Improved percutaneous device for clamping a blood vessel

Abstract

The percutaneous device (100) for clamping a blood vessel according to the invention comprises: an internally hollow main body (1); a distal clip (2) and a proximal clip (3) housed in the main body (1); a tie rod (4) on which the distal clip (2) is fixed and on which the proximal clip (3) slides; an abutment element (5) housed in the main body (1); a handle (7), connected to the main body (1). Advantageously, the distal clip (2) comprises a pointed distal perforation portion (26) that protrudes from the distal opening (12) of the main body (1) in order to form the tip of the device (1). Furthermore, the distal clip (2) comprises a small proximal portion (27), having a smaller diameter, and provided with at least one reinforcement ridge (9), which provides support and stiffness to the small proximal portion (27).

Description

IMPROVED PERCUTANEOUS DEVICE FOR CLAMPING A BLOOD VESSEL

[0001] The subject of the present invention is an improved device for interrupting the function of superficial venous collectors, using percutaneous access and ultrasonic guidance.

[0002] 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 very 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 with foam; mechanochemical ablation; cyanoacrylate glues), in addition to surgical strategies such as endoscopic subfascial ligation of perforating veins or saphenous reflux segmentation.

[0003] As is known, "surgical" techniques are linked to invasiveness and a significant risk of complications, whilst endoluminal ablative techniques entail a share oflong-term failures (recanalizations) and involve a likelihood, albeit very small, of serious complications. Examples of percutaneous devices for the functional interruption of blood vessels are known from the documents EP 3 936059 A2 and WO 2019 / 109029 A1.

[0004] In order to overcome the typical drawbacks of these known techniques, the holder has designed a percutaneous device that through transcutaneous puncture access allows for the functional interruption of venous collectors and allows a venous vessel to be mechanically occluded in a safe and rapid manner. This device is described in the document EP3936059A2. Despite the effectiveness of the device, the applicant has felt the need to improve it in relation to the technical-functional aspects thereof in order to provide the industry with a more miniaturized and stronger device, as well as one that is easy and intuitive for the doctor to use.

[0005] The object of this invention is to provide an improved percutaneous device for interrupting the function of venous collectors that results in minimum space requirements and maximum strength, as well as being easy and intuitive to use, making it possible to mechanically occlude a venous vessel by means of transcutaneous puncture access.

[0006] This object is achieved by a percutaneous devicefor 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.

[0007] The device according to the present invention makes it possible to carry out interventions to intercept and / or clamp a blood vessel using percutaneous access and in a simplified manner, thereby requiring less manual ability. Operating times and the impact on patient acceptance (or compliance) are consequently drastically reduced in comparison to the surgical technique. Further advantages of a percutaneous device according to the present invention will become apparent from the following description, given by way of non-limiting example and in accordance with the accompanying figures, wherein:- Fig. 1 shows the distal portion of a device according to the present invention in a configuration for percutaneous insertion, in an exemplary embodiment;- Fig. 2 shows an exploded view of the device in Fig. 1;- Fig. 3 shows the distal portion of a device according to the present invention in a percutaneous insertion configuration, in a further exemplary embodiment;- Fig. 4 is an exploded view of the device in Fig. 1, in a first exemplary construction;- Fig. 5 is an exploded view of the device in Fig. 1, ina second exemplary construction;- Fig. 6 shows the distal portion of a device according to the present invention, wherein the main body has been partially removed to show the components housed therein, in a percutaneous insertion configuration, in an exemplary embodiment;- Fig. 7 shows the device of Fig. 6, in a closed configuration between the clips of the venous vessel;- Fig. 8 shows a device according to the present invention in a configuration for percutaneous insertion, in an exemplary embodiment with a handle;- Fig. 9A to 9C show the various configurations of the device of Fig. 8 during the steps of the process for clamping a venous vessel, in particular:- 9A: configuration for puncturing the venous vessel;- 9B: configuration for releasing the distal and proximal clips;- 9C: configuration for locking the clips in order to close the venous vessel;- Fig. 10 shows a device according to the present invention in a configuration for percutaneous insertion in a further exemplary embodiment with a handle;- Fig. 11A to 11C show the various configurations of the device of Fig. 8 during the steps of the process for clamping a venous vessel, in particular:11A: configuration for puncturing the venous vessel;- 11B: configuration for releasing the distal and proximal clips;- 11C: configuration for locking the clips such as to close the venous vessel.

