Abstract:
Implants for the treatment of pelvic support conditions and methods of implementing the same. The implants comprise relatively soft, flexible bodies and relatively strong arms extending in predetermined orientations therefrom. Methods and devices for placing the implants minimize trauma to the pelvic floor and provide well-anchored support to pelvic organs without interfering with sexual or other bodily functions.

Description:
RELATED APPLICATIONS 
       [0001]    This application is a divisional of U.S. patent application Ser. No. 12/652,664 filed Jan. 5, 2010 entitled Implants And Procedures For Supporting Anatomical Structures For Treating Conditions Such As Pelvic Organ Prolapse, which claims priority to U.S. Provisional Application Ser. No. 61/142,604 filed Jan. 5, 2009, entitled Implantable Anchors For Use With Mesh Within The Body, and is related to U.S. application Ser. No. 12/652,640, filed Jan. 5, 2010, entitled Implants And Procedures For Supporting Anatomical Structures For Treating Conditions Such As Incontinence (now abandoned), and U.S. application Ser. No. 12/652,706, filed Jan. 5, 2010, entitled Implants And Procedures For Supporting Anatomical Structures (now abandoned), all of which are hereby incorporated herein by reference in their entireties. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention pertains to the field of medical devices for anchoring and supporting anatomical structures and, more particularly, to implantable mesh that are operative to treat pelvic organ prolapse and incontinence. 
       BACKGROUND OF THE INVENTION 
       [0003]    Pelvic floor disorders are a class of abnormalities that affect the pelvic region of millions of men and women. In women, for example, the pelvic region includes various anatomical structures such as the uterus, the rectum, the bladder, and the vagina. These anatomical structures are supported and held in place by a complex collection of tissues, such as muscles and ligaments. When these tissues are damaged, stretched, or otherwise weakened, the anatomical structures of the pelvic region shift and in some cases protrude into other anatomical structures. For example, when the tissues between the bladder and the vagina weaken, the bladder may shift and protrude into the vagina, causing a pelvic floor disorder known as cystocele. Other pelvic floor disorders include vaginal prolapse, vaginal hernia, rectocele, enterocele, uterocele, and/or urethrocele. 
         [0004]    Pelvic floor disorders often cause or exacerbate urinary incontinence (UI). One type of UI, called stress urinary incontinence (SUI), effects primarily women and is often caused by two conditions—intrinsic sphincter deficiency (ISD) and hypermobility. These conditions may occur independently or in combination. In ISD, the urinary sphincter valve, located within the urethra, fails to close (or “coapt”) properly, causing urine to leak out of the urethra during stressful activity. In hypermobility, the pelvic floor is distended, weakened, or damaged. When the afflicted woman sneezes, coughs, or otherwise strains the pelvic region, the bladderneck and proximal urethra rotate and descend. As a result, the urethra does not close with sufficient response time, and urine leaks through the urethra. 
         [0005]    UI and pelvic floor disorders, which are usually accompanied by significant pain and discomfort, are often treated by implanting a supportive sling or mesh in or near the pelvic floor region to support the fallen or shifted anatomical structures or more generally, to strengthen the pelvic region by promoting tissue in-growth. Often, treatments of stress incontinence are made without treating the pelvic floor disorders at all, potentially leading to an early recurrence of the stress incontinence. 
         [0006]    Existing systems, methods, and kits for treatment typically employ delivery devices to position a supportive surgical implant into a desired position in the pelvic region. However, some of these systems and methods require a medical operator to create multiple incisions and deliver the implant using complex procedures. Moreover, many existing surgical implants are not suitably sized or shaped to properly fit within a patient and treat pelvic floor disorders. Accordingly, medical operators and patients need improved systems, methods, and surgical kits for the treatment of pelvic floor disorders and/or urinary incontinence. 
       OBJECTS AND SUMMARY OF THE INVENTION 
       [0007]    The present invention provides improved methods and devices for supporting pelvic organs in the treatment of conditions such as incontinence and various pelvic floor disorders including but not limited to cystocele, enterocele and rectocele. 
         [0008]    Devices of the present invention include implants having soft, flexible support bodies and anchors that are sturdy and durable. 
         [0009]    Other devices of the present invention include introducers that allow an implant to be deeply implanted so as not to cause damage to the pelvic floor and to preserve the natural length of the vagina. 
         [0010]    Methods of the present invention include the use of multiple implants for treating multiple disorders, including treating pelvic floor disorders and incontinence. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]    These and other aspects, features and advantages of which embodiments of the invention are capable of will be apparent and elucidated from the following description of embodiments of the present invention, reference being made to the accompanying drawings, in which 
           [0012]      FIG. 1  is a partial plan view of an implant according to an embodiment of the present invention. 
