HK1159460B - Minimally invasive implant - Google Patents

Description

Minimally invasive implant

RELATED APPLICATIONS

This application claims priority to U.S. provisional application No.61/091,586 filed on 25/8/2008, the entire contents of which are incorporated herein by reference.

Technical Field

The present invention relates to devices, tools, and methods for treating pelvic conditions by providing and using one or more pelvic implants to support pelvic tissue.

Background

It has been reported that men and women in various stages of the U.S. over 13,000,000 are suffering from urinary incontinence and fecal incontinence. Social implications for incontinent patients include loss of self-esteem, embarrassment, limitation of social and sexual activity, isolation, depression, and, in some cases, reliance on caregivers. Incontinence is the most common cause of delivering elderly people to specialized institutions for treatment.

The urinary system includes the kidneys, ureters, bladder and urethra. The bladder is a hollow, muscular, balloon-like bladder that serves as a storage container for urine. The bladder is located behind the pubis and protected by the pelvis. Ligaments hold the bladder in place and connect the bladder to the pelvis and other tissues. Fig. 1 schematically shows the female anatomy concerned. The urethra 16 is the conduit for urine to flow from the bladder 14 out of the body. The narrower internal opening of the urethra 16 within the bladder 14 is the bladder neck 18. In this region, the fascicular (bundled muscularis) fibers of the bladder turn into the striated sphincter muscle, known as the internal sphincter. Figure 2 schematically shows the male anatomy concerned. The urethra 16 extends from the bladder neck 18 to the end of the penis 22. The male urethra 16 is made up of three parts: a prostate portion, a bulbous portion, and a pendulous portion. The prostatic portion, which is the widest part of the duct, passes through the prostate 24. Fig. 3 is a schematic view of the anatomy of the anus and rectum. Rectum 1 is the most distal portion of the gastrointestinal tract. The external opening of the rectum is the anus 2. Bowel control involves the control of the external 3 and internal 4 anal sphincters.

Urinary incontinence occurs when muscles of the urinary system are injured, malfunctioning or weakened. Other factors such as trauma to the urethral area, nerve damage, hormonal imbalances, or drug side effects can also contribute to or assist in the development of 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 due to a sudden increase in abdominal pressure caused by activities such as coughing, sneezing, rising, straining, exercise, and in severe cases even simply changing body position. Urge incontinence, also known as "hyperactive bladder", "frequent/urge syndrome" or "irritable bladder", occurs when a person urgently urinates and loses control of the bladder before reaching a toilet. Mixed incontinence is the most common form of incontinence. Inappropriate bladder contractions and a weak sphincter usually cause this type of incontinence. Mixed urinary incontinence is a combination of incontinence conditions, both stress and urge incontinence. Overflow incontinence is a constant drop or leak of urine caused by an overfilled bladder. Functional incontinence results when it is difficult for a person to move from one location to another. Functional incontinence is often caused by factors outside the lower urinary tract, such as impairment in physical function and/or cognitive function.

SUI is generally thought to be associated with overactivity of the bladder neck or an intrinsic urethral sphincter deficiency. A variety of treatment options are currently available for treating incontinence. Some of these treatment options include external devices, behavioral therapy (e.g., biofeedback, electrical stimulation, or kegel exercises), injectable materials, prosthetic devices, and/or surgery. Depending on age, medical condition and personal preference, surgery may be used for complete prosthetic continence.

Conservative treatment of SUI includes lifestyle changes, such as weight loss, smoking cessation, and altered intake of diuretic fluids such as coffee and alcohol. With respect to surgical treatment, the so-called "gold standard" is the vaginal urethral sling (Burch coloposvision) in which the bladder neck is suspended. Mid-urethral slings have been equally effective. One treatment that is considered to be a particularly successful treatment option for SUI in men and women is the sling and support treatment.

