US20120029538A1 - Surgical Tack and Tack Drive Apparatus - Google Patents

Abstract

A fastener is provided for attaching body tissue to body tissue or another material to body tissue. The fastener includes a head portion, a body portion, and an anchoring element. The anchoring element is on the distal end of the fastener, and has one or more barbs or similar anchoring devices that are configured to prevent removal of the fastener once it is attached to the body tissue. The head is located on the proximal end of the fastener, and anchors the body tissue or other material when the fastener is attached to the body tissue. The disclosure also provides a driver apparatus for inserting the fasteners. The applicator device includes an indexer for sequentially indexing one or more fasteners, and a driver for applying an insertion force to a fastener that is sufficient to insert the fastener and attach it to body tissue. The disclosure also provides a method of using the fastener and applicator device.

Description

FIELD OF THE INVENTION
• The present invention relates generally to surgical fasteners and drive apparatus for use with surgical fasteners. More specifically, the present invention relates to soft tissue surgical tacks and a tack drive system for the fixation of hernia mesh.
DESCRIPTION OF RELATED ART
• Fasteners are used in various surgical procedures to secure tissue and objects to tissue. One such surgical procedure is the repair of a hernia. A common solution in hernia repair is to attach a mesh patch over the defect so that bowel and other abdominal tissue are blocked from forming an external bulge that is typical of abdominal hernias.
• At present, there are a variety of devices and fasteners available to attach the mesh patch to the inguinal floor or abdominal wall. Such devices and fasteners include sutures, surgical staples, and tacks. The role of the devices and fasteners is to keep the mesh in proper position until tissue in-growth is adequate to hold the mesh in place under various internal and external conditions.
• A hernia repair surgery can be performed either through the traditional open procedure or through the current trend of less invasive procedures such as laparoscopic procedures. Certain previously used devices and fasteners are better suited for open procedures while other devices and fasteners are better suited for laparoscopic procedures.
SUMMARY
• In view of the foregoing, there exists a need for a hernia mesh fastener that is simple to deploy, securely fastens to bodily tissue, and can be absorbed by the body after a period of time when the tissue in-growth to the mesh obviates the need for a fastener. A need also exists for a simple inexpensive fastener drive apparatus that is easy to handle and use by a surgeon and is adaptable for use in both open and laparoscopic procedures. Accordingly, various embodiments disclosed herein provide a fastener, a drive apparatus, and a method for using the drive apparatus to apply a fastener
• It is therefore a feature of an embodiment to provide a fastener for attaching to a body tissue, having a longitudinal direction, a proximal end, and a distal end. The fastener comprises a head portion disposed near the proximal end of the fastener and having a proximal surface, a distal surface, and a passage that extends through the head portion from the proximal surface to the distal surface. The fastener further comprises a body portion extending from the distal surface of the head portion in the longitudinal direction. The fastener further comprises an anchoring element extending from the body portion, and including at least one barb that is at least partially disposed adjacent the distal end of the fastener.
• It is another feature of an embodiment to provide an applicator for applying a barbed fastener to a body tissue, the applicator comprising an elongated tubular portion having a longitudinal axis extending from a proximal end to a distal end and having a tube interior accessible by proximal and distal tube openings. The tube interior is sized and configured for receiving the barbed fastener. The applicator further comprises an indexer disposed at least partially inside the tube interior. The indexer has an elongated indexer body member and a fastener engaging portion adapted to engage the barbed fastener and move the barbed fastener from an initial fastener position in the tube interior to a firing position as the indexer moves from a first longitudinal position to a second, more distal longitudinal position. The applicator also comprises a driver disposed at least partially inside the tube interior. The driver has a driver engaging portion at its distal end. The driver engaging portion is adapted to engage the barbed fastener in the firing position and selectively apply an ejection force to the barbed fastener, thereby ejecting the barbed fastener from the tube interior through the distal opening.
• It is another feature of an embodiment to provide a method a method of applying a fastener to a pre-determined target insertion point on a body tissue. The method comprises providing a fastener having a head portion having a passage formed therethrough, an anchoring element configured for engaging the body tissue, and a body portion extending distally from the head portion to connect the anchoring element thereto. The method further comprises providing a fastener applicator comprising an elongated tubular portion having a longitudinal axis extending from a proximal end to a distal end and having a tube interior accessible by proximal and distal tube openings, an indexer disposed at least partially inside the tube interior, the indexer being adapted to selectively move the fastener from an initial position to a firing position adjacent the distal tube opening, and a driver disposed at least partially inside the tube interior, the driver being adapted to engage the fastener in the firing position and selectively apply an ejection force to the fastener. The method still further comprises placing the fastener in the initial position within the tube interior and causing the indexer to selectively move the fastener from the initial position to the firing position. The method also comprises positioning the distal opening of the tube assembly adjacent the target insertion point and causing the driver to apply the ejection force to the fastener, thereby ejecting the fastener through the distal opening and into the body tissue at the target insertion point.
• These and other objects, features, and advantages of the present invention will appear more fully from the following description of the exemplary embodiments, taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a perspective view of a fastener in accordance with an exemplary embodiment;
• FIG. 2 is a top view of a fastener in accordance with an exemplary embodiment;
• FIG. 3 is a front view of a fastener in accordance with an exemplary embodiment;
• FIG. 4 is a perspective view of a fastener in accordance with an exemplary embodiment;
• FIG. 5 is a partial sectional side view of a tube assembly of a drive apparatus and fasteners, in accordance with an exemplary embodiment;
• FIG. 6 is a partial sectional perspective view of a distal portion of a tube assembly of a drive apparatus and fasteners, in accordance with an exemplary embodiment;
• FIG. 7 is a partial sectional bottom view of a distal portion of a tube assembly of a drive apparatus and fasteners, in accordance with an exemplary embodiment;
• FIG. 8 is a partial sectional top view of a distal portion of a tube assembly of a drive apparatus and fasteners, in accordance with an exemplary embodiment;
• FIG. 9 is a partial sectional top view of a distal portion of a tube assembly of a drive apparatus and fastener, in accordance with an exemplary embodiment;
• FIG. 10 is a partial sectional side view of a handle/actuation portion of a drive apparatus in an initial position, in accordance with an exemplary embodiment;
