Patent Publication Number: US-10314681-B2

Title: Pelvic implant system and method

Description:
PRIORITY 
     This Application is a continuation of U.S. Nonprovisional Patent application Ser. No. 13/556,167, filed Jul. 23, 2012, which claims priority to and the benefit of U.S. Provisional Patent Application No. 61/510,726, filed Jul. 22, 2011, U.S. Provisional Patent Application No. 61/515,180, filed Aug. 4, 2011, U.S. Provisional Patent Application No. 61/545,104, filed Oct. 7, 2011, U.S. Provisional Patent Application No. 61/547,467, filed Oct. 14, 2011, U.S. Provisional Patent Application No. 61/547,503, filed Oct. 14, 2011, U.S. Provisional Patent Application No. 61/607,332, filed Mar. 6, 2012, U.S. Provisional Patent Application No. 61/607,891, filed Mar. 7, 2012, U.S. Provisional Patent Application No. 61/608,436, filed Mar. 8, 2012, U.S. Provisional Patent Application No. 61/608,478, filed Mar. 8, 2012, U.S. Provisional Patent Application No. 61/653,199, filed May 30, 2012, U.S. Provisional Patent Application No. 61/653,213, filed May 30, 2012, U.S. Provisional Patent Application No. 61/653,224, filed May 30, 2012, and U.S. Provisional Patent Application No. 61/653,236, filed May 30, 2012; with each of the above-referenced applications and disclosures incorporated herein by reference in their entirety. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to apparatus, tools and methods for treating pelvic conditions and, more particularly, systems and methods to support pelvic tissue by acting on, stabilizing, positioning or controlling the position of the perineal membrane or like anatomical structures. 
     BACKGROUND OF THE INVENTION 
     It has been reported that over 13 million American men and women of all ages suffer from urinary and fecal incontinence. The social implications for an incontinent patient include loss of self-esteem, embarrassment, restriction of social and sexual activities, isolation, depression and, in some instances, dependence on caregivers. Incontinence is the most common reason for institutionalization of the elderly. 
     The urinary system consists of the kidneys, ureters, bladder and urethra. The bladder is a hollow, muscular, balloon-shaped sac that serves as a storage container for urine. The bladder is located behind the pubic bone and is protected by the pelvis. Ligaments hold the bladder in place and connect it to the pelvis and other tissue. The urethra is the tube that passes urine from the bladder out of the body. The narrow, internal opening of the urethra within the bladder is the bladder neck. In this region, the bladder&#39;s bundled muscular fibers transition into a sphincteric striated muscle called the internal sphincter. The urethra extends from the bladder neck to the end of the penis. The male urethra is composed of three portions: the prostatic, bulbar and pendulus portions. The prostatic portion is the widest part of the tube, which passes through the prostate gland. The rectum is the most distal portion of the gastrointestinal tract. The exterior opening of the rectum is the anus. Fecal continence is related to control of the exterior sphincter and interior sphincter of the anus. 
     Urinary incontinence may occur when the muscles of the urinary system are injured, malfunction or are weakened. Other factors, such as trauma to the urethral area, neurological injury, hormonal imbalance or medication side-effects, may also cause or contribute to incontinence. There are five basic types of incontinence: stress incontinence, urge incontinence, mixed incontinence, overflow incontinence, and functional incontinence. Stress urinary incontinence (SUI) is the involuntary loss of urine that occurs due to sudden increases in intra-abdominal pressure resulting from activities such as coughing, sneezing, lifting, straining, exercise and, in severe cases, even simply changing body position. Urge incontinence, also termed “hyperactive bladder,” “frequency/urgency syndrome,” or “irritable bladder,” occurs when an individual experiences the immediate need to urinate and loses bladder control before reaching the toilet. Mixed incontinence is the most common form of urinary incontinence. Inappropriate bladder contractions and weakened sphincter muscles usually cause this type of incontinence. Mixed incontinence is a combination of the symptoms for both stress and urge incontinence. Overflow incontinence is a constant dripping or leakage of urine caused by an overfilled bladder. Functional incontinence results when a person has difficulty moving from one place to another. It is generally caused by factors outside the lower urinary tract, such as deficits in physical function and/or cognitive function. 
     SUI is generally thought to be related to hypermobility of the bladder neck or an intrinsic urethral sphincter defect. A variety of treatment options are currently available to treat incontinence. Some of these treatment options include external devices, behavioral therapy (such as biofeedback, electrical stimulation, or Kegal exercises), injectable materials, prosthetic devices and/or surgery. Depending on age, medical condition, and personal preference, surgical procedures can be used to completely restore continence. 
     Conservative management of SUI can include lifestyle changes, such as weight loss, smoking cessation, and modification of intake of diuretic fluids such as coffee and alcohol. Mid-urethral slings have been effective. One type of procedure, found to be an especially successful treatment option for SUI in both men and women, is a sling and support procedure. 
     A sling procedure is a surgical method involving the placement of a sling to stabilize or support the bladder neck or urethra. There are a variety of different sling procedures. Slings used for pubovaginal procedures differ in the type of material and anchoring methods. In some cases, the sling is placed under the bladder neck and secured via suspension structures or sutures to a point of attachment (e.g., tissue or bone) through an abdominal and/or vaginal incision. Examples of sling procedures are disclosed in U.S. Pat. Nos. 5,112,344; 5,611,515; 5,842,478; 5,860,425; 5,899,909; 6,039,686, 6,042,534, 6,110,101, 6,911,003, 6,652,450, and International PCT Publication No. 2008/057261, all of which are herein incorporated by reference in their entirety. 
     Fecal incontinence, like urinary incontinence, has proven to be challenging to treat. Patients whose fecal incontinence is caused by external anal sphincter injury is treated surgically, as with a sphincteroplasty. Other patients, though, are considered to have neurogenic or idiopathic fecal incontinence, and efforts to treat these patients has been less successful. Various procedures, such as postanal repair, total pelvic floor repair, muscle transposition techniques, dynamic graciloplasty, artificial sphincter procedures, and sacral nerve stimulation. Success has been limited, and the various treatment modalities can result in morbidity. 
     There is a desire for a minimally invasive yet highly effective treatment modality that can be used with minimal to no side effects for the treatment of both urinary and fecal incontinence. Such a modality should reduce the complexity of a treatment procedure, be biocompatible, should reduce pain, operative risks, infections and post operative hospital stays, and have a good duration of activity. Further, the method of treatment should also improve the quality of life for patients. 
     SUMMARY OF THE INVENTION 
     The present invention can include surgical instruments, implantable articles, and methods for urological applications, particularly for the treatment of stress and/or urge urinary incontinence, fecal incontinence, and prolapse by implanting a paraurethral constraining device. The constraining device or implant can control and eliminate rotation of the urethra that is associated with incontinence. 
     Embodiments of the present invention can include apparatus and methods for treating urinary incontinence, fecal incontinence, and other pelvic defects or dysfunctions, in both males and females using one or more implants to reinforce the supportive tissue of the urethra. The implants are configured to engage and pull (e.g., pull up) or reposition the supportive tissue, such as the perineal membrane. The perineal membrane is the fibrous membrane in the perineum that intersects the urethra and vagina near the midurethra location and can thus be stabilized or controlled in a manner that helps restore continence. As such, systems, methods and implants can be utilized to eliminate the need for mesh or other supportive structures under the urethra that is common with other incontinence slings. The implants can be shaped to facilitate such support, e.g., provided with anchoring end portions, barbs or other devices of many available shapes and configurations. One or more anchors or tissue engagement portions can be employed to attach and stabilize the implants or devices to tissue. 
     Embodiments of the present invention can provide smaller implants or devices, fewer implant or device components, thus reducing the size and number of incisions, improving implant manipulation and adjustment, the complexity of the insertion and deployment steps, and healing times. 
