Embolism protection device, folding procedure thereof and shaping device

Abstract

Embolism protection device (1) for delivery into an aortic arch, comprising a filter unit (3), a frame (5) and a delivery unit (7), wherein the filter unit (3) is disposed in the frame (5) and the frame (5) has a proximal region (9) comprising a proximal form (11) that is disposed in an inner region of the frame (5) and is connected to the delivery unit (7), wherein the proximal form (11) comprises a first part (13) and a second part (15), wherein the second part (15) is formed at one end of the first part (13).

Description

Embolism protection device, folding procedure thereof and shaping device The invention relates to an embolism protection device according to the preamble of claim 1, which prevents unwanted macroscopic particles from entering the bloodstream in one or more vascular branches of a major vessel, such as the aortic arch. The invention also relates to a forming device for shaping the embolism protection device according to the invention, as well as a method for folding and unfolding the embolism protection device according to the invention by means of the forming device. Cerebral embolism is a well-known complication in cardiac surgery and interventional cardiology. Particles can be dislodged during surgical or interventional procedures. These particles can enter the bloodstream and cause an embolism, particularly in the brain. In the case of a cerebral embolism, this can lead to a stroke or even be fatal. For example, embolism protection devices are known from the applicant's publication EP2859864. Furthermore, WO 2015 / 177322 A1 discloses an embolism protection device for placement in the aortic arch. The objective of the present invention is to specify an improved embolism protection device so as to prevent in a simple manner unwanted macroscopic particles from the bloodstream from entering one or more vascular branches of a main vessel. The objective is achieved according to the invention through the features of the independent claims. Advantageous further developments of the invention result from the dependent claims. A first aspect of the invention relates to an embolism protection device for placement in an aortic arch, comprising a filter unit, a frame, and a placement unit, wherein the filter unit is disposed on the frame. The frame has a proximal zone including a proximal form disposed in an interior zone of the frame and connected to the placement unit. The proximal form includes a first part and a second part; the second part is formed at one end of the first part. The interior zone of the frame includes both the plane encompassing the frame and the zone above or below this plane. The embolism protection device according to the invention advantageously specifies a device characterized in that the connection between the proximal form and the placement unit creates a spring mechanism that ensures the embolism protection device in the aorta, essentially in the distal zone, in the direction of the vessels in the head, is pressed against the vessel wall. With the embolism protection device, unwanted macroscopic particles are essentially diverted. The proximal end is positioned anterior to the ostium of the left subclavian artery by retracting the placement unit. This ensures a stable position in the aortic arch. In an alternative positioning scenario, the embolism protection device can also be delivered via the right subclavian artery. The proximal end is positioned anterior to the ostium of the brachiocephalic trunk by pulling back the placement unit. The spring mechanism is formed in particular by the geometry of the proximal shape. The first part of the proximal shape is preferably positioned below the frame plane, particularly in the inner area of ​​the frame. The first part is advantageously arched. The second part of the proximal shape is preferably positioned above the frame, particularly in the inner area of ​​the frame. The second part is advantageously straight. The first and second parts are preferably angled to each other and / or to the frame plane. In other words, at least the first and / or the second part may be positioned above or below the frame plane, in which case the angle between the first part and the frame plane is different from the angle between the second part and the frame plane, such that the first and second parts enclose an angle. The proximal section can be deployed by applying tension through the placement unit, so that the spring effect is transmitted through the proximal section to the entire frame of the embolism protection device. This particular tension transfer folds the distal section of the frame upwards. The frame of the embolism protection device extends in a two-dimensional plane and, in the proximal area, adopts a proximal shape that can project advantageously downward or upward from this plane. This proximal shape, located within the frame and connected to the placement unit, creates the spring mechanism that ensures the frame with the filter unit can be secured over one or more blood vessels, protecting or covering them. Radial forces act when the filter unit is clamped. Positioning of the embolism protection device is achieved by both the spring mechanism and the placement unit. Furthermore, haptic feedback is provided when the embolism protection device is placed, and resistance is felt when the placement unit is removed, allowing verification of the device's correct positioning.In particular, the main vessel, through which the embolism protection device is introduced, is also covered and protected in this way. Due to the geometry of the frame, particularly the proximal and / or distal shape, the embolism protection device adapts flexibly and independently to the anatomical conditions in the aortic arch and provides complete coverage of all head vessels. Advantageously, the first and second parts of the proximal form are located inside the frame. Specifically, the connection point between the proximal form and the placement unit is also located inside the frame, ensuring that the access vessel is covered. In other words, the proximal portion of the frame or filter unit covers and extends well beyond the ostium of the access vessel. Simultaneously, the proximal portion of the frame or filter unit is in contact with the aortic wall. This ensures, in particular, that the access vessel is covered when the embolism protection device is placed in the aortic arch. The embolism protection device according to the invention, in particular the frame and the filter unit arranged therein, can be fully folded and unfolded. In the folded state, the embolism protection device is preferably dimensioned to have a diameter of essentially 1.4–2.2 mm, particularly 1.7–1.8 mm. The embolism protection device has three states: an unfolded state, in which the device is in its basic form (basic state); a folded state, for example, as a catheter (folded state); and an extended state (placement state) when the device is used according to its design, for example, in the aortic arch in its extreme position. Hereinafter, the final position in the aortic arch is also referred to as the placement position. The geometry of the three states differs. During transport and preparation for implantation, the embolism protection device is in its basic form, as shown in the figures. This basic form is transformed into a folded state through mechanical reshaping. The reversibly deformable frame material, such as superelastic nitinol wire, can be deformed to allow the embolism protection device to be inserted into a catheter. The embolism protection device is then stretched along its direction, transforming into a straight or stretched shape by folding the distal and proximal forms on an external area of ​​the frame. The change in length associated with this is due to a reduction in width.The folded frame, meaning the two sides of the frame outside the distal and / or proximal sections, are parallel to each other on the catheter from the tip to the end of the frame, i.e., from the distal to the proximal section. The specially attached filter unit follows this mechanical deformation and is located in the space between the catheter and the wire. The nitinol frame