KR20120098835A - Patterned sling implant - Google Patents

Abstract

Elongated pelvic implants are provided for treating pelvic diseases such as incontinence. The implant 10 includes a tissue support 12, one or more extensions 14, and one or more anchors 16. The implant consists of a single nonwoven sling. The implant is constructed or formed elongate to provide a lateral support structure of repeated cells formed by a plurality of strut members 15 spaced from and coupled to the fixed intersection.

Description

Patterned Sling Implants {PATTERNED SLING IMPLANT}

preference

This application claims priority to US Provisional Application No. 61 / 267,888, filed Dec. 9, 2009, Provisional Application No. 61 / 291,385, filed Dec. 31, 2009, and No. 12 / 953,268, filed November 23, 2010. Its claims are made, the entire contents of which are hereby incorporated by reference.

The present invention relates generally to a surgical method and apparatus, and more particularly to a sling device that can be surgically inserted and a method of manufacturing and using the same.

Pelvic health in men and women is a medical field of increasing importance due to an aging population. Examples of common pelvic diseases include incontinence (stool and urine), pelvic tissue prolapse (eg vaginal prolapse in women), and pelvic floor diseases.

Urinary incontinence can be classified into different types such as stress urinary incontinence (SUI), compulsive incontinence, and mixed incontinence. Urinary incontinence can be characterized by impairment or reduction in the ability of the urinary sphincter to remain closed when the bladder is full of urine. In general, stress incontinence (SUI) in men or women occurs when a patient is physically stressed.

Various means of providing mesh implants suitable for improving the support of each pelvic tissue for therapeutic purposes have been implemented over the years. For example, slings and other implant devices are known that provide support of the urethra or bladder neck for urinary incontinence treatment of patients.

Many of the implants for promoting incontinence and other pelvic disease treatment retained the material and geometric limitations of conventional stents and hernia implants. While objectively effective in their respective applications, these stents and hernia implants are naturally configured to treat very different matters. That is, the essential barrier, rigidity, and tissue fusion and compatibility requirements of the hernia mesh or vascular stent may be very different from the properties required to treat pelvic incontinence.

These traditional mesh implants have provided surprising benefits for patients suffering from incontinence, but there is still room for improvement. Accordingly, there is a desire to obtain uniquely applicable, minimally invasive, highly effective mesh supports that can be used to treat incontinence and other pelvic diseases.

The present invention describes sling implants and methods for treating pelvic diseases such as incontinence (various forms such as bowel incontinence, tension incontinence, urge incontinence, mixed incontinence, etc.) and other diseases due to muscle or ligament weakness. Other uses include plastic surgery supports, hernia repairs, and ortho repairs and supports, to name a few. Embodiments of the implant may include tissue supports, one or more extensions, and one or more anchors. Some embodiments may consist of a single sling implant. The implant may generally be constructed or formed in elongate or rectangular form, or may have a number of other compatible configurations or forms. The support is located under the tissue or organ, such as the urethra or bladder, and is suitable for support. The extension extends from the support so that the anchor can be deployed for tissue fixation.

In various embodiments, the implant may be formed into a cell patterned in a manner such as molding, die casting, laser etching, laser cutting extrusion, punching, 3-D printing, or the like. Such pattern cut or formed implants may be constructed of polymeric material to provide a lattice support structure of repeating cells. Unlike conventional implants of woven or knitted, embodiments of the present invention are a uniform single construct.

Portions of the implant may be formed of sinusoidal or other waveform strut members to control and promote stretching, expansion or contraction along a single or multiple axes. As such, the controlled and specified stress, tension, and compression distributions are encouraged along specific or local regions of the construct. In addition, portions of the implant can be coated to promote or protect additional control over swelling and tissue in-growth.

The implant can be formed such that the region or portions can include a fixation feature that facilitates the attachment and attachment of the implant to the desired tissue location. In addition to fixation to internal tissue, it is also possible to extend one or more portions of the implant out of the incision or hole of the patient.

