Abstract:
A surgical instrument for applying sutures to tissue includes a needle deployment mechanism and a catch mechanism. In some embodiments, the needle deployment mechanism employs a linear path. Alternatively, it can employ a curved needle. The surgical instrument may include a rotatable head, a bend, and/or a malleable elongated body member formable into various shapes.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This is a continuation of U.S. Ser. No. 11/398,038, filed on Apr. 4, 2006, now U.S. Pat. No. 8,382,774, which is a continuation of U.S. Ser. No. 10/365,277, filed Feb. 12, 2003, now U.S. Pat. No. 7,048,749, which is a continuation of U.S. Ser. No. 09/579,455, filed May 26, 2000, now U.S. Pat. No. 6,551,329, which is a divisional of U.S. Ser. No. 09/273,117, filed Mar. 19, 1999, now U.S. Pat. No. 6,096,051, which claims the benefit of and priority to provisional U.S. Ser. No. 60/078,916, filed Mar. 20, 1998. In addition, related U.S. Ser. No. 09/925,957, filed Aug. 9, 2001, now U.S. Pat. No. 6,454,778, is a continuation of U.S. Ser. No. 09/579,455, filed May 26, 2000, now U.S. Pat. No. 6,551,329, which is a divisional of U.S. Ser. No. 09/273,117, filed Mar. 19, 1999, now U.S. Pat. No. 6,096,051, which claims the benefit of and priority to provisional U.S. Ser. No. 60/078,916, filed Mar. 20, 1998. The entire contents of all of the above-referenced applications and patents are incorporated herein by reference. 
    
    
     TECHNICAL FIELD 
     The invention generally relates to surgical instruments for applying sutures to tissue. More particularly, the invention relates to needle deployment mechanisms and catch mechanisms. 
     BACKGROUND INFORMATION 
     Suturing of body tissue is a time consuming aspect of many surgical procedures. For many surgical procedures, it is necessary to make a large opening in the human body to expose the area that requires surgical repair. There are instruments available that allow for viewing of certain areas of the human body through a small puncture wound without exposing the entire body cavity. These instruments, called endoscopes, can be used in conjunction with specialized surgical instruments to detect, diagnose and repair areas of the body that previously required open surgery to access. 
     Currently, most surgical instruments used in endoscopic procedures are limited by the manner in which they access the areas of the human body in need of repair. In particular, the instruments may not be able to access tissue or organs located deep within the body or that are in some way obstructed. Also, many of the instruments are limited by the way they grasp tissue, apply a suture, or recapture the needle and suture. In addition, many of the instruments are complicated and expensive to use due to the numerous parts and/or subassemblies required to make them function properly. 
     SUMMARY OF THE INVENTION 
     The present invention generally is directed to medical instruments for inserting a suture through body tissue in a quick and easy manner using needle deployment mechanisms and catch mechanisms. In some embodiments, the needle deployment mechanism employs a linear needle path. In other embodiments, the needle deployment mechanism employs a curved needle path. Some embodiments of the needle deployment and catch mechanism include a rotatable head. 
     The instruments of the present invention are useful for application of sutures to approximate the sides of a tissue wound in; for example, open, mini-incision, trans-vaginal, or endoscopic surgical procedures. These instruments may be used in surgical procedures such as burch colposuspension, sacrospinous vaginal vault suspension, paravaginal repair, radical prostatectomy, sub-urethral sling, oopherectomy, myomectomy, nissen fundoplication, cholecystectomy, and urethral anastomosis, for example. 
     In one aspect, the invention relates to a suturing instrument comprising an elongated body member, a head, and a needle carrier. The head extends from a distal end of the elongated body member, and the head defines a longitudinal groove and an opening in communication with the longitudinal groove. The head also includes a needle catch disposed within the opening. The needle carrier is for holding a needle, and the needle carrier is disposed and movable within the longitudinal groove to advance linearly the needle into the opening and towards the needle catch. 
     Embodiments according to this aspect of the invention can include the following features. The needle carrier can define a needle holder and a recess for suture material. The needle carrier can include a U-bend. The needle catch can include an opening with at least two flexible edges. The suturing instrument can include a handle located opposite the distal end of the elongated body member, and the handle can include an actuator coupled to the needle carrier. 