• FIG. 11 is an enlargement of portion A-A ofFIG. 10, in accordance with an exemplary embodiment;
• FIG. 12 is a partial sectional side view of a handle/actuation portion of a drive apparatus in an intermediate position in accordance with an exemplary embodiment;
• FIG. 13 is a partial sectional side view of a handle/actuation portion of a drive apparatus in a pre-fired position in accordance with an exemplary embodiment; and
• FIG. 14 is a partial sectional side view of a handle/actuation portion of a drive apparatus in a post-fired position in accordance with an exemplary embodiment.
DETAILED DESCRIPTION OF THE EMBODIMENTS
• Hereinafter, aspects of methods and apparatuses in accordance with various exemplary embodiments will be described. As used herein, any term in the singular may be interpreted to be in the plural, and alternatively, any term in the plural may be interpreted to be in the singular.
• As used herein, the term “proximal” refers to the portion of a fastener or fastener drive apparatus closest to the user (i.e., the person inserting the fastener), while the term “distal” refers to the portion of a fastener or fastener drive apparatus furthest from the user.
• Exemplary embodiments include a fastener and fastener drive apparatus for use in surgical procedures. B y way of example, the embodiments are illustrated and described in reference to devices and methods used in conjunction with a hernia repair procedure using a mesh patch. Thus, in the exemplary embodiments, the fasteners may be referred to as a hernia mesh tack and the drive apparatus may be referred to as a tack drive apparatus. However, it is appreciated that the exemplary embodiments are applicable to various other surgical procedures that require the use of a fastener and a fastener drive apparatus.
• The fasteners of the exemplary embodiments are configured to secure body tissue to body tissue, or to secure another material, such as a mesh, to body tissue. For example, a fastener of the exemplary embodiments may be used as a hernia tack that secures a mesh structure to body tissue in a hernia repair procedure. In the exemplary embodiments, the hernia tack is of the axial insertion or “push” type variety and is configured for insertion upon application of a rapid axial insertion impulse, as compared to a steady, drawn out insertion force. The hernia tack of the exemplary embodiments includes barbs that enable easy penetration of the tissue with minimal tissue cutting. The fasteners of the exemplary embodiments can be used in conjunction with a drive apparatus that is configured to position a fastener for insertion, and to apply a rapid insertion impulse to the fastener to permanently insert the fastener into a body tissue. Various exemplary embodiments of such fasteners and drive apparatuses are described in more detail below.
• Referring now toFIGS. 1-4, in which like reference numerals identify similar or identical elements, the details of an exemplary embodiment of afastener100 are described in greater detail. Generally, thefastener100 has a longitudinal direction L_F, as indicated by the arrow inFIG. 1. Along the longitudinal direction, thefastener100 has adistal end104, and aproximal end102. In the exemplary embodiments, thedistal end104 of thefastener100 generally is the portion of thefastener100 that is first inserted through the body tissue. In the embodiments, thefastener100 includes ananchoring element130 located near thedistal end104 of thefastener100, ahead portion110 located near theproximal end102 of thefastener100, and abody portion120 located intermediate the two ends102,104, connecting theanchoring element130 and thehead portion110.
• In the exemplary embodiments, thehead portion110 of thefastener100, can be configured to engage with a body tissue, or other material, such as a mesh, to hold the tissue or material in place against a body tissue. As illustrated inFIGS. 1-4, in the exemplary embodiments, the outer surface ofhead portion110 of thefastener100 can include adistal head face111, aproximal head face112, anupper head face113, and alower head face114. Each of thefaces111,112,113,114, can be flat or substantially flat surfaces, or they can be arcuate to provide a concave or convex surface. For example, in the exemplary embodiment illustrated inFIGS. 1-4,upper head face113 is a flat surface, andlower head face114 is generally an arcuate surface with a convex shape, such as one formed by a smooth arcuate surface, or a series of adjoining arcuate or flat facets. In exemplary embodiments, the arc defined by thelower head face114 can extend at least about 180 degrees and less than 360 degrees. In the embodiment illustrated inFIGS. 1-4, the arcuatelower head face114 provides a 180 degree arc that connects one transverse edge of theupper head face113 to the other transverse edge of theupper head face113. It is appreciated that any or all of thefaces111,112,113,114, can be configured to have any desired shape
• In various embodiments, thehead portion110 may have apassage115 that extends through thehead portion110 from theproximal head face112 to thedistal head face111. Thepassage115 is configured to enable thefastener100 to slide along the drive sequencing indexer mechanism, as will be discussed in more detail later. In exemplary embodiments, thepassage115 may be shaped in such a way as to compliment the shape of the indexer. For example, thepassage115 may be in the form of a bore or a channel that at least partially surrounds the indexer, enabling thefastener100 to slide along the indexer. For example, in embodiments in which the indexer has a rectangular cross-sectional shape, thepassage115 may have a corresponding rectangular shaped bore. In other exemplary embodiments, thepassage115 may be formed as a channel rather than a closed passage, an that it surrounds only a portion of the indexer. It will be understood that thepassage115 may be configured in other suitable forms and shapes suitable for adapting the fastener to slide along an indexer. Thehead portion110 also may be configured to facilitate deployment from an applicator.
• In various exemplary embodiments, thehead portion110 may include one or more anchoring devices such asanchor tabs116 extending from thedistal head face111. Theanchor tabs116 may be configured to assist in anchoring the mesh or other material in place when thefastener100 is inserted. Theanchor tabs116 may provide an attachment that secures more readily to large-holed mesh. For example, during hernia surgery, theanchor tabs116 may engage the hernia mesh strand to provide a more secure bond between the mesh and the tissue. Theanchor tabs116 may have any shape that would enable thetabs116 to anchor the mesh. For example, in embodiments such as those illustrated inFIGS. 1-4, theanchor tabs116 may have a triangular shape. It will be understood that theanchor tabs116 may have many alternative shapes.
• In various exemplary embodiments, thebody portion120 offastener100 extends distally from thehead portion110, and has aproximal body end122 joined with thedistal head face111, and adistal body end121. In exemplary embodiments, thebody portion120 and thehead portion110 may be integrally formed to form a single unit. However, it will be understood that thebody portion120 andhead portion110 may be separately formed, and joined together to form thefastener100. Thebody portion120 additionally may have anupper body face123 and alower body face124. In exemplary embodiments, theupper body face123 and thelower body face124 may have flat or substantially flat surfaces, or surfaces that have a partial curve. In some embodiments, theupper body face123 may be coplanar with theupper head face113. In some embodiments, thelower body face124 may be coplanar with theupper passage surface117.