has a shape memory effect. In the aortic arch position, the geometry of the embolism protection device frame flexibly adapts to the aortic wall and sits in a slight arc, following the curvature of the aorta, in front of the head vessels. Upon removal from the catheter, both the distal and proximal sections fold back to their original shape, allowing for atraumatic placement of the frame against the aortic wall. The special shape of the folded distal and proximal sections avoids transitions or corners with sharp edges. Radial forces generated by the frame's shape memory effect stretch the filter surface. Physiological conditions in the aorta further stabilize the frame, as the blood flow, acting against the filter's surface resistance, additionally presses the embolism protection device frame in its position. The frame material is preferably nitinol. The frame can be a wire or a hollow wire into which a platinum / platinum-iridium / tantalum wire is inserted, in which case the cavity is almost completely filled. Alternatively, the frame can be made of DFT wire, for example, from Fort Wayne Metals, or a wire with a tightly bonded platinum / tantalum core. These examples of frame material have the advantage that the frame is visible and radiopaque. The filter unit comprises a filter material that is selectively permeable to prevent, for example, unwanted macroscopic particles from the bloodstream from entering one or more vascular branches of a major vessel, such as the aortic arch. The filter material can be made from various materials, including plastics or metal-like materials such as nitinol. Depending on the material used, the filter material can be woven, cast, laser-treated, or die-cut. Preferably, the filter material is a woven membrane made of polyamide. The filter material preferably has a pore size of 40–150 µm and an open porosity of 35–60%, ensuring good protection against unwanted particles while maintaining good blood permeability. The filter material may have rectangular or square perforated areas. The thickness of the filter material is preferably 20–120 µm. The positioning unit is a coiled stainless steel wire tube, but other materials are available. The unit is stable in the folds and transmits torque and force when positioning the embolism protection device. Advantageously, the positioning unit is 120–250 cm long with a diameter of 1.5 mm and has a plastic coating (Pebax, polyethylene (PE), polytetrafluoroethylene (PTFE), or polyamide (PA)). The length of the embolism protection device is advantageously 50 to 100 mm. Advantageously, the width of the embolism protection device is 15 to 45 mm. In an advantageous advanced development, the embolism protection device provides that the first part of the proximal form presents a first angle with respect to the frame plane, and the second part presents a second angle with respect to the first part of the proximal form. Advantageously, the first and second parts of the proximal form are coaxially aligned at the point of connection between them and form the spring mechanism by changing the angular dimensions via the placement unit, so that the embolism protection device can be fixed in the placement position on the aortic arch. The first part of the proximal form has an angle of approximately 25 to 50 degrees, preferably 30 degrees, downward with respect to the two-dimensional plane of the frame, measured from the first part to the plane. The first part is straight or arched and preferably has a length of 0.5 to 2.5 cm.The second part, preferably straight, is positioned at the end of the first part. The second part forms a second angle, preferably 80 to 115 degrees, with the first part, measured from the second part towards the first part. When this second angle is measured towards the two-dimensional plane of the frame, it is approximately 110 to 145 degrees, measured from the second part towards the plane. The length of the second part is preferably between 1 and 5 cm. This geometric shape of the proximal form ensures that, in its positioned state, it has a geometry that conforms to the anatomy. Another advantageous advanced development involves the proximal form comprising two frame ends that run parallel to each other in the inner zone of the frame. This leads to greater frame stability in both the longitudinal and transverse directions. In advanced developments of the embolism protection device, the two ends are connected to the placement unit via an adhesive connection. Therefore, the cable ends are not freely accessible. Advanced developments are also possible in which the proximal form comprises only one frame end, in which case the second frame end is connected to the placement device, for example. In further advantageous developments, the frame is envisaged to have a distal zone that includes a distal shape arranged within the frame. Advantageously, the tip of the distal shape is coated with an atraumatic material (e.g., membrane material, polymer, rubber, or hard adhesive), thus providing atraumatic protection. This material can advantageously be shaped into a droplet-like nose. In another advantageous development, the distal form is characterized by a narrowing directed inward toward the frame. This narrowing serves as the connection point for the filter unit. It also aids in positioning within the aorta, as it is equipped with radiopaque markers and can be used to indicate the frame's orientation on the catheter. The distal form, located within the frame, also serves as a positioning aid when inserting the embolism protection device into a catheter via a shaping device. The distal form can be hooked onto or into the shaping device and folded in the opposite direction. In other words, the distal form can be folded outward, i.e., to a location outside the inner frame.This has the advantage that, when pushing through a catheter, for example, the frame can be positioned within the catheter, saving space. By folding the distal form, torsional forces are transmitted to the frame, resulting in the distal form folding inward when the embolism protection device is deployed in the aortic arch. The connection between the frame and the filter unit is, according to the invention, an adhesive tunnel connection. The adhesive tunnel connection is designed as a polymer form that wraps around the frame. In other words, the adhesive wraps around the frame in a tubular or cylindrical shape. The polymer form creates a so-called adhesive tunnel in which the frame is arranged and can be overridden relative to it. Advantageously, the connection between the adhesive tunnel and the filter unit can also be mechanically stable. The separation of the filter unit from the frame creates flexibility in the distal and proximal areas, which allows, or at least facilitates, folding of these areas when folding or unfolding the embolism protection device. Another advantageous advanced development involves connecting the filter unit to the frame outside the proximal and / or distal zone. This connection is mechanically stable, meaning there is no relative movement between the bond and the frame. The connection is advantageously configured as a flexible connection. For example, the connection can be bonded, geometrically closed, welded, or sewn. The bonding tunnel allows for a stable and flexible connection, especially during folding or unfolding of the embolism protection device. In another advantageous advanced development, the filter unit is connected to the frame in the distal area essentially up to the narrowing point. This prevents the filter unit from accidentally folding under the frame. The connection can be formed up to the beginning of the narrowing. In another advantageous advanced development, the filter unit is connected to the frame in the proximal zone essentially up to the first part of the proximal section. The connection can be formed up to the beginning of the first part. In another advantageous advanced development, the filter unit is flexibly connected to the frame in the distal and proximal zones. This allows relative movement between the frame and the filter unit. This ensures that the frame is movably connected to the filter unit in the proximal and distal zones. On the other hand, the frame is permanently connected