] In another embodiment of the embolic protection device, the distal area tapers towards the tip, resulting in a streamlined cross-sectional distribution. This leads to a better geometric adaptation of the distal tip to the aortic arch and reduces the surface area exposed to the bloodstream during placement. Simultaneously, a gradual increase in contact pressure with the aortic arch is achieved.

[0021] A support may be arranged on the filter fabric of the embolic protection device, which is connected directly or via the ends of the frame to the feed unit and by which the filter fabric is passively drawn towards the aortic roof in the expanded state.

[0022] Such support is advantageously constructed from a rigid element†, such as a spring or a flexible material, such as silicone or rubber.

[0023] In an alternative embodiment, the filtering tissue can also be connected to a device by which the filtering tissue can be actively drawn towards the aortic roof.

[0024] The device is preferably designed such that it can be guided through the catheter to the handle area independently of the delivery unit and actively operated there by the user. Various materials are suitable for this purpose; preferably, wire or yarn can be used.

[0025] In an independently inventive embodiment, the embolic protection device is designed† such that the proximal region can be arranged separately from the distal region in the supply vessel and the distal region separately from the proximal region in the aortic arch. The frame is thus formed into a proximal vessel section and a distal aortic section†.

[0026] This embodiment has the advantage that possible interactions with devices used in the aortic arch are reduced.

[0027] The geometry of the aortic segment remains unaffected, which can be achieved by a significant change in the curvature direction within the filter frame. The frame is thus divided into a proximal vessel segment and a distal aortic segment.

[0028] Due to the independent shaping of the vessel and aortic parts and their anatomical adaptation, the filter unit† can be fixed in the access vessel and in the aortic arch in such a way that haptic and / or visual feedback is provided when it is positioned exactly†.

[0029] This embodiment has the advantage that possible interactions with devices used in the aortic arch are reduced.

[0030] In an alternative, also independently inventive embodiment, the embolic protection device is characterized in that the entire filter unit can be arranged completely within the aortic arch. When the filter unit is properly positioned within the aortic arch, the proximal region is shaped distal to the supply vessel. After the tensioned filter unit is opened and inserted into the aortic arch, a filter surface extending in the direction of flow is formed, which, by drawing the frame towards the roof of the aortic arch via the supply unit, ensures the coverage of the cerebral vessels.

[0031] Preferably, a variant of the embolism protection device is designed such that the ends of the frame are arranged in an obtuse angle W3 to the proximal filter plane when unfolded, so that by pulling the frame towards the aortic arch roof a proximal filter surface extending in the direction of flow is formed†.

[0032] This improves the contact pressure of the proximal end against the aortic arch wall, leading to a reduction in interactions with devices used, for example, to perform the TAVI procedure.

[0033] Because the entire filter unit is positioned in the aortic arch and extends proximal beyond the delivery vessel, pulling on the delivery unit generates a haptic signal that indicates the correct positioning of the filter unit.

[0034] In another variant, the proximal area is divided in such a way that the ends of the proximal area describe an arc shape such that the first part of the arc shape is formed towards the distal area and the second part towards the proximal area (see Figure 9 c).

[0035] An advantage here is that the second part forms a sharp downward angle W5, as this presses the end of the proximal area against the aortic arch roof when the embolic protection device is finally placed. This enhances haptic feedback and further minimizes interaction with other devices.

[0036] In a further advantageous embodiment of the invention, the ends of the frame can be arranged at an acute angle W1 to the distal filter plane when the filter unit is unfolded (see Figure 1 1 a)), so that by drawing the frame towards the aortic arch roof, the frame expands in such a way that the width of the end of the proximal region increases. In a particular embodiment, this is achieved by arranging the ends of the frame to dip below the filter plane at the connection to the proximal frame (see Figure 1 1 b)), thereby transferring a tension to the frame which results in a widening of the proximal region when it is drawn towards the feed vessel.In another embodiment, the filter unit is divided into two parts such that the proximal area protrudes from the filter plane†, so that by reshaping the proximal area during placement a torsion is transferred to the distal area, which increases the pressure on the aortic arch roof.

[0037] Alternatively, the filter unit of the embolism protection device is divided in such a way that the proximal area protrudes from the filter plane†, so that the proximal area widens upon placement.

[0038] Furthermore, a torsion can develop in such a way that the distal end arches towards the aortic roof†.

[0039] This arrangement provides haptic feedback to the user upon successful positioning of the filter unit†.

[0040] This also results in improved coverage of the cerebral vessels.

[0041] In a further independently inventive advantageous embodiment of the invention, the filter unit of the embolic protection device can be divided into two parts such that the proximal area can be actively and / or passively folded away independently of the distal area when the embolic protection device is removed.

[0042] In another variant, the filter unit is divided into two parts such that the ends of the proximal area describe an arc shape, with the first part of the arc shape pointing towards the distal area and the second part pointing towards the proximal area.

[0043] In a particular embodiment, the proximal region can be angled independently of the distal region in the direction of flow; in a preferred embodiment, both the distal and proximal regions can be angled by 5° to 85°, particularly preferably by 25° to 75°, and most preferably by 60° relative to the feed unit. This particularly preferably applies to the proximal frame.

[0044] In a particular embodiment, the side sections can be angled independently of one another perpendicular to the flow direction. In a preferred embodiment, the angle is between 5° and 85°, particularly preferably between 25° and 75°, and most preferably between 60° relative to the feed unit. This results in better coverage of the vessels, a more stable position, and stronger haptic feedback.

[0045] In another independently inventive variant of the embolism protection device, the filter unit is divided in such a way that the proximal area and the distal area each have their own frame, over which a separate filter is stretched.

[0046] Preferably, the embolic protection device is characterized in that the second part of the frame ends is connected to the filter fabric and / or the proximal frame via a device, and the proximal area can be actively folded inwards towards the delivery vessel via this device. This allows the device to be easily removed again via the catheter.

