Embolism prevention device to be introduced to inside of aortic arch

Abstract

To provide an improved embolism prevention device.SOLUTION: An embolism prevention device includes a filtration unit and a delivery unit and is to be inserted to the inside of an aortic arch. The filtration unit includes a frame and filter meshes (29, 30). The filter meshes (29, 30) are arranged on the frame. The filtration unit includes a proximal frame (27) and a distal frame (28). The filtration unit may be arranged at least partially in the inside of an aortic arch.SELECTED DRAWING: Figure 14

Description

[Technical field]

[0001] The present invention relates to an embolic protection device for insertion into the aortic arch to prevent the entry of particles or other debris into the cerebral vasculature, and further relates to a handle for such an embolic protection device, a system consisting of said handle and a catheter, a system consisting of said handle and an embolic protection device, a system consisting of an embolic protection device and a catheter, and a system consisting of a handle, an embolic protection device and a catheter, as well as methods of using the embolic protection device, a method of using the handle, and a method of using the system consisting of the embolic protection device and / or the handle and / or the catheter.

[0002] The area of ​​application is the medical field, in particular cardiac surgery and interventional cardiology. [Background technology]

[0003] The risk of ischemic brain injury, including stroke, is one of the most feared complications in cardiac surgery, especially following minimally invasive procedures such as transcatheter aortic valve implantation (TAVI).

[0004] During such procedures, macroscopic particles may detach and subsequently travel via the branches of the aortic arch to the brain, where they may cause embolism.

[0005] In order to prevent such particles from entering the branching vessels, embolic protection devices are already known from the prior art which can be inserted as filters in the aortic arch during cardiac and interventional procedures.

[0006] However, a problem in this regard is the correct placement of the filter within the aortic arch. Small gaps allow particles to pass by the filter in the first place, which is why stringent requirements must be placed on the fit. Furthermore, it is not clear to the user whether the filter is correctly placed, so it is difficult to assess when the optimal final position has been reached. Further factors such as very slight distortions of the catheter relative to the delivery unit can make precise placement of the filter difficult. Summary of the Invention [Problem to be solved by the invention]

[0007] The task of the present invention was therefore to provide an improved embolic protection device. [Means for solving the problem]

[0008] This task is solved by the features of claim 1 and the further independent claims. The dependent claims relate to advantageous refinements of the invention.

[0009] According to the present invention, there is provided an embolic protection device to be inserted into the aortic arch, comprising a filtering unit and a delivery unit, the filtering unit comprising a frame and a filter mesh, the filter mesh being disposed on the frame, the filtering unit having a proximal region and a distal region, the filtering unit being designed in such a manner that the filtering unit can be at least partially disposed within the aortic arch.

[0010] Advantageously, the embolic protection device can be positioned by a controlled connection to the feeding unit made via an area. The connection between the frame and the feeding unit via an area allows for adjustment of the position of the filter in the deployed state.

[0011] Once the filtration unit is properly positioned, tactile or visual feedback is advantageously generated to inform the user of the final position.

[0012] Advantageously, this allows the user to sense whether the embolic protection device is correctly positioned. The embolic protection device may be designed such that tactile and / or visual feedback is generated when the filtering unit takes its position within the aortic arch.

[0013] The tactile feedback is especially generated by the high anatomical conformity of the filtering units, which respond when the user pulls them under some resistance and reaches their optimal position, thereby indicating that they have fitted correctly within the aortic arch. Alternatively or additionally, a visual check can be performed by attaching radiopaque markers.

[0014] In addition to proper placement aided by tactile and / or visual feedback, stable placement during deployment and minimization of interactions with alignment procedures are critical to the functionality of the embolic protection device.

[0015] Increased stability of the embolic protection device may be achieved, inter alia, by an optimized fit of the filtering unit to the placement environment. Furthermore, radial stiffness of the embolic protection device is achieved by reinforcements in the proximal region and residual stresses (torsion) of the frame.

[0016] Also beneficial for the functionality of the embolic protection device is that the stable positioning of the embolic protection device is not affected during the placement of the interventional equipment required for the positioning procedure, which is also achieved by the optimized fit. By placing the proximal region of the embolic protection device in the feeder vessel, a further advantageous minimization of possible interactions is achieved. In this regard, it is particularly advantageous that due to this configuration, when the proximal end of the embolic protection device is hidden in the feeder vessel, no edge is formed between the embolic protection device and the roof of the aortic arch, but a smooth transition is achieved.

[0017] The feeding unit contemplated by the present invention is a device for transmitting force to the filtering unit, through which the filtering unit can be moved in the catheter, in particular by pulling or pushing it, through the aortic arch. It is preferably designed as a coil of wire, preferably of several thin wires, in the embolic protection device. Further embodiments are also conceivable.

[0018] The embolic protection device is advantageously designed in such a way that the frame in the proximal region has two ends which run parallel to each other inside the frame and are connected to the feeding unit via a region, so that the filtering unit can be guided by the feeding unit through the catheter and moved within the aortic arch.

[0019] In one embodiment of the present invention, the proximal region of the filtering unit includes a stop, which increases the radial stiffness of the frame, which contributes to a more stable positioning and a more robust feedback of the tactile signal.

[0020] In a further embodiment of the embolic protection device, the distal region is designed to taper towards the tip, resulting in a streamlined cross-sectional distribution, which allows the geometry of the distal tip to better fit the aortic arch and reduces the contact surface in the blood flow during deployment, while simultaneously achieving a gradual increase in contact pressure against the aortic arch.

[0021] A support can be placed on the filter mesh of the embolic protection device, which is connected to the delivery unit, either directly or via the ends of a frame, via which the filter mesh in the expanded state is passively pulled to the aortic roof.

[0022] Such a support is advantageously constructed from a force element, for example a spring, or even from a flexible material such as silicone or rubber.

[0023] In an alternative embodiment, the filter mesh may also be connected to a device that can actively pull the filter mesh towards the aortic roof.

[0024] The device is preferably constructed in such a way that it can be guided through the catheter independently of the delivery unit to the handle area where it can be actively manipulated by the user. Various materials are contemplated in this regard. Preferably, wire or thread can be used.

[0025] In an equally independently inventive embodiment, the embolic protection device is designed in such a way that the proximal region can be configured separately from the distal region within the delivery vessel, and the distal region can be configured separately from the proximal region within the aortic arch. The frame is then divided into a proximal vessel section and a distal aortic section.

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

[0027] During the procedure, the geometry of the aortic section is not affected, which can be achieved by significantly changing the direction of curvature of the filter frame, which in this case is divided into a proximal vessel section and a distal aortic section.

[0028] Due to the independent design of the vascular and aortic sections and their anatomical fit, the filtering unit can be secured within the delivery vessel and the aortic arch in a manner such that tactile and / or visual feedback is received when correctly positioned.

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

[0030] In an alternative, equally independent, inventive embodiment, the embolic protection device is characterized in that the entire filtration unit can be configured entirely within the aortic arch. When properly positioned within the aortic arch, the filtration unit defines a proximal region distal to the delivery vessel. In this regard, the filtration unit is inserted within the aortic arch and then deployed under tension to define a filtration surface extending in the direction of flow, which protects the cerebral vessels by using the delivery unit to pull the frame toward the roof of the aortic arch.