to the filter unit in the remaining zone. According to the invention, this connection is an adhesive tunnel connection, preferably formed as a polymer shape enveloping the frame. For an adhesive tunnel connection, the frame is embedded in an adhesive. As the adhesive dries, it migrates and forms a polymer shape within the filter unit (like a tube). Changes to the geometry of the embolism protection device, particularly the frame, such as folding or unfolding the frame or the filter unit, can be easily implemented to prevent delays or, in extreme cases, damage to the embolism protection device. Preferably, the frame is connected to the filter unit under pretension. For example, the frame can be connected to the filter unit with slight compression to maintain pretension. The connection of the filter material to the frame is preferably configured so that the frame exerts pretension on the filter unit in both its basic and installed states. Advantageously, the filter unit is attached to the frame from below. This allows for a smooth surface to be created facing the bloodstream. In an advantageous advanced development, the edge of the filter unit is sealed before it is attached to the frame to prevent shape changes during application and to allow the most atraumatic interaction with the aortic wall possible. Another advantageous advanced development involves the filter unit protruding from the frame. The filter unit preferably has this overhang outside the proximal and / or distal area. This overhang is advantageously between 0.5 and 2.0 mm wide, forming a sealing lip against the vessel wall when the frame is placed in the aortic arch in the positioned state. This sealing lip facilitates atraumatic placement of the frame and ensures its dimensional stability. Furthermore, this sealing lip closes with the aortic wall in the positioned state, thus acting as a valve to prevent leakage in the lateral area of ​​the embolism protection device. The overhang is advantageously sealed, giving the filter material a smooth finish. This also facilitates atraumatic frame installation. Another advantageous advanced development involves folding the filter unit over the frame from the bottom to the top, either proximally or distally. The filter unit thus protrudes beyond the frame. Folding or twisting the filter unit over the proximal and / or distal frame improves its attachment, ensuring complete coverage of all head vessels when the embolism protection device is placed in the aortic arch. The filter unit is positioned as a double layer in the proximal and / or distal area, thereby enhancing the filtering effect. In another advantageous advanced development, the filter unit is fixed to the distal or proximal form in the distal and / or proximal area by means of a thread, filament, or wire. Furthermore, this connection can be sealed to achieve dimensional stability. Additionally, due to the sealed connection, this area appears atraumatic. In an advanced and advantageous development, the filter unit is attached to the distal section by means of an adhesive. The connection can be made with a hard adhesive. Thanks to this adhesive, the frame has an atraumatic tip at the distal end, so that, should the distal end come into contact with the aortic wall, for example, the wall is protected from injury. Advantageously, the filter unit is secured in the proximal area by a filament. The filament is formed as a stainless steel wire that wraps around the ends of the frame, preferably in a spiral shape. The filament stabilizes the connection between the filter unit and the placement unit. Furthermore, the filament design facilitates shape changes during folding and unfolding of the embolism protection device. To further improve the embolism protection device, an advantageous advanced development provides that the filter unit has a fiber material, in which case the fibers are aligned such that they form an angle of approximately 45 degrees with respect to a longitudinal axis of the frame. The fiber material consists of a woven membrane, which ensures greater flexibility in both the longitudinal and transverse directions of the frame. The longitudinal direction of the frame extends from the proximal to the distal region and is preferably the centerline of the frame. Preferably, the inclination of the fibers forms an angle of 45 ± 10 degrees with respect to the longitudinal axis of the frame. In another advantageous advanced development, the proximal form is connected to the placement unit, in which case the two ends of the frame are wrapped with a wire whose ends are arranged parallel to the ends of the frame. The connection of the proximal form of the frame to the placement unit is preferably made by gluing. The ends of the frame are inserted into an open lumen of the placement unit and glued there. The wire that wraps the ends of the frame and thus secures them is preferably stainless steel and serves to provide additional stabilization of the frame ends. The ends of the wrapped stainless steel wire are parallel to the ends of the wire of the frame and are preferably glued together in the placement unit.The transition of the wire from the frame to the placement unit and the wrapped stainless steel wire are preferably sealed flexibly, for example, with a polymer mixture to allow a smooth surface and a uniform transition. Preferably, the frame of the embolism protection device has a basic oval shape. This oval shape conforms to the natural shape of the aortic arch roof, thus ensuring reliable coverage of the three main vessels. The upper portion of the aortic arch at this point resembles the interior of an inverted oval bowl. Inserting the oval shape achieves a geometric seal. The oval shape preferably tapers proximally. In other words, the cross-section of the aorta at the point where the embolism protection device is placed is oval, and therefore the oval shape of the frame advantageously conforms to the physiological shape at that point. A second aspect of the invention relates to a shaping device for reshaping the embolism protection device according to the invention. The embolism protection device has all or at least some of the features mentioned; these are not individually repeated herein. The reshaping takes place to insert the embolism protection device into a catheter, in which case the frame with the filter unit of the embolism protection device, arranged therein, is reshaped from an expanded to a stretched state. The shaping device has two partial zones that meet in a very narrow cross-section. Each of the partial zones is preferably funnel-shaped. The distal partial zone is preferably configured as a flat or round funnel and serves to insert the embolism protection device according to the invention.The proximal portion is preferably designed as a circular funnel and serves to hold a substantially circular tube, such as a commercially available introducer lock or catheter. The shaping device is a tool whose geometry allows the embolism protection device, particularly its frame, to be reshaped so that its diameter in the folded state is preferably essentially 1.4–2.0 mm, and more specifically 1.7–1.8 mm. The shaping device ensures that the embolism protection device can be easily inserted into a substantially circular tube, such as a commercially available introducer lock or catheter. In an advanced development, the preferred flat or round opening of the shaping device is designed so that the proximal and / or distal portions of the embolism protection device frame are folded outward. This ensures, among other things, correct and damage-free insertion of the embolism protection device, for example, into a catheter. In other words, the proximal and / or distal portions, which in the basic form of the embolism protection device extend inward into the frame, are folded in the opposite direction, i.e., outward, through the flat or round opening. A third aspect of the invention relates to a method for folding the embolism protection device according to the invention using the forming device. The embolism protection device has all or at least some of the features mentioned; these are not individually repeated here. The method includes the following steps: insert the frame of the embolism protection device