US20100191046A1 - Implants And Procedures For Supporting Anatomical Structures - Google Patents

Abstract

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

Description

RELATED APPLICATIONS
• This application claims priority to U.S. Provisional Application Ser. No. 61/142,604 filed Jan. 5, 2009, entitled Implantable Anchors For Use With Mesh Within The Body, and is related to U.S. application Ser. No. (Not yet assigned), filed Jan. 5, 2010, entitled Implants And Procedures For Supporting Anatomical Structures For Treating Conditions Such As Incontinence, and U.S. application Ser. No. (Not yet assigned), filed Jan. 5, 2010, entitled Implants And Procedures For Supporting Anatomical Structures For Treating Conditions Such As Pelvic Organ Prolapse, all of which are hereby incorporated herein by reference.
FIELD OF THE INVENTION
• The present invention pertains to the field of medical devices for anchoring and supporting anatomical structures and, more particularly, to implantable mesh that are operative to treat pelvic organ prolapse and incontinence.
BACKGROUND OF THE INVENTION
• Pelvic floor disorders are a class of abnormalities that affect the pelvic region of millions of men and women. In women, for example, the pelvic region includes various anatomical structures such as the uterus, the rectum, the bladder, and the vagina. These anatomical structures are supported and held in place by a complex collection of tissues, such as muscles and ligaments. When these tissues are damaged, stretched, or otherwise weakened, the anatomical structures of the pelvic region shift and in some cases protrude into other anatomical structures. For example, when the tissues between the bladder and the vagina weaken, the bladder may shift and protrude into the vagina, causing a pelvic floor disorder known as cystocele. Other pelvic floor disorders include vaginal prolapse, vaginal hernia, rectocele, enterocele, uterocele, and/or urethrocele.
• Pelvic floor disorders often cause or exacerbate urinary incontinence (UI). One type of UI, called stress urinary incontinence (SUI), effects primarily women and is often caused by two conditions—intrinsic sphincter deficiency (ISD) and hypermobility. These conditions may occur independently or in combination. In ISD, the urinary sphincter valve, located within the urethra, fails to close (or “coapt”) properly, causing urine to leak out of the urethra during stressful activity. In hypermobility, the pelvic floor is distended, weakened, or damaged. When the afflicted woman sneezes, coughs, or otherwise strains the pelvic region, the bladderneck and proximal urethra rotate and descend. As a result, the urethra does not close with sufficient response time, and urine leaks through the urethra.
• UI and pelvic floor disorders, which are usually accompanied by significant pain and discomfort, are often treated by implanting a supportive sling or mesh in or near the pelvic floor region to support the fallen or shifted anatomical structures or more generally, to strengthen the pelvic region by promoting tissue in-growth. Often, treatments of stress incontinence are made without treating the pelvic floor disorders at all, potentially leading to an early recurrence of the stress incontinence.
• Existing systems, methods, and kits for treatment typically employ delivery devices to position a supportive surgical implant into a desired position in the pelvic region. However, some of these systems and methods require a medical operator to create multiple incisions and deliver the implant using complex procedures. Moreover, many existing surgical implants are not suitably sized or shaped to properly fit within a patient and treat pelvic floor disorders. Accordingly, medical operators and patients need improved systems, methods, and surgical kits for the treatment of pelvic floor disorders and/or urinary incontinence.
OBJECTS AND SUMMARY OF THE INVENTION
• The present invention provides improved methods and devices for supporting pelvic organs in the treatment of conditions such as incontinence and various pelvic floor disorders including but not limited to cystocele, enterocele and rectocele.
• Devices of the present invention include implants having soft, flexible support bodies and anchors that are sturdy and durable.
• Other devices of the present invention include introducers that allow an implant to be deeply implanted so as not to cause damage to the pelvic floor and to preserve the natural length of the vagina.
• Methods of the present invention include the use of multiple implants for treating multiple disorders, including treating pelvic floor disorders and incontinence.
BRIEF DESCRIPTION OF THE DRAWINGS
