Embolic protection device, folding method and forming device

Abstract

An embolic protection device (1) for insertion into the aortic arch, comprising a filter unit (3), a frame (5) and a feeding unit (7), wherein the filter unit (3) is arranged at the frame (5) and the frame (5) provides a proximal region (9) comprising a proximal body (11) arranged in an inner region of the frame (5) and connected to the feeding unit (7), wherein the proximal body (11) comprises a first portion (13) and a second portion (15), wherein the second portion (15) is formed at one end of the first portion (13).

Description

[0001] This invention relates to an embolism protection device according to the preamble of claim 1, which prevents unwanted macroscopic particles in the bloodstream from entering one or more branch vessels of the main blood vessel (such as the aortic arch). The invention also relates to a forming apparatus for shaping the embolism protection device of the invention, and a method for folding and unfolding the embolism protection device of the invention using said forming apparatus.

[0002] Cerebral embolism is a known complication of cardiac surgery and interventional cardiology. Surgical or interventional procedures can cause particles to dislodge. These particles can enter the bloodstream, particularly causing an embolism in the brain. If a cerebral embolism occurs, it can lead to stroke or even death.

[0003] For example, embolism protection devices are known from the applicant's EP 2859864.

[0004] The object of the present invention is to provide an improved embolism protection device that prevents unwanted macroscopic particles from the blood flow from entering one or more branch vessels of the main vessel in a simple manner.

[0005] The solution of the invention is achieved through the features of the independent claims. The dependent claims provide further advantageous developments of the invention.

[0006] According to a first aspect of the invention, an embolism protection device for insertion into the aortic arch is provided, the embolism protection device comprising a filter unit, a frame, and a feed unit, wherein the filter unit is disposed at the frame. The frame provides a proximal region comprising a proximal shape disposed in an internal region of the frame and connected to the feed unit, wherein the proximal shape comprises a first portion and a second portion, wherein the second portion is formed at one end of the first portion. The internal region of the frame includes a plane unfolded by the frame and a region below or above the plane.

[0007] The embolism protection device of the present invention advantageously provides an apparatus characterized by a spring mechanism formed by the connection of the proximal body and the feed unit, which provides that the embolism protection device is pressed against the vessel wall of the aorta in substantially the distal region along the direction of the head vessel. Using this embolism protection device substantially deflects unwanted macroscopic particles.

[0008] By retracting the feed unit, the proximal region is positioned anterior to the orifice of the left subclavian artery. This achieves a stable position within the aortic arch. In an alternative positioning scheme, the embolization protection device can also be inserted via the right subclavian artery. In this case, by retracting the feed unit, the proximal region is positioned anterior to the orifice of the brachiocephalic artery.

[0009] The spring mechanism is particularly formed by the geometry of the proximal end shape. Preferably, a first portion of the proximal end shape is arranged below the plane of the frame, particularly in the inner region of the frame. The first portion is advantageously arched. A second portion of the proximal end shape is preferably arranged above the frame, particularly in the inner region of the frame. The second portion is advantageously straight. Preferably, the first and second portions form an angle with each other and / or with the plane of the frame. In other words, at least the first and / or the second portion can be arranged above or below the plane of the frame, wherein the angle between the first portion and the plane of the frame is different from the angle between the second portion and the plane of the frame, such that the first and second portions form an angle.

[0010] Using this feed unit, the proximal shape can be under tension, causing the spring effect to be transmitted through the proximal shape to the entire frame of the embolization protection device. Due to this tension transmission, the distal region of the frame is particularly folded up.

[0011] The frame of the embolization protection device extends in a two-dimensional plane and transforms into a proximal shape in the proximal region, which advantageously protrudes downwards or upwards from the plane. The proximal shape, arranged within the frame and connected to the feed unit, forms the spring mechanism, ensuring that the frame with the filter unit can be secured to one or more blood vessels, thereby protecting or covering them. A radial force is applied when the filter unit is deployed. The positioning of the embolization protection device is performed by the spring mechanism and the feed unit. Furthermore, tactile feedback is provided when the embolization protection device is positioned, or resistance is felt when the feed unit is retracted, thereby allowing for corresponding checks of the correct position of the embolization protection device. In particular, the cephalic blood vessels to which the embolization protection device is introduced are also covered and protected.

[0012] Due to the geometry of the frame, particularly the proximal and / or distal shape, the embolization protection device can flexibly adapt to the anatomical conditions in the aortic arch regardless of the access path and provides complete coverage of all head vessels.

[0013] Advantageously, the first and second portions of the proximal shape are arranged in the internal region of the frame. Specifically, the connection point between the proximal shape and the feed unit is located in the internal region of the frame, thereby ensuring coverage of the incoming blood vessel. In other words, the proximal region of the frame or the proximal region of the filter unit covers the opening of the incoming blood vessel and extends far beyond it. Simultaneously, the proximal region of the frame or the proximal region of the filter unit contacts the aortic wall. Therefore, particularly when the embolization protection device is placed in the aortic arch, this ensures coverage of the incoming blood vessel.

[0014] The embolization protection device of the present invention, particularly the frame and the filter unit disposed on the frame, can be completely folded and unfolded. In the folded state, the embolization protection device is preferably sized such that its diameter is substantially 1.4 mm to 2.2 mm, particularly 1.7 mm to 1.8 mm. The embolization protection device has three states: an unfolded state, in which the embolization protection device is in its basic form (basic state); a folded state, for example, in a catheter (folded state); and an unfolded state (placement state), when the embolization protection device is intended, for example, in the final position in the aortic arch. The final position in the aortic arch is also referred to hereinafter as the placement position.

[0015] The geometry of the three states is different. During transport and implantation preparation, the embolization protection device is in its basic state, as shown in the figure. This basic state is transformed into a folded state due to mechanical shaping. The reversibly deformable material of the frame (e.g., hyperelastic nitinol wire) can be shaped so that the embolization protection device can be pushed into the catheter. In doing so, the embolization protection device extends along its direction, where it becomes a straight or elongated shape by folding the distal and proximal shapes into the outer region of the frame. The resulting length variation depends on the reduction in width. In this case, the folded frame (i.e., the two sides of the frame outside the distal and / or proximal shapes) is positioned from the ends of the frame to the ends, i.e., from the distal to the proximal shapes, parallel to each other in the catheter. Specially attached filter units are able to follow this mechanical deformation and are located in the intermediate space between the catheter and the wire. The frame made of nitinol provides a so-called shape memory effect.

[0016] In its placement within the aortic arch, the geometry of the embolization protection device's frame flexibly adapts to the aortic wall and is positioned in a slightly arched shape following the aortic curve anterior to the head vessel's outflow outlet. Upon catheter removal, both the distal and proximal portions fold back to their original shapes, allowing for non-invasive positioning of the frame within the aortic wall. The specific shapes of the folded distal and proximal portions avoid transitions or corners with sharp edges. Radial forces generated by the frame's shape memory effect cross the filter surface. Additional frame stability is achieved through physiological conditions within the aorta due to the surface resistance of the filter and the resulting pressure from blood flow into the frame's placement.