     The implants can resist movement of tissue such as, for example, forward rotational movement of the urethra or surrounding tissue. The present implant embodiments can utilize a perineal incision or puncture and a paraurethral constraining device. Alternatively, the device may be implanted transvaginally. 
     In certain embodiments, one or more paraurethral support devices are provided. Paraurethral suspension elements are provided for the treatment of SUI and other disorders. The support, extension or suspension elements can apply mechanical traction to the urethra in a manner similar to a mini-sling device, wherein tension is applied at the midurethral position to lift and support that anatomical structure during stress events, such as coughing or physical activity. 
     An anchoring element or portion, such as a medial or proximal anchor, is fixed on each side of the urethra on the far side of a tissue layer that is known to have relatively high strength and toughness. Such anatomical structures can include the uterovaginal fascia, endopelvic fascia, perineal membrane or other anatomical features at which connective support of the urethra can be established. The medial anchor can include a self-expanding anchor, a “toggle” anchor, which is a small elongated structure that can be placed through the tissue via a small puncture or like incision and then rotates after deployment so that it cannot back out through the incision hole, or a myriad of other anchoring and tissue engagement devices. 
     Placing the medial anchor device on the far side of the fascia is advantageous because it is less likely to be palpable than one placed in the mucosal and muscle layer. It can be placed in an area of loose connective tissue in which the anchor can easily rotate or expand into a locking or engaging orientation. 
     A second anchor device, such as a distal anchor or engagement device, is placed in a lateral or superior position such that a connection between the medial and lateral anchors (via a suture, mesh, wire or like connection) can provide tensile support for the urethra during stress events. The distal anchor device can be fixated to, or around, the tendinous arch of the levator ani (white line), the Cooper&#39;s ligament, the obturator foramen, obturator internus, abdominal fascia, sacrospinous ligament, prepubic fascia or muscle, the pubic symphysis cartilage, or other stable anatomical structures. The distal anchor devices can include a body portion, a beveled tip, one or more expandable barbs, a thru-aperture, and an opposing end. The suture or like extension member is adapted to string or thread through the respective apertures of a series or array of such anchors. The array of anchors can be inserted within and along the interior lumen of a needle, cannula or like inserter or delivery tool for deployment. In addition, the distal anchor, or anchor array, can be directed down below the urethra for fixation, to provide an alternate control over the position and rotation of the urethra. 
     The final position of the implanted device creates a support structure that can include a generally straight, suspension orientation. The medial anchor can spread or better distribute the tension load over a larger surface compared to a thin suture cutting edge surface. This, in turn, promotes stability of the anchor and connecting suture and, ultimately, the target support tissue. 
     Various procedural steps or methods can be implemented to deploy and anchor the implant of the present invention. In one embodiment, the medial anchor is implanted, a needle is withdrawn, a free suture or connector end is delivered through the insertion opening, the second distal anchor is delivered and implanted, and the connecting suture is properly tensioned between the anchors to provide proper support. The suture or other support extensions members can be constructed to be generally flexible, or to have limited elasticity—e.g., bungee-type attributes. 
     Various anchoring systems, device, techniques and placement locations are provided to facilitate the support and rotational prevention of exemplary embodiments, as well as hingable anchor constructs and configurations, as well as suture pathways and anchoring positions. 
     A benefit of certain embodiments of the present invention is that a transvaginal placement of the support devices does not leave exposed material inside the vaginal cavity. For example, the final device position can be completely blind, beyond the superficial mucosal layer of the vaginal wall. Reducing or eliminating the exposed material minimizes the risk of infection, irritation at the surface of the vaginal wall, and provides cosmetic improvement and reduces interference with sexual activity. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a schematic view of various anatomical structures of the female pelvic region, including urinary and reproductive systems. 
         FIGS. 2-6  are schematic views of various anatomical structures of the female pelvic region, and bilateral implants having medial and lateral anchors, in accordance with embodiments of the present invention. 
         FIG. 7  shows a side view of an implant system having medial and lateral anchors, and sutures, in accordance with embodiments of the present invention. 
         FIG. 8  is a top view of an implant system having medial and lateral anchors, in accordance with embodiments of the present invention. 
         FIG. 9  is a perspective view of a distal anchor/barb in accordance with embodiments of the present invention. 
         FIG. 10  is a partial sectional view of the distal anchor/barb of  FIG. 9 . 
         FIG. 11  is a side schematic view of a distal anchor array and suture within a delivery needle device, in accordance with embodiments of the present invention. 
         FIG. 12  is a side view of a distal anchor array and suture deployed from a delivery needle device, in accordance with embodiments of the present invention. 
         FIG. 13  is a perspective view of a distal anchor array and suture within a slotted needle device, in accordance with embodiments of the present invention. 
         FIG. 14  is a side schematic view of a distal anchor array and suture within a slotted needle device, in accordance with embodiments of the present invention. 
         FIG. 15  is a side view of a distal anchor array and suture deployed from a slotted needle device, in accordance with embodiments of the present invention. 
         FIG. 16  is a side view of a distal anchor array and suture at least partially tensioned, in accordance with embodiments of the present invention. 
         FIG. 17  is a perspective view of a distal anchor array and dual suture, in accordance with embodiments of the present invention. 
         FIG. 18  is a perspective view of a distal anchor/barb in accordance with embodiments of the present invention. 
         FIG. 19  is a side view of distal anchor array and suture in a collapsed state, in accordance with embodiments of the present invention. 
         FIG. 20  is a side view of a distal anchor array and suture in an expanded state, in accordance with embodiments of the present invention. 
         FIG. 21  is a side view of a distal anchor array and suture, showing exemplary load and moment data, in accordance with embodiments of the present invention. 
         FIG. 22  is a perspective schematic view of a distal anchor array, with dual barbs, and a suture partially within a needle device, in accordance with embodiments of the present invention. 
         FIG. 23  is a perspective view of a distal anchor, or anchor portion, having dual barbs, in accordance with embodiments of the present invention. 
         FIG. 24  is a side schematic view of a medial anchor and suture within a delivery tube or oversleeve, in accordance with embodiments of the present invention. 
         FIG. 25  is a sectional schematic view of a medial anchor and suture within a delivery tube or oversleeve, in accordance with embodiments of the present invention. 
         FIG. 26  is a side schematic view of a medial anchor and suture, with the medial anchor expanded and deployed from a delivery tube or oversleeve, in accordance with embodiments of the present invention. 
         FIG. 27  is a perspective schematic view of a medial anchor and suture, with the medial anchor expanded and deployed from a delivery tube or oversleeve, in accordance with embodiments of the present invention. 
         FIGS. 28-30  are schematic views of various anatomical structures of the female pelvic region, and an implant system having medial and lateral anchors, and the deployment method, in accordance with embodiments of the present invention. 
         FIGS. 31-38  are schematic views of paraurethral implant systems and methods, with a suture or extension member interwoven or thread through tissue, in accordance with embodiments of the present invention. 
         FIG. 39  is a schematic view of a coil spring device operably connected to one or more of anchors for use in an implant system and method in accordance with embodiments of the present invention. 
         FIG. 40  is a schematic view of tissue engagement devices for a medial anchor, in accordance with embodiments of the present invention. 
         FIGS. 41-42  are schematic views of a dilating medial anchor device in accordance with embodiments of the present invention. 
         FIGS. 43-45  are schematic views of a grasping medial anchor device, and implantation method, in accordance with embodiments of the present invention. 
         FIGS. 46-47  are views of a generally star-shaped medial anchor device, in accordance with embodiments of the present invention. 
         FIGS. 48-54  are schematic views of a suture and cinch device implant, in accordance with embodiments of the present invention. 
         FIG. 55  is a schematic view of various anatomical structures of the female pelvic region, and an implant system having medial anchors, lateral anchors, and crossing extension members, in accordance with embodiments of the present invention. 