• These and other aspects, features and advantages of which embodiments of the invention are capable of will be apparent and elucidated from the following description of embodiments of the present invention, reference being made to the accompanying drawings, in which
• FIG. 1 is a partial plan view of an implant according to an embodiment of the present invention.
• FIG. 2A-2C are partial plan views of an implant according to an embodiment of the present invention.
• FIG. 3 is a plan view of an implant according to an embodiment of the present invention.
• FIG. 4 is a perspective view of an anchor according to an embodiment of the present invention.
• FIG. 5 is a cross-sectional, perspective view of an anchor according to an embodiment of the present invention.
• FIG. 6 is a perspective view of an anchor according to an embodiment of the present invention.
• FIG. 7 is a perspective view of an anchor according to an embodiment of the present invention.
• FIGS. 8A and 8B are cross-sectional views of an anchor according to an embodiment of the present invention.
• FIGS. 9A-9F is a series of drawings showing a process of assembling an implant according to an embodiment of the present invention.
• FIG. 10A is a plan view of an anchor according to an embodiment of the present invention.
• FIGS. 10B-10D is a series of drawings showing a process of assembling an implant according to an embodiment of the present invention.
• FIGS. 11A-11D are plan views of one end of an implant according to certain embodiments of the present invention.
• FIGS. 12A-12C is a series of drawings showing a process of assembling an implant according to one embodiment of the present invention.
• FIG. 13 is a perspective view of a locking member according to an embodiment of the present invention.
• FIG. 14 is a plan view of a locking member according to an embodiment of the present invention.
• FIG. 15A is a side elevation view and a cut-away view of a delivery system according to an embodiment of the present invention.
• FIG. 15B is a cross-sectional view of a delivery system according to an embodiment of the present invention.
• FIG. 16 is a cross-sectional view of a delivery system according to an embodiment of the present invention.
• FIG. 17 is a cross-sectional view of a delivery system taken along section line B-B ofFIG. 14.
• FIG. 18 is a perspective view of and implant and a delivery system according to an embodiment of the present invention.
DESCRIPTION OF EMBODIMENTS
• Specific embodiments of the invention will now be described with reference to the accompanying drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention. In the drawings, like numbers refer to like elements.
• Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
• The implant according to the present invention may, for example, be employed to provide support for organs in treatment for conditions such as incontinence and various pelvic floor disorders including but not limited to cystocele, enterocele and recetocel. In this regard, the implant is operative to provide a single-incision solution for implanting a surgical support member within the body specifically for pelvic organ prolapse applications. The implant, the implant delivery system, and the associated methods for implanting the implant provide a strong anchor with a delivery method that is safe, fast, and easy to deploy for surgeons of various experience levels. The present invention allows for easy and controlled deployment of an anchor deep within the body, preferably under palpation control, while providing the ability to easily adjust the mesh tension prior to locking the implant in place.
• Broadly speaking, as shown inFIG. 1, animplant10 according to certain embodiments of the present invention includes a supportingmember20 having one ormore arms26 extending from thesupport member20 and associated with ananchor30 that secures theimplant10 to tissue within the body, e.g. the obturator member (OM), the obturator internus fascia, the obturator internus muscle, the arcus tendineus levator ani, the levator ani muscle, the sacrospinous ligaments (SSL), the illiococcygeus muscle, or the arcus tendineus facia pelvis (white line). Theimplant10 further includes atether25 which is associated with theanchor30 at adistal end27 and associated with the support member at aproximal end29. The portion of theproximal end29 of thetether25 is inserted through a lockingmember150 that is integrated into thesupport member20. For the sake of clarity,FIG. 1 shows only one side of theimplant10. It is understood that the side not shown is a mirror image of the side shown.FIGS. 2A-2C show alternative configurations of the supportingmember20 and thearms26. Suitable supportingmembers20 are further described in the Assignee's U.S. patent application Ser. No. 11/936,063, the contents of which are herein incorporated by reference. In certain embodiments of the present application, the supportingmember20 has a simpler shape that is approximately rectangular, oval, or circular and in which thearms26 are less pronounced or even absent.
