MXPA06004254A - Surgical clip - Google Patents

Abstract

A clip is provided that canbe used for ligating tissue, such as vessels, other tubular ducts, and the like. The clip has opposed first and second leg members having proximal and distal ends. The proximal end of each leg member is connected by an apex having a notch formed therein. Moreover, each leg member has an inner tissue-contacting surface and an outer compression-receiving surface, both of which include features to provide a more secure ligation of the vessel or duct. A method for ligating vessels is also provided.

Description

SURGICAL BROOCH FIELD OF THE INVENTION The present invention relates to surgical instruments, and in particular to surgical fasteners and methods used to ligate vessels, other ducts and the like.

BACKGROUND OF THE INVENTION During many surgical procedures, the surgeon will have to close or ligate several blood vessels and other ducts before cutting them to avoid excessive bleeding and reduce the risk of other complications for the patient. Another binding technique is to sew a suture around the vessel to close it. Alternatively, a surgeon may place a clasp that has a pair of limbs connected to its proximal ends around the vessel and urge or press the limbs together to close the vessel. A disadvantage associated with some current brooches used to attach cups is that the ends of the brooch tend to detach some degree after the release of a brooch applicator. This phenomenon is known as duckbill. The duckbill can result in insufficient bonding of a vessel, thus leading to an excessive loss of blood and / or unnecessary damage to the vessel. Additionally, some known fastening clips are often difficult to preload on a fastener applicator due to the resistance between the fabric disposed between the jaws and the fastening characteristics at the ends of the fastener. Accordingly, there is a need for an improved surgical instrument and method and in particular surgical clips used to ligate blood vessels, other ducts and the like.

BRIEF DESCRIPTION OF THE INVENTION The present invention provides various methods and devices for ligating tissue, such as vessels, other ducts and the like. In one aspect, a surgical clip is provided which includes a pair of opposed first and second end members with a hinge portion formed therebetween. Although the apex may have a wide variety of configurations, in one embodiment, the apex may have opposite ends joining the proximal ends of said first and second limb elements. Still further, the apex may include a notch formed in an interior surface thereof. The clasp can have a variety of features that help provide a more secure bonding of the vessel. In an exemplary embodiment, the first and second end members may include an interior surface having at least one tissue fastener formed on this one. The tissue fastener elements may have a variety of configurations, such as a longitudinal tongue formed on the first end member and a longitudinal groove formed on the second end member. The tongue and groove can be complementary and arranged opposite one another. Still further, the tongue and groove may extend along the entire length of the inner surface of each end element or a portion thereof. The tissue fastener elements of the first and second end members may also include at least one channel oriented at an angle to the longitudinal axis of the first and second end members. In another example embodiment, the first and second end members may include an outer surface having at least one raised portion formed thereon. The raised portion may be a pad disposed on an outer surface of each of the first and second end members located near a point approximately halfway between the apex and the hinged portion of each end element. In one embodiment, the raised area may be approximately one third of the path between the apex and the joint and closer to the apex. In another aspect, a device is described for ligating tissue having first and second end elements, such as a joint portion formed therebetween. An apex can join the proximal ends of the first and second limb elements so that the first element of limb and the second extremity element are opposite each other. Although the apex may have a variety of configurations, in an exemplary embodiment the apex includes a notch formed in an interior surface thereof. In another aspect, a surgical clip is described which has the shape of a substantially U-shaped element that includes an apex joining first and second extremity members. The apex may also include a notch formed thereon. In an exemplary embodiment, the end members may include at least one tissue fastener element formed on an inner surface thereof and a joint portion formed between the proximal and distal ends thereof. Furthermore, each limb element can have a width of less than about 1.27 mm, and a deformation resistance greater than about 1968.59 kg / cm2. In another exemplary embodiment, the clasp may include a raised area disposed on an outer surface of each of the first and second extremity members near a point between the apex and the portion of each limb member. The elevated area may be approximately one third of the path between the apex and the joint and closer to the apex. In another aspect, there is provided a device for ligating tissue having opposed first and second end members with proximal and distal ends and a joint portion that is formed between the proximal ends of each of the end members.

An apex having opposite ends joins the proximal and distal ends of the opposite end members. The end elements further include interior and exterior surfaces, the exterior surface having at least one raised area on a portion thereof. In one embodiment, the raised area is located approximately one third of the path between the apex and the joint portion, closest to the apex. In other embodiments, the device may further include at least one tissue holding feature formed on the inner surface of the opposite end members, as well as a notch formed on the inner surface of the apex. In another aspect, a tie clip is provided having a pair of opposite ends joined together at a proximal end by an apex. The opposite ends may have a distal end and a joint portion disposed distally of the apex and a raised area formed on an outer surface of each end between the apex and the joint. The raised area is effective to share with the articulation portions a load applied by a closing force so that the articulation portions are subjected to less plastic deformation and retain some elasticity, where upon releasing the closing force the distal ends of the clasp they remain in contact with one another. A method for ligating vessels is also provided wherein a closing force is applied to each end member so that in a partially closed position the articulation portions of each element of limb are substantially parallel to each other when the distal ends of each limb element are in contact with each other. As the closing force continues to apply to the clasp, the raised areas and the articulation portions share a load applied by the closing force such that the articulation portions undergo less plastic deformation and retain some elasticity, where upon releasing the force Closing the distal ends of the clasp are in contact with each other.