[0017] The preferred material for the frame is nitinol. The frame can be a wire or a hollow wire with platinum / platinum-iridium / tantalum wire placed within its hollow space, almost filling the hollow space. Alternatively, the frame can be made of, for example, DFT wire from Fort Wayne Metals, or it can be a wire with a firmly attached platinum / tantalum core. These examples of materials used for the frame have the advantage of the frame being non-transparent.

[0018] The filtration unit includes a filter material that is selectively permeable, preventing unwanted macroscopic particles, such as those from the bloodstream, from entering one or more branch vessels of the main blood vessel (e.g., the aortic arch). For example, the filter material includes various materials, such as plastics or metals (e.g., nitinol). Depending on the material used, the filter material can be woven, cast, laser-cut, or stamped. Preferably, the filter material is a woven membrane made of polyamide. The filter material preferably has a pore size of 40 μm to 150 μm and an open porosity of 35% to 60%, thereby ensuring good protection against unwanted particles while maintaining good porosity for blood. The filter material can have a square or rectangular open surface. The thickness of the filter material is preferably 20 μm to 120 μm.

[0019] The feed unit is made of a tube of wound stainless steel wire, but other materials can also be selected. The feed unit is kink-resistant and is used to transmit torque and force when positioning the plug protection device. Advantageously, the feed unit is 120cm to 250cm in length, 1.5mm in diameter, and has an external plastic coating (pebax coating, polyethylene (PE), polytetrafluoroethylene (PTFE), polyamide (PA)).

[0020] The length of the embolism protection device is advantageously 50 mm to 100 mm. The width of the embolism protection device is advantageously 15 mm to 45 mm.

[0021] In a further development, the embolization protection device provides a first portion of the proximal shape forming a first angle with the plane of the frame, and a second portion forming a second angle with the first portion of the proximal shape. Advantageously, the first and second portions of the proximal shape are coaxially aligned at the connection point between the first and second portions, and a spring mechanism is formed by changing the angle via a feed unit, allowing the embolization protection device to be fixed in place within the aortic arch. Measured from the first portion to the plane, the first portion of the proximal shape forms an angle of approximately 25 to 50 degrees, preferably 30 degrees, downwards with respect to the two-dimensional plane of the frame. The first portion is straight or curved and preferably has a length of 0.5 cm to 2.5 cm. The second portion is preferably straight and formed at the end of the first portion. The second portion and the first portion surround a second angle of preferably 80 to 115 degrees, measured from the second portion to the first portion. If the second angle with respect to the two-dimensional plane of the frame is measured, the angle measured from the second portion to the plane is substantially 110 to 145 degrees. Preferably, the second portion is substantially 1 cm to 5 cm long. This geometry of the proximal form ensures that the geometry of the proximal form in its positioning state is adapted to the anatomical structure.

[0022] Another advantageous further development provides that the proximal shape comprises two ends of the frame, which extend parallel to each other in the internal region of the frame. This makes the frame more stable in both the longitudinal and transverse directions. In a further development of the embolism protection device, these two ends are glued and attached to the feed unit by adhesive. Therefore, the ends of the wire cannot be freely accessed. Further developments are also possible, in which the proximal shape comprises only one end of the frame, with the second end of the frame attached to, for example, the feed device.

[0023] In a further advantageous development, a frame is provided having a distal region comprising a distal form disposed within an internal region of the frame. Advantageously, the tip of the distal form is coated with a non-invasive material (e.g., a membrane material, polymer, rubber, or resin adhesive) to provide non-invasive protection. Advantageously, the material can be formed into a teardrop-shaped nose.

[0024] In another advantageous further development, the distal form is characterized by providing a constriction portion facing inwards towards the frame. This constriction portion serves as the connection point for the filter unit. This constriction portion also aids in positioning within the aorta because it has a radiopaque marker and can advantageously serve as a device for indicating frame alignment within the catheter. Furthermore, the distal form, arranged in the inner region of the frame, is advantageously used to aid in positioning when the embolization protection device is pushed into the catheter via the shaping device. In this process, the distal form can hook onto or within the shaping device and fold in the opposite direction to its original orientation. In other words, the distal form can fold outwards, i.e., fold into a region outside the inner region of the frame. The advantage of this is that, for example, the frame can be arranged within the catheter to save space when pushed through. By folding the distal form, torque is transmitted to the frame, causing the distal form to fold back into the inner region of the frame when the embolization protection device is deployed in the aortic arch.

[0025] Advantageously, the joint between the frame and the filter unit is an adhesive channel connection. The adhesive channel connection is formed as an encapsulated polymer shape surrounding the frame. In other words, the adhesive encapsulates the frame into a tube or cylinder shape. The polymer shape forms a so-called adhesive channel in which the frame is arranged and is movable relative to the adhesive channel. Advantageously, the joint between the adhesive channel and the filter unit can also be mechanically stable. By separating the filter unit from the frame, flexibility is created in the distal and proximal regions, which enables or at least facilitates folding in these regions when folding or unfolding the embolization protection device.

[0026] In another advantageous further development, the filter unit is provided to be externally connected to the frame in the proximal and / or distal regions. This connection is mechanically stable, i.e., there is no relative movement between the adhesive and the frame. Advantageously, the connection is formed as a flexible joint. For example, the joint can be an adhesive joint, a form-fit joint, a welded joint, or a stitched joint. The adhesive channel also enables, or particularly, a stable and flexible connection during the folding or unfolding of the embolism protection device.

[0027] In a further advantageous development, the filter unit in the distal region is essentially connected to the frame up to the contraction section. This prevents the filter unit from unintentionally folding downwards under the frame. This connection can be formed up to the starting point of the contraction section.

[0028] In another advantageous further development, the filter unit in the proximal region is connected to the frame, essentially extending to the first part of the proximal shape. This connection can be formed to the starting point of the first part.

[0029] In another advantageous further development, the filter units in the distal and proximal regions are flexibly connected to the frame. This allows for relative movement between the frame and the filter units. This ensures that the proximal and distal regions of the frame are movably connected to the filter units. Conversely, the remaining regions of the frame are immovably connected to the filter units.

[0030] Advantageously, the connection is an adhesive channel connection, which is formed into an encapsulated polymer shape surrounding the frame. For an adhesive channel connection, the frame is immersed in the adhesive. During adhesive drying, the adhesive moves and forms a polymer shape (such as a tube) on the filter unit. For example, when the frame or filter unit is folded or unfolded, geometric changes to the embolism protection device, particularly the frame, can be easily made, thus avoiding delays or, in the most extreme cases, damage to the embolism protection device.