[0047] The embolic protection device can also be designed such that the filter unit is divided into two parts, with the proximal and distal sections each having their own frame. A single filter can be stretched across both frames. Preferably, in this embodiment, a support is arranged between the filter fabric and / or the frame of the proximal section, allowing the proximal frame to be passively folded towards the delivery vessel. This facilitates removal of the device.

[0048] Alternatively, also independently inventive, the filter unit of the embolism protection device can be divided into two parts such that a second frame lies on the outside of the first frame and the second frame is only connected to the filter fabric in the distal area of ​​the first frame and the proximal end of the first frame can be pulled towards the supply vessel, whereby the second frame is pulled towards the roof of the aortic arch and a wedge is formed.

[0049] Preferably, the first frame is constructed from a thicker wire than the second frame, as it can be actively moved and pull the second frame along with it. The wedge shape is particularly advantageous because this flexible system allows for effective coverage of the vessel branches.

[0050] An alternative further development is an embolism protection device in which the frame of the filter unit is connected to a return device through which the frame can be returned to the catheter, the circumference of the filter fabric exceeds the circumference of the frame, the filter fabric being connected to the feed unit so that a funnel is formed when the filter fabric is pulled towards the feed vessel.

[0051] In this variant, a self-contained frame without a stabilizing connection to the delivery unit is used. Since the adaptation to the aortic arch is achieved via the filter fabric, the frame can be shaped in various ways, for example, round or oval. Removal of the frame from the aortic arch is achieved by a separate retraction device, preferably a wire, which is either connected to the delivery unit or is returned separately to the user for active actuation.

[0052] The filter unit† is pulled to the feed vessel by the feed unit, alternatively it can also be provided with† an independent active device.

[0053] The funnel design ensures optimal coverage of the vessel branches. With optimal placement, these designs also transmit a haptic signal to the user.

[0054] Another independent inventive aspect relates to a handle for an embolism protection device, characterized in that the handle comprises a first connecting piece, a handle shell, a slider and / or a second connecting piece, wherein the first connecting piece is designed as an actively secured connection and / or the second connecting piece as a reversible clamping connection.

[0055] In a further embodiment, the handle is characterized in that the handle comprises a first connecting piece, a handle shell, a slider and / or a second connecting piece. The first connecting piece can be designed as an actively or passively secured connection and / or the second connecting piece as a permanent clamping connection.

[0056] The handle enables various functions. For example, a secure connection to a catheter can be established. This is preferably achieved by designing the first connector in such a way that an actively secured connection to a catheter can be established. A Luer-lock connection can be made between the catheter and the first connector. Preferably, the connector has indentations on its inner surface into which the wings of the catheter can be inserted. The sleeve of the first connector can then be slid onto the catheter. This improves the handling of the embolic protection device, as the catheter is fixed and thus protected against rotation. A reversible clamp connection to the delivery unit can be established using the second connector to transmit tensile or compressive forces and torques to the delivery unit.

[0057] Furthermore, the handle can include a slider designed to exert a pulling and / or pushing mechanism for loading and positioning devices. Preferably, the slider has a locking mechanism that allows the relative position of the slider to the handle to be fixed. The slider can be reversibly fixed, for example, in the end position to secure devices after preparation before use. In one embodiment, a push button on the handle with a detent mechanism can be arranged for this purpose.

[0058] Preferably, the handle shell is designed to fit snugly and prevent twisting against the slider†, in this case it† is advantageous for the slider not to have a round geometry†.

[0059] These features of the handle have proven advantageous when using, for example, an embolism protection device, since even the smallest movements can lead to problems in the insertion, positioning and removal of the filter unit, and the transmission of rotary movements is essential for positioning devices.

[0060] Another preferred embodiment of the invention consists in the handle containing a hemostasis valve, which is preferably arranged in the front handle area. This hemostasis valve may include a flushing function.

[0061] Furthermore, the handle shell can have an inner guide tube that can be inserted into the slide. The guide tube serves to guide the feed unit, preventing it from buckling when pressure is applied by advancing the slide inside the handle part.

[0062] The invention further relates to a system comprising an embolic protection device and a catheter. Advantageously, in this system, the embolic protection device is designed in such a way that it can be passed through the catheter.

[0063] This system is particularly preferred as a unit with a non-reversible connection, but a reversible connection is also possible. For example, for the placement of other interventional equipment. In particular, the handle and catheter can be a single unit or reversibly connected. This unit can also be reversibly or irreversibly connected to the embolic protection device during manufacturing.

[0064] In another embodiment of the invention, it relates to a system consisting of an embolism protection device and a handle.

[0065] The invention also relates to a system comprising an embolic protection device, a handle, and a catheter. The catheter can be fixed in the handle, and the embolic protection device can be passed through the catheter and connected to the handle via the delivery unit. This system is particularly preferred as a unit with non-reversible connections between the catheter and the handle, as well as between the handle and the embolic protection device; however, reversible connections are also possible.

[0066] Also independently inventive is a method for positioning the embolic protection device using the device. The method is characterized in that, upon proper positioning of the filter unit, haptic feedback is generated, signaling the final position to the user.

[0067] By applying tensile and / or compressive forces to the feed unit and, if necessary, other active devices, it is possible to insert the filter unit into the aortic arch, to position it optimally, and to remove it.

[0068] Further independent inventive aspects of the invention relate to a method for using an embolic protection device, a method for using a handle, and a method for using a system comprising an embolic protection device and / or a catheter and / or a handle. In particular, the method can serve for rotational correction of the distal area, especially during filter placement, by rotating the handle and transmitting torque through the reversible clamping connection and thus the delivery unit, as well as simultaneously transmitting torque through the catheter and thus via the friction connection to the folded filter.