BRIEF DESCRIPTION OF THE DRAWINGS The invention will be better understood from the following detailed description taken in conjunction with the accompanying drawings, wherein: Figure 1 is a perspective view of one embodiment of a surgical snap described herein; Figure 2A is a side perspective view of a brooch in accordance with another embodiment of the invention; Figure 2B is a side perspective view of a portion of the distal end and an end element of the clasp of Figure 2A; Figure 2C is a plan view of the clasp of Figure 2A; Figure 2D is a sectional view of the clip of Figure 2C along Figures 2D-2D; Figure 2E is a sectional view of the clasp of Figure 2C along the lines 2E-2E; Figure 3 is another perspective view of a brooch in accordance with the invention; Figure 4A is a perspective view of a brooch in accordance with the invention; Figure 4B is a top plan view of an interior portion of the apex of Figure 4A; Figure 4C is a side perspective view of an anterior portion of the apex of the clasp of Figure 4A; Figure 5A is another side perspective view of a clasp in accordance with the invention in an open position; Figure 5B is a side perspective view of the clasp of Figure 5A in a first partial closing condition; Figure 5C is a side perspective view of the clasp of Figure 5A in a state of near full closure; Figure 5D is a side perspective view of the clasp of Figure 5A completely closed; and Figure 5E is a side perspective view of the clasp of Figure 5A after its release by a snap applicator.