[0031] Preferably, the frame is connected to the filter unit by applying prestress. For example, a slightly pressed frame can be connected to the filter unit to maintain the applied prestress. The connection between the filter material and the frame is preferably arranged such that the frame applies prestress to the filter unit in both the basic state and the positioned state.

[0032] Advantageously, the filter unit is glued to the frame from below. The result is a smooth surface for blood flow.

[0033] In a further advantageous development, the edges of the filter unit are sealed before being attached to the frame to prevent deformation during use and to achieve, as far as possible, non-invasive interaction with the aortic wall.

[0034] In another advantageous further development, a filter unit is provided that protrudes beyond the frame. Preferably, the filter unit protrudes beyond the proximal and / or distal regions. The protrusion of the filter unit on the frame outside the distal or proximal region is advantageously 0.5 mm to 2.0 mm wide, such that when the frame is positioned in the placement state within the aortic arch, a sealing lip is formed against the vessel wall. The sealing lip supports the non-invasive placement of the frame and the stability of its shape. Furthermore, the sealing lip, when in the placement state, closes against the aortic wall, thereby preventing leakage, for example, through valves, around the sides of the embolization protection device.

[0035] Advantageously, the protrusions are sealed, thus providing a smooth closure of the filter material. This also supports non-invasive placement of the frame.

[0036] In another advantageous further development, the filter unit is provided to fold from the underside to the topside of the frame in the proximal and / or distal regions. Thus, the filter unit protrudes into the outer region of the frame. Due to the folding or flipping / folding of the filter unit in the proximal and / or distal regions of the frame, the attachment of the filter unit to the frame is improved, ensuring complete coverage of all head vessels when the embolization protection device is positioned in the aortic arch. The filter unit, as a double layer in the proximal and / or distal regions, thereby improving the efficiency of the filter.

[0037] In another advantageous further development, the filter unit is fixed to the distal or proximal shape by threads, yarns, or filaments in the distal and / or proximal regions. Additionally, this connection can be sealed to achieve a stable shape. Furthermore, due to the seal, the connection in this region is non-invasive.

[0038] In a further advantageous development, the filter unit is fixed to the distal form by gluing. This gluing can be achieved using a resin adhesive. Due to the gluing, the frame has a non-invasive tip in the distal region, thus protecting the aortic wall from damage should the distal region come into contact with, for example, the aortic wall.

[0039] Advantageously, the filter unit is attached to the proximal region by a coil. The coil is made of stainless steel wire, which is preferably wound in a spiral shape around the end of the frame. The coil serves to stabilize the connection between the filter unit and the feed unit. Additionally, the coil shape supports shape changes during the folding and unfolding of the embolism protection device.

[0040] To further improve the embolism protection device, a favorable further development provides a filter unit made of fibrous material, wherein the fibers are aligned such that they form an angle of approximately 45 degrees with the longitudinal axis of the frame. The fibrous material consists of a woven membrane, ensuring increased flexibility in both the longitudinal and transverse directions of the frame. The longitudinal direction of the frame extends from the proximal region to the distal region and is preferably the centerline of the frame. Preferably, the inclination direction of the fibers forms an angle of 45 ± 10 degrees with the longitudinal axis of the frame.

[0041] In another advantageous further development, a proximal end form is provided for connection to the feed unit, wherein the two ends of the frame are wound with wire, the ends of which are arranged parallel to the ends of the frame. The connection between the proximal end form of the frame and the feed unit is preferably accomplished by adhesive bonding. The ends of the frame are inserted into an open lumen of the feed unit, where these ends are glued together. The wire that winds and thus secures the ends of the frame is preferably stainless steel wire and serves to provide additional stability to the ends of the frame. The ends of the wound stainless steel wire are parallel to the ends of the frame wire and are preferably glued together within the feed unit. The transition from the frame wire to the feed unit and the wound stainless steel wire are preferably flexibly sealed, for example, with a polymer mixture to provide a smooth surface and a uniform transition.

[0042] Preferably, the frame of the embolization protection device has a basic elliptical shape. The ellipse matches the original shape of the aortic arch dome, thus reliably covering all three head vessels. At this point, the upper region of the aortic arch resembles, for example, the interior of an inverted elliptical bowl. Therefore, a shape fit is achieved by inserting the elliptical shape. Preferably, the ellipse tapers proximally. In other words, the cross-section of the aorta at the point where the embolization protection device is placed is elliptical, allowing the elliptical shape of the frame to advantageously adapt to the physiological shape at that point.

[0043] According to a second aspect of the invention, a forming apparatus is provided for shaping the embolism protection device of the invention. The embolism protection device has all or at least some of the features described herein, which will not be repeated here. Shaping is performed to feed the embolism protection device into a catheter, wherein the frame of the embolism protection device, on which a filter unit is arranged, changes from an expanded state to an elongated state. The forming apparatus has two sub-sections that meet at their narrowest cross-section. Each sub-section is preferably funnel-shaped. The distal end portion is preferably formed as a flat or circular funnel and serves as the inlet of the embolism protection device of the invention. The proximal end portion is preferably formed as a circular funnel and is used to receive a substantially circular tube (e.g., a commercially available inlet sheath or a commercially available catheter). The forming apparatus is a tool having a geometry that allows the embolism protection device, particularly its frame, to change its shape such that its diameter in the folded state is preferably substantially 1.4 mm to 2.0 mm, particularly 1.7 mm to 1.8 mm. The forming apparatus ensures that the embolism protection device can be easily inserted into a substantially circular tube (e.g., a commercially available inlet sheath or a commercially available catheter).

[0044] In further development, the preferred flat or circular opening of the forming device is shaped such that the proximal and / or distal portions of the frame of the embolization protection device can be folded outwards. Furthermore, this ensures that the embolization protection device is correctly and undamagedly introduced into, for example, a catheter. In other words, the proximal and / or distal portions extending toward the interior of the frame in the basic state of the embolization protection device are folded in the opposite direction, i.e., outwards, through the flat or circular opening.

[0045] According to a third aspect of the invention, a method is provided for folding the embolism protection device of the invention using a forming device. The embolism protection device has all or at least some of the described features, which will not be repeated here. The method includes the following steps:

[0046] The frame of the embolization protection device is moved to the front of the flat or circular opening of the forming device, wherein the feed unit is guided through the forming device; the proximal shape is introduced or retracted into the forming device, wherein the proximal shape is folded outward; the distal shape is hooked onto the outer edge of the distal terminal portion of the forming device, wherein, by further insertion, the distal shape is folded outward and inserted into the forming device.

[0047] In a further development of the method, it is advantageously provided that, by inserting the frame into the forming device, the frame is pushed together and extends longitudinally. Due to the tapered shape of the distal end portion of the forming device, the frame is pushed together from both sides such that when the frame leaves and enters the narrowest section of the forming device, the frame has a longitudinally elongated shape.