Various anchors may be formed or provided in the implant, with or without extending tines. The anchor may be integrally formed with the implant or may be formed by cutting or otherwise. Portions or anchors of the implant can be adapted to collapse, fold or to some extent to facilitate engagement with the introducer or needle and / or to facilitate penetration and fixation of tissue.

The material and cell configuration of the sling implant can be configured to promote flexibility while providing optimal implant strength and tissue support. In addition, the stable geometric and dimensional properties of the implant provide a flexible device that can be easily positioned and deployed while avoiding the bending or jumping of the implant. This configuration generally encourages the sling implant to remain substantially planar during deployment and tissue fixation.

The sling implant or portions thereof can be modified to provide the desired control, stress distribution, fixation, stabilization, variable elongation, and the like.

1 is a perspective view of a single pattern sling implant having a transversely extending fixation feature according to an embodiment of the present invention.
FIG. 2 is a top view of the single pattern sling implant of FIG. 1. FIG.
3 is an enlarged view of a portion of the single pattern sling implant of FIG. 1.
4 is a partially enlarged view of a securing feature, transition region and extension of a single pattern sling implant according to an embodiment of the invention.
5 is a perspective view of a single patterned sling implant with transversely extending fixation features in accordance with this embodiment.
FIG. 6 is a top view of the single patterned sling implant of FIG. 5.
FIG. 7 is an enlarged view of a portion of the single patterned sling implant shown in FIG. 6.
8 is a partially enlarged view of the securing features, transition regions and extensions of a single patterned sling implant according to an embodiment of the invention.
9 is a perspective view of a single patterned sling implant with planar extension fixation features in accordance with an embodiment of the present invention.
FIG. 10 is a top view of the sling implant shown in FIG. 9.
FIG. 11 is an enlarged view of a portion of the sling implant shown in FIG. 10.
12 is a perspective view of a single patterned sling implant with planar extension fastening features in accordance with an embodiment of the present invention.
FIG. 13 is a top view of the sling implant shown in FIG. 12.
FIG. 14 is an enlarged view of a portion of the sling implant shown in FIG. 13.
15 is a perspective view of a single patterned sling implant having planar extension fixation features in accordance with an embodiment of the present invention.
FIG. 16 is a top view of the sling implant shown in FIG. 15.
FIG. 17 is an enlarged view of a portion of the sling implant shown in FIG. 16.
18 is a perspective view of a single patterned sling implant with planar extension fastening features in accordance with an embodiment of the present invention.
19 is a top view of the sling implant shown in FIG. 18.
20 is an enlarged view of a portion of the sling implant shown in FIG. 19.
21-22 illustrate an exemplary sling introducer in accordance with an embodiment of the present invention.
23-34 illustrate various patterned cell structures and spacer members for sling implants in accordance with embodiments of the present invention.
35-50 illustrate various tier zones, structures and methods for sling implants in accordance with embodiments of the present invention.

Various embodiments of the patterned sling implant 10 and method are shown in FIGS. 1-50. In general, the implant 10 may include a support 12, one or more extensions 14, and one or more fastening features 16. Extension 14 includes a material structure extending from support 12 to each fixed feature 16. The various portions of the implant 10 may be constructed of polymeric material, for example molded into a generally flat structure or cut from a generally flat thin film or sheet material. Examples of polymeric materials that can be used to construct or form the implant 10 and its components may include biocompatible materials such as polypropylene, polyethylene, fluoropolymers, and the like.

Several implants 10, structures, properties, and methods described in detail herein are described in U.S. Pat. And for use in many known implants and repair devices (eg, for men and women), including those disclosed in US Patent Publication Nos. 2010/0261955, 2002/151762 and 2002/147382. . Accordingly, the aforementioned disclosures are incorporated herein by reference in their entirety.