     In another aspect, the invention relates to a suturing instrument comprising an elongated body member, a needle catch, and a needle carrier. The needle catch includes at least one opening for receiving a needle, and the needle catch is movable from within the elongated body member to outside of the elongated body member. The needle carrier is for holding the needle, and the needle carrier is movable from within the elongated body member to outside of the elongated body member. 
     Embodiments according to this aspect of the invention can include the following features. The suturing instrument can include a pusher movably disposed within the elongated body member and coupled to the needle carrier and needle catch. The suturing instrument can also include a needle catch driver coupled to the pusher and the needle catch and/or a needle carrier driver coupled to the pusher and the needle carrier. The pusher can move the needle carrier and needle catch from within the elongated body member to outside the elongated body member. The pusher can move the needle carrier and needle catch towards each other, and in one embodiment, the needle carrier and needle catch can intersect. In addition, the suturing instrument can include a distal end with an inner taper to direct the needle carrier and needle catch towards each other when moved from within the elongated body member to outside the elongated body member. The needle carrier can include a needle holder and a recess for suture material located it its distal end. The needle catch can include a point for tissue penetration. 
     In yet another aspect, the invention relates to a suturing instrument comprising an elongated body member, a curved needle, and a pusher. The elongated body member includes a distal portion and defines a curved channel within the distal portion. The curved needle includes a series of notches and is receivable within the curved channel. The pusher is movably disposed within the elongated body member and contacts the notches of the needle to advance the needle out of the curved channel. 
     Embodiments according to this aspect of the invention can include the following features. The curved channel and/or the curved needle can comprise a semi-circular shape. The series of notches disposed on the curved needle can be located on the needle&#39;s concave or convex surface. The suturing instrument can define an opening leading to the curved channel and a protruding edge at the opening for engaging the series of notches of the needle. 
     In still another aspect, the invention relates to a suturing instrument comprising an elongated body member and a head. The elongated body member includes a first engaging element located at its distal end. The head includes a second engaging element located at its proximal end that engages with the first engaging element of the elongated body member to position the head in one of a plurality of orientations with respect to the elongated body member. 
     Embodiments according to this aspect of the invention can include the following features. The first engaging element can include a female configuration, and the second engaging element can include a male configuration for mating with the first engaging element. Alternatively, the first engaging element can include a male configuration and the second engaging element can include a female configuration for mating with the first engaging element. The female configuration can include a series of notches and/or a flexible detent for engaging the male configuration, and the male configuration can include a series of protuberances, notches, and/or fluted cuts for engaging the female configuration. The head of the suturing instrument can be secured in position by engaging the first and second engaging elements, and the head can be rotated when the first and second engaging elements are disengaged. Alternatively, the head can be positioned by rotating one engaging element with respect to the mating engaging element, and in this configuration the head is secured in place by mechanical engagement of the two engaging elements. The head can be rotated with respect to the body member in increments as small as 10°. The head can include a needle deployment mechanism and a catch mechanism located at its distal end, and the distal end can be bullet-shaped to maintain a body lumen in a dilated state. 
     Additional embodiments according to any of the foregoing aspects of the invention can include the following features. The elongated body member of the suturing instrument can be adapted to access remote tissue or organs within the body. The elongated body member can include a bend or bends. The bend can take the shape of an elbow, a soft curve, a double curve, or any other shape suited to access remote organs or tissue within the body. The elongated body member can be preshaped and permanently bent and comprised of sturdy or resilient material. The elongated body member can also be comprised of a malleable material and thus be bent and shaped to a desired form. The shaping can be done manually outside the body, or remotely within the body to fit the required course for the instrument. 
     In still yet another aspect, the invention relates to a needle catch for use with a suturing instrument. The needle catch includes at least one opening for receiving a needle, and the needle catch includes a point for tissue penetration. The point can be formed by at least two tapered edges. The needle catch can also be bent to include convex and concave surfaces, and the needle catch can comprise stainless steel. 
     These and other objects, along with advantages and features of the present invention herein disclosed, will become apparent through reference to the following description of embodiments of the invention, the accompanying drawings, and the claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       In the drawings, like reference characters generally refer to the same parts throughout the different figures. Also, the drawings are not to scale; emphasis instead generally being placed upon illustrating the principles of the invention. 
         FIG. 1A  is a top view of the distal end of one embodiment of the suturing system according to the invention. 