[0031] One variation of the embolic protection device is preferably designed in such a way that the end of the frame in the deployed state is placed at an obtuse angle W3 to the proximal filtration level, and a proximal filtration surface extending in the direction of flow is created by pulling the frame towards the roof of the aortic arch.

[0032] This improves the contact pressure of the proximal end against the aortic arch wall, which leads to reduced interaction with devices such as those used to perform a TAVI procedure.

[0033] As the filtration unit is pulled, the delivery unit generates a tactile signal due to the complete filtration unit being positioned within the aortic arch and the proximal region spanning the delivery vessel, which tactile signal indicates proper placement of the filtration unit.

[0034] In a further variation, the proximal region is divided into two sections in such a manner that the end of the proximal region describes an arcuate shape such that a first portion of the arcuate shape is formed towards the distal region and a second portion towards the proximal region, see FIG. 9c).

[0035] In this regard, it is advantageous for the second portion to form a downwardly extending acute angle W5 when the embolic protection device is deployed in its final position, with the second portion pressing the end of the proximal region against the roof of the aortic arch, and tactile feedback is enhanced in the process, while interaction with other devices is further reduced.

[0036] In a further advantageous embodiment of the invention, the end of the frame can be placed at an acute angle W1 with respect to the distal filtration level when the filtration unit is in the deployed state (see FIG. 11 a)), so that by pulling the frame towards the roof of the aortic arch, the frame is shaped such that the end of the proximal region becomes wider. In a particular embodiment, this is achieved by the end of the frame being below the filtration level at the junction to the proximal frame (see FIG. 11 b)), which can then transmit tension to the frame, resulting in an expansion of the proximal region as it is pulled towards the delivery vessel.

[0037] In another embodiment, the filtration unit is divided into two sections in such a manner that the proximal region protrudes from the filtration level, so that when the device is deployed, twisting is transmitted through the deformed proximal region to the distal region, thereby increasing the contact pressure on the roof of the aortic arch.

[0038] Alternatively, the filtration unit of the embolic protection device is divided into two sections in such a manner that the proximal region protrudes from the filtration level, such that the proximal region flares out when the device is deployed.

[0039] The kink may also be formed in the frame in such a way that the distal end bends against the aortic roof.

[0040] Through this configuration, tactile feedback is conveyed to the user upon successful placement of the filtration unit.

[0041] An additional benefit is better cerebrovascular protection.

[0042] In a further advantageous embodiment of the invention, which is also independently inventive, the filtering unit of the embolic protection device can be divided into two sections in such a manner that the proximal region can be actively and / or passively folded independently of the distal region when the embolic protection device is removed.

[0043] In a further variation, the filtration unit is divided into two sections in such a manner that the end of the proximal region describes an arcuate shape such that a first portion of the arcuate shape is formed toward the distal region and a second portion toward the proximal region.

[0044] In special embodiments, the proximal region can be bent in the flow direction independently of the distal region. In preferred embodiments, both the distal and the proximal region can be bent by 5°-85°, particularly preferably by 25°-75°, and most particularly preferably by 60°, relative to the feed unit. This particularly preferably concerns the proximal frame.

[0045] In a special embodiment, the lateral regions can be bent independently of one another at an angle perpendicular to the flow direction, in a preferred embodiment, this bending is at an angle of 5° to 85°, particularly preferably 25° to 75°, and even more particularly preferably 60°, both distal and proximal regions relative to the feed unit.

[0046] This results in better protection of the vessel, more stable placement, and clearer tactile feedback.

[0047] In a variation of the embolic protection device that is also independently inventive, the filtration unit is divided into two sections in such a manner that the proximal and distal regions each have their own frame over which their corresponding filters are stretched.

[0048] The embolic protection device is preferably characterized in that the second part of the end of the frame is connected to the filter mesh and / or the proximal frame via a device which allows the proximal region to be actively folded in the direction of the delivery vessel, so that it can be easily removed again via the catheter.

[0049] However, the embolic protection device can also be designed in such a way that the filtering unit is divided into two sections, so that the proximal and distal regions each have their own frame, and the individual filters can be stretched to cover both frames. In this embodiment, a support is preferably placed between the filter mesh and / or the frame of the proximal region, which can passively fold the proximal frame in the direction of the delivery vessel, which facilitates removal of the device.

[0050] As an alternative, also independently inventive, the filtration unit of the embolic protection device may be divided into two sections in such a manner that the second frame is present in the outer region of the first frame, the second frame is connected to the filter mesh only in the distal region of the first frame, and the proximal end of the first frame can be pulled in the direction of the delivery vessel, and the second frame is pulled towards the roof of the aortic arch, whereupon a wedge appears.

[0051] The first frame is preferably constructed of thicker wire than the second frame, since it can be actively moved and routes the second frame. The formation of the wedge is particularly advantageous since the branching vessels can be well protected with this flexible system.

[0052] An alternative improvement is constructed with an embolic protection device in which the frame of the filtering unit is connected to a return device that can return the frame into the catheter, the perimeter of the filter mesh is longer than the perimeter of the frame, and the filter mesh is connected to a delivery unit, and when the filter mesh is pulled in the direction of the delivery vessel, a funnel is formed. is being formed.

[0053] In this variant, an independent frame is used and no stabilizing connection with the feeding unit is used. The frame can be formed in various ways, for example it can be round or ovoid, as the adaptation to the aortic arch is realized via the filter mesh. The withdrawal of the frame from the aortic arch is realized by an independent return device, preferably a wire, which is either connected to the feeding unit or returned separately to the user so that it can be actively operated.

[0054] The filtration unit is pulled into the delivery vessel via the delivery unit. Alternatively, the filtration unit may comprise an independent active device on the other hand.

[0055] The funnel design provides optimal coverage of branching vessels. These embodiments also provide a tactile signal to the user when the device is ideally positioned.

[0056] A further, also independently inventive, aspect relates to a handle for an embolic protection device, the handle comprising a first connecting piece, a handle shell, a slider and / or a second connecting piece, characterized in that the first connecting piece is designed as a connection to be actively locked and / or the second connecting piece is designed as a reversible clamping connection.

[0057] In a further embodiment, the handle is characterized in that it comprises a first connecting piece, a handle shell, a slider and / or a second connecting piece, in this respect the first connecting piece can be designed as a connection to be actively or passively clamped and / or the second connecting piece can be designed as a permanent clamping connection.

[0058] The handle allows various functions. For example, a fixed connection to the catheter can be created. This is preferably realized by the first connection piece, which is designed in such a way that a connection that will be actively fixed to the catheter can be created. For this purpose, a Luer lock connection can be created between the catheter and the first connection piece. The connection piece preferably has a recess on its inner surface into which the blade of the catheter can be inserted. In this regard, the sleeve of the first connection unit can be pushed onto the catheter. This allows for better handling of the embolic protection device, since the catheter is fixed and thus prevented from rotating.

