MXPA06008891A - Fasteners for use with gastic restriction - Google Patents

Abstract

A fastener is used during endoscopic procedures in which a suture is used in creating a predefined pouch through tissue apposition within the stomach. The fastener includes a fastener body having a tissue anchor for selectively securing the fastener body to tissue. The fastener body also includes a connection aperture shaped and dimensioned for passage of a suture therethrough.

Description

CLOSURE MECHANISMS FOR USE IN GASTRIC RESTRICTION FIELD OF THE INVENTION The present invention relates to gastric reduction surgery. More particularly, the present invention relates to closure mechanisms specifically adapted for use during endoscopic gastric reduction surgery.

BACKGROUND OF THE INVENTION Morbid obesity is a serious medical condition. In fact, morbid obesity has become highly pervasive in the United States, as well as in other countries and the trend seems to be heading in a negative direction. Complications associated with morbid obesity include hypertension, diabetes, coronary artery disease, congestive heart failure, multiple orthopedic problems, and pulmonary insufficiency with significantly decreased life expectancy. With this in mind, and as those skilled in the art will appreciate with certainty, the economic and physical costs associated with morbid obesity are substantial. In fact, it was estimated that the costs related to obesity exceed 100 billion dollars, only in the United States. A variety of surgical procedures have been developed to treat obesity. The most commonly performed procedure is Roux gastric deviation in Y (RYGB). This procedure is highly complex and is commonly used to treat people who exhibit morbid obesity. However, and with this in mind, approximately 100,000 procedures are performed annually in the United States alone. Other forms of bariatric surgery that include the Fobi sac, the biliary-pancreatic diversion, and the "stomach stapling" or gastroplastic. In addition, devices that can be implanted are known to limit the passage of food through the stomach and affect satiety. Another commonly used gastric reduction procedure is vertical gastroplasty. This procedure is achieved by applying a series of horizontal sutures to create an incomplete horizontal line that defines a small back pocket for restricting food intake. This procedure is commonly used laparoscopically and as such requires substantial preoperative, operative and postoperative resources. Regardless of the procedure employed, many gastric reduction procedures require that a suture (s) be installed, creating a defined region through which nutrients can pass and restricting oral intake. The sutures used during these Procedures are commonly secured to the stomach wall through the implementation of closure mechanisms provided with openings through which the suture can be passed to secure them within the stomach wall. Passing the suture through a series of locking mechanisms placed in an appropriate manner, you have the ability to create a sachet of previously defined dimensions within the stomach of an individual. With this in mind, the problems associated with gastric restriction surgery are strongly linked to the issue of apposition, restraint and tissue control. Because these procedures are relatively new and the associated closure mechanisms have already been fully developed for the specific problems encountered during gastric reduction procedures, there is a need for new closure mechanisms designed to function optimally during the reduction procedures Gastric Said closure mechanisms must be provided for the maintenance of apposition of the tissue, holding and controlling the tissue in a way that prevents erosion of the sutures through the stomach wall and provides a penetration depth that can be predicted through the wall stomach The present invention provides such a variety of closure mechanisms specifically adapted for gastric reduction procedures through tissue apposition.

BRIEF DESCRIPTION OF THE INVENTION Accordingly, it is an object of the present invention to provide a closure mechanism for use during endoscopic procedures in which a suture is used to create a previously defined sachet through the apposition of tissue into the stomach. The closure mechanism includes a body of the closure mechanism having a tissue anchor to selectively secure the body of the closure mechanism to the tissue. The body of the closure mechanism also includes a connection opening formed and sized for the passage of a suture therethrough. It is also an object of the present invention to provide a locking mechanism wherein the body of the locking mechanism is substantially W-shaped. It is another object of the present invention to provide a locking mechanism, wherein a body of the locking mechanism includes the first and second C-shaped segments extending from the connection opening. It is still a further object of the present invention to provide a locking mechanism, wherein the body of the closing mechanism includes first, second and third anchors extending downwardly therefrom and first and second activation wings.