[0008] In the aforementioned figures, similar components are identified in different figures by the same reference sign.

[0009] Reference sign 100 represents a percutaneous device for interrupting the function of superficial venous collectors according to this invention. This device is suitable for intercepting and clamping a blood vessel, for example the saphenous vein.

[0010] The device 100 comprises a main body 1 which extends along a longitudinal axis X and is internally hollow in order to house a pair of clamping clips 2,3 and an abutment element 5 for the clips 2,3 and a tie rod 4. The pair of clips comprises a distal clip 2 for intercepting the vessel and a proximal clip 3 for clamping the vessel. The clips 2,3 are both fitted onto a tie rod 4. It should be noted that in Fig. 1 to 5 the tie rod 4 has been omitted for reasons of visual simplification; the tie rod 4 is instead visible in the remaining figures.

[0011] The main body 1 is a cannula, preferably a metallic cannula, which may be inserted percutaneously,and is provided with a distal end 11 having a distal opening 12 for the release of the clips 2,3. In one embodiment, shown in Fig. 1, the distal end 11 of the main body has a rough surface 119 that increases the echogenicity thereof.

[0012] As may be seen in Fig. 2, at the distal end 11, the end wall that defines the distal opening 12 of the main body 1 is substantially orthogonal with respect to the longitudinal axis X. This solution makes it possible to provide an optimal abutment surface at the distal end 11 of the main body 1, which helps with pushing the distal clip 2 during the step of rotating and orienting said distal clip.

[0013] The abutment element 5 is a rod preferably having a cylindrical or elliptical or semi-circular shape. The abutment element 5 extends along the longitudinal axis X, and is provided with a passageway for the tie rod 4 whereupon the clips 2,3 are fitted. The passageway for the tie rod 4 is, for example, a central hole such that the tie rod 4 slides internally in the abutment element 5, or a lateral groove such that the tie rod 4 slides externally to the abutment element 5. The abutment element 5 is provided with a distal zone 51 adapted to push the proximal clip 3.

[0014] The device 100 comprises a handle 7 which isconnected to the proximal portion of the main body 1 and is adapted to maneuver the clips 2,3 and the tie rod 4.

[0015] The overall configuration of the device 100 is such that the pair of clamping clips 2,3 and the abutment element 5 may be slidingly inserted inside the main body 1, such that the pair of clips 2,3 may exit from the distal opening 12 and may be maneuvered from the outside by means of the handle 7.

[0016] Preferably, the clips 2,3 are substantially in the form of a bar or rod, i.e., they have a substantially cylindrical and elongated shape. For example, the clip has a circular or variable cross section, as in Fig. 4 and 5.

[0017] As seen, for example, in Fig. 6, the mutually facing ends 211,311 of the clips 2,3 are shaped to allow for partial overlapping of said clips once inserted into the main body 1. In this example, the clips 2, 3 have oblique, inclined, and parallel faces. This solution allows the clips 2, 3 to be correctly aligned with respect to the plane of rotation, thus facilitating the transverse positioning thereof during release.

[0018] The distal clip 2 has a distal portion and an opposite proximal portion. The distal clip 2 has a pointed distal perforation portion 26, substantially a tip, for first piercing the subcutaneous tissue and subsequently the wall of a blood vessel and for passing through saidvessel from one side to the other. Due to the fact that the distal clip 2 is provided with a pointed distal perforation portion 26, the distal end 11 of the main body 1 may be provided with a substantially orthogonal abutment surface for an optimal thrusting of the distal clip 2.

[0019] The distal clip 2 has a small proximal portion 27, i.e., having a smaller diameter than the diameter of the distal perforation portion 26. In fact, during the step of percutaneous insertion of the device 100, only the distal perforation portion 26 exits the distal opening 12 of the main body 1 such as to form the needle tip of the device 100; on the contrary, the small proximal portion 27 is completely inserted inside the main body 1.