Sling procedures are a surgical procedure that involves the placement of a sling to stabilize or support the bladder neck or urethra. There are a number of different sling treatments. Braces for pubovaginal (pubovaginal) procedures differ in the type of material and the method of anchoring. In some cases, the sling is placed under the bladder neck and secured to the attachment point (e.g., tissue or bone) via a suspension structure or suture through an abdominal incision and/or vaginal incision. In U.S. Pat. Nos. 5,112,344; 5,611,515, respectively; 5,842,478, respectively; 5,860,425, respectively; 5,899,909; examples of sling treatments are disclosed in U.S. Pat. Nos. 6,039,686, 6,042,534, 6,110,101, 6,911,003, 6,652,450, and International PCT publication No.2008/057261, the entire contents of which are incorporated herein by reference.

Although the serious complications associated with sling treatment are rare, they may occur. Complications of certain sling procedures may include urethral obstruction, re-development of urge incontinence, bleeding, prolonged urinary retention, infection, damage to surrounding tissues, and erosion.

Fecal incontinence, like urinary incontinence, has proven challenging to treat. As with sphincteroplasty, surgery is used to treat patients with fecal incontinence due to damage to the external anal sphincter. While other patients are thought to have neurological or paroxysmal fecal incontinence, efforts to treat these patients have been less successful. There are a variety of treatments, for example, post-anal repair, total pelvic floor repair, muscle replacement techniques, dynamic gracilioplasty (dynamic sphincter), artificial sphincter treatment, and sacral nerve stimulation. Success is limited and a variety of treatment modalities may lead to morbidity.

A minimally invasive and efficient treatment modality that can be used with minimal to no side effects for treating both urinary and fecal incontinence is desired. This approach should reduce the complexity of the therapeutic treatment, be biocompatible, should reduce pain, reduce surgical risk, infection and post-operative hospital stay, and have a better duration of activity. In addition, the treatment should also improve the quality of life of the patient.

Disclosure of Invention

The present invention may include surgical instruments, implantable articles, and methods for urological applications, particularly for the treatment of stress and/or urge incontinence, fecal incontinence, and prolapse and perineal floor repair. It should be noted that common treatments for SUI include placing a sling to compress the urethral sphincter or to lift or support the neck of the bladder defect.

Embodiments of the invention may include devices and methods for treating urinary incontinence, fecal incontinence, and other pelvic defects or dysfunctions in both men and women using one or more lateral implants to reinforce the supportive tissue of the urethra. The implant is configured to engage and pull (e.g., pull up) lateral urethral support (e.g., endopelvic fascia) tissue to cause sub-urethral tissue to tighten and relax, thereby improving support. In this way, the implant can be used to eliminate the need for a mesh or other supportive structure under the urethra, which is common with other incontinence slings. The implant may be shaped to aid in such support, for example, the implant may be provided with an anchoring end portion or may be configured in a "U-shape", "V-shape", or the like. In addition, one or more anchors or tissue engaging portions may be employed to attach and stabilize the implant to tissue.

Other embodiments of the invention may include a supportive sling implant having one or more arm portions and a tensioning rod. As described herein, these embodiments may be disposed in a conventional supportive structure beneath the urethra, or positioned laterally relative to the urethra.

Embodiments of the present invention may provide smaller implants, fewer implant components, thereby reducing the size and number of incisions, improving implant handling and adjustment, and reducing the complexity of the insertion and deployment steps.

Drawings

Fig. 1 shows a schematic view of a female urinary system;

fig. 2 shows a schematic diagram of a male urinary system;

FIG. 3 shows a schematic view of the anatomy of the anus and rectum;

fig. 4 shows a pelvic implant device according to an embodiment of the invention;

FIG. 5 illustrates an introducer or insertion device that can be used with embodiments of the present invention;

fig. 6 illustrates a generally U-shaped pelvic implant device, according to an embodiment of the invention;

fig. 7 illustrates an anchor of a pelvic implant device, according to an embodiment of the invention;

fig. 8 shows a side view of an anchor rod of the pelvic implant device of fig. 7;

fig. 9 illustrates a pelvic implant device having an anchor member along a portion of an extension portion, according to an embodiment of the invention;

fig. 10 illustrates an anchoring pelvic implant device, according to an embodiment of the invention;

fig. 11 illustrates a pelvic implant device having an anchor with multiple barbs, according to an embodiment of the invention;

fig. 12-15 illustrate various pelvic implant devices having leading and trailing end bases or bulk anchors, according to embodiments of the present invention;