[0069] In particular, the invention relates to an embolism protection device for delivery into an aortic arch, comprising a filter unit and a delivery unit, wherein the filter unit comprises a frame and a filter fabric and the filter fabric is arranged on the frame, the filter unit has a proximal region and a distal region, wherein the filter unit is designed in such a way that it can be arranged at least partially in the aortic arch.

[0070] The filter unit is particularly preferably designed in such a way that it is divided into two parts, so that the proximal area and the distal area each have their own frame.

[0071] The embolic protection device according to the invention thus has a two-part frame structure.

[0072] Preferably, the embolism protection device is designed† in such a way that, when the filter unit† is positioned correctly,† a haptic or visual feedback is generated, which signals the final position to the user.

[0073] In a particular embodiment, the embolic protection device is characterized in that the proximal frame and the distal frame each comprise two ends in the proximal area which extend parallel to each other in the inner area of ​​the frame and / or are arranged perpendicular to the frame and are connected to the feed unit.

[0074] According to the invention, both frames each have two ends, as shown in Figure 14, which are connected to the delivery unit. This means that a total of four wires are guided into the catheter to the delivery unit.

[0075] In a special variant of the embolic shield device, the distal and proximal areas are fixed in such a way that the radial stiffness is increased.

[0076] This fixation can be achieved using a wire or similar material.

[0077] In an alternative form of the embolic scute device, the distal area is tapered† towards the tip and thus has† a streamlined cross-section filing.

[0078] In another variant, the embolic protection device is designed such that the frame ends can be angled along the flow direction (see Figure 16A) and / or perpendicular to the flow direction (see Figure 16B). This results in a widening of the filter area when the filter unit is drawn towards the aortic arch roof. This widening provides better coverage of the vessels in the aortic arch and also provides haptic feedback when correctly positioned. In a particular embodiment, the proximal area can be angled in the flow direction independently of the distal area. In a preferred embodiment, the frame ends and / or the frame faces can be angled between 5° and 85°, preferably 25° to 75°, and particularly preferably 60° in the flow direction and / or perpendicular to it.

[0079] This leads to better coverage of the vessels, a more stable position, and stronger haptic feedback.

[0080] It is particularly advantageous if the ends of the frames are arranged at an acute angle to the filter plane when unfolded, so that by pulling the frames towards the aortic arch roof they are shaped in such a way that the length of the filter area is increased.

[0081] The frames can be actively or passively drawn towards the roof of the aortic arch.

[0082] Preferably, the filter unit of the embolism protection device is divided into two parts such that the proximal area can be actively and / or passively folded away independently of the distal area when the embolism protection device is removed.

[0083] The proximal area and / or the distal area can be folded inwards towards the supply vessel or in the opposite direction.

[0084] A further preferred embolism protection device is one in which the filter unit is divided in such a way that the proximal area can be actively and / or passively folded away independently of the distal area when the embolism protection device is removed.

[0085] It can be particularly advantageous if, via a device connected to the filter fabric and / or the proximal frame, the proximal area can be actively folded inwards towards the feed vessel.

[0086] In a preferred version of the embolism protection device, a separate filter is stretched over each of the two frames.

[0087] In another embodiment of the invention, the embolic protection device is constructed such that the filter unit is divided into two parts, with the proximal and distal regions each having their own frame, and a single filter is stretched over both frames. A further inventive aspect relates to a handle for a medical device, characterized in that the handle comprises a first connecting piece, a handle grip, a slider, and / or a second connecting piece, wherein the first connecting piece is designed as an actively secured connection and / or the second connecting piece as a reversible clamping connection.

[0088] In a further embodiment, the handle is characterized in that the handle comprises a first connecting piece, a handle shell, a slider and / or a second connecting piece, wherein the first connecting piece is designed as a passively secured connection and / or the second connecting piece as a permanent clamping connection.

[0089] The handle enables various functions. For example, a secure connection to a catheter or other medical devices can be established. This is preferably achieved by designing the first connector in such a way that an actively secured connection to, for example, a catheter or other device can be established. A Luer-lock connection can be made between the catheter and the first connector for this purpose. In one variant, the connector has indentations on the inside into which the wings of the catheter can be inserted. The sleeve of the first connector can then be slid onto the catheter. This leads to improved handling of the embolic protection device, as the catheter is fixed and thus protected against rotation.

[0090] The second connecting piece allows a reversible clamping connection to be made to the feed unit in order to transfer tensile or compressive force and moments to the feed unit.

[0091] Furthermore, the handle can include a slider designed to exert a pulling and / or pushing mechanism for loading and positioning devices. This pushing mechanism can be implemented, for example, by an internal guide that prevents the feed unit from buckling or warping.

[0092] Preferably, the handle shell has an inner guide tube that can be inserted into the slide. This can serve as a guide tube for connected medical devices, such as catheters, and prevents these devices from buckling under pressure. Preferably, the slide has a locking mechanism that allows the relative position of the slide to the handle shell to be fixed. The slide can be reversibly fixed, for example, in the end position to secure devices after preparation before use. In one embodiment, a push button on the handle with a detent mechanism can be arranged for this purpose.

[0093] Furthermore, the handle may contain a hemostasis valve. This valve can be used, among other things, to perform rinsing procedures.

[0094] The invention further relates to a system consisting of the embolism protection device, the handle and a catheter.

[0095] A system in which the embolic protection device is pre-placed in the handle-catheter combination is particularly preferred. In one embodiment of the invention, the system includes a fixed, non-reversible connection between the handle and the catheter and a fixed, non-reversible connection to the delivery unit.

[0096] The invention also relates to a method for using an embolism protection device.

[0097] A further object of the invention is a method for using a handle.

[0098] A method for using a system consisting of an embolism protection device, a handle and / or a catheter is also the subject of the invention.

[0099] In particular, the method can be used for rotational correction of the distal area, especially during the placement of the filter by rotating the handle and torque transmission through the reversible clamping connection and thus the delivery unit† as well as the simultaneous torque transmission through the catheter and thus via the friction connection to the folded filter.