in front of the flat or round opening of the forming device, in which case the placement unit is passed through the forming device; insert the proximal shape into the shaping device, in which case the proximal shape folds outwards; hook the distal shape over the outer edge of the distal partial zone of the shaping device, in which case by further pulling the distal shape folds outwards and is inserted into the shaping device. In an advanced development of the procedure, it is advantageously provided that, upon insertion of the frame into the forming device, the frame is compacted and elongated. Due to the conical shape of the distal portion of the forming device, the frame is compacted from both sides, so that it has an elongated shape when it emerges from the narrower cross-section of the forming device. In an advanced development of the procedure, it is advantageously envisaged that the embolism protection device is pushed from the aforementioned tubing, which contains the folded embolism protection device and may be, for example, a commercially available introducer lock, into a catheter previously placed in the aortic arch. A hemostasis valve at the proximal end of the catheter is used to accommodate and secure the tubing while minimizing blood loss during placement. The embolism protection device is then pushed out of the tubing into the catheter, advancing it into the placement unit. Once the frame is fully seated on the catheter, the tubing can be removed and withdrawn through the placement unit. The embolism protection device can then be advanced into the aortic arch beyond the distal end of the catheter into the placement unit. In another advanced development of the procedure, it is advantageously envisaged that the embolism protection device will be pushed out of the aforementioned tubing, which may be a commercially available catheter, for example, into a lock previously placed in the aortic arch. By advancing the tubing through the lock, the embolism protection device can be inserted into the tubing up to the distal end of the lock in the aortic arch. In all advanced developments of the embolism protection device according to the invention, it is foreseen that the folded proximal shape transmits a pre-tension to the frame that is essentially the same as the tension resulting from straightening the curved proximal shape. Furthermore, a method for deploying the embolism protection device from a catheter containing it is also provided. The invention further contemplates that the embolism protection device can be housed in an elongated or cylindrical device, or a catheter-like structure, for example, by folding the embolism protection device. When deploying the embolism protection device from the catheter, it is first pushed outward until the distal portion of the frame has emerged from the catheter. As the embolism protection device is advanced further out of the catheter, the distal portion is pushed outward and folded back into the frame. By folding the distal portion, the frame in the distal portion returns to the pre-tensioned state prior to folding the embolism protection device.Folding the distal form serves as an orientation aid and allows the embolism protection device frame to change shape so it can be inserted into almost any catheter. Furthermore, folding the distal form is atraumatic. The placement unit may have two marks on its proximal area, in which case the first mark indicates, when the embolism protection device is subsequently placed through the guide catheter, that the distal shape is directly opposite the catheter exit opening, and the second mark indicates that the frame has completely exited the catheter. In an advanced and advantageous development, the frame's direction is indicated by one or more markers. These markers can be radiopaque. Specifically, they can be placed in the distal portion of the frame. The distal portion indicates the frame's direction as it extends out of the catheter. This has the advantage that the exact position of the frame, its direction of advancement, and its placement can be precisely determined. Further details of the invention can be found in the exemplary embodiments described below with reference to the figures. All the details of the invention set forth below are not limited to the specified exemplary embodiments, but may also occur individually, selectively, in combination, or as a whole in other exemplary embodiments. They are shown as follows: Figure 1: Embolism protection device according to the invention; Figure 2: Plan view of the frame of the embolism protection device of Figure 1; Figure 3: Side view of the frame of Figure 2; Figure 4: perspective view of the proximal area of ​​the frame in Figure 2; Figure 5A: frame with a configuration of radiopaque markers; Figure 5B: frame with another configuration of radiopaque markers; Figure 6: connection of a proximal form according to the invention with the placement device; Figure 7: representation of an adhesion tunnel in section with frame, filter unit and seal; Figure 8: plan view of a frame with a filter unit disposed therein; Figure 9: distal filter unit of Figure 8; Figure 10: Plan view of a proximal form with the filter unit arranged; Figure 11: perspective view of the proximal shape of Figure 10; Figure 12: Plan view of a distal form with the filter unit arranged; Figure 13: perspective view of the distal shape of Figure 12; Figure 14: View of an embolism protection device folded onto a catheter; Figures 15A-F: reformation of a frame of an embolism protection device according to the invention from a folded state to an unfolded state; Figure 16: Schematic view of a deployed state of the embolism protection device after exiting a catheter; Figure 17: Deployment sequence of an embolism protection device after catheter exit in an aortic arch; Figure 18: Covering the outlets of the head vessels in the aorta by means of the embolism protection device after leaving the catheter as in Figure 17; Figure 19: shaping device for reshaping a stroke protection device according to the invention; Figure 20: perspective view of the shaping device of Figure 19; Figure 21: folding procedure of the embolism protection device according to the invention by means of a forming device. Figure 1 shows an embolism protection device 1 according to the invention. The embolism protection device 1 comprises a frame 5 in which a filter unit 3 is arranged. The frame 5 is connected to a positioning unit 7. The length of the frame 5 is advantageously from 50 to 100 mm. The width of the frame 5 is advantageously from 15 to 45 mm. In this embodiment, the frame 5 consists of a single, continuously bent wire. However, the described properties and advantages of the embolism protection device also apply to other embodiments. Frame 5 has a two-dimensional and a three-dimensional zone. The two-dimensional zone, i.e., the plane encompassed by the frame, has an oval shape that becomes a proximal shape 11 and a distal shape 4 in distal and proximal zones 2, 9. The proximal shape 11 and the distal shape 4 constitute the three-dimensional zone of frame 5, in which case the remaining zone of frame 5 forms the two-dimensional zone, i.e., the oval shape. The embolism protection device 1 is shown in its basic form. Figure 2 shows a plan view of frame 5 of the embolism protection device 1 of Figure 1. The proximal zone 9 of frame 5 is the one that leads to the open ends 17, 19 of frame 5, in this embodiment the ends of the wire. The proximal zone 9, and therefore also the proximal shape 11, is defined by the two loose ends 17, 19 of frame 5 or wire used. The proximal shape 11 has a first part 13 and a second part 15 formed by the parallel ends 17, 19 in this embodiment. In the distal zone 2, frame 5 changes to a distal shape 4. The distal shape 4 has a constriction 12 of the wire inside frame 5 or, in other words, inside the two-dimensional oval zone, approximately 1-3 cm in diameter. In this embodiment, the constriction 12 is a loop with a head diameter of approximately 1–1.8 mm and with the wire otherwise lying parallel to each other. The loop and the parallel wire are in the same two-dimensional plane of frame 5. Figure 3 shows a side view of frame 5 from Figure 2. The proximal form 11 extends with