[0059] By means of the second connecting piece a reversible clamping connection with the feed unit can be created for transmitting traction or compression forces and moments to the feed unit.

[0060] The handle may furthermore comprise a slider designed in such a way that it is possible to actuate a traction and / or a pushing mechanism for loading and positioning the device. The slider is preferably equipped with a locking device that allows adjustment of the position of the slider relative to the handle shell. In this regard, the slider may be reversibly fixed, for example in an end position, to lock the device ready for use. In one embodiment, a push button may be provided on the handle and a detent may be provided on the slider for this purpose.

[0061] The handle shell is preferably designed in a form-fitting manner such that it cannot rotate relative to the slider, and in this respect it makes sense for the slider not to have a rounded geometric shape.

[0062] These features of the handle have proven advantageous, for example, when using embolic protection devices, since even the slightest movement can be problematic in inserting, positioning, and removing the filtration unit, as well as in transmitting the rotational movements necessary for device positioning.

[0063] Another preferred refinement of the invention resides in the handle including a hemostasis valve, preferably arranged in the front area of ​​the handle, which may include a rinsing option.

[0064] The handle shell also further comprises an inner guide tube insertable into the slider which serves to guide the feed unit such that the feed unit is prevented from bending when pressure is applied to the feed unit by the slider being pushed forward inside the handle portion.

[0065] The invention further relates to a system consisting of an embolic protection device and a catheter, in which the embolic protection device is advantageously designed in such a way that it can be passed through the catheter.

[0066] It is particularly preferred that the system is a unit with a non-reversible connection, although reversible connections are also possible, for example in the case of placement of other interventional instruments.

[0067] The handle and the catheter may in particular be an integral unit or may be reversibly connected to each other, said unit may additionally be reversibly or even irreversibly connected to an embolic protection device during manufacture.

[0068] In another refinement of the invention, it concerns a system consisting of an embolic protection device and a handle.

[0069] The invention also relates to a system consisting of an embolic protection device, a handle and a catheter. In this respect, the catheter may be designed to be fixed in the handle and the embolic protection device may be designed to pass through the catheter and to be connectable to the handle via a delivery unit. The system is particularly preferably conceived as a unit with irreversible connections between the catheter and the handle and between the handle and the embolic protection device, although reversible connections are also possible.

[0070] The subject of the invention, which is also independently inventive, is a method for placing an embolic protection device using said device, characterized in that, once the filtering unit has been properly placed, tactile feedback is generated to inform the user of the final position.

[0071] By exerting traction and / or compression forces on the delivery unit and, if applicable, on further active devices, it is possible to insert the filtering unit into the aortic arch, position it in an ideal manner and remove it.

[0072] Further independent inventive aspects of the invention relate to methods of using the embolic protection device, methods of using the handle and methods of using a system consisting of the embolic protection device and / or catheter and / or handle. In particular, the methods can be used to adjust the rotation of the distal region by rotating the handle to transmit a moment through the reversible clamping connection and thus the feeding unit, in particular during placement of the filter, and to simultaneously transmit a moment through the catheter and thus through the friction joint to the stenosed filter.

[0073] In particular, the present invention relates to an embolic protection device to be inserted into the aortic arch, comprising a filtering unit and a feeding unit, the filtering unit comprising a frame and a filter mesh, the filter mesh being arranged on the frame, the filtering unit having a proximal region and a distal region, the filtering unit being designed in such a way that the filtering unit can be at least partially arranged in the aortic arch.

[0074] Particularly preferably, the filtration unit is designed in such a way that it is divided into two sections, such that the proximal and distal regions each have their own frame.

[0075] The embolic protection device according to the invention in this case has a framework divided into two sections.

[0076] Preferably, the embolic protection device is designed in such a way that once the filtration unit is properly placed, tactile or visual feedback is generated to inform the user of the final position.

[0077] In certain embodiments, the embolic protection device is characterized in that the proximal and distal frames each have two ends in the proximal region, extending parallel to each other inside the frame and / or arranged perpendicularly to the frame, and connected to a delivery unit.

[0078] According to the invention, both frames in this case have two ends each, see figure 14, which are connected to the feeding unit, which means that a total of four wires are led to the feeding unit inside the catheter.

[0079] In certain variations of the embolic protection device, the distal and proximal regions preferably have stops that are designed in such a way as to provide increased radial stiffness.

[0080] The locking portion may be realized using a wire or similar material.

[0081] In an alternative form of the embolic protection device, the distal region is designed to taper towards the tip, thus having a streamlined cross-sectional distribution.

[0082] In another variation, the embolic protection device is constructed in such a way that the frame ends are angled along the direction of flow (see FIG. 16A) and / or perpendicular to the direction of flow (see FIG. 16B). This results in an enlargement of the filtering surface as the filtering unit is pulled towards the roof of the aortic arch. This enlargement provides better coverage of the aortic arch vessels and also provides tactile feedback when the device is properly placed.

[0083] In special embodiments, the proximal region can be bent at an angle in the direction of flow independently of the distal region. In preferred embodiments, the frame ends and / or sides of the frame can be angled in the direction of flow and / or perpendicular to the direction of flow by an angle of 5°-85°, preferably 25°-75°, particularly preferably 60°.

[0084] This results in better protection of the vessel, more stable placement, and clearer tactile feedback.

[0085] It is particularly preferred if the ends of the frame, in the extended state, are arranged at an acute angle to the filtering level, so that the roof of the aortic arch is formed in such a way that the length of the filtering surface is increased by drawing the frame towards this roof.

[0086] The frame can be actively or passively pulled toward the roof of the aortic arch.

[0087] The filtering unit of the embolic protection device is preferably divided into two sections in such a manner that the proximal region can be actively and / or passively folded independently of the distal region when the embolic protection device is withdrawn. In this regard, the proximal and / or distal regions can be folded towards the delivery vessel or in other directions.

[0088] Furthermore, an embolic protection device is preferred in which the filtration unit is divided into two sections in such a manner that the proximal region can be actively and / or passively folded independently of the distal region when the embolic protection device is removed.

[0089] It may be particularly advantageous to be able to actively fold the proximal region in the direction of the delivery vessel via a device connected to the filter mesh and / or the proximal frame.

[0090] In a preferred variation of the embolic protection device, a corresponding separate filter is deployed over both frames.

[0091] In another variation of the present invention, the embolic protection device is designed in such a way that the filtration unit is divided into two sections, such that the proximal and distal regions each have their own frame, and the individual filters are stretched to cover both frames.

[0092] A further inventive aspect relates to a handle for a medical device, the handle comprising a first connecting piece, a handle shell, a sliding part and / or a second connecting piece, characterized in that the first connecting piece is designed as a connection to be actively locked and / or the second connecting piece is designed as a reversible clamping connection.

[0093] In a further embodiment the handle is characterized in that it comprises a first connecting piece, a handle shell, a sliding part and / or a second connecting piece, the first connecting piece being designed as a connection to be passively secured and / or the second connecting piece being designed as a permanent clamping connection.

