Abstract:
Described herein are devices and methods comprising a system for tissue reinforcement, such as stabilization of fascial structures of the pelvic floor in vaginal wall prolapse. The surgical treatment can provide a mechanical support or bridging material for a fascial defect. An implant with four arms, for example two proximal arms and two distal arms, can provide post-surgical adjustability of the graft position, enabling tension free placement of the implant. In addition, a four-point fixation of the implant with apical support can ensure a suitable anatomical repair. Furthermore, instrumentation is disclosed herein, including an introducer device capable of fixing a wide variety of materials, such as mesh arms and suture, to tissue.

Description:
[0001]    This application is related to and claims benefit of priority to co-pending U.S. Provisional Patent Application No. 61/234,811, filed Aug. 18, 2009, and titled “P ELVIC  F LOOR  R EPAIR  S YSTEM ,” the contents of which are incorporated herein by reference in their entirety. 
     
    
       [0002]    According to certain embodiments, the present disclosure relates to systems and methods for pelvic floor repair. Pelvic organ prolapse disorders typically result from weakness in or damage to normal pelvic organ support structures. Pelvic organ prolapse disorders can include cystoceles (whether ventral or lateral), rectoceles, enteroceles, urethreoceles, hysteroceles, vaginal vault prolapse, uterine prolapse, and/or any other prolapse or combination of such disorders. Also, the system may be configured to treat pelvic floor disorders of both males and females. These disorders can result from childbirth, removal of the uterus, connective tissue defects, postmenopausal atrophy, and heavy labor. 
         [0003]    The prolapse repair system in accordance with the present disclosure can be used for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor, wherein surgical treatment is intended either as mechanical support or bridging material for the fascial defect. This includes, but is not limited to the following procedures: vaginal wall prolapsed repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair. 
         [0004]    According to various aspects of the disclosure, there is provided a prolapse repair system for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse, where surgical treatment is intended either as mechanical support or bridging material for the fascial defect. An implant with four arms, for example two proximal arms and two distal arms, can provide post-surgical adjustability of the graft position, enabling tension free placement of the implant. In addition, a four-point fixation of the implant with apical support can ensure a suitable anatomical repair. 
         [0005]    According to one aspect of the invention, there is provided a pelvic floor repair system comprising an introducer having a proximal end and a distal end, wherein a needle housing is located at the proximal end, a handle is located at the distal end, and a shaft connects the needle housing to the handle; the needle housing comprises a curved needle carrier having a proximal end and a distal end, wherein the curved needle pivots about the center of its axis of rotation, the needle housing further comprising a first aperture from which the distal end of the needle carrier exits upon actuation, and a second aperture; the handle comprises a manual actuation mechanism that drives movement of the distal end of the needle carrier to exit from the first aperture towards second aperture; an implant comprising a support portion and at least one extension connected to the support portion, wherein the at least one extension has a proximal end and a distal end, and the proximal end is connected to the support portion and the distal end is connected to a needle. 
         [0006]    The at least one extension can comprise a tubular mesh arm defining a lumen extending at least partially therethrough. According to certain aspects of the disclosure, the needle is a bullet needle having a distal end configured to pierce tissue, a shoulder, and a proximal end that receives the distal end of the at least one extension. The proximal end of the bullet needle can be crimped around the distal end of the at least one extension. 
         [0007]    The second aperture can include a needle catch configured to releasably capture the needle. Furthermore, the needle housing can further a manual release mechanism to release the needle from the needle catch. 
         [0008]    According to various aspects of the disclosure, the introducer handle has a proximal end, a distal end, and a gripping region between the proximal and distal ends; the proximal end of the handle is connected to the distal end of the shaft; the shaft and the proximal end of the handle share the same longitudinal axis; and the longitudinal axis of the shaft and the longitudinal axis of the gripping region intersect at an angle ranging from 200° to 80°. The angle can be 170°, 160°, 150°, 140°, or any other suitable, ergonomic angle. The system can further comprise at least one introducer needle having a proximal end and a distal end and defining an inner lumen, the introducer needle further having an opening that provides access to the inner lumen; and a drive wire terminating in an implant coupling element, the drive wire being configured to be positioned within the inner lumen of the introducer needle, wherein the implant coupling element is extendable from the introducer needle opening to an extended position in which the implant coupling element is positioned outside of the inner lumen and retractable to a retracted position in which the implant coupling element is positioned within the inner lumen. According to one embodiment, the implant coupling element is a loop that can receive at least the distal end of the at least one extension. 