the ends of frame 17, 19, as well as the frame in the distal form 4, parallel to and inside frame 5. The first part 13 of the proximal form has a first angle W1, preferably 25 to 50 degrees downwards with respect to the two-dimensional plane of frame 5, in which case the angle is measured from the first part 13 to the plane of the frame. After, preferably 0.5 to 2.5 cm in length from the first part 13, a second part 15 is arranged at the end of the first part 13 at a second angle W2, preferably 110 to 145 degrees upwards from the two-dimensional plane of frame 5, in which case the angle is measured from the second part 15 to the level of the frame. The length of the second part 15 is 1 to 5 cm.The lengths of the first and second parts 13, 15 as well as their angle with respect to the frame plane 5 can also be selected larger or smaller according to the requirements of the embolism protection device. The first and second parts 13, 15 form the proximal shape 11 which is arranged in an interior region of the frame 5, in which case the proximal shape 11 extends above and below the plane of the frame 5. This geometric shape of the proximal shape 11 prestresses the frame 5 and at the same time stabilizes it in the longitudinal and transverse directions. It is possible that the first part 13 extends into the plane of frame 5, that is, that angle W1 is equal to 0 degrees and only the second part 15 is inclined into the plane of frame 5 at a second angle W2. The distal form 4, which includes the narrowing 12, is located in the two-dimensional plane of frame 5. Figure 4 shows a perspective view of the proximal zone 9 of the frame of Figure 2. The proximal shape 11 comprises the first part 13, which is bent at a first angle W1 with respect to the plane of the frame 5, the second part 15 which is bent at a second angle W2 with respect to the plane of the frame 5, and the two ends 17, 19 of the frame 5. Both the first part 13 and the second part 15 of the proximal shape 11 each have two frame wires. Figures 5A and 5B show a frame 5 with a configuration of 20 radiopaque markers. The 20 radiopaque markers are attached to the frame 5 at locations prominent for radiopaque visibility. For example, the 20 radiopaque markers are attached at the narrowing zone 12 and to the frame at the distal zone 2, so that the exact position of the tip of the frame 5 can be determined. In addition, the 20 radiopaque markers are attached to the frame 5 outside the distal or proximal zone 2, 9. The distance between the 20 markers can be used to determine the stage at which the embolism protection device 1 is being folded or unfolded. The exact position of the embolism protection device 1 in the aortic arch can also be determined using the 20 radiopaque markers. The markers can be platinum / iridium caps that are inserted into or hooked onto the frame.The bushings have an inner diameter slightly larger than frame 5, have a wall thickness of approximately 50-100 µm and are fixed with an adhesive. Figures 5A and 5B show only some possibilities for positioning radiopaque markers. There are also several options for placing radiopaque markers, depending on the desired outcome. Figure 6 shows a connection of a proximal form 11 according to the invention with a placement device 7 according to the invention, in which case the ends 17, 19 of the frame 5 of the proximal form 11 are shown in the drawing. The ends 17, 19 are also at the same time the end of the second part 15 of the proximal form 11. In this embodiment, the placement unit 7 comprises a stainless steel filament and has a liner seal. In this embodiment, the outer diameter of the placement unit 7 is 1.5 mm and its open lumen has a diameter of 0.8 mm. The total length of the placement unit 7 is 150 cm. Other dimensions for the placement unit 7 are possible. The proximal form 11 of frame 5 is connected to the placement unit 7 via an adhesive unit 8, for example, polyurethane adhesive. The wire ends 17, 19 of the proximal form 11 are inserted into the open inner lumen of the placement unit 7 and bonded. For clarity, the adhesive unit 8 is shaded in the figure. For additional stabilization, the ends of wire 17, 19, i.e., the second part 15 of the proximal form 11, are secured by means of a coiled stainless steel wire 6. The wire ends 10 of the coiled stainless steel wire 6 are bonded, parallel to the ends 17, 19 of the frame 5 in the placement unit 7. The transition from the proximal form 11 to the placement unit 7 and the coiled stainless steel wire 6 are also coated with polyurethane to ensure a smooth surface and a uniform transition. Figure 7 shows an enlarged cross-sectional view of the connection between frame 5 and filter unit 3. The connection is made by wrapping a polymer form around frame 5. This polymer form creates an adhesive tunnel 41 in which frame 5 is arranged within filter unit 3. The seal 42 is shown on the outer edge of filter unit 3 in this figure. Figure 8 shows a plan view of a frame 5 with a filter unit 3 mounted on it. The length of the frame 5 is advantageously 50 to 100 mm. The width of the frame 5 is advantageously 15 to 45 mm. In this embodiment, the filter unit 3 is attached to the frame 5 by means of an adhesive or a polyurethane-based adhesive. The adhesive runs continuously along the outside of the frame 5. The portions of the frame 5 in the proximal and distal areas, which are folded inward in the basic shape, are not bonded to the filter unit 3. The filter unit 3 is bonded to the frame 5 from the underside so that the surface of the filter unit 3 faces the central bloodstream when the frame 5 is placed in its position on the aortic arch. Frame 5, made of nitinol in this embodiment, is bonded to filter unit 3 in a pre-tensioned state to achieve an improved clamping force of frame 5. The width of frame 5 is compressed from 35-45 mm to 25-35 mm. The filter unit 3 protrudes with an overhang 14 of approximately 1 mm over the frame 5 on its upper side and is folded or creased in the distal and proximal areas 2, 9 of the frame 5 from the lower side over the frame 5 towards the upper side. The overhang 14 of the filter unit 3 extending beyond the outer edge of the frame 5 also serves as a flexible sealing lip against the aortic wall when the embolism protection device 1 is in the placement position in the aortic arch. The folded area of ​​the filter unit 3 comprises a proximal filter unit 21 and a distal filter unit 22. The proximal and distal filter units 21, 22 are not attached to the frame with adhesive, thus facilitating the desired deformation when pushed by the catheter as intended.The proximal filter unit 21 is fixed together with the second part 15 of the proximal form 11 under the wrapped stainless steel wire 6 and is sealed in this area; see also the representation in Figure 7. The distal filter unit 22 is attached to the narrowing 12 of the distal form 4. The distal filter unit 22 extends further inside the frame 5 by means of the narrowing 12 by approximately 2-5 mm and is further flexibly sealed. The fibers of filter unit 3 are aligned at a 45° angle to the centerline of frame 5 from end to end. This allows filter unit 3 to stretch more in the longitudinal direction, while providing stability in the transverse direction. The outer edges of overhangs 14, 21, and 22 are additionally sealed. Figure 9 shows an extreme area of ​​the distal filter unit 22 of filter unit 3 in Figure 8. The distal filter unit 22 is cut in such a way that it not only extends about 2 mm beyond the narrowing 12 but also widens again behind the narrowing 12 and takes the shape of a small flag 23. This flag 23 is wound up. The ends of the thread used are enclosed within the flag 23 for securing. The adhesive secures the distal filter unit 23 so that it does not unwind. The diameter of the wound distal filter unit 22 is less than 1.6 mm. In addition to securing the distal filter unit 23, an additional protective cushion is also formed between the frame 5 and the aortic wall to prevent injury. Figure 10 shows a plan view of a proximal form 11 with the filter unit 3 in place. The proximal filter unit 21 is folded around the frame 5 towards the upper side. In this embodiment, both the first part 13 of the proximal form 11 and the second part 15 of the