• In exemplary embodiments, thedistal body end121 may have one ormore anchoring elements130. The anchoringelement130 andbody portion120 may be integrally formed, or may be separately formed and operably joined together. In the embodiment illustrated inFIGS. 1-4, the anchoringelement130 has a pair ofbarbs131,132.Barbs131,132 may have aproximal anchor point136 that has a width (measured at its widest point) that is wider than thedistal edge137, which prevents expulsion or removal of thefastener100 from the body tissue once thefastener100 is applied. Thebarbs131,132 also may haveupper facets133 andlower facets134 that taper to an angledleading edge135. Theleading edge135 is configured to have a cutting portion and a stretching portion. When thefastener100 is inserted, the width of the incision is only as wide as the effective diameter from the proximal ends of the cutting portions of the twobarbs131,132. The stretching portion serves to widen the incision to admit the tack without further tissue cutting. When thebarbs131,132 are fully inserted into the tissue the stretched incision tends to close back up, thereby improving the security of the tissue attachment to the insertedfastener100.
• In some embodiments, thefirst barb131 is longitudinally offset from thesecond barb132. Where the impact force is directed through the centerline of thebody portion120, the offset barb configuration provides a more acute angle of penetration than with non-offset barbs. It is believed that the offset barb configuration allows for easier tissue penetration by utilizing less force, and also allowing the relationship to theproximal anchor point136 and thedistal body end121 to be geometrically enhanced allowing for increased tissue pull out force. In addition, it is believed that the offset allows less tissue cutting and stretching relative to the effective width of the two proximal anchor points136. While the anchoringelement130 is shown with two offsetbarbs131,132, it will be understood that the anchoringelement130 may have more barbs or fewer barbs, and the barbs configuration may vary.
• Thefastener100 and components thereof may be made of any of various materials suitable for insertion into the human body. In various embodiments, thefastener100 of the may be made of biocompatible material, such as stainless steel or titanium. In various exemplary embodiments, thefastener100 may be made of an absorbable material, such as a polymer. Exemplary absorbable materials include homopolymers and copolymers of lactide, glycolide, polyglycolide, polylactide, or various combinations or mixtures thereof. It will be understood that there are various suitable polymers and that each exhibits different absorption rates, and different shear and tensile strengths when molded.
• It will be understood that thefastener100 will have dimensions suitable for insertion into the human body, and suitable to provide a stable anchoring structure. For example, in various embodiments, thefastener100 may have an effective overall length (measured longitudinally fromproximal end102 to distal end104) in the range of about 4 mm to about 6 mm. In the various embodiments, the diameter of thehead portion110 measured transversely at the widest point may be in the range of about 4 mm to about 10 mm
• In exemplary embodiments, thefasteners100 may be adapted so that a plurality offasteners100 may be loaded for application by adrive apparatus200. In various exemplary embodiments, one ormore fasteners100 may be loaded into afastener drive apparatus200 and inserted into the surgical field, either directly, as in the case of open surgery, or through a trocar cannula. Thefasteners100 should be sized to be compatible with the size of thedrive apparatus200 and associated devices. For example, thefasteners100 may be sized to fit through different diameter tube assemblies, thus different size trocar ports.Smaller fasteners100 enable the use of smaller tube assemblies. For example,small fasteners100 having a diameter of about 4 mm make possible the use of a trocar cannula with a diameter as small as about 5 mm.
• Turning now toFIGS. 5-14 adrive apparatus200 according to an exemplary embodiment will be described. In various embodiments,drive apparatus200 is configured to enable a user such as a surgeon to insert and secure afastener100 to a body tissue. Preferably, thedrive apparatus200 is configured for easy manipulation and one-handed use by a user. In an exemplary embodiment, one ormore fasteners100 may be loaded into thedrive apparatus200, so that they may be individually deployed by thedrive apparatus200. In exemplary embodiments, thedrive apparatus200 may have a sequencer orindexer260 to align and shift thefasteners100 inside thedrive apparatus200. Thedrive apparatus200 further may have adriver mechanism270 to provide a rapid impulse force to afastener100, ejecting thefastener100 from thedrive apparatus200 with sufficient force to insert thefastener100 into a body tissue.
• As illustrated inFIG. 10, in various exemplary embodiments, thedrive apparatus200 has a handle/actuation assembly210 and atube assembly250. Thetube assembly250 may be configured to house a plurality offasteners100. Thetube assembly250 has adistal end254, from which thefasteners100 are ejected. The handle/actuation assembly210 provides ahandgrip214 that enables the user to manipulate thedrive apparatus200. In exemplary embodiments, the handle/actuator assembly210 further includes atrigger216 that, when triggered, actuates theindexer260, thedriver mechanism270, or both.
• In exemplary embodiments, thetube assembly250 has an elongatedtube portion252, extending in a longitudinal direction, L_T, and having a length Y. At its proximal end, theelongated tube portion252 is joined with the handle/actuation assembly210. The distal end of theelongated tube portion252 coincides with thedistal end254 of thetube assembly250, from which the one ormore fasteners100 are ejected. The length Y of theelongated tube portion252, measured from its proximal end to its distal end, may be selected according to the intended use of thedrive apparatus200. For example, in an embodiment in which thedrive apparatus200 is used in laparoscopic procedures, theelongated tube portion252 may have a length of about12 inches to about 15 inches. In an embodiment in which thedrive apparatus200 is used for non-laparoscopic applications, a length of about 4 inches to about 9 inches may be more suitable. As guided by the disclosure herein, it will be understood by one of ordinary skill in the art how to select a suitable length for theelongated tube portion252, depending on the intended use of thedrive apparatus200.
• Turning now toFIGS. 5-9, thetube assembly250 will be described in more detail. As illustrated in the figures, in various exemplary embodiments, thetube assembly250 houses anindexer260, adriver270, and a spacer. Generally speaking, theindexer260 serves the purpose of indexing the one ormore fasteners100 within thetube assembly250, and moving them toward thedistal end254 of thetube assembly250 so that they may be ejected. Thedriver270 generally serves the purpose of ejecting thedistal-most fastener100 from thedistal end254 of thetube assembly250. The spacer generally serves the purpose of aligning thedriver270, theindexer260 within thetube assembly250. Each of these devices is explained in more detail herein.
• In various exemplary embodiments, theindexer260 may have anelongated member262 adapted to temporarily secure thefasteners100 within thetube assembly250, and to index thefasteners100 in a distal direction along the longitudinal direction L_Tof thetube assembly250. For example, theindexer260 may have anelongated member262 that is adapted to fit within thepassage115 of the one ormore fasteners100 loaded in thedrive apparatus200. It will be understood that in other exemplary embodiments, theelongated member262 may be disposed along one or more sides of thefasteners100, rather than through thecentral passage115 of thefasteners100.
