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EP-4197459-B1 - PERCUTANEOUS DEVICE FOR CLOSING A BLOOD VESSEL

EP4197459B1EP 4197459 B1EP4197459 B1EP 4197459B1EP-4197459-B1

Inventors

  • Bergamaschi, Gastone

Dates

Publication Date
20260513
Application Date
20221213

Claims (14)

  1. A percutaneous device (100) for closing a blood vessel, comprising: - an internally hollow main body (1) provided with a distal tip (11) having a distal opening (12); - a distal clip (2) and a proximal clip (3) slidingly accommodated inside the main body (1), said clips (2, 3) being in the form of a cylindrical and elongated rod, and being connected to each other by means of a tie rod (4); wherein the distal clip (2) is fastened to the tie rod (4) and the proximal clip (3) slides with respect to the tie rod (4); wherein the distal tip (11) of the main body (1) is not a perforation tip, and the distal clip (2) has a needle-shaped distal perforation end (26) that protrudes from the distal opening (12) of the main body (1) and that is configured to puncture the wall of the blood vessel and to pass through said vessel from one side to the other; and wherein the distal clip (2) is provided with a proximal housing (22), and the proximal clip (3) is provided with both a distal housing (32) and a proximal housing (33), - an abutment element (5) for the clips (2, 3), slidingly accommodated inside the main body (1), said abutment element (5) being provided with a longitudinal passageway for the tie rod (4); wherein the tie rod (4) is positioned inside the proximal housing (22) of the distal clip (2), the distal housing (32) of the proximal clip (3) and the proximal housing (33) of the proximal clip (3) when the clips (2, 3) are inserted into the main body (1) ; - a handle (7), connected to the main body (1), to maneuver the clips (2, 3), the abutment element (5), and the tie rod (4); characterized in that the proximal housing (22) of the distal clip (2), the distal housing (32) of the proximal clip (3) and the proximal housing (33) of the proximal clip (3) being a longitudinal groove formed on the outer surface of the clip.
  2. A percutaneous device (100) according to claim 1, wherein the distal tip (11) of the main body (1) has a distal face (113) inclined at an angle α of between 90° and 45°.
  3. A percutaneous device (100) according to claim 2, wherein said distal face (113) is inclined at an angle α of 90°.
  4. A percutaneous device (100) according to claim 1, wherein the proximal housing (22) of the distal clip (2), the distal housing (32) of the proximal clip (3) and the proximal housing (33) of the proximal clip (3) have a rectangular or square or triangular or U-shaped or C-shaped or crescent-shaped section.
  5. A percutaneous device (100) according to any one of the preceding claims, wherein the distal clip (2) is provided with a distal seat (21) in which the tie rod (4) is fastened, and said distal seat (21) transversally crosses the distal clip (2).
  6. A percutaneous device (100) according to claim 5, wherein the distal clip (2) comprises a path for the tie rod (4) which starts from the distal seat (21) and continues along the proximal housing (22) of the distal clip (2), and wherein said path occupies half the length of the distal clip (2).
  7. A percutaneous device (100) according to any one of the preceding claims, wherein the proximal clip (3) is provided with a proximal seat (31) in which the tie rod (4) is slidingly inserted, and said proximal seat (31) is a through hole which obliquely crosses the proximal clip (3).
  8. A percutaneous device (100) according to claim 7, wherein the proximal clip (3) comprises a path for the tie rod (4) which starts from the distal housing (32) of the proximal clip (3) , continues into the proximal seat (31) through the proximal clip (3) to exit from the opposite side and continue along the proximal housing (33) of the proximal clip (3), said path occupies the entire length of the proximal clip (3).
  9. A percutaneous device (100) according to any one of the preceding claims, wherein the clips (2, 3) and the tie rod (4) are made of a resorbable material.
  10. A percutaneous device (100) according to any one of the preceding claims, wherein the tie rod (4) has a circular and/or flattened section.
  11. A percutaneous device (100) according to any one of the preceding claims, wherein the tie rod (4) is provided, proximally with respect to the proximal clip (3), with a predetermined breaking point (44) and/or radial space.
  12. A percutaneous device (100) according to any one of the preceding claims, wherein the distal clip (2) is provided with an end (211) facing an end (311) of the proximal clip (3), and wherein said ends (211, 311) facing each other have inclined faces parallel to each other.
  13. A percutaneous device (100) according to claim 12, wherein, when the proximal clip (3) and the distal clip (2) are inserted into the main body (1), said mutually facing ends (211, 311) transversely overlap each other.
  14. A percutaneous device (100) according to any one of the preceding claims, wherein the tie rod (4) is provided with fastening tabs (421) present at least in an intermediate portion (42) defined between the distal clip (2) and the proximal clip (3) when inserted into the main body (1).

