![]() VENAS PERCUTANEOUS CLOSURE DEVICE (Machine-translation by Google Translate, not legally binding)
专利摘要:
Percutaneous closure device. It is applicable to pierce and close by pressure a vessel (v) vein varicose veins, and comprises a tip (2) in whose distal end (2b) incorporates two fasteners (4, 5) associated with a sliding mechanism whose operation the it unfolds and moves approximating them to each other, so that, after drilling the vessel (v) of the vein to be closed with said tip (2), they press between both walls of the vessel on diametrically opposite sides until it closes. The distal fixator (4) acts as a harpoon on the opposite wall of the vessel (v) to the point of penetration with the tip (2), and the proximal (5) press on the vessel wall (v) at the point of penetration. It comprises a hollow sheath (8) located longitudinally in the intermediate zone of the tip (2). The sliding mechanism is retracted by pressing the button (6). The fasteners (4, 5) are provided with respective deployable flaps, oriented in opposite directions linked to a helical screw (9) thanks to which, they move closer to each other. (Machine-translation by Google Translate, not legally binding) 公开号:ES2709683A1 申请号:ES201731344 申请日:2017-11-21 公开日:2019-04-17 发明作者:Serrats Juan Andres Sancho 申请人:Serrats Juan Andres Sancho; IPC主号:
专利说明:
[0001] [0002] VENAS PERCUTANEOUS CLOSURE DEVICE [0003] [0004] OBJECT OF THE INVENTION [0005] [0006] The invention, as expressed in the statement of the present specification, refers to a device for percutaneous closure of veins that provides, to the function to which it is intended, advantages and characteristics that will be described in detail below and that represent a remarkable novelty in the current state of the art. [0007] [0008] The object of the present invention resides, specifically, in a device for percutaneous vein closure applicable, as an alternative to microincision, for the practice of hemodynamic techniques in veins with varicose conditions, with the mission of closing the vein percutaneously with a minimum of local anesthesia or with topical application and on an outpatient basis without needing an incision, since it works by means of a simple puncture performed with a tip that crosses the vessel and in which a mechanism that anchors it with a harpoon-type fixator is contemplated. one side and, by means of a second complementary fixer, press the glass on the opposite side until it is closed. [0009] [0010] FIELD OF APPLICATION OF THE INVENTION [0011] [0012] The field of application of the present invention is part of the sector of the industry dedicated to the manufacture of instruments, devices, and medical devices, focusing particularly on the scope of those intended to solve varicose veins problems. [0013] BACKGROUND OF THE INVENTION [0014] [0015] As is known, varicose veins are a disease that affects the veins of the legs. Due to various factors, the veins widen, become tortuous and insufficient, that is, unable to perform their mission well. One in ten people suffers from them, being more frequent in women. [0016] [0017] Varicose veins are formed by a malfunction of the valves of the veins of the legs. These valves help the blood follow its path to the heart. Most of the time we remain standing or sitting, so the blood of the legs to return to the heart is against gravity, that is, it needs the aspiration force (Venturi) that the muscular pump of the legs provides, and the push that brings the blood that is reaching the legs via arterial. But when sitting or standing without walking the muscle pump is stopped and the blood by its own weight (gravity) tends to reflux (back) to the feet. And this is where the venous valves come into play, avoiding with their anti-reflux mechanism that the blood recedes and its malfunction is what produces the venous disease. [0018] [0019] By not avoiding blood reflux, a column of hydrostatic pressure is produced between the heart (or the last continent valve) and the feet. The last valve of the legs is usually at the level of the groin (saphenous arch) or a little higher, in the femoral or iliac vein. [0020] [0021] When functioning badly, the blood stagnates in the veins, enlarging them and making them even more insufficient (they do not act correctly). [0022] [0023] Approximately 70% of varicose veins are caused by a failure of the valves of the internal saphenous vein, (Great Safena or Long Safena in Anglo-Saxon terms) and the valve of the saphenous arch in the groin is mostly affected. [0024] [0025] The treatment of varicose disease in hemodynamic terms consists in sectioning the pressure column, to avoid that the increase of the same produces the symptomatology (pain, heaviness, itching, skin ulcers, etc.). [0026] [0027] Until the end of the twentieth century, the classic treatment consisted of removing the dilated veins that had become varicose veins, but in the 90's Dr. Claude Franceschi exposed the CHIVA strategy (Hemodynamic Cure of Ambulatory Venous Insufficiency) which consists of sectioning the pressure column in certain segments of the venous network and distribute the load to segments with competent valves. [0028] [0029] The techniques to achieve this goal are divided into two: [0030] [0031] 1 / Ablative or destructive techniques. [0032] [0033] They consist of occluding light throughout the varicose segment or in a large part of it. They destroy the vein. [0034] [0035] - Striping, ( mechanical removal). Requires regional or general anesthesia [0036] - Thermal occlusion with several Radio-Frequency or VNUS closure systems, Endolaser or EVLT, Water vapor; Although the FDA (Food and Drug Administration ) approved them as ambulatory methods, they require