• In exemplary embodiments, theelongated member262 may move in a direction substantially parallel to the longitudinal direction L_Tof thetube assembly250. Theelongated member262 may have one or more features that enable it to transport the one ormore fasteners100 within thetube assembly250. For example, theindexer260 may further have a plurality ofindexer engagers264,266, that temporarily secure thefasteners100 to theindexer260, so that thefasteners100 move with theindexer260. In the exemplary embodiment illustrated inFIG. 6, theindexer260 has anelongated member262 that is coupled with adistal index engager264 and aproximal index engager266. Theelongated member262 fits inside thepassage115 of one or more fasteners100 (seeFIGS. 5 and 7). Theproximal index engager266 is configured to engage with theproximal head face112 offastener100. Thedistal index engager264 is configured to temporarily engage with thedistal head face111 offastener100. In this configuration, theindex engagers264,266, temporarily secure thefastener100 to theelongated member262 so that thefasteners100 move with theelongated member262.
• In various embodiments, theindexer260 may be configured to enable thefasteners100 to move independently from theindexer260. For example,index engagers264,266, may be configured to enable thefasteners100 to slide in a distal direction along theelongated member262, but prevent thefasteners100 from moving in a proximal direction. In the exemplary embodiment illustrated inFIG. 6, theproximal index engager266 has two angledarms267 that extend toward theproximal head face112 of thefastener100. At its widest point, which is adjacent theproximal head face112, thearms267 render theproximal index engager266 wider than thepassage115 of thefastener100, providing a stop that prevents the proximal movement of thefastener100 relative to theindexer260. Thearms267 are sufficiently flexible to enable thefastener100 to slide over theproximal index engager266 in a distal direction. However, once thefastener100 has slid past theproximal index engager266, thearms267 shift back to their initial configuration, preventing the proximal movement of thefastener100 relative to theindexer260. In the exemplary embodiment ofFIG. 6, thedistal index engager264 has twoarms265 extending toward thedistal head face111 of thefastener100. Thearms265 have rounded ends that are capable of limiting the distal movement of thefastener100 relative to theindexer260, but when a force that exceeds a predetermined threshold is applied to thefastener100, thearms265 flex inward, enabling thefastener100 to slide in a distal direction over thedistal index engager264. It will be understood how to specify the predetermined threshold, consistent with the guidance provided herein.
• In various exemplary embodiments, thetube assembly250 may be configured to limit the proximal movement of thefasteners100 relative to thetube assembly250. In the exemplary embodiment illustrated inFIG. 6, theelongated tube portion252 may have, along its inner surface, one ormore lance tabs256 that provide an interference point along theelongated tube portion252, preventing the proximal movement of thefasteners100 relative to theelongated tube portion252. For example, in the embodiment illustrated inFIG. 6,lance tabs256 project from the inner surface of theelongated tube portion252, at an angle toward the distal end of theelongated tube portion252. At its distal end, thelance tabs256 reduces the width of theelongated tube portion252 so that it is narrower than the width of thehead portion110 of thefastener100, providing a stop that prevents thefastener100 from moving in a proximal direction relative to theelongated tube portion252. However, thelance tabs256 are capable of flexing outward when thefastener100 slides past them in a distal direction. In exemplary embodiments, thelance tabs256 may be provided in pairs, disposed on opposite sides of theelongated tube portion252. In certain embodiments, thelance tabs256 are made of punch-outs on theelongated tube portion252, that are flexed or bent toward the center of theelongated tube portion252. In this configuration, thelance tabs256 are integral with theelongated tube portion252. However, it will be understood that thelance tabs256 may be separately formed, and attached to the inner surface of theelongated tube portion252, to provide projections, flanges, or other suitable structures along the interior of theelongated tube portion252. It will be understood that other features may be provided as an alternative to, or in addition to thelance tabs256, to limit the proximal movement of thefasteners100 relative to theelongated tube portion252.
• In various exemplary embodiments theindexer260 is configured to indexmultiple fasteners100 within theelongated tube portion252.FIG. 5 illustrates aside elevation view of anexemplary tube assembly250, with a portion of theelongated tube portion252 cut away to reveal the internal elements.FIG. 7 illustrates a bottom view of anexemplary tube assembly250, with a portion of theelongated tube portion252 cut away to reveal the internal elements. In these exemplary embodiment, threefasteners100a,100b,and100care shown, but it will be understood that thedrive apparatus200 may be configured to hold more, or fewer,fasteners100.Indexer260 preferably has a number ofproximal index engagers266, anddistal index engagers264 that is equal to or greater than the number offasteners100 loaded in thedrive apparatus200, so that eachfastener100 is secured to theindexer260 prior to being expelled from thedrive apparatus200.Indexer260 has anelongated member262, that extends through the passage (not shown) of therespective head portions110a,110b,110c,of each of thefasteners100a,100b,100c.Adjacent the distal head face (111a,111b,111c) of each head portion is adistal index engager264a,264b,264c,and adjacent each proximal head face (112a,112b,112c) isproximal index engager266a,266b,266c.Lancetabs256 are located on the inner surface of theelongated tube portion252, and are shown abutting the proximal head faces (112a,112b,112c) of thefasteners100a,100b,100c.
• The operation of theindexer260 will now be described in reference to the embodiments ofFIGS. 5,7, and8. For purposes of discussion, theindexer260 inFIGS. 5 and 7 is illustrated in its initial, proximal-most position (i.e., the position it holds during the initial stage of operation),which is also its reset position; theindexer260 inFIG. 8 is illustrated in its distal-most position, which is its position at the pre-firing stage. From this position, theindexer260 may be described as having a cyclical movement, during which it may move distally from its initial position to its pre-firing stage position (the distal stroke) and then proximally back to the initial position (the proximal stroke), completing a full cycle of movement.
• In an exemplary embodiment, during the indexer's260 distal stroke, theindexer260 moves thefasteners100a,100b,and100cwhich are held in place by therespective index engagers264a-cand266a-c.The distal stroke of theindexer260 may end when thefasteners100a,100b,100cadvance beyond thenext lance tab256, as illustrated inFIG. 8. This places thedistal-most fastener100ain its firing position relative to thetube assembly250; i.e., the position at which it is ready to be ejected from thetube assembly250, such as bydriver270. After theindexer260 reaches its pre-firing stage position, it may commence its proximal stroke. During the indexer's260 proximal stroke, thelance tabs256 prevent the proximal movement of thefasteners100a,100b,100crelative to thetube assembly250, as described above. Therefore, the proximal movement of theindexer260 creates a force between thedistal index engagers264a,264b,264c,and the respective distal head faces111a,111b,111c.When this force reaches a certain threshold, thedistal index engagers264a,264b,264cwill flex inward and slide through the passage (not shown) of therespective fastener100a,100b,100c,enabling theindexer260 to continue its proximal stroke without moving thefasteners100a,100b,100c.The indexer's260 proximal stroke continues untilindex engagers264a-cand266a-c,engage with the next proximal fastener (e.g.,index engagers264aand266amay engage with nextproximal fastener100b,andindex engagers264band266bmay engage with nextproximal fastener100c,etc.) At this point, theindexer260 has returned to its initial position, completing a full cycle. In exemplary embodiments, the length of the distal stroke of theindexer260 is about equal to the distance betweenadjacent lance tabs256. Theindexer260 may repeat this cycle one or more times, advancing all of thefasteners100 distally within thetube assembly250 as described above.