proximal form 11 are wrapped with a stainless steel wire 6 (to better illustrate the stainless steel wire, the first and second parts 13 and 15 of the proximal form are not shown).The first part 13 has a first angle W1 with respect to the plane of frame 5 and the second part 15 is folded at a second angle W2 with respect to the plane of frame 5. Figure 11 shows a perspective view of proximal form 11 of Figure 10. Figure 12 shows a plan view of a distal form 4 with a filter unit disposed 3, in particular a distal filter unit 22. The distal filter unit 22 is fixed to the narrowing 12 of the distal form 4 by means of a thread 43, which in other embodiments may also be a filament or wire, and protrudes into the inside of the frame 5. Figure 13 shows a plan view of a proximal form 11 with a filter unit 3 in place. The flag 23 is rolled up and secured with thread, as described in Figure 9 and not repeated here. Figure 14 shows an embolism protection device 1 folded onto a catheter 25. The embolism protection device 1 is in the folded state. The basic shape of the embolism protection device, as shown, for example, in Figures 1 to 13, is converted into the folded state by mechanical reshaping. The reversibly deformable material of the frame 5, for example, a superelastic nitinol wire, can be deformed in such a way that the embolism protection device 1 can be inserted into a catheter 25. The embolism protection device 1 extends along its direction. The distal form 4 and also the proximal form 11 are folded into an outer area of ​​the frame 5. By folding the distal form 4 and the proximal form 11, the frame 5 is transformed into a straight or stretched shape. The change in length associated with this is due to the reduction in the width of the frame 5. The folded frame 5, i.e., the two sides of the frame outside the distal form 4 and / or the proximal form 11, are parallel to each other in the catheter 25. The filter unit 3 can follow this mechanical deformation and is located in the space between the catheter 25 and the frame 5. In this stretched shape, the embolism protection device can be inserted into a catheter with an inner diameter of, for example, 1.7 mm. Figures 15A-F show a reformation of a frame 5 of an embolism protection device 1 according to the invention from a folded state to an unfolded state. When the embolism protection device is placed outside a catheter 25, for example, in the aortic arch, the embolism protection device 1, in particular the frame 5 with the filter unit 3 arranged therein, is pushed out of the catheter 25. This is shown in Figures 15A-F. The frame 5, which is made of reversibly deformable material, attempts to return to its original basic shape, as shown in Figure 1, for example. The filter unit 3 arranged in the frame 5 follows the reformation. By advancing the forward-folded distal form 4 located in the catheter 25, it folds back halfway in the direction of its originally intended position when it leaves the catheter 25, approximately after advancing 1-2 cm (see Figure A). The direction of the distal form 4 indicates the position of the embolism protection device 1 within the catheter 25.Radiopaque markers that can be installed on the distal form 4 allow identification of the position of the distal form 4. The orientation direction of the distal form 4 indicates the upper side of the embolism protection device 1. The placement position, for example, in the aortic arch, can be adjusted by rotating the catheter 25. Since the constriction 12 in the distal area of ​​the embolism protection device 1, i.e., the distal form 4, folds immediately after exiting the catheter 25 (compare with FIG.15A-B), the risk of possible damage to the vessel wall due to a subsequent advancement of the embolism protection device 1 is minimized. In addition, the frame 5 is wrapped in the distal form 4 with atraumatic material that has an overhang of approximately 1-2 mm and thus also counteracts possible injuries. As the advancement into the aortic arch continues, frame 5 continues to unfold until it is fully deployed. This can be seen, for example, in Figures 15C–F. Figure 15D shows the same deployed state as Figure 15C from a side view, and Figure 15C shows the deployed state from a top view. The distal form 4, now almost completely folded back, and the deployable frame 5, as well as the deployable filter unit 3, are shown. In the fully deployed state, frame 5 is extended and filter unit 3 is held by frame 5. Figure 15E shows the fully deployed frame or the deployed embolism protection device 1 in a top view, and Figure 15F shows it in a side view. The action of the spring mechanism by means of the proximal form 11 can be seen in the transition from Figure 15C to Figure 15E or from Figure 15D to Figure 15F. Figure 16 schematically shows the deployed state of the embolism protection device 1 after catheter 25 has been removed. Due to the special geometry of the proximal form 11 up to the transition to the placement unit 3, the frame 5 is pre-tensioned to the same extent as the previously bent proximal form 11 is straightened. The figure shows two different states of the deployed state. The position of the filter unit is identical in both illustrations. The position of the first and second parts 13, 15, which are connected to the placement unit (not shown), is shown in both the relaxed and tensioned states. This results in a spring-like effect, which is explained in more detail below. As soon as the embolism protection device 1 is correctly positioned, for example, on the aortic arch, the transmitted tension from the proximal form 11 presses the distal form 4 against the aortic wall, thus enabling stable fixation against the bloodstream. This is indicated by the short, thick arrow on the distal form 4 in Figure 16, shown as a sketch. The proximal form 11 follows a movement represented by the thin, curved arrow. Without the resistance of the aortic wall, the frame 5 would follow the marked folding direction—represented by the thin, curved arrow in Figure 16—as shown, for example, in Figure 15E-F.As shown in Figure 16, the proximal form 11 changes to a form in which the first part 13 has a first angle W1 of 25 to 50 degrees above the frame plane, measured from the plane toward the first part 13, and the second part 15 has an angle W2 of 30 to 110 degrees above the frame plane, measured from the second part 15 toward the plane. The specified degrees of the angles depend on the aortic geometry and are only examples. Figure 17 shows a schematic sequence of the deployment of an embolism protection device 1 after leaving a catheter 25 in an aortic arch. Part (a) of the figure shows the insertion of the catheter 25 through the left subclavian artery, where the distal form 4 of the embolism protection device 1 is at least partially folded back. Parts (b) to (d) of the figure show the further advancement and deployment of the embolism protection device 1, where in part (d) of the figure the proximal form 11 has also emerged from the catheter. Part (e) of the figure shows the embolism protection device 1 fully deployed in the positioned state. The proximal zone 9 of the frame 5 protrudes beyond the surface of the ostium of the left subclavian artery, so the embolism protection device 1 also covers the access pathway.At the same time, this cantilever provides haptic feedback when placing the embolism protection device: by pulling on the placement unit 7, a slight resistance can be felt as soon as the cantilever of the embolism protection device 1, or more precisely frame 5, is correctly positioned in front of the ostium 27. The intended position is achieved through the left subclavian artery in the aortic arch with the distal zone 2 of frame 5 in the direction of the heart valve. The right subclavian artery can also serve as an alternative access route. The sequence is similar to that shown in Figure 16, but in a mirror image. Here, distal zone 2 of frame 5 points in the direction of the descending aorta. Figure 18 shows the embolism protection device 1 covering the head 29 blood vessel outlets into the aorta after leaving the catheter 25 as in Figure 17. Due to the special geometry of the frame 5, the embolism protection device 1 adapts to the anatomical conditions of the aortic arch