[0048] In a further development of the method, it is advantageously provided that an embolization protection device is pushed out of the aforementioned tube and into a catheter pre-placed in the aortic arch, the tube comprising the folded embolization protection device and which may be, for example, a commercially available inlet sheath. A hemostatic valve on the proximal end of the catheter is used here to receive and secure the tube while minimizing blood loss upon placement. By pushing the feed unit forward, the embolization protection device is now pushed out of the tube into the catheter. Once the frame is fully in the catheter, the tube can be removed and retracted through the feed unit. The embolization protection device can then be pushed forward through the feed unit and into the aortic arch through the distal end of the catheter.

[0049] In another further development of the method, it is advantageous to push the embolization protection device out of the aforementioned tube and into a sheath pre-placed in the aortic arch, the tube being, for example, a commercially available catheter. By pushing the tube through the sheath, the embolization protection device in the tube can be pushed to the distal end of the sheath in the aortic arch.

[0050] In all further developments of the embolism protection device of the present invention, a folded proximal shape is provided to transfer prestress to the frame, which is substantially equal to the tension that causes the bent proximal shape to straighten.

[0051] Furthermore, a method for deploying an embolization protection device from a catheter containing the embolization protection device is provided. The invention also includes a method for folding the embolization protection device, which allows the device to be received in a longitudinal, cylindrical, or similar catheter-like device. When deploying the embolization protection device outside the catheter, the device is first pushed out until the distal region of the frame is away from the catheter. By further pushing the embolization protection device out of the catheter, the distal shape is pushed out and folds back into the inner region of the frame. Due to the folding of the distal shape, the distal region of the frame returns to its prestressed state before the folding of the embolization protection device. The folding of the distal shape facilitates orientation and allows the frame of the embolization protection device to be reshaped, enabling insertion into virtually any catheter. Furthermore, the folding of the distal shape is non-invasive.

[0052] In its proximal region, the feed unit may have two markings, where the first marking indicates that the distal body is directly in front of the catheter's outlet opening as the embolization protection device is later placed via the guide catheter, while the second marking indicates that the frame has completely left the catheter.

[0053] In a further advantageous development, the orientation of the frame is indicated by one or more markings. These markings may be radiopaque. In particular, the markings may be placed in the distal region of the frame. The distal region indicates the orientation of the frame as it is ejected from the conduit. The advantage of this is that it allows for precise determination of the frame's position, feed direction, and placement.

[0054] Further details of the invention can be derived from the following examples of embodiments described with reference to the figures. Furthermore, the details described herein are not limited to the provided examples of embodiments, but may be represented individually, selectively together, or in their entirety in other examples of embodiments.

[0055] As shown in the following figure:

[0056] Figure 1 The embolism protection device according to the present invention;

[0057] Figure 2 : Figure 1 A top view of the frame of the embolism protection device;

[0058] Figure 3 : Figure 2 The side view of the frame;

[0059] Figure 4 : Figure 2 A perspective view of the near-end region of the frame;

[0060] Figure 5A : A frame with a non-transparent marking configuration;

[0061] Figure 5B : A frame with another non-transparent marking configuration;

[0062] Figure 6 The connection between the proximal shape of the present invention and the insertion device;

[0063] Figure 7 Cross-sectional diagram of the adhesive channel, frame, filter unit, and seal;

[0064] Figure 8 Top view of the frame in which the filter units are arranged;

[0065] Figure 9 : Figure 8 The remote filter unit;

[0066] Figure 10 Top view of the near-end structure with filter units arranged;

[0067] Figure 11 : Figure 10 A perspective view of the proximal shape;

[0068] Figure 12 Top view of the far end of the structure where the filter units are arranged;

[0069] Figure 13 : Figure 12 A perspective view of the distal form;

[0070] Figure 14 : A view of the embolism protection device folded in the catheter;

[0071] Figures 15A to 15F The frame of the embolism protection device of the present invention is formed from a folded state to an unfolded state;

[0072] Figure 16 : A schematic diagram of the deployed state of the embolism protection device after it leaves the catheter;

[0073] Figure 17 The sequence of deploying the embolization protection device after the catheter is removed from the aortic arch;

[0074] Figure 18 :exist Figure 17 As shown, after exiting the catheter, the outlet of the head vessel in the aorta is covered by the embolization protection device;

[0075] Figure 19 : A molding apparatus for forming the embolism protection device of the present invention;

[0076] Figure 20 : Figure 19 A perspective view of the molding apparatus;

[0077] Figure 21 : A method for folding the embolism protection device of the present invention using a forming device.

[0078] Figure 1 An embolism protection device 1 according to the present invention is shown. The embolism protection device 1 includes a frame 5 to which a filter unit 3 is arranged. The frame 5 is connected to a feed unit 7. Advantageously, the length of the frame 5 is 50 mm to 100 mm. Advantageously, the width of the frame 5 is 15 mm to 45 mm. In this embodiment example, the frame 5 is constructed from a single continuously bent wire. However, the aforementioned features and advantages of the embolism protection device also apply to other embodiment examples.

[0079] Frame 5 has two-dimensional and three-dimensional regions. The two-dimensional region (i.e., the plane where the frame unfolds) is elliptical, transforming into distal shape 4 and proximal shape 11 at distal region 2 and proximal region 9. Proximal shape 11 and distal shape 4 constitute the three-dimensional region of frame 5, while the remaining regions of frame 5 form the two-dimensional region, i.e., the elliptical shape. This shows the embolism protection device 1 in its basic state.

[0080] Figure 2 It shows Figure 1A top view of the frame 5 of the embolism protection device 1. The proximal region 9 of the frame 5 is the proximal region leading to the open ends (in this embodiment, the ends of the lines) 17, 19 of the frame 5. The proximal region 9, and therefore the proximal shape 11, is defined by the two loose ends 17, 19 of the frame 5 used, or by the lines used respectively. The proximal shape 11 has a first portion 13 and a second portion 15 formed by the parallel ends 17, 19 in this embodiment. In the distal region 2, the frame 5 becomes the distal shape 4. The distal shape 4 has a constricted portion 12 of the line about 1 cm to 3 cm long that enters the interior of the frame 5, or alternatively, that enters the interior of an elliptical two-dimensional region.

[0081] In this embodiment, the contraction section 12 is a loop with a head diameter of approximately 1 mm to 1.8 mm and additional lines laid parallel to itself. The loop and the lines laid parallel to itself are located in the same two-dimensional plane of the frame 5.

[0082] Figure 3 It shows Figure 2 A side view of frame 5. The proximal form 11 extends into the ends 17 and 19 of the frame, and the frame enters the interior of frame 5 parallel to each other at the distal form 4. In this case, the first portion 13 of the proximal form preferably forms a first angle W1 downwards of 25 to 50 degrees relative to the two-dimensional plane of frame 5, wherein this angle is measured from the first portion 13 to the plane of the frame. Preferably, after the first portion 13, which is 0.5 cm to 2.5 cm in length, a second portion 15 is arranged at the end of the first portion 13 at a second angle W2 upwards of 110 to 145 degrees from the two-dimensional plane of frame 5, wherein this angle is measured from the second portion 15 to the plane of the frame. The length of the second portion 15 is 1 cm to 5 cm. The lengths of the first portion 13 and the second portion 15, and the angles they form with the plane of frame 5, can be selected to be larger or smaller depending on the requirements of the embolism protection device.