[0094] The handle allows various functions. For example, a fixed connection with a catheter or another medical device can be created. This is preferably realized by the first connection piece, which is designed in such a way that a connection can be created that is to be actively locked to the catheter or another device. For this purpose, a Luer lock connection can be created between the catheter and the first connection piece. In one variant, the connection piece has a notch on its inner surface into which the blade of the catheter can be inserted. In this regard, the sleeve of the first connection unit can be pushed over the catheter. This allows for better handling of the embolic protection device, since the catheter is fixed and thus prevented from rotating.

[0095] By means of the second connecting piece a reversible clamping connection with the feed unit can be created for transmitting traction or compression forces and moments to the feed unit.

[0096] The handle may furthermore include a slide designed in such a way that it can actuate a pulling and / or pushing mechanism for loading and positioning the device. The pressure mechanism may be realized, for example, by an inner guide that prevents the feeding unit from being compressed or rippling.

[0097] The handle shell preferably has an inner guide tube insertable into the slide, which can act as a guide tube for a connected medical device, such as a catheter, and, among other things, prevents such a device from bending when pressure is applied.

[0098] The slider is preferably equipped with a locking device that allows adjustment of the position of the slider relative to the handle shell. In this respect, the slider can be reversibly fixed, for example in an end position, in order to lock the device primed before use. In one embodiment, a push button can be provided on the handle and a detent on the slider for this purpose.

[0099] The handle may further include a hemostasis valve, through which a rinsing action may also be performed, among other things.

[0100] The present invention still further relates to a system consisting of an embolic protection device, a handle and a catheter.

[0101] Particularly preferred are systems in which the embolic protection device is pre-installed in place on the combined handle / catheter. In one variation of the invention, the system includes a fixed, irreversible connection between the handle and the catheter, and a fixed, irreversible connection with the delivery unit.

[0102] The subject of the present invention is also a method of using the embolic protection device.

[0103] A further subject of the present invention is a method of using the handle.

[0104] Methods of using the system of handle embolic protection devices and / or catheters are also the subject of the present invention.

[0105] In particular, the method can be used to coordinate rotation of the distal region, particularly during filter placement, by rotating the handle and transmitting moment through the reversible clamping connection and thereby to the feeding unit, and to simultaneously transmit moment through the catheter and thereby through the friction joint to the stenosed filter.

[0106] Further details of the invention can be inferred from the exemplary embodiments described below on the basis of the drawings, in which any further details of the invention cited are not limited to the exemplary embodiments specified, but may otherwise appear individually, selectively combined or entirely in other exemplary embodiments. [Brief description of the drawings]

[0107] [Figure 1] FIG. 13 is a top view of a frame of an embolic protection device having a tapered tip. [Diagram 2] FIG. 13 is a top view of the frame of the embolic protection device separated into an aortic section and a vascular section. [Diagram 3] FIG. 3 is a cross-sectional view through the aortic arch in which the embolic protection device having the frame of FIG. 2 is positioned. [Figure 4] FIG. 13 is a top view of an embolic protection device of a frame with radial stabilization stops. [Diagram 5] FIG. 1 shows a) a side view, b) a front view, and c) a front and top oblique perspective view of a passive filter mesh support arrangement. [Figure 6] 4A-C are side views of a passive filter mesh support. [Figure 7] FIG. 13 is a side view of a passive filter mesh support configuration. [Figure 8A] FIG. 13 is a side view of an active filter mesh support configuration. [Figure 8B] FIG. 2 is a front, top, and oblique perspective view of an active filter mesh support arrangement. [Figure 8C] 13 is a detailed view of the connection of the frame with the feed unit. [Figure 9A] FIG. 13 is a top view of the frame of the embolic protection device with the end facing the direction of flow, which will be fully deployed within the aortic arch. [Figure 9B] FIG. 13 is a side view of the frame of the embolic protection device with the end facing in the direction of flow, to be fully deployed within the aortic arch. [Figure 9C]FIG. 13 shows the frame of the embolic protection device in a catheter constricted state with the end facing the direction of flow, which will be fully deployed within the aortic arch. [Figure 10] FIG. 10 is a cross-sectional view through the aortic arch in which the embolic protection device of FIG. 9 is positioned. [Figure 11] FIG. 13 shows a) a perspective view of the frame from a posterior oblique superior perspective, b) a front view, c) a side view, and d) a top view of the frame of the embolic protection device with the proximal filtration level at the bottom. [Figure 12] FIG. 2 is a top view of a filtration unit having dual (first and second) frames. [Figure 13] FIG. 2 is a perspective side view from obliquely above of an embolic protection device having an expanded funnel shape. [Figure 14] FIG. 13 is a top view of an embolic protection device having a frame divided into two sections and a separate filter. [Figure 15] FIG. 13 is a top view of an embolic protection device having a frame divided into two sections and an integral filter. [Figure 16A] FIG. 13 is a side view of an embolic protection device in which the filter is split into two sections and the proximal region is actively pulled back. [Figure 16B] FIG. 13 is a front view of an embolic protection device in which the filter is split into two sections and the proximal region is actively pulled back. [Figure 16C] FIG. 13 is a diagram of the embolic protection device in a constricted state during insertion and removal. [Figure 17A] FIG. 13 is a side view of the embolic protection device in a deployed state with the filter split into two sections. [Figure 17B] FIG. 13 is a side view of the placement of the embolic protection device within a catheter during insertion. [Figure 17C] FIG. 13 is a side view of the placement of the embolic protection device within the catheter and upon removal. [Figure 18A] FIG. 13 is a side view of the handle with the sliding portion extended. [Figure 18B]1 is a front perspective view of a first connecting piece of the handle. [Figure 19] 13 shows a cross-section of a second connecting piece of the handle as viewed from the side. [Figure 20] 1 shows a cross-section of a first connecting piece of the handle as viewed from the side. [Figure 21] 1 shows a cross section of a first connecting piece of the handle as viewed from the front. [Figure 22] FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0108] FIG. 1 shows a 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 formed with a tapered distal tip 17. This results in the achievement of a streamlined cross-sectional distribution, designated by arrow 13, for a gradual increase in contact pressure against the aortic arch 9. This results in a reduced contact surface in the blood flow during deployment of the device. This also results in an improved fit of the geometry of the distal tip 17 to the aortic arch.

[0109] 2 also shows a top view of the frame 3 of the embolic protection device 1, including its separation into an aortic section 8 and a vascular section 10. The separation is achieved by a large change in the direction of the curvature made in the filter frame geometry at a location 15 on the frame 3. This results in the frame being separated into an aortic section 8 in a distal region 7 and a vascular section 10 in a proximal region 6 in such a manner that the geometry of the aortic section is not affected as the vascular section 10 is pulled into the delivery vessel 11.

[0110] In Fig. 3 one can see a cross section through the aortic arch 9 with a deployed embolic protection device 1 with the frame 3 of the embodiment of Fig. 2. This figure shows how in the aortic arch an aortic section 8 is deployed in the distal region 7 of the frame 3, and in a delivery vessel 11 a vessel section 10 is fixed in the proximal region 6 of the frame 3. The proximal region 6 of the frame 3 is connected with the feeding unit 4, which deploys the filtration unit 2. Pulling the vessel section 10 back into the delivery vessel 11 helps to reduce any possible interaction with the device used in the aortic arch 9.

