Abstract:
A medical device for installing sutures to close an incision in tissue or human skin is disclosed. The suturing device may provide first and second arcuate needles. Once properly positioned, the first and second arcuate needles are driven through the sub-dermal layer, or alternatively through a superficial surface, of two sections of skin to be joined. This is done in arcuate fashion and at identical and symmetrical rates of angular displacement. In so doing, the sections of skin are pushed toward one another thus assuring horizontal and vertical alignment of the two sections of skin. During the driving or retraction process of the first and second arcuate needles, a suture is positioned within both the first and second sections of skin and transformed from a planar or a multi-planar serpentine orientation to a helical orientation. The resulting suturing process is thus much faster than conventional or manual suturing and results in superior wound approximation/alignment that will lead to decreased scarring compared to prior art devices.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application is based on and claims priority from U.S. Provisional Application Ser. No. 61/427,003, filed on Dec. 23, 2010. 
     
    
     FIELD OF THE DISCLOSURE 
       [0002]    The present disclosure generally relates to medical devices, and more particularly relates to medical devices for suturing skin. 
       BACKGROUND OF THE DISCLOSURE 
       [0003]    The closure of incisions or lacerations in human skin has long been a need in the medical industry. Whether the incision is the result of surgeries such as cosmetic surgery or internal organ operations, or those generated by traumatic events or accidents, surgeons are continually presented with patients needing closure of such skin openings. For example, modern studies indicate that approximately 30 million such operations are performed each year in the U.S. alone. 
         [0004]    In closing such incisions, surgeons are able to choose from a relatively limited number of options currently available. One of those options is manual suturing. This is perhaps the oldest of the available options and conventionally involves the physician directing a needle, to which is temporarily attached a suturing filament, through one section of skin, across the incision and into the other side of the incision. This process is repeated as many times as necessary to result in a certain number of “stitches” closing the incision. Upon reaching the end of the incision, the physician ties off the last suture to complete the process. While effective, manual suturing is certainly not without its drawbacks. For example, in the case of body contouring surgery, relatively large incisions in excess of many centimeters may be made which can often take the surgeon a very long time to close. It is not uncommon for the suturing of the incision to take longer than the actual operation itself. Not only is it time consuming, but surgeons often view the process as tedious. Moreover, the repeated movement of the needle through the skin of the patient necessarily increases the risk to the surgeon or assistant of being exposed to a needle prick which in turn can lead to certain transmissions of diseases including but not limited to Hepatitis C and HIV. 
         [0005]    Given the time and difficulty involved with manual suturing, another closure option which is commonly employed is referred to as stapling. This process typically uses metal staples that are reminiscent of the staples commonly used in office settings to clip papers together. Specifically, stapling involves directing first and second parallel prongs of the staple into the first and second sections of skin to be connected, and against an anvil-like surface provided on the outside of the incision. When the prongs penetrate through the skin and contact the anvil, the prongs are deformed so as to be transverse to the main body of the staple and thus secured in position. The prongs are typically canted slightly inwardly so as to facilitate this deformation. The staples are installed using a medical device typically having some form of spring biased drive mechanism to quickly and effectively deploy the staples. 
         [0006]    While significantly faster than manual suturing, staples themselves are also associated with certain drawbacks. Foremost among those drawbacks is the significant scarring associated with staples. The scarring is often referred to as “railroad tracks”, as the scar will typically include the linear incision itself laterally flanked by pairs of matching demarcations where the prongs of the staple enter the skin. Moreover, staples are significantly more painful to the patient in that they need to be removed after being installed and after the incision is healed. Suturing, on the other hand, can often be performed with absorbable sutures which disintegrate or are absorbed by the body after installation. 
         [0007]    In light of the foregoing, a still further option currently available to surgeons is known as an absorbable dermal stapler wherein the staples are manufactured from a material or anchor which can be absorbed by the patient. One example of such an absorbable dermal stapler is marketed under the trademark “Insorb™”. This can potentially avoid a significant level of pain associated with metal staple removal, but may result in significant scarring or poor wound healing in general. This is due to: (a) less than optimal alignment associated with such absorbable staplers between the two sections of skin to be fastened; (b) poor wound holding strength which can result in areas of wound separation if there is any tension on the wound edges (tension which is not uncommon during the post-operative period) and; (c) and creation of small areas of wound separation where the thick fasteners extrude through the incision (known clinically as “spitting” of the fasteners). In order to most effectively close an incision with minimal scarring, it is advantageous to position the first and second sections of skin so as to both be within the same plane (vertical alignment), and to approximate the skin edges as close together as possible (horizontal alignment). If these sections of skin are not well approximated with regard to horizontal alignment, the resulting scar will be relatively wide as the body will fill in the gap with additional connective tissue. If the wound edges are not well aligned in the vertical dimension, then the scar will heal with a “step-off” which causes the scar to be more prominent. 