           [0013]      FIG. 2A-2C  are partial plan views of an implant according to an embodiment of the present invention. 
           [0014]      FIG. 3  is a plan view of an implant according to an embodiment of the present invention. 
           [0015]      FIG. 4  is a perspective view of an implant according to an embodiment of the present invention. 
           [0016]      FIG. 5  is a cross-sectional, perspective view of one end of an implant according to an embodiment of the present invention. 
           [0017]      FIG. 6  is a perspective view of an anchor according to an embodiment of the present invention. 
           [0018]      FIG. 7  is a perspective view of an anchor according to an embodiment of the present invention. 
           [0019]      FIGS. 8A and 8B  are cross-sectional views of an anchor according to an embodiment of the present invention. 
           [0020]      FIGS. 9A-9F  is a series of drawings showing a process of assembling an implant according to an embodiment of the present invention. 
           [0021]      FIG. 10A  is a plan view of an anchor according to an embodiment of the present invention. 
           [0022]      FIGS. 10B-10D  is a series of drawings showing a process of assembling an implant according to an embodiment of the present invention. 
           [0023]      FIGS. 11A-11D  are plan views of one end of an implant according to certain embodiments of the present invention. 
           [0024]      FIGS. 12A-12C  is a series of drawings showing a process of assembling an implant according to one embodiment of the present invention. 
           [0025]      FIG. 13A  is a side elevation view and a cut-away view of a delivery system according to an embodiment of the present invention. 
           [0026]      FIG. 13B  is a cross-sectional view of a delivery system according to an embodiment of the present invention. 
           [0027]      FIG. 14  is a cross-sectional view of a delivery system according to an embodiment of the present invention. 
           [0028]      FIG. 15  is a cross-sectional view of a delivery system taken along section line B-B of  FIG. 14 . 
           [0029]      FIG. 16  is a perspective view of and implant and a delivery system according to an embodiment of the present invention. 
           [0030]      FIG. 17  is a plan view of an anchor according to an embodiment of the present invention. 
           [0031]      FIGS. 18A and 18B  are partial perspective views of an implant according to an embodiment of the present invention. 
           [0032]      FIG. 19  is a cross-sectional view of an anchor according to an embodiment of the present invention. 
           [0033]      FIG. 20  is a perspective view of an anchor according to an embodiment of the present invention. 
           [0034]      FIG. 21  is a plan view of an implant according to an embodiment of the present invention. 
           [0035]      FIGS. 22A and 22B  are plan views of an anchor according to an embodiment of the present invention. 
           [0036]      FIG. 23  is a perspective view of an anchor according to an embodiment of the present invention. 
           [0037]      FIG. 24  is a plan view of an anchor according to an embodiment of the present invention. 
           [0038]      FIG. 25  is a plan view of a locking member according to an embodiment of the present invention. 
           [0039]      FIG. 26A-26D  are plan views of an anchor according to an embodiment of the present invention. 
           [0040]      FIG. 27  is a plan view of an anchor according to an embodiment of the present invention. 
           [0041]      FIGS. 28A and 28B  are plan views of an anchor according to an embodiment of the present invention. 
           [0042]      FIG. 29  is a plan view of an anchor according to an embodiment of the present invention. 
           [0043]      FIG. 30A and 30B  are plan views of an anchor according to an embodiment of the present invention. 
       
    
    
     DESCRIPTION OF EMBODIMENTS 
       [0044]    Specific embodiments of the invention will now be described with reference to the accompanying drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention. In the drawings, like numbers refer to like elements. 
         [0045]    Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein. 
         [0046]    The implant according to the present invention may, for example, be employed to provide support for organs in treatment for conditions such as incontinence and various pelvic floor disorders including but not limited to cystocele, enterocele and recetocel. In this regard, the implant is operative to provide a single-incision solution for implanting a surgical support member within the body specifically for pelvic organ prolapse applications. The implant, the implant delivery system, and the associated methods for implanting the implant provide a strong anchor with a delivery method that is safe, fast, and easy to deploy for surgeons of various experience levels. The present invention allows for easy and controlled deployment of an anchor deep within the body, preferably under palpation control, while providing the ability to easily adjust the mesh tension prior to locking the implant in place. 