It is also an object of the present invention to provide a locking mechanism wherein the locking mechanism body includes a tongue anchor with a retracting tip. It is also another object of the present invention to provide a closure mechanism, wherein the body of the closure mechanism is composed of an elongate, elastic member, the elongate member includes a first end and a second end. The first and second ends are pointed to pierce the tissue from the application. The elongate element includes a first closed loop and a second loop created by aligning the first end and the second end of the elongate element. It is still another object of the present invention to provide a closure mechanism, wherein the body of the closure mechanism is comprised of first and second interlocking semicircular loops for closing and locking within the tissue of an individual. Other objects and advantages of the present invention will become apparent from the following detailed description, when viewed in conjunction with the accompanying drawings, which establish certain embodiments of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a cross-sectional view showing the purpose of closure mechanisms in gastric reduction surgery.

Figures 2, 3 and 4, describe a first embodiment of closing mechanism according to the present invention. Figures 5, 6 and 7 show another embodiment of a closing mechanism according to the present invention. Figures 8, 9 and 10, show another embodiment of a closing mechanism according to the present invention. Figures 11, 12 and 13, still show another embodiment of a closing mechanism according to the present invention. Figures 14 and 15, still describe another embodiment of a closing mechanism according to the present invention. Figures 16, 17 and 18, show another embodiment of a closing mechanism according to the present invention. Figures 19, 20 and 21, show an additional embodiment according to the present invention.

DESCRIPTION OF THE PREFERRED MODALITIES At this point the detailed mode is described. However, it should be understood that the described mode is only exemplary of the present invention, which may be represented in various forms. Therefore, the details described in this description should not be interpreted as limiting, but only as the basis for the Claims and as a basis for teaching those skilled in the art how to make and / or use the present invention. Making reference to the various figures, a variety of locking mechanisms according to the present invention is described. The closure mechanisms are specially adapted to be used during endoscopic procedures, in which a suture is used for the creation of a previously defined sachet through the apposition of tissue into the stomach (or other hollow organ) of an individual. Generally, and with reference to Figure 1, a series of locking mechanisms 10 are secured along the gastric wall 12 in a previously determined configuration. For example, the closure mechanisms 10 can be applied vertically along the stomach 14 creating a closure mechanism configuration necessary to ultimately form a mattress point pattern. Although a mattress stitch pattern is described in accordance with a preferred embodiment of the present invention, those skilled in the art will appreciate that other stitch patterns may be employed in accordance with a preferred embodiment of the present invention. The exact direction in which the closure mechanisms are applied is not critical and medical practitioners can apply the closure mechanisms in one direction and another that is better suited to the specific patient. For example, the closing mechanisms 10 can be applied to the gastric wall 12 alternating between the inner wall 12a and the rear wall 12b of stomach 14 as an applicator moves proximally distally or vice versa. Once the closing mechanisms 10 are suitably applied along the gastric wall 12, the suture 16 is linked through a connection opening 18 within the closing mechanism 10, is connected to the closing mechanisms 10. According to a preferred embodiment, the suture 16 is linked to create a mattress stitch pattern within the stomach 14 in a substantially vertical direction extending proximally and distally within the stomach 14. Once all the mechanisms of closure 10 is placed along the gastric wall 12 and the suture 16 is linked through the connection openings 18 of the closure mechanisms 10 in a mattress point pattern, the suture 16 can be pulled taut to attract the gastric walls 12a, 12b in approximation to each other. The resulting structure of the stomach 14 is that of a tubular element that connects the esophagus to the pylorus with the gastric remnant, allowed to pass the gastric acid into the food stream. This produces a lower stomach volume, as well as restriction media for the bolus. The various closure mechanisms described in accordance with the present invention are intended as two-stage deployment devices. In particular, the first stage of the deployment is to pierce the fabric with the tips of the closing mechanism (the locking mechanism being loaded) in the applicator and the deployment stage one is performed with the closing mechanism in a deformed or loaded position). The second stage of deployment, that is, the stage of deployment two, consists in releasing the application mechanism responsible for maintaining the aforementioned loaded position of the closing mechanism, thus allowing the closing mechanism to jump to its natural position . From the translation of the closing mechanism into the natural position, the tips of the closing mechanism, both pierce the tissue deeper, and - push the tissue to the apex of the closure mechanism, thus capturing the suture in a semi-stable position. With reference to Figures 2, 3 and 4, a first embodiment of the present invention is described. The closing mechanism 100 includes a main body 12 substantially in the form of W, with the first and second anchors 104, 106 depending on this. In particular, the main body 102 includes four angularly oriented segments 108, 110, 112, 114, which are adapted to move relative to achieve the objectives of the present invention. The first and second inner segments 108, 110 are coupled to create an apex or opening 116, in which the suture 118 is contained securely. The third and fourth outer segments 112, 114 extend respectively from the first and second segments 108, 110 and from there bear the respective anchors. According to a preferred embodiment of the present invention, the anchors 104, 106 are curved elements extending from the third and fourth segments 112, 114 in a way that optimizes the secure connection during activation thereof. In practice, the closure mechanism 100 is a diagonal spring, and maintained in an orientation as shown substantially in Figure 3 with the third and fourth segments 112, 114 being drawn to the first and second segments 108, 110, and the tips of the first and second anchors 104, 106 substantially parallel to each other. The closing mechanism 100 is maintained in this orientation by an applicator. With this in mind, the closure mechanism 100 is held in this position until it is urged into the stomach tissue at a desired location with the anchors 104, 106 inserted perpendicularly within the tissue. Once placed properly as shown in Figure 4, the closing mechanism 100 is released by the applicator and the third and fourth outer segments 112, 114 of the closure mechanism 100 are allowed to swing away from the respective first and second segments 108, 110 toward the tissue of the individual. The tips of the anchors 104, 106, therefore, leap towards each other and the closing mechanism 100 ultimately pierces the tissue within the anchors 104, 106. With the anchors 104, 106 securely held within the tissue and the first and second segments 108, 110 defining an apex 116 in which the suture 118 is maintained, the suture 118 is securely supported in relation to the tissue of the individual undergoing the procedure.