FIG. 16 illustrates a pelvic implant device implanted into lateral urethral support tissue, according to an embodiment of the invention;

FIG. 17 schematically illustrates a U-shaped pelvic implant device implanted into lateral urethral support tissue, in accordance with an embodiment of the invention;

FIG. 18 schematically illustrates a U-shaped pelvic implant device implanted into lateral urethral support tissue, in accordance with an embodiment of the invention;

FIG. 19 schematically illustrates implantation of an implant device having a leading anchor and a trailing bulk anchor for providing tensioned support for lateral urethral support tissue in accordance with an embodiment of the invention;

figures 20 through 21 schematically illustrate implantation of an implant device having a leading anchor and a trailing bulk anchor for providing tensioned support for lateral urethral support tissue in accordance with an embodiment of the present invention;

figures 22 through 23 schematically illustrate implantation of an implant device through an obturator foramen into lateral urethral support tissue, in accordance with an embodiment of the present invention;

figures 24-25 schematically illustrate a retropubic implantation of an implant device providing tensioned support for lateral urethral support tissue, according to an embodiment of the present invention;

fig. 26 illustrates an implant device having a toggle bolt (anchor) anchor selectively engaged with an introducer device in accordance with an embodiment of the present invention;

fig. 27 shows an implant device with a bolt with a collar bolt and a tubular base bolt according to an embodiment of the invention;

FIG. 28 schematically illustrates implantation of the implant device of FIG. 27 for providing support to lateral urethral support tissue, in accordance with an embodiment of the present invention;

FIG. 29 illustrates an implant device having a toggle bolt anchor, a tubular base anchor, and an intermediate urethral rolling (crawling) portion in accordance with an embodiment of the present invention;

FIG. 30 shows a tubular implant device of a device portion according to an embodiment of the invention;

FIG. 31 illustrates an implant device having a tubular portion and a substantially planar portion according to an embodiment of the present invention;

figure 32 schematically illustrates implantation of a tubular and/or planar implant device for providing tensioned support for lateral urethral support tissue, in accordance with an embodiment of the invention;

FIG. 33 illustrates an implant device having a first arm, a second arm, and an adjustment member according to an embodiment of the present invention;

FIG. 34 schematically illustrates implantation of the implant device of FIG. 33 along a retropubic approach, in accordance with an embodiment of the present invention;

figure 35 schematically illustrates implantation of the implant device of figure 33 along a trans-obturator pathway, according to an embodiment of the present invention.

Detailed Description

Referring generally to fig. 1 through 35, wherein like reference numbers may indicate like, similar, or corresponding parts throughout the several views. The following description is merely exemplary in nature and is not intended to limit other embodiments of the invention, which will be apparent to those skilled in the art from this disclosure.

One aspect of the present invention is directed to an apparatus and method for treating urinary incontinence in males or females. In various embodiments, one or more implants or implant members are placed in strategically positioned locations to pull up or otherwise tension tissue and/or muscles transverse to the urethra to generally re-establish the patient's original anatomy. A variety of systems, devices, structures, techniques and methods, alone or in combination, disclosed in U.S. patent nos. 6,911,003, 6,612,977, 6,802,807, 2002/0161382, 2004/0039453 and 2008/0045782 and international PCT publication No.2008/057261, the disclosures of which are incorporated herein by reference in their entirety, may be used with the present invention. The devices or structures described herein may be used or introduced into the pelvic region of a patient vaginally, percutaneously, or in any other manner known to those skilled in the art.