         FIG. 56  is a schematic view of an implant system having suture anchors in the perineal membrane, in accordance with embodiments of the present invention. 
         FIG. 57-62  are schematic views of an anchor and needle introduction system for use with embodiments of the present invention. 
         FIGS. 63-67  are partial schematic sectional views of a tissue separation device for use with embodiments of the present invention. 
         FIG. 68  is a schematic view of a suture locking device for use with embodiments of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
       FIG. 1  shows a schematic view of relevant portions of the female pelvic region, and the urinary and reproductive system, including the pelvis PE, vagina V, uterus UT, urethra U, bladder B and the deep clitoral vein C. Further, a portion of the perineal membrane PM is shown at the midurethra/distal location, providing a viable paraurethral target for stabilizing or controlling the position and movement of the urethra to assist in restoring continence. 
     Embodiments of the present invention can include apparatus and methods for treating urinary incontinence, fecal incontinence, and other pelvic defects or dysfunctions, in both males and females using one or more lateral implants to reinforce the supportive tissue of the urethra. One or more implant devices  10  are configured to engage and pull (e.g., pull up) or reposition support tissue (e.g., paraurethral), such as the perineal membrane, uterovaginal fascia, endopelvic fascia, or other anatomical features at which connective support of the urethra can be established. The perineal membrane intersects the urethra and vagina at the midurethra/distal location and can thus be stabilized or controlled in a manner that helps restore continence. As such, the implants  10  can be utilized to eliminate the need for mesh or other supportive structures under the urethra that is common with other incontinence slings. The implants can be shaped to facilitate such support, e.g., provided with anchoring end portions  12 , barbs or other devices of many available shapes, sizes and configurations, and extension members  30 . 
     Various embodiments of the extension members  30  can be constructed of a suture, a thin flat member, braided fibers, braided nano-fibers, an elongate mesh and other various materials and constructs. For those embodiments including braided nano-fibers, the extension member  30  can enhance and draw more collagen-producing cells to the material to promote tissue ingrown and healing. The extension member  30  of certain embodiments of the present invention can be constructed to be generally flexible, or to have limited elasticity—e.g., bungee type attributes. For instance, the member  30  extending between the anchors  14  and anchors  16  can be an elongate member constructed of an elastomeric material having desirable tensile properties. As such, the member  30  can be stretched out for deployment and then released to provide desirable taut tension. The travel or stretching/rebound characteristics of the member  30  can vary depending on the particular elastomeric materials used in its construction. The extension member  30 , such as a suture, can further include various extending tines or barbs to facilitate the tissue traction and grabbing during and after deployment. 
     One or more opposing anchors  14 ,  16  or tissue engagement portions can be employed to attach and stabilize the implants to the tissue, as well as provide selective adjustment. The anchors or engagement portions can be configured to engage soft tissue and can include various barbs, tines, serrated edges, extending fibers, or other similar structural feature to promote tissue fixation. The anchors can be implanted in a direction lateral from the urethra. The anchors can generally be small enough for to be unnoticeable by both the patient and the patient&#39;s sexual partner. The anchors and other devices and components of the system  10  may be constructed from various biocompatible materials, such as known polymers and metals that promote long-term resilience, or other materials known to those skilled in the art. 
     In various embodiments, the one or more implants  10  can be placed in strategically located positions to pull up or otherwise tighten tissue and/or muscle lateral or otherwise intersecting or attached (directly or indirectly) with the urethra to generally stabilize the anatomical structure of the patient. Various systems, devices, structures, techniques and methods, alone or in combination, as disclosed in U.S. Patent Publication Nos. 7,500,945, 7,407,480, 7,351,197, 7,347,812, 7,303,525, 7,025,063, 6,911,003, 6,691,711, 6,648,921, 6,612,977, 6,802,807, 2002/0161382, 2002/0147382, 2002/151762, 2004/0039453, 2008/0057261, 2008/0045782, 2010/0105979, 2011/0144417, and 2011/0201876 and International PCT Publication Nos. WO 2008/057261 and WO 2007/097994, can be employed with the present invention, with the above-identified disclosures being incorporated herein by reference in their entirety. The devices or structures described herein can be employed or introduced into the pelvic region of the patient transvaginally, percutaneously or in any other manner known by those of ordinary skill in the art. 
     Referring generally to  FIGS. 2-6 , various embodiments are shown of the tissue constraining or positioning implant system  10  having one or more attachment points in one or more membranes or other target tissue locations. Embodiments can function to restrict, limit or control movement of the mid or distal urethra, or surrounding tissue. Further, embodiments can assist in resisting forward rotational movement of the urethra or surrounding tissue, and can provide support and tension during events, such as coughing or physical activity. Various advantages of the implant  10  embodiments depicted herein include, frontal access and simpler anatomy to address, less vascularity and bleeding, reduced risk of creating retention and de novo urge, and the ability to test for continence before surgery. Additionally, the implants  10  act to oppose rotational movement of the urethra, thereby eliminating or lessening the effects of stress urinary incontinence. 
     A viable treatment, therefore, will be one that most efficiently opposes rotational movement of the urethra. Urethral rotation still occurs in non-hypermobile patients, just to a lesser extent. The concept of rotational mechanics also suggests that obturator anchored implants should be placed with higher initial tension and be positioned as far distally as possible on the urethra. Applying this principle of rotational resistance gives rise to devices in accordance with the present invention whereby urethral movement is inhibited near the distal urethra, while the bladder neck continues to move. 
     When a midurethral support is implanted in the female patient, the midurethra is restrained from movement. However, the bladder neck remains mobile and moves downward during a stress event due to elevated abdominal pressure. The resultant effect is that the urethra can be kinked at the midurethra location, causing a closure of the urethra. Like kinking a garden hose, the flow of fluid is restricted or prevented. 
     Referring again to  FIGS. 2-8 , the implant system  10  can include one or more anchor devices  12  adapted for use with various embodiments of the present invention, including those adapted to penetrate tissue or soft tissue as disclosed herein. Certain of the devices  12 , e.g., the lateral anchor  16 , can be generally provided in a back-to-back serial configuration, with a suture or like extension member extending to provide adjustable support between the anchor devices  12 . As shown in  FIGS. 7-8 , the anchor devices  12  can include one or more first medial or proximal anchor devices  14 , and one or more second lateral or distal anchor devices  16 . 
     Referring generally to  FIGS. 9-23 , the lateral anchor devices  16  can include a body portion  18 , one or more expandable barbs  20 , a thru-aperture  22 , and an opposing end  24 . A suture  30  or like member is adapted to string or thread through the respective apertures  22  of a series or array  16   n  of such anchors to define the general elongate and expandable configuration shown. The array of anchors  16   n  can be inserted within and along the interior lumen  41  of a needle  40 , cannula or like inserter or delivery tool. 
     In various embodiments, the lateral anchor devices  16  can be directed for engagement with tissue distal the anchors  14  at target sites such as the obturator foramen, obturator internus muscle, sacrospinous ligament, prepubic fascia or muscle, abdominal fascia, rectus fascia, puboprostatic ligament, the tendinous arch of the levator ani, the Cooper&#39;s ligament, and the pubic symphysis. Other distal target tissue sites for the anchors  16  capable of permitting tensioning support for the perineal membrane or other urethra-supporting tissue is envisioned as well. Unlike conventional sling device and implantation methods, the path from the perineal membrane to the distal anchor  16  of the present invention can follow a generally straight line into the obturator internus muscle, or like distal tissue. Furthermore, because it intersects the muscle at an oblique angle, more tissue can be engaged for securement. 