Referring to Figures 5, 6 and 7, a second embodiment of a closing mechanism 200 according to the present invention is described. The closure mechanism 200 includes a substantially W-shaped main body 202 with first and second anchors 204, 206 depending thereon. In particular, the main body 202 includes four angularly oriented segments 208, 210, 212, 214, which are adapted to move in relation to achieve the objectives of the present invention. The first and second inner segments 208, 210 are coupled to create an apex or opening, in which the suture 218 will be contained safely. The third and fourth outer segments 212, 214, respectively, extend from the first and second segments 208. , 210 and support the respective anchors 204, 206 therefrom. According to a preferred embodiment of the present invention, the anchors 204, 206 are curved elements extending from the third and fourth segments 210, 212, in a way that optimizes the secure connection from the activation thereof. In practice, the closing mechanism 200 is a spring inclined to an orientation substantially like that shown in Figure 6, with the third and fourth segments 212, 214 twisted in relation to the first and second segments 208. , 210 along the longitudinal axes of the respective third and fourth segments 212, 214. The closure mechanism 200 is maintained in this orientation by an applicator. When the closing mechanism 200 is oriented in this inclined configuration, the tips of the first and second anchors 204, 206 are substantially parallel to each other. The closure mechanism 200 is held in this position until it is urged into the stomach tissue at a desired location with the anchors 204, 206 perpendicularly inserted into the tissue. Once properly positioned as shown in Figure 7, the closing mechanism 200 is released by the applicator and the third and fourth outer segments 212, 214 of the closing mechanism 200 are allowed to rotate relative to the first and second. respective segments 208, 210, and around the longitudinal axes of the respective third and fourth segments 212, 214, towards the individual's tissue. The tips of the anchors 204, 206, thus, jump downwardly into the tissue, ultimately anchoring the closure mechanism 200 within the tissue. With the anchors 204, 206 defining an apex 216, in which the suture 218 is maintained, the suture 218 is supported securely in relation to the tissue of the individual undergoing the procedure. Referring to Figures 8, 9 and 10, a third embodiment of the closing mechanism 300 according to the present invention is described. The closure mechanism 300 includes a main body 302 with first and second anchors 304, 306 depending on it. In particular, the main body 302 includes a central opening section 308 with the first and second C-shaped segments 310, 312 extending therefrom. The central opening section 308 is generally V-shaped and is formed and sized for the passage of a suture 314 once the closure mechanism 300 is adequately secured to the gastric tissue. The first and second C-shaped segments 310, 312 extend from opposite ends of the central opening section 308 reside in a plane, which is substantially perpendicular to that of the V-shaped central opening section 308. With this in mind, the first and second C-shaped segments 310, 312 are oriented to reside on the fabric, forming a base for the closure mechanism 300, while the central opening section 308 is adapted to extend away from the tissue that defines an opening 316 through which the suture 314 can pass. Each of the C-shaped segments 310, 312, includes a first leg 314, 318 and a second leg 316, 320 with the first leg 314, 318 coupled to the central opening section 308 and the second leg 316, 320 extending substantially parallel thereto. The second legs 316, 320 of the first and second C-shaped segments 310, 312 each include a downwardly directed anchor 304, 306 extending therefrom. According to a preferred embodiment of the present invention, the anchors 304, 306 are curved elements extending from the second legs 316, 320 of the first and second respective C-shaped segments 310, 312 in a form that optimizes the secure connection from the activation of them.