DETAILED DESCRIPTION OF THE INVENTION Certain exemplary embodiments will now be described to provide a comprehensive understanding of the principles of structure, function, manufacture and use of the devices and methods described herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are modalities of non-restrictive examples and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with an example embodiment may be combined with the characteristics of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention. The present invention provides various devices for ligating tissue, such as vessels, other tubular ducts and the like. Figures 1-4C illustrate exemplary embodiments of a snap described here in an open position. Referring generally to Figure 1, the clasp 10 in its open position is generally U-shaped having opposite end members 12, 14 attached at an apex 22. Each end member 12, 14 has a joint portion 20 disposed distally of the apex 22. Moreover, each end member 12, 14 has a contact surface with the inner tissue 12, 14 and an opposite outer surface 12c, 14c, both of which may have characteristics to provide a safer bonding of the vessel or duct. For example, the interior surface (s) 12d, 14d may include several tissue fastener elements formed therein (discussed in greater detail below). The interior surface (s) 12c, 14c, may (have) at least one raised area 26 (shown in Figure 3) formed thereon between the articulation portion 20 and the apex 22. Although the clasp 10 of the invention is described herein in the context of a device for ligating vessels, a person skilled in the art will appreciate that the surgical clasp 10 of the present invention can be used to ligate a variety of other body tissues, including without restriction of veins, arteries, ducts or any other tubular element within a patient for which binding is required. Still further, the brooch 10 can be used in a variety of brooch applicators, thereby effecting a wide range of surgical procedures. Although the clasp 10 is described herein with respect to the bond, it is understood that a variety of other applications are possible. The clasp can have any shape in its open configuration which allows a vessel to be effectively linked as a substantially U-shaped or substantially V-shaped design. As noted above in an exemplary embodiment, the clasp 10 is substantially U-shaped. That is, the proximal portions 12a, 14a of the end elements 12, 14 of the clasp 10 are oriented at an acute angle to the central axis A of the clasp 10 and the transition to a joint portion 20 to an orientation wherein the distal portions 12b, 14b, of the end members 12, 14 are parallel to one another and to the central axis A. One skilled in the art will recognize that the size of the clasp 10 may vary depending on its application in particular. In an exemplary embodiment, the clasp 10 may have a length l on the scale of about 5 mm to 15 mm, and more preferably on the scale of about 7.5 mm to 8.5 mm. In its open configuration, the clasp 10 can have a width W as shown in Figure 3 measured between opposing inner surfaces 12d, 14d of the end members 12, 14 on the scale of about 2mm to 8mm, and more preferably of scale of about 3 mm to 4 mm. The size of the end members 12, 14 may also vary depending on the particular application, however in one embodiment, each end member 12, 14 may have a width w, which is shown in Figures 2D and 2E, less 1.27 mm, more preferably on the scale of about 0.63 mm to about 1.01 mm, more preferably less than about 0.88 mm. Furthermore, each end member 12, 14 can have a height H (shown in Figure 3) on the scale of about 0.38 mm to 0.76 mm, and more preferably on the scale of 0.45 mm to 0.63 mm, and more preferably on the scale from 0.48 mm to 0.50 mm. The clasp can also have physical properties, such as resistance to deformation that are appropriate for a desired application. In one example embodiment, the resistance to deformation is greater than around 1968.59 kg / cm2 and less than around 4218 kg / cm2, and more preferably on the scale of about 2019 kg / cm2 to 3515 kg / cm2. In general, the clasp 10 constructed in accordance with the present invention has a resistance to deformation that is equivalent to or greater than the clasps having larger dimensions. The clasp 10 of the present invention is further designed in such a way that, when closed, a vessel, for example, is completely enclosed between the end elements 12, 14 of the clasp 10. This is done by urging the end elements. 12, 14 of the clasp 10 to be closed together, typically with the assistance of an applicator, to encircle the vessel. Referring now to Figures 2A-2E, the clasp 10 has first and second opposite end members 12, 14 each with proximal and distal ends 12a, 14a, 12b, 14b. The proximal and distal ends 12a, 14a, 12b, 14b have opposite inner tissue contact surfaces 12d, 14d and outer compression receiving surfaces 12c, 14c that are connected by upper and lower sides 12e, 14e, 12f, 14f. One skilled in the art will appreciate that the end members 12, 14 can have any transverse shape that allows them to effectively close and join tissue, such as a vessel. Exemplary transverse shapes include, without restriction, triangular, rectangular, trapezoidal and pentagonal. However, as shown, the end members 12, 14 are substantially rectangular. The substantially rectangular tip shape is believed to provide an optimal design that includes greater Flexural strength for a given snap extremity space envelope. The end members 12, 14 may also have a variety of features formed within or on these to assist in the ligation of a vessel or duct. For example, the inner surface 12c, 14c of each end member 12, 14 may include tissue fastener elements and the outer surface 12c, 14c of each end member 12, 14 may include a joint portion 20, as well as less an elevated area 26. Optionally, one or more notches may be formed on the