[0111] The arrow indicates the location where the vessel section 10 is pulled back into the delivery vessel 11 to reduce interaction with the device in the aortic arch 9. The proximal region 6 is designed for a good anatomical fit.

[0112] A further advantageous embodiment is shown in the example of Fig. 4, which is a top view of the frame 3 of the embolic protection device 1 with radially stabilizing stops. Here, two open ends of the frames 18 and 19 are shown, connected by a stop 16 at the distal end of the proximal region 6. This provides a frame geometry that provides radial stability to allow tactile feedback when the filtering unit 2 is properly positioned in the aortic arch 9 and stable positioning during application.

[0113] A radially stable region 41 can be found at the proximal end. In this embodiment, the design of the proximal and distal frame geometries are identical so that a synchronous distribution of forces occurs.

[0114] 5 shows the configuration of the passive filter mesh support 21 in a) side view, b) front view, and c) oblique perspective view from the front and top. The passive support 21 is mounted on the ends 18 and 19 of the frame, which are connected to the feeding unit 4. On the other side, the support 21 is connected to the filter mesh 20 and, in the expanded state, passively pulls the filter material towards the roof 22 (not shown) of the aortic arch. In addition to a better coverage of the branching vessels, a more stable positioning of the embolic protection device 1 is also achieved to prevent macroscopic particles from entering these vessel branches.

[0115] 6 shows some examples of such supports 21 in side view. In this regard, in a) a leaf spring element is shown in side view, as well as in b) and c) a coil spring. Other materials for the supports can be silicone, rubber, or other elastic synthetic materials, and molded Nitinol in certain geometric shapes.

[0116] In figure 7 the configuration of the support 21 at the end 18 or 19 and on the filter mesh 20 using a flexible material is shown in side view. The anchoring on the filter mesh 20 directly results in a better coverage of the branching vessels, since the latter is more elastic than the frame 3 and can apply a certain additional tension to the latter.

[0117] 8A shows a side view of an active filter mesh support in the form of a device 23, which is likewise connected to the filter mesh 20, but which is actively operated by the user. The device 23 is likewise placed in the catheter 12, like the delivery unit 4. When the device 23 is actively pulled in the direction of the arrow, the filter mesh 20, and therefore also the frame 3, is pulled towards the roof 22 of the aortic arch.

[0118] In Fig. 8B the configuration of the device 23 is shown in a front and a top oblique perspective view, from both figures it is clear that the device 23 is here not connected to the feeding unit 4 but is in independent communication with the user and can be operated independently by the feeding unit 4 from there.

[0119] FIG. 8C shows a cross section of the connection between the frame end and the feed unit.

[0120] FIG. 9 shows the frame 3 of the embolic protection device 1, which will undergo complete configuration within the aortic arch 9 with its flow-facing ends 18 and 19, in a) top view, b) side view, and c) pulled back state.

[0121] In the relaxed state, ends 18 and 19 are bent towards the proximal filtering level 25, resulting in an acute angle W5 between the distal filtering level 24 and the point where ends 18 and 19 meet the frame, as shown in FIG. 9b). In other words, ends 18 and 19 of proximal region 6 define an arcuate shape, with a first portion a of the arcuate shape being formed towards the distal region 7 and a second portion b being formed towards the proximal region 6.

[0122] In other words, in a relaxed state (outside the body), the ends 18 and 19 of the proximal region 6 define an arch shape (FIG. 9b), which can be divided into portions a and b, with portion a of the arch being formed towards the distal region 7 and a second portion, portion b, being formed towards the proximal region 6, forming an acute angle W5 with each other.

[0123] When ends 18 and 19 are inserted into catheter 12 (FIG. 9c), they are positioned within the catheter parallel to proximal and distal filtration levels 25 and 24.

[0124] Upon exiting the catheter 12, the frame assumes its final shape under the impulse of the delivery unit 4, which can be positioned within the aortic arch 9 by pulling with the delivery unit 4, such that part a of the proximal region 6 is placed behind the delivery vessel 11 and part b is in the actual delivery vessel. As the delivery unit 4 is pulled back, a tactile signal is generated to inform the user of the final position.

[0125] In Figure 10, the embolic protection device of Figure 9 is shown in a final position as a cross section through the aortic arch 9. In the deployed state, the ends 18 and 19 of the frame 3 are disposed at an obtuse angle W3 relative to the proximal filtration level 25.

[0126] Pulling the frame 3 towards the roof 22 of the aortic arch creates a filtering surface that extends in the direction of flow, thereby protecting the cerebral vessels, and also reduces interaction with the TAVI procedure by improving the contact pressure of the proximal region 6 against the roof 22 of the aortic arch.

[0127] 11 shows a further embodiment of the present invention and its frame geometry. Shown are a) a perspective view of the frame 3 from above and behind, b) a front view, c) a side view, and d) a top view of the frame 3 of the embolic protection device 1.

[0128] It can be seen that the ends 18 and 19 of the frame 3 in the deployed state are arranged at an acute angle W1 relative to the distal filtering level 24, and particularly preferably relative to the proximal filtering level 25 (as shown in the figure), so that this roof portion 22 is shaped so as to increase the width of the end 6 in the proximal region by drawing the frame 3 towards the roof portion 22 of the aortic arch.

[0129] This unfolding after placement in the aortic arch 9 (see arrow E in FIG. 11d) is achieved by the proximal frame being below the filtration level (indicated by angle W4 in FIG. 11c), resulting in twisting of the frame which in turn results in lifting of the distal region (also indicated by rotational arrow T in FIG. 11c).

[0130] This lifting of the distal region allows the frame to be positioned in a more stable manner, and the increased width allows for better cerebrovascular protection and creates tactile feedback to inform the user of the final position.

[0131] In Fig. 12, a top view of the filtration unit 2 with a double frame 3 is shown. The second frame 32 can be seen outside the first frame 33. The distal ends of both frames (32, 33) are connected to the filter mesh 20. The proximal end of the first frame 33 is not connected to the filter mesh 20, so that by actively pulling back the proximal end of the first frame 33 using the device 23, a wedge created from the filter mesh 20 appears at the proximal end in the direction of the delivery vessel 11, which minimizes interaction with the device in the aortic arch 9.

[0132] Furthermore, the second frame 32 is pulled towards the roof 22 of the aortic arch, so that an improved fit of the aortic arch 9 is achieved.

[0133] 13 shows a perspective side view from above of the embolic protection device 1 with an expanded funnel shape for an embodiment with a filter mesh 20, the circumference of which is longer than that of the frame 3 and therefore not clamped. Said filter mesh 20 is connected with the delivery unit 4, so that a funnel 34 is formed when the filter mesh 20 is pulled towards the delivery vessel 11. As a result, the frame 3 is also pulled towards the aortic arch wall, which provides a very good protection of the vessel branches.