[0083] The first part 13 and the second part 15 form a proximal shape 11 arranged in the inner region of the frame 5, wherein the proximal shape 11 extends above and below the plane of the frame 5. Due to this geometry of the proximal shape 11, the frame 5 is pre-tensioned and stabilized simultaneously in the longitudinal and transverse directions.

[0084] The first part 13 can extend into the plane of the frame 5, i.e., the angle W1 is equal to 0 degrees, and only the second part 15 is tilted relative to the plane of the frame 5 by a second angle W2.

[0085] The distal shape 4, including the contraction section 12, is located in the two-dimensional plane of the frame 5.

[0086] Figure 4 It shows Figure 2A perspective view of the near-end region 9 of the frame.

[0087] The proximal form 11 includes: a first portion 13, which is bent at a first angle W1 relative to the plane of the frame 5; a second portion 15, which is bent at a second angle W2 relative to the plane of the frame 5; and two ends 17 and 19 of the frame 5. Both the first portion 13 and the second portion 15 of the proximal form 11 have two frame lines.

[0088] Figure 5A and Figure 5B A frame 5 with radiopaque markings 20 is shown. The radiopaque markings 20 are applied to prominent locations on the frame 5 to achieve radiopaque visibility. For example, the radiopaque markings 20 are applied in the region of the constriction 12 and on the distal region 2 of the frame, allowing for precise determination of the exact location of the ends of the frame 5. Furthermore, the radiopaque markings 20 are applied outside the distal region 2 or proximal region 9 of the frame 5. The distance between the markings 20 can be used to determine whether the embolization protection device 1 is in a folded or unfolded state. Moreover, the precise location of the embolization protection device 1 within the aortic arch can be determined using the radiopaque markings 20.

[0089] The radiopaque markings can be sleeves made of platinum / iridium, which are placed on or applied to the frame. The sleeves have an inner diameter at least larger than that of the frame 5, a wall thickness of about 50 μm to 100 μm, and are attached by adhesive.

[0090] exist Figure 5A and Figure 5B The image shows only some possible locations for locating the radiopaque markers. Furthermore, depending on the desired outcome, there are various possibilities for applying the radiopaque markers 20.

[0091] Figure 6 The connection between the proximal body 11 of the present invention and the feeding device 7 of the present invention is shown in the figure, wherein, in this figure, the ends 17 and 19 of the proximal body 11 of the frame 5 are shown. At the same time, the ends 17 and 19 are also the ends of the second part 15 of the proximal body 11.

[0092] The feed unit 7 in this embodiment example includes a stainless steel coil, and the sleeve is sealed. In this embodiment example, the outer diameter of the feed unit 7 is 1.5 mm, and the diameter of its opening cavity is 0.8 mm. The total length of the feed unit 7 is 150 cm. Other dimensions of the feed unit 7 are possible.

[0093] The proximal end 11 of frame 5 is connected to feed unit 7 via adhesive unit 8 (e.g., polyurethane adhesive). The wire ends 17, 19 of proximal end 11 are pushed into the inner cavity of feed unit 7 and glued. For clarity, adhesive unit 8 is shown in shaded line in the figure.

[0094] For added stability, the wire ends 17, 19 (i.e., the second portion 15 of the proximal shape 11) are secured by wound stainless steel wire 6. In this case, the wire ends 10 of the wound stainless steel wire 6 are parallel to the ends 17, 19 of the frame 5 and are glued into the feed unit 7. The transition from the proximal shape 11 to the feed unit 7 and the wound stainless steel wire 6 are also coated with polyurethane to ensure a smooth surface and a uniform transition.

[0095] Figure 7 An enlarged view of the connection between the frame 5 and the filter unit 3 is shown in cross-section. This connection is implemented as an encapsulating polymer form surrounding the frame 5. The polymer form forms an adhesive channel 41, in which the frame 5 is arranged on the filter unit 3. A sealing portion 42 is shown at the outer edge of the filter unit 3 in this figure.

[0096] Figure 8 A top view of a frame 5 is shown, on which a filter unit 3 is arranged. Advantageously, the length of the frame 5 is 50 mm to 100 mm. Advantageously, the width of the frame 5 is 15 mm to 45 mm. In this embodiment, the filter unit 3 is fixed to the frame 5 by an adhesive or by a polyurethane-based adhesive. The adhesive extends continuously over the outer portion of the frame 5. In its basic state, portions of the proximal and distal regions of the frame 5, which are folded inward, are not adhesively attached to the filter unit 3. The filter unit 3 is adhesively attached to the frame 5 from below such that when the frame 5 is positioned in its placement within the aortic arch, the surface of the filter unit 3 is directly facing the central blood flow.

[0097] In this example embodiment, the frame 5, made of nitinol, is prestressed to the filter unit 3 to achieve better tensile strength on the frame 5. In doing so, the width of the frame 5 is reduced from 35mm to 45mm to 25mm to 35mm.

[0098] The filter unit 3 protrudes above the upper side of the frame 5 through a protrusion 14 of approximately 1 mm, and is flipped or folded from the lower side to the upper side in the distal region 2 and proximal region 9 of the frame 5. When the embolization protection device 1 is in the placement position in the aortic arch, the protrusion 14 of the attached filter unit 3 above the outer edge of the frame 5 has the additional function of a flexible sealing lip abutting against the aortic wall.

[0099] The folding area of ​​filter unit 3 includes proximal filter unit 21 and distal filter unit 22. Proximal filter unit 21 and distal filter unit 22 are not glued to the frame, which facilitates the desired deformation whenever the frame is pushed through the conduit. Proximal filter unit 21, together with the second part 15 of proximal form 11, is secured under the wound stainless steel wire 6 and sealed in this area, as well as... Figure 7 As shown.

[0100] The distal filter unit 22 is fixed to the constricted portion 12 of the distal body 4. The distal filter unit 22 extends further into the frame 5 by about 2 mm to 5 mm on the constricted portion 12 and is also flexibly sealed.

[0101] The fibers of filter unit 3 are aligned such that they are aligned at a 45° angle to the centerline of frame 5 from start to end. This allows filter unit 3 to extend better in the longitudinal direction while providing stability in the lateral direction. The outer edges of protrusions 14, 21, and 22 are also sealed.

[0102] Figure 9 It shows Figure 8 The end region of the distal filter unit 22 of the filter unit 3. The distal filter unit 22 is cut such that it not only extends about 2 mm above the constriction portion 12, but also becomes wider than the constriction portion 12 and takes the shape of a flag 23.