regional or local anesthesia and many times sedation. [0037] - Sclerosis or Chemical Abrasion. Varicose foam microfoam. Very used. The vein is occluded by a substance that causes a chemical phlebitis of the vein. It is ambulatory, does not require anesthesia but there is little control of the microfoam at the level of the saphenous arch in the groin (risk of femoral vein thrombosis and pulmonary embolism). [0038] [0039] 2 / Hemodynamic techniques. CHIVA, Fetish ligature Phlebectomy of varicose branches. [0040] They pursue, as has been explained, to close the vanishing point where reflux begins. [0041] They conserve most of the venous system, it is done with local anesthesia and small incisions (5 mm) to be able to section and ligate the vein. They can be accompanied by sclerosis with foam of small segments (aesthetic motif). [0042] In some cases, although originally they were not designed for this need, some new devices have been used, such as: [0043] [0044] • Amplatzer Vascular Plug AGA-endovascular occluder, is not designed but has been used to close the saphenous vein in the arch (morbid obesity) [0045] • Proglide percutaneous closure for Abbott arterial punctures. [0046] [0047] • Ligasure used for hepatic, thyroid, etc. surgery, cuts and coagulates. [0048] • Endoscopic clips, but their cost prohibits their widespread use. [0049] [0050] In Spain, about 15,000 anal varicose surgeries are practiced. [0051] [0052] The objective of the present invention is, therefore, the development of a device indicated as an alternative to microincision for the practice of the techniques VENAS PERCUTANEOUS CLOSURE DEVICE [0053] [0054] OBJECT OF THE INVENTION [0055] [0056] The invention, as expressed in the statement of the present specification, refers to a device for percutaneous closure of veins that provides, to the function to which it is intended, advantages and characteristics that will be described in detail below and that represent a remarkable novelty in the current state of the art. [0057] [0058] The object of the present invention resides, specifically, in a device for percutaneous vein closure applicable, as an alternative to microincision, for the practice of hemodynamic techniques in veins with varicose conditions, with the mission of closing the vein percutaneously with a minimum of local anesthesia or with topical application and on an outpatient basis without needing an incision, since it works by means of a simple puncture performed with a tip that crosses the vessel and in which a mechanism that anchors it with a harpoon-type fixator is contemplated. one side and, by means of a second complementary fixer, press the glass on the opposite side until it is closed. [0059] [0060] FIELD OF APPLICATION OF THE INVENTION [0061] [0062] The field of application of the present invention is part of the sector of the industry dedicated to the manufacture of instruments, devices, and medical devices, focusing particularly on the scope of those intended to solve varicose veins problems. [0063] same, and that is associated with a sliding mechanism whose actuation deploys two fasteners provided for closing the vessel at its distal end, namely a first harpoon-type fixator, which is anchored in the opposite vessel wall to which the tip has penetrated, and a second complementary fixer, which moves towards the first fixator by pressing on the vessel on the opposite side, that is, by the wall of the vessel in which it has been drilled, until it is closed. [0064] [0065] In the preferred embodiment, the sliding actuating mechanism of the device is housed in the operating handle with which it is attached to the proximal end of the tip and comprises a manually sliding button that is inserted in a guide that directs and limits its travel from a initial point of rest to a final closing point of the vessel, in the course of which an intermediate longitudinal hollow sheath of the tip retracts towards said handle the distance necessary to release the respective folding fins of the two fixators, housed therein in the initial resting position, and move them on a helical screw bringing them closer to one another in an intermediate point, in the final closing position, to press the vein between them to close it. [0066] [0067] Following the characteristics of the device of the invention, it should be noted that the tip and the mechanism of fasteners that incorporates are manufactured with a non-absorbable material. [0068] [0069] The main advantage it offers, compared to internal occluders, is that there is no risk of intraluminal displacement. When using it to close veins, with a simple compression and with the leg in Trendelemburg position, that is to say inclined about 45 ° with respect to the floor, it is possible to reduce the pressure and extravasation, reducing the appearance of bruises. [0070] Another advantage is that it can be used in as many points as necessary. Although, it is worth mentioning that it is indicated for veins with a diameter greater than 3mm, which are usually varicose veins of the internal saphenous vein or its branches. For veins of smaller caliber, sclerosis is sufficient. [0071] [0072] The described percutaneous vein closure device consists, then, in an innovative structure of characteristics unknown until now for the purpose for which it is intended, reasons that, together with its practical utility, provide it with sufficient grounds to obtain the privilege of exclusivity that is request [0073] [0074] DESCRIPTION OF THE DRAWINGS [0075] [0076] To complement the description that is being made and in order to help a better understanding of the characteristics of the invention, the accompanying descriptive memory is included, as an integral part thereof, a set of plans in which illustrative and not limiting the following has been represented: [0077] [0078] Figures 1-A, 1-B, 1-C, 1-D and 1-E.