[0134] The frame is connected to a return device 35 that allows the frame to be returned into the catheter 12 .

[0135] The frame 3 itself does not separately comprise any further stabilisation device for the feeding unit 4 .

[0136] 14 shows a filtration unit 2 of an embolic protection device 1 including a frame divided into two sections and a filter divided into two sections. In the top view of the embolic protection device including a filter divided into two sections shown, it can be seen that the frame 3 is divided into a distal frame 28 and a proximal frame 27 with a distal filter 30 and a proximal filter 29.

[0137] The division of the frame results in the presence of four ends (shown as dots) running parallel to one another and / or protruding at a perpendicular angle from the frame plane (if extended, not shown), resulting in a total of four wires being connected to the feed unit.

[0138] The filtering unit 2 is preferably placed centrally in front of the mouth of the supplying vessel 11. By dividing it into two sections, an improved contact pressure, both proximal and distal, of the frame 3 against the aortic arch wall is achieved.

[0139] 15 shows a top view of an embolic protection device with a frame 27, 28 divided into two sections and a single filter 31. The filtration unit 2 is also preferably placed centrally in front of the mouth of the delivery vessel 11. By dividing the frame 3 into two sections, improved contact pressure both proximally and distally against the aortic arch wall is achieved.

[0140] An active device 23, guided through the catheter 12 to the user, is configured to withdraw the filtration unit (FIG. 16A). During withdrawal, the proximal region 6 is actively folded by the device 23 towards the delivery vessel 11, so that the entire filtration unit 2 can be withdrawn from this vessel.

[0141] 16B depicts a front view of the filtration unit 2, showing the possible bending of the filter frame perpendicular to the flow direction, by drawing it towards the aortic roof, which notably spreads the filtering surface and / or improves its abutment against the aortic roof, resulting in a dimensionally stable position and improved tactile and / or visual feedback.

[0142] FIG. 16C shows the embolic protection device in a stenosed state, both during insertion into and withdrawal from the aortic arch 9.

[0143] 17A shows a side view of the device upon deployment after exiting the catheter 12. The proximal and distal frames 27, 28 are deployed and positionable within the aortic arch 9.

[0144] 17B shows the filtering unit 2 in the catheter 12 connected to the delivery unit 4 upon insertion into the aortic arch 9. In this regard, the proximal frame 27 is folded back so that the proximal frame 27 and the distal frame 28 are positioned side-by-side.

[0145] 17C shows the configuration of the filtration unit 2 within the sluice upon removal from the aortic arch 9, where the proximal and distal sections are positioned parallel to one another.

[0146] FIG. 18A shows a side view of the handle 5 with the slider extended between the handle shell 37 and the second connecting piece.

[0147] 18B shows a front oblique perspective representation of the first connecting piece 36 of the handle 5. A notch 42 can be seen, which can create a connection that will be actively locked with the blade 40 of the catheter 12.

[0148] In FIG. 19 a cross section from a side view of the second connecting piece 39 of the handle is shown, which comprises at least one device for creating a reversible connection 43 with the feeding unit 4 .

[0149] 20 shows a cross-section from a side view of the first connecting piece 36 of the handle 5. A notch 42 on the inner surface is shown which mates with a blade 40 of the catheter 12, in which case the catheter 12 is secured in such a manner that it cannot rotate.

[0150] FIG. 21 shows a cross-section of the first connecting piece 36 of the handle 5 in a front view with the catheter 12 inserted and the blade 40 engaging with the notch 42.

[0151] FIG. 22 shows a side view of a handle 5 for a medical device, in particular for the embolic protection device 1 , having a first connecting piece 36 , a handle shell 37 and a second connecting piece 39 .

[0152] The feeding unit, and thus the embolic protection device (1), can be moved to a specific position by means of a slide so as to achieve advantageous positioning of the filtering unit (2) by means of the feeding unit (4) extending into the handle (5).

[0153] The present invention relates to an embolic protection device (1) for insertion into an aortic arch (9), comprising a filtering unit (2) and a feeding unit (4), The filtration unit (2) includes a frame (3) and a filter mesh (20), the filter mesh (20) being disposed on the frame (3); The filtration unit (2) has a proximal region (6) and a distal region (7); The filtration unit (2) relates to an embolic protection device (1), characterized in that the filtration unit (2) is designed in such a way that it can be placed at least partially within the aortic arch (9).

[0154] In an improved form of the embolic protection device (1), the embolic protection device (1) is characterized in that, once the filtration unit (2) is properly positioned, tactile and / or visual feedback is generated to inform the user of the final position.

[0155] In one refinement of the embolic protection device (1), the frame (3) is provided in the proximal region (6) with two ends (18) and (19) which extend parallel to each other inside the frame (3) and are connected to the delivery unit (4).

[0156] In one refinement of the embolic protection device (1), the device is characterized in that the proximal region (6) has a stop (16) that is designed in such a way that it has an increased radial stiffness.

[0157] In one refinement of the embolic protection device (1), the distal region (7) is designed to taper towards the tip (17) and thus have a streamlined cross-sectional profile.

[0158] In an equally independently inventive improvement of the embolic protection device (1), a support (21) is configured between the filter mesh (20) and the delivery unit (4), which passively draws the filter mesh (20) in an expanded state against the aortic roof (22).

[0159] In one refinement of the embolic protection device (1), the support (21) is a spring.

[0160] In an equally independently inventive improvement of the embolic protection device (1), the filter mesh (20) is connected to a device (23) through which the filter mesh (20) can be actively pulled toward the aortic roof portion (22).

[0161] In one refinement of the embolic protection device (1), the device (23) is a wire or thread.

[0162] In one refinement of the embolic protection device (1), the proximal region (6) may be configured separately from the distal region (7) within the delivery vessel (11), and the distal region (7) may be configured separately from the proximal region (6) within the aortic arch (9).

[0163] In an improved version of the embolic protection device (1), the proximal region (6) can be adjusted to and secured within the delivery vessel (11) by changing the direction of curvature of the frame geometry.

[0164] In one equally independently inventive refinement of embolic protection device (1), filtration unit (2) can be positioned entirely within the aortic arch (9), such that when filtration unit (2) is properly positioned within the aortic arch (9), a proximal region (6) is formed distal to delivery vessel (11).

[0165] In one refinement of the embolic protection device (1), the ends (18, 19) of the frame (3) in the deployed state are disposed at an acute angle W1 with respect to the distal filtration level (24), such that the roof portion 22 is shaped to increase the width of the end of the proximal region (6) by drawing the frame (3) towards the roof portion (22) of the aortic arch.

[0166] In one refinement of the embolic protection device (1), the ends (18, 19) of the frame (3) are configured, in the deployed state, at an acute angle W3 relative to the proximal filtration level (25) such that drawing the frame (3) toward the roof (22) of the aortic arch creates a proximal filtration surface (26) that extends in the direction of flow.

[0167] In one improvement of the embolic protection device (1), the filtration unit (2) is divided into two sections in such a manner that the proximal region (6) can be actively and / or passively folded independently of the distal region (7) when the embolic protection device (1) is removed.