         [0008]    Current absorbable dermal stapling technology provides less than optimal horizontal and vertical alignment. In addition to ensuring precise alignment of the superficial skin surface (epidermis), optimal wound closures should provide good approximation and support in the deeper strength-bearing layer of the skin (dermis). When the dermis is effectively secured, the wound forms a wound surface that is well aligned but slightly protrusive at the superficial surface, a desirable wound configuration that is clinically known as “eversion.” As the wound heals, the eversion gradually settles, resulting in a flat/optimal scar. The converse of eversion is wound inversion, which is characterized by the closed wound edges dipping inward. Inversion must be avoided in order to prevent the wound from forming a scar with a recessed valley appearance. Current dermal staplers attempt to position the wound in an everted fashion. However, the method in which the fasteners hold the wound edges in eversion results in prominent “dimpling” of the skin where the fasteners secure the skin edges, a closure appearance which can cause concern to surgeons when they try dermal staplers for wound closure. 
         [0009]    With all these drawbacks in mind, a most recent effort has been made to provide a medical device which provides the fast and efficient closure afforded by staplers, with the decreased scarring associated with suturing. For example, U.S. Publication No. 2009/0093824 discloses a wound closure device which is adapted to position an anchor specifically known as an “H-Type” fastener between first and second sections of skin to be secured. The device includes channels in which the first and second sections of skin are to be positioned and includes a single arcuately shaped rotating needle adapted to enter one section of skin through the sub-dermal layer and carry the H-shaped anchor therewith. While the &#39;824 application attempts to position the first and second sections of skin relative to one another, the use of such an H-shaped anchor does not adequately pull the two sections close together after insertion and thus would result in longer healing times and more scarring than is acceptable. More specifically, the leading prong of the “H” needs to be pulled entirely through the second section of skin in order to deploy. Once it is so deployed and released, the anchor is pulled back by the opposite prong and the normal tension on the wound edges, thus resulting in slack in the anchor and a loose “seam”. Moreover, the &#39;824 application uses a complex system of rotating approximation arms to push the first and second sections of skin toward one another prior to insertion of the anchor. Not only does this make the device more complicated and expensive to manufacture and prone to reliability problems, but once the approximation arms are retracted so too are the sections of skin and again the resulting closure does not ensure optimal alignment, which would lead to prominent or otherwise poor scarring. 
       SUMMARY OF THE DISCLOSURE 
       [0010]    In accordance with one aspect of the disclosure, a suturing device is disclosed. The suturing device may comprise a first arcuate needle adapted to rotate in a first direction through a dermal layer of a first section of skin to be sutured and through the dermal layer of a second section of skin to be sutured, a second arcuate needle adapted to rotate in a second direction opposite to the first rotational direction and through a dermal layer of a second section of skin to be sutured and through the dermal layer of the first section of skin to be sutured, and a drive mechanism forcing rotation of the first and second arcuate needles upon activation by a user and adapted to insert a suture detachably attached to the first and second arcuate needles. 
         [0011]    In accordance with another aspect of the disclosure, a method of suturing skin is disclosed. The method may position a suturing device proximate first and second sections of skin to be sutured together, drive first and second arcuate needles in opposing directions of rotation into the first and second sections of skin, and deploy a suture connecting the first and second sections of skin upon movement of the first and second needles. The first and second needles may separately enter dermal layers of the first and second sections of skin. 
         [0012]    In accordance with yet another aspect of the disclosure, a tissue suture is disclosed. The tissue suture may comprise an elongated filament having first and second ends, a first needle guide positioned at the first filament end, and a second guide surface positioned at the second filament end. The filament may have a pre-insertion orientation and a post-insertion orientation. The pre-insertion orientation may be within at least one plane, and the post-insertion orientation may be helical. 