     Referring generally to  FIGS. 11-16 , the needle  40  can include an exit or opening  42  at a needle tip  42   a.  A series of anchors  16 , such as the anchor array  16   n,  can include a lead anchor  16   a  adapted to first exit through the opening  42  upon deployment. In certain embodiments, the suture  30  path is generally undulating while within the needle  40 , and even upon initial departure from the needle  40  ( FIGS. 11 and 13-15 ), while it is generally brought into a straight or taut state upon full deployment from the needle  40  ( FIGS. 7, 12 and 16 ). The end portion  24  of the lead anchor  16   a  can be permanently attached to the end of the suture  30  via bonding, adhesive, welding, knotting, or the like. The anchor  16  or its respective components can be molded together or otherwise attached to create the construct depicted and disclosed. 
     Each successive anchor  16 , e.g., after lead anchor  16   a,  is alternately arranged such that they can be closely aligned along or within the lumen  41  of the delivery needle  40 . The suture  30  passes through these anchors  16 , and the anchors  16  can be adapted to slide on the suture  30 . Again, when the anchor array  16   n  is inside the needle  40 , the suture  30  can follow a serpentine or otherwise undulating path. A pusher rod  43 , or like mechanism or device may be biased or pushed against the proximate anchor  16   b  (e.g., opposite end from the lead anchor  16   a ), as illustrated in  FIGS. 14-15 , such that the array of anchors  16   n  pushes against the distal end, or lead anchor  16   a,  that is fixed to the suture  30 . This can help maintain the close alignment of the anchors  16  while inside the lumen  41  of the needle  40  and thus facilitate deployment. 
     When the delivery needle  40  is at the intended anchor position or target tissue, the array  16   n  can be deployed in various ways. In one method, the pusher  43  simply forces the anchors  16   n  out of the lumen of the needle  40 . Some suture  30  tension can be maintained so that the anchors  16   n  are efficiently driven out in a straight line or path. In another method, the position of the anchors  16   n  relative to the tissue remains fixed or stationary (e.g., with the aid of the pusher  43 ) while the needle  40  is retracted back or away (e.g., slid) from the array  16   n  such that the anchors  16  are deployed from the lumen  41 . With either approach, after the array of anchors  16   n  is completely outside the needle  40 , tension can be applied against or upon the suture  30 . This forces the individual anchors  16  to slide together and tilt outward at an angle relative to the suture while they embed into the tissue, creating firm engagement. The tilt angle, relative to a straightened suture, ensures engagement into tissue and is preferably 25 to 45 degrees. The pusher rod or member  43  can be a wire or tube that fits inside and through the proximal end of the needle  40 , through the lumen  41 , and acts against at least one of the anchors, directly or indirectly, including the most proximal anchor. 
     Other embodiments of the anchor  16 , as shown in  FIGS. 18-20 , can include an extended thru-aperture  22 , generally along the length of the body  18  of the anchor  15 , that allows the suture  30  to pass in a generally straight line through the array  16   n  while in the lumen  41  of the needle  40 , and bend or reform into a general serpentine or undulating shape after the anchors  16  have been deployed and the barbs  20  expand outward for tissue engagement. This approach can have the advantage of utilizing the suture  30  tension to resist the rotation of the barbs  20  working against tissue. 
     Referring generally to  FIG. 21 , and various embodiments, when the barbs  20  are engaged within the target tissue site, they can be subjected to a moment load M. This moment is opposed by the suture line tension moment which is proportional to T*L, where T is the tension and L is the moment arm. This moment arm increases as the angle θ of the serpentine or undulation increases. Thus, such a configuration during initial application of tension is better able to work in the tissue than one in which the suture is in a straight line (θ=0) after anchor deployment. By controlling the serpentine angle in the barb design, the effectiveness of the anchor array  16   n  may be optimized. The bending stiffness of the suture  30  will also affect the rotational resistance, and a solid suture  30  will have more bend stiffness than a braided one of similar material. 
     Another embodiment of the anchors  16  and anchor array  16   n  configuration is provided in  FIGS. 22-23 . A dual-tipped/barbed anchor  60  is included that flexes about a hinge  62  at the base  18 . Again, the anchors  60  are provided in an array  60   n  with a lead anchor  60   a.  The array of barbs  16   n  are spaced apart along the suture  30  while inside the lumen  41  of the needle  40 , and condense or compress together as they are pushed out of the needle  40 , or the needle  40  is removed, and put under tension. The two barbs  20  of each anchor  60  are forced further open by the body portion  18  of the adjacent abutting anchor  60 . For instance, the body portion  18  of the preceding anchor  60  can slide into the gap between the two barbs  20  of the next leading anchor  60  to cause those barbs  20  to flare out or expand, as shown in  FIG. 20 . This configuration may be more compact than the single barb designed anchor  16  and also may not depend as much on the suture  30  tension to oppose the load on the tips. Namely, the tissue fixation may better resist backing out of the tissue target site compared to various other embodiments for cases where an increased degree of fixation is required or desired. 
     In certain embodiments, the anchors  16 , or anchors  60 , can be fabricated using a metal injection molding process, or from a molded resin material (e.g., 720FC resin, polycarbonate, PEEK, nylon), with an exemplary Prolene monofilament, or braided, suture  30  threaded therethrough. The components can be easily inserted through the lumen  41  of the needle  40  and arranged in an alternating pattern—e.g., angular orientation pattern—along the suture  30 . For instance, the alternating angular pattern of the anchors  16  in  FIG. 7  is approximately 180 degrees, whereas the alternating angular pattern of the anchors  60  in  FIG. 22  is approximately 90 degrees. Of course, a myriad of alternate angular patterns and orientations are envisioned for embodiments of the invention depending on the particular deployment, anchoring and engagement needs. The suture  30  can be lightly tensioned to bring all the anchors  16  in the array  16   n  together while holding the pusher  43  in place. Again, while holding the pusher  43  stationary, the needle or cannula  40  can be retracted, leaving the array  16   n,  or  60   n,  and the respective anchor barbs  20  embedded in tissue. A slight tug of the suture  30  can bring the anchors together and take up any initial slack in the suture line  30 . 
     As shown in  FIGS. 7-8 , embodiments of the tissue anchoring devices and methods can include a reduced trauma explantation (e.g., removal from tissue) configuration and mechanism for the barbed soft tissue anchors, e.g., the anchors  16 , described and depicted herein. For instance, one solution is to attach an explantation tether  50  to the leading anchor  16   a  of the array  16   n.  This could be in the form of a suture, or continuation of the existing traction suture  30  that leads back out of the implantation path. To remove the anchor  16 , or anchor array  16   n,  the physician simply pulls on this tether  50 , causing the anchor  16  to double-back on itself and pull out atraumatically—e.g., through the defined tissue path or tissue penetration site. This could be done during the initial implantation procedure or at a later time in the event that the device  16 , or implant  10 , must be disengaged or removed. 
     The average normal pullout force of an engaged anchor  16  or anchor array  16   n  can be approximately 4 to 7 lbs with various embodiments, while the explantation force of the embodiments having the explantation tether  50  can be around 1 to 3 lbs. By leaving a segment of loose tether  50  attached to the leading anchor  16   a,  the physician can pull out the entire assembly by tugging on it. Pulling up on the explant suture or tether  50  causes the anchors to double-back on themselves and continue out of the tissue in the non-resistant direction, lead by anchor  16   a.  This reduces the removal force and associated tissue trauma. This type of explant method can be used with any implanted device that has an anchoring end that is generally flexible or segmented enough (e.g., series of separate anchors  16  strung along the member  30  of the anchor array  16   n ) to allow doubling-back. The implant can be designed such that the free end of the explant tether  50 , generally opposite the end attached to or proximate the lead anchor  16   a,  can be accessed by a physician. This could be done by leaving the suture  50  end hanging out of the implantation puncture. The free end can be later trimmed or removed when explantation is no longer needed. In various embodiments, the tether  50  can be constructed of an absorbable material. Alternatively, a tag or loop can be included at the free end of the tether  50 . This tag or loop can remain just below the skin surface and can be accessed later if the implant  10  or device  16  require explantation. 