1-20, embodiments of various implants 10 are shown. Portions of implant 10, such as support 12 and extension 14, may be formed or patterned by a polymer molding process to create a single homogeneous non-woven or non-knitted device or configuration. Can be converted. Other embodiments may be formed from a single homogeneous sheet or film through processes such as laser cutting, die cutting, stamping, and the like. In some incontinence sling embodiments of the plant, the extension 14 may extend to nearby muscles, ligaments, or other tissues for fixation, such that the support 12 may be urethra or bladder (which includes bladder, urethra, bladder neck, It may have a configuration and form located below and supporting the mid-urethra or any position of the proximal end of the urethra. Implants can also be used to support pelvic tissues such as vaginal tissue, perineal tissue, coccygeus, levator ani, levator hiatus, and rectum.

The length, width and other dimensional characteristics, components and elements of the implant can vary widely. In an exemplary embodiment, the width at any portion may be 5-15 mm and the length from end to end may be 6-15 cm.

Repeating cells or patterns of the implant 10 form a lattice structure. Portions of the implant 10 are formed of sinusoidal or other corrugated struts 15 to control elongation or compression along a single or multiple axes, to form the desired pattern density of the overall reduced surface area, and to distribute and shape the applied load ( Allows you to control shaping. The ability to mold, form, or cut struts 15 in a nearly infinite array of sinusoidal configurations provides an implant 10 that can better fit or simulate the anisotropic behavior of physiological tissue. Various patterned implant configurations, features, and methods disclosed in US Patent No. 12 / 953,268, filed November 23, 2010 may be incorporated herein in whole or in part, the entire contents of which are hereby incorporated by reference. It is done. The controlled and intended stress distribution is enhanced along certain or more areas of the implant 10. In various embodiments, the film or unitary configuration of the implant may have a thickness T of about 0.005 to 0.012 inches, and the strut 15 may have a width W of about 0.005 to 0.012 inches. Different configurations, shapes, and sizes for the various portions of the implant 10 can be used to facilitate and facilitate the deployment, use, and support of the implant 10 disclosed herein.

In some embodiments, as shown in FIGS. 1-8, the patterned struts 15 are first angled to intersect or traverse at repetitive fixation intersections 24 to form cellular voids 26. A general pinwheel pattern is formed that includes an angular strut line 20 and a second angled strut line 22. The thickness, size, and spacing of the struts 15 can be modified to make the implant 10 having different surface area and cell density properties. The strut 15 can have a uniform or variable width or thickness, can be tapered, can include holes, and can be defined shapes and / or patterns, for example sinusoidal, square, oval, It can include triangles, elbows, straight lines or other simple or complex shapes and patterns. A unique strut 15 design and cell pattern can be included in one implant 10 to provide areas with different stress, load distribution or compression characteristics. Other post 15 designs and patterns may also be used to have the functionality described herein.

The dimensional design of the implant strut 15 may be configured to promote the desired strength and flexibility. For example, the material width J at the fixed intersection 24 may be greater than the material width I of the strut 14 in the middle of the intersections so that the strength increases at the intersection. The reinforced and wide cross sections 24 and 34 can absorb and withstand more tension or torque due to implant positioning, torsion, and general manipulation. Conversely, narrow strut portions in the middle of the intersections 24, 34 promote increased flexibility and controllability of the implant 10 during positioning and manipulation. This flexibility will also allow the implant 10 to fit well into the unique patient's body structure and to be positioned flat against this body structure to provide properties such as optimal support distribution, tissue ingrowth, and the like. Depending on the particular application, strength, flexibility, tension distribution, or other performance requirements of the implant, other dimensional ranges or ratios for the posts or posts are expected.

Additional advantages are provided for the homogeneous nonwoven design of the implant 10 and the desired area of strength (eg, fixed intersections). That is, a flexible but strong implant 10 is provided while still maintaining a low surface area, lower inflammatory response, less scarring, and increased density.

The patterned implant 10 also offers advantages over conventional woven or knitted mesh in the compression zone and longitudinal extension displacement. Conventional woven or knitted mesh implants tend to compress and narrow during longitudinal elongation, resulting in a positive Poisson effect or ratio. In contrast, the sinusoidal cell and strut configuration of the patterned implant 10 of the present invention exhibits a negative Poisson effect or ratio. In particular, when the implant 10 is loaded or stretched (eg, at ends, anchors, corners or on a flat surface), the strut and cell structure resists compression and is stable for tissue or organ support. And generally expands to provide a flat surface. The combination of strut and fixed intersection facilitates this negative Poisson effect.