         FIG. 1B  is a side view of the distal end of one embodiment of the suturing system according to the invention featuring a Z-bend needle catch. 
         FIG. 1C  is a longitudinal section view of the distal end of one embodiment of the suturing system according to the invention taken along line C-C. 
         FIG. 1D  is a side view of an embodiment of a needle and suture for use with the invention. 
         FIG. 2A  is a schematic representation of one embodiment of the invention for suturing transversely positioned tissue. 
         FIG. 2B  is another schematic representation of one embodiment of the invention for suturing transversely positioned tissue. 
         FIG. 3A  is a section view of the distal end of the suturing system of the embodiment shown in  FIGS. 2A and 2B  in the retracted position. 
         FIG. 3B  is a section view of the distal end of the suturing system of the embodiment shown in  FIGS. 2A and 2B  in the extended position. 
         FIG. 4  is a perspective view of one embodiment of a needle catch for use with the suturing system of  FIGS. 2 and 3 . 
         FIG. 5A  is a longitudinal section view of the distal end of one embodiment of the suturing system of the invention. 
         FIG. 5B  is a cross-section view of the distal end of one embodiment of the suturing system of the invention taken at line B-B. 
         FIG. 5C  is a side view of one embodiment of a needle with suture. 
         FIG. 5D  is a perspective side view of one embodiment of a pusher. 
         FIGS. 6A-6C  are schematic, perspective, side-view representations of one embodiment of the suturing system of the invention featuring an elbow-shaped, elongated body member with a rotatable head shown in various rotated positions, but not showing a needle deployment mechanism or a needle catch mechanism. 
         FIGS. 6D-6F  are schematic representations of some details of the rotatable head shown in  FIGS. 6A-6C  and featuring a needle deployment mechanism, a needle catch mechanism, and the engaging elements. 
         FIG. 7A  is a schematic representation of one embodiment of a suturing system of the present invention featuring an elbow-shaped, elongated body member with a rotatable suturing head used in connection with a grasper. 
         FIG. 7B  is a schematic representation of one embodiment of a suturing system of the present invention showing a sectional view of the grasper in the extended position. 
         FIG. 7C  is a schematic representation of one embodiment of a suturing system of the present invention shown located in the urethra and bladder. 
     
    
    
     DESCRIPTION 
     In general, the present invention is directed to various improvements of components and mechanisms of needle deployment systems for suturing devices, such as those disclosed in U.S. Pat. No. 5,713,910 to Gordon et al., U.S. Pat. No. 5,578,044 to Gordon et al., U.S. Pat. No. 5,575,800 to Gordon, U.S. Pat. No. 5,540,704 to Gordon et al., U.S. Pat. No. 5,458,609 to Gordon et al., and U.S. Pat. No. 5,364,408 to Gordon, all of which are incorporated herein by reference in their entirety. 
     Referring to  FIGS. 1A and 1B , the distal end  10  of one embodiment of a suturing system according to the present invention defines a distal longitudinal groove  12  located at the tip  14  of the distal end  10  and intersecting with the distal wall  16  of an opening  18 . The suturing system can include a handle located opposite the distal end of the elongated body member. The handle could take a variety of forms, for example, the handle could be one of the types used with Boston Scientific Corporation suturing systems, in particular the Laurus-Capio Push &amp; Catch suturing system. The distal end  10  may be fabricated from molded or machined plastic material such as polycarbonate or glass-filled polycarbonate. Located within the opening  18  and in a plane substantially perpendicular to the needle carrier  44  path is a needle catch  20  having a distal side  22  resting on the floor  24  of the opening  18  and a proximal side  26  resting against the proximal wall  28  of the opening  18 . Between the two sides  22  and  26 , the needle catch  20  forms a concave bend  30  proximal to side  22  and a convex bend  32  proximal to side  26  forming a Z-like shape. Between the two sides  22  and  26  of the needle catch  20  and aligned with the distal longitudinal groove  12  is an opening  34  formed by two flexible edges  36  and a mouth  38 . The lateral sides  40  of the needle catch  20  wrap around the distal end  10  of the suturing system and are secured in place by notches  42  turned inward into the body of the distal end, or alternatively into small grooves. The needle catch  20  is preferably made of thin stainless steel material, in particular, high temper stainless steel. The needle catch may be manufactured by stamping, laser machining or chemical etching, for example. 