         [0009]    According to one embodiment, the implant comprises two proximal extensions and two distal extensions, wherein at least two of the four extensions are each comprised of a tubular mesh defining a lumen extending at least partially therethrough. Furthermore, the implant can comprise two proximal extensions, each comprised of a tubular mesh defining a lumen extending at least partially therethrough; and two distal extensions, each comprised of a flat mesh. 
         [0010]    According to one embodiment, the needle housing comprises a tissue engagement portion. The tissue engagement portion can have a concave shape that facilitates in-flow of tissue. According to one embodiment, the concave shape is defined by an arc. A line tangent to each end of the arc defines a first axis, and the shaft of the introducer defines a second axis. The first axis can intersect the second axis at an angle ranging from 15° to 80°, for example 20° to 70°, 30° to 60°, or 40°to 50°. Any other ergonomically effective angle can also be used. 
         [0011]    According to one embodiment, the distal end of the needle carrier receives the proximal end of the needle. According to another embodiment, the shaft of the introducer comprises at least one bracket configured to receive and releasably secure the at least one implant extensions. 
         [0012]    The present disclosure, according to certain non-limiting embodiments, relates to a pelvic floor repair system comprising an introducer having a proximal end and a distal end, wherein a needle housing is located at the proximal end, a handle is located at the distal end, and a shaft connects the needle housing to the handle; the needle housing comprises a curved needle carrier having a proximal end and a distal end, wherein the curved needle pivots about the center of its axis of rotation, the needle housing further comprising a first aperture from which the distal end of the needle carrier exits upon actuation, and a second aperture; the handle comprises a manual actuation mechanism that drives movement of the distal end of the needle carrier to exit from the first aperture towards second aperture; an implant comprising a support portion and at least one extension connected to the support portion, wherein the at least one extension has a proximal end and a distal end, and the proximal end is connected to the support portion and the distal end is connected to a needle; and a locking feature associated with at least one of the extensions, wherein the locking feature is configured to substantially lock the at least one extension in position relative to tissue. 
         [0013]    The needle housing can comprise at least one external feature that provides tactile feedback to the user. The locking feature can be a securement ring, through which the at least one extension is received. The internal diameter of the securement ring can comprises at least one feature that substantially permits movement of the extension through the ring in one direction, and substantially inhibits movement of the extension through the ring in the opposite direction. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]    The disclosed systems and methods can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. 
           [0015]      FIG. 1  is a perspective view of one embodiment of an introducer. 
           [0016]      FIG. 2A  is a cutaway view of a needle housing with the needle carrier in the retracted configuration. 
           [0017]      FIG. 2B  is a cutaway view of a needle housing with the needle carrier in the extended configuration. 
           [0018]      FIG. 2C  is a cutaway view of a needle housing with the bullet needle seated in the needle carrier. 
           [0019]      FIG. 2D  is a cutaway view of a needle housing with the bullet needle in the needle catch. 
           [0020]      FIG. 2E  is a cutaway view of a needle housing, with the needle carrier in the retracted position and the bullet needle in the needle catch. 
           [0021]      FIGS. 2F-2G  is a close up of the positioning of the bullet needle in the needle carrier. 
           [0022]      FIG. 2H  is a close up of the bullet needle being released from the needle catch. 
           [0023]      FIG. 2I  is a cutaway view of the needle housing. 
           [0024]      FIG. 3  is a cutaway view of the introducer handle. 
           [0025]      FIG. 4  is a plan view of an implant suitable for an anterior pelvic floor repair procedure. 
           [0026]      FIG. 5  is a plan view of an implant suitable for a posterior pelvic floor repair procedure. 
           [0027]      FIG. 6  is a close up view of a bullet needle. 
           [0028]      FIG. 7  is a close up view of a securement ring. 
           [0029]      FIG. 8  is a close up view of a support extension encircled by a securement ring. 
           [0030]      FIG. 9A  is a perspective view of a deployment tool. 
           [0031]      FIG. 9B  is a cutaway view of a deployment tool. 
           [0032]      FIG. 9C  is a cutaway view of the distal end of the deployment tool. 
           [0033]      FIG. 10  is a cutaway view of a deployment tool. 
           [0034]      FIG. 11A  is a perspective view of a snare introducer needle, with the snare partially deployed. 
