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EP-4736787-A2 - PERCUTANEOUS DEVICE FOR CLOSING A BLOOD VESSEL

EP4736787A2EP 4736787 A2EP4736787 A2EP 4736787A2EP-4736787-A2

Abstract

The percutaneous device (100) for closing a blood vessel according to the invention comprises: a distal clip (2) and a proximal clip (3) slidingly accommodated inside a main body (1), said clips (2, 3) being connected to each other by means of a tie rod (4); a handle (7), connected to the main body (1), to maneuver the clips (2, 3), the abutment element (5), and the tie rod (4). Said device is characterized in that the distal clip (2) has a needle-shaped distal perforation end (26).

Inventors

  • Bergamaschi, Gastone

Assignees

  • VCD MEDICAL S.R.L.

Dates

Publication Date
20260506
Application Date
20221213

Claims (15)

  1. A percutaneous device (100) for closing a blood vessel, comprising: - a main body (1) which extends along a longitudinal axis (X), said main body (1) being internally hollow and housing a pair of clamping clips (2, 3) and an abutment element (5) for the clamping clips (2, 3), said pair of clamping clips (2, 3) comprises a distal clip (2) for intercepting the blood vessel and a proximal clip (3) for clamping the blood vessel, said clamping clips (2, 3) being connected to each other by means of a tie rod (4); - a handle (7) connected to a proximal portion of the main body (1) and adapted to maneuver the clamping clips (2, 3) and the tie rod (4); characterized in that - said abutment element (5) is integral with the handle (7); - said handle (7) comprises a handle body (71) provided with a track in which an operating lever (72) for operating the clamping clips (2, 3) and the tie rod (4) is slidably accommodated; - said tie rod (4) is provided with a traction element adapted to pull the tie rod (4) with respect to the handle (7).
  2. A percutaneous device (100) according to claim 1, wherein the operating lever (72) comprises at least one seat (722) for the passageway of the tie rod (4) such that the lever may slide on the tie rod (4).
  3. A percutaneous device (100) according to claim 1 or 2, wherein the operating lever (72) comprises, at the rear, a lever stop (725) adapted to abut against a tie rod stop (45).
  4. A percutaneous device (100) according to any of the preceding claims, wherein the handle (7) extends predominantly longitudinally and is formed by two half-shells mechanically connected together.
  5. A percutaneous device (100) according to any of the preceding claims, wherein the operating lever (72) extends predominantly longitudinally and comprises a slider (721) on an upper side.
  6. A percutaneous device (100) according to claim 5, wherein said operating lever (72) comprises, in proximity to the slider (721), a cutting button (723) provided with a blade (724) adapted to sever the tie rod (4).
  7. A percutaneous device (100) according to claim 6, wherein said cutting button (723) is vertically slidable between a rest position in which the blade (724) is spaced apart from the tie rod (4) and a cutting position in which the blade (724) is pushed against the tie rod (4) to sever it.
  8. A percutaneous device (100) according to any of the preceding claims, wherein said traction element: - is connected to a proximal end (43) of the tie rod (4) and at least partially exits from the handle (7) in order to be gripped and pulled; or - is a wheel (47) connected to the proximal end (43) of the tie rod (4) and at least partially exits from the handle (7) in order to be rotated.
  9. A percutaneous device (100) according to any of the preceding claims, wherein the main body (1) is provided with a distal tip (11), said distal tip (11) comprising a distal opening (12) from which the clamping clips (2, 3) exit.
  10. A percutaneous device (100) according to claim 9, wherein the distal tip (11) is a perforation tip shaped as a needle to puncture the wall of a blood vessel (V) and to pass through said vessel from one side to the other.
  11. A percutaneous device (100) according to claim 9, wherein the distal clip (2) has a distal perforation end (26) shaped as a needle to puncture the wall of a blood vessel (V) and to pass through said vessel from one side to the other, and wherein at least the distal perforation end (26) of the distal clip (2) exits from a distal opening (12) of the main body (1).
  12. A percutaneous device (100) according to any of the preceding claims, wherein said clamping clips (2, 3) are provided with at least one housing in which the tie rod (4) is positioned when the clamping clips (2, 3) are inside the main body (1), said housing being a longitudinal groove formed on an outer surface of the clamping clips (2, 3).
  13. A percutaneous device (100) according to any of the preceding claims, wherein said clamping clips (2, 3) are in the form of a bar or rod, preferably said clamping clips (2, 3) have a cylindrical and elongate shape.
  14. A percutaneous device (100) according to any of the preceding claims, wherein the tie rod (4) is provided, proximally with respect to the proximal clip (3), with a breaking point (44), preferably the breaking point (44) of the tie rod (4) is a pre-incision or a weakened portion.
  15. A percutaneous device (100) according to any of the preceding claims, wherein said main body (1) is a metal cannula suitable for being inserted percutaneously.

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. 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 according to this invention in a configuration for percutaneous insertion;Fig. 1B shows a device according to this invention in a configuration for release of the distal clip;Fig. 1C shows a device according to this invention in a configuration for release of the proximal clip;Fig. 1D shows a device according to this invention in configuration for closing the venous vessel;Fig. 2 is an axonometric view of the distal clip in one embodiment 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 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;Fig. 8A and 8B are an axonometric view and a cross-sectional view, respectively, of the proximal clip in a further embodiment;Fig. 9A and 9B show the distal clip in one embodiment comprising two slots adapted to receive the tie rod element;Fig. 10A and 10B show the device according to this invention having a further configuration of the clips;Fig. 11A and 11B show the device according to this inv