         [0047]    Broadly speaking, as shown in  FIG. 1 , an implant  10  according to certain embodiments of the present invention includes a supporting member  20  having one or more arms  26  associated with an anchor that secures the implant  10  to tissue within the body, e.g. the obturator member (OM), the obturator internus fascia, the obturator internus muscle, the arcus tendineus levator ani, the levator ani muscle, the sacrospinous ligaments (SSL), the illiococcygeus muscle, or the arcus tendineus facia pelvis (white line). For the sake of clarity,  FIGS. 1-2  show only one side of the implant  10 . It is understood that the side not shown is a mirror image of the side shown.  FIGS. 2A-2C  show alternative configurations of the supporting member  20  and the arms  26 . Suitable supporting members  20  are further described in the Assignee&#39;s U.S. patent application Ser. No.: 11/936,063, the contents of which are herein incorporated by reference. In certain embodiments of the present application, the supporting member  20  has a simpler shape that is approximately rectangular, oval, or circular and in which the arms  26  are less pronounced or even absent. 
         [0048]    The support member  20  may be fabricated of a synthetic material, such as surgical mesh and the like, natural tissues, such as tissues harvested from either an animal, cadaverous source or the patient himself, and/or combinations of synthetic and natural materials. In a preferred embodiment, the support member  20  is fabricated of a mesh or weave. 
         [0049]    In certain embodiments, a support member suture  50 , shown in  FIG. 16 , is advantageously attached to the support member  20 . The support member suture  50  is looped through, tied to, or otherwise associated with the support member  20 . Preferably, the support member suture  50  is affixed to the support member  20  at a proximate mid-point of the support member  20 . As would be understood by one of ordinary skill in the art, it may also be advantageous to employ a plurality of the support member sutures  50  at predetermined positions on or within the support member  20  in order to provide a plurality of markers along a dimension of the support member  20 . In order to distinguish the various individual sutures, the sutures may be provided in different colors, lengths, or other indicating means that would allow a user to distinguish one suture from another. Indicating marks may also be provided along a length of the suture that can be employed to determine a depth of the suture within the body. 
         [0050]    Turning next to the tissue anchoring element of the implant  10  of the present invention. Each of the below disclosed anchors includes a tissue piercing portion and a proximal portion having an element for associating the anchor with the support member  20 . 
         [0051]      FIGS. 3-7  show an anchor  30  according to one embodiment of the present invention. The anchor  30  has a distal portion  60  and a proximal portion  70  associated with one another by mid-portion  80 . A proximal end of the distal portion  60  of the anchor  30  is associated with or attached to a distal end of the mid-portion  80 . Conversely, a distal end of the proximal portion  70  is associated with or attached to a proximal end of the mid-portion  80  of the anchor  30 . The mid-portion  80  of anchor  30  is formed as a shaft or spacer that serves to provide space between the distal portion  60  and the proximal portion  70  to, for example, accommodate a depth of tissue through which the distal portion  60  has penetrated. 
         [0052]    The distal portion  60  of the anchor  30  employs a piercing tip  62  for penetrating tissue and a tissue-retention protrusion  64  proximal of the piercing tip  60  that anchors or secures the distal portion  30  within tissue. The distal portion  60  may have, for example, an arrowhead-like shape as shown in  FIGS. 3-6 . Alternatively, distal portion  60  may have a more complex shape configured to employ more than two, for example as shown in  FIG. 7 , four tissue-retention protrusions  64 . The distal portion  60  may further employ a conical or cone-like shape having a circular tissue-retention protrusion  64 . One of ordinary skill in the art would recognize that alternative shapes and configurations of the distal portion  60  are possible while still achieving the desired objective. For example, distal portion  60  may employ resilient, spring loaded and/or self-tensioning tissue-retention protrusions  64 . 
         [0053]    The proximal portion  70  of anchor  30  comprises a shoulder  72  for providing a back-stop for the support member  20  and a guide member  74  for engagement with a delivery system, as discussed in greater detail below. The proximal portion  70  may further employ recesses  76  and eyelet  78 . The anchor suture  40  passes through the eyelet  78  and is, for example, secured back to itself to form a loop. The recesses  76  may be positioned on one or both side of the eyelet  78  and configured so as to accept the anchor suture  40  such that the presence of the anchor suture  40  does not add to or change an outer dimension of the guide member  74 . 
         [0054]    The anchor  30  may be formed from a variety of materials, including but not limited to metal alloys, such as titanium, stainless steel, or cobalt-chome alloys, polymeric materials, such as polyethylene (PE), polypropylene (PP), polysulfone, polyether ether ketone (PEEK), polyether imide (PEI), and biodegradable materials, such as polylactic acid (PLA) and polyglycolic acid (PGA) based materials. The anchor  30  may be formed of a single material or a combination thereof. For example, as illustrated in  FIGS. 8A and 8B , the anchor  30  may be formed of a combination of primary material  90 , such as titanium, and a biodegradable material  92 , shown in as hashed, assembled or molded over the primary material  90 . 
