WO2007013906A2

WO2007013906A2 - Mechanical method and apparatus for sequential tissue fastening

Info

Publication number: WO2007013906A2
Application number: PCT/US2006/027624
Authority: WO
Inventors: James A. Peterson
Original assignee: Incisive Surgical, Inc.
Priority date: 2005-07-15
Filing date: 2006-07-17
Publication date: 2007-02-01
Also published as: US20150127046A1; US20120083831A1; WO2007013906A3; US20070049969A1; US9592049B2; US8940016B2; US8100939B2

Abstract

A mechanical system for rotatably, sequentially securing opposing sides of a tissue wound with a fastener. An applicator apparatus is capable of imparting rotatable motion to a falcate tissue penetrator that sequentially pierces and carries a fastener into a first side and a second side of the tissue wound. The first side and second side of tissue can be simultaneously captured and positioned with respect to a tissue definition member or alternatively, the first tissue side and second tissue side can be individually, sequentially captured and positioned relative to the tissue definition member. The applicator apparatus can comprise a single fastener for small tissue wounds or resections or alternatively, the applicator can comprise a plurality of staged fasteners for use in closing a larger wounds or wounds with increased tension.

Description

MECHANICAL METHOD AND APPARATUS FOR SEQUENTIAL TISSUE FASTENING

PRIORITY CLAIM

The present application claims priority to United States Provisional Application Serial No. 60/699,460 filed My 15, 2005, and entitled "MECHANICAL METHOD AND APPARATUS FOR SEQUENTIAL TISSUE FASTENING", which is herein incorporated by reference in its entirety.

FIELD OF THE INVENTION The present invention relates generally to the field of surgical instruments such as surgical staplers, clip applicators and sutureless closure devices. More particularly, the present invention relates to a mechanical method and apparatus for fastening tissue by rotatably, sequentially securing opposed sides of a tissue wound.

BACKGROUND OF THE INVENTION

When an opening in tissue is created either through an intentional incision or an accidental wound or laceration, biological healing of the opening commences through the proximity of the opposed living tissue surfaces. If the opening is very large or if its location subjects the wound to continual movement, a physician will seek to forcibly hold the sides of the opening in close proximity so as to promote the healing process.

In the case of skin tissue, for example, healing occurs best when the opposing dermal layers of the skin tissue are held in proximity with each other. Human skin tissue is comprised of three distinct layers of tissue. The epidermal layer, also known as the epidermis, is the outermost layer and includes non-living tissue cells. The dermal layer, or dermis, is the middle layer directly below the epidermal layer and comprises the living tissue of the skin that is the strongest of the three layers. The subcutaneous, or hypodermis layer is the bottom layer of skin tissue and includes less connective tissue making this the weakest layer of skin tissue.

The most prevalent method for forcibly closing a tissue opening is through the use of a suture or "stitches." As early as the second century, the Greeks were using sutures to physically close skin openings, hi its simplest form, a suture is simply a length of material that is attached to a tissue-piercing device, such as a needle, and looped through the opposing sides of an opening. The suture is then pulled tight and the loop closes causing the opposing sides of the tissue to come into close physical proximity. The suture loop is held tight by the tying of a knot or some other locking mechanism. The first sutures were made of animal gut. Eventually other natural suture materials including leather, horsehair, flax, cotton and silk came into use.

As the sciences of medical and materials technology have advanced over the course of the past century, new bioabsorbable materials have been developed to further improve upon the basic suturing concept. Examples of more recent improvements to the suturing process include enhancements to the suturing apparatus as shown, for example, in U.S. Patents Nos. 2,439,383, 2,959,172 and 3,344,790, as well as advances in sutures and suture materials as shown, for example, in U.S. Patents Nos. 3,123,077, 3,297,033, 3,636,956, 3,792,010 4,027,676 and 4,047,533. While traditional suturing remains a popular method of effectuating closure of skin openings, the use of staples and staplers as a skin closure technique has become increasingly popular, especially in surgical settings where the opening is created through a purposeful incision, m these settings, the incision tends to make a clean, straight cut with the opposing sides of the incision having consistent and non-jagged surfaces. Typically, stapling of a skin opening, for example, is accomplished by manually approximating the opposing sides of the skin opening and then positioning the stapler so that a staple will span the opening. The stapler is then manipulated such that the staple is driven into the skin with one leg being driven into each side of the skin and the cross-member of the staple extending across the opening external to the skin surface. Generally, the legs of the staple are driven into an anvil causing the staple to deform so as to retain the skin tissue in a compressed manner within the staple. This process can be repeated along the length of the opening such that the entire incision is held closed during the healing process.

Much work has been devoted to improving upon the basic stapling process. Developments have gone in a variety of directions and include work devoted to the stapling ^' apparatus as shown, for example, in U.S. Patents Nos. 3,082,426, 3,643,851, 4,410,125, 4,493,322, 4,592,498, 4,618,086, 4,776,506, 4,915,100, 5,044,540, 5,129,570, 5,285,944, 5,392,979, 5,489,058, 5,551,622, 5,662,258, 5,794,834, 5,816,471, 6,131,789 and 6,250,532. In addition to the stapling apparatus, developments have also been made in the staple design as shown, for example, in U.S. Patents Nos. 2,351,608, 2,526,902, 2,881,762, 3,757,629, 4,014,492, 4,261,244, 4,317,451, 4,407,286, 4,428,376, 4,485,816, 4,505,273, 4,526,174, 4,570,623, 4,719,917, 4,741,337, 5,007,921, 5,158,567, 5,258,009, 5,297,714, 5,324,307, 5,413,584, 5,505,363 and 5,571,285. While suturing and stapling techniques continue to provide an effective manner of effectuating skin closure, there remains a series of inherent disadvantages in using either of these techniques. The standard technique for both suturing and stapling includes puncturing both the epidermis and dermis. This can result in a wound closure causing patient discomfort and having an unaesthetically pleasing appearance on the surface of the skin. The presence of the fastener exposed through the skin surface provides an opportunity for infection and for accidentally catching the fastener and tearing the wound open. In the case of non-absorbable fasteners, further action by a medical professional is necessary in order to remove the fastener once biological healing is complete. In order to overcome these limitations, practitioners have developed a number of specialized suturing techniques where the suture is passed only through the dermis effectively positioning the suture below the skin surface, or in a subcuticular fashion. A surgeon has the choice of placing individual or interrupted sutures along the length of an opening. Another suturing option is for the surgeon to use a single strand of suture material to place a plurality of continuing suture loops or running sutures along the length of an opening. While the presence of the suture below the surface can improve the aesthetic nature of the closure, it requires greater skill and technique to accomplish effectively and takes longer than conventional external suturing.

While there has been active development of dermal layer suturing techniques, little has been done in the area of staples and staplers for use in connection with the dermal layer. In a series of patents issued to Green et al., including U.S. Patents Nos. 5,292,326, 5,389,102, 5,489,287 and 5,573,541, a subcuticular stapling method and apparatus are disclosed that were ultimately commercialized as the U.S. Surgical SQS Subcuticular Stapling Apparatus. The Green et al. patents describe a stapling technique employing a handheld apparatus with jaws to proximate, interdigitate and overlap opposing sides of dermal layer tissue along the length of a skin opening. The apparatus then drives a single spike through the interdigitated and overlapped dermal layers of the opposing skin surfaces in order to secure both sides of the dermal tissue on the single spike. Although this technique reduced the time required to effectuate a subcuticular skin closure, the SQS device was not commercially successful in part because it was difficult to achieve a secure uniform closure and the resulting closure produced an undesirable wave-like closure with gaps that sometimes did not heal effectively.

A novel approach to fastening dermal tissue using bioabsorbable fasteners is disclosed and described in U.S. Patent No. 6,726,705, as well as in U.S. Publ. Nos. US2003-0236551 Al, US2004-0059377 Al and US2004-0059378 Al to Peterson et al, all of which are commonly assigned to the assignee of the present application and all of which are incorporated by reference in their entirety. In one embodiment, this approach to tissue fastening utilizes a first apparatus to manipulate opposed sides of tissue to form target tissue zones followed by a second apparatus that effects a simultaneous bilateral insertion of a tissue fastener to retain opposed dermal layers across an incision or wound in close approximation to facilitate healing. By maintaining contact of the dermal layers through the healing process, the healing process is enhanced which results in less chance of infection, faster recovery and improved aesthetic appearance. In addition, no subsequent medical follow-up is necessary to remove fasteners as is typically necessary with non-absorbable fasteners.

While the tissue fastening methods and apparatus taught by Peterson et al. provide many advantages, there are opportunities to improve upon the principles taught by Peterson et al. with respect to tissue fastening applications. For example, it would be desirable to provide for a fastening apparatus providing for increased simplicity in manufacturing and implementation.