           [0035]      FIG. 11B  is a perspective view of a snare introducer needle with the snare in the fully retracted position. 
           [0036]      FIG. 12  is a perspective view of the needle housing seated against the sacrospinous ligament. 
           [0037]      FIG. 13  is a perspective view of an implanted anterior support member. 
           [0038]      FIG. 14A  is a close up view of a deployment tool pressed against the sacrospinous ligament. 
           [0039]      FIG. 14B  is a close up view of a suspension member once it has been drawn through the sacrospinous ligament. 
       
    
    
     DESCRIPTION 
       [0040]    The following description and accompanying figures, which describe and show certain embodiments, are made to demonstrate several possible configurations that a pelvic floor repair system can take including to include various aspects and features of the present disclosure. In some of the figures, an illustrated embodiment is shown in use in a pelvic cavity of a patient. The illustration of the medical device in this context is not intended to limit the disclosed aspects and features of the invention to the specified embodiments or usage only within the pelvic cavity. Those of skill in the art will recognize that the disclosed aspects and features of the invention are not limited to any particular embodiment of a surgical system or device. 
         [0041]    According to various embodiments, the introducer  10  illustrated in  FIG. 1  is suitable for implanting a medical device, such as suture or an implant, for example a pelvic floor implant. The introducer includes a handle  24  having a gripping area  26  and a trigger  29 . According to one embodiment, the trigger  29  can be compressed with the user&#39;s fingers while the palm of the user&#39;s hand is wrapped around the gripping area  26 . The user&#39;s thumb is typically resting at the distal end of handle  24 . The distal end of the handle is connected to shaft  20 , and the distal end of shaft  20  is connected to needle housing  12 . The needle housing  12  can include at least one tactile feedback feature  13 , which allows the user to tactilely locate the position and orientation of the needle housing  12  when the distal end of the introducer is not visible (e.g., situated within a patient&#39;s body during a surgical procedure). 
         [0042]    According to one embodiment, needle housing  12  also includes a shaped tissue engagement portion  15  configured to allow tissue such as, for example, ligament, tendon, muscle, or any other tissue to “tent up” or “pillow in” to the shape. By way of example, the shaped tissue portion can have a concave shape. The needle housing  12  also includes a first aperture  14 , through which the distal end of a needle can exit, and a second aperture  16  that can receive the distal end of a needle. A needle catch ( 38  in  FIG. 2B ), which is an active, as opposed to passive, catch can release the needle when tab  39  is depressed. 
         [0043]    A cutaway view of needle housing  12  is illustrated in  FIG. 2A . Drive shaft  52  extends through the proximal end  54  of the housing. The distal end of drive shaft  52  is connected to the drive linkage  50  via a pin (not shown) that is perpendicular to the longitudinal axis of the drive shaft  52 . The pin extends into, and moves axially along, recessed cam surface  46 . A second pin  48  connects drive linkage  50  to center linkage  49 , and the second pin  48  moves along recessed cam surface  44 . Such features define a splined (composite) curve that translates the linear motion of the drive shaft  52  to rotational motion of the needle carrier  28 . The center linkage  49  can be directly or indirectly connected to needle carrier  28 , which pivots about axis post  36 . The proximal end of a driving element, for example a needle, such as a surgical needle or a bullet needle  72  ( FIG. 6 ) can be seated within distal end  32  of needle carrier  28 . Aperture  34  is configured to receive a filamentary element, such as a suture, strip of mesh, or tubular mesh arm  68  in  FIG. 4  or  100  in  FIG. 5  connected to the proximal end of a driving element, such as a needle. Slot  30  receives the filamentary element trailing from aperture  34 . 
         [0044]    Active needle catch  38  receives at least a portion of a needle, for example the distal end of a needle, when needle carrier  28  completes its rotation around axis post  36 . Referring to bullet needle  72  in  FIG. 6  as an example, the distal end of the needle  72  is first received within aperture  16 , and further movement of the conical head  126  moves collar  40  upwards towards axis post  36 . As illustrated in  FIG. 2D , once conical head  126  clears collar  40 , collar  40  snaps back down and is received within groove  128  of needle  72 . The tip of the needle is then received within second collar  42 . The shoulder characterized by the step between conical head  126  and groove  128  ( FIG. 6 ) prevents unintentional dislodgment of bullet needle  72  from collar  40 . As shown in  FIG. 2E , once the needle  72  is captured within catch  38 , trigger  29  is released and needle carrier  28  retracts into needle housing  12 . To release the needle from catch  38 , collar  40  is released from groove  128  towards axis post  36  by pressing tab  39  ( FIG. 2H ). 