         [0055]    Turning next to  FIGS. 9A-9F ,  FIGS. 9A-9F  show the steps of assembling the implant  10  according to various embodiments of the present invention. For the sake of clarity,  FIGS. 9A-9F  show only the assembly of one arm  26  of the implant  10 . First, a tool  90  is used to form an opening  110  through the arm  26  proximate an end of the arm  26  by penetrating, stretching, or spreading the mesh or knitted material of the arm  26  of the support member  20 . The tool  90  has a tapered or pointed end and a cross-section shape in the form of a circle, rectangle, oval or most any other shape. The distal portions  60  of the anchors  30  are then inserted through the openings  110  in the arm  26  until the arm  26  rests against the shoulders  72  of the proximal portions  72  of the anchors  30 . In a preferred embodiment, the openings  110  are formed interior of the outer perimeter of the arm  26  such that there is sufficient material of arm  26  so that the openings  110  do not substantially expand or rip though the outer perimeter of the support member  20 . 
         [0056]    In an alternative embodiment of the present invention, as shown in  FIG. 10A-10D , the shoulder of the anchor  31  is formed of a plastic or metal pin  73  that is inserted through a receiving hole  75  formed through the proximal portion of the anchor  31 . During assembly of the implant  10 , once the openings  110  are formed through the arm  26 , the guide  74  and/or proximal portion  70  of anchor  31  is placed through the opening  110  and the pin  73  is inserted through the receiving hole  75  to form an element functionally similar to the shoulder  72  previously described. As one of ordinary skill in the art would recognize, this embodiment provides the advantage that a smaller opening  110  may be formed when assembling the implant  10 . The smaller opening  110 , in turn, provides the advantage of the arm  26  having a greater resistance to tearing and deformation. 
         [0057]    In certain other embodiments of the present invention, the assembled implant  10  as described above may be subjected to additional fabrication steps. For instance, as shown in  FIGS. 11 and 12 , after insertion of the anchor  30  through the opening  110  of arm  26 , a portion of the arm  26  between the opening  10  and the outer perimeter of the arm  26  is folded over the shoulder of the anchor  30  back on to itself to form a folded portion  22 . The folded portion  22  may then be bonded, sutured, welded, or tacked to it self to form bond  24  to better maintain the fold. Formation of the folded portion  22  serves, in part, to decrease resistance to penetration of the anchor  30  into tissue. The fold  22  may additionally help insure that the anchor  30  remains inserted through the arm  26  during handling and implantation of the implant  10 , as well as provide a more visually appealing appearance to the implant  10 . As shown in  FIGS. 11 and 12 , the shape of the portion of the arm  26  that forms the fold  22  may be manipulated so as to, for example, result in the arm  26  having a tapered end. A tapered end may be formed by forming a portion of the arm  26  so as to have a width that narrows at a fold line  26 , as shown in  FIG. 11A . A tapered end may also be formed through a secondary folding of the extremities or corners of the fold  22  towards one another, as shown in  FIG. 11B . Alternatively, as shown in  FIG. 11C , once the folded portion  22  is formed a suture may be threaded through the fold  22  and cinched and bound to itself so as to form a tapered end of the anchor  30 . A tapered end may also be formed in the implant  10  by cutting or trimming the corners of the fold  22  after the fold  22  has been formed, as shown in  FIG. 11D . 
         [0058]      FIGS. 12A-12C  show yet another embodiment of the implant  10  in which, prior to formation of the fold  22 , the arm  26  is twisted  180  degrees or more. Again, this method of assembly decreases resistance to penetration of the anchor and helps ensure that the anchor  30  remains inserted through the arm  26  during handling and implantation. One of ordinary skill in the art will, however, recognize that other methods of assembling the support member  20  and the anchor  30  to achieve the desired characteristics of the implant  10  are known in the art. 
         [0059]    Turning now to the delivery system of the present invention. Broadly speaking, the delivery system is configured to receive a portion of the anchor  30  of the assembled implant  10 .  FIG. 13A  shows a delivery system  120  having a handle  125  and a shaft  140 . The handle  125  is preferably ergonomically shaped to facilitate grasping and manipulating. The handle  125  is preferably marked, colored, textured or otherwise configured so as to indicate to a user the orientation of the delivery system  120 . The shaft  140  protrudes from or is an extension of the handle  125 . The shaft  125  is, for example, formed of stainless steel or other metal in the general shape of a needle. A curved distal portion  142  of the shaft  140  includes a cavity  144  and a slot  146 . 