As shown in FIG. 4, various embodiments of the present invention may include a tensioning or supporting implant device 30, the tensioning or supporting implant device 30 having an extension portion 32 and one or more engagement portions 34. The one or more engagement portions may include a first anchor 34a at a first or leading end of the tensioning device 30 and a second anchor 34b disposed at an opposite trailing end of the tensioning device 30. The extension portion 32 may be constructed of a compatible mesh or similar porous material known to be usable and compatible with urethral slings, other pelvic support devices, and the like. The mesh material may help the tissue and cells to pass through the interior of extension 32 to promote tissue ingrowth and, in turn, secure device 30 to the surrounding anatomy. Extension 32 may also include protrusions, serrated edges, extended fibers, or similar features to promote tissue fixation and ingrowth into the meat. In other embodiments, the extension 32 may be constructed from a flexible or semi-rigid length of compatible, substantially non-porous material. The length and flexibility of device 30 and corresponding extension 32 may vary significantly depending on the particular procedure and anatomical support application. Extension portion 32 may be generally planar at the point of introduction, pre-shaped or pre-formed or otherwise configured to allow for adjustment, manipulation and shaping during the implantation procedure. Various embodiments of the extension portion 32 may be a device that can be formed into a generally V-shape or U-shape (fig. 6), or otherwise adjusted for flexible or selective manipulation and traversing (transversal) through, around, and/or along various tissues and muscles of the pelvic region. In certain embodiments, the length of the device 30 may range from.5 cm to 6 cm. The device 30 may also have a length in the range of greater or less than 5cm to 6 cm.

In certain embodiments, the implant may be configured in the form of a foldable synthetic mesh patch (patch), and may include an adhesive covering (e.g., a fibrin glue). Additionally, the umbrella feature may include a wire spline or member extending from the patch. The umbrella feature may be connected with a patch via a connection structure such as a ring, fastener, or the like. A portion of the implant introducer (e.g., a plunger and/or a wire) may be configured to advance the patch and deploy and/or expand the umbrella feature to provide tissue engagement for the patch.

The one or more engagement portions 34 may be configured as a fixation or self-fixation tip or anchor 34, the fixation or self-fixation tip or anchor 34 adapted to penetrate and be secured within a target tissue or muscle (T) of the pelvic region. As shown in fig. 4, 6 and 7-11, the anchors 34 can vary in shape, size and placement along the device 30. For example, as shown in fig. 4 and 6, the anchor bar 34 may be integral with the end of the extension portion 32, attached to the end of the extension portion 32, or otherwise disposed near the end of the extension portion 32. The extension portion 32 may be connected to the anchor bar 34 via an end portion 36 of the anchor bar 34. A number of attachment structures or techniques may be used to connect the end of the extension portion 32 to the end portion 36 of the anchor bar 34. Additionally, the anchor 34 can include opposing tines or barbs 38 to aid in penetrating and securing within the target tissue. Other embodiments, such as those depicted in fig. 9-11, may include one or more tines 38 (fig. 9) disposed along portions of the extension portion 32, or a plurality of barbs 38 (fig. 11) disposed along the anchor 34. Further, the one or more engagement portions 34 may be configured as a toggle bolt anchor (fig. 26), a tubular member, a planar member, a bulbous member, and the like, any of which may be constructed of a compatible polymer, metal, mesh, or non-porous material, or a bioabsorbable or non-absorbable material. As depicted and described herein, the engagement portion 34 can be adapted to engage a variety of target tissue regions including the endopelvic fascia, the rectus fascia/muscle, the obturator muscle, and other anatomical structures of the pelvis.

Additionally, as depicted in FIG. 10, a sheath or sleeve 40 may optionally be provided along a length of the extension 32 to assist in guiding and inserting the device 30 into the pelvic region of the patient. One or more insertion or guide devices 42 may be employed to assist in traversing of the device 30 within the pelvic region, and to assist in deployment of the device 30 (e.g., anchor bar 34) into a target tissue location. A variety of known insertion devices 42 may be utilized, including those disclosed in the previously incorporated patent documents. The needle embodiment of device 42 can include a handle, a tubular member 43 (linear or curved member), and a tip 45 adapted for selective engagement with one or more components of the implants disclosed herein. As shown in FIG. 10, the extension portion 32 may include a plurality of fibrous materials or hinge lines 44 adapted to further promote tissue ingrowth and fixation.

As described in detail herein, various embodiments of the present invention are configured to treat urinary incontinence by providing support to tissue or anatomical structures near or around the urethra, rather than by providing a more traditional hammock-like support below the urethra. As described in detail herein, the device 30 and the engagement aspects of the invention for these embodiments may vary significantly.