SUMMARY OF THE INVENTION

The present invention is a mechanical system for rotatably, sequentially securing opposed sides of a tissue wound. An applicator apparatus includes an insertion head portion positioned proximate a tissue wound. Utilizing a tissue manipulator, a first side of tissue is positioned within a first receiving portion on the insertion head. A rotatable drive mechanism rotatably inserts a first cleat portion of a fastener through a portion of the first side of tissue. The tissue manipulator releases the first side of tissue and manipulates a second side of tissue such that it is positioned within a second receiving portion on the insertion head. The rotatable drive mechanism rotatably inserts the first cleat portion of the fastener though a portion of the second side of tissue while substantially simultaneously capturing the first side of tissue with a trailing second cleat portion of the fastener. Following capture of the both the first and second tissue sides with the fastener, the rotatable drive mechanism is reversibly rotated such that the insertion head can be removed from the tissue wound while the fastener retainably approximates the first and second tissue sides so as accomplish the wound closure.

In one aspect, the present application is directed to an apparatus for sequentially, rotatably inserting a fastener into the dermal layer on opposed sides of a tissue wound. In another aspect, the present application is directed to a fastener adapted for rotatable insertion into the dermal layer of opposed sides of a tissue wound.

In another aspect, the present invention is directed to methods for closing tissue wounds through rotatable, sequentially positioning of a tissue fastener across the tissue wound. In another aspect, the present invention is directed to a laproscopic tissue fastening device for joining tissue wounds through rotatable, sequential positioning of a laproscopic tissue fastener.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a perspective view of a representative tissue opening in a skin surface. Figure 2 is a section view of the representative tissue opening of Figure 1.

Figure 3 is a section view of the representative tissue opening of Figure 1 in a substantially everted disposition.

Figure 4 is a top view of a representative wound closure accomplished using a prior art subcuticular stitching method. Figure 5 is a top view of a representative wound closure accomplished using a prior art surgical stapling method.

Figure 6 is a top view of a representative wound closure accomplished using a prior art subcuticular, rod-like fastener method.

Figure 7 is an exploded, perspective view of an embodiment of a tissue closure device. Figure 8 is a perspective view of the tissue closure device of Figure 7 in a pre-fastener deployment configuration.

Figure 9 is a perspective view of the tissue closure device of Figure 7 in a post-fastener deployment configuration.

Figure 10 is a perspective view of a biasing member used with the tissue closure device of Figure 7.

Figure 11 is a perspective view of a spring member used with the tissue closure device of Figure 7.

Figure 12 is a perspective view of an insertion member used with the tissue closure device of Figure 7. Figure 13 is a side view of the insertion member of Figure 12.

Figure 14 is an end view of the insertion member of Figure 12. Figure 15 is a section view of a penetrator portion of the insertion member of Figure 12. Figure 16 is a detailed view of an embodiment of a penetrator piercing end.

Figure 17 is a perspective view of a body member used with the closure device of Figure 7.

Figure 18 is a side view of the body member of Figure 17. Figure 19 is an end view of the body member of Figure 17.

Figure 20 is a perspective view of a gripping member used with the closure device of Figure 7.

Figure 21 is a perspective view of a tissue definition member used with the closure device of Figure 7. Figure 22 is a perspective view of the tissue definition member of Figure 21.

Figure 23 is a side view of the tissue definition member of Figure 21.

Figure 23 a is a side view an embodiment of a tissue definition member including a plurality of retaining proj ections.

Figure 24 is an end view of the tissue definition member of Figure 21. Figure 24a is an end view of the tissue definition member of Figure 23a including a plurality of retaining projections.

Figure 25 is an end view of the tissue definition member of Figure 21.

Figure 26 is a top view of an embodiment of a fastener for use with the closure device of Figure 7. Figure 27 is a perspective view of the fastener of Figure 26.

Figure 28 is an end view of the fastener of Figure 26.

Figure 29a is a top view of the fastener of Figure 26.

Figure 29b is a top view of the fastener of Figure 26.

Figure 30 is a partially hidden side view of an embodiment of an insertion member having a plurality of staged fasteners.

Figure 31 is a top view of a skin wound being approximated with respect to an embodiment of a tissue closure device.

Figure 32 is partially sectioned, end view of a tissue closure device with a first side of tissue positioned for capture and piercing. Figure 33 is a partially sectioned, end view of a tissue closure device with a first side of tissue being pierced and also having a second side of tissue positioned for subsequent capture and piercing.

Figure 33a is a top view of skin wound with a first tissue side being captured and pierced. Figure 34 is a partially sectioned, end view of a tissue closure device with both first and second sides of tissue being pierced and having a fastener positioned therein.

Figure 35 is a top view of a partially closed skin wound wherein a portion of the skin wound has been closed with fasteners deployed from a tissue closure device and with the tissue closure device deploying an additional fastener to further effectuate closure of the skin wound.

Figure 36 is a top view of an embodiment of a fastener for use with a tissue closure device.

Figure 37 is a side view of an embodiment of a tissue fastening device.

Figure 38 is a perspective, end view of a fastening end of the tissue fastening device of Figure 37.

Figure 38a is a perspective, end view of the fastening end of the tissue fastening device of Figure 37 including a plurality of staged fasteners.

Figure 39 is an exploded, perspective view of an insertion member and fastener of the tissue fastening device of Figure 37. Figure 39a is a perspective view of an alternative embodiment of an insertion member and fastener of the tissue fastening device of Figure 37a.

Figure 40 is a top view of the fastener of Figure 39.

Figure 40a is a top view an embodiment of a fastener for use with the tissue fastening device of Figure 37 having a reduced thickness arcuate body portion. Figure 41 is an end view of the fastening end of the tissue fastening device of Figure 37 during a first fastening step for closing a skin wound.

Figure 42 is an end view of the fastening end of the tissue fastening device of Figure 37 during a second fastening step for closing a skin wound.

Figure 43 is an end view of the fastening end of the tissue fastening device of Figure 37 during a third fastening step for closing a skin wound.

Figure 44 is an end view of the fastening end of the tissue fastening device of Figure 37 during a fourth fastening step for closing a skin wound.

Figure 44a is a perspective end view of the fastening end of the. tissue fastening device of Figure 37 during the fourth fastening step of Figure 44. Figure 45 is an end view of the fastening end of the tissue fastening device of Figure 37 during a fifth fastening step for closing a skin wound with a first internally projecting cleat located within a third insertion gap. Figure 45a is an end view of the fastening end of the tissue fastening device of Figure 37 during a fifth fastening step for closing a skin wound with a first internally projecting cleat located with a second tissue capture zone.

Figure 46 is an end view of the fastening end of the tissue fastening device of Figure 37 during a sixth fastening step for closing a skin wound.

Figure 47 is an end view of the fastening end of the tissue fastening device of Figure 37 during a seventh fastening step for closing a skin wound.

Figure 48 is a perspective view of the tissue fastening device of Figure 37 being repositioned in a skin wound for deployment of the fastener of Figure 40. Figure 49 is a perspective view of the tissue fastening device of Figure 37 deploying the fastener of Figure 40 to close a skin wound.

Figure 50 is a perspective view of an everted wound closure being closed with a plurality of the fasteners of Figure 40.

Figure 51 is a perspective view of an embodiment of a minimally invasive tissue fastening device.

DETAILED DESCRIPTION OF THE EMBODIMENTS

In Figures 1 and 2, there is shown a depiction of a typical opening 100 in the surface of skin 102, such as may be made, for example, by a surgical incision or a wound. Opening 100 defines a first side 104 and a second side 106 on opposed sides of the opening 100. First side 104 and second side 106 can comprise a substantially parallel arrangement as illustrated in Figure 1, or alternatively, first side 104 and second side 106 comprise substantially non-parallel portions such as commonly associated with wounds as opposed to surgical incisions. As illustrated in Figure 1, for purposes of describing the present invention, opening 100 may be described as having a length or longitudinal orientation parallel to the y-y axis, a width orientation parallel to the x-x axis, and a depth orientation parallel to the z-z axis. The x-y-z axis, for purposes of one embodiment of the present invention, is defined with respect to an external tissue surface, which in the case of skin 102 is the outer surface. References to a vertical and horizontal planar orientation in connection with the present invention are made with respect to the external tissue surface at the site of the opening in question. As described herein, opening 100 can have a length from about 8 mm, which can reflect surgical procedures such as, for example, a mole resection, to about 60 cm, which can reflect surgical procedures such as, for example, an abdominoplasty.

As illustrated in Figure 2, in one embodiment, a first vertical inner surface 108 associated with first side 104 and a second vertical inner surface 110 associated with second side 106 can be visualized as meeting along a generally vertical interface 112. It will be understood that in the case of an opening that extends over a curved tissue surface, the corresponding horizontal and vertical surfaces associated with the opening will be defined with respect to such curved tissue surface. It also will be understood that the vertical interface 112 may be vertical in only one orientation with respect to the tissue surface, such as in the case when an angled incision has formed the opening 100.

As illustrated in the sectional view of Figures 2 and 3, human skin 102 generally has three discrete layers. These layers comprise an epidermal layer 114 of mostly non-living tissue having an exterior surface 116, a dermal layer 118 of mostly living tissue, and a subcutaneous tissue layer 120. Although certain representative embodiments of the present invention will be described with respect to human skin tissue 102, it will be understood that the present invention is applicable to closure of openings in other types of tissue having generally defined surfaces with membranes, layers or wall such as, for example, fascia, membranes, organs, vessels, vasculature, vascular pedicles, skin grafts, bladder and other biocompatible materials with generally defined surfaces also having membranes, layers or walls such as, for example, artificial skin, artificial membranes and synthetic mesh.