[0103] The flag 23 is curled inward. In doing so, the end of the thread used for securing it is trapped inside the flag 23. Adhesive secures the distal filter unit 23 to prevent it from curling up. The diameter of the curled distal filter unit 22 is less than 1.6 mm. In addition to securing the distal filter unit 23, this creates an additional protective pad between the frame 5 and the aortic wall to prevent injury.

[0104] Figure 10 A top view of the proximal body 11 with the filter unit 3 arranged is shown. The proximal filter unit 21 is flipped to the upper side of the frame 5. In this embodiment example, both the first portion 13 and the second portion 15 of the proximal body 11 are wound with stainless steel wire 6 (the first portion 13 and the second portion 15 of the proximal body are not shown for better visibility of the stainless steel wire). The first portion 13 is bent at a first angle W1 relative to the plane of the frame 5, and the second portion 15 is bent at a second angle W2 relative to the plane of the frame 5.

[0105] Figure 11 It shows Figure 10 A perspective view of the proximal shape 11.

[0106] Figure 12A top view of the distal form 4, in which the filter unit 3, particularly the distal filter unit 22, is arranged, is shown. The distal filter unit 22 is secured by a thread 43 (which may be yarn or filament in other embodiments) at the contraction portion 12 of the distal form 4 and protrudes into the interior of the frame 5.

[0107] Figure 13 A top view of the proximal shape 11, in which the filter unit 3 is arranged, is shown. The flag 23 is rolled inwards, with threads used to secure the flag, as... Figure 9 As mentioned above, it will not be repeated here.

[0108] Figure 14 The embolization protection device 1 folded in catheter 25 is shown. The embolization protection device 1 is shown in its folded state. This is due to mechanical forming, for example in... Figures 1 to 13 The basic state of the embolization protection device shown is changed to a folded state. The reversibly deformable material of the frame 5 (e.g., superelastic nitinol wire) can deform such that the embolization protection device 1 can be pushed into the catheter 25. In doing so, the embolization protection device 1 extends longitudinally along its orientation. The distal shape 4 and the proximal shape 11 are folded into the outer region of the frame 5.

[0109] By folding the distal shape 4 and the proximal shape 11, the frame 5 transforms into a straight or elongated shape. The resulting change in length depends on the reduction in the width of the frame 5. The folded frame 5, i.e., the two sides of the frame outside the distal shape 4 and / or the proximal shape 11, are parallel to each other in this case within the catheter 25. The filter unit 3 can follow this mechanical deformation and is located in the intermediate space between the catheter 25 and the frame 5. In this elongated shape, the embolism protection device can be pushed into the catheter with an inner diameter of, for example, 1.7 mm.

[0110] Figures 15A to 15F The frame 5 of the embolism protection device 1 of the present invention is shown to be formed from a folded state to an unfolded state.

[0111] When the embolization protection device is positioned from catheter 25, for example, in the aortic arch, the embolization protection device 1, particularly the frame 5 with the filter unit 3, is pushed out of catheter 25. This is in Figures 15A to 15F As shown in the image.

[0112] The frame 5, formed of a reversibly deformable material, attempts to recover to, for example... Figure 1 The original basic state is shown. The filter unit 3 arranged on the frame 5 follows this shaping. By advancing the folded distal shape 4 located in the conduit 25, advancing about 1 cm to 2 cm when leaving the conduit 25, up to half of the shape folds back in the direction initially provided, as shown. Figure 15AIn doing so, the orientation of the distal shape 4 specifies the location of the embolization protection device 1 within the catheter 25. A radiopaque marking that can be applied to the distal shape 4 allows for the determination of its position. In this case, the pointing direction of the distal shape 4 specifies the upper side of the embolization protection device 1. The placement position, for example, in the aortic arch, can be adjusted by rotating the catheter 25.

[0113] Because the constriction portion 12 in the distal region of the embolization protection device 1 (i.e., the distal shape 4 just after leaving the catheter 25) is as Figures 15A to 15B This deployment minimizes the risk of potential damage to the vessel wall through further delivery of the embolization protection device 1. Additionally, the frame 5 is wrapped with a non-traumatic material protruding approximately 1 mm to 2 mm from the distal portion 4, thus preventing any possible injury.

[0114] As the implantation continues forward within the aortic arch, frame 5 expands further until it is fully expanded. This can be achieved, for example... Figures 15C to 15F I saw it there. Here, Figure 15D Showing the side view of Figure 15C The same unfolded state, in which Figure 15C The expanded state is shown from above. Now almost fully expanded, the distal shape 4, the expanded frame 5, and the expanded filter unit 3 are shown.

[0115] In the fully extended state, frame 5 is extended and filter unit 3 is stretched by frame 5. Figure 15E Showing from above and Figure 15F This shows the fully deployed frame or deployed embolism protection device 1 as viewed from the side. Figures 15C to 15E or Figures 15D to 15F The effect of the spring mechanism of the proximal shape 11 on the transformation is obvious.

[0116] Figure 16 The diagram schematically illustrates the deployed state of the embolism protection device 1 after exiting the conduit 25. Due to the special geometry of the proximal body 11 up to the transition to the feed unit 3, the degree of prestress generated on the frame 5 is the same as the degree to which the pre-bent proximal body 11 straightens. The figure illustrates two different conditions of the deployed state. In both figures, the filter unit is positioned identically. The positions of the first part 13 and the second part 15 connected to the feed unit (not shown) are shown in both the stress-free and stress-prone states. As a result, a spring function is provided, which will be explained in more detail below.

[0117] Once the embolization protection device 1 is correctly positioned, for example, in the aortic arch, the tension transmitted by the proximal shape 11 presses the distal shape 4 against the aortic wall, thereby providing stable restraint on blood flow. Figure 16This is schematically indicated by a short, thick arrow on the distal shape 4. The proximal shape 11 moves in the direction indicated by the thin, curved arrow. In the absence of resistance from the aortic wall, the frame 5 will follow the indicated folding direction—in Figure 16 The middle is a thin, curved arrow - for example Figures 15E to 15F As shown. Figure 16 As shown, the proximal portion 11 is shaped such that the first portion 13 lies above the plane of the frame at a first angle W1 of 25 to 50 degrees, measured from the plane to the first portion 13, and the second portion 15 lies above the plane of the frame at an angle W2 of 30 to 110 degrees, measured from the second portion 15 to the plane. The degrees given for the angles depend on the geometry of the aorta and are given only as examples.

[0118] Figure 17 The diagram illustrates the sequence of deployment of the embolization protection device 1 after it exits the catheter 25 in the aortic arch. In part (a) of the figure, the catheter 25 is shown being introduced through the left subclavian artery, with the distal portion 4 of the embolization protection device 1 at least partially folded back. Parts (b) to (d) of the figure show further forward feeding and deployment of the embolization protection device 1, with the proximal portion 11 also exiting the catheter in part (d). Part (e) of the figure shows the fully deployed embolization protection device 1 in its placement position. During this process, the proximal region 9 of the frame 5 protrudes over the orifice region of the left subclavian artery, thereby also achieving coverage of the embolization protection device 1 along the access path. Simultaneously, this protrusion provides tactile feedback when positioning the embolization protection device: by pulling the feed unit 7, a slight resistance can be felt once the protrusion of the embolization protection device 1 or the protrusion of the frame 5 is correctly positioned anterior to the orifice 27. The intended location is achieved via the left subclavian artery in the aortic arch, with the distal region 2 of frame 5 facing the heart valve.