As shown in FIGS. 1-3, the support 12 may have physical and design features that promote tissue or tracheal support and reduce or eliminate undesirable erosion. The support 12 can be wider than the extension 14 in some embodiments. The relatively narrow extension 14 can facilitate positioning and flexibility of the implant 10 in the patient without damaging the size and effectiveness of the support 12. In other embodiments, the support 12 may include one or more holes 13 to reduce tissue erosion and promote tissue inward growth, flexibility, and tissue support.

Embodiments of the implant 10 may include one or more transitions or transition regions 30, in particular as shown in FIGS. 4 and 8. In general, this region 30 provides a material transition between the cell configuration of the support 12 and the fastening features of the implant 10 such as, for example, anchors, eyelets. Transition region 30 may vary in size, shape, and design to provide increased strength and stress absorption / distribution for portions of implant 10 that are pulled, pushed, and twisted during deployment and positioning of implant 10. Can have Embodiments of region 30 may include an arc or straight member 30a extending to or from extension 14 and anchor 16. The member can be tapered to or from extension 14 or fixture 16 to facilitate stress and tensile distribution such that struts 15 and cells of extension 14 or support 12 can be tapered. The structure may be protected from tearing, flaring or other material breakage. Moreover, this design provides useful flexibility and handling characteristics during deployment.

9-20 and 23-24 illustrate implant 10 and / or implant cell portions having several linear, angled and shaped struts 15 to form unique patterned cell configurations. Shows. In addition, the thickness, size and spacing of the struts 15 can be modified to form an implant 10 having different surface area, void shape / size, and cell density properties. As shown in FIGS. 9, 12, 15, and 18, the support 12 is more than the extension 14 to facilitate support, reduce erosion and bunching, improve considerations, and the like. It can take a pattern or size configuration. As shown in FIGS. 23-34, the post cell pattern may be separated or symmetrically distributed by various spacer members 15a. The width, length, shape, number and distribution of the spacer member 15a connecting the geometrically shaped cavities can be modified to obtain the desired mechanical properties. Using the principle of symmetry, a uniform (eg isotropic) implant 10 can be provided in the plane of the implant 10 regardless of the direction of the applied stress. Alternatively, the implant 10 can be configured such that the mechanical properties are along the selected axis (eg, the support 12 or extension 14).

Implant 10 may also include edge features 32 such that certain edges or other portions provide a fixation point for material or tissue that passes near the implant, or serve as an aid to tissue fixation during or after deployment of implant 10. ), For example, can be formed or cut to include teeth, branches, thorns, angled areas, small slits, members, supports, stablizers, and the like.

The formed or cut cells or patterns can be configured to optimize or increase tissue ingrowth, to enhance the load along a particular portion of the implant, and to compensate for firmness, elongation, tensile strength and warpage or bunching resistance. Implant 10 (eg, supports and extensions 12, 14) may include a plurality of protrusions extending and positioned into the cell structure or strut 15 configuration of the implant. One or more protrusions may be included in some or all of the cell cavities 26 formed therein. The protrusion may extend along or across the same surface substantially as the implant 10. The protrusions can provide increased load support and contact sites without substantially increasing the surface area of the implant 10.

The structure and design of the fixing portion 16 of the implant 10 can vary greatly depending on the support needs and insertion procedures of a particular sling device (eg, FIGS. 4, 6, 11, 14, 17, 20). In certain embodiments, fixation 16 may include first and second end anchors 34, 36 extending from implant 10.