     The anchor array  16   n  is thread or otherwise provided along the suture  30 , or paired sutures  30  (e.g.,  FIG. 17 ), and can be delivered via a percutaneous passage inside a hypotube or the needle  40 . This allows for controlled delivery of the anchor array  16   n  such that the needle tip  42   a  can be selectively repositioned before the anchors are set in soft tissue. 
     Referring generally to  FIGS. 13-16 , embodiments of the needle system  40  can include a slotted needle configuration, with the needle  40  including a slot or groove  64  along a distal or end portion of the needle  40  body such that a portion of the suture  30  can pass outside the lumen  41  of the needle  40  during deployment. The slot  64  can be created in or along a portion of the needle  40  by milling, laser cutting, EDM machining, or using other similar fabrication, manufacturing or formation methods. For needles  40  requiring some curvature to facilitate use and deployment, the slot machining may be done before or after the bending operation for the needle  40 . With a curved needle  40 , the slot  64  can be on the outer side of the bend. This, in turn, can promote keeping the portion of the suture  30  that lies in the slot  64  to stay inside the lumen  41  when under tension. 
     As described, a pair of sutures  30 , e.g.,  FIG. 17 , can pass through each anchor  16  in the array  16   n,  and follow a serpentine or undulating path within the needle  40 . A knot, bead, stop, member or like structure  31  at the distal end of the suture  30  proximate or in front of the leading anchor  16   a  can act as a stop for the lead anchor  16   a.  A second knot, bead, stop, member or like structure  31   a,  can be included at a portion of the suture  30 , or paired suture, near the most proximal anchor  16   b,  and/or outside the slot  64  (e.g.,  FIGS. 13-14 ). 
     Embodiments employing a paired suture  30  configuration can include members, structures or other constructs, including the apertures  22  of the anchors  16 , having a generally rectangular or oval shape such that the pair can be passed through to hold them side-by-side. By doing this, the barbs  20  are less able to rotate on the axis of the suture line  30  and will stay properly oriented. By creating anchors  16  that have different through hole angles or shapes it is also possible to fix the angular position of the anchors  16   n  to create a larger anchor spread. 
     Again, a pusher  43  can be positioned behind, or abut against, the proximal anchor  16   b  that acts as a stop (prevent backing out of array  16   n  within needle lumen  41 ) during the needle insertion and deployment process. The pusher  43  can also serve to maintain the anchors  16  and respective barbs  20  barbs in a fixed position, relative to the tissue, as the needle  40  is retracted or pulled away from the array  16   n.  The slot  64  can be sized to allow the suture  30  to freely pass through, but does not allow the anchors  16  or respective barbs  20  out through that portion of the needle  40 . The length of the slot  64  can assume many size configurations, depending on the size of the anchors  16  in the array  16   n  and the number of serially aligned anchors  16  in the array  16   n . However, the slot  64  could also extend along the entire length of the entire needle  40  in certain embodiments, or take on various other size and shape configurations depending on particular device and application needs. Moreover, the slot  64  length can be defined by the anticipated length of depth of the tissue targeted for penetration. 
     Further, embodiments of the needle  40  including the slot  64  configuration can facilitate easier and more efficient use of a medial anchor  14 . The medial anchor  14  is attached to, or threaded or provided along a portion of the suture  30  that does not need to be constrained or fit within the relatively thin and small needle  40  or lumen  41 . As such, the slot  64  provides a length of suture  30  that can ride outside of the lumen  41 , with the medial anchor  14  attached or provided along that external length of suture  30 . This provides greater flexibility for the design and construct of the medial anchor  12  and the respective delivery method. In addition, the pusher  43  will not interfere (e.g., traverse alongside) with the proximal length of the suture  30  provided before the anchor array  16 , as the proximal portion of the needle lumen  41  will be free of the suture  30 . Also, there can be a reduced tendency for the anchors  16  to wedge together and jam if subjected to excessive push forces because the slot  64  provides more room for movement and spreading compared to non-slotted embodiments of the needle  40  where everything within the lumen  41  is confined to the lumen walls. Still further, the slot  64  keeps the exiting suture  30  portion from unwanted turning and twisting, thereby assisting in keeping the attached anchors  16  also fixed in a preferred angular orientation within the needle  40 . 
     The proximal stop  31   a  can also be used to keep the anchor barbs  20  from spreading apart during assembly and during the deployment of the anchors  16   n.  With the slotted needle  40 , the knot, bead or stop  31   a  can be positioned either inside or outside the lumen  41 . One advantage for positioning the stop  31   a  outside is that it can introduce enough drag to enable retraction of the needle  40  while still keeping the anchors  16  in place. In certain embodiments, this can preclude the need for an internal pusher  43  to hold the anchors  16  in place upon deployment. The stop  31   a  could take on nearly any size or shape, and material. Also, the anchor system can include intermediate knots, beads or stops  31  that separate smaller or distinct groupings of anchors  16 . For example, a stop  31  between a fourth and fifth anchor  16  can result in two groups of four barbs forming on the suture line  30 . Such a grouping configuration can assist in redistributing the tension on the suture line  30  in stages or segments, as well as to reduce the amount of pulling that is required to initially set the anchors  16  in tissue. It can also improve the overall tissue anchoring force and stability. 
     Embodiments of the lateral anchors  16  can include self-expanding structures or materials such that the anchors  16 , or anchor array  16   n,  can be generally collapsed or reduced in sized during deployment, with or without a needle device  40 , and expanded after penetration in the target tissue site to provide desired tissue engagement. Certain anchors  16  can include one or more shape memory portions, or living hinges, to facilitate this structural self-expansion upon deployment and tissue engagement. Further, embodiments of the lateral anchor  16 , or anchor array  16   n,  can include helical portions, threaded portions, hooks, clips, flexible barbs, textured surfaces, and like members or structures to promote tissue engagement. In addition, still other embodiments of the lateral anchor  16  can be adapted to include a plurality of anchors, extending from one or more separate members  30 , spread out into multiple anchoring features for deployment into tissue to provide support and treatment. Such a spanning multi-anchor device  16  can create a neo-ligament to reduce or eliminate rotation of the urethra U or surrounding tissue through the use of multiple anchoring spots. 
     As shown in  FIGS. 24-27 , the medial anchors  14  can include metal or like members or tubing, such as nitinol, stainless steel, titanium, or polymer, laser cut or formed into longitudinal petals  44  that are capable of selectively collapsing and expanding in a flex leaf construct. The cutting may be done such that any number of petals is formed. Exemplary embodiments can include two, three or four petal constructs. 
     In certain embodiments, the formation and configuration of the petals  44  can be accomplished using a heat-treatment process where the petals  44  are set in the opened state. In other words, ends  45  of the petals  44 , which are a distance from a hinge  48 , are radially expanded and set in that position. Alternatively, due to the elasticity or hingability of the material, these petals  44  can be temporarily closed, facilitating the insertion of the anchor  14  into a small puncture, such as within the tissue of the perineal membrane PM. Once positioned, the anchor  14  can self-expand, e.g., via shape memory, to the opened state to provide tissue engagement and fixation. 
     Various embodiments of the medial anchors  14  can include slots  49  (e.g., laser cut) in the petals  44  to develop the bend or living hinges, as shown in  FIGS. 26-27 . These slots  49  can be very narrow (e.g., approximately 0.001″-0.003″ wide) and allow a limited degree of localized bending along a portion of the corresponding petal  44 . As a result, the petals  44  can easily flex to the opened state, but can require a greater load to move beyond that point where the slots  49  have closed together. Thus, the petal  44  is less likely to overbend or flip out of position. Another advantage is that this embodiment can be easily adapted to a variety of flexibility configurations depending on the desired attributes. For example the number, sizing, and spacing of the slots  49  can be varied to adjust the amount of allowable bending and the load required to achieve that bend. As with the previously described embodiments, the component or petal  44  can be heat-set to the opened position so that it self-expands from a closed position. 