         [0045]      FIG. 2B  shows needle carrier  28  in its fully extended position, having been extended by depressing trigger  29  ( FIG. 1 ). Drive shaft  52  is urged distally, resulting in movement of the drive and center linkages  50  and  49 , respectively, and then rotation of needle carrier  28  about axis post  36 . Also shown in  FIG. 2B  is tactile feature  56 , allowing a user to manually locate and identify the orientation of the needle housing  12  when it is out of the field of view. 
         [0046]    Although certain embodiments relate to the use of introducer  10  for throwing mesh arms through ligaments, the present disclosure is not so limited. The introducer  10  can also suitably be used as a suturing instrument, and thus used in a wide variety of surgical instruments. In one embodiment, the introducer  10  has a spool (not shown) or other suitable feature configured to hold a length of suture. According to certain embodiments, the introducer can be employed to implant slings, including urethral slings, in a patient. A discussion of urethral slings and methods for their implantation can be found, for example, in commonly owned U.S. patent application Ser. No. 12/441,123, filed Sep. 12, 2007, titled  URETHRAL SUPPORT SYSTEM ; U.S. patent application Ser. No. 12/269,749, filed Nov. 12, 2008, titled A DJUSTABLE  T ISSUE  S UPPORT  M EMBER ; and U.S. patent application Ser. No. 12/093,493, filed Nov. 14, 2006, titled  SLING ANCHOR SYSTEM , the disclosures of which are each incorporated herein by reference in their entirety. 
         [0047]    In  FIG. 2C , bullet needle  72  is situated within distal end  32  of needle carrier  28 . Distal end  70 / 102  of extension  68 / 100  is received through aperture  34  and slot  30 .  FIGS. 2F-2G  illustrate loading of bullet needle  72  into needle housing  12  by placing needle  72  and distal end  70 / 102  of extension  68 / 100  into slot  30  of the housing  12 . According to various embodiments, tactile and/or audible feedback (such as a click) may be received by the user once the needle  72  is properly seated within housing  12  ( FIG. 2G ). 
         [0048]    As illustrated in  FIG. 2I , tissue engagement portion  15  can have a certain orientation with respect to the longitudinal axis defined by drive shaft  52 . Line a in  FIG. 2I  is tangent to points  11  and  17  on the needle housing  12 , and the lines a and b form an angle a. According to various embodiments, the angle can range from 100° to 170°. For example, the angle can range from 120° to 160°, including 135°. Any angle suitable for engaging and receiving tissue can be used. 
         [0049]      FIG. 3  is a cutaway view of handle  24 , illustrating one possible embodiment of a mechanism that translates actuation of trigger  29  to movement of drive shaft  52 . Lead screw  31  can be rotated to adjust the length of throw of the needle carrier  28 . For example, rotation of the lead screw  31  in a clockwise direction will shorten the throw, and rotation in a counterclockwise direction with lengthen the throw of the needle carrier  28 . Lead screw  31  is but one embodiment of an adjusting feature; other known suitable adjusting features performing substantially the same function can also be used. 
         [0050]      FIG. 4  illustrates one embodiment of an implant  60  suitable for an anterior prolapse repair. Implant  60  comprises a support member  86 , two proximal extensions (or arms)  68 , and two distal extensions (or arms)  74 . Throughout this disclosure, the term “extension,” “arm,” and “filamentary element” can be used interchangeably. Support member  86  is configured to support tissue or an organ such as, for example, a bladder. According to various embodiments, the tissue support member  86  can comprise a central portion  83  and two lateral portions  92 . In some embodiments, the support member  86  comprises a woven mesh. The central portion  83  can have a mesh construction that is different from the lateral portions  92 . For example, the central portion  83  can be constructed from a mesh that has a density lower than the density of the two lateral portions  92 . According to various embodiments, the longitudinal axis of the support portion can be defined by a midline indicator  84 . 