         [0060]    Optionally, as shown in  FIG. 13B , the delivery system  120  may further employ a sheath  148 . The sheath  148  is a slit tube or u-shaped channel that functions, in part, to protect the support member  20  and various associated sutures from exposure to tissue during implantation. The sheath  148  also functions to limit the depth of penetration of the anchor  30  in to the target tissue. This function is achieved by configuring the sheath  148  to be a distance D shorter than a length of the implant  10  and shaft  140  when assembled and have an outer diameter greater than that of the shaft  140  and the anchor. Because the sheath  148  is displaceable along the axis of the shaft  140 , arrow E of  FIG. 13B , the user, after first piercing the target tissue with the distal portion  60  of the anchor  30 , may move the sheath to determine or measure the approximate depth of that the anchor  30  within the target tissue. 
         [0061]    Referring now to  FIGS. 14 and 15 ,  FIG. 14  shows the implant  10  and delivery system  120  assembled ready for implantation of the implant  10 .  FIG. 15  shows a cross-sectional view of the assembled implant  10  and delivery system  120  viewed along section line B-B of  FIG. 14 . As will be noted, the shape of the cavity  144  corresponds to the shape of the guide  74  of the anchor  30 . That is to say that the guide  74  of the anchor  30  of the implant  10  and the cavity  144  of the shaft  140  of the delivery system  120  are complementary elements, the cavity  144  forming a female receiving element for the male guide  74 . Preferably, the cavity  144  and the guide  74  are formed in the shape of a square, rectangle, oval, triangle, star, or other shape that resists the guide  74  rotating within the cavity  144 . In certain embodiments of the present invention, the cavity  144  and the guide  74  form a friction fit such that the guide  74  is maintained within the cavity  144  during handling and deployment of the implant  10  but is readily released from the cavity  144  upon engagement of the distal portion  60  of the anchor  30  with tissue. A portion of the slot  146  penetrates radially through the shaft  140  into the cavity  174  and extends axially along a length of the distal portion  142  of the shaft  140 . Preferably, the slot  146  extends axially along the shaft  140  to a greater extent than the cavity  174 . The slot  146  thereby receives and forms a channel through which the anchor suture  40  of anchor  30  is positioned along an axis of the shaft  140 . 
         [0062]    A method for deploying or implanting the implant  10  incorporating the anchors  30  will now be described. First, a single incision or entry point is made in the patient followed by blunt dissection as necessary or desired. One side of the implant  10  incorporating the anchor  30  that is engaged with the delivery system  120  is then inserted through the entry point and the anchor  30  that is engaged with the delivery system  120  is forced into or through a portion of the target tissue, e.g. the transobturator, the obturator internus fascia, the obturator internus muscle, the obturator member (OM), the arcus tendineus levator ani, or levator ani muscle. The delivery system  120  is retracted away from the anchor  30  that has penetrated the target tissue thereby breaking the engagement between the delivery system  120  and the anchor  30 . During this process and particularly while the delivery system  120  is being retracted, the user secures the corresponding anchor suture  40  such that the delivery system  120  is retracted while an end of the anchor suture  40  is maintained extending out from the entry point. The arm  26  of a second, opposite side of the implant  10  that is engaged with the delivery system  120  is then implanted as described with regard to the first side. 
         [0063]    Substantially concurrent with the implantation of the second side of the implant  10 , the support member  20  of the implant  10  is positioned so as to support at least a portion of the desired organ. The support member suture  50 , shown in  FIG. 16 , may be used to determine the position and/or tension of the implanted support member  20 . The tension of the support member  20  spanning between the two sides of the implant  10  incorporating the anchors  30  is initially adjusted by pushing the delivery system  20  engaged with the anchor  30  of the second arms  26  of the implant  10  further into the target tissue. The delivery system  120  is then retracted from the second arm  26  of the implant  10 . An end of the second anchor suture  30  is also maintained such that it extends out from the entry point. 
         [0064]    Should it be determined that greater tension is desired or if it is otherwise desirable to reengage of the delivery system  120  with one of the anchors  30 , the present invention provides a particularly advantageous means for achieving such. As shown in  FIG. 16 , the end of the anchor suture  40  of the relevant anchor  30  that extends from the entry point is tensioned and secured. The slot  146  of the delivery system  120  is then positioned such that the anchor suture  40  passes through the slot  146 , and serves as a guide for the delivery system  120  to the relevant anchor  30 . The delivery system  120  is advanced towards the relevant anchor  30  along the anchor suture  40 . The guide  74  of the anchor  30  is thereby received by the cavity  144  of the delivery system  120  and, if desired, the friction fit between the anchor  30  and the delivery system  120  is reestablished. It is then possible to adjust the tension of the support member  20  of the implant  10  by pushing the delivery system  120  so as to drive the anchor further into the target tissue. The implant can be retracted by pulling upon the suture thereby releasing all or a portion of the tension present in the implant  10 . 