[0020] An abutment wall 28 is defined between the distal perforation portion 26 and the small proximal portion 27 against which the distal end 11 of the main body 1 rests.

[0021] As mentioned above, one of the objects of the present invention is that of miniaturizing the clips as much as possible in order to facilitate the percutaneous insertion of the device 100.

[0022] Therefore, at least the distal clip 2 is provided with at least one reinforcement ridge 9 which extends longitudinally at least partially at the proximal portion. In fact, the proximal portion is a small proximal portion 27, with a smaller diameter than the diameter of the distalperforation portion 26. The reinforcement ridge 9 allows for greater support and stiffness to be given to the small proximal portion 27.

[0023] The reinforcement ridge 9 may be a single continuous ridge, as in the figures, or it may be interrupted by open spaces, or a sequence of ridges arranged longitudinally.

[0024] The reinforcement ridge 9 preferably extends in a proximal direction, starting from the abutment wall 28.

[0025] The reinforcement ridge 9 preferably extends at least to the seat 21,31 into which the tie rod 4 is inserted.

[0026] In the example in Fig. 4, the distal clip 2 comprises a single reinforcement ridge 9. In the example in Fig. 2 and 5, the distal clip 2 comprises two reinforcement ridges 9, arranged on opposite sides of said clip.

[0027] In the example in Fig. 1 and 2, the reinforcement ridge 9 is a short ridge, i.e., occupying only part of the small proximal portion 27. In the example in Fig. 3 and 4, the reinforcement ridge 9 is a long ridge, i.e., occupying the entire small proximal portion 27.

[0028] In a preferred exemplary embodiment, shown in Fig. 3-5, the proximal clip 3 is also provided with at least one reinforcement ridge 9 extending longitudinally.In fact, the distal clip 3, which is always completely housed inside the main body 1 during the step of percutaneous insertion of the device 100, has a smaller diameter than the diameter of the distal perforation portion 26 of the distal clip 2. The reinforcement ridge 9 allows for greater support and stiffness to be given to the proximal clip 3.

[0029] In the example in Fig. 4, the proximal clip 3 comprises a single reinforcement ridge 9. In the example in Fig. 5, the proximal clip 3 comprises two reinforcement ridges 9, arranged on opposite sides of said clip.

[0030] In the proximal clip 3, the reinforcement ridge 9 extends in the proximal direction, starting from the oblique end 311.

[0031] In one embodiment, the reinforcement ridge 9 is a short ridge, namely occupying only one part of the proximal clip 3. In the example in Fig. 4 and 5, the reinforcement ridge 9 is a long ridge, namely occupying the entire proximal clip 3.

[0032] Advantageously, the reinforcement ridge 9 is inserted into a respective track 91 made longitudinally through the main body 1 of the device 100. The track 91 is a longitudinal cut made starting from the distal opening 12. This solution allows the clips 2,3 to be locked in rotation when they are inserted into the main body 1,avoiding unwanted rotations between the clips and said main body.

[0033] In the example in Fig. 4, the main body 1 comprises only one track 91. In the example in Fig. 2 and 5, the main body 1 comprises two tracks 91, arranged on opposite sides of said body.

[0034] In the example in Fig. 1, the track 91 is a short track, i.e., that extends from one part of the distal clip 2. In the example in Fig. 3, the track 91 is a long track, i.e., that extends also to the proximal clip 3.

[0035] Each clip 2, 3 preferably has a length determined by the specific surgical requirements and by the dimensions of the vessel to be treated, for example in a range of approximately 6-12 mm. The clips 2, 3 may be the same length or may be different lengths.

[0036] The clips 2,3 are connected therebetween by means of the tie rod 4 or an equivalent means. The tie rod 4 has a preferably circular cross section, or a semicircular cross section or a flat ribbon cross section.