[0119] As an alternative approach, the right subclavian artery can also be used. The sequence is similar. Figure 16 The order shown is reversed, but executed in a mirror manner. In this case, the distal region 2 of frame 5 points towards the descending aorta (descending aorta).

[0120] Figure 18 It shows that in such Figure 17 After exiting the catheter 25, the embolization protection device 1 covers the outlet 29 of the head vessels in the aorta. Due to the special geometry of the frame 5, the embolization protection device 1 can flexibly adapt to the anatomical conditions in the aortic arch, independent of the mode of entry, and provides complete coverage across all the head vessels 29.

[0121] In its placement within the aortic arch, the geometry of the frame 5 of the embolization protection device 1 flexibly adapts to the aortic wall and forms a slight arch following the aortic bend in front of the outlet of the head vessel. Figure 17 As shown in (e). Upon exiting catheter 25, both the distal shape 4 and the proximal shape 11 fold back towards their original shape, i.e., towards the inner region of frame 5, thus enabling non-invasive positioning of frame 5 on the aortic wall. The folding avoids sharp edges or corners at the transition. As blood flow also presses frame 5 of embolism protection device 1 into its placement position, additional stability of frame 5 is achieved through physiological conditions in the aorta.

[0122] Figure 19 Various views of the molding apparatus 31 used to form the embolism protection device 1 of the present invention are shown. To facilitate forming the embolism protection device from its unfolded state in its basic state to its stretched state, the embolism protection device is retracted into the distal terminal portion 33 of the molding apparatus 31. The distal terminal portion 33 of the molding apparatus 31 has a flattened funnel shape, with a flat opening 35 approximately 25 mm to 40 mm wide and an opening height of approximately 3 mm to 10 mm. Along the length of the distal terminal portion 33 of the molding apparatus 31, measured to be approximately 60 mm to 80 mm, the opening area gradually tapers to a narrow circular cross-section 39 with a diameter of approximately 1.7 mm. The proximal terminal portion 40 of the molding apparatus 31 expands from the narrow cross-section 39 to a circular opening 37, which has a diameter of approximately 1.8 mm to 5 mm over a length of 20 mm to 40 mm. Therefore, the total length of the molding apparatus 31 is 80 mm to 120 mm.

[0123] Figure 20 It shows Figure 19 A perspective view of the molding device 31.

[0124] Figure 21 The various steps of a method for folding the embolism protection device of the present invention via a forming device 31 are shown, wherein the folded embolism protection device 1 is pushed into a substantially circular tube 38, such as a commercially available inlet sheath or a commercially available catheter (with an inner diameter of 1.8 mm to 2.5 mm) 38. In step S1, the frame 5 of the embolism protection device 1 is moved in front of the flat opening 35 of the forming device 31 by the guidance of the feeding unit 7. During this process, the proximal end of the feeding unit 7 is guided through the distal end of the forming device 31. The substantially circular tube 38 pushes its distal end proximal to the feeding unit 7 until it is in front of the circular opening 37 of the forming device 31, where the feeding unit 7 protrudes from the tube 38.

[0125] In step S2, the tube 38 and the forming device 31 are connected together, for example, by a plug connection, in the widened or conical circular opening 37 of the forming device 31. The plug protection device 1 is straightened by pulling the feed unit 7.

[0126] By further pulling the feed unit 7, in step S3, the proximal shape 11 folds over the outer edge of the distal end portion 33 of the forming device 31, so that it stretches open when it is pulled past the forming device 31.

[0127] In step S4, the feed unit 7 is further pulled so that the distal shape 4 is pushed past the outer edge of the distal end portion 33 of the forming device 31, wherein the distal shape 4 hooks onto the edge and folds outward. This is also emphasized in the side view of the figure.

[0128] In step S5, the embolism protection device 1 is fully extended by retracting through the forming device 31. By further pulling the feed unit 7, the sides of the frame 5 are pushed inward until the entire elongated frame is drawn into the tube 38. The embolism protection device 1 remains in this tube 38. The forming device 31 can now be removed from the tube 38.

[0129] In summary, by the described method, the embolism protection device (1) of the present invention is maintained as intended for insertion into the aortic arch. The embolism protection device includes a filter unit (3), a frame (5), and a feed unit (7), wherein the filter unit (3) is arranged on the frame (5), and the frame (5) has a proximal region (9) including a proximal body (11) arranged in the inner region of the frame (5) and connected to the feed unit (7), wherein the proximal body (11) includes a first portion (13) and a second portion (15), wherein the second portion (15) is formed at one end of the first portion (13).

[0130] In a further development of the embolism protection device (1), the first part (13) of the proximal body (11) forms a first angle (W1) with the plane of the frame (5), and the second part (15) forms a second angle (W2) with the first part (13) of the proximal body (11).

[0131] According to the present invention, an embolism protection device (1) for insertion into the aortic arch is provided, the embolism protection device comprising a filter unit (3), a frame (5) and a feed unit (7), wherein the filter unit (3) is disposed on the frame (5) and the frame (5) has a proximal region (9) comprising a proximal body (11) disposed in the inner region of the frame (5) and connected to the feed unit (7), wherein the proximal body (11) comprises a first portion (13) and a second portion (15), wherein the first portion (13) and the second portion (15) are arranged together such that they form a spring mechanism.

[0132] In a further development of the embolism protection device (1), the proximal shape (11) can be set under tension by the feed unit (7).

[0133] In a further development of the embolism protection device (1), the proximal body (11) includes two ends (17, 19) of the frame (5), which extend parallel to each other in the internal region of the frame (5).

[0134] In a further development of the embolism protection device (1), the proximal body (11) is connected to the feed unit (7), wherein the two ends (17, 19) of the frame (5) are wound with wire (6), and the ends (10) of the wire are arranged parallel to the ends (17, 19) of the frame (5).

[0135] In a further development of the embolism protection device (1), the frame (5) has a distal region (2) which includes a distal shape (4) arranged in the internal region of the frame (5).

[0136] In a further development of the embolism protection device (1), the distal body (4) has a constriction (12) facing the inside of the frame (5).

[0137] In a further development of the embolism protection device (1), the connection between the frame (5) and the filter unit (3) is implemented through an adhesive channel or adhesive channel connection.

[0138] In a further development of the embolism protection device (1), the filter unit (3) is connected to the frame (5) outside the proximal and / or distal regions (9, 2).