It has long been known that the most rapid healing of a skin opening 100 with a minimum of scarring occurs when vertical inner surfaces 108, 110 of the living dermal layer 118 at each side of the vertical interface 112 of skin opening 100 are brought together and held in close contact in what is referred to as an everted position as is shown in exaggerated fashion in Figure 3. To the extent that the primarily non-living material of epidermal layer 114 can be excluded from the healing opening, the rapidity and level of scar tissue formed during the healing process will be minimized.

With respect to skin opening 100 as illustrated in Figures 4 and 5, there exists an optimal target tissue zone 122 on each side of vertical interface 112 for placement of a fastener 124 in order to achieve optimal dermal contact for healing. As described in the previously referenced and incorporated Peterson et al. patent documents, one method by which these target tissue zones 122 can be presented and accessed is through a bilateral capture and fastening process. With respect to the present disclosure, a method for rotabably, sequentially presenting and accessing these same target tissue zones via a generally circular path of travel is defined. In addition, the present rotatatable, sequential methods and apparatus disclosed herein permit the path of travel to and through the target tissue zones to be accomplished at a variety of angles and orientations making placement of the fastener 124 convenient to the medical professional, hi addition, the rotatable, sequential nature of the presently disclosed apparatus and systems provide for an easily scalable system allowing for easy adaptation of system dimensionality for a variety of surgical procedures including different type of tissue having generally define surfaces.

As illustrated in Figures 4 and 5, target tissue zone 122 for a skin closure lies within the dermal layer 118, and can be visualized as a rectangular cross-sectional area when the tissue is in a relaxed condition, hi addition, within each target tissue zone 122, there exists a most preferred area 126 for tissue engagement. In the depth orientation, target tissue zone 122 lays between a distance L3 of about 0.1 mm below the exterior surface 116 of epidermal layer 114, and a distance L4 up to 2.0 mm below the exterior surface 116. The most preferred area 126 lies between a distance L5 of about 0.2 mm and a distance L6 of about 0.8 mm below the exterior surface 116. hi the width orientation, target tissue zone 122 lies between a distance L7 of about 1.0 mm and a distance L8 of about 20.0 mm from vertical interface 112. Most preferred area 126 lies between a distance L9 of about 2.0 mm and a distance LlO of about 8.0 mm from vertical interface 112. Because the target tissue zone 122 is not visible to an operator, a tissue manipulator assembly and rotatable applicator assembly are preferably designed to consistently and repeatedly enable the operator to position the target tissue zone 122 for deployment of a fastener 124 as will be subsequently described.

As illustrated in Figure 6, the advantages of the various embodiments of the present invention are accomplished by an apparatus and method that rotatably, sequentially engage the target tissue zones 122, hereafter referred to as a first target tissue zone 128 associated with first side 108 and a second target tissue zone 130 associated with second side 110, on each side of a skin opening 100 with fastener 124 that is preferably made of a bioabsorbable material. The location, geometry and orientation of the fastener and the dermal layers in relation to the mechanical apparatus of the present invention are all important considerations to obtaining the most optimal contact and compression of the dermal layer for efficacious closing of the opening in this embodiment. While the skin opening 100 will be described in connection with an opening in a single piece of tissue, it will be understood that the opening 100 could also be between two separate and otherwise unconnected pieces of tissue, or even between a piece of tissue and a piece of biocompatible material to be secured to that piece of tissue, hi addition, the methods and systems of the present invention are applicable to a wide variety of sizes and configurations for skin opening 100, such as, for example, the lengthy, purposeful incisions associated with surgical procedures such as removing excess skin after bariatric surgery or for very small openings associated with procedures such as a mole resection. A representative embodiment of a tissue fastening device 200 of the present invention is illustrated in Figures 7, 8 and 9. Tissue fastening device 200 is generally defined by a proximal fastening end 202 and a distal biasing end 204, with the terms proximal and distal reflecting relative positioning with respect to tissue opening 100 during use of the tissue fastening device 200 to close tissue opening 100. Tissue fastening device 200 can comprise a biasing member 206, a spring member 208, an insertion member 210, fastener 124, a body member 212, a gripping member 214, a retention pin 216 and a tissue definition member 218. Tissue fastening device 200 can be fabricated of medically acceptable materials including metals such as, for example, stainless steel or medical grade polymers. As depicted in Figure 8, tissue fastening device 200 is depicted in a pre-fastener deployment configuration 220 while in Figure 9, tissue fastening device 200 is depicted in a post-fastener deployment configuration 222.

Biasing member 206 is illustrated in more detail in Figure 10. Biasing member 206 generally comprises a biasing surface 224 having an underside 224a, a biasing body 226 and a biasing interface 228. Biasing interface 228 can comprise a flat configuration or alternatively, a biasing projection 230. Spring member 208, as illustrated in Figure 11, can comprise a metal or polymer-based spring having a suitable spring tension for use in a hand-operated instrument, for example an instrument capable of hand squeezing and initiation such as tissue fastening device 200. Spring member 208 defines a spring length 232 and a spring diameter 234. An appropriate spring diameter 234 can be selected to as to fully surround the biasing body 226 so as to directly interface with the underside 224a of biasing surface 224, as illustrated in Figure 8.

Insertion member 210 as illustrated in Figures 12, 13 and 14 can comprise an engagement surface 236, an insertion body 238, an extension member 240 and a penetrator 242. Insertion body 238 can in some representative embodiments comprise a generally cylindrical orientation and may comprise a solid body or alternatively, a hollow body, depending upon criteria such as material selection, component fabrication methods and the number of fastener 124 to be stored and/or deployed by the tissue fastening device 200. In some representative embodiments, extension member 240 and penetrator 242 can be integrally formed as a single component. Penetrator 242 generally comprises a generally falcate or sickle-shaped configuration defined by piercing end 244, a penetrator body 246 and a penetrator distal end 248 abutting and/or operably connected to the extension member 240. Insertion body 238 can comprise an external drive mechanism such as, for example, an external thread 250 or "rifling" so as to translate linear movement of insertion body 238 into rotatable movement of the penetrator 242. The external dive mechanism can in some embodiments comprise a groove and/or channel for receiving interfacing with an external member.

Penetrator 242 is more clearly illustrated in detailed Figures 15 and 16. For example, penetrator body 246 is more clearly illustrated in section view in Figure 15 as having a bottom penetrator surface 252 defined between a radial exterior wall surface 254 and a radial inner surface 256. Bottom penetrator surface 252 can comprise a bottom wall thickness 252a while radial exterior wall surface 254 can comprise a radial exterior wall thickness 254a. Bottom penetrator surface 252 comprises a bottom surface width 252b while radial exterior wall surface 254 comprises a radial exterior wall height 254b. Piercing end 244 as illustrated in Figure 16 can comprise a dual-face penetrator 256 having a vertical cutting surface 258 and a horizontal cutting surface 260. Both the vertical cutting surface 258 and horizontal cutting surface 260 can comprise a first cutting facet 262 with a first facet length 262a and a second cutting facet 264 with a second facet length 264a. hi some presently contemplated embodiments, first face length 262a can comprise anywhere from about ¹A to about % of the individual lengths of vertical cutting surface 258 and horizontal cutting surface 260. As illustrated in Figures 17, 18 and 19, body member 212 generally comprises a first body portion 266 and a second body portion 268. Body member 212 has a generally cylindrical configuration with a hollow interior 270 extending between a first body end 272 and a second body end 274. Hollow interior 270 defines an internal body diameter 271 sized so as to allow placement of insertion member 210 within hollow interior 270. First body portion 266 can comprise an exterior channel 276 extending from the exterior of first body portion 266 into the hollow interior 270. First body portion 266 and second body portion 268 are distinguished by a body flange 278. Second body portion 268 comprise an exposed portion 280 proximate the second body end 274, which generally corresponds to proximal fastening end 202.

Gripping member 214, as illustrated in Figure 20, generally comprises a hollow, cylindrical gripping body 282 and a flanged body portion 284. An interior portion 286 of the gripping member 214 extends between a first gripping end 288 and a second gripping end 290. Interior portion 286 comprises a gripping member interior diameter 292 generally sized such that body member 212, and more specifically first body portion 266 can be accommodated within interior portion 286. A gripping aperture 294 extends through a gripping body wall 296 of the cylindrical gripping body 282. Flanged body portion 284 defines a gripping surface 298.