         [0013]    These and other aspects and features of the disclosure will be better understood upon reading the following detailed description when taken into conjunction with the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]      FIG. 1  is a perspective view of a suturing tool constructed in accordance with the teachings of the disclosure; 
           [0015]      FIG. 2  is an enlarged perspective view of the suturing tool of  FIG. 1 ; 
           [0016]      FIG. 3 . is a side view of the suturing tool of  FIG. 1 ; 
           [0017]      FIG. 4  is a perspective view of the suturing tool of  FIG. 1 , with certain portions of its exterior cut-away to reveal the drive mechanism of the tool; 
           [0018]      FIG. 5  is an enlarged perspective view of the drive mechanism of  FIG. 5 ; 
           [0019]      FIG. 6  is an enlarged perspective view of the drive mechanism of  FIG. 5 , shown from the opposite side of  FIG. 5 ; 
           [0020]      FIG. 7  is an enlarged front view of the operating end of the suturing tool of  FIG. 1 ; 
           [0021]      FIG. 8  is a cartridge constructed in accordance with one embodiment of the present disclosure and used in conjunction with the suturing tool of  FIG. 1 ; 
           [0022]      FIGS. 9A-9B  are enlarged plan views of suturing needles constructed in accordance with the teachings of the disclosure; 
           [0023]      FIGS. 10A-10I  are schematic views of slider plates configured to secure engagement between the needles and sutures; 
           [0024]      FIGS. 11A-11J  are perspective views of multiple embodiments of sutures constructed in accordance with the teachings of the disclosure; 
           [0025]      FIGS. 12A-12B  are schematic views of a suture pre-insertion and post-insertion depicting how outwardly extending elements of the suture avoid medialization and retraction; 
           [0026]      FIG. 13  is a perspective view of a test fixture version of the suturing device in actual use and shown in an engaged position; 
           [0027]      FIG. 14  is a bottom perspective view of the test fixture version of suturing device of  FIG. 13 ; 
           [0028]      FIGS. 15A-15E  depict plan views of an incision at various stages after the suturing tool of the present disclosure has been used; 
           [0029]      FIGS. 16A-16F  are schematic representations of the suture pre-insertion when the closed helix configuration of the technology is used; 
           [0030]      FIG. 16G  is a schematic representation of the suture post-insertion as viewed from the deep skin surface when the closed helix configuration of the technology is used; 
           [0031]      FIGS. 16H-16M  are schematic representations of the suture pre-insertion when the open helix configuration of the technology is used; 
           [0032]      FIG. 16N  is a schematic representation of an oblique view of the suture post-insertion as viewed from the superficial skin surface when the open helix configuration of the technology is used; 
           [0033]      FIG. 17  is a perspective view (from the bottom/sub-dermal/undersurface) of the skin sections sutured together in open helix configuration in accordance with the teachings of the disclosure; 
           [0034]      FIG. 18  is a plan view of two other sections of skin after being sutured by the present disclosure and showing the specific shape and position of multiple sutures after insertion in open helix configuration; 
           [0035]      FIG. 19  is a perspective view of the superficial/exterior skin surface of  FIG. 17 ; 
           [0036]      FIGS. 20A-20C  are perspective views of prior art closure devices in comparison to the closure device of the present disclosure. 
           [0037]      FIG. 21  is a perspective view of an alternative embodiment of a suturing tool constructed in accordance with the teachings of the disclosure and adapted to interface with the epidermal layer of skin, wherein the suture and cartridge (e.g., the alternate version of  FIG. 8 ) have been removed for illustration purposes; 
           [0038]      FIG. 22  is an enlarged perspective view of the operating end of the suturing tool depicted in  FIG. 21 ; 
           [0039]      FIG. 23  is an end view of the operating end of  FIG. 21  and depicting the insertion needles in a pre-insertion position; 
           [0040]      FIG. 24  is an end view similar to  FIG. 23  but showing the needles in an engaged position; 
           [0041]      FIG. 25  is a side view of a portion of the drive mechanism and operating end of the suturing tool of  FIG. 21 ; 
           [0042]      FIG. 26  is a front perspective view of the drive mechanism and operating end of  FIG. 25 ; 
           [0043]      FIG. 27  is a bottom perspective view of the drive mechanism and operating end of  FIG. 25 ; 
           [0044]      FIG. 28  is a longitudinal cross-sectional view of a test version of a drive mechanism and drive shafts showing the coaxial disposition of the drive shafts for the first and second needles; 
           [0045]      FIG. 29  is a perspective view of a laparoscopic embodiment of a suturing tool constructed in accordance with the disclosure; 
           [0046]      FIG. 30  is an enlarged perspective view of the operating end of the laparoscopic embodiment of  FIG. 29 , with the needles shown in retracted positions; and 
           [0047]      FIG. 31  is an enlarged perspective view of the operating end of the laparoscopic embodiment with the needles shown in extended positions. 
       
    
    
       [0048]    While the present disclosure is susceptible to various modifications and alternative constructions, certain illustrative embodiments thereof have been shown in the drawings and will be described below in detail. It should be understood, however, that there is no intention to limit the present invention to the specific forms disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions and equivalents falling within the spirit and scope of the present disclosure. 
       DETAILED DESCRIPTION 
       [0049]    Referring now to the drawings, and with specific reference to  FIG. 1 , a suturing device constructed in accordance with the teachings of the present disclosure is generally referred to by reference numeral  20 . The device, as will be described in further detail herein, is advantageous for surgically closing incisions, not only quickly, but with closely approximated edges and minimal scarring. Of course, the suturing device  20  can also be used to close lacerations from traumatic events such as accidents, or the like. The first embodiment of  FIGS. 1-9  of the suturing tool  20  is designed to be placed under the skin sections of the skin to be sutured, and then place a suture into the dermal layers of the skin. In later described embodiments, suturing tools are described to be used against the epidermal layer of the skin, from the outer skin surface, or be used laparoscopically. Although the embodiments disclosed herein demonstrate suturing as applied to skin, it will be understood that the present disclosure may be equally or similarly applied to tissues other than skin. 
         [0050]    Again referring to  FIG. 1 , it will be noted that the suturing device  20  includes a grip  22  consisting of a handle  24  and a trigger  26 . Compression of the trigger  26  toward the handle  24  by the hand of the surgeon causes a drive mechanism  28  to move the internal components of an operating end  30  and thereby install a suture  32  into the dermal layers of skin of a patient (not shown in  FIG. 1 , but shown later herein). 