         [0065]    Upon completion of the implantation of the implant  10 , the anchor sutures  40  and support member sutures  50  can be left in place for possible use in a follow-up procedure or may be removed from the patient. 
         [0066]      FIGS. 17-24  show an anchor  130  according to another embodiment of the present invention. The anchor  130  has a distal portion  60  and a proximal portion  70  associated with one another by mid-portion  80 . A proximal end of the distal portion  60  of the anchor  130  is associated with or attached to a distal end of the mid-portion  80 . Conversely, a distal end of the proximal portion  70  is associated with or attached to a proximal end of the mid-portion  80  of the anchor  130 . The mid-portion  80  of anchor  130  is formed as a shaft or spacer that serves to provide space between the distal portion  60  and the proximal portion  70  to, for example, accommodate a depth of tissue through which the distal portion  60  has penetrated. 
         [0067]    The distal portion  60  of the anchor  130  employs a piercing tip  62  for penetrating tissue and one or more tissue-retention protrusions  64  proximal of the piercing tip  60  that anchor or secures the distal portion  130  within tissue. The distal portion  60  may have, for example, an arrowhead-like shape as shown in  FIGS. 17-24 . Alternatively, the distal portion  60  may have a more complex shape and configuration as described above, and shown in  FIG. 7 , regarding the anchor  30  disclosed above. 
         [0068]    As shown in  FIG. 17 , the proximal portion  70  of anchor  130  comprises an aperture  132  for receiving a portion of the support member  20 , the arm  26  of the support member  20 , or a suture and may optionally comprise a guide member  74  for engagement with a delivery system. The guide member  74  of the anchor  130  may function and be configured as described above regarding the anchor  30  disclosed above. Accordingly, implantation of the implant  10  incorporating the anchor  130  may be achieved substantially as described above regarding implantation of the implant  10  incorporating the anchor  30 . However, as will become apparent from the following description, the implant  10  incorporating the anchor  130 , provides certain alternative methods and systems for adjusting the tension of the support member  20  spanning between two anchors  130 . 
         [0069]    The anchor  130  may be formed from a variety of materials, including but not limited to, titanium, metal alloys, polyethylene (PE), polypropylene (PP), polysulfone, polyether ether ketone (PEEK), polyether Imide (PEI) or other suitable plastic, polymer, and biodegradable materials. As described above with respect to the anchor  30  shown in  FIGS. 8A and 8B , the anchor  130  may also be formed of a single material or a combination thereof. The overall size of the anchor  130  is approximately 1-30 mm long and 1-25 mm wide, and preferably 5-15 mm long and 5-15 mm wide. 
         [0070]    As shown in  FIGS. 17-25 , the aperture  132  of the anchor  130  may, for example, be circular, rectangular, or ellipsoidal in shape. In certain embodiments, as shown in  FIGS. 17 ,  18 A and  18 B,  22 A and B, and  23 , an interior surface of the aperture  132  is substantially smooth thereby allowing the support member  20  or arm  26  to pass freely through the aperture in either direction. In such embodiments, as shown in  FIG. 18A and 18B , the end of the support member  20  or arm  26  that passes through the aperture  132  is secured back to itself, to another anatomical structure, or a combination thereof in order to tension the implant  10 . 
         [0071]    Alternatively, as shown in  FIGS. 19-21  and  24 , the anchor  130  may employ an aperture  132 ′ having teeth or other surfaces that form an engagement member  134  that projects substantially towards an interior of the aperture  132 ′. As shown in  FIG. 19 , the engagement member  134  may be angled to one side such that the support member  20  or the arm  26  slides freely in the direction of the arrow  135  through the aperture  132 ′ but is prevented from sliding in the opposite direction due to engagement with the angled engagement members  134 .  FIG. 20  shows another embodiment of the anchor  130  incorporating the engagement members  134  in which a cover  136  is employed. The cover  136  is incorporated into the proximal portion  70  of the anchor  130  but attachment using a hinge or similar element allowing the cover  136  to be opened and closed. The cover  136  functions to lock the support member  20  or arm  26  into place through the aperture  132 ′, as well as to protect the engagement members  134  such that the engagement members do not become entangled with other structures within the body or tools used during the implantation procedure. 