outer surface 12c, 14c in the same manner. As shown in Figures 2A-2E, the tissue fastener elements formed on an inner surface 12d, 14d of each end member 12, 14 may include both primary elements 16, 17 and secondary 18 tissue fasteners. The primary fabric fastener elements 16, 17 may have any configuration that allows them to effectively hold a vessel or tissue. In one embodiment, the primary fabric fastener elements may include at least one tongue 17 formed on the inner surface 14 of the second end member 14 and at least one groove 16 formed on the inner surface 12d of the first end member 12. The groove 16 and tongue 17 can extend continuously along the inner surface 12d, 14d of each end element 12, 14. Alternatively, the inner surface 12d, 14d may include multiple slot segments 16 and tab 17 formed thereon. The slot 16 and tab 17 can be formed in a variety of locations on each of the first and second end members 12, 14. In one embodiment, the slot 16 and tab 17 can extend longitudinally along the entire length or along of at least a portion of the length of the inner surface 12d, 14d of each corresponding end member 12, 14. Alternatively, the tongue 17 and groove 16 may extend from the distal end 12b, 14b of each end member 12, 14 a just distal of the apex 22, or from the distal end 12b, 14b of each end member 12, 14 a just distal to the hinge portion 20. Further, the groove 16 and tab 17 may extend distally from the apex 22 at a position just distal to the articulation portion 20. As a non-restrictive example, Figure 1 illustrates a longitudinal groove 16 and a longitudinal tongue 17 that extend through the art portion. 20 and ends just distal to the notch 24 at the apex 22. Alternatively, Figure 2A illustrates a longitudinal groove 16 and a longitudinal tongue 17 extending from the distal end 12b, 14b of each end element 12, 14 to a position just distal to the joint portion 20. A second longitudinal slot 16 'and a longitudinal tab 17' in combination are formed just distal to the joint portion 20 extending just distal to the apex 22. Further, FIG. 4A illustrates a longitudinal slot 16 and a longitudinal tab 17 that are formed along the entire interior surface 12d, 14d of each of the first and second end members 12, 14. The slot 16 and tab 17 in combination shown in FIG. Figure 4A terminate at notch 24 of apex 22, as will be discussed in more detail below. The tongue 17 and groove 16 may be arranged to complement one another. Alternatively, the tongue 17 and slot 16 can be located in different locations along each corresponding end member 12, 14. In an exemplary embodiment, the tongue 17 and slot 16 are complementary and arranged opposite each other, so that when the brooch 10 is applied to a cup the tongue 17 will urge the tissue of the blood vessel walls towards the corresponding juxtaposed groove 16. This cooperation between the tongue 17 and the groove 16 inhibits the wrong longitudinal and angled positioning of the brooch 10 in relation with the cup, and also effectively reduces the space between the inner surfaces (in contact with the tissue) of each end member 12, 14. One skilled in the art will appreciate that the slot 16 can have a variety of shapes. In an example embodiment, the groove 16 complements the tongue 17 in shape and can be hemispherical, rectangular, triangular, trapezoidal or oblong. As shown in Figure 2B, an example embodiment uses a groove 16 that is somewhat triangular, having opposite side walls 16a, 16b connected by a base portion 16c. The side walls 16a, 16b can be oriented at various angles with respect to the inner surface 12d, 14d of the end elements 12, 14. In one embodiment, the side walls 16a, 16b are oriented at an angle of less than 120 degrees relative to the inner surface 12d, 14d of the end elements 12, 14, and more preferably at an angle less than 110 degrees relative to the inner surface 12d, 14d of the end members 12, 14. One skilled in the art will appreciate that the base portion 16c may have a variety of configurations. . For example, the base portion 16c may be flat or slightly rounded. In an example embodiment, however, the base portion 16c is slightly rounded. One skilled in the art will appreciate that the slot 16 must have dimensions that are effective in ligating the fabric. For example the slot 16 can have depths in the scale of about 0.03 mm to 0.17 mm, more preferably, on the scale of about 0.06 mm to 0.10 mm. In an exemplary embodiment, the slot 16 may have a depth of about 0.06 mm. Still further, the slot 16 can have a width in the range of about 0.10 mm to 0.50 mm, more preferably in the range of about 0.15 mm to 0.33 mm. Still further, the width of the slot 16 may be uniform across the entire length of the slot 16 or may decrease in the proximal or distal direction. In an exemplary embodiment, the slot 16 has a uniform width. One skilled in the art will also appreciate that the tongue 17 can also have a variety of configurations. However in a example mode, the tongue 17 is complementary in shape and size to the groove 16. Thus, the tongue 17 may be hemispherical, rectangular, triangular, trapezoidal or oblong. In an exemplary embodiment, the tongue 17 is substantially rectangular or trapezoidal. The tongue 17 may also vary in size, however in one example embodiment, the tongue 17 has a size that is complementary to the size of the groove 16, with a height and width no greater than, and preferably slightly less than, the dimensions of the slot 16. This provides space for the tissue of the vessel and minimizes the action of shear stress and excessively local pressures on the vessel tissue during the formation of the clasp. That is, the tab 17 can have a scale height of about 0.03 mm to 0.17 mm, more preferably, on the scale of about 0.06 mm to 0.10 mm. In an exemplary embodiment, the tongue 17 can have a height of about 0.06 mm. The tab 17 may also have a width in the