As illustrated in Figures 21, 22, 23, 24 and 25, tissue definition member 218 generally comprises a tissue definition body member 300 having a first definition member end 302 and a second definition member end 304, wherein the second definition member end 304 generally corresponds to proximal fastening end 202. Tissue definition body member 300 defines a generally arcuate perimeter body surface 306 sized and shaped to generally conform to exposed portion 280 of the body member 212. Second definition member end 304 comprises a first projecting block 308a, a second projecting block 308b, a third projecting block 308c and a central projecting member 310 all projecting outward from an end wall 311. Central projecting member 310 comprises a first projecting portion 312a, a second projecting portion 312b and a third projecting portion 312c. A first tissue capture area 314 is defined generally as the area bounded within first projecting block 308a, second projecting block 308b, first projecting portion 312a and second projecting portion 312b. A second tissue capture area 316 is defined generally as the area bound within second projecting block 308b, third projecting block 308c, second projecting portion 312b and third projecting portion 312c. A first insertion gap 318a is defined between first projecting block 308a and first projecting portion 312a. A second insertion gap 318b is defined between second projecting block 308b and second projecting portion 312b. A third insertion gap 318c is defined between third projecting block 308c and third projecting portion 312c. As illustrated in Figure 25, tissue definition body member 300 further comprises an arcuate interior space 320 that generally matches and conforms to the size and shape of exposed portion 280. End wall 311 defines a first opening 322 corresponding to first insertion gap 318a and a second opening 324 corresponding to third insertion gap 318c.

A representative embodiment of fastener 124 is illustrated in Figures 26, 27, 28, 29a and 29b. Fastener 124 is comprised of a generally bioabsorbable polymer selected to maintain effective retention strength for a period of at least 5 to 21 days within the body, and optimally at least 14 days before eventually being fully absorbed within the human body. Most preferably, bioabsorbable polymer comprises a blended bioabsorbable copolymer comprised of 63% polylactide and 37% polygycolide, commonly referred to as PLGA. While the PLGA copolymer is used in one representative embodiment, other bioabsorbable polymers such as, for example, a lactide/glycolide copolymer, a poly(dl-lactide), a poly(l-lactide), a polyglycolide, a poly(dioxanone), a poly(glycolide-co-trimethylene carbonate), a poly(l-lactide-co-glycolide), a poly(dl-lactide-co-glycolide), a poly(l-lactide-co-dl-lactide), a poly(glycolide-co-trimethylene carbonate-co-dioxanone), collagen, and elastin, either individually, in blends or as copolymers, sharing similar traits including absorption traits, injection molding traits and polymer creep traits could be used as well. Similar to other polymers, the PLGA copolymer used in one representative embodiment exhibits viscoelastic properties in which the entangled molecules under stress tend to slide past one another, creating a viscoelastic creep.

Generally, fastener 124 comprises an arcuate body portion 326 operably connecting a pair of internally projecting cleats 328a, 328b at elbow portions 330a, 330b. Elbow portions 330a, 330b each preferably include a rounded cleat tip 332a, 332b. Arcuate body portion 326 can comprise a generally constant radius between the internally projecting cleats 328a, 328b defining an arc in range of about 125° to about 165°. Arcuate body portion 326 is generally defined by an arcuate exterior, perimeter surface 334 and an arcuate interior surface 336. The arcuate shape of interior surface 336 functions to even out and focus fastener loading forces and reduces potential rocking of fastener 124 during tissue retention. Fastener 124 can have a generally constant cross-sectional appearance between elbow portions 330a, 330b. hi order to facilitate removal of fastener 124 from a molding process, fastener 124 can comprise a plurality of distinct segments and surfaces as illustrated in Figures 27 and 28.

Internally projecting cleats 328a, 328b are generally defined by an outwardly facing cleat surface 338, an inwardly facing cleat surface 340 and rounded cleat tips 332a, 332b. Each inwardly facing cleat surface 340 connects to the interior surface 336 at a cleat base 344 so as to define a pair of durable tissue retention zones 346a, 346b. In combination, interior surface 336 and the inwardly facing cleat surfaces 340 define an initial tissue capture zone 348.

The features of one embodiment of fastener 124 are further illustrated in Figures 28, 29a and 29b. These features can include an effective fastener center line 350 about which internally projecting cleans 328a, 328b can be symmetrically oriented. The intersection of arcuate body portion 326 with internally projecting cleats 328a, 328b creates internal elbow angles 352a, 352b relative to fastener 124. Elbow portions 330a, 330b are generally defined as the areas proximate the corresponding elbow angle 352a, 352b. Other features can include a fastener length 353, a body width 354, a fastener height 355, a outwardly facing cleat surface length 356, a cleat cross- sectional width 357 measured transversely to the arcuate body portion 326, an inwardly facing cleat surface length 358, a cleat width 360 and a cleat gap 362. Fastener length 353 can comprise a variety of length preferably not exceeding 22 mm in length. Similarly, fastener height 355 can comprise a variety of lengths with the preferable limitation that a ratio of fastener length 353 to fastener height 355 exceeds 2:1. Body width 354 can comprise a variety of widths preferably not exceeding 4 mm of cross-sectional width. Cleat cross-sectional width 357 can comprise a variety of widths with the preferable limitation that cleat cross-sectional width 357 exceeds the body width 354 by at least 50%. Cleat gap 362 preferably has a gap length from about lmm to about 12 mm. After fastener 124 has been employed to retain and/or fasten tissue, stresses placed on the fastener 124 at elbow portions 330a, 330b can cause the arcuate body portion 326 to dynamically transition from the generally constant radius arc to a more linear disposition. After this dynamic transition, the ratio of fastener length 353 to fastener height 355 may increase by at least 10%.

Due to the expense of the bioabsorbable polymer resins used in fabricating fastener 124, it is preferable to avoid unnecessary waste during the molding process. In order to reduce waste, fastener 124 can be preferably formed using a micromolding injection molding process. Micromolding injection molding is typically used when the molding shot size is less than 1 gram. Using an appropriate micromolding injection system, for example a Battenfeld Microsystem M50, resin waste can be significantly reduced during production of a fastener 124 in accordance with the present invention. In addition, a micromolding injection system has other processing advantages such as allowing high injection speeds to promote dimensional stability, low residence times at elevated temperatures and integrated part handling capabilities.

Tissue fastening device 200 is generally assembled as illustrated in Figures 7, 8 and 9. Insertion member 210 is positioned with respect to body member 212 such that penetrator 242 can be slidably inserted from first body portion 266, through hollow interior 270 such that penetrator 242 resides proximate exposed portion 280. Gripping member 214 is placed over first body portion 266 of body member 212 and retention pin 216 is slidably inserted through gripping aperture 294 such that retention pin 216 retentively engages the exterior channel 276 on body member 212 as well as threaded channel 250 on the insertion member 210. When fully inserted, retention pin 216 operatively couples gripping member 214, insertion member 210 and body member 212.

Next, fastener 124 can be positioned and mounted with respect to penetrator 242 as illustrated in Figure 32. As depicted in Figures 7, 8 and 9, tissue fastening device 200 can comprise a single fastener 124 for use in closing small tissue wounds such as, for example, skin biopsies and mole resections and various small-scale dermatology procedures. Alternatively, tissue fastening device can comprise a plurality of fasteners 124 arranged in a stacked configuration within an at least partially hollow version of insertion member 210 as shown in hidden view in Figure 30. Insertion member 210 can comprise an advancing member 364 such as, for example, a spring, mounted within a hollow portion 365 to sequentially advance individual fasteners 124 into a mounting arrangement with respect to penetrator 242. By staging multiple fasteners 124 within insertion member 210, tissue fastening device 200 can be utilized to close larger wounds such as, for example, surgical incisions requiring more than one fastener 124 to accomplish successful wound closure.

After one or more fasteners 124 have been loaded, tissue definition member 218 can be operably mounted to exposed portion 280 such as, for example, with an adhesive or snap-fit arrangement. To complete assembly of tissue fastening device 200, spring member 208 is positioned over first body portion 266 of body member 212 such spring member 208 interfaces with the flanged body portion 284 of gripping member 214. Finally, biasing member 206 is operatively coupled to first body portion 266 of body member 212 such that biasing projection 230 abuts the engagement surface 236.

In use in one embodiment, tissue fastening device 200 can be utilized by dermatologists, physicians, clinicians and other medical personnel to accomplish a variety of skin closures including intentional, surgical incisions as well as accidental cuts, tears or piercings. Generally, a first step in effectuating wound closure with tissue fastening device 200 is to position proximal fastening end 202 proximate the wound as illustrated in Figure 31. Tissue fastening device 200 should be in a pre-firing orientation, for example pre-fastener deployment configuration 220 as illustrated in Figure 8. In some instances, proximal fastening end 202 can be positioned within the wound below the surface of skin 102 or alternatively, proximal fastening end 202 can be positioned above the surface of skin 102 wherein a user can manipulate first side 104 and second side 106 with a suitable grasping member 366 to lift skin 102 to the tissue fastening instrument 200 and achieve an everted disposition as illustrated in Figure 3. Grasping member 366 can comprise a traditional forceps or a sequential tissue forceps as disclosed in United States Patent Publication No. 2006/0135988A1 ,which is herein incorporated by reference in its entirety.