In practice, the closing mechanism 300 is a spring inclined to an orientation substantially like that shown in Figure 9 with the second legs 316, 320 of the first and second C-shaped segments 310, 312 drawn upwards in relation with the central opening section 308 and the first legs 314, 318 of the first and second C-shaped segments 310, 312, respectively. The closing mechanism 300 is maintained in this orientation by an applicator. In this orientation, the tips of the first and second anchors 304, 306 are substantially parallel to each other. With this in mind, the closure mechanism 300 is held in this position until it is urged into the stomach tissue to a desired location with the anchors 304, 306 inserted perpendicularly within the tissue. Once properly positioned as shown in Figure 10, the closing mechanism 300 is released by the applicator and the second legs 316, 320 of the first and second C-shaped segments 310, 312 of the locking mechanism 300 are released. It allows oscillating down towards the individual's tissue. The tips of the anchors 304, 306, thus jump away from each other and the closing mechanism 300 ultimately pierces the tissue within the anchors 304, 306. With the anchors 304, 306 securely held within the tissue and the central opening section 308 defining an apex 316 in which the suture 314 is maintained, the suture 314 is securely supported in relation to the tissue of the individual undergoing the procedure.

With respect to Figures 11, 12, and 13, an additional embodiment of a locking mechanism 400 according to the present invention is described. This embodiment includes a main body 402 with first, second and third anchors 404, 406, 408 extending down therefrom. The main body 402 further includes a pair of activation wings 410, 412 extending therefrom. In particular, the main body 402 includes a central segment 414, which is inclined in an elastic manner for the inversion of a concave configuration into a convex configuration, in which the anchors 404, 406, 408 securely grip and engage the fabric in which they are mounted. The central segment 414 includes a first end 416 and a second end 418. The first and second activation wings 410, 412 extend respectively from the first and second ends 416, 418 of the central segment 414. The first and second activation wings 410, 412 are secured to the central segment 414 in a shape that allows movement in the form of a pivot relative thereto. In this sense, the first and second activation wings 410, 412 are selectively rotated from an insertion position, in which they extend upwards from the central segment 414, to a partially unfolded state, in which they are oriented in obliquely in relation to the central segment 414, and finally to a fully deployed position, where they are aligned substantially with the central segment 414.