         [0051]    Implant  60  can also comprise at least one arm that holds the support portion  86  in a desired position. As illustrated in  FIG. 4 , implant  60  can comprise two proximal arms  68 . The proximal arm  68  has a distal end  70  terminating in a bullet needle  72 , and a proximal end  64  connected at joint  90  to support member  86 . The distal end  70  of proximal arm  68  can be connected to bullet needle  72  by any suitable method known in the art, including swaging, crimping, gluing, etc. Proximal end  64  can be connected to support member  86  by any suitable method, including but not limited to sewing, gluing, and ultrasonic welding. Distal arm  68  can have a varying diameter along its length. For example, proximal end  64  can have a first diameter that necks down at  66  to a second diameter. The diameter change can be stepped, or gradual. According to certain embodiments, distal end  70  has a first diameter, and proximal end  64  has a second diameter greater than the first diameter, facilitating dilation of the path of arm  68  through tissue. 
         [0052]    According to certain embodiments, proximal arm  68  can be a suture, a strip of mesh, or any other material, including biomaterials, that can be drawn through tissue. According to one embodiment, proximal arm  68  is constructed of a tubular mesh defined by a lumen extending at least partially therethrough. A tubular mesh construct can be advantageous by permitting tissue in-growth into its pores upon implantation. In addition, a tubular mesh arm can slide through a ligament, such as a sacrospinous ligament, like a suture. Furthermore, the tubular mesh arm can act as a dilator. The tubular mesh can be constructed by methods known in the art of mesh knitting. 
         [0053]    As illustrated in  FIG. 4 , implant  60  can also comprise two distal arms  74 , having a proximal end  80  and a distal end  76 . According to various embodiments, the proximal arms can be folded at a location  78 , which is proximate to the distal end  76 . The folded feature can assist the user in determining whether the implant  60  is corrected oriented in a patient, and whether the arm  74  is twisted within the patient. In addition, the fold  78  can facilitate proper capture of the arm  74  by a snare introducer  168  ( FIGS. 11A-11B ). Arms  74  are illustrated as flat mesh. However, the arms can also be sutures, tubular mesh, cord, or any other material that can be drawn through tissue. 
         [0054]      FIG. 5  illustrates one embodiment of an implant  96  suitable for a posterior prolapse repair. Implant  96  comprises a support member  116 , two proximal extensions (or arms)  100 , and two distal extensions (or arms)  108 . Support member  116  is configured to support tissue or an organ such as, for example, the rectum. According to various embodiments, the tissue support member  116  can comprise a central portion  119  and two lateral portions  117 . In some embodiments, the support member  116  comprises a woven mesh. The central portion  119  can have a mesh construction that is different from the lateral portions  117 . For example, the central portion  119  can be constructed from a mesh that has a density lower than the density of the two lateral portions  117 . According to various embodiments, the longitudinal axis of the support portion can be defined by a midline indicator  118 . 
         [0055]    Implant  96  can also comprise at least one arm that holds the support portion  116  in a desired position. As illustrated in  FIG. 5 , implant  96  can comprise two proximal arms  100 . The proximal arm  100  has a distal end  102  terminating in a bullet needle  72 , and a proximal end  98  connected at joint  124  to support member  116 . The distal end  102  can be connected to bullet needle  72  by any suitable method known in the art, including swaging, crimping, gluing, etc. Proximal end  98  can be connected to support member  116  by any suitable method, including but not limited to sewing, gluing, and ultrasonic welding. Proximal arm  100  can have a varying diameter along its length. For example, proximal end  98  can have a first diameter that necks down at  104  to a second diameter. The diameter change can be stepped, or gradual. According to certain embodiments, distal end  102  has a first diameter, and proximal end  98  has a second diameter greater than the first diameter, facilitating dilation of the path of arm  100  through tissue. 
         [0056]    According to certain embodiments, arm  100  can be a suture, a strip of mesh, or any other material that can be drawn through tissue. According to one embodiment, arm  100  is constructed of a tubular mesh defined by a lumen extending at least partially therethrough. A tubular mesh construct can be advantageous by permitting tissue ingrowth into its pores upon implantation. The tubular mesh can be constructed by methods known in the art of mesh knitting. 
         [0057]    As illustrated in  FIG. 5 , implant  96  can also comprise two distal arms  108 , having a proximal end  114  and a distal end  110 . According to various embodiments, the proximal arms can be folded at a location  112 , which is proximal the distal end  110 . The folded feature can assist the user in determining whether the implant  96  is correctly oriented in a patient, and whether the arm  108  is twisted within the patient. In addition, the fold  112  can facilitate proper capture of the distal end  110  of distal arm  108  by a snare introducer  168  ( FIGS. 11A-11B ). Arms  108  are illustrated as flat mesh. However, the arms can also be sutures, tubular mesh, cord, biomaterials, wire, or any other material that can be drawn through tissue. 