Depending upon various wound characteristics such as, for example, body location, tissue type, wound tension, body type, patient age and similar variables, first side 104 and second side 106 can be simultaneously positioned with respect to proximal fastening end 202 or alternatively, a first side 104 be positioned, and captured with fastener 124, as describe below, followed by capture and fastening of a second side 106. Sequential capture, as opposed to simultaneous fastening, of first side 104 and second side 106 may be especially applicable to large wounds or high tension wounds wherein simultaneously capturing, positioning and retaining tissue is made increasingly difficult. First side 104 is gripped and stretched by grasping member 366 such that first side 104 resembles the stretched configuration illustrated in Figure 3. Once stretched, first side 104 is positioned with respect to tissue definition member 218 such that dermal layer 118 substantially occupies and fills first tissue capture area 314 as illustrated in Figure 32. Because of the stretched configuration of first side 104, epidermal layer 114 and subcutaneous tissue layer 120 are kept substantially out of and preferably entirely absent from first tissue capture are 314. If any of the first projecting block 308a, second projecting block 308b and/or central projecting member 310 include retaining projections 325, the retaining projections 325 further assist to capture and retain the dermal layer 118 within the first tissue capture area 314. Once the dermal layer 118 of first side 104 is positioned within first tissue capture area

314, a medical professional such as, for example, a doctor or nurse squeezes together biasing member 206 and gripping member 214. This squeezing action causes retention pin 216 to begin traversing the threaded channel 250, thus imparting a rotational spin to insertion member 210. As insertion member 210 spins, rotational motion is imparted to penetrator 242 such that piercing end 244 is rotatably directed through first insertion gap 318a. Continued squeezing together of the biasing member 206 and gripping member 214 directs piercing end 244 through the first tissue capture are 314, which simultaneously results in piercing end 244 piercing and passing through the dermal layer 118 of first side 104 as illustrated in Figure 33. As penetrator 242 rotatably traverses the first tissue capture area 314, fastener 124 is carried through the pierced opening such that internally projecting cleat 328a passes though dermal layer 118 of first side 104. As internally projecting cleat 328a has a cross-section substantially greater than penetrator 242, the elastic tissue of dermal layer 118 is required to stretch around and over inwardly projecting cleat 328a. As piercing end 244 approaches second insertion gap 318b, first side 104 can be released by grasping member 366 as first side 104 is now fully retained by penetrator 242 and fastener 124 as illustrated in Figure 33 a.

Next, second side 106 is gripped and stretched by grasping member 366 such that second side 106 resembles the stretched configuration illustrated in Figure 3. Once stretched, second side 106 is positioned with respect to tissue definition member 218 such that dermal layer 118 substantially occupies and fills second tissue capture area 316 as illustrated in Figure 33. For similar reasons as previously discussed with respect to first side 104, epidermal layer 114 and subcutaneous tissue layer 120ι are kept substantially out of and preferably entirely absent from second tissue capture are 316. If any of the second projecting block 308b, third projecting block 308c and/or central projecting member 310 include retaining projections 325, the retaining projections 325 further assist to capture and retain the dermal layer 118 within the second tissue capture area 316.

After positioning second side 106, the medical professional continues with the squeezing together of biasing member 206 and gripping member 214. As discussed previously, this squeezing action causes insertion member 210 to spin such that penetrator 242 is rotatably advanced into the second tissue capture area 316. As discussed previously with respect to first side 104, piercing end 244 pierces and passes through the dermal layer 118 of second side 106. As penetrator 242 rotatably traverses the second tissue capture area 316, fastener 124 is carried through the pierced opening such that internally projecting cleat 328a passes though dermal layer 118 of first side 104 as illustrated in Figure 34. At the same time, projecting cleat 328b rotatably follows into the first tissue capture area 314 wherein the dermal layer 118 is generally piled into and retained within the durable tissue retention zone 346b as projecting cleat 328b has a cross- section substantially larger than the opening pierced by penetrator 242. As biasing member 206 and gripping member 214 are squeezed to their closest orientation, piercing end 244 exits dermal layer 118 of second side 106 through the third insertion gap 318c. As inwardly projecting cleat 328a passes through the third insertion gap 318c, the elastic tissue of dermal layer 118 is required to stretch around and over inwardly projecting cleat 328a whereby second side 106 is elastically captured within durable tissue retention zone 346a.

Generally, biasing member 206 and gripping member 214 reach an orientation, for example, in the post-fastener deployment configuration 222 shown in Figure 9, where further squeezing together is impossible and/or prevented. This orientation generally corresponds to the point in time where piercing end 244 and inwardly projecting cleat 328a have passed through the third insertion gap 318c. During the squeezing of biasing member 206 and gripping member 214, spring member 208 has been compressed. At this point, the medical professional releases the gripping member 214 causing spring member 208 to rebound and direct gripping member 214 and biasing member 206 apart. The rebound of spring member 208 causes retention pin 216 to begin reversibly traversing the threaded channel 250, thus imparting a reverse rotational spin to insertion member 210. As insertion member 210 spins in an opposite direction, this opposite rotational motion is imparted to penetrator 242 such that piercing end 244 is rotatably sequentially withdrawn though third insertion gap 318c, second tissue capture area 316, second insertion gap 318b, first tissue capture area 314 and first insertion gap 318a. While penetrator 242 is rotatably withdrawn, fastener 124 remains positioned within the dermal layers 118 of first side 104 and second side 106 as the increased cross-sectional areas of projecting cleats 328a, 328b prevent fastener 124 from being rotatably withdrawn. As such, first side 104 and second side 106 remain in a retained, proximate orientation as illustrated in Figure 35 due to the tissue captured within the durable tissue retention zones 346a, 346. The proximal fastening end 202 is then removed from the opening 100. For wounds requiring more than one fastener 124 to effectuate closure, tissue fastening device 200 can be advanced to the next preferred fastening location wherein the process can be repeated for insertion of additional fasteners 124.

In addition to previously described fastener 124, tissue fastening device 200 can utilize alternative fastener designs such as, for example, a fastener 400 as illustrated in Figure 36. Fastener 400 can comprise a leading body portion 402, a suture body portion 404 and a trailing body portion 406. Leading body portion 402 can comprise an outer wall 408, an inner wall 410, an inwardly projecting cleat 412 and a leading attachment wall 414. Suture body portion 404 generally comprises a non rigid suture material such as, for example, materials commonly used in suturing and/όr stitching wounds closed. Trailing body portion 406 can comprise a pair of anchoring cleats 416a, 416b and a trailing attachment wall 418. Fastener 400 can be fabricated of similar bioabsorbable materials as previously described with respect to fastener 124. When fastener 400 is utilized for wound closure using the method previously described with respect to tissue fastening device 200, leading body portion 402 functions substantially similar to internally projecting cleat 328a while the anchoring cleats 416a, 416b essentially perform a dual anchoring function by simultaneously retaining tissue within a pair of anchoring tissue retention zones 420a, 420b.

As will be recognized by one of skill in the art, suitable fasteners for use with the presently disclosed methods and apparatus may comprise a variety of configurations, especially with respect to trailing portions of the fastener. Generally speaking, suitable fasteners will comprise a trailing anchoring mechanism for effectuating tissue capture and retention, such as internally projecting cleat 328b and anchoring cleats 416a, 416b. In addition, suitable fasteners will include a suitable connecting element such as arcuate body portion 326 and suture body portion 404, for effectively connecting leading portions of the fastener such as internally projecting cleat 328a and leading body portion 402 during insertion and over the period of time required for healing of skin opening 100. Another representative embodiment of a tissue fastening device 500 of the present invention is illustrated in Figures 37 and 38. Tissue fastening device 500 can comprise generally similar features and components as tissue fastening device 200 so as to accomplish similar tissue capture and closure results. Tissue fastening device 500 can include a trigger style biasing end 502 for manipulating a fastening end 504. Tissue fastening device 500 can further comprise a pair of pivoting tissue capture members 506a, 506b for capturing and positioning tissue to be fastened within a tissue definition member 508. The tissue capture members 506a, 506b can be sequentially actuated during use through squeezing of the trigger style biasing end 502 or alternatively, by biasing a first body portion 510 over a second body portion 512 so as to force the approximation of the tissue capture members 506a, 506b with the tissue definition member 508.

As shown in Figure 38, fastening end 504 is generally defined by an exterior body wall 514 and the tissue definition member 508. Tissue definition member 508 generally comprises a central projecting member 516 having a first projecting arm 516a, a second projecting arm 516b and a third projecting arm 516c. Exterior body wall 514 comprises a non-interrupted wall 518 and a wall separator 520. Cooperatively the non-interrupted wall 518 and wall separator 520 define a first wall gap 522 and a second wall gap 524. Non-interrupted wall 518 defines a wall arc 526 exceeding at least 180° while a tissue interface arc 528 defined by the first wall gap 522, second wall gap 524 and wall separator 520 is less than 180°. A first insertion gap 530 is defined between the non-interrupted wall 518 and the first projecting arm 516a. A second insertion gap 532 is defined between the wall separator 520 and the second projecting arm 516b. Third projecting arm 516c includes a gap cover 534 extending to the non-interrupted wall 518 so as to define an enclosed third insertion gap 536. As depicted in Figures 38 and 38a, the tissue capture members 506a, 506b are illustrated in a substantially closed, tissue capturing disposition 538. Tissue capture members 506a, 506b can include one or more tissue gripping members 539 to promote tissue capture and retention during a fastening procedure. Tissue gripping members 539 can comprise a variety of configuration including, for example, barbs, projecting cubes, pyramids, rounded bumps and castles, hi tissue capturing disposition 538, a first tissue capture area 540 is defined in the area bounded by the first insertion gap 530, the second insertion gap 532, tissue capture member 506a, first projecting arm 516a and second projecting arm 516b while a second tissue capture area 542 is defined in the area bounded by the second insertion gap 532, the enclosed third insertion gap 536, tissue capture member 506b, the second projecting arm 516b and the enclosed third insertion gap 536.