         [0072]      FIG. 21  shows an alternative embodiment of the present invention in which a tube  138  and suture  139  are employed so as to further facilitate engagement and disengagement of the support member  20  or arm  26  and the engagement members  134 . The suture  139  enters the aperture  132 ′ through a first hole  131  in the structure forming the aperture  132 ′ above the engagement members  134 . The suture  139  then passes through the tube  138  that is sized to move freely within the aperture  132 ′, exits the tube  138 , and exits the aperture  132 ′ through a second hole  131  in an opposite side of the structure forming the aperture  132 ′. The suture  139  is fixed to itself so as to form a loop. An end of the suture  139  is left to extend from the entry point. 
         [0073]    In operation, the suture  139  is maintained without tension and the support member  20  or the arm  26  is passed through the aperture  132 ′ and tensioned such that the support member  20  or the arm  26  engages the engagement members  134  and thereby becomes locked in place. Since the suture  139  is not tensioned, tube  138  is free to move and is pulled by the support member  20  or the arm  26  toward and beyond the engagement members  134  as the support member  20  or the arm  26  engages the engagement members  134 . Should it be determined that the tension of the support member  20  or the arm  26  needs to be adjusted the support member  20  or the arm  26  are disengaged from the engagement members  134  by tensioning the suture  139  thereby lifting the support member  20  or the arm  26  off of the engagement members  134 . The tension of the support member  20  or the arm  26  is adjusted while maintaining tension upon the suture  139 . Following adjustment of the tension of the support member  20  or the arm  26 , the tension on the suture  139  is released thereby reengaging the support member  20  or the arm  26  with the engagement members  134 . 
         [0074]      FIGS. 22A and 22B  show yet another embodiment of the anchor  130  of the present invention in which the anchor  130  incorporates a slide lock  133  having engagement members  134 . The slide lock  133  is incorporated into and integral with the anchor  130  such that the slide lock  133  slides laterally away from and towards the aperture  132 . In the open or unlocked state, shown in  FIG. 22A , the slide lock  133  is withdrawn or cleared from the aperture  132  and the support member  20  or the arm  26  is passed through the aperture  132  freely. In the locked or closed state, shown in  FIG. 22B , the slide lock has been displaced so as to extend into and/or across the aperture and thereby engage the support member  20  or the arm  26  with the engagement members  134  of the slide lock  133 . In order to maintain the slide lock in the closed state, the slide lock may incorporate resilient portions  137  that slide into receiving elements or other structural features that prevents the slide lock from further movement absent disengagement of the resilient portions  137  from the receiving elements. One of ordinary skill in the art will recognize that there are various known structures and configurations possible for achieving the above described embodiment, for example, the slide lock may slide within a channel formed in proximal portion  70  of anchor  130  and the resilient portions  137  may engage openings or recesses formed within the channel so as to lock the slide lock into a fixed position. 
         [0075]    In certain of the embodiments, for example the embodiments shown in  FIGS. 17 ,  18 A and  18 B,  22 A and  22 B, and  23 , it is further contemplated that a locking or fixing of the support member  20  or the arm  26  relative to the anchor  130  is facilitated by a separate locking member  150  as shown in  FIGS. 23 and 25 . The locking member  150  and aperture  132 ′ may incorporate any of the above described features for engaging the support member  20  or the arm  26 . In operation, the support member  20  or the arm  26  passes through the aperture  132 ′ of the locking member  150 . The locking member  150 , in turn, is configured so as to resist or be incapable of passing through the aperture  132  of the anchor  130 . It is also contemplated that a suture, not shown, be attached to the locking member  150  in order to facilitate location and manipulation of the locking member during the procedure. 
         [0076]    A method for deploying or implanting the implant  10  incorporating the anchors  130  will now be described. First, a single incision or entry point is made in the patient followed by blunt dissection as necessary or desired. One or more anchors  130  are delivered at various locations in the body using the delivery system  120  described above. Sutures that are secured to the support member  20  or the arm  26  at one end are passed through the aperture  132 ,  132 ′ of the anchor  130  and used to tension the support member  20  within the body thereby setting the support member  20  in position within the body. Alternatively, the suture is omitted and the support member  20  or the arm  26  is directly passed through the aperture  132 ,  132 ′ in order to set the support member  20  in position within the body. The tension of the support member  20  spanning between two corresponding anchors  132 ,  132 ′ is adjusted as described above and the ends of the suture, the support member  20  or the arms  26  are secured so as to maintain the necessary tension. The ends of the suture, the support member  20  or the arm  26  are either trimmed or left in place, and the incision is closed. 