         [0051]    More specifically, the operating end  30  is shown in further detail in  FIGS. 2-7 . As will be noted herein, the operating end  30  includes a first arcuate needle  34  and a second arcuate needle  36  adapted to rotate about a common axis  37  as will be described in further detail herein. The motion begins upon compression of the trigger  26  toward the handle  24  which causes a lever arm  39  to rotate about a pivot  40  to thus cause a rack  41  to rearwardly retract. This in turn causes a pinion  42  connected to the drive axle  43 , and rotatably journalled in plate  44 , to rotate. As shown, the drive axle  43  terminates in a first bevel gear  45  which meshes with second and third bevel gears  46 ,  47  positioned at right angles relative to the first bevel gear  45 . Rotation of the second and third bevel gears  46 ,  47  causes first and second needles  34 ,  36  to rotate due to coaxial drive shafts  48 ,  49  being positioned therebetween. As will be noted, drive shaft  48  is hollow to allow drive shaft  49  to be rotatable therein. Other mechanical and electrical transmissions and gear arrangements, including motorized drive mechanisms, are certainly possible and encompassed within the scope of this disclosure. 
         [0052]      FIGS. 4-7  further depict the rotational characteristics of the first and second arcuate needles  34 ,  36 . In an initial or resting position prior to insertion of the suture  32 , the first and second arcuate needles  34 ,  36  are retracted within the operating end  30 . Upon compression of the trigger  26  toward the handle  24 , the first and second arcuate needles  34 ,  36  are caused to rotate. By way of example, the needles  34 ,  36  could rotate approximately 180-270 degrees, but the exact angle may depend on the specific fastener configuration used. In so doing, the first and second arcuate needles  34 ,  36  are driven through the first and second sections of skin, respectively. Moreover, as will be described in further detail herein, such rotational motion of the first and second arcuate needles  34 ,  36  can cause the suture  32  to be driven or pulled through the first and second sections of skin, respectively. 
         [0053]      FIGS. 4-7  depict the drive mechanism  28  in greater detail. As shown, the operating end  30  includes first and second guide channels  50 ,  52  adapted to receive first and second sections of skin to be sutured. In addition, the operating end  30  further includes a septum blade  54  therebetween. By providing such an arrangement, where two arcuate needles  34 ,  36  are rotated toward one another relative to guides  50 ,  52  and a septum blade  54 , the portions of skin being connected are forced toward each other upon activation. This in turn assists in vertically and horizontally aligning the sections of skin and forming a tightly grouped closure. 
         [0054]    While the method of suturing will be described in further detail herein, the structure of the suture  32  will first be described with respect to  FIG. 8 . As shown herein, in one embodiment the suture  32  may include an elongated filament  56  having first and second ends  58 ,  60 . Each of the first and second ends  58 ,  60  may terminate with a needle guide  62  to facilitate temporary attachment and release of the suture  32  to one of the first and second arcuate needles  34 ,  36 , respectively. For example, the needle guide  62  may simply be an enlarged diameter aperture  64  which is shaped so as to circumnavigate a terminus  66  of either the first or second arcuate needles  34 ,  36 . The sutures  32  may each be provided within a cartridge  68  as shown in  FIGS. 5-8 . Moreover, the suture  32  may be temporarily held in the cartridge  68  by frangible connections  70  connecting the suture  32  to a cartridge frame  71  which are broken when needles  34 ,  36  penetrate or pull termini  66 . In alternative modifications, the suture  32  may also be temporarily held in the cartridge  68  by guide channels, grooves, recesses, apertures, or the like. 
         [0055]    Additionally, the cartridge frame  71  may include a plurality of serrations  75  to facilitate holding the skin without the need for restraining jaws, or the like. The frame  71  may also include angled side beams  81  for mounting the serrations  75 . In so doing, first and second sections of skin (not shown) are held between the angled side beams  81 , the guide channels  50 ,  52 , and the septum blade  54  in the aforementioned “everted” position to most effectively form a skin closure with minimal scarring. Furthermore, the cartridge  68  may be configured to be wholly replaceable such that, for instance, a new cartridge  68  may be loaded onto the operating end  30  before each suturing operation. Alternatively, the cartridge  68  may be permanently disposed within the suturing device  20  and configured to receive replaceable sets of sutures  32  before each suturing operation. 
         [0056]    As shown in  FIGS. 9A-9B , the needles  34 ,  36  of the suturing device  20 , may include tips  72  having recesses  74  to facilitate engagement and removal of the suture  32  from the cartridge  68 . In particular, for retrograde applications, where the needle guides  62  are pulled through the skin, the recess  74  of each needle  34 ,  36  may be outwardly configured to engage the respective needle guide  62  while exiting the skin, for example, upon release of the suturing device  20 . Alternatively, for antegrade applications, where the needle guides  62  are driven into the skin, the recess  74  of each needle  34 ,  36  may be inwardly configured to engage the respective needle guide  62  while entering the skin, for example, upon engagement of the suturing device  20 . In still further modifications, the recess  74  may be disposed along the outer surface of the needle  34 ,  36  rather than the inner surface as shown in  FIGS. 9A-9B . 