With further reference to Figures 38 and 39, fastening end 504 of the tissue fastening device 500 further comprises a penetrator 544 operably attached to an insertion member 546. Both penetrator 544 and insertion member 546 can substantially resemble penetrator 242 and insertion member 210 as previously described with reference to tissue fastening device 200. Insertion member 546 is operably adapted to rotate within the exterior body wall 514 such that penetrator 544 is rotatably movable through a fastener insertion path 548 corresponding generally to the tissue interface arc 528 as will be described in detail below. Referring to Figures 39 and 40, an embodiment of a fastener 550 for use with penetrator

544 is illustrated. Fastener 550 can comprise similar components and fabrication techniques so as to provide fastener 550 with similar bioabsorption and dynamic transitioning capabilities as previously described with respect to fastener 124. While fastener 550 is generally described as comprising a bioabsorbable polymer such as, for example, the polymer and copolymer blends previously described with respect to fastener 124, it may be advantageous in certain surgical applications to utilize non-bioabsorbable materials such as, for example, stainless steel, nitinol and other medical grade alloys to fabricate fastener 550.

Generally, fastener 550 comprises an arcuate body portion 552 operably connecting a pair of internally projecting cleats 554a, 554b at elbow portions 556a, 556b. Elbow portion 556a can include a rounded elbow tip 558 while elbow portion 556b includes a fastener biasing surface 559. Arcuate body portion 552 can comprise a generally constant radius between the internally projecting cleats 554, 554b 'defining a fastener arc in the range of about 125° to about 165°. Arcuate body portion 552 is generally defined b3<^r an arcuate exterior, perimeter surface 560 and an arcuate interior surface 562. The arcuate shape of interior surface 562 functions to even out and focus fastener loading forces and reduces potential rocking of fastener 550 during tissue retention. Fastener 550 can have a generally constant cross-sectional appearance between elbow portions 556a, 556b. Internally projecting cleats 554a, 554b are generally defined by an outwardly facing cleat surface 564, an inwardly facing cleat surface 566 and rounded cleat tips 568a, 568b. Each inwardly facing cleat surface 566 connects to the interior surface 562 at a cleat base 570 so as to define a pair of durable tissue retention zones 572a, 572b. In combination, interior surface 562 and the inwardly facing cleat surfaces 566 define an initial tissue capture zone 574. Additional dimensional features of fastener 550 can substantially resemble fastener 124 as previously described including an effective fastener center line, elbow angles, fastener length, body width, fastener height, outwardly facing cleat surface length, cleat cross-sectional width, inwardly facing cleat surface length, cleat width and cleat gap.

As illustrated in Figure 40a, an embodiment of a fastener 550a for use with the penetrator 544 can substantially resemble fastener 550 with the exception of a reduced thickness arcuate body portion 552a operably connecting internally projecting cleats 554a, 554b at elbow portions 556a, 556b. Internally projecting cleats 554a, 554b and elbow portions 556a, 556b have increased thicknesses allowing the fastener 550a to retain strength in areas such as, for example, the durable tissue retention zones 572a, 572b, that are most effected by wound stress during healing. The reduced sectional profile of reduced thickness arcuate body portion 552a transitions to the increased profile of the elbow portions 556a, 556b at a pair of transition zones 553a, 553b. As reduced thickness arcuate body portion 552 has a reduced cross-sectional profile, less bioabsorbable material is required during fabrication. Reducing the amount of bioabsorbable material in fastener 550a can significantly reduce the cost of manufacturing each fastener 550a while at the same time being less irritating to captured tissue. In addition, reducing the cross-sectional profile of reduced thickness arcuate body portion 552 can be advantageous as fastener 550a is generally more flexible than fastener 550, allowing fastener 550a to more readily adapt to tissue stress and quickly assume a tensile mode.

Referring again to Figure 39, fastener 550 generally resides within a fastener holding portion 576 on the penetrator 544 defined by a bottom penetrator surface 578, a radial exterior wall surface 580, a radial inner surface 582 and a biasing wall 584. Fastener 550 is positioned within the fastener holding portion 576 such that the arcuate body portion 552 lies against the bottom penetrator surface 578 and the radial exterior wall surface 580 with the elbow portion 556a proximate a penetrator piercing end 586 and the fastener biasing surface 559 positioned against the biasing wall 584. Through the interface of biasing wall 584 and the fastener biasing surface 559, fastener 550 is forcibly carried with penetrator 544 as insertion member 546 rotates with respect to fastening end 504 such that fastener 550 is carried through the fastener insertion path 548. In addition to or alternatively to using the interaction of biasing wall 584 and fastener biasing surface 559 to carry fastener 550, penetrator 544 can comprise a projecting member 588 within the fastener holding portion 576 for engaging a notched section 589 on the fastener 550 so as to carry fastener 550 with the penetrator 544 as illustrated in Figure 39a. The interaction of projecting member 588 and notched section 589 can provide an additional benefit of properly aligning the fastener 550 within the fastener holding portion 576, which may be especially useful when tissue fastening device 500 comprises a plurality of staged fasteners 550.

Use of tissue fastening device 500 for closure of a tissue wound is illustrated sequentially in Figures 41-47. As presently discussed, tissue fastening device 500 is described with reference to closure of a skin wound for illustrative purposes though it will be understood that tissue fastening device 500 is similarly applicable to a variety of related tissue closure and/or joining applications. Due to the rotatable insertion nature of fastener 550, fastening end 504 can be positioned in a wide range of angular orientations with respect to the opening 100 allowing fastener 550 to access the target tissue zones 122 in a variety of angular orientations with respect to the exterior surface 116 of the skin tissue 102.

Referring to Figure 41, a first fastening step 590 generally comprises positioning fastening end 504 within opening 100. Using the trigger style biasing end 502, the tissue capture member 506a is biased closed such that it resides proximate the first wall gap 522. As tissue capture member 506a approaches the first wall gap 522, first side 104 is grasped and squeezed such that the first target tissue zone 128 is presented, retained and defined within the first tissue capture area 540. As first side 104 is captured within first tissue capture area 540, penetrator 544 and fastener 550 remain positioned fully within the wall arc 526.

Following the positioning of the first side 104 within the first tissue capture area 540, further biasing of the trigger style biasing end 502 initiates rotation of the insertion member 546 and correspondingly, penetrator 544 such that piercing end 586 rotates through the first insertion gap 530 and commences rotational travel along the tissue interface arc 528 during a second fastening step 592 as illustrated in Figure 42. As piercing end 586 rotates along the tissue interface arc 528, the piercing end 586 cuts through the dermal layer 118 of captured first side 104. As piercing end 586 rotatably traverses the first tissue capture area 540, internally projecting cleat 554a is carried through the dermal layer 118. As the cross-sectional width of the internally projecting cleat 554a exceeds the cross-sectional width of the piercing end 586 and the penetrator 544, the first side 104 essentially piles up along the outwardly facing cleat surface 564 until the internally projecting cleat 554a approaches and enters the second insertion gap 532 wherein the first side 104, still captured and retained by tissue capture member 506a is elastically stretched and pulled over the internally projecting cleat 554a such that the arcuate body portion 552 of fastener 550 resides within a pierced opening of the first side 104. Once piercing end 586 reaches the second insertion gap 532, further biasing of the trigger style biasing end 502 causes tissue capture member 506b to close such that it resides proximate the second wall gap 524 in a third fastening step 594 as illustrated in Figure 43. As tissue capture member 506b approaches the second wall gap 524, second side 106 is grasped and squeezed such that the second target tissue zone 130 is presented, retained and defined within the second tissue capture area 542. As second side 106 is captured within second tissue capture area 542, piercing end 586 remains positioned within the second insertion gap 532 so as to not interfere with the capture of second side 106. Once the second target tissue zone 130 is defined within the second tissue capture area 542, further biasing of the trigger style biasing end 502 causes piercing end 586 to commence rotational travel through the second tissue capture area 542 during a fourth fastening step 596 as illustrated in Figures 44 and 44a. As piercing end 586 rotates along the tissue interface arc 528, the piercing end 586 cuts through the dermal layer 118 of captured second side 106. As the internally projecting cleat 554a is carried through the second tissue capture area 542, the second side 106 piles up along the outwardly facing cleat surface 564 until the internally projecting cleat 554a approaches and enters the enclosed third insertion gap 536. As piercing end 586 and consequently, the internally projecting cleat 564a enter the enclosed third insertion gap 536, the piercing end 586 and internally projecting cleat 564a leave the tissue interface arc 528 and enter the wall arc 526. As internally projecting cleat 564a begins traversing the wall arc 526, rounded cleat tip 568a enters the enclosed third insertion gap 536 such that the second side 106 which has been piled along the outwardly facing cleat surface 564 is elastically stretched and forced over the internally projecting cleat 564a by the enclosed third insertion gap 536. At the same time that internally projecting cleat 564a traverses the second tissue capture area 542, internally projecting cleat 564b is advanced into the first tissue capture area 540 wherein the internally projecting cleat 564b essentially acts as an anchor and captures first side 104 within the durable tissue retention zone 572b. As first side 104 is in an elastically stretched condition due to its initial capture by internally projecting cleat 564a, first side 104 is elastically retained within the durable tissue retention zone 572b and cannot escape capture by the internally projecting cleat 564b.