• Thesupport member20 and thetether25 may be fabricated of a synthetic material, such as surgical mesh and the like, natural tissues, such as tissues harvested from either an animal, cadaverous source or the patient himself, and/or combinations of synthetic and natural materials. In a preferred embodiment, thesupport member20 and thetether25 are fabricated of a mesh or weave.
• In certain embodiments, asupport member suture50, shown inFIG. 18, is advantageously attached to thesupport member20. Thesupport member suture50 is looped through, tied to, or otherwise associated with thesupport member20. Preferably, thesupport member suture50 is affixed to thesupport member20 at a proximate mid-point of thesupport member20. As would be understood by one of ordinary skill in the art, it may also be advantageous to employ a plurality of the support member sutures50 at predetermined positions on or within thesupport member20 in order to provide markers along a dimension of thesupport member20. In order to distinguish the various individual sutures, the sutures may be provided in different colors, lengths, or other indicating means that would allow a user to distinguish one suture from another. Indicating marks may also be provided along a length of the suture that can be employed to determine a depth of the suture within the body.
• FIGS. 3-7 show ananchor30 according to one embodiment of the present invention. Theanchor30 has adistal portion60 and aproximal portion70 associated with one another by mid-portion80. A proximal end of thedistal portion60 of theanchor30 is associated with or attached to a distal end of the mid-portion80. Conversely, a distal end of theproximal portion70 is associated with or attached to a proximal end of the mid-portion80 of theanchor30. The mid-portion80 ofanchor30 is formed as a shaft or spacer that serves to provide space between thedistal portion60 and theproximal portion70 to, for example, accommodate a depth of tissue through which thedistal portion60 has penetrated.
• Thedistal portion60 of theanchor30 employs a piercingtip62 for penetrating tissue and a tissue-retention protrusion64 proximal of the piercingtip60 that anchors or secures thedistal portion30 within tissue. Thedistal portion60 may have, for example, an arrowhead-like shape as shown inFIGS. 3-6. Alternatively,distal portion60 may have a more complex shape configured to employ more than two, for example as shown inFIG. 7, four tissue-retention protrusions64. Thedistal portion60 may further employ a conical or cone-like shape having a circular tissue-retention protrusion64. One of ordinary skill in the art would recognize that alternative shapes and configurations of thedistal portion60 are possible while still achieving the desired objective. For example,distal portion60 may employ resilient, spring loaded and/or self-tensioning tissue-retention protrusions64.
• Theproximal portion70 ofanchor30 comprises ashoulder72 for providing a back-stop for thesupport member20 or thetether25 and aguide member74 for engagement with a delivery system, as discussed in greater detail below. Theproximal portion70 may further employrecesses76 andeyelet78. The anchor suture40 passes through theeyelet78 and is, for example, secured back to itself to form a loop. Therecesses76 may be positioned on one or both sides of theeyelet78 and configured so as to accept theanchor suture40 such that the presence of theanchor suture40 does not add to or change an outer dimension of theguide member74.
• Theanchor30 may be formed from a variety of materials, including but not limited to metal alloys, such as titanium, stainless steel, or cobalt-chome alloys, polymeric materials, such as polyethylene (PE), polypropylene (PP), polysulfone, polyether ether ketone (PEEK), polyether imide (PEI), and biodegradable materials, such as polylactic acid (PLA) and polyglycolic acid (PGA) based materials. Theanchor30 may be formed of a single material or a combination thereof. For example, as illustrated inFIGS. 8A and 8B, theanchor30 may be formed of a combination ofprimary material90, such as titanium, and abiodegradable material92 assembled or molded over theprimary material90.