• In exemplary embodiments, theindexer260 is operably coupled with the handle/actuation assembly210 so that movement of theindexer260 is controlled by one or more mechanisms within the handle/actuation assembly210, which is described in more detail below.
• In various embodiments, thedriver assembly200 has adriver270 that is configured to provide an ejection force to afastener100, expelling thefastener100 from thedistal end254 of thetube assembly250. In exemplary embodiments, the vector of the ejection force is substantially parallel to the longitudinal direction L_Tof thetube assembly250, and the force is applied to thefastener100 so that thefastener100 is expelled in a direction that is substantially parallel to the longitudinal direction L_Tof thetube assembly250. In exemplary embodiments, the ejection force is sufficient to insert thefastener100 into a body tissue. In certain embodiments, the ejection force is an impulse force that fires thefastener100 from thedistal end254 of thetube assembly250.
• As illustrated inFIG. 5, in various exemplary embodiments thedriver270 may be an elongated member, such as a beam or shaft, that terminates on its distal end at anejector portion276. The elongated driver member may have a rectangular cross section; however, it will be understood that the elongated driver member may have any of a number of suitable different shapes and configurations. In exemplary embodiments, the elongated member of thedriver270 may have astraight portion272, anangular portion274 that is angled downward toward theejector portion276. In this configuration, thestraight portion272 of thedriver270 may be offset from the pathway of movement of thefasteners100a,100b,100c,while theejector portion276 delivers the ejection force along the pathway of movement of thefasteners100a,100b,100c.It will be understood that thedriver270 may have other physical configurations consistent with its function of delivering the ejection force to thefasteners100a,100b,100c.
• The operation of thedriver270 will now be described in reference to the embodiments ofFIGS. 5,7,8, and9. For purposes of discussion, thedriver270 inFIGS. 5 and 7 is illustrated in its initial position (also the reset position); thedriver270 inFIG. 8 is illustrated in its pre-firing position, and thedriver270 inFIG. 9 is illustrated in its firing position. From its initial position, thedriver270 is at or near its distal-most position. From this position, thedriver270 may be described as having a cyclical movement, during which may move proximally toward the handle/actuation assembly210 of the driver apparatus200 (the proximal stroke) and then distally back to the initial position (the distal stroke), completing a full cycle of movement. In exemplary embodiments, thedriver270 may move in a direction substantially parallel to the longitudinal direction L_Tof thetube assembly250.
• In the exemplary embodiment illustrated inFIG. 5, thedriver270 is shown in its initial position (also reset position) with theejector portion276 of thedriver270 adjacent thedistal end254 of thetube assembly250. During its proximal stroke, thedriver270 retracts away from thefiring position258 of thetube assembly250, while theindexer260 indexes thedistal-most fastener100 into thefiring position258. At the end of its distal stroke,driver270 is in its pre-firing position, as illustrated inFIG. 8. In the pre-firing position,ejector portion276 of thedriver270 is adjacent to theproximal head surface112 of thefastener100 that is in thefiring position258. During its distal stroke, thedriver270 delivers an ejection force (e.g., an impulse force) to thedistal-most fastener100 located in thefiring position258. As illustrated inFIG. 9, when thedriver270 is in its firing position, it is ejecting thisfastener100 from thedistal end254 of thetube assembly250. In exemplary embodiments, thedriver270 ejects thefastener100 with sufficient force and speed that thefastener100 is securely inserted into the surgical field, such as into a hernia mesh or a body tissue. Once thefastener100 is ejected by thedriver270, thedriver270 is in its initial position (or reset position), as illustrated inFIGS. 5 and 7,
• As illustrated inFIG. 5, thedriver270 may be disposed near the upper portion of theelongated tube portion252, so that it is above theindexer260, andfasteners100. In this configuration, thestraight portion272 of the elongated member is generally disposed above thefasteners100. In various embodiments, theejector portion276 of thedriver270 may move up and down during the driver's270 cycle of movement. For example, in the driver's270 proximal stroke, thedriver270 may flex or pivot upward from its initial position so that theejector portion276 moves out of the indexing pathway offasteners100. During the distal stroke of thedriver270, theejector portion276 may drop down behind thefastener100 that is in thefiring position258, so that theejector portion276 pushes thefastener100 along a path of movement that is parallel to the longitudinal direction L_Tof thetube assembly250.
• While the embodiments thus far have been described with respect to adriver270 that is located above thefasteners100, it will be understood that thedriver270 may be located instead in a different area or region, such as above or to one or more sides of thefasteners100, or thedriver270 may be aligned with the path of movement of thefasteners100.
• In exemplary embodiments, the direction and speed of the movement of thedriver270 is independent of the movement of theindexer260. For example, thedriver270 may be in its distal stroke when theindexer260 is in its proximal stroke. In addition, during their respective distal strokes, the rate of speed of thedriver270 may be faster than the speed of theindexer260.
• In exemplary embodiments, thedriver270 is operably coupled with the handle/actuation assembly210 so that movement of thedriver270 is controlled by one or more mechanisms within the handle/actuation assembly210, which is described in more detail below.
• In exemplary embodiments, thedrive apparatus200 may have a spacer disposed with in thetube assembly250, in theelongated tube portion252. The spacer may be configured to maintain the alignment of thedriver270, theindexer260, and thefasteners100, within theelongated tube portion252. In exemplary embodiments, the spacer is stationary relative to theelongated tube portion252. However, it will be understood that the spacer may move relative to one or more components of the tube assembly.
• As previously indicated, thedrive apparatus200 may have a handle/actuation assembly210 that provides ahousing212, ahandgrip portion214, and atrigger216.FIG. 10 illustrates a section view of a handle/actuation assembly210 according to an exemplary embodiment. Thehousing212 defines an interior space that houses the mechanical elements of the handle/actuation assembly210. It will be understood that only one side of thehousing212 is illustrated inFIG. 10, and that thecomplete housing212 may include a mirror image portion, fastened to the illustrated portion, such as by screws or other mechanical fasteners, or by welding. The distal end of thehousing212 has atube assembly opening220, through which thetube assembly250 is inserted so that it may be operably coupled with one or more mechanical elements inside thehousing212. The proximal portion of the handle/actuation assembly210 comprises ahandgrip portion214, which is configured for easy manipulation for a user. It will be understood how to design thehandgrip portion214 with various contours and features suitable for this purpose.