         [0057]    In order to secure the engagement between the suture  32  and the needle  34 ,  36  during deployment, slider plates  73  as shown in  FIGS. 10A-10I , or the like, may be provided to temporarily hold and align each needle guide  62  along the rotational path of its corresponding needle  34 ,  36 . Moreover, in the retrograde configuration of  FIGS. 10A-10I , the slider plates  73  may be configured to enable the needles  34 ,  36  to pass through the needle guides  62  upon actuation of the suturing device  20  and securely seat the needle guides  62  in the corresponding recesses  74  of the needles  34 ,  36  upon release of the suturing device  20  and prior to deployment of the suture  32 . As shown in  FIGS. 10A-10B , the slider plates  73  may be slidably disposed within the cartridge  68  and shaped to receive the needle guide  62  of a suture  32  therein. As shown in  FIG. 10C , each slider plate  73  may provide grooves  77  within which the needle guides  62  of the suture  32  are seated. While the embodiments of  FIGS. 10A-10I  are shown with looped needle guides  62 , it should be understood that the slider plates  73  may be adapted to receive other needle guide designs as well. 
         [0058]    The slider plates  73  may also be slidable relative to the cartridge  68  so as to enable the slider plates  73  to move in accordance with the rotation of the needles  34 ,  36 . Additionally, as further disclosed in  FIG. 10D , the slider plate  73  may include a recess  83  which slidably mates with the cartridge  68  to house a biasing mechanism. Moreover, the biasing mechanism may employ a spring, or the like, configured to bias the slider plates  73  in a substantially medial position, a lateral position, or any combination thereof, relative to the cartridge  68 . The slider plates  73  may further comprise a cam slot  85  having surfaces which interface with the inner and/or outer edges of each needle  34 ,  36 , and more particularly, with the needle tip  72  thereof. More specifically, the surfaces of the cam slot  85  may be sized, angled, and generally configured to abut the edges of each needle tip  72  as the needles  34 ,  36  are advanced therethrough and to secure engagement between the recesses  74  of the needles  34 ,  36  and the corresponding needle guides  62 . 
         [0059]    As shown in the retrograde application of  FIGS. 10E-10F , for example, when the suturing device  20  is engaged and the needles  34 ,  36  are advanced, the outer edge of each needle tip  72  may push against the inwardly facing surfaces of the cam slots  85 , causing the slider plates  73  to slide outwardly relative to the needles  34 ,  36  and the cartridge  68 . Such outward motion of the slider plates  73  may be limited by the abutment between the outwardly facing surface of the clam slots  85  and the inner edge of the needles  34 ,  36 , as shown for example in  FIGS. 10G-10H . Biasing mechanisms disposed between the slider plates  73  and the cartridge  68  may also limit the outward motion of the slider plates  73  as the needles are advanced therethrough. As further depicted in  FIG. 10I , when the suturing device  20  is disengaged and while the needles  34 ,  36  are refracted, the surfaces of the cam slot  85  may abut the inner and/or outer edges of the needles  34 ,  36  in a manner configured to secure the needle guide  62  within the needle recesses  74 . Accordingly, it can be seen that the slider plates  73  enable the needles  34 ,  36  to substantially freely pass therethrough while conforming to the shape and movement of the needles  34 ,  36  so as to ensure that each needle guide  62  is securely held by the respective needles  34 ,  36  prior to and during deployment. It should be understood that the slider plates  73  may be similarly adapted for antegrade configurations employing needles  34 ,  36  with recesses  74  configured to engage with needles guides  62  upon advancement rather than retraction. 
         [0060]    Turning now to  FIGS. 11A-11J , alternative embodiments for the suture  32  which can be used in conjunction with the teachings of the present disclosure are disclosed. For example, while  FIGS. 1-9  depict the suture  32  with a smooth filament  56 ,  FIGS. 11A-11F  depict sutures  32  with multiple tines  76  or other elements radially and outwardly extending from the cylindrical filament  56 . As will be noted, in some embodiments, the elements  76  all extend in the same direction, while in other embodiments, they extend in opposite directions. The elements  76  may be canted in one direction to facilitate insertion in that direction, but hinder removal in the opposite direction. For example, the elements or tines  76 , as depicted in  FIGS. 11A-11F , may also be provided in the substantial shape of spheres, cones, pyramids, fins, or any other two- or three-dimensional structures having canted sides  78  adapted to facilitate insertion of the suture  32  through the tissue of the skin while enabling the skin to cam thereagainst. Furthermore, the elements or tines  76  may be formed using a combination of different shapes, for example, as shown by the finned, cone-type retention elements  76  of  FIG. 11E . Not only do the tines  76  serve as frictional interference devices to better grip the first and second sections of skin once installed, but given the orientation which the suture  32  ultimately assumes upon insertion, the tines  76  can actually interlock so as to form an even tighter closure, and avoid retraction and medialization as will be described in further detail herein. Moreover, as shown in  FIGS. 12A-12B , such tines  76  prevent medialization and refraction. As used herein, retraction refers to the tines preventing reverse movement of the suture out of the skin or away from the intersecting portion on the suture after installation and medialization refers to laterally inward sliding of the suture past a central portion of the suture after being installed in the closed helical configuration of  FIG. 12A . 