• Turning next toFIGS. 9A-9F,FIGS. 9A-9F show the steps of assembling theimplant10 according to various embodiments of the present invention. For the sake of clarity,FIGS. 9A-9F show only the assembly of onearm26 of theimplant10. First, atool90 is used to form anopening110 through thearm26 proximate an end of thearm26 by penetrating, stretching, or spreading the mesh or knitted material of thearm26 of thesupport member20. Thetool90 has a tapered or pointed end and a cross-section shape in the form of a circle, rectangle, oval or most any other shape. Thedistal portions60 of theanchors30 are then inserted through theopenings110 in thearm26 until thearm26 rests against theshoulders72 of theproximal portions72 of theanchors30. In a preferred embodiment, theopenings110 are formed interior of the outer perimeter of thearm26 such that there is sufficient material ofarm26 so that theopenings110 do not substantially expand or rip through the outer perimeter of thesupport member20.
• In an alternative embodiment of the present invention, as shown inFIG. 10A-10D, the shoulder of theanchor31 is formed of a plastic ormetal pin73 that is inserted through a receivinghole75 formed through the proximal portion of theanchor31. During assembly of theimplant10, once theopenings110 are formed through thearm26, theguide74 and/orproximal portion70 ofanchor31 is placed through theopening110 and thepin73 is inserted through the receivinghole75 to form an element functionally similar to theshoulder72 previously described. As one of ordinary skill in the art would recognize, this embodiment provides the advantage that asmaller opening110 may be formed when assembling theimplant10. Thesmaller opening110, in turn, provides the advantage of thearm26 having a greater resistance to tearing and deformation.
• In certain other embodiments of the present invention, the assembledimplant10 as described above may be subjected to additional fabrication steps. For instance, as shown inFIGS. 11 and 12, after insertion of theanchor30 through theopening110 ofarm26, a portion of thearm26 between theopening10 and the outer perimeter of thearm26 is folded over the shoulder of theanchor30 back on to itself to form a foldedportion22. The foldedportion22 may then be bonded, sutured, welded, or tacked to it self to formbond24 to better maintain the fold. Formation of the foldedportion22 serves, in part, to decrease resistance to penetration of theanchor30 into tissue. Thefold22 may additionally help insure that theanchor30 remains inserted through thearm26 during handling and implantation of theimplant10, as well as provide a more visually appealing appearance to theimplant10. As shown inFIGS. 11 and 12, the shape of the portion of thearm26 that forms thefold22 may be manipulated so as to, for example, result in thearm26 having a tapered end. A tapered end may be formed by forming a portion of thearm26 so as to have a width that narrows at afold line26, as shown inFIG. 11A. A tapered end may also be formed through a secondary folding of the extremities or corners of thefold22 towards one another, as shown inFIG. 11B. Alternatively, as shown inFIG. 11C, once the foldedportion22 is formed a suture may be threaded through thefold22 and cinched and bound to itself so as to form a tapered end of theanchor30. A tapered end may also be formed in theimplant10 by cutting or trimming the corners of thefold22 after thefold22 has been formed, as shown inFIG. 11D.
• FIGS. 12A-12C show yet another embodiment of theimplant10 in which, prior to formation of thefold22, thearm26 is twisted 180 degrees or more. Again, this method of assembly decreases resistance to penetration of the anchor and helps ensure that theanchor30 remains inserted through thearm26 during handling and implantation. One of ordinary skill in the art will, however, recognize that other methods of assembling thesupport member20 and theanchor30 to achieve the desired characteristics of theimplant10 are known in the art.
• It will be understood that, while the above described assembly has been made only with reference to the assemble of thearm26 with theanchor30 the, assembly of thetether25 with theanchor30 is substantially identical.
• Turning now to the lockingmember150,FIGS. 13 and 14 show different embodiments of lockingmember150 according to the present invention.FIG. 13 shows acircular locking member150 having anaperture132 from whichflexible teeth152 extend inward. Theteeth152 provide for one-way movement of thetether25 in the direction of arrow154 through theapertures132 but lock against movement of thetether25 through theaperture132 in the direction of thearrow156.