• In exemplary embodiments, atrigger216 is pivotably coupled with the handle/actuation assembly210 attrigger pivot218, located at least partially withinhousing212.Trigger216 may be configured so that it may be easily manipulated by a user from outside of the housing. For example, in the embodiment illustrated inFIG. 10, thetrigger216 may be a lever arm adjacent thehandgrip portion214. Thetrigger216 may be manipulated by the user, for example, by squeezing the lever arm toward thehandgrip portion214, causing thetrigger216 to rotate in a counter-clockwise direction abouttrigger pivot218. It will be understood thattrigger216 may comprise one of various other triggering devices now known or later developed, consistent with the teachings provided herein. In exemplary embodiments,trigger216 is biased toward the untriggered position. For example, thetrigger216 may be biased by using a torsion spring, a spring clip, or other suitable devices. One of ordinary skill in the art would be able to design and configure various devices suitable for biasing thetrigger216, using the guidance provided herein.
• In exemplary embodiments,trigger216 is operably coupled with at least one actuator, such that manipulation of thetrigger216 actuates theindexer260, thedriver270, or both. In exemplary embodiments,trigger216 is operably coupled with anindexer actuator assembly230 that is operably coupled with (either directly or indirectly) theindexer260. In exemplary embodiments,trigger216 is operably coupled with adriver actuator assembly240 that is operably coupled with (either directly or indirectly) thedriver270. In the various embodiments,indexer actuator assembly230 anddriver actuator assembly240 are disposed at least partially withinhousing212, and are operably coupled with thetube assembly250, which at least partially extends from thetube opening220 inhousing212.
• In exemplary embodiments,indexer actuator assembly230 is operably coupled with theindexer260, to provide the mechanical action necessary to move theindexer260 through its full cycle of motion. Theindexer actuator assembly230 of an exemplary embodiment will now be described with reference toFIGS. 10-13. In exemplary embodiments, theindexer actuator assembly230 includes acam232 that is operably coupled with thetrigger216 and translates the rotational movement of thetrigger216 about thetrigger pivot218, into longitudinal movement ofpusher arm231.FIG. 10 illustrates the exemplaryindexer actuator assembly230 at or near its initial position (also its reset position), in which thetrigger216 has not been squeezed, and thepusher arm231 is at its proximal-most position. In the exemplary embodiment, astrigger216 is squeezed, thetrigger216 pivots in a counter clockwise direction abouttrigger pivot218. When thetrigger216 pivots, thecam232 causes thepusher arm231 to move in a distal direction.FIG. 12 illustrates the exemplaryindexer actuator assembly230 in this intermediate position, in which thetrigger216 has been squeezed, so that it has partially rotated abouttrigger pivot218, andcam232 has engaged withpusher arm231 to push it in a distal direction. Theindexer260 is operably coupled withindexer actuator assembly230, such that distal movement of thepusher arm231 causes distal movement of the indexer260 (i.e., the distal stroke of the indexer260). When thetrigger216 is fully squeezed, as illustrated inFIG. 13, thepusher arm231 reaches its distal-most position, and theindexer260 completes its distal stroke. When thetrigger216 is thereafter released, a biasing force acts on theindexer actuator assembly230 to move thepusher arm231 in a proximal direction, thereby causing theindexer260 to move in its proximal stroke. The biasing force may be provided by one or more biasing devices that are operably coupled with thetrigger216, thetrigger pivot218, thecam232, thepusher arm231, or any combination thereof. The biasing force is sufficient to return the pusher arm231 (and therefore the indexer260) to its initial position (e.g.,FIG. 10).
• In exemplary embodiments, driveactuator assembly240 is operably coupled with thedriver270, to provide the mechanical action necessary to move thedriver270 through its full cycle of motion. Thedriver actuator assembly240 of an exemplary embodiment will now be described with reference toFIGS. 10-13. In exemplary embodiments, thedriver actuator assembly240 includes aslideable plunger245 that is slidably coupled with acentral shaft247, so that theplunger245 may move in a proximal and distal direction along theshaft247.FIG. 10 illustrates the exemplarydriver actuator assembly240 at or near its initial position (or reset position), in which thepusher arm245 is at its distal-most position. Thedriver270 may be coupled with thedriver actuator assembly240 such that proximal movement of theslideable plunger245 causes proximal movement of the driver270 (e.g., its proximal stroke), and distal movement of theslidable plunger245 causes distal movement of the driver270 (e.g., its distal stroke). A biasingspring248 biases theplunger245 toward the distal end of theshaft247, and therefore biases the driver toward thedistal end254 of thetube assembly250.
• In exemplary embodiments, theslideable plunger245 ofdriver actuator assembly240 is operably coupled with thetrigger216, so that the squeezing thetrigger216 moves the slideable plunger245 (and likewise the driver270) in a proximal direction. For example, scissor beams241 may be attached at one end to the handle/actuation assembly210, such as at abeam pivot242; thefree end244 of the scissor beams241 may be operably coupled with the proximal end of theslideable plunger245, such as atlip246. The scissor beams241 are joined at elbow joint243, and are biased toward a closed position, such as with a torsion spring or other suitable device. Elbow joint243 may be operably coupled with thetrigger216, such that squeezing of thetrigger216 causes the scissor beams241 to straighten at the elbow joint243, so that thefree end244 of thebeams241 pushes on thelip246 of theslideable plunger245, causingplunger245 to slide in a proximal direction alongshaft247.FIG. 12 illustrates thedriver actuator assembly240 in an intermediate position, in which thetrigger216 has not been fully squeezed, the scissor beams241 are partially straightened or extended, and theplunger245 has moved in a proximal direction along thecentral shaft247. The proximal movement of theplunger245 causes thedriver270 to move along its proximal stroke. When thetrigger216 is fully squeezed, theplunger245 reaches a pre-firing position (illustrated inFIG. 13), at which point theplunger245 is at its proximal-most point and thebeams241 are still engaged with thelip246. After thedriver actuation assembly240 reaches the pre-firing position, when thetrigger216 is further squeezed, thebeams241 are configured to automatically disengage from theplunger245, enabling the biasingspring248 to force theplunger245 to slide in a distal direction.FIG. 14 illustrates thedriver actuator assembly240 in a post-firing position, just after the scissor beams241 have released from theplunger245, and theplunger245 has moved in a distal direction alongcentral shaft247. The distal movement of theplunger245 causes thedriver270 to move along its distal stroke, thereby “firing”fastener100, or ejecting it from thedistal end254 of thetube assembly250. In exemplary embodiments the biasingspring248 is configured to deliver an impulse force to theplunger245 toward its initial distal-most position. This impulse movement is translated along thedriver270, to theejector portion276 of thedriver270, which delivers the impulse force to thefastener100 that is in thefiring position258 within thetube assembly250, thereby ejecting thefastener100 with sufficient force to insert thefastener100 into the surgical field, such as through a hernia mesh or body tissue. One of ordinary skill in the art would understand how to configurespring248 to exert such a force, and would be able to apply such a spring to adrive apparatus200, using the guidance provided herein.