As the first and second activation wings 410, 412 rotate from their insertion position to the fully deployed position, a fulcrum is created, which causes the central segment 414 to undergo a change in the shape of its concave configuration to its convex configuration. The movement of the central segment 414 between the concave configuration and the convex configuration causes the first, second and third anchors 404, 406, 408 to be removed together in a form that facilitates the coupling to the fabric. As the central segment 414 moves between its convex configuration and its concave configuration, the anchors 404, 406, 408 are simultaneously extracted together in a form that engages the tissue in which they are assembled. More particularly, when the closing mechanism 400 is oriented in its initial insertion form, with the first and second activation wings 410, 412 extending therefrom and the central segment 414 in a concave configuration, the first, second and third anchors 404, 406, 408 extend downwardly into the tissue with the second anchor 406 extending deep inside the tissue. As the activation wings 410, 412 are rotated to their partially unfolded position, the center segment 414 is inverted to its convex configuration with the second anchor 406 being pushed up and the first and third anchors being pulled toward the second anchor 406. As the first and second activation wings 410, 412 move further towards the tissue, and the closing mechanism 400 reaches its orientation completely unfolded, the first and third anchors 404, 408 are further extracted from each other, piercing the tissue therebetween and engaging the closure mechanism 400 in position along the tissue. Referring to Figures 14 and 15, another embodiment of a closure mechanism 500 according to the present invention is described. The closure mechanism 500 includes a tongue anchor 508 with a retractable tip 506. The closure mechanism also includes a loop 510 at its distal end. In practice, the retractable tip 506 extends during penetration into the gastric tissue. A suture is placed through the loop 510 and the closure mechanism 500 can thus be applied to the tissue. As the anchor 508 penetrates the tissue with the tip 506 in its extended position, the tabs 512 along the anchor 508 hold the closure mechanism 500 within the tissue in place. Once properly positioned, tip 506 can be retracted allowing for a smoother penetration and reducing the possibility of tissue damage. The retraction of the tip 506 of the closing mechanism 500 is additionally achieved by incorporating an inclined spring 502 into the body of the closing mechanism 504. The inclined spring 502 acts from the tip shaft 412 which forces the tip 506 to a position retracted when the closure mechanism 500 is not loaded inside an applicator. Referring to Figures 16, 17 and 18, a sixth embodiment of a closing mechanism 600 according to the present invention is described. invention. The closure mechanism includes a main body 602 composed of an elongate, elongate element 604. The elongate member 604 includes a first end 606 and a second end 608. As will be apparent from the following description, the first and second ends are oriented to pierce the fabric from the application and function as anchors within the spirit of the present invention. The elongated member 604 is generally formed in the form of an "8" with a first closed loop 610 and a second loop 612 created by aligning the first and second ends 606, 608 of the elongate member 604. The first loop 610 has the form and is sized to receive a suture 612 that passes through it. The second loop 612, with the first and second ends 606, 608 in an orientation relationship are formed and sized for the selective opening allowing the tissue to be "pinched" and retained therein. With this in mind, the closing mechanism 600 operates in a manner very similar to a spring loaded clip, and preferably, the tips thereof overlap. The closing mechanism 600 is designed in such a way that it can be elastically inclined, pulling the first and second ends 606, 608 of the elongated element 604 away from each other before securing them inside the fabric and as such, can be made from materials with shape memory, for example, Nitinol. This creates an opening into which tissue can be placed. Once the closing mechanism 600 is placed suitably with the tissue within the second loop 612, the closure mechanism 600 can be released allowing the first and second ends 606, 608 of the elongate member 604 to move toward each other and securely couple the closure mechanism 600 to the tissue gastric. That is, the closure mechanism 600 is formed much like a "tight loop" in which, when the first loop 600 is tightened, the anchors, ie, the first and second ends 606, 608 of the elongate element are allowed. 