[0100] Further details of the invention can be found in the exemplary embodiments described below with reference to the figures. All details of the invention listed below are not limited to the specified exemplary embodiments, but can also occur individually, selectively together, or in their entirety in other exemplary embodiments. The figures show:

[0101] Fig. 1: Top view of the frame of the embolic shield device with tapered

[0102] Great;

[0103] Fig. 2: Top view of the frame of the embolic protection device with separation in

[0104] Aortic part and vascular part:

[0105] Fig. 3: Cross-section through the aortic arch with positioned

[0106] Emboliation protection device with frame from Fig. 2:

[0107] Fig. 4: Top view of the frame of the embolic protection device with radial stabilizing fixation:

[0108] Fig. 5: Arrangement of the passive filter fabric support in a) side view, b)

[0109] Front view and c) perspective view from oblique front and oblique top:

[0110] Fig. 6: Examples of passive filter fabric support a)-c) in side view; Fig. 7: Arrangement of passive filter fabric support in side view;

[0111] Fig. 8A Arrangement of the active filter fabric support in side view;

[0112] Fig. 8B: Arrangement of the active filter fabric support in perspective from an oblique front and oblique top view:

[0113] Fig. 8C: Detailed view of the connection between the frame and the feeding unit

[0114] Fig. 9: Frame of the embolic protection device for complete arrangement in

[0115] Aortic arch with ends pointing in the direction of flow in a) top view, b) side view and c) in folded state in the catheter

[0116] Fig. 10: Cross-section through the aortic arch with positioned

[0117] Embolism protection device from Fig. 9:

[0118] Fig. 1 1 : Frame of the embolic protection device with submerged proximal

[0119] Filter plane a) perspective view of the frame from a slightly oblique rear top, b) front view, c) side view, d) top view

[0120] Fig. 12: Top view of the filter unit with double (first and second) frames. Fig. 13: Perspective side view from a slightly oblique angle.

[0121] Emboliation protection device with a funnel shape

[0122] Fig. 14: Top view of the embolism protection device with two-part frame and separate filters

[0123] Fig. 15: Top view of the embolism protection device with two-part frame and one-piece filter

[0124] Fig. 1 6A: Side view of the embolic protection device with two-part filter and active retraction of the proximal area

[0125] Fig. 16B: Front view of the embolic protection device with two-part filter and active retraction of the proximal area. Fig. 16C: View of the embolic protection device in the folded state during insertion and removal.

[0126] Fig. 1 7A: Side view of the embolic protection device with two-part filter in the unfolded state

[0127] Figs. 17B and 17C: Side view of the positioning of the embolic protection device in the catheter during insertion (Fig. 17B) and removal (Fig. 17C).

[0128] Fig. 18 A: Side view of the handle with the slider extended

[0129] Fig. 18 B: Perspective view from an oblique front view of the first

[0130] Connecting piece of the handle:

[0131] Fig. 19: Cross-section through the side view of the second connecting piece of the

[0132] Handles:

[0133] Fig. 20: Cross-section through the side view of the first connecting piece of the

[0134] Handles:

[0135] Fig. 21: Cross-section through the front view of the first connecting piece of the

[0136] Handle.

[0137] Fig. 22: Side view of the handle

[0138] Fig. 1 shows the top view of the frame 3 of the embolic protection device 1, which comprises a distal region 7 and a proximal region 6. In this embodiment, the frame 3 is designed with a tapered distal tip 1 7. This achieves a streamlined cross-sectional distribution (indicated by arrows 13) to realize the gradual increase of the contact pressure against the aortic arch 9. This leads to a reduction in the surface area exposed to the bloodstream when the device is placed. Furthermore, it results in a better geometric adaptation of the distal tip 1 7 to the aortic arch.

[0139] Fig. 2 also shows a top view of the frame 3 of the embolic protection device 1 with separation into an aortic part 8 and a vessel part 10. This separation is achieved by a significant change in the direction of curvature in the filter frame geometry at position 15 on the frame 3. This results in the frame being separated into an aortic part 8 in the distal region 7 and a vessel part 10 in the proximal region 6, such that when the vessel part 10 is drawn into the supply vessel 1 1, the geometry of the aortic part remains unaffected.

[0140] Fig. 3 shows a cross-section through the aortic arch 9 with a positioned embolic protection device 1 and the frame 3 from the embodiment shown in Fig. 2. It illustrates how the aortic part 8 is positioned in the distal region 7 of the frame 3 within the aortic arch, and how the vessel part 10 is fixed in the proximal region 6 of the frame 3 within the access vessel 11. The proximal region 6 of the frame 3 is connected to the supply unit 4, through which the filter unit 2 is positioned. The insertion of the vessel part 10 into the supply vessel 11 serves to reduce possible interactions with devices used in the aortic arch 9.

[0141] The arrow indicates† the position of reduced interaction with devices in the aortic arch 9 through the vessel segment 10 drawn into the supply vessel 1 1. The proximal region 6 is shaped† for good anatomical adaptation.

[0142] Another advantageous embodiment is shown in the example of Fig. 4, a top view of the frame 3 of the embolic protection device 1 with radially stabilizing fixation. Here, the two loose ends of the frame 18 and 19 are shown, which are connected by a fixation 16 far at the end of the proximal region 6. This results in a radially stable frame geometry to enable haptic feedback when the filter unit 2 is correctly positioned in the aortic arch 9, as well as a stable position during the application period.

[0143] The radial stability area 41 is realized at the proximal end†. In this embodiment, the proximal and distal frame geometry are shaped identically to generate a synchronous force distribution.