[0037] It should be noted that the tie rod 4 is provided with a radial dimension, for example a flattened portion or a thickened portion in a proximal position such as to prevent the tie rod from being able to reenter the seat 31 of the proximal clip 3 once this radial dimension has exited therefrom. This solution makes it possible tomaintain the correct clamping of the vessel between the distal clip 2 and the proximal clip 3, thus avoiding the need to produce a node on the tie rod that has to be pushed into position. In a further exemplary embodiment, the tie rod 4, and in particular at least the intermediate portion 42 arranged between the two clips, is provided with protruding fastening tabs adapted to prevent the proximal clip 3 from retracting during the step of clamping the vessel.

[0038] In an alternative embodiment, shown in Fig. 6, a retainer 84 is arranged on the tie rod 4 that is slidable when pushed by the abutment element 5. In one embodiment, the retainer 84 is made of a soft material, such as to create friction with the tie rod 4. In another exemplary embodiment, the retainer 84 is provided with an inner hole having a diameter slightly less than the outer diameter of the tie rod in order to engage therewith by means of friction.

[0039] The clips 2, 3 are preferably made of biocompatible metal material or made of bioresorbable material.

[0040] The tie rod 4 is preferably made of nylon or polyester or is made of resorbable material.

[0041] Depending on the specific application, the tie rod 4 and the clips 2, 3 may be made of non-resorbable orresorbable material.

[0042] The clips 2, 3 are provided with a seat 21, 31 into which the tie rod 4 is inserted. The distal clip 2 is provided with a distal seat 21 into which the tie rod 4 is fastened. The distal seat 21 is preferably a through hole which has a circular or rectangular cross section. The distal seat 21 preferably transversely crosses the distal clip 2 perpendicularly. This solution makes it possible to correctly orient and turn over the distal clip 2 once it has been released. The proximal clip 3 is provided with a proximal seat 31 into which the tie rod 4 is slidably inserted. The proximal seat 31 is preferably a through hole which has a circular or oval or else rectangular cross section. The proximal seat 31 preferably transversely crosses the proximal clip 3 obliquely. This solution makes it possible both to correctly orient the proximal clip 3 once it has been released and to correctly slide the tie rod 4.

[0043] As seen, for example, in Fig. 9B, a distal end 41 of the tie rod 4 is fastened within the seat 21 of the distal clip 2. The tie rod 4 is furthermore slidingly inserted into the seat 31 of the proximal clip 3 such that an intermediate portion 42 of the tie rod 4 is arranged between the clips 2,3. A proximal end 43 of the tie rod 4 may instead be maneuvered by the surgeon, either directlyor by means of a handle 7.

[0044] The clips 2,3 preferably have a transverse dimension (i.e. a diameter) such as to be able to slide freely, possibly with minimal friction in order to prevent slipping, inside the main body 1. When the clips 2, 3 are inserted inside the main body 1, the longitudinal axis of the clips 2, 3 is in line with the longitudinal axis of the main body 1.

[0045] For the correct functioning of the device 100, it is important that the tie rod 4, inside the main body 1, should not interfere with the correct sliding of the clips 2,3. The clips 2,3 are therefore preferably provided with at least one housing 22,32,33 in which the tie rod 4 is arranged when the clips 2,3 are inside the main body 1.

[0046] The housing 22,32,33 is a longitudinal groove formed on the outer surface of the clip 2,3 such that the tie rod 4 is inserted into such groove and therefore fits inside the volume of space occupied by the clip 2,3. The distal clip 2 is provided with a proximal housing 22, and optionally also a distal housing for fastening the tie rod. The proximal clip 3 is provided with both a distal housing 32 and a proximal housing 33.

[0047] The housings are preferably longitudinal grooves on the outer surface of the clips 2, 3, and the proximal housing 22 of the distal clip 2 occupies at least aproximal portion of the distal clip 2, the distal housing32 of the proximal clip 3 occupies at least a distal portion of the proximal clip 3, and the proximal housing33 of the proximal clip 3 occupies at least a proximal portion of the proximal clip 3.

[0048] It should be noted that the distal housing and the proximal housing are arranged on opposite sides of the clip. The distal clip 2 therefore comprises a path for the tie rod 4 that starts from the seat 21 and continues along the housing 22. The path for the tie rod 4 occupies approximately half of the length of the distal clip 2. The proximal clip 3 comprises a path for the tie rod 4 that starts from the housing 32 and continues into the seat 31 through the clip in order to exit from the opposite side and continue along the housing 33. The path for the tie rod 4 occupies the entire length of the proximal clip 3.