range of about 0.10 mm to 0.50 mm, more preferably in the range of about 0.15 mm to 0.33 mm. Still further, and also similar to the groove 16 above, the tongue 17 may have a uniform width or a width that decreases in the proximal or distal direction. In an example embodiment, the tongue 17 has a uniform width. In addition to the primary fabric fastener elements 16, 17, the inner surfaces 12d, 14d of each of the first and second end members 12, 14 may have at least one element secondary tissue fastener 18, as shown in Figure 2B. Although in one embodiment the tissue fastening side elements 18 are formed on the inner surfaces 12d, 14d of both the first and second end members 12, 14, the tissue fastener secondary element 18 can optionally be formed on the surface 12d, 14d of only one of the first and second end members 12, 14. One skilled in the art will learn that the interior surfaces 12d, 14d of the first and second end members 12, 24 can have any number of tissue fastening side elements 18. In In the exemplary embodiment, the inner surface 12d, 14d has at least four secondary tissue fastening elements 18. The tissue fastening secondary elements 18 may have any configuration that allows them to hold tissue after the application of the clasp 10 to the vessel or conduit . As shown in Fig. 2B, exemplary tissue fastener elements 18 are in the form of channels having opposite first and second walls 18a, 18b connected by the base wall 18c. The channels are generally shaped in serrated teeth, however they can also be cut flush. In an exemplary embodiment, the first wall 18a is formed at an acute angle related to the inner surface 12d, 14d of each end member. In an exemplary embodiment the angle is in the range of about 40 degrees to 90 degrees and more preferably the angle of about 75 degrees. The second wall 18b is also oriented in an acute angle related to the inner surface 12d, 14d of each end element. The acute angle of the second wall 18b, which is generally shallower than the angle of the first wall 18a, may be in the range of about 15 degrees to about 75 degrees, and more preferably is about 45 degrees. One skilled in the art will appreciate that the walls 18a, 18b, 18c may be straight or arched but in the exemplary embodiment the walls 18a, 18b, 18c are slightly arched to facilitate clamping. As shown in Figures 2D-2E, the fabric fastening side elements 18 extend through the width W of the first and second end members 12, 14 at an angle (eg about 45 degrees) relative to an axis. Longitudinal of the limb elements 12, 14. In an exemplary embodiment, a segment of the secondary fabric fastener element 18 is located on one side of the tongue 16 or slot 17 in the first end member 12 and a second element 18 continues at the same angle in the other one. side of the tongue 16 or slot 17 in the first end member 12 and a second element 18 continues at the same angle on the other side of the tongue 16 or groove 17. The tissue attaching side elements 18 are similarly constructed in the second end element 14, however, are at an angle in an opposite orientation to that of the first end element 12. Thus, when the end elements 12, 14 close around a vessel or duct, they form an "x", superimposed , as the picture shows 2E. This configuration allows a higher percentage of the fabric to be held by the fabric fastening secondary elements 18, thus resulting in a more effective binding. The end members 12, 14 may be any number of tissue fastener side elements 18 formed thereon. In the exemplary embodiment, however, each end member 12, 14 has three tissue fastener secondary elements 18 formed thereon. One of ordinary skill in the art will appreciate that the fabric fastener side elements 18 may be uniformly or non-uniformly spaced from one another. In an exemplary embodiment, the fabric fastener side elements 18 are evenly spaced from one another at a distance in the scale of about 1.27 mm to 2.03 mm. Still further, the tissue fastener secondary elements 18 may have any size and depth that is effective in joining and maintaining contact with the fabric. However, in an exemplary embodiment, the fabric fastener side elements 18 have a size on the scale of about 0.20 mm to 0.30 mm in width and about 0.036 mm to 0.08 mm in depth. One skilled in the art will appreciate that the end members 12, 14 of the example snap 10 as shown in Figures 1-4C may include any combination of primary fabric fastener elements 16, 17 and secondary tissue fastener element 18. Without However, an example snap 10 includes both primary elements and secondary fabric fasteners 16, 17, 18. In another exemplary embodiment (not shown), the inner surface 12d 14d of the end members 12, 14 can be smooth and free of primary and secondary tissue fastening elements. The structure and closure properties of the clasp 10, as discussed herein, allow adequate tissue bonding without the need for any type of tissue fastener elements formed on the inner surface 12d, 14d of the end members 12, 14. As shown, for example, in Figure 3, the outer surface 12c, 14c of each end member 12, 14 may include a flexing or hinge portion 20. The hinge portion 20 allows the end members 12, 14 to travel of an acute angle in relation to. the central axis A of the clasp 10 to be substantially parallel in relation to each other and to the central axis A of the clasp 10. The angled articulation portions 20 of the end elements 12, 14 can be formed in a variety of angles in relation to with the central axis A of the brooch 10; however, in one example embodiment the angle may be on the scale of about 45 degrees to about 65 degrees. In one embodiment, the hinge portion 20 is designed to be parallel to the force applying the jaws of a snap applicator during part of the snap closure process as shown in Figure 5B. This construction is believed to improve the retention of the snap by the snap applicator during its implementation.