Description

The subject of the present invention is a device for interrupting the function of superficial venous collectors, using percutaneous access and ultrasonic guidance. Surgical treatment for superficial venous insufficiency of the lower limbs has seen dramatic development in recent decades. The widespread need for less invasive surgery, together with technological evolution, has resulted in the most traumatic procedures (such as the Linton operation) becoming completely obsolete and standard procedures (such as saphenous vein stripping) being greatly scaled back, and has resulted in low-invasive procedures being used, such as the ablation of superficial venous collectors by means of thermal techniques (laser; radiofrequency) or non-thermal techniques (sclerosis foam; mechanochemical ablation; cyanoacrylate glues), in addition to surgical strategies such as endoscopic subfascial ligation of perforating veins or saphenous reflux segmentation. Some of the aforementioned known techniques are intended for well-defined niche pathologies, whereas others are, in the absence of a clear hierarchy, valid alternative therapies in terms of efficacy, reduction of complications, long-term results and costs. It is nevertheless noted that the "surgical" techniques are linked to invasiveness and a significant risk of complications, while the endoluminal ablative techniques entail a share of long-term failures (recanalizations) and involve a likelihood, albeit very small, of serious complications. With regard to the aforementioned ablative techniques, it is widely believed that the point of maximum criticality in the methodology can be found in the sapheno-femoral confluence, i.e. the short venous site which, in the event of over- or under-treatment, may place the patient at risk of thrombosis that extends to deep circulation or central embolism and at risk of more or less extensive recanalization of the vessel by blood reflux, with recurrence of the varicose syndrome. In the field of treating superficial venous insufficiency of the lower limbs, there is therefore a strong need to carry out a procedure which is to all effects "surgical," such as interruption in order to ligate a venous collector, but without necessarily exposing the patient to the invasiveness and the preventable complications involved therewith. Examples of known devices comprising a distal clip and a proximal clip connected to each other by means of a tie rod are known from US 2006/265042 A1, US 2014/296881 A1 and US 10 010 315 B2. The object of this invention is to provide a percutaneous device for interrupting the function of venous collectors that makes it possible to mechanically occlude a venous vessel by means of transcutaneous puncture access. This object is achieved by a percutaneous device for interrupting the function of venous collectors according to claim 1. Other embodiments of the percutaneous device according to the invention are described in the dependent claims. The device according to this invention makes it possible to carry out operations to intercept and/or close a blood vessel using percutaneous access in a simplified manner, which requires reduced manual ability which is not necessarily surgical. As a result, the operating times and the impact on patient approval acceptance (or compliance) are drastically reduced by comparison with "open" surgery techniques. Further advantages of a percutaneous device according to this invention will become apparent from the following description, given by way of non-limiting example and in accordance with the accompanying figures, in which: Fig. 1A shows a device that is not part of this invention in a configuration for percutaneous insertion;Fig. 1B shows a device that is not part of this invention in a configuration for release of the distal clip;Fig. 1C shows a device that is not part of this invention in a configuration for release of the proximal clip;Fig. 1D shows a device that is not part of this invention in configuration for closing the venous vessel;Fig. 2 is an axonometric view of the distal clip in one embodiment that is not part of this invention comprising a slot which is adapted to receive the tie rod element and has a U-shaped cross section;Fig. 3A and 3B are an axonometric view and a cross-sectional view, respectively, of the proximal clip in one embodiment;Fig. 4 is an axonometric view of the distal clip in a further embodiment that is not part of this invention comprising a slot which is adapted to receive the tie rod element and has a V-shaped cross section;Fig. 5 is an axonometric view of the proximal clip in a further embodiment;Fig. 5A and 5B show two embodiments of the hole in the proximal clip;Fig. 6A and 6B show a device according to this invention in one embodiment comprising a flattened tie rod;Fig. 7 is an axonometric view of the distal clip in a further embodiment that is not part of this invention;Fig. 8A and 8B are an axonometric view and a cross-sectional view, respective