     Embodiments of the medial anchor  14  can include a body portion  47  and one or more apertures therethrough to receive or connect with the suture  30 . Further, a medial needle device or oversleeve  59  can be included with embodiments of the invention to facilitate introduction and deployment of the medial anchor  14 .  FIGS. 24-25  show the anchor  14  in a contracted state within the lumen of the needle  59  during deployment, with  FIGS. 26-27  showing the anchor  14  expanding when pushed, pulled or otherwise removed from the inner constraints of the needle  59 . Exemplary anchors  14  can include substances, such as an adhesive (e.g., light activated adhesive) to assist in the tissue engagement process. 
       FIGS. 28-30  depicts a medial anchor  14  at the perineal membrane PM implanted via a transverse insertion through the anterior vaginal wall, between the perineal membrane PM and the superficial skin lateral to the urethral meatus, according to an embodiment of the implant  10 . While the anchor  14  is held in this position, a needle  40  pass is made from the lateral side of the meatus that intercepts the medial anchor  14  and passes through a pre-made hole or punctures the anchor  14 . The needle  40  pass continues on to the obturator muscle, or other distal tissue, where the lateral anchor  16 , or anchor array  16   n,  is delivered. The medial anchor  14  can be placed in the superficial space between the perineal membrane PM and the distal skin layer at the meatus. The small medial anchor  14  can be held with a custom holder or forceps until the intersecting needle  40  pass. 
     Referring generally to  FIGS. 29-30 , while the anchor  14  is held, the needle  40  passes through the hole in the anchor  14  and after the distal anchor  16  is deployed and the needle  40  has been retracted, there will be a trailing suture  30  that can include a one-way slider  90 , or like sliding or locking device, on it. The slider  90  can be pushed along the suture  30 , mating with the anchor  14 . Tension is increased by pushing the slider  90  farther along the suture, thereby pressing tighter against the anchor  14 , and/or the surrounding tissue. An advantage to this approach is that the placement of the medial anchor  14  at the perineal membrane can be greatly controlled, and can be deployed with minimal disruption to the surrounding tissue. In contrast, an anchor  14  that is passed through a skin puncture lateral to the meatus may need to be turned such that its major axis is parallel to the puncture hole, then rotated or expanded to face the perineal membrane. The medial anchor  10  for this transvaginal method generally would not have the same size or orientation limits and could therefore be substantially larger and better able to resist pull-through failure. 
     Furthermore, the medial anchor  14  position could in fact be in the anterior wall of the vagina V for any of the disclosed treatment and anchoring embodiments. Unlike the previous attempts that focused on the anterior vagina, the traction force vector will be more parallel to the vaginal wall with the disclosed embodiments of the present invention so that an optimal rotational resistance of the urethra U can be achieved. 
     The anchor  14  can be implanted via a puncture at the skin surface, but the introducer needle  40  can still be passed within the thickness of the vaginal wall as described. The anchor  14  can be constructed of a flexible material to reduce the sensation or recognition of the anchor  14  to the patient or the patient&#39;s sexual partner. Furthermore, while the anchor  14  is under tension it can bend such that the line of force is generally more parallel to the suture (e.g., reducing the “cheese-cutter” effect). Alternatively, the two ends of the medial anchor  14  can be relatively rigid but flexible in a middle body portion, such that the urethral kinking effect is enhanced when there is tension (e.g., if the flex is near the perineal membrane). 
     The support or extension members  30  can apply mechanical traction to the urethra in a manner similar to a mini-sling device. However, a benefit of embodiments of the present invention is that the transvaginal placement of the structures and devices does not leave exposed material (e.g., implant mesh) inside the vaginal cavity. For example, the implanted device  10  position is generally blind and lies beyond the superficial mucosal layer of the vaginal wall. Reducing or eliminating the exposed material minimizes the risk of infection, irritation at the surface of the vaginal wall, and provides cosmetic improvement and reduces interference with sexual activity. 
     As shown in  FIGS. 31-38 , various embodiments of the implant system  10  can include anchoring elements or portion that is fixed on each side of the urethra, e.g., on the far side of a tissue layer that is known to have relatively high strength and toughness. The medial or proximal anchor  14  can include a “toggle” anchor, which is a small, elongated structure that can be placed through a small puncture or like incision and then rotates after deployment so that it cannot back out through the incision hole. Other anchoring devices and methods can be employed in accordance to exemplary embodiments. 
     As shown with various embodiments, the suture  30  can weave or thread in and out of, and along, the tissue, e.g., the perineal membrane, to provide a supportive undulating layout for the suture  30  and anchor  14  combination. This can facilitate attachment, better distribute pulling force on or along the tissue, and provide like support benefits. For instance, one or more sutures  30  can be woven or interwoven (e.g., in and out) of the perineal membrane, with anchors  14  engaging at or proximate the posterior symphysis. When tightened, the suture  30  pulls and compresses tissue toward the posterior symphysis to provide support and strength. Again, a suture lock device or technique can be included to fix the tension or support adjustment of the sutures  30 . 
     Placing the anchor device  14  on the far side of the fascia is advantageous because it is less likely to be palpable than one placed in the mucosal and muscle layer—also because it is placed in an area of loose connective tissue in which the toggle anchor  14  can easily rotate into a locking orientation. 
     The distal or anchor device  16  is placed in a lateral or superior position such that a connection (e.g., suture  30  or wire connection) between the medial and lateral anchors  14 ,  16  can provide tensile support for the urethra during stress events. The anchor device  16  can be fixated to, or engaged with, the obturator membrane, obturator internus, tendinous arch of the levator ani (white line), the Cooper&#39;s ligament, sacrospinous ligament, prepubic fascia or muscle, the pubic symphysis cartilage, abdominal fascia, or other stable anatomical features. 
     The final position of the implanted device  10  creates a support structure that is similar to a needle suspension. The medial anchor  14  can spread or better distribute the tension load over a larger surface (as opposed to a thin suture cutting edge surface) than other procedures and devices. This, in turn, promotes stability of the anchor and connecting suture or spanning support member. 
     Various procedural steps or methods can be employed to deploy the implant  10  of the present invention. In one embodiment, as demonstrated with  FIGS. 31-35 , the medial toggle anchor  14  is implanted, a needle  70  is withdrawn, a free suture or connector end is delivered through the insertion opening, the lateral (e.g., obturator) anchor  16  is delivered and implanted, and the connecting suture  30  is properly tensioned between the anchors  14 ,  16  to provide proper support. 
     The needle  70  can be adapted to contain the toggle anchor  14  with a tip  70   a  directed for penetration through the perineal membrane or like paraurethral support tissue. In other embodiments, the toggle anchor  14  can include a sharp or beveled tip to facilitate penetrating through the target tissue. The needle  70  is then withdrawn with the suture  30  extending therefrom and a distal anchor  16  attached or provided at the opposing free end of the suture  30 . The anchor  16  can be small enough to pass through the small punctures in the tissue and deploy at the obturator foramen or like tissue targets. Various delivery tools and devices disclosed herein, or known, can be used to direct and deploy the anchor  16 . Upon implantation of the anchor  16 , the suture  30  can be tensioned to provide the desired level of support for the paraurethral tissue ( FIG. 35 ). In addition, the medial anchor  14  can include a one-way tension holding feature (e.g., zip tie-like) that allows the physician to pull out excess suture material without the excess slipping back through the anchor  14 . 
       FIGS. 36-38  show another embodiment of the implant  10  having a toggle anchor configuration. A suture needle  72  can be utilized to create a loop or “bite”  71  through the paraurethral tissue to provide additional stability and anchoring support. The suture needle  72  can be included with the suture  30 , and can be removable with certain embodiments. 