Fixings 16, such as end anchors 34, 36, are formed integrally with a single implant 10 (eg, molding), cut or otherwise formed. Fixing portion 16 includes a distal portion 40 adapted to penetrate or engage a patient's tissue and one or more extensions (eg, angled, straight, curved, etc.) to facilitate tissue fixation, or It may include a barb 42. The branches 42 may be deformed or pliable to compress or fold when a level of force is applied on the branches 42. Once the tissue is engaged with the top of the branch 42 or a force is applied from the bottom of the branch 42, the branch 42 is stretched and fixed to the tissue. In an exemplary embodiment, the anchor width (eg, branch tip to tip) may be about 4-8 mm and the anchor length (eg, tip to tail) may be about 5-10 mm.

Various embodiments of the anchor 16 may also include a barrel or fuselage 46, as shown in FIGS. 4 and 8. Fuselage portion 46 may include an interior lumen 48 that is selectively engaged with an insertion or introduction tool (eg, insertion needle tip). As shown in FIGS. 1-8, the anchor 16 may extend laterally from the surface of the extension 14 of the sling implant 10. This anchor design weakens the insertion force while increasing the desired fixation force in the tissue. As shown in FIGS. 9-20, the anchor 16 may extend therefrom along the same plane as the extension 14 of the sling implant 10.

Embodiments of the anchoring anchor 16 as shown in FIGS. 9-10 are made of anchors 34 and 36 relatively thin (eg, relative to the thickness of the support 12 and extension 14) or Can be cut. As shown in FIGS. 15-20, the anchors 34, 36 may form two mirror symmetries 37a, 37b. The mirror symmetry portions 37a and 37b can be folded together with respect to the central portion 39 to form a three-dimensional anchor so that a needle or other introducer can be secured at or near the other portion of the central portion 39 or the fixing portion 16. It may be attached to the government 16 (e.g., the hole 39a).

Fixation 16 may include various holes, slits, lumens, barrels, clips, snaps, structures or regions to facilitate selective engagement or connection with a needle or other introducer. In addition, the fixing part 16 may be integrally formed with or separate from the implant 10 or the extension part 14.

In addition to the fixing 16 described above, other configurations are also contemplated. For example, the anchors 34, 36 may be fixed to the sling implant 10 to be rotatable or axially rotatable.

Various embodiments of the implant 10 may include markings or markings to mark lines or regions that aid in deployment, positioning, and adjustment. In addition, measures or features may be included, such as scoring, pressing, compressing, or the like along one or more portions of the implant 10 to indicate trimming or sizing lines or areas.

In addition to molding or laser cutting of the implant 10, punching, die cutting, 3-D printing, and other methods or techniques may be used to manufacture or form the implant 10. Portions of the implant 10 may be coated to provide additional dilation control and to encourage or protect against tissue ingrowth. The material surface or surfaces of the implant 10 or cell may be smoothed or roughened to improve mechanical or tissue ingrowth properties.

The ability to manufacture or cut supports and extensions 12, 14, or other portions of the implant 10 in an almost myriad of configurations provides an implant that can better control or mimic the anisotropic behavior of physiological tissue. do. Or it can provide a sling implant 10 having a surface that is considerably less than a conventional mesh implant.

These configurations for the patterned sling implant 10 help to maintain the implant in a flat or predetermined face or position during deployment, which makes it easier for the doctor to position and the development of pain syndrome, erosion, etc. Decreases.

By adjusting the density of the cell pattern in embodiments of the implant 10 of the present invention, it is possible to adjust the stretching, load or strength characteristics of the implant 10 in accordance with specific needs or support requirements. Moreover, one or more materials can be used to construct the implant 10 to further control the desired load and stress properties, such as for example combining different polymers such as polypropylene, PEEK, PET, PTFE, PGA, PLA. Can be. The polymer may also be combined with a metal member to alter the strength and stretching profile of the implant 10. Stronger materials will allow a faster way to stress the stresses from the larger load areas, thereby allowing a method of selectively controlling the performance characteristics of the implant 10. Moreover, a polymer or metal frame may be provided along the periphery or other optional area of the implant 10 to provide additional strength or stiffness properties.