-They show, in respective plan views and section, a schematic representation of the device of the invention in successive phases of operation to close a venous vessel; [0079] [0080] Figure 2 shows a perspective view of a preferred embodiment of the device object of the invention, its general configuration and the main parts comprising; [0081] [0082] Figures 3-A, 3-B, 3-C and 3-D. - They show, in respective views in lateral perspective, the tip of the device, according to the invention, and the elements and fasteners provided therein, represented in successive phases of operation, the configuration and arrangement of which being appreciated; Y [0083] [0084] Figure 4 shows an enlarged view of the two fasteners provided on the tip of the device, represented independently of it and with the helical screw that allows the approach between them to close the vessel. [0085] [0086] PREFERRED EMBODIMENT OF THE INVENTION [0087] [0088] In view of the mentioned figures, and in accordance with the numeration adopted therein, a non-limiting example of the percutaneous vein closure device of the invention can be appreciated, which comprises the parts and elements that are indicated and described in detail then. [0089] [0090] Thus, as seen in said figures, the device (1) of the invention consists, essentially, of a tip (2) fixed, by its proximal end (2a), to a handle (3) for handling, and in which distal end (2b) incorporates two fixators (4, 5) that, through a sliding mechanism to which they are linked, unfold and move approximating each other, so that, after drilling the vessel (v) of the vein to Close with said tip (2), press both walls of the vessel between diametrically opposite sides until it closes. [0091] [0092] In the preferred embodiment, the sliding mechanism of the device (1) is housed in the handle (3) and comprises a manually operated sliding button (6), which is inserted in a guide (7) that directs and limits its travel from an initial point (7a) of rest to a closing point (7a) of closure of the vessel, whose button (6) is associated with a cover (8) hollow, located longitudinally in the intermediate zone of the tip (2), which is retracted towards the handle (3) when said button (6) is pressed and inside which the fasteners (4, 5) are housed while the handle is not actuated. mechanism. [0093] [0094] The fasteners (4, 5), on the other hand, consist of two fasteners: one distal (4) that acts as a harpoon on the opposite wall of the vessel (v) to the point of penetration with the tip (2), and one proximal (5). ) pressing on the vessel wall (v) at the point of penetration, both fasteners (4, 5) being provided with two deployable flaps, oriented in opposite directions, which tend to open, for example by means of elastic means, of so that, when sliding the sheath (8) in which they are housed while the mechanism is not actuated, said fins of the fasteners (4, 5) are deployed progressively, that is, first those of the distal fastener (4) and then the of the proximal fixator (5), as shown in figures 3-A to 3 D. [0095] [0096] Finally, as seen in Figure 4, the fasteners (4, 5), move closer together due to the existence of a screw (9) to which they are linked, at least in the proximal fixator (5), and which, also linked to the sliding mechanism, rotates with the actuation of the button (6) causing said displacement. [0097] [0098] Referring to Figures 1-A to 1-E, the phases of the above device operation are observed. Specifically, in Figure 1 -A, the beginning of the penetration of the vessel (v) with the distal end (2b) of the tip (2) is shown, at which time the two fixators (4, 5) are housed in said tip (2) inside the intermediate sheath (8) thereof and with the wings folded, abutting against the wall of said sheath (8). In Figure 1-B a posterior phase is observed, where the tip (2) has perforated completely the glass (v) crossing the two walls of the same one and leaving by the one of the opposite side to the one of penetration. After that, in the next phase, as shown in Figure 1-C, the sliding mechanism is activated, by manually operating the button (6) that controls it, causing the cover (8) to withdraw towards the handle area (3) and, consequently, the deployment of the fins of the fixators. Specifically, first, there is the deployment of the fins of the distal fixator (4), in the form of a harpoon, which when pulled slightly from the device is stuck in the wall of the vessel (v) opposite to the penetration, and, afterwards, the deployment of the fins of the proximal fixator (5), which has remained on the opposite side of the vessel (v), with its fins oriented in the opposite direction, as shown in Figure 1 -D. And, finally, the maintenance of the drive of the mechanism until the end of its travel causes the displacement of the proximal fixator (5) on the helical screw (9) approaching it towards the distal fixator (4) and, therefore, pressing between both fixators ( 4, 5) the glass (v) until its closure. [0099] [0100] Having sufficiently described the nature of the present invention, as well as the way of putting it into practice, it is not considered necessary to make its explanation more extensive so that any expert in the field understands its scope and the advantages derived therefrom, stating that, within its essentiality, it may be carried out in other modes of realization that differ in detail from that indicated by way of example, and which will also achieve the protection that is sought as long as it is not altered, changes or modifies its fundamental principle .