     In various embodiments, the suture  30  can be woven in and out of multiple portions of the perineal membrane or like tissue, with or without a medial anchor  14 , such that pulling on the suture  30  can compress or cinch up the tissue. One or more suture locking devices  77 , e.g., diametric suture lock of  FIG. 68 , can be inserted through a portion (e.g., free end) of the suture  30  to selectively lock the suture in place after the desired tension is obtained. In certain embodiments, the suture locking devices  77  can include a one-way locking mechanism constructed of a generally cylindrical body having one or more cuts  77   a  (e.g., laser cut) defined in a surface or portion of the device  77  to define inward extending tines  77   b.  The tines  77   b  can permit the suture  30  to ride or slide within the device  77  in a direction not against the direction of the tine  77   b  angles. However, backing out of the suture  30  will be prevented in the opposite direction when the tines  77   b  grab onto the suture (e.g., braided suture) and restrict movement in that direction. Other suture locking devices are envisioned for use with various embodiment of the present invention as well. 
     As illustrated in  FIG. 39 , embodiments of the present invention can include a coil spring device  76  operably connected to one or more of the anchors  14 ,  16 . The device  76  can be held in a slightly extended state that generates a preload tension. The device  76  can include a spring mechanism  78 , which is connected at either end to the suture  30  and is forced open with stops  80  that impose a fixed extension against a rigid structure or housing  82 . Thus the spring  78  may extend, but only after the suture tension exceeds the preload force. Alternatively, a conventional coil extension spring can be employed such that when the spring relaxes to its solid height, some pretensioning load is maintained—e.g., it is unable to further contract due to the coils being in full contact. Other methods for mechanically creating initial tension and load control are envisioned as well. 
     In certain circumstances, it may be desirous to provide pre-loaded tension options for one or more of the anchors  14 ,  16 . Preloading can be achieved by pretensioning the suture during the implantation procedure or could be achieved by creating mechanical pretension internally in the anchor devices  14 ,  16 , or mechanisms operably connected to the devices  14 ,  16 . As such, a constant rest load against tissue (which might stretch) can be provided. 
     As shown in  FIG. 40 , embodiments of can include one or more generally C-shaped, or like shaped, medial anchors  14 . The anchors  14  can be placed adjacent the urethra U to provide a medial anchor configuration. The sutures  30  can extend from the anchors  14  to one or more distal anchors  16 . 
     Certain embodiments of the anchors  14 , or  16 , can include space-expanding characteristics or attributes. A expandable portion anchors  14 ,  16  can be constructed of shape memory materials (e.g., polymers or metals) adapted to collapse under a bias within a delivery tool or under other pressure, with the anchors  14 ,  16  expandable upon deployment to provide traction-like fixation or connectivity to tissue. 
       FIGS. 41-42  show an embodiment of the medial anchor device  14  having an anchor base portion  14   a  and a dilating anchor portion  14   b.  The dilating anchor portion  14   b  is adapted for deployment to rest or otherwise stop or abut against a portion of the perineal membrane PM, or other like tissue. The suture or other extension member  30  can extend between the two anchors  14 ,  16 . In a rest state ( FIG. 41 ), the dilating anchor portion  14   b  is not generally applying pressure to the urethra U. However, during a straining event or state, the dilating anchor portion  14   b  expands (e.g., expands under compression) to apply a level of pressure on the urethra U to promote continence, as depicted in  FIG. 42 . 
       FIGS. 43-45  are directed to a medial anchor device adapted to puncture through the skin and into the perineal membrane PM or like tissue. Such a superficial skin puncture can be targeted at the crease between the labia minora and majus, directed at the space between the bulb of vestibule and clitoral crus, in certain embodiments. A tube or delivery needle  84  can include or contain a pair of anchoring or stop members  86   a,    86   b  and at least a portion of the member  30 . The needle  84  operably connects or carries the stop members  86   a,    86   b  and extends beyond them. Upon insertion into the perineal membrane, as shown in  44 , the delivery needle  84  can be removed, leaving behind the stop members  86   a,    86   b  and the member  30 , such as a suture, with a stop member on each side of the perineal membrane PM. The members  86   a,    86   b  can then be drawn to compress or otherwise secure the stop members on each side of the membrane, as shown in  FIG. 45 . A knot or other device  87  or technique can be created or provided along a portion of the member  30 , e.g., on each side of the stop members  86   a,    86   b,  to secure the members in place. As an alternative to a knot, a clip, tie, washer, lock mechanism or other devices and techniques can be employed to secure the stop members  86   a,    86   b  in place against the perineal membrane. Once implanted and adjusted, the device can provide tension and a twisting motion on the membrane, thereby translating to rotational torque. Again, the free end of the extension member  30  can include one or more lateral anchor devices  16  as disclosed herein. 
       FIGS. 46-47  show a medial anchor device  14  having a generally star-shaped construct. The device  14  is collapsible and expandable to facilitate introduction and deployment. The anchor  14  can be constructed of a shape memory material such that it can be implanted in a collapsed state ( FIG. 47 ) and expands once through the tissue to provide desired engagement ( FIG. 46 ). Various metal or polymer materials can be used to construct such an anchor  14  to adjust tensioning and tissue positioning at the perineal membrane to promote continence. Other selective expansion anchor devices can be employed as well, including anchors constructed of an expandable balloon or bladder-like material, adapted to expand within a tissue or compartment. Other anchors can include threading or drill-like configurations for engaging and anchoring into tissue such as the perineal membrane PM. Twisting or rotating motion of the anchor at the target tissue site (e.g., electric, mechanical or manual), can facilitate penetration and affixation of the anchors with the perineal membrane PM. 
     Certain embodiments of the medial anchor  14  can include structures adapted to attach to or span across a portion of the perineal membrane, or like tissue, to facilitate engagement, compression or anchoring with the tissue. For instance, a plate, mesh material, tissue cinching device, stent-like device, ring, clip, coil, spring, strap, pad, patches, or similar structures, can be affixed to, directly or indirectly, the perineal membrane, with such anchors  14  then being connected to the lateral anchor  16  via the extension member  30 . These structures can be attached to tissue via sutures, anchors, and similar tissue engagement devices. The anchors  14  and related structures can include rigid, semi-rigid or flexible polymer or metal materials. 
     One-way locking devices can be incorporated with any of the anchors  14 ,  16 , or along (e.g., thread along) the member  30  such that the physician can adjust the tensioning of the implant  10  to the desired level and fix the tension for optimal support and the promotion of continence. 
     In use, a patient could be placed in a lithotomy position for the implantation procedure. A physician may make one or more incisions through the perineal tissue lateral to the urethra of the patient. Alternatively, the physician may make one or more vaginal incisions to access the tissue superior to the urethra. The physician may use the needle delivery device  40  to implant the devices or anchors. The medial or proximal anchor  14  can then be implanted through the perineal incision, thereby reducing the invasiveness of the procedure. The delivery device  40  may be configured to allow insertion through a single or multiple perineal or transvaginal incisions. In other embodiments of the implant treatment procedure, needle  40  can be directed “outside-in,” from the skin through the obturator membrane, then with an anchor  14  engaged with the perineal membrane. Further, the anchor  14  can include suture loops. The loops can be tied from the peritoneum side. From the obturator side, the multiple loops or sutures  30  can then be tied around the anchor for fixation. 
     In other embodiments, the distal anchor  16  is a wrap-around device adapted to go around the inferior ramus. This, in turn, can reduce or eliminate the chance of pull-out from soft tissue. Sutures, clips, clamps, loops and like devices can be employed to facilitate and affix the wrap-around configuration. Certain embodiments can use distal anchors, such as anchors  16 , to attach to the retropubic space of the patient as well, with the attached suture  30  again extending to the medial anchor  14  at the perineal membrane. 