[0144] Fig. 5 shows the arrangement of the passive filter fabric support 21 in a) side view, b) front view, and c) perspective view from an oblique front and oblique top view. The passive support 21 is arranged at the ends of the frame 18 and 19, which are connected to the feed unit 4. On the other side, the support 21 is connected to the filter fabric 20 and passively draws the filter material, in its expanded state, towards the aortic arch roof 22 (not shown). Besides providing better coverage of the vessel branches to prevent the entry of macroscopic particles into these branches, this also results in a more stable position of the embolic protection device 1.

[0145] Figure 6 shows some examples of such a support 21 in side view†, where a) is the side view of a flat spring element as in b), and c) a coil spring. Other materials for the support can be silicones, rubber or other elastic plastics, as well as molded nitinol geometries.

[0146] Fig. 7 shows the arrangement of the support 21, made of a flexible material, in a side view at the ends 18 and 19 and on the filter fabric 20.† Fixing it directly to the filter fabric 20 leads† to better coverage of the vessel branches, since the filter fabric 20 is more elastic than the frame 3 and can build up some additional tension against the frame 3.

[0147] Fig. 8A shows a side view of the arrangement of the active filter tissue in the form of a device 23. The device 23 is also connected to the filter tissue 20, but is actively actuated by the user. It is also arranged in the catheter 12 like the delivery unit 4; when actively pulled in the direction of the arrow, the filter tissue 20 and thus also the frame 3 are drawn towards the aortic arch roof 22.

[0148] In Fig. 8B, the arrangement of the device 23 is shown in perspective from an oblique front and oblique top view; in both figures it can be seen that the device 23 is not connected to the feed unit 4, but is guided independently to the user and can be operated from there independently of the feed unit 4.

[0149] Fig. 8C shows the connection of the frame ends with the feed unit in section.

[0150] Fig. 9 shows the frame 3 of the embolic protection device 1 for the execution of the complete arrangement in the aortic arch 9 with the ends 18, 19 pointing in the direction of flow in a) top view, b) side view and c) in the retracted state.

[0151] The ends 18 and 19 are bent towards the proximal filter plane 25 in the relaxed state, so that, as shown in Fig. 9 b), an acute angle W5 is formed between the distal filter plane 24 and at the junction of the ends 18 and 19 with the frame. In other words, the ends 18, 19 of the proximal region 6 describe an arc shape, such that the first part a of the arc shape is formed towards the distal region 7 and the second part b is formed towards the proximal region 6.

[0152] In other words, in the relaxed state (outside the body), the ends 18, 19 of the proximal region 6 describe an arc shape (Fig. 9b). This arc shape can be described into part a and part b, where part a of the arc shape is formed towards the distal region 7 and the second part b is formed towards the proximal region 6 and form an acute angle W5 to each other.

[0153] The ends 18 and 19 are arranged parallel in the catheter when inserted into the catheter 12 (Fig. 9c) to the proximal filter plane 25 and to the distal filter plane 24.

[0154] When the catheter 12 exits the catheter by means of the delivery unit 4, the frame assumes its final shape and can be positioned in the aortic arch 9 by pulling the delivery unit 4 so that part a of the proximal region 6 is arranged behind the delivery vessel 1 and part b lies within the delivery vessel itself. When the delivery unit 4 is withdrawn, a haptic signal is generated, which indicates the final position to the user.

[0155] In Fig. 10, the embolic protection device from Fig. 9 is shown in a cross-section through the aortic arch 9 in its end position†. In the unfolded state, the ends 18 and 19 of the frame 3 are arranged at an obtuse angle W3 to the proximal filter plane 25†.

[0156] By drawing the frame 3 towards the aortic arch roof 22, a filter surface extending in the direction of flow is formed, which ensures the coverage of the cerebral vessels. This also reduces the interaction with the TAVI procedure due to the improved contact pressure of the proximal area 6 against the aortic arch roof 22.

[0157] Fig. 1 1 shows† a further embodiment of the invention and its frame geometry, depicting† the frame 3 of the embolic protection device 1 in a) perspective view of the frame 3 from oblique rear top, b) front view, c) side view† and d) top view.

[0158] It can be seen that the ends 18, 19 of the frame 3, when unfolded, are arranged at an acute angle W1 to the distal filter plane 24, particularly preferably to the proximal filter plane 25 (shown in the figure), so that by pulling the frame 3 towards the aortic arch roof 22, it is shaped in such a way that the width of the end of the proximal area 6 increases.

[0159] This widening after positioning on the aortic arch 9 (see Fig. 11 d. arrow E) is realized by a subduction of the proximal frame from the filter plane (shown by the angle W4 in Figure 11c) and results in a frame torsion which in turn leads to the lifting of the distal area (also shown in Fig. c, rotation arrow T).

[0160] Raising the distal area in this way allows for more stable positioning†. In addition, increasing the width allows for better coverage of the cerebral vessels† and provides haptic feedback†, which signals the final position to the user†.

[0161] Fig. 12 shows a top view of a filter unit 2 with a double frame 3. A second frame 32 is located outside a first frame 33. The distal end of both frames (32, 33) is connected to the filter tissue 20, while the proximal end of the first frame 33 is not connected to the filter tissue 20. By actively retracting the proximal end of the first frame 33 by means of a device 23 at the proximal end towards the supply vessel 1, a wedge of filter tissue 20 is formed, which minimizes the interaction with devices in the aortic arch 9.

[0162] In addition, the second frame 32 is brought close to the aortic arch roof 22, thus achieving an improved adaptation to the aortic arch 9.

[0163] Fig. 13 shows a perspective side view from an oblique angle of the embolic protection device 1 with a funnel shape stretched across an embodiment with a filter fabric 20 whose circumference exceeds the circumference of the frame 3 and is therefore not fixed in place. This filter fabric 20 is connected to the feed unit 4, so that when the filter fabric 20 is pulled towards the feed vessel 1, a funnel 34 is formed. This also pulls the frame 3 against the arch wall, ensuring very good coverage of the vessel branches.