         [0058]    The midline indicators  84  and  118  can be formed in any suitable manner, as the present disclosure is not limited in this respect. In one embodiment, the midline indicator is added after the implant is formed using a suitable ink or paint. In another embodiment, the color band results from a differently colored strand of knitted mesh that is knitted in during knitting of the implant. Alternatively, the midline indicator may be formed as a separate element that is subsequently woven through the interstices of a mesh implant. In one embodiment, the midline indicator is blue; however, any other suitable color(s) may be employed, as the present disclosure is not limited in this respect. Any indicia identifying the midline of the support portion can be used. 
         [0059]    It should be appreciated that the present disclosure is not limited to repair of prolapsed organs. Rather, the system may be used to aid in the repair of other tissue or muscle defects or incisions, including but not limited to hernias or torn ligaments, or may be used as a graft, an anastomosis wrap or other gastric band, all whether located in the pelvic area, abdominal area, or other areas, as the present disclosure is not limited in this respect. 
         [0060]    According to various embodiments, the implants  60  and  96  comprise a flexible material. The implant material can be formed of a synthetic material, a natural material, or a combination of both synthetic and natural materials. Irrespective of the material used to construct the implants, the implants are highly flexible yet have the strength needed for tension-free fixation. 
         [0061]    According to certain embodiments, the support members  86  and  116  are formed from a sheet of synthetic material that may be formed from a sheet of knitted polypropylene monofilament mesh fabric, such as Bard Mesh available from C. R. Bard, Inc. of Murry Hill, N.J. When implanted, the polypropylene mesh promotes tissue or muscle ingrowth into and around the mesh structure. According to another aspect of the disclosure, a hybrid implant formed of both synthetic and more natural materials is provided. In this manner, the synthetic material aids in providing the permanence of an implant as the underlying support, while the more natural material acts as buffer between the synthetic material and host tissue of the patient. 
         [0062]    According to various embodiments, the natural material can be any suitable material, including but not limited to biologically-derived materials, such as cadaveric (human) or xenographic tissue (particularly of bovine or porcine origin)—for example dermis processed to make an acellular collagen scaffold or intestinal submucosa or other biological material and/or bioengineered materials. Collagen materials can be obtained from various sources such as that available from Cook Biomedical, Inc. under the name C OOK  S URGISIS . In one embodiment, the natural material comprises a cross-linked porcine dermal collagen material such as P ELVICOL ® surgical implant from Tissue Science Laboratories plc, or P ELVISOFT ® acellular biomesh produced by Sofradim. Other suitable bioengineered materials may be employed as the present disclosure is not limited in this respect. 
         [0063]    According to certain embodiments, the support members  86  and  116  are formed from a non-absorbable monofilament polypropylene mesh having a knit pattern that allows the mesh to be cut in any shape without unraveling, and provides multidirectional elasticity and stretch. Implants suitable for tissue repair and that can be used in accordance with the present disclosure are discussed in U.S. patent application Ser. No.  12 / 282 , 641 , filed Mar. 15, 2007, the disclosure of which is incorporated herein by reference in its entirety. 
         [0064]    In accordance with the present disclosure, various types of needles can be used to insert the implant arms through tissue, including various types of surgical needles and bullet needles.  FIG. 6  illustrates one example of a bullet needle in accordance with the present disclosure. The distal end  70 / 102  of the implant arm  68 / 100  terminates in the shaft  132  of bullet needle  72 , and is held there by, for example, crimping the shaft around the mesh arm. Tip  126  is configured to have a sharp point to penetrate tissue. Groove  128  and shoulder  130  facilitate capturing the bullet needle  72  in a needle catch, such as needle catch  38  in  FIG. 2A . The needles in accordance with the present disclosure can be made of any biocompatible material, including stainless steel, polypropylene, polytetrafluoroethylene, and bioabsorbable materials. Suitable compatible materials are well-known in the medical device field. 
         [0065]      FIG. 7  illustrates a securement ring  134  configured to secure an implant arm in a substantially fixed location relative to tissue. The implant arm is received in inner diameter  139  as shown in  FIG. 8 , and flanges  136  permit movement of the arm through the washer in one direction, but resist movement in the opposite direction. The securement ring provides an additional measure of securement over the frictional forces of the tissue until tissue in-growth occurs. 