• FIG. 14 shows another embodiment in which the lockingmember150 incorporates anaperture132 and aslide lock133 havingengagement members134. Theslide lock133 is incorporated into and integral with the lockingmember150 such that theslide lock133 slides laterally away from and towards theaperture132. In the open or unlocked state, shown inFIG. 14, theslide lock133 is withdrawn or cleared from theaperture132 and thetether25 passes through theaperture132 freely. In the locked or closed state, not shown, theslide lock133 is displaced so as to extend across theaperture132 and thereby engage thetether25 with theengagement members134. In the closed position, theengagement members134 snag or penetrate thetether25 so as to prevent movement of the tether through theaperture132. In order to maintain the slide lock in the closed state, the slide lock may incorporate resilient portions that slide into receiving elements or other structural features that prevent the slide lock from further movement absent disengagement of the resilient portions from the receiving elements. One of ordinary skill in the art will recognize that there are various known structures and configurations possible for achieving the above described embodiment, for example, theslide lock133 may slide within a channel formed in the lockingmember150 and the resilient portions may engage openings or recesses formed within the channel so as to lock the slide lock into a fixed position.
• It will be understood by one of ordinary skill in the art that while the lockingmember150 has been described as being incorporated or otherwise attached to thesupport member20, alternative configurations are contemplated. For example, in certain embodiments of the present invention, thesupport member20 incorporates an eyelet in place of the lockingmember150. Thetether25 passes first through the eyelet of thesupport member20 and then passes through anindependent locking member150 positioned on a backside of thesupport member20. The lockingmember150 is sized and/or shaped so as to be incapable of passing through the eyelet and therefore provides a secure back-top against which thesupport member20 rests.
• Turning now to the delivery system of the present invention. Broadly speaking, the delivery system is configured to receive a portion of theanchor30 of the assembledarm26 ortether25.FIG. 15A shows adelivery system120 having ahandle125 and ashaft140. Thehandle125 is preferably ergonomically shaped to facilitate grasping and manipulating. Thehandle125 is preferably marked, colored, textured or otherwise configured so as to indicate to a user the orientation of thedelivery system120. Theshaft140 protrudes from or is an extension of thehandle125. Theshaft125 is, for example, formed of stainless steel or other metal in the general shape of a needle. A curveddistal portion142 of theshaft140 includes acavity144 and aslot146.
• Optionally, as shown inFIG. 15B, thedelivery system120 may further employ asheath148. Thesheath148 is a slit tube or u-shaped channel that functions, in part, to protect thesupport member20 ortether25 and various associated sutures from exposure to tissue during implantation. Thesheath148 also functions to limit the depth of penetration of theanchor30 in to the target tissue. This function is achieved by configuring thesheath148 to be a distance D shorter than a length of theimplant10 andshaft140 when assembled and have an outer diameter greater than that of theshaft140 and the anchor. Because thesheath148 is displaceable along the axis of theshaft140, indicated by arrow E ofFIG. 15B, the user, after first piercing the target tissue with thedistal portion60 of theanchor30, may move the sheath to determine or measure the approximate depth of that theanchor30 within the target tissue.
• Referring now toFIGS. 16 and 17,FIG. 16 shows theimplant10 anddelivery system120 assembled ready for implantation of thearm26 or thetether25 of theimplant10.FIG. 17 shows a cross-sectional view of the assembledarm26 or thetether25 and thedelivery system120 viewed along section line B-B ofFIG. 16. As will be noted, the shape of thecavity144 corresponds to the shape of theguide74 of theanchor30. That is to say that theguide74 of theanchor30 of theimplant10 and thecavity144 of theshaft140 of thedelivery system120 are complementary elements, thecavity144 forming a female receiving element for themale guide74. Preferably, thecavity144 and theguide74 are formed in the shape of a square, rectangle, oval, triangle, star, or other shape that resists theguide74 rotating within thecavity144. In certain embodiments of the present invention, thecavity144 and theguide74 form a friction fit such that theguide74 is maintained within thecavity144 during handling and deployment of theimplant10 but is readily released from thecavity144 upon engagement of thedistal portion60 of theanchor30 within tissue. A portion of theslot146 penetrates radially through theshaft140 into the cavity174 and extends axially along a length of thedistal portion142 of theshaft140. Preferably, theslot146 extends axially along theshaft140 to a greater extent than the cavity174. Theslot146 thereby receives and forms a channel through which theanchor suture40 ofanchor30 is positioned along an axis of theshaft140.