[0164] The frame is connected to a retraction device 35, which allows the frame to be retracted into the catheter 12.

[0165] The frame 3 itself is otherwise not provided with any further stabilizing device for the feed unit 4.

[0166] Figure 14 shows a filter unit 2 of an embolic protection device 1 with a two-part frame and a two-part filter. In the top view of the embolic protection device with two-part filter shown, it is shown 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.

[0167] The division of the frame results in the presence of four ends (marked with points that run parallel to each other and / or project perpendicularly out of the plane of the frame (in their extension, not shown), so that a total of four wires are connected to the feed unit.

[0168] This filtration unit† 2 is preferably placed centrally in front of the osfium of the supply vessel 1 1, the double row† ensures improved contact pressure of the frame 3 against the aortic arch wall proximally as well as distally†.

[0169] Fig. 15 shows a top view of the embolic protection device with a two-part frame 27, 28 but a single filter 31. This filter unit 2 is also preferably placed in front of the ossification of the supply vessel 1 1; the division of the frame 3 achieves improved contact pressure against the aortic arch wall both proximally and distally.

[0170] To remove the filter unit, an active device 23 is arranged (Fig. 16A), which is guided to the user through the catheter 12. During removal, the device 23 actively folds the proximal area 6 towards the access vessel 1, allowing the entire filter unit 2 to be removed from the vessel.

[0171] Fig. 16 B shows the filter unit 2 in a front view and indicates a possible angulation of the filter frames perpendicular to the flow direction, which, by pulling them towards the aortic roof, among other things, results in a widening of the filter area and / or an improvement in the contact with the aortic roof, thus leading to an increase in the shape stability and haptic and / or visual feedback.

[0172] Fig. 16 C shows the embolic protection device in its folded state, both during insertion and removal into the aortic arch 9.

[0173] Fig. 1 7 A shows the device in a side view when unfolded after exiting the catheter 12. The proximal frame 27 and the distal frame 28 unfold and can be positioned in the aortic arch 9.

[0174] Fig. 1 7B shows the filter unit 2 in the catheter 12 connected to the delivery unit 4 during insertion into the aortic arch 9. Here, the proximal frame 27 is folded backward so that the proximal frame 27 and distal frame 28 are arranged sequentially.

[0175] Fig. 1 7 C shows the arrangement of the filter unit 2 in the sheath when removed from the aortic arch 9. Here, the proximal and distal parts lie parallel to each other.

[0176] Fig. 18A shows the side view of the handle 5 with the slider extended between the handle shell 37 and the second connecting piece.

[0177] Fig. 18B shows a perspective view from an oblique front view of the first connecting piece 36 of the handle 5. Notches 42 are visible with which an actively secured connection with the wings 40 of the catheter 12 can be established. Fig. 19 shows a cross-section through the side view of the second connecting piece 39 of the handle, which contains at least one device for establishing reversible connections 43 to the delivery unit 4.

[0178] Fig. 20 shows a cross-section through the side view of the first connecting piece 36 of the handle 5, the indentations 42 on the inside are shown into which the wings 40 of the catheter 12 engage and the catheter 12 is thus fixed in a twist-proof manner.

[0179] Fig. 21 shows a cross-section through the front view of the first connecting piece 36 of the handle 5 with the inserted catheter 12 and the wings 40 engaging in the notches 42.

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

[0181] By means of the slider, the feed unit and thus the embolism protection device (1) can be brought into a specific position, so that the feed unit (4), which runs through the handle (5), can be advantageously positioned as the filter unit (2) can be.

[0182] The invention relates to an embolic protection device (1) designed for delivery into an aortic arch (9), comprising a filter unit (2) and a delivery unit (4), wherein

[0183] - the filter unit† (2) comprises a frame (3) and a filter fabric (20)† and the filter fabric (20) is arranged† on the frame (3),

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

[0185] - wherein the filter unit† (2) is designed† in such a way that it can be arranged at least partially in the aortic arch (9).

[0186] In a further development of the embolic protection device (1 ) it is characterized in that, when the filter unit† (2) is positioned correctly, a haptic or visual feedback is generated† which signals the final position to the user.

[0187] In a further development of the embolic protection device (1), the frame (3) comprises two ends (18) and (19) in the proximal region (6), which extend parallel to each other in the interior of the frame (3) and are connected to the feed unit (4). In a further development of the embolic protection device (1), it is characterized in that the proximal region (6) has a fixation (16) such that the radial stiffness is increased.

[0188] In a further development of the embolic protection device (1 ), the distal area (7) is tapered† towards the tip (1 7) and thus has† a streamlined cross-section filing.

[0189] In a further development of the embolic protection device (1) which is also independently inventive, a support (21) is arranged between the filter tissue (20) and the supply unit (4), by which the filter tissue (20) is passively drawn towards the aortic roof (22) in the expanded state.

[0190] In a further development of the embolic protection device ( 1 ), the support (21 ) is a spring.

[0191] In a further development of the embolic protection device (1) which is also independently inventive, the filter fabric (20) is connected to a device (23) so that the filter fabric (20) can be actively drawn to the aortic roof (22) via the device (23).

[0192] In a further development of the embolic protection device (1 ), the device (23) is a wire or a yarn.

[0193] In a further development of the embolic protection device (1 ), the proximal area (6) can be arranged separately from the distal area (7) in the supply vessel ( 1 1 ) and the distal area (7) can be arranged separately from the proximal area (6) in the aortic arch (9).

[0194] In a further development of the embolism protection device (1 ), the proximal area (6) can be adapted to the supply vessel (1 1 ) and fixed therein by changing the direction of curvature in the frame geometry.

[0195] In a further development of the embolic protection device (1) that is also independently inventive, the entire filter unit† (2) can be arranged in the aortic arch (9) and, with the proper positioning of the filter unit† (2) in the aortic arch (9), the proximal area (6) is formed distal to the supply vessel (1 1 ).