         [0077]    Alternatively, the anchors  130  are assembled with the support member  20  prior to initiating the procedure. In such case, the step of introducing a suture, support member  10 , or arm  26  through the aperture  132 ,  132 ′, after the anchor  130  has been implanted is omitted. Once the anchors  130  have been implanted, the support member  20  spanning between the corresponding anchors  130  is tensioned and adjusted as described above. 
         [0078]    Upon completion of the implantation of the implant  10 , the anchor sutures  40  and support member sutures  50  can be left in place for possible use in a follow-up procedure or may be removed from the patient. 
         [0079]      FIGS. 26-30  show yet another embodiment of the present invention in which the anchors  160  take the form of a staple. As shown in  FIG. 27 , the anchors  160  comprises one or more retention loops  162  for piercing and engaging the target tissue and a tail loop  166  or associating the support member  20  or arm  26  with the staple  160 . As shown in  FIGS. 26A-26D , the shape and size of the retention loops  162  may be circular, rectangular, triangular, oval or a combination thereof. The tail loop  166  may also be formed in a variety of shapes and sizes. The tail loop  166  may, for example, be an open of closed loop and may be shaped so as to pinch a suture, the support member  20 , and/or the arm  26  of the support member  20 . A suture or suture loop, not shown, may further be affixed to the tail loop  166  in order to assist in assembly and implantation of the staple  160 . 
         [0080]      FIG. 28A and 28B  show alternative embodiments of the anchor  160  in which a portion of the tail loop  166  passes through a hollow tube  164 .  FIG. 29  shows another embodiment of the present invention in which the anchor  160  is incorporated into a head  168 . The head  168  may initially function to pierce the target tissue and then to assist in anchoring the anchor  160  in the target tissue.  FIGS. 30A and 30B  show a simplified embodiment of the anchor  160  employing a singular retention loop  162  attached to a tail loop  166 . 
         [0081]    In operation, the anchor  160  is first retracted into a hollow piercing needle by pulling upon the tail loop  166  such that the anchor enters the hollow piercing needle and assumes a substantially straightened, folded configuration within the hollow piercing needle. The piercing needle is introduced into the target tissue. A pusher is inserted into an opposite end of the hollow piercing needle and used to push the anchor into the target tissue. The hollow piercing needle may, but need not be retracted from the target tissue simultaneously as the anchor  160  is pushed from out the end of the needle. As the anchor  160  exits the needle, the staple  160  penetrates in to the target tissue as it assume its unconstrained shape. 
         [0082]    After implantation of the anchor  160  within the target tissue, the support member  20  or arm  26  is associated with the tail loop  162  by securing a suture connected to the support member  20  to the tail loop  162  or by directly securing the support member  20  or arm  26  to or through the tail loop by using any of the embodiments herein described with relation to the anchors  30  and  130 . 
         [0083]    The anchor  160  may be formed of a single or multi filament or wire fabricated from Nitinol, stainless steel or other metals, polymer or other shape memory material. The staple may be 1-30 mm tall and 1-30 mm wide. 
         [0084]    A method for deploying or implanting the implant  10  incorporating the anchor  160  will now be described. First, a single incision or entry point is made in the patient followed by blunt dissection as necessary or desired. One or more anchor  160  are implanted at various locations within the body. Sutures that are passed through the tail loop  162  and secured to the support member  20  or the arm  26  at one end are used to tension the support member  20  within the body. Alternatively, the support member  20  or the arm  26  is directly passed through the tail loop  162  of the anchor  160  in order to set the support member  160  in position within the body. The support member  20  tension is adjusted as desired. The ends of the suture, the support member  20  or the arms  26  are secured so as to maintain the necessary tension and trimmed as desired and the incision is closed. 
         [0085]    The implants  10  according to the present invention may employ the anchors  30 ,  130 , or  160  exclusively or, as shown in  FIGS. 1 and 2C , may employ a combination of different types of anchors. For example,  FIGS. 1 and 2C  shows a portion of the implant  10  that employs the anchors  30  on a first set of arms  26  and the anchors  130  on a second set of arms  26 . During implantation, the anchors  30  incorporated into the first set of arms  26  are first implanted in or through the transobturator, and the anchors  130  incorporated into the second set of arms  26  are next implanted in or through the sacrospinous ligaments, SSL. It will be understood by one of skill in the art the different anchors of the present invention will each lend themselves to implantation within potentially different target tissues having different characteristics and locations within the body. 
         [0086]    While the present invention has been described for use in treating pelvic floor disorders and incontinence, it would be understood by one of skill in the art that the present invention can be used support other organs within the body or as a means of fixation of tissue or implants within the body. 
         [0087]    Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.