     The implant  10 , or corresponding anchors, can benefit from a wound healing response that restores or even improves tissue strength. However, such healing and tissue reinforcement can take several weeks. As such, one solution to this problem is to implant the anchor  14  or graft several weeks prior to implantation of the tensioning sutures and anchors  16 ,  16   n.  The anchor  14  can be embedded or engaged at the perineal membrane with a minor procedure and allowed to fully heal and integrate with the surrounding tissue for a period of days or weeks. Because there is no active loading on the anchor  14  during this period, the patient can maintain full physical activity levels during this healing process. Then, in a follow-up visit, a minimal procedure is conducted to attach this fully anchored element  14  to the distal anchor  16 , or array  16   n,  via the tensioning suture  30 . 
     In certain embodiments, it may be beneficial to modify the target anchor zone or site (e.g., perineal membrane) through the use of injectables such as a scarring agent, proteins, polymers, or other materials that significantly increase tissue strength in the region. After allowing this treatment to set up, the continence implant  10  can be implanted in a follow-up procedure. 
     Alternatively, the full implant  10  can be implanted but left in a loosened state with the free end of the suture  30  left hanging or free. After several weeks, the implant  10  can be tightened by pulling the suture  30  (or by adjusting a locking or securement device) further out and then trimming it off. 
     Below the perineal membrane is the superficial perineal pouch (SPP), which is large enough to accommodate various implants or anchors  14  for embodiments of the present invention. The SPP is the compartment of the perineum that lies between the perineal membrane and the perineal fascia (Colles fascia). The anterior SPP can be dissected from the frontal side in order to expose the tissue in this space. This area generally consists of layers of connective tissue and fascia, and some thin muscle. The tissue in this region is easily penetrated or compressed with a blunt needle, until reaching the perineal membrane. Thus, there can be ample room and favorable tissue properties in this region to accommodate the implant  10  or anchoring devices. 
       FIGS. 48-54  depict implants  10  adapted for fixation with the perineal membrane to provide adjustment (such as lift), to thereby provide support and adjustment of the patient&#39;s urethra U.  FIGS. 50-51  show an embodiment having two perineal membrane PM piercing or penetration points, with the implant including a small cinch ring  100  adapted to pull on the members  30  (such as suture, strand, mesh, etc.) to provide the desired adjustment—e.g., along a suture loop. Lateral anchors  16  can be adapted to penetrate through the perineal membrane PM for fixation and securement distal the paraurethral tissue. The cinch ring  100  can slide up to the desired position along the members  30  to provide selective adjustment and tensioning, as shown in  51 . The ring  100  can include a stop button or collar having a one-way draw string or device to provide securement as well.  FIGS. 52-53  show an embodiment of the implant adapted for a single perineal membrane piercing or penetration. Further,  FIG. 54  depicts a curved profile for the ring  100  to distribute pressure from the implant  10 . 
     As shown in  FIG. 55 , embodiments of the implant system  10  can include members, such as sutures  30 , adapted to cross over each other, with distal end anchors  16  fixated in tissue away from the perineal membrane PM. This, in turn, can coapt or compress the urethra while providing tension and desirable support characteristics, while reducing undesirable rotation. Medial anchors  14 , such as patches or like anchor structures, can press against, affix or engage the perineal membrane to provide a larger anchoring area. 
     Certain embodiments, like that shown in  FIG. 56 , can engage and anchor to the perineal membrane with only sutures  30 . Namely, a length of suture  30  is pushed through the tissue (e.g., one on each side of the urethra U in the perineal membrane PM) with an end anchored in the disclosed distal anchor target tissue via anchor  16  (e.g., obturator or like target locations) and another end anchor  102  anchored in other tissue, such as the rectus fascia or like tissue. 
       FIGS. 57-62  are directed various embodiments of anchor introduction system  110  for use with embodiments disclosed herein.  FIGS. 57-58  show problems with tissue deflection that can occur when the needle  40  punctures the skin, for those embodiments employing percutaneous anchor or implant deployment, as the needle  40  approaches the perineal membrane PM, next to the urethra U. The needle  40  can be undesirably diverted laterally before puncturing the perineal membrane PM. Embodiments of the system  110  are therefore provided to limit the movement of tissue being punctured or traversed by a needle deployment device  40  to ensure that a proper and desirable puncture depth is achieved. 
     The system  110  can include the needle  112  having a helical or corkscrew-like end member  114 . Upon insertion of the member  114  through the skin and toward the perineal membrane PM, the needle path is controlled such that it does not divert laterally. The coil member  114  will engage the perineal membrane PM ( FIG. 61 ) and provide an operative path for the needle device  40  to enter through the skin and through the membrane PM ( FIG. 62 ). In certain embodiments, the member  114  can be constructed of a bioabsorbable material, such as a bioabsorbable polymer, and left behind in the patient. As such, the member  114  can serve as a temporary support for an anchor device  14  inserted via the needle. 
     As shown in  FIGS. 63-67 , a tissue separation device  120  can be constructed as a rigid or elastic part that includes a vacuum chamber  122  into which tissue can be drawn, one or more vacuum ports  124  connected to an external vacuum source, and an aperture  126  through which an introduction or delivery device  40  can pass. 
     The device  120  can be particularly useful in creating appropriate needle pathways for minimally invasive (percutaneous) insertion of implants or anchors. The traction provided by the vacuum also serves to hold the tissue stationary so that minimal “tenting” or displacement of the tissue occurs during the needle penetration. 
     The tissue separation device  120  includes features specifically directed to creating separation of tissue layers. The aperture  126  can be surrounded by a perimeter configuration that is angled down and adapted to contact tissue to form an interior vacuum seal. The perimeter can be constructed of a rigid or elastic material that is suitable for forming a good seal against tissue, such as the perineal membrane or the vaginal mucosal layer. 
     As shown in  FIG. 64 , the interior geometry of the device  120  is sized and shaped such that only the thin tissue layer is drawn into the cup space. The tissue wall is drawn in because it is more elastic and is thin enough to fold into the space. For vaginal wall traction, the underlying muscularis is too thick and stiff to fit into the space. As such, a separation of the tissue layers is created. 
     A first anchor (e.g., toggle)  14  of an implant device  10 , as shown in  FIGS. 65-66 , can be introduced through the aperture  126  that penetrates through the mucosal or other tissue layers, leaving the anchor  14  deployed on the opposite side of the tissue. After the first anchor  14  of the implant is deposited or fixated, the needle  40  can be partially withdrawn into the dissected space and redirected toward the distal or lateral anchor target (e.g., via anchor  16 , or anchor array  16   n ). 
     For those embodiments including one or more needles  40  to introduce and deploy anchors for tissue engagement, a trocar slidably housed within the needle to control and facilitate tissue traversal and piercing or penetration at the target site. 
     The systems, devices, configurations and methods disclosed herein have generally described anchors that are symmetrically, bilaterally, positioned about the urethra. However, a single side deployment configuration can still achieve continence and is available with various embodiments. For instance, a single medial anchor  14  and lateral anchor  16 , or lateral anchor array  16   n,  can be connected by a suture  30  to support and adjust the perineal membrane, above, below, or on a side of the urethra. 
     The systems, their various components, structures, features, materials and methods of the present invention may have a number of suitable configurations as shown above. Various methods and tools for introducing, deploying, anchoring and manipulating implants or to treat incontinence and prolapse as disclosed in the previously-incorporated references are envisioned for use with the present invention as well. 
     A variety of materials may be used to form portions or components of the implants and devices, including Nitinol, polymers, elastomers, porous mesh, thermoplastic elastomers, metals, ceramics, springs, wires, plastic tubing, and the like. The systems, components and methods may have a number of suitable configurations known to one of ordinary skill in the art after reviewing the disclosure provided herein. 
     All patents, patent applications, and publications cited herein are hereby incorporated by reference in their entirety as if individually incorporated, and include those references incorporated within the identified patents, patent applications and publications. 
     Obviously, numerous modifications and variations of the present invention are possible in light of the teachings herein. It is therefore to be understood that within the scope of the appended claims, the invention may be practiced other than as specifically described herein.