[0168] In one refinement of the embolic protection device (1), the filtering unit (2) is divided into two sections in such a manner that the proximal region (6) protrudes from the filtering level, such that reshaping of the proximal region (6) during deployment of the device transfers twist to the distal region (7), thereby increasing the contact pressure against the roof of the aortic arch (22).

[0169] In one improvement of the embolic protection device (1), the filtration unit (2) is divided into two sections in such a manner that the proximal region (6) protrudes from the filtration level, such that the proximal region (6) flares out when the device is deployed.

[0170] In one refinement of the embolic protection device (1), the filtration unit (2) is divided into two sections in such a manner that the ends (18, 19) of the proximal region (6) define an arcuate shape such that an arcuate first portion (a) is formed towards the distal region (7) and a second portion (b) is formed towards the proximal region (6).

[0171] In an also independently inventive improvement of the embolic protection device (1), the filtration unit (2) is divided into two sections in such a manner that the proximal region (6) and the distal region (7) each have their own frames (27, 28) over which corresponding independent filters (29, 30) extend.

[0172] In one improvement of the embolic protection device (1), the second part (b) is connected to the filter mesh (20) and / or the proximal frame (27) via a device (23), and the proximal region (6) can be actively folded towards the delivery vessel (11) via said device (23).

[0173] In one also independently inventive refinement of the embolic protection device (1), the filtration unit (2) is divided into two sections in such a manner that the proximal region (6) and the distal region (7) each have their own frames (27, 28), and a single filter (31) extends over both frames.

[0174] In one improvement of the embolic protection device (1), a support (21) is placed between the filter mesh (20) and / or the frame (3) of the proximal region (6), which support (21) allows the proximal frame (27) to passively fold towards the delivery vessel (11).

[0175] In one also independently inventive improvement of the embolic protection device (1), the filtration unit (2) is divided into two sections in such a manner that the second frame (32) is present in the outer region of the first frame (33), the second frame (32) is connected to the filter mesh (20) only in the distal region (7) of the first frame (33), and the proximal end (6) of the first frame (33) can be pulled in the direction of the delivery vessel (11), whereupon the second frame (32) is pulled to the roof portion (22) of the aortic arch and a funnel-shaped portion (34) appears.

[0176] In one refinement of the embolic protection device (1), the frame (3) of the filtering unit (2) is connected to a return device (35) that can return the frame into the catheter (12), and the perimeter of the filter mesh (20) is greater than the perimeter of the frame (3). The filter mesh is connected to the delivery unit (4) such that a funnel (34) is formed when the filter mesh (20) is pulled towards the delivery vessel (11).

[0177] An improvement which is also independently inventive relates to a handle (5) for an embolic protection device (1), the handle (5) comprising a first connecting piece (36), a handle shell (37), a sliding part (38) and / or a second connecting piece (39), characterized in that the first connecting piece (36) is designed as a connection to be actively locked and / or the second connecting piece (39) is designed as a reversible clamping connection.

[0178] In one refinement of the handle (5), the first connecting piece (36) is designed in such a way that it can create a connection that will be actively fixed to the catheter.

[0179] In one refinement of the handle (5), the connecting piece (36) has on its inner surface a notch (42) into which the blade (40) of the catheter (12) can be inserted.

[0180] In one refinement of the handle (5), a second connecting piece (39) makes it possible to create a reversible clamping connection with the feeding unit (4).

[0181] In one refinement of the handle (5), the slider (38) is designed in such a way that it allows the application of a traction and / or compression mechanism for loading and positioning the device.

[0182] In one refinement of the handle (5), the slider (38) has a locking device for locking, allowing adjustment of the position of the slider relative to the handle shell (37).

[0183] In one refinement of the handle (5), the handle (5) comprises a hemostasis valve.

[0184] In one refinement of the handle, the handle shell (37) has an inner guide insertable into the slider (38).

[0185] The improvement, which is also independently inventive, relates to a system consisting of an embolic protection device (1) and a catheter (12).

[0186] In one refinement of the [word missing], the embolic protection device (1) is designed to be able to pass through a catheter (12).

[0187] In one refinement of the system, the system includes an embolic protection device (1), a handle (5), and a catheter (12).

[0188] In one refinement of the system, the catheter (12) can be fixed in the handle (5) and the embolic protection device (1) can be passed through the catheter (12) and can be connected to the handle (5) via the delivery unit (4).

[0189] An improvement which is also independently inventive relates to a method of using the embolic protection device (1).

[0190] An improvement which also has an independent inventive step relates to the method of using the handle (5).

[0191] The improvement, which is also independently inventive, relates to a method of using the system consisting of the embolic protection device (1) and / or the handle (5) and / or the catheter (12).

[0192] [Note] [1] An embolic protection device (1) for insertion into an aortic arch (9), comprising a filtering unit (2) and a feeding unit (4), The filtration unit (2) includes a frame (3) and a filter mesh (20), the filter mesh (20) being disposed on the frame (3); The filtration unit (2) has a proximal region (6) and a distal region (7), the filtering unit (2) is designed in such a manner that the filtering unit (2) can be placed at least partially within the aortic arch (9); the filtration unit (2) is divided into two sections in such a manner that the proximal region (6) has a proximal frame (27) and the distal region (7) has a distal frame (28); An embolic protection device (1). [2] The embolic protection device (1) according to [1], characterized in that when the filtering unit (2) is properly positioned, tactile or visual feedback is generated to inform the user of the final position. [3] The embolic protection device (1) according to [1] or [2], characterized in that the proximal frame (27) and the distal frame (28) each have two corresponding ends in the proximal region (6), extending parallel to each other inside the frame (3) and / or arranged perpendicular to the frame (3), and connected to the feeding unit (4). [4] The embolic protection device (1) according to any one of [1] to [3], characterized in that the distal region (7) and the proximal region (6) include locking portions (16) designed in such a manner as to improve radial stiffness. [5] The embolic protection device (1) according to any one of [1] to [4], characterized in that the frame ends can be bent along the direction of flow and in a direction perpendicular to the direction of flow. [6] The embolic protection device (1) according to any one of [1] to [5], characterized in that an angle of 5° to 85° can be imparted to the end of the frame and / or to the side of the frame in the direction of flow and / or in a direction perpendicular to the direction of flow. [7] The embolic protection device (1) according to [6], The angle is between 25° and 75°. An embolic protection device (1). [8] The embolic protection device (1) according to [7], said angle being 60°; An embolic protection device (1). [9] The embolic protection device (1) according to any one of [1] to [8], characterized in that the filtering unit (2) is divided into two sections in such a manner that the proximal region (6) can be actively and / or passively folded independently of the distal region (7) when the embolic protection device (1) is removed.

[10] The embolic protection device (1) according to any one of [1] to [9], characterized in that the proximal region (6) can be actively folded towards the delivery vessel (11) via a device (23) connected to the filter mesh (20) and / or the proximal frame (27).

[11] The embolic protection device (1) according to any one of [1] to

[10] , characterized in that the filter mesh (20) includes a distal filter (30) and a proximal filter (2), the distal filter (30) covering the distal frame (28) and the proximal filter (29) being expanded to cover the proximal frame (27).