         [0061]    With particular reference to  FIGS. 11G-11J , further alternative embodiments for the suture  32  can be implemented in accordance with the teachings of the present disclosure. In contrast to the sutures  32  of  FIGS. 11A-11F  in which tines  76  and/or canted elements  78  were disposed on the filament  56 , the sutures  32  of  FIGS. 11G-11J  provide substantially smooth filaments  56  and instead provide tines  76  and/or canted elements  78  directly on the needle guides  62 . As with previous embodiments, the sutures  32  of  FIGS. 11G-11J  are similarly configured to facilitate insertion of the ends of the suture  32  in a corresponding direction while hindering removal in an opposing direction. More specifically, each needle guide  62  may be configured to at least partially collapse upon insertion so as to minimize physical resistance with the skin, but expandable when pulled in an opposing direction so as to maximize resistance and hinder removal thereof. Additionally or optionally, each end of the suture  32  may have more than one needle guide  62  as shown in phantom lines in  FIG. 11G  so as to further hinder removal from the skin once inserted. While the tip of each needle guide  62  in  FIG. 11G  is rounded, alternative modifications may employ needle guides  62  with more canted or sharper tips to further facilitate insertion thereof as depicted in  FIGS. 11H-11J . Moreover, the needle guides  62  can generally be formed in the shape of a loop, circle, ellipse, oval, square, triangle, polygon, or any other suitable shape which at least marginally facilitates insertion thereof into skin but hinders removal. The needle guides  62  may additionally be formed as a simple thickening without an aperture that is sized and configured to be engaged by the recesses  74  of the first and second needles  34 ,  36  during insertion into the skin, as well as to prevent retraction from the tissue once deployed. Furthermore, with any of the foregoing types of sutures, the device  20  may include a magazine (not shown) of sutures so as to advance each into successive position automatically after installation of the preceding suture. 
         [0062]    In operation, the suturing device  20  can be used to quickly and effectively close an incision in human skin with precise alignment of the sections of skin to be closed, close approximation of the closure edges, and minimal scarring. With reference to  FIGS. 13-14 , first and second sections of skin  79 ,  80  are shown inserted into the first and second guide channels  82 ,  84  of a test fixture  86  constructed in accordance with the teachings of this disclosure. Of course, for complete disclosure, it should be noted that  FIGS. 13-14  are simply a depiction of a test version of the suturing device  20  completing a closure in accordance with a sample of skin. In actual operation, an incision may be provided somewhere within the human body, and the operating end  30  may be positioned under the skin relative to the incision such that the skin sections  79 ,  80  are received in the guides channels  50 ,  52 , and the sub-dermal side of the skin sections  79 ,  80  may rest on the serrations  75  of the cartridge frame  71 . In one of the several possible methods of using the suturing device  20 , the suturing device  20  may initiate its operation at one end of the incision  89 , install a suture  32 , and then longitudinally retract along the closure until the next suture is inserted and so on. This process would continue until the incision is completely closed as depicted in  FIGS. 15A-15E . Additionally, first and second restraining jaws  90 ,  92  may be provided which, when rotated upwardly, are configured to engage the sub-dermal layer  94  of the skin sections  79 ,  80 . The restraining jaws  90 ,  92  may be omitted or added as an optional feature in certain embodiments, such as in the embodiment of  FIGS. 1-9  which has serrations  75  configured to serve essentially the same purpose. 
         [0063]    In an alternative method of use, for example, the suturing device  20  may initiate its operation and install a suture  32  substantially at the middle of the incision  89  so as to segment the incision  89  into two halves. Subsequent sutures  32  may be installed in a similar manner and positioned so as to further segment each remaining half of the incision  89  into two smaller halves, and so forth, until the incision  89  is completely closed. In a still further method, the suturing device  20  may be used to install sutures  32  beginning at the ends of the incision  89  until the sutures  32  meet at the middle to completely close the incision  89 . Further alternative methods of using the suturing device  20  will be apparent to those skilled in the art. 