权利要求:
Claims (7) [1] 1. Percutaneous vein closure device that, applicable to pierce and close by pressure a vessel (v) of vein in affectations of varicose veins, is oaraterized by comprising a tip (2) in whose distal end (2b) incorporates two fixators ( 4, 5) associated with a sliding mechanism whose operation deploys and displaces them by bringing them closer together, so that, after drilling the vessel (v) of the vein to be closed with said tip (2), they press between both walls of the vessel by diametrically opposed sides until it closes. [2] 2. Percutaneous vein closure device, according to claim 1, oaraterized because the two fixators (4, 5) are a distal (4) that acts as a harpoon on the opposite wall of the vessel (v) to the point of penetration with the tip (2), and a proximal one (5) that presses on the vessel wall (v) at the point of penetration. [3] 3. Percutaneous vein closure device, according to claim 2, oaraterized because the sliding mechanism comprises a manually operated sliding button (6), and a hollow sheath (8) located longitudinally in the intermediate area of the tip (2) , where the fasteners (4, 5) are housed while the mechanism is not actuated, which is retracted when said button (6) is actuated. [4] 4. Percutaneous vein closure device, according to claims 1 to 3, orteoterizado because the fixators (4, 5) are equipped with two deployable flaps, oriented in opposite directions and tend to open, so that, when sliding the cover (8) in which they are housed while the mechanism is not actuated, are deployed progressively when it retracts, that is, first those of the distal fixator (4) and then the of the proximal fixator (5) ,. [5] 5. Percutaneous vein closure device according to any of claims 1 to 4, orteoterizado because the fixators (4, 5) are linked to a helical screw (9) thanks to which, by actuating the sliding mechanism, move approaching each other. [6] 6. Percutaneous vein closure device according to any of claims 1 to 3, orteoterizado because the tip (2) is fixed, by its proximal end (2a), to a handling handle (3). [7] 7. Percutaneous vein closure device, according to claim 3, orteoterizado because the sliding button (6) manually operated sliding mechanism, is inserted into a guide (7) of the handle (3) that directs and limits its travel from a starting point (7a) of rest to a closing point (7a) of closure of the vessel.
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同族专利:
公开号 | 公开日 ES2653974B2|2018-10-25| ES2653974A1|2018-02-09|
引用文献:
公开号 | 申请日 | 公开日 | 申请人 | 专利标题 WO2010127083A2|2009-04-30|2010-11-04|Mayo Foundation For Medical Education And Research|Body lumen occlusion apparatus and methods| US20170049453A1|2011-01-11|2017-02-23|Amsel Medical Corporation|Multiple occluder delivery devices and methods| WO2013151712A1|2012-04-04|2013-10-10|Gagne Paul J|Methods and systems for ligating a blood vessel| WO2013166509A1|2012-05-04|2013-11-07|Amsel Medical Corporation|Injectable valve and other flow control elements| WO2014102767A2|2012-12-27|2014-07-03|Javelin Medical Ltd.|Apparatus and method of monofilament implant delivery in a body vessel of a patient| GB147916A|1919-01-29|1922-01-09|British United Shoe Machinery|Improvements in or relating to shoemaking lasts| DE9313947U1|1993-09-10|1993-11-25|Mahlmeister Guenter|Shoe lasts| ITMI20071260A1|2007-06-22|2008-12-23|Magari S R L|PROCESS OF PRODUCTION OF FORMS FOR THE MANUFACTURE OF FOOTWEAR| CN106723668A|2017-01-19|2017-05-31|广东易秀科技有限公司|A kind of Shoe last structure produced suitable for footwear with shoe tree 3D printing|
法律状态:
2019-04-17| BA2A| Patent application published|Ref document number: 2709683 Country of ref document: ES Kind code of ref document: A1 Effective date: 20190417 | 2019-09-27| FA2A| Application withdrawn|Effective date: 20190923 |
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