         [0066]    A deployment tool  138  preloaded with the securement ring  134  is illustrated in  FIG. 9A . Once an implant arm has been positioned in tissue, for example the sacrospinous ligament, the distal end of the arm is fed through the center of securement ring  134 , and out aperture  152 . A cutaway view of the device  138  is shown in  FIG. 9B . A user grips the device at the ribbed feature  148 , push-button  140  is urged distally and against the bias of spring  160 , and blade  156  severs the implant arm that extends through lumen  158 . Simultaneously, securement ring  134  is deployed. A close-up of a cutaway view of the distal end of the deployment tool  138  is illustrated in  9 C.  FIG. 10  illustrates mesh arm  70 / 102  after it has been fed through securement ring  134  and lumen  158 , exiting from aperture  152 . Also shown in  FIG. 10  is a lock-out feature having a catch  162  that irreversibly locks against abutment  164  once the deployment tool has been used. 
         [0067]      FIGS. 11A and 11B  illustrate a snare introducer  168  that can be used to deploy an implant. The introducer  168  includes a handle  170  and a needle having a shaft  184  with a proximal end  188  and a distal end  190 . Proximal end  188  is joined to handle  170 . Distal end  190  includes a tissue penetrating tip  180 , and an aperture communicating with the lumen (not shown) defined by shaft  184 . Drive wire  178  is fixed to button  172 , so that as button  172  is moved in a proximal or distal direction along slot  174 , wire  178  is also moved in a proximal or distal direction. An implant coupling element, such as loop  176 , is configured to capture a portion of an implant and secure it as it is being manipulated. For example, an implant arm can be fed into loop  176 , and the loop can then be withdrawn into aperture  182  by moving button  172  distally, thereby pulling at least a portion of the implant arm into the aperture. 
         [0068]      FIG. 11B  shows button  172  positioned in its distal-most position, such that loop  176  is disposed completely within shaft  184 . Devices such as that of  FIGS. 11A  and  11 B are described in U.S. patent application Ser. No. 12/282,641, filed Dec. 4, 2008; U.S. patent application Ser. No. 11/993,003, filed Jan. 22, 2008; U.S. patent application Ser. No. 11/993,089, filed Jun. 9, 2010; U.S. patent application Ser. No. 12/159,589, filed Aug. 15, 2008; and U.S. patent application Ser. No. 11/993,375, filed Feb. 6, 2009, the disclosures of which are each incorporated by reference herein in their entirety. 
         [0069]    A method for surgically repairing a pelvic floor defect will now be described. A patient is catheterized and placed in the dorsal lithotomy position. Small incisions are made in the anterior or posterior vaginal wall (dependent on the repair compartment) through the vaginal mucosa and fascia and into the plane beyond. Advantageously, a thick dissection is created, leaving as much endopelvic fascia on the mucosa as possible. Tissue is dissected laterally and proximally to the sacrospinous ligament on both sides of the spine. The sacrospinous ligament is cleared of any excess fascia or muscle. 
         [0070]    The distal end  70 / 102  of the first proximal implant arm  68 / 100  is attached to the needle housing  12  as shown in  FIGS. 2F and 2G . The needle housing  12  is inserted into the vaginal dissection and positioned at the level of the sacrospinous ligament  302 , approximately 2 cm medial to the ischial spine  301  ( FIG. 12 ). Direct pressure is applied to the tactile feature  56  ( FIG. 2D ) on the needle housing  12 . Trigger  29  ( FIG. 1 ) is fully depressed, and then released. This action drives the bullet needle  72  and trailing implant arm  70 / 102  through the sacrospinous ligament, and into the needle catch  38 . The needle housing  12  is withdrawn from the vaginal incision. Needle release tab  39  is depressed, releasing the bullet needle from the needle catch ( FIG. 2H ). 
         [0071]    Care should be taken to ensure the tubular mesh arm remains on the underside of the support member  86 / 116 . A hemostat can be clipped close to the end of the implant arm and clipped to the drape close to the vaginal incision. The entire process is then repeated on the contralateral side. 
         [0072]    Once both proximal arms  68 / 100  have been drawn through the sacrospinous ligament  302 , traction is applied to draw the support member  86 / 116  into place. The midline indicator  84 / 118  is used to ensure the support member  86 / 116  is positioned appropriately. 