         [0064]    Still referring to  FIGS. 13 and 14 , when the trigger  26  of the suturing device  20  is compressed toward the handle  24 , the first and second arcuate needles  34 ,  36  rotate and thereby insert themselves through the dermal layer  94  of the first and second sections of skin  79 ,  80 , respectively. In so doing, using a pair of needles  34 ,  36  as configured in  FIG. 9A , the suture  32  can be installed in a retrograde fashion in that the first and second arcuate needles  34 ,  36  can be fully rotated, and then only after being fully rotated, will both needle guides  62  of the suture  32  be captured and, upon retraction of the needles  34 ,  36  and release of the suturing device  20 , pulled through the respective skin sections  79 ,  80  in opposite directions. Conversely, using a pair of needles  34 ,  36  as configured in  FIG. 9B , the suture  32  can be pushed in an antegrade manner by the needle guide  62  through the section of skin which it first enters, cross over interface  96  between the first and second sections of skin  79 ,  80  and into the second section of skin. In either the antegrade or the retrograde configuration, as both needles  34 ,  36  are simultaneously moving and rotating substantially equal distances, both needle guides  62  are being so pushed or pulled in opposing directions. In alternative embodiments, each needle  34 ,  36  may be rotated substantially equal distances but at unequal rates of angular displacement. 
         [0065]    Using either an antegrade or a retrograde suturing scheme, after installation of the suture  32 , the needles  34 ,  36  will have pierced both sections of skin  79 ,  80 , and the suture  32  will be transformed from a planar, bi-planar, multi-planar, or any other non-helical configuration to a substantially helical configuration. Furthermore, using either one of the antegrade or the retrograde configuration, the suturing device  20  may be adapted to form a closed helix or an open helix simply by adjusting the starting position of the suture  32  relative to the needles  34 ,  36 . As shown in  FIGS. 16A-16N , for example, a single suturing device  20  used in the retrograde configuration can form both closed helix and open helix closures using identical sutures  32  simply by adjusting the starting position of the suture  32  placed thereon prior to engaging the suturing device  20 . Although not shown, a single suturing device  20  used in the antegrade configuration can similarly be used to form both closed helix and open helix closures using identical sutures  32  simply by adjusting the starting position of the suture  32  placed thereon prior to engaging the suturing device  20 . 
         [0066]    With particular reference to  FIGS. 16A-16G , the retrograde suturing device  20  can be used to form closed helix closures by setting the suture  32  in the starting position shown in  FIG. 16A . In the starting position shown, the suture  32  is positioned such that each needle guide  62  thereof is adapted to receive its corresponding needle  34 ,  36  and be engaged by the recess  74  of the needle  34 ,  36  upon compression of the suturing device  20 . Moreover, in order to form a closed helix closure, the filament  56  of the suture  32  is routed around the outside of and between the needle tips  72 , as shown in  FIG. 16A . As the suturing device  20  is engaged, each needle tip  72  may rotate toward its corresponding needle guide  62 , as shown in  FIGS. 16B-16C , until the recesses  74  engage both needle guides  62 , as shown in  FIGS. 16D-16F . Once each needle guide  62  is engaged, release of the suturing device  20  may pull the needles guides  62  through the skin in retrograde fashion until a closed helix or a closed helical knot-like configuration is formed, as shown in  FIG. 16G . 
         [0067]    Turning now to  FIGS. 16H-16N , the retrograde suturing device  20  can also be used to form open helix closures by setting the suture  32  in the starting position shown in  FIG. 16H . In the starting position shown, and similar to the closed helix starting position of  FIG. 16A , the suture  32  is positioned such that each needle guide  62  thereof is adapted to receive its corresponding needle  34 ,  36  and be engaged by the recess  74  of the needle  34 ,  36  upon compression of the suturing device  20 . To form an open helix closure, the filament  56  of the suture  32  is routed away from but still between each needle tip  72 , as shown in  FIG. 16H . As the suturing device  20  is engaged, each needle tip  72  may rotate toward its corresponding needle guide  62 , as shown in  FIGS. 16I-16K , until the recesses  74  engage both needle guides  62 , as shown in  FIGS. 16L-16M . Once each needle guide  62  is engaged, release of the suturing device  20  may pull the needles guides  62  through the skin in retrograde fashion until an open helix configuration is formed, as shown in  FIG. 16N . 
         [0068]    The embodiments of  FIGS. 17-18  depict similar open helical fastener configurations that are inserted into exemplary wounds. For example,  FIG. 17  shows the dermal layer  94  of the first and second sections of skin  79 ,  80  after suture insertion with the filament  56  traversing through the first and second sections of skin  79 ,  80  and across the interface  96 , with the first and second ends  58  and  60  of the filament  56  outwardly extending away from the dermal layer  94 . The closure of  FIG. 18  is very similar to  FIG. 17  but simply shows a plurality of such sutures after installation. Perhaps most importantly,  FIG. 19  shows the exterior or epidermal layer  88  of the first and second sections of skin  79 ,  80  after suture insertion. As shown therein, the first and second sections of skin  79 ,  80  are horizontally aligned such that the interface  96  is linear and tightly grouped. In addition, the first and second sections of skin  79 ,  80  are vertically aligned so as to be positioned within the same plane. This is effectively illustrated in a comparison of  FIGS. 20A-20C . 