As shown in fig. 12-15, the device 30 may include a barbed anchor 34 at a leading end of the extension portion 32 and a bulk base member 50 at an opposite trailing end. The extension 32 may be constructed from a mesh material (fig. 12) or other porous or non-porous material (fig. 14-15). In addition, the base member 50 may be a mesh, or other porous or non-porous material, and may take any variety of shapes including planar, bulbous, tubular, and the like. The base member 50 may be integral with the extension portion 32 or attached, bonded, or otherwise attached using fasteners 52 (e.g., rivets) using known structures and techniques. In other embodiments, the extension portion 32 can be made of any fibrous or woven, braided, twisted, or knitted polymeric material.

As depicted in fig. 16, the device 30 may be inserted along a path generally toward the obturator foramen for penetrating the Endopelvic Fascia (EF) on either or both sides of the urethra 16. Thus, the anchors 34 are positioned for fixation with tissue or muscle adjacent to the fascia such that the base member 50 is disposed on the entry side of the fascia. The base member 50 of each device 30 may be sized and shaped such that the base member 50 remains on the entry side of the fascia and may include one or more anchors, protrusions, or similar structures to provide additional engagement and retention against the fascia. The anchors 34 are advanced and positioned to penetrate or otherwise engage selected target tissue so as to pull laterally extending sub-urethral tissue, such as the endopelvic fascia, upward, thereby removing slack and repositioning the fascia and/or urethra to a more optimal and correct anatomical location. Other adjustment mechanisms and techniques can also be used to elevate the fascia to provide desired tension or slack relief in the laterally extending urethral support tissue. The device 30 of fig. 14-15 functions in the same manner, except that the extension portion 32 and the base member 50 may take on different design configurations and may be constructed of different materials, such as relatively stiff or flexible polymers, meshes, non-porous meshes, and other known compatible materials.

Various structures or portions of the various embodiments described in detail herein may be made from materials such as polypropylene, polyglycolide, poly-l-lactide, or other known biodegradable (resorbable) or non-biodegradable polymers. Additionally, growth factors or stem cells may be seeded or otherwise provided with one or more components of device 30 to aid in healing or tissue ingrowth. In addition to guiding and deploying the device 30 with a needle introducer device, a cannula or catheter system may also be utilized.

The embodiment of fig. 16-17 includes an implant device 30 having an extension portion 32 and one or more engagement or anchor portions 34 disposed at one end region of the extension portion 32. The device 30 may be designed to have a degree of flexibility that allows a user to easily direct and advance the device 30 and to manipulate the device 30 during deployment and anchoring to bring the device 30 into a generally U-shaped or similar configuration. In one embodiment, device 30 is adapted to generally dilate the lateral tissue of the patient's supportive pelvic floor. For example, a first one of the anchors 34a can be inserted through the endopelvic fascia for fixation within tissue. Likewise, the other anchor bar 34b can be adjusted or pulled to tension and lift the supportive urethral tissue. One or more of the anchors 34a, 34b can be secured to tissue at or near the obturator internus muscle or obturator membrane. When the supporting tissue is pulled up to substantially obtain the correct anatomical urethral support, the second anchor is secured within the proximal tissue with the bend of the extension portion 32 extending through the fascia. This process can be repeated for supportive tissue on the other side of the urethra to provide bilateral dilation and support.

Fig. 18 shows an embodiment of the device 30 having a first anchor 34a and a second anchor 34b, with a portion 32 extending between the first anchor 34a and the second anchor 34 b. The anchors 34a, 34b can be configured according to the various designs disclosed herein. For example, the first anchor 34a may be a penetrating tip and the second anchor 34b may be shaped as a tubular or bulk (bulk) anchor. One of the anchors may be secured in tissue above the fascia, and the other anchor is secured at or near or through the fascia to pull up the supportive urethral tissue, thereby eliminating slack in the tissue. This process can be repeated on the other side of the urethra to provide bilateral dilation and support. Embodiments of the extension 32 may be constructed of mesh, braded, twisted, knitted, tubular, or collagen matrix materials to aid in fixation and tissue ingrowth. Additionally, a plurality of such devices 30 may be implanted on either or both sides of the urethra to facilitate tissue expansion and support.