flexibly and independently of the access route and provides complete coverage of all head 29 vessels. In the positioned on the aortic arch, the geometry of frame 5 of the embolism protection device 1 flexibly adapts to the aortic wall and lies in a slight curve, following the curvature of the aorta, opposite the outflow tracts of the head (see also Figure 17(e)). Upon exiting the catheter 25, both the distal form 4 and the proximal form 11 fold back into their original shape, i.e., towards the interior of frame 5, thus allowing frame 5 to be placed atraumatically on the aortic wall. This folding prevents transitions with sharp edges or corners. Further stabilization of frame 5 is achieved by the physiological conditions in the aorta, as the blood flow additionally presses frame 5 of the embolism protection device 1 into its positioned position. Figure 19 shows a forming device 31 for reshaping an embolism protection device 1 according to the invention in different views. To simplify reshaping the embolism protection device from an unfolded state in its basic form to a stretched state, the embolism protection device is inserted into the distal partial zone 33 of the forming device 31. The distal partial zone 33 of the forming device 31 has a flat funnel with a flat opening 35 with an opening width of approximately 25–40 mm and an opening height of approximately 3–10 mm. Over the length of the distal partial zone 33 of the forming device 31, which is approximately 60–80 mm, the opening area on the front side narrows to a narrower circular cross-section 39 with a diameter of approximately 1.7 mm.The proximal partial zone 40 of the shaping device 31 widens from the narrower cross-section 39 towards the round opening 37 to a diameter of approximately 1.8 to 5 mm for a length of 20 to 40 mm. This results in a total length of the shaping device 31 of 80 to 120 mm. Figure 20 shows a perspective view of the shaping device 31 of Figure 19. Figure 21 shows individual steps of the procedure for folding the embolism protection device according to the invention using a shaping device 31, wherein the folded embolism protection device 1 is inserted into a substantially circular tube 38, for example, a commercially available introducer sleeve or a commercially available catheter 38 (with an inside diameter of 1.8 to 2.5 mm) is inserted. In step S1, the frame 5 of the embolism protection device 1 is inserted in front of the flat opening 35 of the shaping device 31, with the placement unit 7 in front. The proximal end of the placement unit 7 passes through the distal end of the shaping device 31.The essentially circular hose 38 is opened by pushing its distal end over the placement unit 7 from the proximal end to the front of the round opening 37 of the shaping device 31, in which case the placement unit 7 protrudes from this flexible tube 38. In step S2, the hose 38 and the forming device 31 are connected to each other at the flared or conical round opening 37 of the forming device 31, for example, by means of a plug connection. The embolism protection device 1 is aligned by pulling on the positioning unit 7. Pulling further on the placement unit 7, in step S3, the proximal shape 11 folds into the outer edge of the distal partial zone 33 of the shaping device 31, so that it is pulled out stretched through the shaping device 31. By pulling further on the positioning unit 7, in step S4, the distal form 4 is inserted through the outer edge of the distal partial zone 33 of the forming device 31, at which point the distal form 4 engages the edge and folds outwards. This is also illustrated in the side view of the figure. In step S5, the embolism protection device 1 is pulled fully extended through the forming device 31. By pulling further on the positioning unit 7, the sides of the frame 5 are tucked in until the entire frame is pulled out fully extended into the hose 38. The embolism protection device 1 remains in this hose 38. The forming device 31 can now be removed from the hose 38. In summary, it should be noted that, by means of the measures described, a protection device against embolisms (1) is configured according to the invention for placement in an aortic arch, comprising a filter unit (3), a frame (5) and a placement unit (7), the filter unit (3) being disposed in the frame (5) and the frame (5) having a proximal zone (9) comprising a proximal shape (11), which is disposed in an inner zone of the frame (5) and connected to the placement unit (7), the proximal shape (11) comprising a first part (13) and a second part (15), the second part (15) being formed at one end of the first part (13). In a further embodiment of the embolism protection device (1), the first part (13) of the proximal shape (11) has a first angle (W1) with respect to the frame plane (5), and the second part (15) has a second angle (W2) with respect to the first part (13) of the proximal shape (11). According to the invention, an embolism protection device (1) is provided for placement in an aortic arch, comprising a filter unit (3), a frame (5), and a placement unit (7), the filter unit (3) being disposed in the frame (5) and the frame (5) having a proximal zone (9) comprising a proximal form (11), which is disposed in an inner zone of the frame (5) and connected to the placement unit (7), the proximal form (11) comprising a first part (13) and a second part (15), the first and second parts (13, 15) being arranged with each other in such a way as to form a spring mechanism. In a further embodiment of the embolism protection device (1), the proximal form (11) can be put under tension through the placement unit (7). In a further embodiment of the embolism protection device (1), the proximal form (11) comprises two ends (17, 19) of the frame (5), which extend parallel to each other in the inner zone of the frame (5). In a further embodiment of the embolism protection device (1), the proximal form (11) is connected to the placement unit (7), the two ends (17, 19) of the frame (5) being wound by a wire (6), the ends (10) of which are arranged parallel to the ends (17, 19) of the frame (5). In a further embodiment of the embolism protection device (1), the frame (5) has a distal zone (2) comprising a distal shape (4), which is arranged in an inner zone of the frame (5). In a further embodiment of the embolism protection device (1), the distal form (4) has a narrowing (12) directed towards the inside of the frame (5). According to the invention, the connection between the frame (5) and the filter unit (3) of the embolism protection device is made by means of an adhesion tunnel or an adhesion tunnel joint. In a further embodiment of the embolism protection device (1), the filter unit (3) is attached to the frame (5) outside the proximal and / or distal zone (9, 2). In a further embodiment of the embolism protection device (1), the filter unit (3) is attached to the frame (5) in the distal area (2) essentially up to the beginning of the distal shape (4). In a further embodiment of the embolism protection device (1), the filter unit (3) is attached to the frame (5) in the proximal area (2) essentially up to the first part (13) of the proximal shape (11). In a further embodiment of the embolism protection device (1), the filter unit (3) is flexibly attached to the frame (5) in the distal and proximal area (2, 9). In a further embodiment of the embolism protection device (1), the frame (5) is joined to the filter unit (3) with a transverse pretension. In a further embodiment of the embolism protection device (1), the filter unit (3) has an overhang (14) that protrudes from the frame (5). In a further embodiment of the embolism protection device (1), the cantilever (14) is sealed. In a further embodiment of the embolism protection device (1), the cantilever (14) is configured as a sealing lip. In a further embodiment of the embolism protection device (1), in the proximal and / or distal area (9, 2) of the frame (5), the filter unit (3) is folded over the frame (5) from the lower face to the upper face. In a further embodiment of the embolism protection device (1), the filter unit (3) is attached to the distal form (4) by means of a thread, wire or strand. In a further embodiment of the embolism protection device (1), the fixation