The hinge portion 20 may have a variety of configurations for carrying out the transition of the end members 12, 14; however, an example hinge portion 20 has a beveled or flattened outer surface 20a and an arcuate inner surface 20b. The beveling on the outer surface 20a may extend over any length sufficient to affect the transition; however, in an exemplary embodiment the bevelling is on the scale of about 0.76 mm to 1.27 mm. The outer surface 20a of the hinge portion 20 may optionally include a groove (not shown) formed therein to facilitate the formation of a raised tongue 17 on the inner surface 12d, 14d of the end members 12, 14. The groove may have similar shape and size to the longitudinal groove 16, which is discussed herein with respect to Figures 2A-2E. The inner surface 20b of the hinge portion 20 may also optionally include features to assist with the ligation of the vessel, duct or tissue. For example, the inner surface 20b may include primary and / or secondary tissue fasteners 16, 17, 18 similar to those discussed above with respect to Figures 2B-2D. As noted above, the outer surface 12c, 14c of each end member 12, 14 may have features to help provide safer occlusion and performance of the clasp. In one embodiment, shown in Figure 3, an elevated area 26 extends over a portion of the width of the end members 12, 14 which is slightly proximal to the articulation portion 20. In an embodiment of For example, the raised area 26 is located approximately one-third of the way between the apex 22 and the articulation portion 20, closest to the apex 22. The raised portion 26 is believed to help reduce overstretching of the joint 20 as well as to assist to keep the ends 12, 14 of the clasp 10 together after the clasp 10 is completely closed. Although Figure 3 shows the raised area 26 formed on both the first and second end members 12, 14, in alternative embodiments, the raised area 26 can be raised on either the first end member 12 or the second end member 14. Even further, the inner surface 12c, 14c of each end member 12, 14 can have any number of raised areas 26. In the exemplary embodiment, the outer surface 12c, 14c of each end member 12, 14 has a raised area 26a, 26b. The raised area 26a, 26b can have any shape that allows effective application of compression force to the apex 22 so that the apex 22 wrinkles to a greater degree than the articulation portion 20. That is, the raised area 26a, 26b is believed to allow the region of the end element 12, 14 between the apex 22 and the joint 20 to be more elastic, the articulation portion 20 springing back a small degree while maintaining adequate contact between the distal ends 12b, 14b of the end elements 12, 14. In an exemplary embodiment, the raised area 26a, 26b is a pad having a shape that is complementary to the shape of the end element 12, 14. Thus, the raised area 26a, 26b may be triangular, rectangular, trapezoidal, pentagonal, etc., but in an exemplary embodiment, the raised area 26a, 26b is substantially rectangular. One skilled in the art will appreciate that the raised area 26a, 26b may have a variety of sizes, depending on whether complete or partial closure of the clasp is necessary. As a non-restrictive example, if a complete closure of the clasp is desired, the height of the raised area 26a, 26b should be able to maintain the preload at distal tips of the end members 12, 14. In an exemplary embodiment, the raised area 26a, 26b has a height on the scale of about 0.01 mm to 0.06 mm, and more preferably is about 0.002 mm. The raised area 26a, 26b may also have a length that is large enough to adequately support the applied pressure from a clip applier. In an exemplary embodiment, the raised area 26a, 26b may have a length of about 0.50 mm, and a width of about 0.25 mm. If partial closing of the clasp is desired, the height of the raised area 26a, 26b may increase. As noted above, the proximal ends of each of the end members 12a, 14b are connected to each other by an apex 22. Although the apex 22 may have a variety of shapes, as shown in Figures 4A-4C, the apex 22 is substantially U-shaped or substantially V-shaped, and has opposite faces (in contact with the fabric) 22d and exterior faces (which have no contact) with the fabric) 22c that are connected by upper and lower surfaces (not shown). The interior surface 22d of the apex 22 can have a variety of configurations to assist with bonding, for example, at least one notch 24 can be formed therein. Although the inner surface 22d may have any number of notches formed therein, an example embodiment utilizes a notch 24. One skilled in the art will appreciate that the notch 24 may have any configuration that permits tissue bonding. In an exemplary embodiment, the notch 24 is formed in a U-shaped channel extending through the inner surface 22d of the apex 22. The U-shaped channel can join the tongue 16 and slot 17 extending to along at least a portion of length of the inner surface 12d, 14d of the end elements 12, 14. The notch 24 can also have a variety of shapes to optimize its mechanical properties and make it rigid and strong for the amount of material in it, although it leaves an open space for the compression material on the inner side of the brooch 10 to flow during the plastic deformation that occurs during the forming of the brooch. In an example embodiment, as shown here, notch 24 is substantially trapezoidal. That is, as shown in Figures 4B-4C, the notch 24 has first and second opposite walls 24a, 24b connected by opposite third and fourth walls 24c, 24d with a base portion 24e extending therebetween. Although the walls 24a, 24b, 24c, 24d may have a variety of configurations, in one example embodiment the walls 24a, 24b, 24c, 24d are formed at an acute angle relative to the interior surface 22d of the apex 22. The angle can be any acute angle, but preferably is on the scale around of 75 degrees. One skilled in the art will appreciate that the walls 24a, 24b, 24c, 24d can also have any shape that provides an area in which deformed tissue can flow. As shown, the walls and the base portion 24a, 24b, 24c, 