• In various exemplary embodiments, when thetrigger216 is released after it has been fully squeezed (so as to deliver the impulse force), thedriver actuation assembly240 returns to its initial position, as illustrated inFIGS. 10 and 11. During the return to the initial position, the scissor beams241 return to their initial position, and thefree end244 of thebeams241 automatically re-engages with thelip246 ofplunger245, so that thedriver actuator assembly240 is ready for another cycle of motion.
• In various exemplary embodiments, the handle/actuation assembly210 also includes atrigger lock233, that prevents thetrigger216 from being released before it reaches its fully squeezed position, which may cause the inadvertent sequencing offasteners100, and release of thedriver270. For example, thetrigger lock233 may include a device that mechanically interferes with the rotation of thetrigger216 aboutpivot218. One of ordinary skill in the art will understand the various devices that could be used as a trigger lock, and would be able to apply them to the handle/actuation assembly210 using the guidance provided herein.
• In exemplary embodiments,trigger216 is operably coupled with bothindexer actuator assembly230, anddriver actuator assembly240, so that manipulation of thetrigger216 actuates bothassemblies230,240. In various embodiments, theindexer260 anddriver270 are independently coupled with thetrigger216 so that thedriver270 and theindexer260 may be moved independently of each other when thetrigger216 is triggered. However, in exemplary embodiments, from the perspective of the user, the triggered actions of thedrive apparatus200 may appear to be simultaneous.
• The method of operation of thedrive apparatus200 to deploy afastener100 may best be understood in reference to the exemplary embodiments illustrated inFIGS. 10-14. In exemplary embodiments, thedrive apparatus200 is manually operated by a user, such as a surgeon, who manipulates thedrive apparatus200 such as by grasping thehandgrip portion214, so as to position thedistal end254 of thetube assembly250 adjacent the location where thefastener100 is to be inserted. The user then squeezes thetrigger216, pulling it toward thehandgrip portion214, which causes thedrive apparatus200 to advance through a series of stages of operation described in more detail below.
• FIG. 10 illustrates anexemplary drive apparatus200 in its initial stage, in which thetrigger216 has not been squeezed. In its initial position,plunger245 ofdriver actuator assembly240 is in its distal-most position, and correspondingdriver270 is in its distal-most position, withejector portion276 adjacent thedistal end254 oftube assembly250. In its initial position,pusher arm231 of theindexer actuator assembly230 is in its proximal-most position, andcorresponding indexer260 is in its proximal-most position. In the initial position, nofastener100 is in thefiring position258 of thetube assembly250.
• In the exemplary embodiment, as thetrigger216 is squeezed, thedrive apparatus200 moves into an intermediate stage, illustrated inFIG. 12. In the intermediate position,plunger245 ofdriver actuator assembly240 has moved in a proximal direction, and correspondingdriver270 has progressed into its proximal stroke, in which theejector portion276 of thedriver270 moves away from thedistal end254 oftube assembly250. In its intermediate position,pusher arm231 of theindexer actuator assembly230 has moved in a distal direction, andcorresponding indexer260 has moved in a distal direction within thetube assembly250,indexing fasteners100 in a distal direction toward thedistal end254 of thetube assembly250.
• Just prior thetrigger216 being fully squeezed, thedrive apparatus200 moves into a pre-firing stage, illustrated inFIG. 13. In the pre-firing position,pusher arm231 of theindexer actuator assembly230 is in its distal-most position, andcorresponding indexer260 has finished its distal stroke, so that thedistal-most fastener100 is in thefiring position258 within thetube assembly250. In the pre-firing position,plunger245 of thedriver actuator assembly240 has moved to its proximal-most position, and correspondingdriver270 has completed its proximal stroke, whereby theejector portion276 of thedriver270 is located adjacent theproximal head face112 ofdistal-most fastener100.
• Just past the pre-firing position, as the user continues to squeeze thetrigger216 to its fully squeezed position, the scissor beams241 release fromlip246 ofplunger245. Once released, theplunger245 retracts to its distal-most position, under the compressive force ofspring248. This motion causes the correspondingdriver270 to fire or eject thedistal-most fastener100 that has been loaded byindexer260 into thefiring position258 oftube assembly250. In the exemplary embodiment, after thetrigger216 is fully squeezed, and thedriver270 fires thedistal-most fastener100 from thetube assembly250, thedrive apparatus200 moves into a post-firing stage, illustrated inFIG. 14. In the post-firing position, scissor beams241 have releasedplunger245, which has retracted to its distal-most position, and correspondingdriver270 has ejected thedistal-most fastener100 from thefiring position258, through thedistal end254 of thetube assembly250. In the post-firing position, thepusher arm231 of theindexer actuator assembly230 is at or near its distal-most position, andcorresponding indexer260 is at or near its distal-most position.
• In the exemplary embodiment, when thetrigger216 is released after being fully squeezed, thedrive apparatus200 returns to its initial position, illustrated inFIG. 10. When released, thedriver actuator assembly240 returns to its initial position with theplunger245 in its distal-most position, and the scissor beams241 retract to their initial position, re-engaging with theplunger245. When released,trigger216 rotates in a clockwise direction abouttrigger pivot218, andcam232 andpusher arm231 move in a proximal direction untilpusher arm231 reaches its proximal-most position. Whenpusher arm231 moves in the proximal direction, theindexer260 completes its proximal stroke until theindexer engagers264,266 engage with the nextproximal fasteners100.
• From the perspective of the user, the triggered actions of thedrive apparatus200 appear to be simultaneous. In other words, the user places thedistal opening254 of thetube assembly250 adjacent the portion of the hernia mesh to be fastened and squeezes thetrigger216 to its fullest extent in one continuous motion. This causes thedistal fastener100 to be ejected from thetube assembly250 and into the hernia mesh and underlying body tissue. Upon release of thetrigger216, thedrive apparatus200 returns to its initial position and is immediately ready to dispense anotherfastener100.
• Many embodiments and adaptations of the present invention, other than those herein described with reference to the exemplary embodiments, will be apparent to those skilled in the art by the foregoing description, without departing from the substance or scope of the invention. While the present invention has been described herein in detail in relation to its exemplary embodiments, it is to be understood that this disclosure is only illustrative and exemplary of the present invention. Accordingly, the foregoing disclosure is not intended to be construed so as to limit the present invention or otherwise to exclude any other such embodiments, adaptations, variations, modifications, and equivalent arrangements. The claimed invention is limited only by the following claims.