[0049] Preferably, moreover, the mutually facing ends 211,311 of the clips 2,3 are also provided with a transverse housing 24,34 to allow for better alignment of the clips when inserted into the main body 1. The transverse housing 24,34 is a groove, which transversely crosses the inclined face of the clip, as seen in Fig. 4. The transverse housings 24,34 are facing therebetween.

[0050] The device 100 comprises a handle 7 which extends predominantly longitudinally, is formed by two half-shellsmechanically connected together, and is connected to the proximal portion of the main body 1.

[0051] The handle 7 comprises a handle body 71 provided with a track 73 in which an operating lever 72 for operating the clips 2,3, and the tie rod 4 is slidingly housed.

[0052] The operating lever 72, which may be seen in detail in Fig. 9A, extends predominantly longitudinally and preferably comprises a shaped slider 721 for facilitating the gripping and sliding thereof inside the track 73. The slider 721 is arranged on an upper side of the handle 7.

[0053] The operating lever 72 slides longitudinally stepwise such as to allow the doctor to understand, even without seeing it, when the correct release of the first distal clip 2 and then the proximal clip 3 has been obtained.

[0054] In the embodiment of Fig. 8, the stepwise sliding of the operating lever 72 is obtained by acting upon the track 73, mainly having a longitudinal extension but also provided with a portion with a transverse progression. The track 73 in fact comprises a first abutment 661 against which the slider 721 stops, thereby indicating the correct release of the distal clip 2, and a second abutment 662 against which the slider 721 stops,thereby indicating the correct release of the proximal clip 3. To continue advancing the slider 721, it is necessary to move said slider transversely and to surpass the first abutment 661.

[0055] In the exemplary embodiment of Fig. 10, the stepwise sliding of the operating lever 72 is obtained by acting on the slider 721 and on the track 73. The slider 721 is provided with a release button 722 which stops the slider 721 from retracting, thereby indicating the correct release of the distal clip 2, and the track 73 is provided with a second abutment 662 against which the slider 721 stops, thereby indicating the correct release of the proximal clip 3. In order to continue retracting the slider, it is necessary to press the release button 722.

[0056] The main body 1 is integral to the operating lever 72, which means that retracting the operating lever 72 also retracts the main body 1, as for example in Fig. 16B.

[0057] During an initial actuation step, shown in Fig. 9A and 11A, the operating lever 72 is slidable with respect to the tie rod 4, i.e., in retracting the operating lever 72 nothing happens to the tie rod 4. The operating lever 72 comprises a tie rod hook 725 adapted to engage a tie rod ratchet 45, integral with the tie rod 4, such that the operating lever 72 is connected in motion to the tierod 4 and such that advancing it results in the retraction of the tie rod 4, as may be seen in Fig. 9B and 9C. The engagement between the operating lever 72 and the tie rod 4 occurs at the second abutment 662 against which the slider 721 stops, thereby indicating the correct release of the proximal clip 3.

[0058] In the example of Fig. 11A-11C, the operating lever 72 is always slidable with respect to the abutment element 5, i.e., in retracting the operating lever 72, nothing happens to the abutment element 5. In this example, in fact, the abutment element 5 is provided with an abutment 510 and is integral with the handle 7.

[0059] In the example in Fig. 9A-9C, on the other hand, during an initial actuation step, shown in Fig. 9A, the operating lever 72 is slidable with respect to the abutment element 5, i.e., when the operating lever 72 is withdrawn, nothing happens to the abutment element 5. The operating lever 72 also comprises an abutment hook 726 adapted to engage an abutment ratchet 46, integral with the abutment element 5, such that the operating lever 72 is connected in motion to the abutment element 5 and such that advancing it results in the advancement of the abutment element 5, as seen in Fig. 9B and 9C. The possibility of advancing the abutment element 5 allows the retainer 84, where present, to be pushed. The engagement between the operatinglever 72 and the abutment element 5 occurs at the second abutment 662 against which the slider 721 stops, thereby indicating the correct release of the proximal clip 3.