As described in detail herein, various structures and elements of the present invention may be integrally formed into a single body through a molding process. For example, an injection molding machine (eg Milacron Roboshot S2000i 33B machine) with internal vacuum and cooling lines can be used. Generally, dry resins such as polypropylene resins (eg, Pro-fax PD 626) are maintained for several hours at high temperatures. The mold apparatus can also be heated. Thereafter, the mold vacuum line can be activated and the injection molding cycle is started. The mold cavity is filled and the device will cool for a period of time. Upon termination, the mold will open and part ejection will commence and be ejected. The mold is then closed and the cycle for injection molding of another implant can be repeated. Other known molding processes and systems can also be used for the present invention.

Another embodiment of the implant 10 is a precision cutting device process (eg, using a DPSS laser system) to cut into implant 10 and strut 15 features and designs from a polymer of a single film or sheet. Can be prepared or cut accordingly. Alternatively, the features and portions of the implant may be stamped with this single film or sheet material.

35-50, various implants 10 and methods of forming these portions are disclosed to facilitate preferred or targeted tear areas. Thus, the implant 10 may include portions that can be removed by a doctor or other user depending on the patient's unique anatomy, surgical requirements, and the like. In general, a direct extrusion or 3-D printing method is used to create the structure or configuration of the implant 10 for the polymer to be extruded or printed onto the face to form the tier area 50. These tier regions 50 allow structures that can be separated in a controlled manner. This is useful where part of the structure or implant 10 is not needed and can be removed with or without a cutting tool. As such, damage to the part or structure of the implant 10 using the cutting tool may be avoided if desired.

The direct extrusion or 3D printing method forms the structure by pushing and pulling the thermosetting plastic above the melting point into a small orifice or nozzle device 54, as shown in FIGS. 46-48. The extruded hot plastic is “drawn” or provided on the surface of the implant (eg, strut, film, etc.) to form a tier structure such that the extrudate is one thin portion of the implant 10 or in design. Form struts, structures or features 52. By controlling how the extrudate adheres to the previously extruded or formed material, the adhesion strength can be controlled to create an area for predetermined tearing. These regions or tier structures / holdings 52 may be increased in size or thickness if more force is required to facilitate tiering, i.e., separation, and relatively thin if less separation, ie, tearing force is required. Can be formed.

As shown in FIGS. 38-50, some methods of controlling the adhesion strength of the region 50 control the amount of physical overlap PO between the new extrudate N and the old crushed material P. FIG. And controlling the time for placing the heated extrusion nozzle on the old material P to result in significant remelting and bonding flow of the fresh extrudate N and the old material P. FIG. In addition, the adhesive strength changes the number of strands or bonds of each constituting the strut (e.g., FIGS. 41-45, 49-50) and bridging the new extrudate (N) to the previous material (P). Can be controlled. As shown in FIGS. 47-50, bridging occurs when the melt is remelted and flown into small portions with a thin bridge that presses the nozzle arrangement 54 into the old material P and adheres to the new extrudate N. FIG. . Other known manufacturing methods and techniques, such as extrusion, molding, printing, and the like, may also be used to form the predetermined tier area 50 in the portions of the implant 10.

The implant 10 described above can be inserted into a patient using several different types of surgical instruments, including insertion tools that are useful tools for engaging and positioning tissue anchors and elongated incontinence slings. Various types of insertion tools are known, including those disclosed in the aforementioned references, and these types and variations thereof can be used in accordance with the present description for inserting the sling implant 10.

Examples of exemplary insertion tools are shown in FIGS. 21-228. Each tool 60 may include a handle 62, a needle 64, and an engaging distal tip 66. The handle 62 is in communication with the distal tip 66 and is adapted to selectively control the engagement and / or disengagement of portions of the implant 10 (eg, anchor 16) and distal tip 66. Device 63 may be included. Needle 64 may be spiral, straight, or curved to enumerate several. A portion of the needle 64, such as the needle tip 66, may be anchored to protect against undesirable tissue contact or penetration during initial deployment and positioning of the implant 10 (eg, prior to desired tissue fixation). And one or more barb guides adapted to receive or abut one or more branches 42.