Once the piercing end 586 and internally projecting cleat 564a have passed fully into the enclosed third insertion gap 536 and the second side 106 has been elastically stretched over the internally projecting cleat 564a, the trigger style biasing end 502 can be released so as to initiate a reverse rotation of the insertion member 546, and consequently, the penetrator 544 in a fifth fastening step 598 as illustrated in Figures 45 and 45a. Penetrator 544 is rotatably withdrawn through the tissue interface arc 528 such that piercing end 586 resides within the second insertion gap 532. As piercing end 586 is withdrawn through the second tissue capture area 542, fastener 550 is preferably slightly withdrawn as depicted in Figure 45a such that the internally projecting cleat 564a exits the enclosed third insertion gap 536. However, in some closure and attachment locations, fastener 550 may remain essentially stationary such that internally projecting cleat 564a continues to reside within enclosed third insertion gap 536 as shown in Figure 45 even as the penetrator 544 is rotatably withdrawn. During a sixth fastening step 600 as illustrated in Figure 46, the penetrator 544 is fully withdrawn such that it resides solely within the wall arc 526, the capture of first side 104 and second side 106 with fastener 550 is completed with the first side 104 elastically captured within the second durable retention zone 572b and the second side 106 elastically captured within the first durable retention zone 572a. If when penetrator 544 fully resides within the wall arc 526, the internally projecting cleat 564a remains within the enclosed third insertion gap 536 as shown in Figure 45, a trailing penetrator member 602 as shown in Figure 45 can be used to bump internally projecting cleat 564a from the enclosed third insertion gap 536.

Finally, tissue capture members 506a, 506b are withdrawn during a seventh fastening step 604 illustrated in Figure 47 such that tissue fastening device 500 can be lifted from the opening 100 and first side 104 and second side 106 are retainably held by fastener 550. Following seventh fastening step 604, the fastening process can be repeated by repositioning tissue fastening device 500 as shown in Figure 48 and 49 at a next desired fastening location along opening 100 if tissue fastening device 500 includes additional fasteners 550 as illustrated in Figure 38a. As illustrated in Figures 48, 49 and 50, tissue fastening device 500 has been utilized to close skin opening 100 with a plurality of fasteners 550 in a generally downwardly facing, non-parallel orientation with respect to exterior surface 116. Fasteners 550 retain first side 104 and second side 106 in the generally everted disposition most advantageous for wound healing. Due to the flexibility of tissue fastening device 500, fastener 550 can be deployed in almost any orientation ranging from substantially parallel to substantially perpendicular with respect to the exterior surface 116 of first side 104 and second side 106. Due to the flexibility of the placement orientation of fasteners 550 within first side 104 and second side 106, a medical professional is provided the option of varying the spacing between adjacent fasteners allowing the medical professional to selectively increase the overall closure strength along the length of opening 100 by placing adjacent fastener 550 in close proximity, which may be especially advantageous in either high-stress wound locations or for larger wounds. As best illustrated in Figure 50, the placement of a plurality of fasteners 550 to close wound 100 essentially simulates a wound closure accomplished using a running, subcuticular suture with the added benefit of each fastener 550 being interrupted so as to reduce the potential for infection and inflammation which can be communicated along the continuous length of a running, subcuticular suture.

As illustrated in Figure 51, the closure principles disclosed in the aforementioned apparatus and method embodiments are applicable to and can be utilized to form a minimally invasive tissue fastening device 700. Similar to tissue fastening devices 200 and 500, minimally invasive tissue fastening device 700 can comprise a biasing portion 702 and an insertion portion 704. Minimally invasive tissue fastening device 700 can further comprise an extended body portion 706 allowing the insertion portion 704 to be inserted through a body wall, such as, for example, an abdominal wall 708 such that insertion portion 704 can fasten tissue within the abdomen 710. Extended body portion 706 can be adapted for direct insertion through the abdominal wall 708 or alternatively, an extended body portion 706 can be inserted through a laproscopic port in the abdominal wall. Biasing portion 702 generally remains outside the body allowing a user to manipulate insertion portion 704 to capture and secure tissue in a manner similar to that previously described with respect to tissue fastening devices 200 and 500. However, tissue fastening device 700 may be used in internal applications wherein the positioning, joining and anchoring of tissue or organ does not suffer the disadvantage associated with "button-holing" or piercing the epidermis during skin tissue closure. As such, tissue capture using minimally invasive tissue fastening device 700 may, in some treatment applications, have less criticality with respect to tissue capture with insertion portion 704.

While various representative embodiments of the present invention have been described with respect to fastening of dermal tissue, it will be recognized that the present invention is also applicable to other types of tissue having membranes walls or layers such as facia, muscle and the like. Although the present invention has been described with respect to a variety of representative, presently contemplated embodiments, it will be understood that numerous insubstantial changes in configuration, arrangement or appearance of the elements of the present invention can be made without departing from the intended scope of the present invention. Accordingly, it is intended that the scope of the present invention be determined by the claims as set forth.

Claims

1. A method for rotatably, sequentially seeming skin tissue with a fastener comprising: positioning a mechanical apparatus in a tissue opening between a first tissue side and a second tissue side, the mechanical apparatus having a falcate penetrator operably carrying a discrete fastener having a leading fastener portion and a trailing fastener portion; manipulating the first tissue side into a first capture portion of the mechanical apparatus, the first capture portion defining a first tissue bite; piercing the first tissue bite with the falcate penetrator such that the leading fastener portion is rotatably advanced through the first tissue bite; manipulating the second tissue side into a second capture portion of the mechanical apparatus, the second capture portion defining a second tissue bite; and piercing the second tissue bite with the falcate penetrator such that the leading fastener portion is rotatably advanced through the second tissue bite and the trailing fastener portion retainably engages the first tissue bite.

2. The method of claim 1, wherein each capture portion of the mechanical apparatus is adapted to cause the steps of manipulating the first and second tissue sides to present a target tissue zone of the tissue within each of the first and second tissue bites.

3. The method of claim 1, wherein the steps of manipulating the first tissue side into the first capture portion and manipulating the second tissue side into the second capture portion occur substantially simultaneously.

4. The method of claim 1, wherein the steps of manipulating the first tissue side into the first capture portion and manipulating the second tissue side into the second capture portion occur sequentially.

5. The method of claim 1, further comprising: retracting the falcate penetrator from the first tissue side and the second tissue side without retracting the fastener such that the leading fastener portion retainably engages the second tissue side while the trailing fastener portion retainably engages the first tissue side.

6. The method of claim 5, further comprising: . repositioning the mechanical apparatus within the tissue opening at a location other than the location of the fastener; and repeating the method for placement of a second fastener.

7. A method for sequentially securing skin tissue with a fastener comprising: causing a first target tissue zone to be presented to a mechanical apparatus; using the mechanical apparatus to advance a curved penetrator operably carrying a discrete fastener into and through the first target tissue zone; causing a second target tissue zone to be presented to the mechanical apparatus; using the mechanical apparatus to advance the curved penetrator operably carrying the discrete fastener into and through the second target tissue zone; and using the mechanical apparatus to remove the curved penetrator from the first and second target tissue zones without carrying the discrete fastener such that the discrete fastener remains in both the first and second target tissue zones.

8. The method of claim 7, wherein the steps of causing the first target tissue zone and the second target tissue zone to be presented to the mechanical apparatus are accomplished substantially simultaneously.

9. The method of claim 7, wherein the steps of causing the first target tissue zone and the second target tissue zone to be presented to the mechanical apparatus are accomplished sequentially.

10. The method of claim 7, wherein the steps of using the mechanical apparatus to advance the curved penetrator are accomplished by causing a member within the mechanical apparatus to rotatably advance the curved penetrator.

11. The method of claim 7, wherein the mechanical apparatus includes a plurality of discrete fasteners stored in a generally stacked fashion parallel to an axis of rotation of the member, and wherein the step of using the mechanical apparatus to remove the curved penetrator causes another fastener to be positioned to be carried by the curved penetrator when the method is repeated.

12. A method for sequentially capturing adjacent tissue with a fastener comprising: providing a medical apparatus that includes a falcate penetrator adapted to pierce tissue along a generally arc-shaped path of travel, the falcate penetrator having a maximum cross-section dimension transverse to the path of travel; providing a discrete fastener adapted to be carried by the falcate penetrator and having a first capture portion and a second capture portion proximate generally opposing ends of the fastener, each capture portion of the fastener having a maximum cross-section dimension transverse to the path of travel of the falcate penetrator that is greater than the maximum cross-section dimension of the falcate penetrator; piercing a first tissue portion with the falcate penetrator, the falcate penetrator operably carrying a first capture portion of the fastener though the first tissue portion; piercing a second tissue portion with the falcate penetrator such that the first capture portion of the fastener is advanced through the second tissue portion while a second capture portion of the fastener operably engages the first tissue portion; and removing the falcate penetrator from the first tissue portion and the second tissue portion without causing the fastener to be withdrawn such that the fastener retainably captures the first tissue portion and the second tissue portion with the first portion of the fastener operably engaging the second tissue portion and the second portion of the fastener operably engaging the first tissue portion.