[0060] The handle 7 comprises a cutting button 723 provided with a blade 724 adapted to sever the tie rod 4. The cutting button 723 is vertically slidable between a resting 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 in order to sever it.

[0061] In one embodiment variant (not shown), the tie rod 4 is provided, proximally with respect to the proximal clip 3, with a predetermined breaking point, for example a pre-incision or a weakening, that is adapted to yield following a certain force of traction that is exerted upon the tie rod 4. Said predetermined breaking point is a calibrated point of weakness that makes it possible to release the pair of clips only after an optimal force of traction has been exerted for the clamping and therefore occlusion of the vessel. This solution makes it possible to leave as little of the tie rod 4 as possible inside the body of the patient after the vessel has been closed.

[0062] The sequence of figures from 9A-9C and 11A-11C, shows the use of the device 100 in order to clamp a blood vessel.

[0063] Fig. 9A, 11A shows the device 100 in a percutaneous insertion configuration. First of all, the main body 1 is introduced percutaneously through the needle tip consisting of the distal perforation portion 26 of the distal clip 2. The tip then punctures the wall of the blood vessel and passes through said vessel from one side to the other.

[0064] Fig. 9B, 11B show the device 100 in a configuration for releasing the distal clip 2 and the proximal clip 3. The distal clip 2 is made to exit the distal opening 12 of the main body 1 by retracting the slider 721 until it encounters the first abutment 661. In fact, by retracting the slider 721 the operating lever 72 is retracted and the main body 1 is retracted therewith; the proximal clip 3 and the abutment element 5 are instead maintained in position. The slider 721 is then moved transversely in order to overcome the first abutment 661. The proximal clip 3 is also made to exit the distal opening 12 of the main body 1 in retracting the slider 721 until it encounters the second abutment 662. Retracting the slider 721 in fact retracts the operating lever 72 and the main body 1 therewith; the abutment element 5 is instead maintained in position. In both variants of Fig. 9B and 11B, at the second abutment 662 against which the slider721 stops, the engagement between the operating lever 72and the tie rod 4 is obtained. At this point, in advancing the operating lever 72, the tie rod 4, a retraction of the tie rod is obtained. In the variant in Fig. 9B only, the engagement between the operating lever 72 and the abutment element 5 is also obtained. At this point, in advancing the operating lever 72, a retraction of the tie rod 4 and an advancement of the abutment element 5 are obtained.

[0065] Fig. 9C, 11C shows the device 100 in a configuration for locking the clips 2,3 such as to close the venous vessel. By advancing the slider 721, the tie rod 4 is retracted in such a way as to retract the distal clip 3, and simultaneously the main body 1 is advanced, thus pushing the proximal clip 3 forward such as to achieve the correct clamping of the vessel between the distal clip 2 and the proximal clip 3. In the variant in Fig. 9B only, by advancing the slider 721, an advancement of the abutment element 5 is also obtained. This solution is particularly advantageous in those embodiment variants with a track 91 that is long, i.e., which also extends to the proximal clip 3, as in Fig. 3. In fact, the advancement of the abutment element 5 confers stiffness and structural strength to the main body 1, which would otherwise be weakened due to the long track 91. Furthermore, the advancement of the abutment element 5 allows the retainer84, where present, to be pushed.

[0066] At this point, it is possible to sever the tie rod 4 by means of actuating the cutting button 723 present on the handle or by means of pulling further if a predetermined breaking point 44 on the tie rod 4 is used.

[0067] Innovatively, a percutaneous device according to the present invention results in a minimum space requirement and maximum strength. In fact, due to the presence of the reinforcement ridge 9, it has been possible to minimize the outer diameter of the distal clip 2 (at the small proximal portion 27) and of the proximal clip 3, and consequently the diameter of the main body 1 into which the clips 2,3 are inserted, without compromising the functionality of the device 100 insofar as the reinforcement ridge 9 allows for support and stiffness to be provided.