Claims (28)

1. A fastener for attaching to a body tissue, having a longitudinal direction, a proximal end, and a distal end, and comprising:

a head portion disposed near the proximal end of the fastener, and having a proximal surface, a distal surface, and a passage that extends through the head portion from the proximal surface to the distal surface;

a body portion extending from the distal surface of the head portion in the longitudinal direction; and

an anchoring element extending from the body portion, and comprising at least one barb at least partially disposed adjacent the distal end of the fastener.

2. The fastener ofclaim 1, wherein the at least one barb has a proximal end and a distal end, and wherein the barb's proximal end is wider than the barb's distal end, as measured in a direction orthogonal to longitudinal direction.

3. The fastener ofclaim 1, wherein the at least one barb further comprises an upper facet and a lower facet, said facets tapering to an angled leading edge.

4. The fastener ofclaim 1, wherein the anchoring element comprises two barbs disposed on opposite sides of the fastener.

5. The fastener ofclaim 4, wherein the two barbs are longitudinally offset from each other.

6. The fastener ofclaim 2, wherein the anchoring element comprises two barbs disposed on opposite sides of the fastener.

7. The fastener ofclaim 6, wherein distal ends of the two barbs are longitudinally offset from each other.

8. The fastener ofclaim 1, wherein the head portion further comprises at least one anchor tab disposed on the distal surface of the head portion.

9. The fastener ofclaim 1, wherein the passage is a bore.

10. The fastener ofclaim 9, wherein the bore is rectangular.

11. The fastener ofclaim 1, wherein the fastener is made of absorbable material.

12. The fastener ofclaim 1, wherein the passage is a channel.

13. The fastener ofclaim 1, wherein the distal head face and proximal head face are substantially flat surfaces.

14. An applicator for applying a barbed fastener to a body tissue, the applicator comprising:

an elongated tubular portion having a longitudinal axis extending from a proximal end to a distal end and having a tube interior accessible by proximal and distal tube openings, the tube interior being sized and configured for receiving the barbed fastener;

an indexer disposed at least partially inside the tube interior, the indexer having an elongated indexer body member and a fastener engaging portion adapted to engage the barbed fastener and move the barbed fastener from an initial fastener position in the tube interior to a firing position as the indexer moves from a first longitudinal position to a second, more distal longitudinal position; and

a driver disposed at least partially inside the tube interior, the driver having a driver engaging portion at its distal end, the driver engaging portion being adapted to engage the barbed fastener in the firing position and selectively apply an ejection force to the barbed fastener, thereby ejecting the barbed fastener from the tube interior through the distal opening.

15. The applicator ofclaim 14, wherein the ejection force is applied to the barbed fastener by the driver as the driver is moved distally from a pre-firing driver position to a distal-most driver position adjacent the distal tube opening.

16. The applicator ofclaim 15 wherein a biasing force is applied to the driver by a spring when said driver is in the pre-firing driver position, said biasing force serving to bias the driver toward the distal-most driver position.

17. The applicator ofclaim 15 wherein the applicator is configured for operation through a repeatable operation cycle comprising:

an initial stage, in which the indexer is in its first longitudinal position and the driver is in its distal-most position;

a pre-firing stage, in which the indexer is in its second, more distal longitudinal position and the driver is in its pre-firing position; and

a post-firing stage, in which the indexer is in its second, more distal longitudinal position, and the driver is in its distal-most position.

18. The applicator ofclaim 17, wherein the indexer and driver are operably coupled with an actuation assembly configured to selectively control and coordinate movement of the indexer and driver from their initial stage positions to their pre-firing stage positions, from their pre-firing stage positions to their post-firing stage positions, and from their post-firing stage positions back to their initial stage positions.

19. The applicator ofclaim 18, wherein the actuation assembly comprises a trigger configured for rotational movement between an initial trigger position, a pre-firing trigger position and a post-firing trigger position, the trigger and actuation assembly being adapted so that movement of the trigger from the initial trigger position to the pre-firing trigger position causes the indexer and driver to move from their initial stage positions to their pre-firing stage positions, further movement of the trigger to the post-firing trigger position causes the indexer and driver to move from their pre-firing stage positions to their post-firing stage positions, and movement of the trigger back to the initial trigger position causes the indexer and driver to move from their post-firing stage positions back to their initial stage positions.

20. The applicator ofclaim 14, wherein the barbed fastener comprises a head portion having a fastener passage formed therethrough and wherein the elongated indexer body member is configured for slidable disposition through the fastener passage.

21. The applicator ofclaim 14, wherein:

the tube interior is sized and configured for receiving one or more additional fasteners substantially identical to the barbed fastener, the additional fasteners being serially positionable within the tube interior proximal to the barbed fastener along the longitudinal axis,

the indexer has one or more additional engaging portions adapted to engage the additional fasteners and to move each of the additional fasteners from a first longitudinal fastener position to a second more distal longitudinal fastener position at the same time the indexer moves the barbed fastener from its initial fastener position to its firing position.

22. The applicator ofclaim 21, wherein the second longitudinal position of the distal-most of the additional fasteners is the same as the initial fastener position of the barbed fastener.

23. The applicator ofclaim 21 further comprising: means for preventing the additional fasteners from moving in a proximal direction when the indexer returns from its second, more distal longitudinal position to the first longitudinal position.

24. The applicator ofclaim 21, wherein the elongated tube portion comprises one or more lance tabs projecting inward from an inner surface of the elongated tube portion at an angle toward the distal end of the elongated tube portion and capable of flexing outward, the lance tabs being configured to engage and prevent the proximal movement of the additional fasteners while allowing their distal movement by the indexer.

25. A method of applying a fastener to a pre-determined target insertion point on a body tissue, comprising:

providing a fastener having a head portion having a passage formed therethrough, an anchoring element configured for engaging the body tissue, and a body portion extending distally from the head portion to connect the anchoring element thereto;

providing a fastener applicator comprising

an elongated tubular portion having a longitudinal axis extending from a proximal end to a distal end and having a tube interior accessible by proximal and distal tube openings,

an indexer disposed at least partially inside the tube interior, the indexer being adapted to selectively move the fastener from an initial position to a firing position adjacent the distal tube opening, and

a driver disposed at least partially inside the tube interior, the driver being adapted to engage the fastener in the firing position and selectively apply an ejection force to the fastener;

placing the fastener in the initial position within the tube interior;

causing the indexer to selectively move the fastener from the initial position to the firing position;

positioning the distal opening of the tube assembly adjacent the target insertion point; and

causing the driver to apply the ejection force to the fastener, thereby ejecting the fastener through the distal opening and into the body tissue at the target insertion point.

26. The method ofclaim 25, wherein the ejection force is applied to the barbed fastener by the driver as the driver is moved distally from a pre-firing driver position to a distal-most driver position adjacent the distal tube opening.

27. The method ofclaim 26 wherein a biasing force is applied to the driver by a spring when said driver is in the pre-firing driver position, said biasing force serving to bias the driver toward the distal-most driver position.

28. The method ofclaim 25, wherein the applicator includes an actuation assembly having a trigger configured for rotational movement between an initial trigger position, a pre-firing trigger position and a post-firing trigger position, the trigger and actuation assembly being adapted so that movement of the trigger from the initial trigger position to the pre-firing trigger position causes the indexer to move the fastener from the initial position to the firing position, further movement of the trigger to the post-firing trigger position causes the driver to apply the ejection force to the fastener, thereby ejecting the fastener through the distal opening and into the body tissue at the target insertion point.

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