13. The method of claim 12, wherein the step of removing the falcate penetrator is accomplished by withdrawing the falcate penetrator back along the path of travel.

14. A surgical fastener for tissue comprising: a bioabsorbable fastener having a generally crescent-shaped backspan extending between a first inwardly projecting cleat and a second inwardly projecting cleat, the generally crescent-shaped backspan defining generally constant radius between the first inwardly projecting cleat and the second inwardly projecting cleat over an arc in a range of about 125 degrees to about 165 degrees with a distance between the first inwardly projecting cleat and the second inwardly projecting cleat having a range of about 1 mm to about 12 mm.

15. The surgical fastener of claim 14, wherein the bioabsorbable fastener comprises a bioabsorbable material selected from the group comprising: a lactide/glycolide copolymer, a poly(dl-lactide), a poly(l-lactide), a polyglycolide, a poly(dioxanone), a poly(glycolide-co- trimethylene carbonate), a poly(l-lactide-co-glycolide), a poly(dl-lactide-co-glycolide), a poly(l- lactide-co-dl-lactide), a poly(glycolide-co-trimethylene carbonate-co-dioxanone), collagen, elastin and combinations thereof.

16. The surgical fastener of claim 14, wherein the backspan has a maximum cross-section dimension defined transverse to the arc and wherein each inwardly projecting cleat has a maximum cross-section dimension defined transverse to the arc that is at least fifty percent greater than the maximum cross-section dimension of the backspan.

17. The surgical fastener of claim 16, wherein the maximum cross-section dimension of the backspan is less than 4 mm.

18. A surgical fastener for tissue comprising: a bioabsorbable fastener having a generally crescent-shaped backspan extending between a first inwardly projecting cleat and a second inwardly projecting cleat, the fastener being adapted to be inserted into tissue along a generally curved insertion path with only one of the first inwardly projecting cleat and the second inwardly projecting cleat leading insertion of the fastener along the insertion path, wherein a fastener length defined between an outer edge of the first inwardly projecting cleat and the second inwardly projecting cleat is less than about 22 mm and a fastener height defined perpendicular to the fastener length between a center point of the fastener length and an outer edge is such that a ratio of the fastener length to the fastener height exceeds 2:1.

19. The surgical fastener of claim 18, wherein the bioabsorbable fastener comprises a bioabsorbable material selected from the group comprising: a lactide/glycolide copolymer, a poly(dl-lactide), a poly(l-lactide), a polyglycolide, a poly(dioxanone), a poly(glycolide-co- trimethylene carbonate), a poly(l-lactide-co-glycolide), a poly(dl-lactide-co-glycolide), a poly(l- lactide-co-dl-lactide), a poly(glycolide-co-trimethylene carbonate-co-dioxanone), collagen, elastin and combinations thereof.

20. The surgical fastener of claim 18, wherein the backspan has a maximum cross-section dimension defined transverse to the arc and wherein each inwardly projecting cleat has a maximum cross-section dimension defined transverse to the arc that is at least fifty percent greater than the maximum cross-section dimension of the backspan.

21. The surgical fastener of claim 20, wherein the maximum cross-section dimension of the backspan is less than 4 mm.

22. The surgical fastener of claim 18, wherein the bioabsorbable fastener is adapted to dynamically transition from a first position to a second position once inserted into tissue, wherein the ratio of the fastener length to the fastener height increases by at least 10 percent.

23. The surgical fastener of claim 18, wherein the bioabsorbable fastener is adapted to deform from a first position to a second position that deforms in a direction other than generally transverse to a direction of insertion of the fastener.

24. A surgical fastening device for sequentially securing tissue with a generally crescent- shaped fastener having a first retaining portion and a second retaining portion comprising: an insertion body having a distal portion and a proximal portion, the distal portion having a tissue interface structure and the proximal portion having an actuator assembly; and a rotatable insertion assembly having a falcate penetrator arranged proximate the tissue interface structure, the rotatable insertion assembly being operably coupled to the actuator assembly, the falcate penetrator being adapted to carry the crescent-shaped fastener when the actuator assembly causes the rotatable insertion assembly to advance the falcate penetrator such that the first retaining portion of the fastener is rotatably directed through tissue proximate the tissue interface structure.

25. The surgical fastening device of claim 24, wherein the actuator assembly includes a biasing member selected from the group comprising: a push-button and a trigger.

26. The surgical fastening device of claim 24, wherein the tissue interface structure comprises a first interface portion and a second interface portion oriented in adjacent, radial relation.

27. The surgical fastening device of claim 24, wherein the rotatable insertion assembly comprises a shaft assembly having a proximal shaft end operably attached to the falcate penetrator and a distal shaft end operably interfacing with the actuator assembly.

28. The surgical fastening device of claim 24, wherein the insertion body defines a body lumen between the proximal portion and the distal portion that houses the shaft assembly.

29. The surgical fastening device of claim 28, wherein the body lumen comprises an internal thread and the shaft assembly comprises an external thread and wherein the internal thread and the external thread interface to rotatably advance the falcate penetrator relative to the tissue interface structure under the direction of the actuator assembly.

30. The surgical fastening device of claim 24, wherein the actuator assembly comprises a return member that rotatably withdraws the falcate penetrator relative to the tissue interface structure.

31. The surgical fastening device of claim 24, wherein the insertion^' body comprises a tissue manipulation assembly adapted to present tissue to the tissue interface structure, the tissue manipulation assembly being operably coupled to the actuator assembly so as to present the tissue prior to advancing the falcate penetrator relative to the tissue interface structure.

32. The surgical fastening device of claim 31, wherein the tissue manipulation assembly comprises a pair of jaws to position tissue with respect to the tissue interface structure such that the jaws are within a range of about .008 inches to about .035 inches from an outward travel path of the falcate penetrator.

33. The surgical fastening device of claim 24, wherein the falcate penetrator comprises: a piercing tip, a carrying surface, a sidewall and a biasing member wherein the carrying surface and sidewall defining a crescent-shaped body with the piercing tip and biasing member at opposed ends and wherein the carrying surface and the sidewall are joined in a non-planar orientation.

34. The surgical fastening device of claim 33, wherein the piercing tip comprises a dual-face piercing tip having a vertical piercing face and a horizontal piercing face.

35. ^' The surgical fastening device of claim 34, wherein both the vertical piercing face and the horizontal piercing face comprise a first cutting facet having a first facet length and a second cutting facet having a second facet length.

36. The surgical fastening device of claim 35, wherein the first facet length comprises from about 50% to about 67% of a total facet length wherein the total face length is the sum of the first facet length and the second facet length.

37. The surgical fastening device of claim 33, wherein the crescent-shaped body has a constant body radius less than 180 degrees.

38. The surgical fastening device of claim 33, wherein the carrying surface and the sidewall are joined in a generally transverse orientation.

39. A surgical fastening device for capturing two tissue regions though generally rotatable introduction of a fastener comprising: a tissue interface assembly having a tissue interface structure and a falcate penetrator, the tissue interface structure having a first capture portion and a second capture portion; a biasing assembly operatively coupled to the falcate penetrator that rotatably advances the falcate penetrator through the first capture portion and the second capture portion; and at least one discrete fastener adapted to be carried by the falcate penetrator.

40. The surgical fastening device of claim 39, wherein the at least one fastener comprises a bioabsorbable fastener.

41. The surgical fastening device of claim 40, wherein the bioabsorbable fastener is fabricated from a bioabsorbable material selected from the group comprising: a lactide/glycolide copolymer, a poly(dl-lactide), a poly(l-lactide), a polyglycolide, a poly(dioxanone), a poly(glycolide-co-trimethylene carbonate), a poly(l- lactide-co-glycolide), a poly(dl-lactide-co-glycolide), a poly(l-lactide-co-dl-lactide), a poly(glycolide-co-trimethylene carbonate-co-dioxanone), collagen, elastin and combinations thereof.

42. The surgical fastening device of claim 39, wherein the biasing assembly comprises a biasing member selected from the group comprising: a trigger and a push-button.

43. The surgical fastening device of claim 39, wherein the biasing assembly comprises a minimally invasive structure capable of introduction within a body via a laproscopic port.

44. The surgical fastening device of claim 39, further comprising: a position indicator that communicates a position of the falcate penetrator with respect to the first capture portion and the second capture portion to an operator of the fastening device.

45. The surgical fastening device of claim 44, wherein the position indicator comprises at least one light emitting diode.

46. The surgical fastening device of claim 39, wherein the biasing assembly comprises at least a partial lumen proximate the tissue interface assembly such that a plurality of fasteners are stored in a generally stacked fashion parallel to an axis of rotation of the falcate penetrator and wherein the plurality of fasteners are adapted for sequential, individual placement onto the falcate penetrator.