     Referring to  FIG. 1C , in the longitudinal groove  12  is positioned a needle carrier  44  having a convex U-bend  46 . At the end  48  of the needle carrier is a needle holder  50  that defines a hole with a recess  52  for lodging the needle  54  and suture  56 . When the needle carrier  44  is actuated along the longitudinal axis of the elongated body member, the needle carrier  44  advances the needle  54  linearly from the distal end of the longitudinal groove  12 , through the tissue located within the opening  18 , and into the needle catch  20 . The release of the needle  54  from the needle carrier  44  occurs upon reverse motion of the needle carrier  44 . 
     Referring to  FIG. 1D , suitable needles  54  for positioning into the needle holder  50 , include a neck  58  with a hole at one of its ends for inserting a suture  56  and at least one shoulder  60 . The body  62  of the needle  54  is tapered from the shoulder  60  to the point  64  to facilitate tissue penetration and insertion into the opening  34  of the needle catch  20 . The shoulders  60  are made of larger dimensions than the opening  34  of the needle catch  20 . During insertion of the needle  54  into the opening  34  of the needle catch  20 , the edges  36  of the opening  34  flex upon pressure exerted by the body  62  of the needle  54  at the shoulders  60  and permit entry of the needle  54  into the opening  34 . The needle  54  is retained within the needle catch  20  when the edges  36  return to their original position once the shoulders  60  have entered the opening  34  and the neck  58  of the needle  54  is lodged in the opening  34 . Preferably, the neck  58  has smaller dimensions than the opening  34  to permit the edges  36  to return to their original position. The needle  54  is released from the needle catch  20  by sliding the neck  58  of the needle  54  toward the mouth  38  of the opening  34 . The dimensions of the mouth  38  are larger than the dimensions of the shoulders  60  to permit the release of the needle  54  from the needle catch  20 . 
     Needle deployment/catch systems as described in  FIGS. 1A-1C  can be made with various dimensions as necessary for a specific application. In particular, this instrument is well suited to being made to minute dimensions. For example, suitable dimensions to use for a instrument for performing an urethral anastomosis can be as follows: the tip  14  may be 1.15 in. long, 0.205 inch wide, and 0.275 in. high; the distal end  10  may be 0.058 in. in diameter; the needle carrier  44  may be 0.032 in. in diameter; the distance between the distal wall  16  of the opening  18  to the opening  30  of the needle catch  20  may be 0.15 in. long. 
     One advantage of the suturing system/instrument of  FIGS. 1A-1D  is that it requires fewer parts; thereby, making it easier and less expensive to manufacture than known devices. 
     Referring to  FIGS. 2A and 2B , in another embodiment of the suturing instrument  66  according to the present invention, the instrument is configured to deploy a needle  54  through tissue  68  positioned substantially perpendicular to the elongated body member  82  of the suturing instrument  66 . The suturing instrument comprises a pusher  72  having a knob  74  at the proximal end and an elongated portion  76  extending from the knob  74  to the distal end and connected to the needle carrier driver  78  and the needle catch driver  80 . The elongated portion  76  of the pusher  72  is positioned within an elongated body member  82 , which includes a tubular body  70  that extends from the proximal end to the distal end where it contacts the tissue  68  to be sutured. The elongated body member  82  includes a handle portion  84  located at the proximal end that provides grip for manipulation of the instrument and support for actuating the pusher  72 . 
     In the retracted position, as shown in  FIG. 2A , the tissue  68  to be sutured is positioned at the distal end of, and substantially perpendicular to, the elongated body member  82 . The needle carrier  44  and the needle catch  20  are positioned within the elongated body member  82 , and the knob  76  is afar from the handle portion  84  of the elongated body member  82 . In an extended position, as shown in  FIG. 2B , the needle carrier  44  holding a needle  54  and the needle catch  20  are moved to a position outside the elongated body member  82  and into the tissue  68 . The needle carrier  44  and the needle catch  22  can be moved simultaneously by the needle carrier driver  78  and the needle catch driver  80  when actuated by the pusher  72 . The needle carrier  44  and the needle catch  22  meet afar from the distal end of the elongated body member and into the tissue  68  such that the needle  54  with a suture  56  attached thereto is pushed through the opening  34  of the needle catch  20  until the shoulders  60  of the needle  54  snap there through. In the extended position, the knob  74  of the pusher  72  is proximal to, and in contact with, the handle  84  of the elongated body member  82 . The suture  56  and the needle  54  are brought back out of the tissue  68  with the needle catch  20  when the suturing system is returned to its retracted position. To facilitate return to the retracted position, the knob  74  of the pusher  72  may alternatively comprise a ring for insertion of a finger by the operator of the instrument. 