24d are rounded or slightly contoured. The notch 24 can have a variety of sizes and depths, perhaps this is better described in relation to the thickness and width of the end elements of the clasp 12, 14. The width of the notch 24 should be such that the webs of material in The apex surface 22d are on the scale of about 0.12 mm to 0.25 mm wide. The depth of the notch 24 should be on the scale of about 30% to 60% between the distance between the apex surfaces 22c and 22d, with an example scale of about 30% and 40% of the distance between the surface 22c and 22d. The length of the notch 24 should be on the scale of about 1 time to 2 times the thickness of the end members of clasp 12, 14, with an example length in the scale of about 1.1 times to 1.4 times the thickness of the snap end elements 12, 14. In the case of larger and larger snaps, optimum results may require the use of two or more notches to keep the webs of material on the surface 22d on the scale of about 0.12. mm to 0.25 mm. Others Multiple notch aspects can be expected by following the guidelines listed above. The outer face 22c of the apex 22 can also have a variety of configurations to aid bonding. In an exemplary embodiment, the outer face of the apex 22c has two opposite beveled surfaces converging on a rounded tip. The outer face 22c of the apex 22 is not formed in an acute manner but rather as a radius induced by manufacture, allowing a more secure bonding. The clasp 10 described herein can be made from a variety of surgically appropriate materials, including metals and polymers. Even more, the material can be a bioabsorbable material or a non-bioabsorbable material. In one embodiment, the clasp 10 can be made of any metal or metal alloy having a relatively high annealed deformation resistance and a relatively high stress hardening rate, as compared to existing binding clasps. Suitable metals include tantalum, titanium, stainless steel or alloys thereof. As a non-restrictive example, the clasp 10 can be made from commercially pure titanium or ASTM grade CP1 titanium. This material, when compared to conventional materials, is capable of being hardened with deformation to a greater degree without causing excessive spaces in the formed clasp 10. Furthermore, a small amount of interstitial elements, such as oxygen and nitrogen, can be added to the Brooch material for maintaining the shape of the clasp 10. In an example embodiment, oxygen can be incorporated into the snap material. Other interstitial elements may include nitrogen, carbon and iron. The brooch 10 can also be optionally coated with an antimicrobial or antibiotic material to increase the effectiveness of the brooch against a broad range of infectious or pathogenic agents. Figures 5A-5E illustrate selected steps of the clasp closure, for example for ligating a vessel. As shown in Figure 5a, an open clasp 10 is presented, and can be placed around a desired vessel. A closing force is then applied to the outer surface 12c, 14c of the end members 12, 14 by, for example, force applicator jaws 100 of a snap applicator. As the brooch closes,, as shown in Figure 5B, the articulation portion 20 and the apex 22 are deformed such that the distal ends 12b, 14b of the end members 12, 14 move inward toward each other. In the position shown in Fig. 5B, the clasp characteristics on the joints 20 are predominantly parallel to one another and to the broach applicator jaws 100, helping to stabilize the clasp 10 in the moradazas 100 of the applicator. As the application of closing force to the clasp 10 continues and the distal ends 12b, 14b of the end members 12, 14 move closer together, the raised area 26 begins to share the radial closing forces of the clasp with the articulation portion 20. As As a result of this reduction in pressure, the joint 20 is deformed to a lesser degree, as shown in Figure 5C. Figure 5D illustrates a condition of complete closure of the clasp, with the closing force still applied to the clasp 10 by the closing jaws 100. In the final tablet stages, the raised area 26a, 26b removes load from the articulation portion 20. , thus reducing the amount of plastic deformation of the hinge portion 20. The raised area 26 thus allows the hinge portion 20 to have greater elasticity, such that, for example, the hinge portion 20 can be bent inwardly slightly when the forming loads are released, preloaded by the tips of the clasp 10. This is particularly convenient in that when the applicator is removed from the clasp 10 as shown in Figure 5E, the raised area 26 allows the end members 12, 14 to remain together from the articulation portion 20 to the distal ends 12b, 14b thereof, thereby decreasing the duckbill of the brooch 10. An advantage provided by the broch The present invention is that it tends to be more resistant to "duckbill," a condition in which the distal tips of the tip elements 12, 14 of the snap 10 tend to separate once the force is removed. closing. Some previously known brooches tend to form duck spikes as a result of residual elasticity within the apex. The brooch 10 of the present invention is believed to overcome the tendency to form duckbills because the apex 22 is able to fold a greater degree and thereby minimize the effect of any retroresort. At the same time, a greater elasticity between the apex 22 and the hinge portion 20 allows any retroresort in the hinge portion 20 directed to distal ends 12b, 14b of the end members 12, 14 toward each other. An additional advantage of the aforementioned features of clasp 10 is that the fabric is capable of being captured at any location within the clasp 10 including near the apex 22 or near the distal ends 12b, 14b of the end elements 12, 14 and will continue to be linked effectively. As a result, a surgeon can safely attach vessels that have a variety of sizes. One skilled in the art will appreciate additional features and advantages of the invention based on the embodiments described above. Accordingly, the invention should not be limited by what has been shown and described in particular, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.