[0068] Advantageously, the percutaneous device according to the present invention is easy and intuitive to use. In fact, the handle 7 houses an operating lever 72 that slides longitudinally stepwise such as to allow the doctor to understand, even without seeing it, when the correct release of the first distal clip 2, and then that of the proximal clip 3, has been obtained. Furthermore, by virtue of the tie rod hook 725 engaging the tie rod ratchet 45, advancing the operating lever 72 results in a retraction of the tie rod 4.

[0069] It is understood that a person skilled in the art could make modifications to the product described above, all of which are contained within the scope of protection as defined by the following claims.

Claims

Claims1. Percutaneous device (100) for clamping a blood vessel, comprising:- an internally hollow main body (1) provided with a distal tip having a distal opening (12);- a distal clip (2) and a proximal clip (3), slidingly housed inside the main body (1);- a tie rod (4) on which the distal clip (2) is fastened and on which the proximal clip (3) slides, said tie rod being provided with means for locking the sliding of the proximal clip (3);- an abutment element (5) housed inside the main body (1), proximally with respect to the proximal clip (3);- a handle (7), connected to the main body (1); characterized in that the distal clip (2) comprises:- a distal pointed perforation portion (26), protruding from the distal opening (12) of the main body (1);- a small proximal portion (27), having a smaller outer diameter than an outer diameter of the distal perforation portion (26), and provided with at least one longitudinally extending reinforcement ridge (9).

2. Percutaneous device (100) according to claim 1, wherein said reinforcement ridge (9) extends longitudinally only over a part of the small proximal portion (27).

3. Percutaneous device (100) according to claim 1 or 2,wherein the reinforcement ridge (9) extends longitudinally over the entire small proximal portion (27).

4. Percutaneous device (100) according to any one of the preceding claims, wherein the proximal clip (3) has a smaller outer diameter than the outer diameter of the distal perforation portion (26) of the distal clip (2), said proximal clip (3) being provided with at least one longitudinally extending reinforcement ridge (9).

5. Percutaneous device (100) according to claim 4, wherein the reinforcement ridge (9) extends longitudinally over the entire proximal clip (3).

6. Percutaneous device (100) according to claim 4 or 5, wherein the distal clip (2) comprises two reinforcement ridges (9) arranged on opposite sides, and / or the proximal clip (3) comprises two reinforcement ridges (9) arranged on opposite sides.

7. Percutaneous device (100) according to any one of the preceding claims, wherein the reinforcement ridge (9) is slidingly inserted into a track (91) made in the main body (1), said track (91) being a longitudinal cut made starting from the distal opening (12).

8. Percutaneous device (100) according to any one of the preceding claims, wherein said means for locking the sliding of the proximal clip (3) is a flattening or a thickening of the tie rod (4), or a retainer (84) fittedonto the tie rod (4) or protruding fastening tabs.

9. Percutaneous device (100) according to any one of the preceding claims, wherein the handle (7) houses an operating lever (72) provided with a slider (721), said operating lever (72) sliding stepwise inside a track (73), wherein the track (73) comprises a first abutment (661) against which the slider (721) stops upon complete release of the distal clip (2), and a second abutment (662) against which the slider (721) stops upon complete release of proximal clip (3).

10. Percutaneous device (100) according to any one of claims 1 to 8, wherein the handle (7) houses an operating lever (72) provided with a slider (721) with release button (722), said operating lever (72) sliding stepwise inside a track (73), wherein the release button (722) stops the sliding of the operating lever (72) upon complete release of the distal clip (2), and the track (73) comprises a second abutment (662) against which the slider (721) stops upon complete release of the proximal clip (3).

11. Percutaneous device (100) according to any one of the preceding claims, wherein the handle (7) houses an operating lever (72) provided with a tie rod hook (725) adapted to engage a tie rod ratchet (45), integral with the tie rod (4), so that the operating lever (72) is movably integral with the tie rod (4).

12. Percutaneous device (100) according to any one of the preceding claims, wherein the handle (7) houses an operating lever (72) provided with an abutment hook (726) adapted to engage an abutment ratchet (46), integral with the abutment element (5), so that the operating lever (72) is movably connected to the abutment element (5) and so that by moving it forward the abutment element (5) also moves forward.

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