     Referring to  FIGS. 3A and 3B , showing a longitudinal section of the distal end of a particular embodiment of a suturing instrument  66 , the interior wall  86  of the elongated body member  82  tapers inward at the distal end. When the pusher  72  is depressed, moving from afar towards the handle  84 , the elongated portion of the pusher  72  pushes simultaneously the needle carrier driver  78  and the needle catch driver  80  towards their extended position. The tapered interior wall  86  directs both, the needle carrier  44  and the needle catch  20  towards each other when pusher  72  is depressed. 
     Alternatively, the needle carrier driver  78  and needle catch  80  can be prebent or include a pivotal system such as a pivot pin or scissors so that the paths of the needle carrier  44  and the catch  20  run from separated lateral positions within the elongated body member  82  to an intersecting point outside the elongated body member  82 . In the fully extended position, shown in  FIG. 3B ., the needle  54  has been pushed through the opening  34  of the needle catch  20  within the tissue  68  to be sutured. When the suturing instrument  66  is returned to its retracted position, as shown in  FIG. 3A , the needle  54  is retained by the needle catch  20  and drawn out of the tissue  68 . The needle  54  can then be released from the needle catch  20  by pulling the needle  54  and cutting the suture  56  off. 
     A needle catch  20 , suitable for use in the suturing instrument  66  shown in  FIGS. 2A and 2B , is shown in  FIG. 4 . The needle catch  20  is preferably made of a sheet of stainless steel which is bent to provide a concave surface  88  and a convex surface  90  for rigidity. The needle catch  20  can contain several openings  34 . The needle catch  20  also comprises two tapered sides  92  that merge into a point  94  for easy penetration of tissue  68 . The needle catch  20  can be mounted and secured to the needle catch driver  80  either by permanent bond using glue or any known interlocking system such as pressure snap-in. 
     Referring to  FIGS. 5A-5D , in another embodiment of the invention the suturing instrument includes an elongated body member  82  having a channel  96  extending from the head portion to the distal end.  FIG. 5A  shows a longitudinal sectional view of the distal end of the suturing instrument  66  with the distal end of channel  96  intersecting tangentially with a curved guiding channel  98 . The guiding channel  98  is positioned along the longitudinal axis of the elongated body member  82  and defines two openings  100 ,  102  on the lateral side of the elongated body member  82 . The proximate opening  100  permits ingress of a needle  104  (shown in  FIG. 5C ) having a curved shape and a series of notches  106  on a portion of the convex surface  108 . The point  110  of the needle having smooth surfaces and being tapered to facilitate penetration of tissue  68 . The tail  112  of the needle  104  having a hole to permit fixation of the suture material  56 . 
     Referring to  FIGS. 5A and 5B , a pusher  114  is positioned in the longitudinal channel  96  with the head  116  forming an edge to provide support and engage into the notches  106  of the needle  104  introduced into the guiding channel  98 . 
     On the outer wall  118  of the distal opening  102  is positioned a protruding edge  120  that provides for locking of the needle  104  during egress from the guiding channel  98 . Each push of the pusher  114  moves the needle  104  within the guiding channel  98  from the proximal opening  100  to the distal opening  102  until a notch  106  locks onto the protruding edge  120 . A pull of the pusher  114  slides the head  116  of the pusher  114  against the sliding sides of the notches  106  until it engages in a notch  106  closer to the tail  112  of the needle. The push and pull motion is repeated several times until all of the needle  104  has passed through the guiding channel  98 , and into tissue positioned parallel to, and in contact with, the distal opening  102 . The needle  104  can then be extracted from the tissue once the point  110  resurfaces out of the mass of the tissue with surgical pliers, tweezers, hemostats, needle holders, or other appropriate surgical instrument. 
       FIG. 5B  shows a cross-sectional view of the distal end of the suturing instrument at the intersection between the longitudinal channel  96  and the guiding channel  98 . 
       FIG. 5D  shows a prospective view of the pusher  114  with the head  116 . 