Figures 20 to 21 show some embodiments of the invention and an apparatus 30 similar to that depicted in figure 16. A bulk anchor 34b (e.g., tubular, collar (fig. 26), flat, etc.) can be inserted through supportive tissue such as the endopelvic fascia, or it can be left behind with the anchor 34a extending up through the tissue. Likewise, either of the anchors 34a, 34b can be positioned on opposite sides of the supportive tissue. In addition, at least one of the anchors can be used to penetrate supportive tissue at one or more locations along the tissue. For example, certain embodiments of device 30 may be used to weave or thread in and out of tissue along the tissue to provide a supportive undulating layout for extension 32. This can aid in attachment, better distribute pulling forces on or along the tissue, and provide similar support advantages.

As shown in fig. 22-23, an outside-in implantation method may be used for device 30. That is, a skin incision may be made below the location where the adductor longus is inserted into the pubic ramus. The first anchor 34a of the device 30 may then be passed near the ischiopubic ramus and inserted through the obturator foramen and the internal muscle into tissue transverse to the urethra, such as the endopelvic fascia supporting the bladder neck and urethra. Once secured, the device 30 can be pulled to provide tension along the extension portion 32 to expand and return the urethral support tissue to the correct anatomical position. In this regard, the extension 32 and the opposite proximal end of the device 30 may be anchored or otherwise positioned to maintain tension on the device 30. The device 30 may be inserted into and deployed within a patient using any of the needle and/or cannula introducer devices described herein. This embodiment of the device 30 may provide easier access and patient positioning, may eliminate the need for an incision below the urethra, and may be implanted while the patient is awake so that the device 30 may be selectively adjusted based on the patient's instructions and movements. Embodiments of the base or end of the extension 32 on the entry side of the tissue may also be glued, sutured, or otherwise secured in or at the tissue using a variety of known structures and techniques. In addition, the device 30 may be implanted on either side of the urethra to provide bilateral support. Fig. 23 discloses a variation of this embodiment in which the extension 32 is constructed of a non-porous material such as a suture, polymer material, rope, or the like.

Figures 24-25 depict another embodiment of an implant device 30, the implant device 30 being introduced along a retropubic approach rather than along a trans-obturator approach. One or more skin incisions are typically made so that the device 30 can extend down on either or both sides of the urethra with at least one anchor 34 extending into the endopelvic fascia to the anterior vaginal wall. As with other embodiments disclosed herein, securing the implant device 30 to the lateral supporting tissue of the urethra allows for adjustment to return the supporting tissue to its correct anatomical position. Further, any of the anchors 34, extension portions 32, and introducer devices described herein may be used in the embodiment of fig. 24-25.

Figures 27-29 illustrate various embodiments of an implant device 30, the implant device 30 including engaging or anchoring portions 34a, 34b at each end of the extension portion 32 to provide lateral support to the urethra. The bolt may include any of the structures or features described herein. For example, one embodiment includes a toggle anchor 34a and a tubular (e.g., mesh) base anchor 34 b. The tubular base 34b may include a cap or other structure 35 disposed at an end thereof. As with other embodiments of the device 30, at least one of the anchors, such as the tubular base 34b, can engage lateral supporting tissue of the urethra so that the tissue can be tensioned or lifted to remove slack. An adjustment member 60, such as a rod, suture, or similar feature, may be included to selectively adjust the device 30 to further assist in tension control. For those embodiments that include a tubular engagement feature 34b, the feature 34b may be a mesh configuration to promote tissue fixation and in-growth into the flesh. As shown in fig. 29, this embodiment of the device 30 may also include an intermediate support 62 adapted to be positioned below the urethra to provide additional support. The support 62 may be porous or non-porous, and either structure (e.g., anchor 34, support 62) may be constructed of resorbable or non-resorbable materials.

Fig. 30-32 depict an implant 70 that can be secured along a portion of lateral urethral support tissue, such as the endopelvic fascia. These implants 70 can include one or more tubular and/or planar mesh structures 72, the mesh structures 72 being adapted to engage supporting tissue to adjust the tension on the tissue and/or tissue. The structures 70, 72 may also be adapted to selectively engage with the introducer device 42 to aid in insertion and deployment. The implant may be provided without anchors 34, wherein the configuration and features of the implant (e.g., protrusions, mesh, abrasion, adhesive, fibers, etc.) may provide the attachment structure necessary to engage and provide adjustable tension on the supporting tissue. Other embodiments may include anchors 34 to pierce or engage the lateral tissue. Additionally, the implant 70 may be constructed of resorbable or non-resorbable materials.