of the filter unit (3) to the distal form (4) by means of a thread, wire or strand is sealed. In a further embodiment of the embolism protection device (1), the filter unit (3) is attached to the distal form (4) by adhesion. In a further embodiment of the embolism protection device (1), the filter unit (3) is secured by a spiral in the proximal area (9). In a further embodiment of the embolism protection device (1), the filter unit (3) comprises a fibrous material, the fibers being oriented in such a way that they form an angle of essentially 45 degrees with respect to a longitudinal axis of the frame (5). In a further embodiment of the embolism protection device (1), the frame (5) has a basic shape configured as an oval shape. According to the invention, a forming device (31) is provided for shaping the embolism protection device (1) for insertion into a hose. This device transforms a frame (5) of the embolism protection device (1), with a filter unit (3) disposed therein, from an expanded state to an elongated state. The frame comprises a flat or round opening (35), a narrower cross-section (39), and an opposing round opening (37). In a further embodiment of the forming device, the flat or round opening (35) of the forming device (31) is configured such that the proximal (11) and / or distal (4) form of the frame (5) of the embolism protection device is folded outwards. According to the invention, a method is provided for folding the embolism protection device by means of the shaping device, comprising displacing (S1) the frame (5) of the embolism protection device to the flat or round opening (35) of the shaping device (31), while the placement unit (7) is guided through the shaping device (31), introducing (S3) the proximal shape (11) into the shaping device (31), folding the proximal shape (11) outwards, engaging (S4) the distal shape (4) over the outer edge of the shaping device (31), folding the distal shape (4) outwards by means of additional traction and being introduced into the shaping device (31). In a further embodiment of the procedure, the frame (5) is lengthened by introducing the frame (5) into the forming device (31). In a further embodiment of the procedure, wherein the folded proximal form (11) transmits a pre-tension to the frame (5) that is substantially equal to the tension resulting from straightening the curved proximal form (11). The description provides a procedure for deploying the embolism protection device when said embolism protection device leaves a catheter containing it, comprising ejecting the embolism protection device out of the catheter, and folding the distal form (4) back into an inner area of ​​the frame (5) when a distal area (2) of the frame of the embolism protection device leaves the catheter. A further embodiment of the procedure comprises indicating the orientation of the frame (5) by means of one or more markers when the distal zone (2) leaves the catheter, the distal zone (2) indicating the orientation of the frame (5). A further embodiment of the procedure, in which by means of the precurvature of both the distal and proximal forms a twist is generated in the frame wire (5), which has a preferred direction when exiting the catheter towards the curved tip of the distal form. List of reference signs 1 Embolism protection device 2 Distal Zone 3 Filter Unit 4 Distal shape 5 Marco 6 Stainless steel wire 7 Placement Unit 8 Adhesion Unit 9 Proximal zone 10 Wire ends 11 Proximal form 12 Narrowing 13 Part One 14 Overhang 15 Part Two 17, 19 Frame extremes 20 Scoreboard 21 Proximal filter unit 22 Distal filter unit 23 Little Flag 25 Catheter 27 Ostium 29 Header outlets 31 Forming device 33 Distal partial zone 35 Flat opening 37 Round opening 38 Hose 39 Narrowest cross section 40 Proximal partial zone 41 Adhesion Tunnel 42 Sealing 43 Thread S1-S5 Procedural Steps W1 First angle W2 Second angle

Claims

1. An embolism protection device (1) for placement in an aortic arch, comprising a filter unit (3), a frame (5), and a placement unit (7), the filter unit (3) being attached to the frame (5), and the frame (5) having a proximal zone (9) comprising a proximal form (11), which is disposed in an inner zone of the frame (5) and attached to the placement unit (7), the proximal form (11) comprising a first part (13) and a second part (15), the second part (15) being formed at one end of the first part (13), characterized in that the connection between the frame (5) and the filter unit (3) is made by means of an adhesion tunnel or an adhesion tunnel joint. 2.Embolism protection device (1) according to claim 1, characterized in that the first part (13) of the proximal form (11) has a first angle (W1) with respect to the plane of the frame (5), and the second part (15) has a second angle (W2) with respect to the first part (13) of the proximal form (11). 3.Embolism protection device (1) for placement in an aortic arch, comprising a filter unit (3), a frame (5), and a placement unit (7), the filter unit (3) being attached to the frame (5), and the frame (5) having a proximal zone (9) comprising a proximal form (11), which is disposed in an inner zone of the frame (5) and is attached to the placement unit (7), the proximal form (11) comprising a first part (13) and a second part (15), the first and second parts (13, 15) being arranged with each other in such a way as to form a spring mechanism, characterized in that the connection between the frame (5) and the filter unit (3) is made by means of an adhesion tunnel or an adhesion tunnel connection.

4. Embolism protection device (1) according to any one of claims 1-3, characterized in that the proximal form (11) can be tensioned via the positioning unit (7). 5.A protection device against embolisms (1) according to any of the preceding claims, characterized in that the proximal form (11) comprises two ends (17, 19) of the frame (5) extending parallel to each other in the inner zone of the frame (5).

6. A protection device against embolisms (1) according to any of the preceding claims, characterized in that the frame (5) has a distal zone (2) comprising a distal form (4), which is disposed in an inner zone of the frame (5).

7. A protection device against embolisms (1) according to claim 6, characterized in that the distal form (4) has a narrowing (12) oriented towards the interior of the frame (5).

8. A protection device against embolisms (1) according to any of the preceding claims, characterized in that the filter unit (3) is attached to the frame (5) outside the proximal zone (9) and / or the distal zone (2) according to claim 6 and / or 7. 9.A system comprising an embolism protection device (1) according to any one of the preceding claims and a forming device (31) for shaping the embolism protection device (1) for insertion into a tube (38), characterized in that a frame (5) of the embolism protection device (1), with a filter unit (3) disposed therein, is formed from an expanded state to an elongated state, comprising a flat or round opening (35) on one side, a narrower cross-section (39), and an opposite round opening (37).

10. A system according to claim 9, wherein the flat or round opening (35) of the forming device (31) is configured such that the proximal shape (11) and / or the distal shape (4) according to claim 6 and / or 7 of the frame (5) of the embolism protection device is folded outwards. 11.A method for folding the embolism protection device according to any one of claims 1-8 by means of the forming device of the system according to any one of claims 9-10, comprising: displacing (S1) the frame (5) of the embolism protection device in front of the flat or round opening (35) of the forming device (31), guiding the placement unit (7) through the forming device (31), inserting (S3) the proximal form (11) into the forming device (31), folding the proximal form (11) outwards, engaging (S4) the distal form (4) over the outer edge of the forming device (31), folding the distal form (4) outwards and inserting it into the forming device (31) by means of additional traction. 12.Method according to claim 11, wherein the folded proximal form (11) transmits to the frame (5) a prestress that is substantially equal to the stress resulting from straightening the curved proximal form (11).

Images