[12] An embolic protection device (1) according to any one of [1] to

[11] , The filter mesh (20) is a single filter (31) that is stretched to cover the distal frame (28) and the proximal frame (27). An embolic protection device (1).

[13] A system comprising an embolic protection device (1) according to any one of [1] to

[12] and a handle (5) having a first connecting piece (36), a handle shell (37), a sliding part (38), and / or a second connecting piece (39).

[14]

[13] The system according to

[13] , A system, characterized in that the handle (5) is designed in such a way that it can create a connection in which the first connecting piece (36) is actively fixed to the catheter.

[15]

[13] or

[14] , wherein the system comprises: The system is characterized in that the handle (5) has a notch (42) on its inner surface, into which a blade (40) of a catheter (12) can be inserted.

[16]

[13] to

[15] , wherein the system comprises: A system, characterized in that the handle (5) is capable of creating a reversible clamping connection with the feeding unit (4) by means of the second connecting piece (39).

[17]

[13] to

[16] , comprising: The system is characterized in that the handle (5) is designed in such a manner that the slider (38) can actuate a traction and / or compression mechanism for loading and positioning the embolic protection device (1).

[18]

[13] to

[17] , comprising: The handle (5) is characterized in that the slider (38) has a locking device for locking, which allows relative positioning of the slider with respect to the handle shell (37).

[19]

[13] to

[18] , comprising: The system, characterized in that the handle (5) includes a hemostasis valve.

[20]

[13] to

[19] , comprising: The handle (5) is characterized in that the handle shell (37) has an inner guide tube insertable into the slider (38). [twenty one] A system comprising an embolic protection device (1) according to any one of [1] to

[12] and a catheter (12). [Explanation of symbols]

[0193] 1 embolic protection device, 2 filtration unit, 3 frame, 4 delivery unit, 5 handle, 6 proximal region, 7 distal region, 8 aortic section, 9 aortic arch, 10 vessel section, 11 delivery vessel, 12 catheter, 13 arrows for specifying a streamlined cross-sectional distribution, 14 position for reducing interaction with the device in the aortic arch, 15 position for changing the direction of curvature, 16 anchoring portion, 17 distal tip, 18 end of frame, 19 end of frame, 20 filter mesh, 21 support, 22 roof of the aortic arch, 23 device, 24 distal filtration level, 25 proximal filtration level, 26 proximal filtration surface, 27 proximal frame, 28 distal frame, 29 proximal filter, 30 distal filter, 31 single filter, 32 second frame, 33 first frame, 34 funnel-shaped portion, 35 return device, 36 first connecting piece, 37 handle shell, 38 sliding portion, 39 second connecting piece, 40 blade, 41 radially stable area, 42 notch, 43 device for creating a reversible connection, first part, arcuate portion a), second part, arcuate portion b), W1 angle, W2 angle, W3 angle, W4 angle, W5 angle, W6 angle, T twist, E width increase.

Claims

1. An embolic protection device (1) for insertion into an aortic arch (9), comprising a filtering unit (2) and a feeding unit (4), The filtration unit (2) comprises a frame (3) and a filter mesh (20), the filter mesh (20) being disposed on the frame (3); The filtration unit (2) has a proximal region (6) and a distal region (7), The embolic protection device (1), characterized in that the filtering unit (2) is designed in such a way that the filtering unit (2) can be placed at least partially within the aortic arch (9).

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

3. The embolic protection device (1) according to claim 1 or 2, characterized in that, once the filtering unit (2) is properly positioned, a tactile or visual feedback is generated to inform the user of the final position.

4. The embolic protection device (1) according to any one of claims 1 to 3, characterized in that the proximal frame (27) and the distal frame (28) each have two corresponding ends in the proximal region (6) which extend parallel to each other inside the frame (3) and / or are arranged standing perpendicular to the frame and are connected to the feeding unit (4).

5. The embolic protection device (1) according to any one of claims 1 to 4, characterized in that the distal and proximal regions (6) comprise locking portions (16) designed in such a way that they increase their radial stiffness.

6. The embolic protection device (1) according to any one of claims 1 to 5, characterized in that the frame ends are bendable along the direction of flow and perpendicular to the direction of flow.

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

8. The embolic protection device (1) according to any one of claims 1 to 7, characterized in that the filtering unit (2) is divided into two sections in such a manner that the proximal region (6) can be actively and / or passively folded independently of the distal region (7) when the embolic protection device (1) is withdrawn.

9. The embolic protection device (1) according to any one of claims 1 to 8, characterized in that the proximal region (6) can be actively folded in the direction of the delivery vessel (11) via a device (23) connected to the filter mesh (20) and / or to the proximal frame (27).

10. An embolic protection device (1), in particular according to any one of claims 1 to 9, characterized in that corresponding independent filters (29, 30) are extended to cover both frames (27, 28).

11. An embolic protection device (1), in particular according to any one of claims 1 to 10, characterized in that the filtering unit (2) is divided into two sections in such a way that the proximal region (6) and the distal region (7) each have their own frame (27, 28) and a single filter (31) extends over both frames.

12. A handle (5) for a medical device, in particular an embolic protection device (1) according to any one of claims 1 to 11, characterized in that the handle (5) comprises a first connecting piece (36), a handle shell (37), a sliding part (38) and / or a second connecting piece (39).

13. A handle (5) according to claim 12, characterized in that the first connecting piece (36) is designed in such a way that it is possible to create a connection that will be actively fixed to the catheter.

14. A handle (5) according to claim 12 or 13, characterized in that the connecting piece (36) has a notch (42) on its inner surface into which the blade (40) of the catheter (12) can be inserted.

15. Handle (5) according to any one of claims 12 to 14, characterized in that the second connecting piece (39) makes it possible to create a reversible clamping connection with the feeding unit (4).

16. The handle (5) according to any one of claims 12 to 15, characterized in that the sliding part (38) is designed in such a way that it is possible to actuate a traction and / or compression mechanism for loading and positioning the device.

17. A handle (5) according to any one of claims 12 to 16, characterized in that the sliding part (38) has a locking device for locking, which allows the relative positioning of the sliding part with respect to the handle shell (37).

18. A handle (5) according to any one of claims 12 to 17, characterized in that the handle (5) comprises a hemostasis valve.

19. Handle according to any one of claims 12 to 18, characterized in that the handle shell (37) has an inner guide tube insertable in the slider (38).

20. A system, characterized in that it consists of an embolic protection device (1) according to any one of claims 1 to 11 and a catheter (12).

21. A system, characterized in that it consists of an embolic protection device (1) according to any one of claims 1 to 11, a handle (5) according to any one of claims 12 to 19, and a catheter (12).

22. A system, characterized in that it consists of a handle (5) according to any one of claims 12 to 19 and a catheter (12).

23. A system, characterized in that it consists of an embolic protection device (1) according to any one of claims 1 to 11 and a handle (5) according to any one of claims 12 to 19.

24. A method for using the embolic protection device of any one of claims 1 to 11.

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

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

Images