Claims (29)

NOVELTY OF THE INVENTION CLAIMS

1. A surgical clasp comprising: a pair of opposed first and second end members having proximal and distal ends with a joint portion formed therebetween, the first and second end elements further include an inner surface having at least one end a tissue fastener element formed thereon and an exterior surface having at least a raised area in a portion thereof; and a part having opposite ends joining the proximal ends of said first and second end elements, the apex further includes at least one notch formed on an inner surface thereof.

2. The clasp according to claim 1, further characterized in that the tissue fastener element of the first end element is a longitudinal tongue and the tissue fastener element of the second end element is a longitudinal groove.

3. The clasp according to claim 2, further characterized in that the tongue and the groove are complementary and are arranged opposite one another.

4. - The clasp according to claim 2, further characterized in that the tongue and the groove extend along the entire length of the inner surface of each end element.

5. The clasp according to claim 2, further characterized in that the tongue has a height in the scale of about 0.03 mm to 0.17 mm.

6. The brooch according to claim 2, further characterized in that the tissue fastener element of the first and second end elements further includes at least one channel oriented at an angle with respect to the inner surface of the first and second end elements. tip.

7. The clasp according to claim 6, further characterized in that the channel is oriented at an angle of about 45 ° with respect to a longitudinal axis of the first and second end elements.

8. The clasp according to claim 1, further characterized in that the notch of the apex has a cross section that is substantially trapezoidal.

9. The clasp according to claim 1, further characterized in that each end element has a width less than about 1.27 mm.

10. - The clasp according to claim 9, further characterized in that the clasp has a resistance to deformation greater than about 1968.59 kg / cm2.

11. The clasp according to claim 1, further characterized in that the raised area is a pad arranged close to a point approximately in path through the apex and the articulation portion of each end element.

12. The clasp according to claim 1, further characterized in that the raised area has a height in the scale of about 0.01 mm to about 0.06 mm.

13. A device for ligating tissue, comprising: a first end element having proximal and distal ends, with a joint portion formed therebetween; a second end element having proximal and distal ends, with a joint portion formed therebetween; and an apex joining the proximal ends of the first and second limb elements, such that the first limb member and the second limb member are opposite each other, the apex further includes at least one notch formed on an inner surface of the same.

14. The device according to claim 13, further characterized in that each of the first and second end element further includes an interior surface having at least one tissue fastener element formed thereon.

15. - The device according to claim 14, further characterized in that the tissue fastener element of the first end element is a longitudinal tongue and the tissue fastener element of the second end member is a longitudinal groove.

16. The device according to claim 15, further characterized in that the tongue and groove are complementary and arranged opposite one another.

17. The device according to claim 14, further characterized in that the tissue fastener element of the first and second end elements further includes at least one channel oriented at an angle with respect to the interior surfaces of each end element.

18. The device according to claim 13, further characterized in that it also includes a raised area arranged on an outer surface of each of the first and second end elements near a point about half way between the apex and the portion of articulation of each limb element.

19. A surgical clasp comprising: a substantially U-shaped element having an apex joining first and second limb elements, the apex further includes at least one notch formed therein and a joint portion formed between one end proximal and distal thereof, each extremity elect also has a width less than about 1.27 mm, and a resistance to deformation greater than around 1968.59 kg / cm2.

20. The clasp according to claim 19, further characterized in that each end element further includes at least one tissue fastener element formed on an inner surface thereof.

21. The brooch according to claim 19, further characterized in that it also includes a raised area arranged on an outer surface of each of the first and second end elements near a point between the apex and the articulation portion of each element tip.

22. A device for ligating tissue, comprising: first and second opposing end elements having proximal and distal ends and also including inner and outer surfaces, the outer surfaces have at least one elevated area on a portion thereof; a joint portion formed between the proximal and distal ends of each of the end members; and an apex having opposite ends joining the proximal ends of the opposite limb elements.

23. The device according to claim 22, further characterized in that the raised area is located approximately one third of the path between the apex and the articulation portion closest to the apex.

24. - The device according to claim 22, further characterized in that the raised area has a height in the scale of about 0.01 mm. to 0.06 mm.

25. The device according to claim 22, further characterized in that it also comprises at least one tissue holding feature formed on the inner surface of the opposite end members.

26. The device according to claim 25, further characterized in that the tissue fastening elements include a longitudinal tongue formed on the first end element and a longitudinal groove formed on the second end element, the tongue and groove adapted to complement each other. one with another.

27. The device according to claim 22, further characterized in that the apex includes at least one notch formed on an inner surface thereof. 28.- A binding clasp, comprising: a pair of opposite ends joined at a proximal end by an apex, the opposite ends each having a distal end and a joint portion disposed distally of the apex and an elevated area formed on a outer surface of each limb between the apex and the joint portions; the raised area is effective to share with the articulation portions a load applied by a closing force such that the articulation portions undergo less plastic deformation and retain certain elasticity, where when releasing the closing force the distal ends of the clasp remain in contact with each other. 29. A method for ligating tissue, comprising: providing a clasp having an opposite extremity joined at a proximal end by an apex, the opposite extremities having a distal end and a joint portion disposed distally of the apex and an elevated area formed on an outer surface of each end element between the apex and the joint portion; applying a closing force to each end member such that in a partially closed position the articulation portions of each end member are substantially parallel to one another when the distal ends of each end member contact one another; and continuing to apply the closing force to the clasp such that the raised areas and the articulation portions share a load applied by the closing force such that the articulation portions undergo less plastic deformation and retain some elasticity, wherein upon release of the closing force the distal ends remain in contact with each other.