604 are separated allowing the tissue to enter the space between the anchors 606, 608. After which, the release of the first loop 610 causes the anchors 606, 608 to jump towards each other by capturing the tissue and securing the closing mechanism 600 to the tissue. Referring to Figures 19, 20 and 21, a seventh embodiment of a closing mechanism 700 according to the present invention is described. According to this embodiment, the closing mechanism 700 is composed of two interconnected semicircular loops 702, 704 for closing and locking within the tissue of an individual. More particularly, the closing mechanism 700 includes a first inner loop 702 and a second outer loop 704. The first inner loop 702 includes a first end 706 and a second end 708. The first end 706 is provided with a sharp point formed and sized to function as an anchor element for penetration through the tissue of an individual. The second end 708 is provided with a blocking element 710 having a locking opening 712 formed and sized for the passage of the second outer loop 704 therethrough. Similarly, the second outer loop 704 includes a first end 714 and a second end 716. The first end 714 of the second outer loop 704 is formed and sized to pass through the blocking opening 712 of the first inner loop 702. The first end 714 of the second outer loop 704 is additionally formed and sized as an anchor element for penetration through the tissue of an individual. The second end 716 of the second outer loop 704 includes an inner lock member 718 having a lock opening 720 formed and sized to receive the first end 716 of the first inner loop 702 in a shape that allows relative locking of the first loop interior 702 relative to it. In practice, the first inner loop 702 sits within the second outer loop 704, such that the first inner loop 702 and the second outer loop 704 conform to each other. As mentioned above, the first end 706 of the first inner loop 702 sits within the blocking opening 720 of the blocking element 717 of the second outer loop 704 and the first end 714 of the second outer loop 704 sits within the opening of the outer loop 704. blocking 712 of the blocking element 710 of the first inner loop 702. In this regard, the first inner loop 702 and the second outer loop 704 are held securely relative to each other, although they are allowed to rotate relative to each other as the first ends 706, 714 of the first and second respective loops 702, 704 pass through the blocking elements 710, 717 of the loops 702, 704. In accordance with a preferred embodiment of the present invention, as the first inner loop 702 is rotated in the clockwise direction and the second outer loop 704 is rotated counterclockwise, the first ends 705, 714 of the first and second respective loops 702, 704 move towards each other while that the blocking elements 710, 717 of the first and second loops 702, 704 also move towards each other in a position diametrically opposite the meeting point of the first ends 706, 714 of the first and second loops 702, 704. When the first ends 706, 714 of the first and second loops 702, 704 are located, the locking elements 710, 717 are also in a substantially circular configuration. When the first inner loop 702 and the second outer loop 704 are thus rotated adjacent to the fabric, the first ends 706, 714 of the first and second loops 702, 704 penetrate the tissue anchoring the closure mechanism 700 there. The blocking elements 710, 718 are locked in relation to the respective loops 702, 704, using tapered locks. Once the blocking elements 710, 718 are locked in relation to the respective loops 702, 704 passing through them, the closing mechanism 700 is maintained from securely in position and the loop 702, 704 is securely coupled to the fabric. The locking elements 710, 718 are additionally provided with openings 722 through which an instrument can be passed to facilitate mounting of the closure mechanism 700 within the stomach tissue. It was contemplated that the various embodiments presented above may be provided with coatings to allow and / or improve the inward growth of the fabric. The devices can also be coated with materials designed to prevent adhesion of bacteria (biofilm) such as those that are commercially available (ie, the closure mechanism only passes through the mucosa) or permanent fixation (ie, the closing mechanism passes through the entire tissue). Although the preferred embodiments have been shown and described, it should be understood that there is no intent to limit the present invention by said description, but instead, it is intended to encompass all modifications and alternative constructions that are within the spirit and scope of the present invention.