[0139] In a further development of the embolism protection device (1), the filter unit (3) is substantially connected to the frame (5) in the distal region (2) up to the starting point of the distal shape (4).

[0140] In a further development of the embolism protection device (1), the filter unit (3) is substantially connected in the proximal region (2) to the frame (5) up to the first part (13) of the proximal shape (11).

[0141] In a further development of the embolism protection device (1), the filter unit (3) is flexibly connected to the frame (5) in the proximal and distal regions (2, 9).

[0142] In a further development of the embolism protection device (1), the frame (5) is connected to the filter unit (3) by prestress in the transverse direction.

[0143] In a further development of the embolism protection device (1), the filter unit (3) has a protrusion (14) on the frame (5).

[0144] In a further development of the embolism protection device (1), the protrusion (14) is sealed.

[0145] In a further development of the embolism protection device (1), the protrusion (14) is formed as a sealing lip.

[0146] In a further development of the embolism protection device (1), in the proximal and / or distal regions (9, 2) of the frame (5), the filter unit (3) is flipped from the lower side to the upper side on the frame (5).

[0147] In a further development of the embolism protection device (1), the filter unit (3) is fixed to the distal body (4) by a wire, filament or yarn.

[0148] In a further development of the embolism protection device (1), the filter unit (3) is sealed to the distal body (4) by means of a wire, filament or yarn.

[0149] In a further development of the embolism protection device (1), the filter unit (3) is fixed to the distal body (4) by gluing.

[0150] In a further development of the embolism protection device (1), the filter unit (3) is fixed in the proximal region (9) by a coil.

[0151] In a further development of the embolism protection device (1), the filter unit (3) has a fibrous material, wherein the fibers are aligned such that they form an angle of approximately 45 degrees with the longitudinal axis of the frame (5).

[0152] In the further development of the embolism protection device (1), the frame (5) has a basic state of being elliptical in shape.

[0153] According to the invention, a forming device (31) is specified for shaping an embolism protection device (1) for insertion into a tube, wherein the frame (5) on which the embolism protection device (1) is arranged with a filter unit (3) deforms from an expanded state to a stretched state, the forming device including a flat or circular opening (35) on one side, a narrowest cross section (39) and a circular opening (37) at the opposite end.

[0154] In a further development of the molding device, the flat or circular opening (35) of the molding device (31) is formed such that the proximal shape (11) and / or distal shape (4) of the frame (5) of the embolization protection device fold outward.

[0155] According to the present invention, a method for folding an embolism protection device by a forming device is specified, the method comprising pushing the frame (5) of the embolism protection device in front of the flat or circular opening (35) of the forming device (31) (S1), wherein a feeding unit (7) is fed through the forming device (31) to pull the proximal shape (11) into the forming device (31) (S3), wherein the proximal shape (11) is folded outward, the distal shape (4) is hooked on the outer edge of the forming device (31) (S4), and is pulled into the forming device (31) by further pulling the distal shape (4) outward.

[0156] In a further development of the method, the frame (5) is stretched longitudinally as it is pulled into the forming device (31).

[0157] In a further development of the method, the folded proximal shape (11) transfers prestress to the frame (5), which is substantially equal to the tension generated therefrom, and the curved proximal shape (11) straightens.

[0158] According to the present invention, a method is specified for deploying an embolization protection device when it leaves a catheter containing the embolization protection device, the method comprising:

[0159] Push the embolism protection device out of the catheter.

[0160] When the distal region (2) of the frame of the embolization protection device leaves the catheter, the distal shape (4) is folded back into the inner region of the frame (5).

[0161] Further developments of the method include indicating the orientation of the frame (5) by one or more markers as the distal region (2) exits the catheter, wherein the distal region (2) specifies the orientation of the frame (5).

[0162] A further development of the method involves a twisting in the filament of the frame (5) due to the pre-bending of the distal and proximal shapes, with the preferred orientation of the frame toward the bent end of the distal shape as it leaves the conduit.

Claims

1. An embolism protection device (1) for insertion into the aortic arch, the embolism protection device comprising: The filter unit (3), frame (5), and feed unit (7) are provided, wherein the filter unit (3) is disposed at the frame (5), and the frame (5) is composed of lines and has a proximal region (9) including a proximal shape (11) and a distal region (2) including a distal shape (4), wherein the frame (5) has an elliptical two-dimensional region, the proximal shape (11) is disposed in the inner region of the frame (5) and connected to the feed unit (7), wherein the proximal shape (11) includes a first part (13) and a second part (15), wherein the second part (15) is formed at one end of the first part (13), and wherein the first part (13) and the second part (15) form the proximal shape (11), wherein when the embolism protection device is in a basically deployed state or a deployed state, the proximal shape (11) extends above and below the plane of the frame (5), and the distal shape (4) demonstrates the contraction (12) of the line in the frame (5) in the elliptical two-dimensional region.

2. The embolism protection device (1) according to claim 1, characterized in that, The first part (13) of the proximal shape (11) forms a first angle (W1) with the plane of the frame (5), and the second part (15) forms a second angle (W2) with the first part (13) of the proximal shape (11).

3. An embolization protection device (1) for insertion into the aortic arch, the embolization protection device comprising: A filter unit (3), a frame (5), and a feed unit (7), wherein the filter unit (3) is arranged at the frame (5), and the frame (5) is composed of lines and has a proximal region (9) including a proximal shape (11) and a distal region (2) including a distal shape (4), wherein the frame (5) has an elliptical two-dimensional region, the proximal shape (11) is arranged in the inner region of the frame (5) and connected to the feed unit (7), wherein the proximal shape (11) includes a first part (13) and a second part (4). 15), wherein the second part (15) is formed at one end of the first part (13), and wherein the first part (13) and the second part (15) form the proximal shape (11), wherein the proximal shape (11) extends above and below the plane of the frame (5) when the embolization protection device is in a basically deployed state or a deployed state, and wherein the first and second parts (13, 15) are arranged to each other such that the first and second parts form a spring mechanism, and the distal shape (4) demonstrates the contraction (12) of the line in the frame (5) in the elliptical two-dimensional region.

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

5. The embolism protection device (1) according to any one of claims 1-3, characterized in that, The proximal shape (11) includes two ends (17, 19) of the frame (5), which extend parallel to each other in the inner region of the frame (5).

6. The embolism protection device (1) according to claim 1, characterized in that, The frame (5) has a distal region (2) including a distal shape (4) arranged in the internal region of the frame (5).

7. The embolism protection device (1) according to claim 3, characterized in that, The frame (5) has a distal region (2) including a distal shape (4) arranged in the internal region of the frame (5).

8. The embolism protection device (1) according to claim 6 or 7, characterized in that, The distal form (4) provides a constriction (12) facing inward toward the frame (5).

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

10. The embolism protection device (1) according to claim 3, characterized in that, The filter unit (3) is connected to the frame (5) outside the proximal and / or distal regions (9, 2).

Images