         [0073]    If the anterior implant  60  is being implanted, then the process for introducing distal arms  74  is as follows. A 1 cm vertical incision is made approximately 1 cm below the superior medial border of the obturator fossa and lateral to the bladder neck for the distal arm  74  of the implant  60 . Ensure that the loop  176  is fully withdrawn into shaft  184  of introducer  168  by sliding button  172  to its distal-most location. Tip  180  of introducer  168  is inserted into the groin incision and gently punctures through the obturator membrane. The introducer  168  is oriented so that shaft  184  is on a horizontal plane, and the tip  180  is directed towards the level of the bladder neck. A finger is inserted into the vaginal incision, and is used to guide introducer tip  180  through the obturator internus, exposing at least 1-2 cm of the tip. A cytoscopy should be performed to confirm integrity of the bladder after the implant  60  has been positioned. 
         [0074]    If the posterior implant  96  is being implanted, then the process for introducing distal arms  108  is as follows. A 1 cm vertical pararectal incision is made approximately 3 cm lateral and 3 cm inferior to the anus. Ensure that the loop  176  is fully withdrawn into shaft  184  of introducer  168  by sliding button  172  to its distal-most location. The tip  180  of introducer  168  is inserted into the pararectal incision, and oriented towards the vaginal introitus. Care should be taken to stay lateral to the anal sphincter and rectum during passage. A finger is inserted into the vaginal incision, and is used to guide the introducer tip  180  through the posterior vaginal wall incision at the perineal body at the most lateral portion of the dissection (the junction of the transverse perineal and bulbocavernosus muscles), exposing at least 1-2 cm of the introducer tip  180 . A digital rectal examination should be performed to confirm integrity of the rectum after the implant  96  is positioned. 
         [0075]    Whether the anterior implant  60  or posterior implant  96  is implanted, the following procedure for placing the distal arms is as follows. The introducer loop  176  is fully exteriorized from the vaginal introitus by sliding button  172  proximally. The distal tip  76 / 110  of the distal arm  74 / 108  is passed into loop  176  up to the fold  78 / 112  (about 4 cm). The loop  176  is retracted by moving button  172  to its proximal-most position. Introducer  168  is then retracted to draw the mesh arm out through the skin incision. Button  172  is moved to its distal-most position, and the distal arm  74 / 108  is removed from loop  176 . The process is then completed on the contralateral side. 
         [0076]    Next, traction is applied to distal arms  74 / 108  to draw implant  60 / 96  into position. The implant can be adjusted and/or trimmed such that the distal end of the midline indicator  84 / 118  is positioned next to the bladder neck (anteriorly), or perineal body (posteriorly). 
         [0077]    Following placement of the distal arms, the proximal arms can be placed as follows. Distal end  70 / 102  of an implant arm is threaded through deployment tool  138  as shown in  FIG. 10 . The deployment tool is slid down the implant arm until it reaches sacrospinous ligament  302  as shown in  FIG. 14A . Button  140  is pressed to release securement ring  134  and trim excess mesh arm  68 / 100 . The deployment device and the excess mesh are removed from the vaginal incision, and the process is repeated on the contralateral side. 
         [0078]    A plan view of an implanted anterior implant  60  is illustrated in  FIG. 13 . The proximal arms  68  have been drawn through the sacrospinous ligament  302  and out the vaginal incision, and the distal arms  74  have been drawn through the obturator foramen  304 . Sutures can be used to secure the implant  60  to surrounding tissue. 
         [0079]    According to various embodiments, the tension on the distal arms can be adjusted postoperatively. The mesh arms can be gently pushed to release a portion of the tension. The securement ring  134  on the proximal arms  68 / 100  will allow minor loosening of the arms while maintaining sufficient hold on the implant to ensure fixation. 
         [0080]    While the invention has been described in terms of particular variations and illustrative figures, those of ordinary skill in the art will recognize that the invention is not limited to the variations or figures described. In addition, where methods and steps described above indicate certain events occurring in certain order, those of ordinary skill in the art will recognize that the ordering of certain steps may be modified and that such modifications are in accordance with the variations of the invention. Additionally, certain of the steps may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. Therefore, to the extent there are variations of the invention, which are within the spirit of the disclosure or equivalent to the inventions found in the claims, it is the intent that this patent will cover those variations as well.