Embodiments of the invention may be inserted into a patient to treat incontinence, such as urinary incontinence. Tool 60 (eg, needle 64) may be inserted through an incision that provides access to the pelvic region. The incision may be, for example, a vaginal incision (for a female body), a perineal incision (for a male body), a rectum or buttocks, a medial thigh or a groin, a pubic region, or the like. The needle 66 is connected to the first portion of the fixation 16 (eg, anchor 34) and positioned in a desired position to secure the fixation 16 to the target tissue, such as in an obtrurator foramen. Can be. Another part of the fixing part 16 (eg anchor 36) may be laterally deployed and secured to the other side of the supported organ (eg to a closed hole). The support 12 can then be adjusted and tensioned with respect to the supported organ / tissue (eg, urethra or bladder) as needed.

The implant 10, its various components, structures, features, materials, and methods may have a number of configurations and applications shown and described in the foregoing references. It is anticipated that various methods and tools for introducing, deploying, securing and manipulating implants to treat incontinence (eg, males and females), such as those disclosed in the aforementioned references, are also contemplated for use in the present invention.

All patents, applications, and publications cited herein are hereby incorporated by reference in their entirety as if included individually, and references included in the cited patents, applications, and publications.

Obviously, various modifications and changes of the present invention will be possible based on the contents disclosed 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 (20)

A support including a plurality of strut members spaced apart from and coupled to the plurality of fixed intersections and formed along a first plane;
First and second extensions; And
At least one anchor integrally formed with at least one of the first and second extensions and having one or more flexible branches adapted to secure to the soft tissue of the patient;
A single patterned implant for treating incontinence of a patient, comprising a single elongated nonwoven sling having a. The implant of claim 1, wherein the at least one tissue anchor extends laterally from a first plane of support. The implant of claim 1, wherein the at least one anchor extends face to the first plane of the support. 4. The implant of claim 3 wherein the at least one anchor is the same thickness as at least one of the first and second extensions. The implant of claim 1, wherein the at least one anchor comprises two opposing end anchors. The implant of claim 1, wherein the plurality of strut members have a sinusoidal shape to form a plurality of flute cell configurations. The implant of claim 1 further comprising a transition strength region extending between the at least one anchor and one of the first and second extensions of the implant. The implant of claim 1, wherein the at least one anchor comprises a lumen adapted to receive a distal end of the tool needle. The implant of claim 1, wherein the plurality of strut members comprises at least one edge fixation extending to provide engagement with tissue. The implant of claim 1 wherein the support is wider than the first and second extensions. A support having a plurality of corrugated strut members spaced apart from and coupled to the plurality of fixed intersections;
First and second extensions; And
First and second anchors extending from each of the first and second extensions and extending to secure to the soft tissue of the patient and having flexible branches; Single elongate nonwoven sling with
An insertion device having a handle and a needle, the needle including a distal tip that selectively engages the first and second anchors to facilitate deployment and tissue fixation;
Single patterned implant system for incontinence treatment of a patient comprising a. 12. The implant system of claim 11 wherein the first and second end anchors are the same thickness as the first and second extensions. 12. The implant system of claim 11 wherein the plurality of strut members have a sinusoidal shape to form a plurality of flute cell configurations. 12. The implant system of claim 11 further comprising a transition strength region extending between the first and second end anchors and one of the first and second extensions of the implant. 12. The implant system of claim 11 wherein the first and second end anchors comprise a lumen adapted to receive a distal end of a tool needle. 12. The implant system of claim 11 wherein the plurality of corrugated strut members comprises at least one edge fixation extending to provide engagement with tissue. 12. The implant system of claim 11 wherein the support is wider than the first and second extensions. 12. The implant system of claim 11 wherein the support is narrower than the first and second extensions. 12. The implant system of claim 11 further comprising an actuator for operatively communicating with the distal tip and releasably engaging the distal tissue anchor of the tip. 12. The implant system of claim 11 wherein the needle of the insertion tool is curved.

Images