• A method for deploying or implanting theanchor30 assembled with thearm26 or thetether25 will now be described. First, a single incision or entry point is made in the patient followed by blunt dissection as necessary or desired. Afirst arm26 ortether25 incorporating theanchor30 that is engaged with thedelivery system120 is inserted through an entry point in the body and theanchor30 is forced into or through a portion of the target tissue, e.g. the obturator member (OM), the obturator internus fascia, the obturator internus muscle, the arcus tendineus levator ani, the levator ani muscle, the sacrospinous ligaments (SSL), the illiococcygeus muscle, or the arcus tendineus facia pelvis (white line). Thedelivery system120 is retracted away from theanchor30 that has penetrated the target tissue thereby breaking the engagement between thedelivery system120 and theanchor30. During this process and particularly while thedelivery system120 is being retracted, theanchor suture40 corresponding to the implantedanchor30 is secured such that thedelivery system120 is retracted while an end of theanchor suture40 is maintained extending out from the entry point. Thearm26 ortether25 incorporating theanchor30 that is opposite the implantedanchor30 is engaged with thedelivery system120 and implanted as described with regard to the first side. In certain embodiments of the present invention, thetethers25 are implanted before thearms26 of thesupport member20 in order to provide a less cluttered work space for the potentially deeper implantation of thetethers25.
• Substantially concurrent with the implantation of the second side of theimplant10, thesupport member20 of theimplant10 is positioned so as to support at least a portion of the desired organ. Thesupport member suture50, shown inFIG. 18, may be used to determine the position and/or tension of the implantedsupport member20. The tension of thesupport member20 spanning between the two sides of theimplant10 is initially adjusted by pushing thedelivery system20 engaged with theanchor30 of thesecond arms26 of theimplant10 further into the target tissue. Thedelivery system120 is then retracted from thesecond arm26 of theimplant10. An end of thesecond anchor suture30 is also maintained such that it extends out from the entry point.
• Thetethers25 are then passed through the lockingmembers150 of thesupport member20, and thesupport member20 is pushed up thetethers25 towards theanchors30 associated with each tether into the desired position.
• Should it be determined that greater tension is desired or if it is otherwise desirable to reengage of thedelivery system120 with one of theanchors30, the present invention provides a particularly advantageous means for achieving such. As shown inFIG. 18, the end of theanchor suture40 of therelevant anchor30 that extends from the entry point is tensioned and secured. Theslot146 of thedelivery system120 is then positioned such that theanchor suture40 passes through theslot146, and serves as a guide for thedelivery system120 to therelevant anchor30. Thedelivery system120 is advanced towards therelevant anchor30 along theanchor suture40. Theguide74 of theanchor30 is thereby received by thecavity144 of thedelivery system120 and, if desired, the friction fit between theanchor30 and thedelivery system120 is reestablished. It is then possible to adjust the tension of thesupport member20 of theimplant10 by pushing thedelivery system120 so as to drive the anchor further into the target tissue. The implant can be retracted by pulling on theanchor suture40 or thesupport member suture50 thus releasing all or a portion of the tension present in theimplant10.
• Upon completion of the implantation of theimplant10 the single entry point is closed. The anchor sutures40 and support member sutures50 can be left in place for possible use in a follow-up procedures or may be removed from the patient.
• Theimplant10 according to the present invention may employ theanchors30 or the anchors described in the Assignee's pending U.S. application Ser. No. (Not yet assigned), filed Jan. 5, 2010, entitled Implants and Procedures for Supporting Anatomical Structures, and U.S. application Ser. No. (Not yet assigned), filed Jan. 5, 2010, entitled Implants and Procedures for Supporting Anatomical Structures, all of which are incorporated herein by reference, exclusively or a combination thereof. It will be understood by one of skill in the art that the different anchors of the present invention will each lend themselves to implantation within potentially different target tissues having different characteristics and locations within the body.
• While the present invention has been described for use in treating pelvic floor disorders and incontinence, it would be understood by one of skill in the art that the present invention can be used support other organs within the body or as a means of fixation of tissue or implants within the body.
• Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.

