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EP-4201377-B1 - EMBOLISM PROTECTION DEVICE, METHOD FOR FOLDING SAME, AND MOLDING DEVICE

EP4201377B1EP 4201377 B1EP4201377 B1EP 4201377B1EP-4201377-B1

Inventors

  • JIMENÉZ DÍAZ, Victor Alfonso
  • PFENNIG, MICHAEL
  • Rasmus, Conrad
  • SCHUMACHER, OLIVER
  • von Mangoldt, Karl

Dates

Publication Date
20260513
Application Date
20170918

Claims (12)

  1. Embolism protection device (1) for delivery into an aortic arch, comprising a filter unit (3), a frame (5) and a supply unit (7), wherein the filter unit (3) is connected to the frame (5), and the frame (5) has a proximal region (9), which comprises a proximal mould (11), which is arranged in an inner region of the frame (5) and is connected to the supply unit (7), the proximal mould (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), characterised in that the connection of the frame (5) and the filter unit (3) is realised by means of an adhesive tunnel or an adhesive tunnel connection.
  2. Embolism protection device (1) according to claim 1, characterised in that the first part (13) of the proximal mould (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 mould (11).
  3. Embolism protection device (1) for delivery into an aortic arch, comprising a filter unit (3), a frame (5) and a supply unit (7), wherein the filter unit (3) is connected to the frame (5), and the frame (5) has a proximal region (9), which comprises a proximal mould (11), which is arranged in an inner region of the frame (5) and is connected to the supply unit (7), the proximal mould (11) comprising a first part (13) and a second part (15), the first and second parts (13, 15) being arranged with respect to one another in such a way that they form a spring mechanism, characterised in that the connection of the frame (5) and the filter unit (3) is realised by means of an adhesive tunnel or an adhesive tunnel connection.
  4. Embolism protection device (1) according to one of claims 1-3, characterised in that the proximal mould (11) can be energised via the supply unit (7).
  5. Embolism protection device (1) according to any of the preceding claims, characterised in that the proximal mould (11) comprises two ends (17, 19) of the frame (5), which extend parallel to one another in the inner region of the frame (5).
  6. Embolism protection device (1) according to any of the preceding claims, characterised in that the frame (5) has a distal region (2), which comprises a distal mould (4), which is arranged in an inner region of the frame (5).
  7. Embolism protection device (1) according to claim 6, characterised in that the distal mould (4) has a constriction (12) directed towards the interior of the frame (5).
  8. Embolism protection device (1) according to any of the preceding claims, characterised in that the filter unit (3) is connected to the frame (5) outside the proximal region (9) and/or distal region (2) according to claim 6 and/or 7.
  9. System comprising an embolism protection device (1) according to any of the preceding claims and a moulding device (31) for forming the embolism protection device (1) for drawing into a hose (38), characterised in that a frame (5) with a filter unit (3) of the embolism protection device (1) arranged thereon is formed from an expanded state into a stretched state, comprising a flat or round opening (35) on one side, a narrowest cross-section (39) and an opposite round opening (37).
  10. System according to claim 9, wherein the flat or round opening (35) of the moulding device (31) is designed such that the proximal mould (11) and/or the distal mould (4) according to claim 6 and/or 7 of the frame (5) of the embolism protection device is folded outwards.
  11. Method for folding the embolism protection device according to one of claims 1-8 by means of the moulding device from the system according to one of claims 9-10, comprising pushing (S1) the frame (5) of the embolism protection device in front of the flat or round opening (35) of the moulding device (31), wherein the supply unit (7) is guided through the moulding device (31), drawing (S3) the proximal mould (11) into the moulding device (31), wherein the proximal mould (11) is folded outwards, hooking (S4) the distal mould (4) over the outer edge of the moulding device (31), wherein the distal mould (4) is folded outwards and drawn into the moulding device (31) by further pulling.
  12. Method according to claim 11, wherein the folded proximal mould (11) transfers a preload to the frame (5) that is substantially equal to the load resulting from straightening the bent proximal mould (11).

Description

The invention relates to an embolic protection device according to the preamble of claim 1, which prevents unwanted macroscopic particles from entering one or more branches of a main vessel, such as the aortic arch, from a bloodstream. The invention also relates to a forming device for shaping the embolic protection device according to the invention, as well as a method for folding and unfolding the embolic protection device according to the invention using the forming device. Cerebral embolism is a known complication in cardiac surgery and interventional cardiology. Particles can be dislodged during surgical or interventional procedures. They can enter the bloodstream and, particularly in the brain, trigger an embolism. In the case of a cerebral embolism, this can lead to a stroke or even be fatal. Emboliation protection devices are made, for example, of EP2859864 the applicant is known. Furthermore, it is disclosed WO 2015/177322 A1 an embolism protection device for delivery into an aortic arch. The object of the present invention is to provide an improved embolism protection device that prevents unwanted macroscopic particles from entering one or more vascular branches of a main vessel in a simple manner. The problem is solved according to the invention by the features of the independent claims. Advantageous embodiments of the invention are described in the dependent claims. A first aspect of the invention relates to an embolic protection device for delivery into an aortic arch, comprising a filter unit, a frame, and a delivery unit, wherein the filter unit is arranged on the frame. The frame has a proximal region comprising a proximal shape, which is arranged in an interior region of the frame and is connected to the delivery unit, wherein the proximal shape comprises a first part and a second part, the second part being formed at one end of the first part. The interior region of the frame includes both the plane spanned by the frame and the region above or below this plane. The embolic protection device according to the invention advantageously provides a A device is described which is characterized by the fact that the connection between the proximal form and the delivery unit creates a spring mechanism that ensures the embolic protection device is pressed against the vessel wall in the aorta, essentially in the distal region, towards the head vessels. The embolic protection device essentially deflects unwanted macroscopic particles. The proximal portion is positioned anterior to the orifice of the left subclavian artery by retracting the delivery unit. This ensures a stable position within the aortic arch. Alternatively, the embolic protection device can also be inserted via the right subclavian artery. In this case, the proximal portion is positioned anterior to the orifice of the brachiocephalic trunk by retracting the delivery unit. The spring mechanism is primarily defined by the geometry of the proximal form. Preferably, the first part of the proximal form is arranged below the plane of the frame, particularly within the frame. The first part is advantageously arc-shaped. The second part of the proximal form is preferably arranged above the frame, particularly within the frame. The second part is advantageously straight. The first and second parts preferably 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 part can be arranged above or below the plane of the frame, with the angle between the first part and the plane of the frame being different from the angle between the second part and the plane of the frame, such that the first and second parts form an angle. The feed unit can put the proximal form under tension, so that the spring action is transferred via the proximal form to the entire frame of the embolic protection device. This tension transfer causes the distal part of the frame to fold upwards. The frame of the embolic protection device spans a two-dimensional plane and transitions in the proximal region into a proximal form that can advantageously project downwards or upwards from this plane. The proximal form, located inside the frame and connected to the delivery unit, creates the spring mechanism that ensures the frame with the filter unit can be fixed over one or more blood vessels in such a way that they are protected or covered. Radial forces act when the filter unit is deployed. The positioning of the embolic protection device is achieved by the spring mechanism and the delivery unit. Furthermore, a Haptic feedback is provided when positioning the embolic protection device, or resistance is felt when retracting the delivery device, thus allowing verification of the correct position of the embolic protection device. In particular, this also covers and protects the head vessel through which the embolic protection device is inserted. Due to the geometry of the frame, in particular the proximal shape and/or the