The embodiment of fig. 33-35 may include an implant device 80 having a first extension arm 82, a second extension arm 84, and an adjustment member 86. The extension arms 82, 84 may include one or more anchors 88 at their respective ends. The arms 82, 84 may be constructed from a porous mesh or other material described herein for the extension portion 32 of the device 30. Similarly, the anchor 88 may take the configuration of any of the anchors 34 described herein. The components of the device 80, including the arms and adjustment members, may be constructed of compatible materials such as polypropylene, PGA, PLLA, mesh, braid, cord, filament, and the like.

In use, each of the arms 82, 84 (e.g., distinct or separate members) is passed through one or more vaginal incisions along a retropubic path until the anchor 88 is secured in tissue such as rectus fascia/muscle. Additionally, a portion of either arm may extend below the urethra to provide rolled support. To tension the device 80, a member 86 (e.g., a rod or polymer extension) of one of the arms 82, 84 may be inserted into or engaged with an attachment or locking mechanism 90 (e.g., a fastener, device, aperture, etc.) of the other arm. The member 86 can then be slid along the locking mechanism 90 to engage the components until the proper tension is achieved. The remainder of the member 86 extending below the arm may be cut away and discarded. In other embodiments, each arm 82, 84 may include a member 86 or similar adjustment mechanism to help achieve balanced or equal tension on either side of the urethra. As shown in fig. 35, the device 80 can be deployed and the method can also be pre-performed along a trans-obturator pathway, with anchors 88 secured in the obturator muscles on either side of the pelvis.

A variety of materials may be used to form the implants and portions or components of the device 30, including nitinol, polymers, elastomers, porous meshes, thermoplastic elastomers, metals, ceramics, springs, wires, plastic tubing, and the like. After reading the disclosure provided herein, the systems, components, and methods may have a number of suitable configurations known to those of skill in the art.

All patents, patent applications, and publications cited herein are hereby incorporated by reference in their entirety as if individually incorporated and include those references which are incorporated within the above-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 otherwise than as specifically described herein.

Claims (9)

1. A pelvic implant system for tensioning lateral urethral support tissue of a patient, the pelvic implant system comprising:

at least one implant device, the at least one implant device having:

a leading end portion, a trailing end portion, and an extension portion extending between the leading end portion and the trailing end portion;

a first anchor portion disposed at a leading end portion of the at least one implant device and configured to penetrate at least a portion of a patient's lateral urethral support tissue on one side of the patient;

a second anchor portion disposed at a trailing end portion of the at least one implant device and adapted to penetrate a portion of the patient's endopelvic fascia on the side of the patient so as to enable tensioning of the tissue to place the tissue generally in a correct anatomical position without the at least one implant device directly contacting the patient's urethra; and

an introducer device capable of inserting and deploying the at least one implant device into and within the patient.

2. The system of claim 1, wherein the at least one implant device comprises a first implant device adapted to support tissue on a first side of the patient and a second implant device adapted to support tissue on a second side of the patient to provide bilateral urethral support.

3. The system of claim 1, wherein the first anchor portion is a fixation anchor having one or more extended barbs.

4. The system of claim 1, wherein the second anchor portion is a bulk anchor that can abut one side of the endopelvic fascia to limit movement of the caudal end portion and assist in tissue tensioning.

5. The system of claim 1, wherein the extension portion is manipulable to form a generally U-shaped configuration for the at least one implant device.

6. The system of claim 1, wherein the extension portion is constructed of a porous mesh material.

7. The system of claim 1, wherein the extension is constructed of a non-porous material.

8. The system of claim 1, wherein the first anchor portion is further engageable with tissue selected from the group consisting of obturator and rectus fascia.

9. The system of claim 1, wherein the second anchor portion comprises a tubular or bulk anchor capable of penetrating a portion of the endopelvic fascia.