Claims (20)

NOVELTY OF THE INVENTION CLAIMS

1. - A closure mechanism for use during endoscopic procedures in which a suture is used to create a previously defined sachet through an apposition of tissue within the stomach, characterized in that the closure mechanism comprises: a closure mechanism body that includes a tissue anchor for selectively securing the body of the closure mechanism to the tissue; The body of the closure mechanism also includes a connection opening formed and sized for the passage of a suture therethrough.

2. The closing mechanism in accordance with the claim 1, further characterized in that the body of the closing mechanism is substantially an inclined spring W-shaped and includes first and second anchors.

3. The closing mechanism in accordance with the claim 2, further characterized in that the body of the closing mechanism includes first and second inner segments coupled to create the connection opening.

4. The closing mechanism in accordance with the claim 3, further characterized in that the third and fourth outer segments extend respectively from the first and second inner segments, and the first and second anchors extend from the third and fourth outer segments.

5. The closing mechanism in accordance with the claim 4, further characterized in that the third and fourth outer segments rotate in a torsional fashion in relation to the first and second inner segments and along the longitudinal axes of the respective third and fourth segments.

6. The closing mechanism according to the claim 4, further characterized in that the third and fourth outer segments rotate in relation to the first and second inner segments and about axes substantially parallel to the longitudinal axes of the respective third and fourth outer segments.

7. The closing mechanism according to claim 1, further characterized in that the body of the closing mechanism includes first and second C-shaped segments extending from the connection opening.

8. The closing mechanism in accordance with the claim 7, further characterized in that the connection opening is generally V-shaped.

9.- The closing mechanism in accordance with the claim. 8, further characterized in that the first and second C-shaped segments extend from opposite ends of the connection opening and they reside in a plane that is substantially perpendicular to that of the V-shaped connection opening.

10. The closing mechanism in accordance with the Claim 8, further characterized in that each of the first and second C-shaped segments includes a first leg and a second leg with the first leg coupled to the connection opening and the second leg extending substantially parallel thereto.

11. The closing mechanism according to claim 1, further characterized in that the body of the closing mechanism includes first, second and third anchors extending downwardly therefrom and first and second activation wings.

12. The closing mechanism according to claim 11, further characterized in that the body of the closing mechanism includes a central segment, which is inclined in an elastic manner for the inversion of a concave configuration to a convex configuration in which, The first, second and third anchors hold securely and attach to the fabric on which they are mounted.

13. The closing mechanism according to claim 1, further characterized in that the body of the closure mechanism includes an anchor with tabs with a retracting tip.

14. The closing mechanism according to claim 13, further characterized in that the body of the closing mechanism also includes a loop at its distal end.

15. - The closing mechanism according to claim 1, further characterized in that the body of the closing mechanism is composed of an elongated, elastic element, wherein the elongate element includes a first end and a second end, the first and second ends are sharp to pierce tissue from the application, the elongated element includes a first closed loop and a second loop created by aligning the first end and the second end of the elongated element.

16. The closing mechanism according to claim 15, further characterized in that the first loop is the connection opening.

17. The closing mechanism according to claim 15, further characterized in that the second loop, with the first end and the second end in an orientation relationship with each other, is formed and dimensioned to open selectively.

18. The closing mechanism according to claim 1, further characterized in that the body of the closure mechanism is composed of first and second interrelated semicircular loops for closing and locking within the tissue of an individual.

19.- The closing mechanism in accordance with the Claim 18, further characterized in that the first and second semicircular loops are respectively a first inner loop and a second outer loop.

20. - The closing mechanism according to claim 19, further characterized in that the first inner loop includes a first end and a second end, the first end being provided with a sharp tip formed and sized to function as an anchor element for penetration through the tissue of an individual and the second outer loop includes a first end and a second end, the first end being provided with a sharp tip formed and sized to function as an anchor element for penetration through the tissue of an individual .