[0196] In a further development of the embolic protection device (1 ), the ends (18, 19) of the frame (3) are arranged in the unfolded state at an acute angle W1 to the distal filter plane (24), so that by pulling the frame (3) towards the aortic arch roof (22) it is shaped in such a way that the width of the end of the proximal area (6) is increased.

[0197] In a further development of the embolic protection device (1 ) the ends (18, 19) of the frame (3) are arranged in the unfolded state at an acute angle W3 to the proximal filter plane (25)†, so that by drawing the frame (3) towards the aortic arch roof (22) a proximal filter surface (26) leading in the direction of flow is formed†.

[0198] In a further development of the embolic protection device (1 ) the filter unit (2) is such that the proximal area (6) can be actively and / or passively folded in independently of the distal area (7) when the embolic protection device (1 ) is removed.

[0199] In a further development of the embolic protection device (1 ) the filter unit† (2) is divided in such a way that the proximal area (6) protrudes from the filter plane†, so that by reshaping the proximal area (6) during placement a torsion is transferred to the distal area (7), which increases the pressure on the aortic arch roof (22)†.

[0200] In a further development of the embolic protection device (1 ) the filter unit† (2) is such that the proximal area (6) protrudes from the filter plane†, so that the proximal area (6) widens upon placement.

[0201] In a further development of the embolic protection device (1 ) the filter unit† (2) is divided in such a way that the ends (18, 19) of the proximal region (6) describe an arc shape such that the first part (a) of the arc shape is formed towards the distal region (7) and the second part (b) is formed towards the proximal region (6).†

[0202] In a further development of the embolism protection device (1) which is also independently inventive, the filter unit (2) is divided into two parts such that the proximal area (6) and the distal area (7) each have their own frame (27, 28) over which each has its own filter (29, 30) stretched.

[0203] In a further development of the embolic protection device (1 ), the second part (b) is described as a

[0204] The device (23) is connected to the filter fabric (20) and / or to the proximal frame (27), and the proximal area (6) can be actively folded over this device (23) towards the supply vessel (11). In a further independent embodiment of the embolic shield device (1), the filter unit (2) is divided into two parts such that the proximal area (6) and the distal area (7) each have their own frame (27, 28), and a single filter (31) is stretched over both frames.

[0205] In a further development of the embolic protection device ( 1 ), a support (21 ) is arranged between the filter fabric (20) and / or frame (3) of the proximal area (6), by means of which the proximal frame (27) can be passively folded inwards towards the supply vessel (1 1 ).

[0206] In a further development of the embolic protection device (1) that is also independently inventive, the filter unit (2) is divided into two parts such that a second frame (32) is located in the outer area of ​​the first frame (33) and the second frame (32) is only connected to the filter fabric (20) in the distal area (7) of the first frame (33), and the proximal end (6) of the first frame (33) can be pulled towards the supply vessel (1 1 ), whereby the second frame (32) is drawn towards the aortic arch roof (22) and a funnel (34) is formed.

[0207] In a further development of the embolic protection device (1 ), the frame (3) of the filter unit (2) is connected to a return device (35) through which the frame can be returned to the catheter (12), the circumference of the filter fabric (20) exceeds the circumference of the frame (3), the filter fabric (20) being connected to the feed unit (4) so ​​that when the filter fabric (20) is pulled towards the feed vessel (1 1 ), a funnel (34) is formed.

[0208] A further inventive development, which is also independent, relates to a handle (5) for an embolism protection device (1), wherein the handle (5) comprises a first connecting piece (36), a handle shell (37), a slider (38) and / or a second connecting piece (39), wherein the first connecting piece (36) is designed as an actively secured connection and / or the second connecting piece (39) is designed as a reversible clamping connection.

[0209] In a further development of the handle (5), the first connecting piece (36) is designed in such a way that an actively secured connection to a catheter can be established.

[0210] In a further development of the handle (5) the connecting piece (36) has indentations (42) on the inside into which the wings (40) of the catheter (12) can be inserted.

[0211] In a further development of the handle (5), a reversible clamping connection to the feed unit (4) can be established by means of the second connecting piece (39). In a further development of the handle (5), the slide (38) is designed such that it can exert a pulling and / or pushing mechanism for loading and positioning devices.

[0212] In a further development of the handle (5)† the slider (38) has a locking mechanism for fixing, which enables the relative position of the slider to the handle shell (37)†.

[0213] In a further development of the handle (5), the handle (5) contains a hemostasis valve.

[0214] In a further development of the handle, the handle shell (37) has an inner guide tube which can be inserted into the slider (38).

[0215] A further development which is also independently inventive relates† to a system consisting of an embolic protection device (1 ) and a catheter ( 12).

[0216] In a further development of the device, the embolic protection device (1) is designed in such a way that it can be passed through the catheter (12).

[0217] In a further development of the system, this features an embolic protection device (1), a handle (5) and a catheter (12).

[0218] In a further development 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 connected to the handle (5) via the supply unit (4).

[0219] One independently inventive development relates to a method for using an embolism protection device ( 1 ).

[0220] One independently inventive development relates to a method for using a handle (5).