Claims (20)

1. A system for supporting an anatomical structure comprising:

a tether having a proximal area and a distal area, said distal area associated with an anchor;

a support member having an aperture through which a portion of said distal area of said tether passes; and

an engagement member configured to receive said portion of said distal area of said tether and transfer a tension on said support member to said tether.

2. The system ofclaim 1 wherein the support member is mesh.

3. The system ofclaim 1 wherein the support member comprises an arm.

4. The system ofclaim 1 wherein at least one removable filament extends from the support member.

5. The system ofclaim 1 wherein at least one removable filament extends from said anchors.

6. The system ofclaim 1 wherein said engagement member resides within said aperture of said support member.

7. The system ofclaim 1 wherein said engagement member comprises displaceable teeth.

8. The system ofclaim 1 wherein said engagement member comprises flexible teeth.

9. The system ofclaim 1 wherein said anchor comprises a proximal protrusion for engagement with a delivery system.

10. The system ofclaim 1 wherein said engagement member comprises a ring through which said portion of said distal area of said tether passes after said portion passes through said aperture of said support member.

11. A system for implanting an implant for supporting an anatomical structure comprising:

an implant comprising;

a tether having a proximal area and a distal area, said distal area associated with an anchor;

a support member having an aperture through which a portion of said distal area of said tether passes; and

an engagement member configured to receive said portion of said distal area of said tether and transfer a tension on said support member to said tether; and

a delivery tool comprising a handle and a shaft, said shaft having a cavity formed within a distal portion, the cavity having a cross-sectional shape complementary to a cross-sectional shape of a proximal protrusion of the anchor.

12. The system ofclaim 11 wherein the distal portion of the delivery tool comprises a slot that extends axially along the shaft.

13. The system ofclaim 11 wherein a removable filament extends from the proximal protrusion of the anchor through the slot of the delivery tool when the proximal protrusion of the anchor is inserted within the cavity of the delivery tool.

14. The system ofclaim 11 further comprising a sheath having a lumen through which the shaft is displaceable.

15. The system ofclaim 11 wherein the sheath is a slit tube.

16. The system ofclaim 12 wherein the sheath is a U-shaped channel.

17. A method for supporting an anatomical structure comprising:

making a single entry point in the body of the patient;

securing a plurality of anchors within said body through said single entry point;

feeding a tether extending from one of said plurality of anchors through an aperture within a support member;

tensioning the support member between at least two of said plurality of anchors secured within said body;

locking said support member in position relative to said tether; and

closing said single entry point.

18. The method ofclaim 17 wherein the step of securing a plurality of anchors within said body through said single entry point comprises:

engaging one of said plurality of anchors with a tool;

advancing said tool engaged with said anchor to a target tissue;

piercing said target tissue with said anchor; and

withdrawing said tool from said anchor.

19. The method ofclaim 18 further comprising the steps of:

introducing a removable filament extending from said anchor outside of said entry point into a guide slot of said tool;

advancing said tool towards said anchor along said removable filament;

reengaging said tool with said anchor from which said removable filament extends; and

forcing said anchor further into said target tissue with said tool thereby increasing a tension upon said support member.

20. The method ofclaim 17 wherein the step of locking said support member in position relative to said tether comprises mechanically engaging said tether.

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