         [0069]    Starting with  FIG. 20A , this shows a closure using manually placed sutures. As shown, the first and second sections of skin  79 ,  80  are both vertically and horizontally aligned, which would result in a minimum level of scarring. However, as indicated above, such manual insertion is time-consuming, tedious, and exposes healthcare workers to disease transmission through needle-stick injuries. On the contrary,  FIG. 20C  shows a prior art device which uses automatic insertion of absorbable staples, but as shown, not only are the first and second sections of skin not vertically and horizontally aligned, but result in a substantial ridge  98  extending from the epidermal layer  88  which would form a significant scar on the patient. The resulting closure afforded by the teachings of the present disclosure, on the other hand, is depicted in  FIG. 20B . As shown therein, the interface  96  is horizontally and vertically aligned and tightly grouped. In addition, a minimum of scarring will result given this close vertical and horizontal approximation, thus avoiding the unsightly scarring of the prior art device of  FIG. 20C . Moreover, as the suturing is performed semi-automatically by the suturing device  20  of the present disclosure, the substantial time commitment required by manual placement of sutures of  FIG. 20A  is avoided. 
         [0070]    Accordingly, a retrograde application of a suture  32  can result in either a closed helix or an open helix configuration depending on the manner in which the suture  32  is set in the starting position and prior to deployment. Although only retrograde applications of both closed and open helix sutures are depicted, it can be seen that an antegrade application of a suture  32  can similarly be used to provide either a closed helix or an open helix suture depending on the manner in which the suture  32  is set in the starting position and prior to deployment. 
         [0071]    Referring now to  FIGS. 21-27 , an alternative embodiment of a suturing tool that can be used against the epidermal layer of the skin is disclosed. In other words, rather than be inserted into an incision such that the needles drive upwardly into the sub-dermal and dermal layers of the skin as with the first embodiment, the alternative embodiment of  FIGS. 21-27  is adapted to rest against the outside or epidermal layer of the skin and install sutures downwardly into the epidermal and dermal layers of the skin. As all other features of the alternative embodiment are similar, rather than walk through each element herein, the reader will note the like elements use like reference numerals as with the first embodiment but for the inclusion of a “100” series prefix. 
         [0072]    Turning to  FIG. 28 , an alternative embodiment of a drive mechanism  228  for a suturing tool is disclosed. For example, the drive mechanism  228  shown may be used with the test fixture  86  of  FIGS. 13-14  so as to provide yet another way to rotate the needles  234 ,  236  in opposite directions. More specifically, the drive mechanism  228  may include coaxial drive shafts  248 ,  249 , where each coaxial drive shaft  248 ,  249  is coupled to a corresponding needle  236 ,  234 . Each coaxial drive shaft  248 ,  249  is further coupled to a corresponding gear  246 ,  247  such that a rotation of the gears  246 ,  247  also causes a corresponding rotation of the needles  236 ,  234 . Moreover, the first gear  246  may be driven by the first gear rack  241 , while the second gear  247  may be independently driven by a second gear rack  242 , which although not shown in  FIG. 28  for illustrative purposes, may substantially mirror the first gear rack  241 . In the configuration shown, when the gear racks  241 ,  242  are pushed in a downward direction, the gears  246 ,  247  are caused to rotate in opposing directions. As the gears  246 ,  247  rotate, the coaxial drive shafts  248 ,  249 , and thus, the corresponding needles  236 ,  234  are also caused to rotate in opposing directions so as to install sutures  32  in accordance with the teachings of the present disclosure. 
         [0073]    The illustration of  FIGS. 29-31  depicts still a further embodiment of the present disclosure. In such an embodiment, the suturing tool  300  can be used laparoscopically. In other words, rather than being used on the dermal layer of the skin or even epidermal or sub-dermal, the tool  300  enables sutures to be placed deep within the body cavity. This enables relatively small access port incisions to be made in the skin through which the tool  300  can then be inserted to access the organ, muscular structure or other tissue needing to be sutured. To facilitate such usage, it will be noted that the tool  300  includes an elongated drive shaft  302  that extends from a handle  304  and actuating trigger  306 . Similar to the other embodiments, actuation of the trigger  306  causes the needles  308  and  310  to rotate. A shroud  312  surrounds the needles  308  and  310 . Such a laparoscopic tool  300  would be used in conjunction with a camera or other navigational tool to enable the needles to be moved to the exact location within the body needing the sutures. From the foregoing, it can be seen that in addition to incision closure market, the teachings of the present disclosure are well suited to laparoscopic and minimally invasive applications. For example, the disclosed fastener technology could be used to fasten prosthetic mesh during laparoscopic hernia repairs. The trend toward more minimally invasive operations will continue to present opportunities for the fastening technology disclosed herein. 
         [0074]    From the foregoing, it can be seen that the present disclosure sets forth a medical device adapted to rapidly and reliably install sutures to close openings provided within human skin. The device not only greatly reduces the time required for placement of sutures compared to manual suturing, but also results in highly accurate positioning of the first and second sections of skin along both the horizontal and vertical axes to thus avoid substantial scarring after the healing process. Moreover, through the unique combination of elements set forth in the suturing device, the first and second sections of skin are tightly held together during the healing process to both increase the speed in the healing process and minimize any resulting scarring.