     In yet another embodiment, the instrument can be adapted to facilitate access into the abdominal cavity and the placement of suture(s) radially in a body lumen. Such instrument may be particularly useful where anastomosis is required such as urethral anastomosis following radical prostatectomy or in blood vessel or bowel anastomosis. Referring to  FIGS. 6A-6C , the suturing instrument  66  includes an elongated body member  82  and a rotatable head  124 . The elongated body member  82  can include an elbow  122  (or bend). The head  124  rotates by angular increments. The elongated body member  82  includes an engaging element located at its distal end  128 . The head  124  includes an engaging element located at its proximal end  126  for mating with the engaging element of the elongated body member  82 . The head  124  includes a dilator cap or a bullet-shaped end at the distal end  130  of the head  124  to maintain the urethra or any body lumen in a dilated configuration. The rotation of the head  124  is performed manually between each application of a suture in a body lumen and before reloading with the needle and suture to permit application of a series of sutures along the circumference of the lumen, at incremental angular positions that can be as small as 10°. The embodiment of the suturing instrument featuring an elbow and rotatable head is particularly adapted to perform suturing after removal of the prostate to connect the bladder to the urethra or generally following any other type of resection. 
     In one embodiment, the rotatability of the head  124  is accomplished with the structure depicted in  FIGS. 6D-6F . The head  124  includes an engaging element with a male configuration  123 . The male configuration  123  includes a series of fluted cuts  133  located along 330° of its perimeter. The male configuration  123  includes a stop to prevent the head from rotating 360°. The elongated body member  82  includes an engaging element with a female configuration  125  and a flexible detent  131 . The female configuration  125  is a substantially circular recess with the flexible detent mounted within the elongated body member  82  and protruding into the substantially circular recess. The flexible detent  131  can be a length of spring wire or a pin, and can be made of nitinol. The head  124  can be positioned by rotating the male configuration  123  engaging element with respect to the female configuration  125  engaging element, deflecting the flexible detent  131 , and then allowing the flexible detent  131  to mechanically engage the fluted cut  133  which corresponds to the desired angular orientation. The head can be positioned in angular increments of 30°. In addition, the head  124  depicted in  FIGS. 6D-6F  includes a needle deployment mechanism  127  and a needle catch mechanism  129 . 
     Referring to  FIGS. 7A-7C , to further facilitate positioning of the instrument within the body passageway, a grasper device  132  may be introduced into the body cavity by a second point of entry. The grasper device comprises a hollow elongated body member  134  for housing a pair of spring-loaded jaws or tweezers  136  at the distal end of the body member  134 . The tweezers  136  are close together in a retracted position as shown in  FIG. 7A  and open to permit grasping of the knob  138  located on the distal end of the head  124  in an extended position as shown in  FIG. 7B . When closed around the ball or knob  138 , the grasping tweezers  136  can allow rotatable movement of the knob  138  and thus rotation of the head  124 . 
     The proximal end of the grasper device  132  features a button  140  that is positioned at the proximal end of a wire  142 . The wire  142  is connected to the tweezers  136  at the distal end. The device is maintained in the retracted position by a spring  144  located in the head  146  of the grasper  132  which rests its proximal end against the button  140  and its distal end against a protuberance  148  positioned in the interior wall of the head  146 . 
       FIG. 7C  shows both the grasper  132  and the suturing instrument  66  located in the urethra  150  and the bladder  152  below the public bone  154  of a male following prostatectomy. The void left by the removed prostate is addressed by using the instrument  66  together with the grasper  132  to insert sutures all around the end of the urethra  150  to join it to the bladder  152 . 
     In yet other embodiments of the instant invention, the aforementioned suturing systems can be used to deploy an anchor or fastener that is to remain in the tissue. Such anchor or fastener may be; for example, a barbed needle, a metal clip, or a staple. 
     Having described embodiments of the invention, it will be apparent to one skilled in the art that other embodiments incorporating the concepts disclosed herein may be used without departing from the spirit of the invention. Thus, numerous other embodiments include, but are not limited to: changes in the dimensions of the instruments; the type of materials employed; the location and type of needle, anchor or fastener; and needle loading mechanisms. All are within the scope of the present invention. The described embodiments are to be considered in all respects only as illustrative and not restrictive. Therefore, it is intended that the scope of the present invention be only limited by the following claims.