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    • 4. 发明公开
    • KIT FOR ENDOURETHRAL PROSTHESIS WITH VALVE
    • EP4431057A1
    • 2024-09-18
    • EP23211025.4
    • 2023-11-20
    • RELIEF S.R.L.
    • Ricotti, LeonardoMazzocchi, TommasoMarziale, LeonardoLucarini, Gioia
    • A61F2/00A61F2/04A61M27/00
    • A61F2002/04720130101A61F2/04A61F2/0022A61F2220/000820130101A61F2250/00620130101A61F2250/00720130101A61F2250/002920130101A61F2250/001820130101A61L31/145A61L31/08A61F2250/006420130101A61M27/008
    • A kit for an endo-urethral prosthesis includes a proximal part (2) and a distal part (4), comprising respective proximal and distal tubular portions (24,46) configured to be arranged within a patient's urethra (7), and respective proximal and distal stents (21,49) configured to anchor internally to a urethra-vesical lumen and urethra, respectively, the proximal and distal tubular portions (24,46) having predetermined radial stiffness, and having, on opposite sides to the proximal and distal stents (21,49), proximal and distal connection ends (29,31) configured to fluid-tightly connect to each other forming a longitudinal duct (5) arranged to convey urine. The distal or proximal tubular portion (46,24) is divided into a first distal or proximal tubular element (35,25) and a second distal or proximal tubular element (45,34) comprising the distal or proximal connection end (31,29), wherein the first distal or proximal tubular element (35,25) and the second distal (45) or proximal tubular element (45,34) have respective mutual fluid-tight connection ends (37,44), the second distal or proximal tubular element (45,25) forming an intermediate part (3), preferably axially flexible, of the prosthesis. In this way, prostheses suitable for the many anatomical variations can be obtained by choosing the length of a single, preferably intermediate, part. In advantageous embodiments, an endo-urethral prosthesis comprises within the proximal and/or distal tubular portion (24,46), at least one valve element (50,150,250) configured to elastically deform, when an opening differential pressure (P*) is exceeded, from a rest closed configuration to a forced open configuration, so that the valve element (50,150,250) can open with an increase in abdominal pressure. In particular, a stopper element (156,256) of an improved valve element (150,250) includes resilient walls (155,255) separated by through slits (157,257) converging from a peripheral portion of the stopper element to a same convergence point (158,258) shifted from the central point of the valve element (150,250) by a predetermined distance (δ) of preferably at least 0,02 mm.