[0221] A further inventive development, which is also independent, relates to a method for using a system consisting of an embolic protection device (1) and / or a handle (5) and / or a catheter (12). TI

[0222] List of reference symbols:

[0223] 1 embolic protection device

[0224] 2 filter units

[0225] 3 frames

[0226] 4 Feed units

[0227] 5 handle

[0228] 6 proximal area

[0229] 7 distal area

[0230] 8 Aorfenfeil

[0231] 9 Aortic arch

[0232] 10 Vessel file

[0233] 1 1 Feed vessel

[0234] 12 catheters

[0235] 13 arrows to indicate the streamlined cross-section filing

[0236] 14. Position of reduced interaction with devices in the aortic arch

[0237] 15 Position for changing the direction of curvature

[0238] 16 Fixation

[0239] 1 7 distal tip

[0240] 18 End of frame

[0241] 19 End of frame

[0242] 20 filter fabrics

[0243] 21 Support

[0244] 22 Aortic arch roof

[0245] 23 Device

[0246] 24 distal filter plane

[0247] 25 proximal filter level

[0248] 26 proximal filter area

[0249] 27 proximal frame

[0250] 28 distal frame

[0251] 29 proximal filter

[0252] 30 distal filters

[0253] 31 individual filters

[0254] 32 second frame

[0255] 33 first frame

[0256] 34 funnels

[0257] 35 Return device 36 First connecting piece

[0258] 37 Handle shell

[0259] 38 sliders

[0260] 39 second connecting piece

[0261] 40 wings

[0262] 41 Area of ​​radial stability

[0263] 42 notches

[0264] 43 Device for producing reversible connections, first part, arc shape a)

[0265] second part arc shape b)

[0266] W1 Angle

[0267] W2 angle

[0268] W3 angle

[0269] W4 angle

[0270] W5 angle

[0271] W6 angle

[0272] T Torsion

[0273] E Increase in width

Claims

Patent claims 1. Embolism protection device (1 ) for delivery into an aortic arch (9), comprising a filter unit (2) and a delivery unit (4), wherein - the filter unit (2) comprises a frame (3) and a filter fabric (20) and the filter fabric (20) is arranged on the frame (3), - the filter unit (2) has a proximal region (6) and a distal region (7), wherein the filter unit (2) is designed in such a way that it can be arranged at least partially in the aortic arch (9).

2. Embolism protection device (1 ) according to claim 1 , characterized in that the filter unit† (2) is divided into two parts such that the proximal area (6) and the distal area (7) each have their own frame (27, 28).

3. Embolism protection device (1 ) according to claim 1 or 2, characterized in that when the filter unit† (2) is positioned correctly, haptic or visual feedback is generated† which signals the final position to the user.

4. Embolism protection device (1) according to one of claims 1 to 3, characterized in that the proximal frame (27) and the distal frame (28) each comprise two ends in the proximal region (6) which extend parallel to each other in the inner region of the frame (3) and / or are arranged perpendicular to the frame and are connected to the feed unit (4).

5. Embolism protection device (1 ) according to one of claims 1 to 4 characterized in that the distal and proximal areas (6) have a fixation (16) such that the radial stiffness is increased.

6. Embolism protection device (1 ) according to one of claims 1 to 5, characterized in that the frame ends can be angled along and perpendicular to the flow direction.

7. Embolism protection device (1 ) according to one of claims 1 to 6, characterized in that the frame ends and / or the frame sides can be angled between 5° and 85°, preferably 25° to 75°, particularly preferably 60° in the direction of flow and / or perpendicular thereto.

8. Embolism protection device (1 ) according to one of claims 1 to 7 characterized in that the filter unit (2) is divided into two parts such that the proximal area (6) can be actively and / or passively folded in independently of the distal area (7) when the embolism protection device (1 ) is removed.

9. Embolism protection device (1 ) according to one of claims 1 to 8, characterized in that the proximal area (6) can be actively folded inwards towards the supply vessel (1 1 ) via a device (23) which is connected to the filter fabric (20) and / or to the proximal frame (27).

10. Embolic protection device (1) in particular according to one of claims 1 to 9, characterized in that a separate filter (29, 30) is stretched over each of the two frames (27, 28). 1 1. Embolic protection device ( 1 ) in particular according to one of claims 1 to 10, characterized in that the filter unit (2) is divided into two parts such that the proximal area (6) and the distal area (7) have their own frame (27, 28) and that a single filter (31 ) is stretched over both frames.

12. Handle (5) for a medical arrangement, in particular an embolic protection device (1) in particular according to one of claims 1 to 1 1 , characterized in that the handle (5) comprises a first connecting piece (36), a handle shell (37), a slider (38) and / or a second connecting piece (39)†.

13. Handle (5) according to claim 12, characterized in that the first connecting piece (36) is designed in such a way that an actively secured connection to a catheter can be established.

14. Handle (5) according to one of claims 12 to 13, characterized in that the connecting piece (36) has indentations (42) on the inside† into which the wings (40) of the catheter (12) can be inserted.

15. Handle (5) according to one of claims 12 to 14, characterized in that a reversible clamping connection to the feed unit (4) can be made by means of the second connecting piece (39).

16. Handle (5) according to one of claims 12 to 15, characterized in that the slider (38) is designed such that it can exert a pulling and / or pushing mechanism for loading and positioning devices. 1 7. Handle (5) according to one of claims 12 to 16, characterized in that the slider (38) has a locking device for fixing, which enables the relative position of the slider to the handle shell (37).

18. Handle (5) according to one of claims 12 to 17 characterized in that the handle (5) contains a hemofacial vesicle.

19. Handle according to one of claims 12 to 18 characterized in that the handle shell (37) has an inner guide tube† which can be inserted into the slide (38).

20. System comprising an embolic shield device (1 ) according to one of claims 1 to 1 1 and a catheter ( 12).

21. System comprising embolic shield device (1 ) according to one of claims 1 to 1 1 , handle (5) according to one of claims 12 to 19 and a catheter ( 12).

22. System comprising a handle (5) according to one of claims 12 to 19 and catheter ( 12).

23. System comprising an embolic shield device (1) according to one of claims 1 to 11 and a handle (5) according to one of claims 12 to 19.

24. Method for using an embolic protection device according to one of claims 1 to 1 1 .

25. Method for using a handle (5) according to any one of claims 12 to 19.

26. Method for using a system consisting of an embolic shield device according to claims 1 to 11 and / or a handle (5) according to one of claims 12 to 19 and / or a catheter (12).

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