Medical device; method for manufacturing a medical device

Abstract

A medical device (10) for treating vascular lesions, in particular aneurysms, comprising a compressible and expandable lattice structure (11) made of lattice elements (12) that delimit lattice openings (13), wherein the lattice structure (11) is covered at least in sections with a, in particular electrospun, membrane (14), wherein the membrane (14) has at least one sealing region (15) and at least one desired opening region (16) in at least one lattice opening (13), the desired opening region (16) of the membrane (14) opening in the implanted state by a pressure gradient that is established between a fluid pressure in an inner lumen of the lattice structure (11) and a fluid pressure outside the lattice structure (11), in order to increase the fluid flow through the membrane (14).

Claims

[1] Medical device (10) for the treatment of vascular lesions (100), in particular aneurysms, with a compressible and expandable lattice structure (11) made of lattice elements (12) which delimit lattice openings (13), wherein the lattice structure (11) is covered at least in sections with a, in particular electrospun, membrane (14), characterized by in that the membrane (14) has at least one sealing region (15) and at least one desired opening region (16) in at least one grid opening (13), which has a smaller wall thickness than the sealing region (15), wherein the desired opening region (16) of the membrane (14) opens in the implanted state by a pressure gradient which is established between a fluid pressure in an inner lumen of the grid structure (11) and a fluid pressure outside the grid structure (11), in order to increase the fluid flow through the membrane (14). [2] Medical device according to claim 1, characterized by in that the membrane (14) comprises a plurality of, in particular electrospun, layers (17) which are arranged one above the other in the radial direction of the lattice structure, wherein the sealing region (15) has a larger number of layers (17) than the desired opening region (16). [3] Medical device according to claim 1 or 2, characterized by that the layers (17) of the membrane (14) are formed from, in particular electrospun, fibers (18), wherein the fibers (18) of the desired opening region (16) tear due to the pressure gradient to increase the liquid flow through the membrane (14). [4] Medical device according to one of the preceding claims, characterized by that the sealing area (15) has a larger proportion of a total area of the membrane (14) per grid opening (13) than the desired opening area (16). [5] Medical device according to one of the preceding claims, characterized bythat the desired opening area (16) is designed as a recess in the sealing area (15) of the membrane (14), which partially penetrates the sealing area (15) in the radial direction of the lattice structure (11). [6] Medical device according to one of the preceding claims, characterized by that the membrane (14) has a plurality of desired opening regions (16) for each grid opening (13), which are arranged at a distance from one another and / or are each delimited by the sealing region (15). [7] Medical device according to one of the preceding claims, characterized by that the desired opening region (16) is substantially round and has a diameter between 10 µm and 300 µm, in particular at least 100 µm, in particular at least 200 µm. [8] Medical device according to one of the preceding claims, characterized bythat the desired opening area (16) is substantially linear and extends within the grid openings (13). [9] Medical device according to one of the preceding claims, characterized by that the wall thickness of the sealing region (15) is at least 20%, in particular at least 30%, in particular at least 40%, in particular at least 50%, in particular at least 60% greater than the wall thickness of the desired opening region (16). [10] Medical device according to one of the preceding claims, characterized by that the sealing region (15) has a wall thickness between 5 µm and 100 µm, in particular at least 10 µm, in particular at least 25 µm, in particular at least 50 µm, and / or the desired opening regions (16) have a wall thickness between 1 µm and 45 µm, in particular at most 25 µm, in particular at most 10 µm, in particular at most 5 µm, in particular at most 2 µm. [11] Medical device according to one of the preceding claims, characterized by that the desired opening region (16) has a depth between 1 µm and 40 µm, in particular at least 10 µm, in particular at least 20 µm, in particular at least 30 µm. [12] Medical device according to one of the preceding claims, characterized by that the sealing region (15) and the desired opening region (16) of the membrane (14) each have a plurality of pores (19), wherein the pore size of the pores (19) of the desired opening region (16) is larger than the pore size of the pores (19) of the sealing region (15). [13] A method for manufacturing a medical device (10) according to any one of the preceding claims, the method comprising the following steps: a. arranging a compressible and expandable lattice structure (11) comprising lattice elements (12) defining lattice openings (13) on a mandrel; b. electrospinning at least one layer around the lattice structure (11) to form a membrane (14); c. Partial perforation of the membrane (14) such that the membrane (14) has at least one sealing region (15) and a desired opening region (16) in at least one grid opening (13), wherein the wall thickness of the desired opening region (16) is smaller than the wall thickness of the sealing region (15).

Images