KR101685431B1 - Patterned sling implant - Google Patents

Abstract

An elongated pelvic implant is provided for treating pelvic diseases such as incontinence. 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 configured or formed elongate to provide a lateral support structure of the repeated cells formed by the plurality of strut members 15 spaced from and engaging the fixed intersection.

Description

A patterned sling implant {PATTERNED SLING IMPLANT}

preference

This application claims priority to U.S. Provisional Application No. 61 / 267,888, filed December 9, 2009, Provisional Application No. 61 / 291,385, dated December 31, 2009, and Application No. 12 / 953,268, dated November 23, 2010, The entire contents of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates generally to surgical methods and devices, and more particularly to a surgically insertable sling device and a method of making and using the same.

The pelvic health of men and women is an increasingly important medical field due to the aging population. Examples of common pelvic diseases include incontinence (bowel and urine), pelvic tissue prolapse (e.g., female vaginal prolapse), and pelvic floor disease.

Incontinence may be classified into different types, such as stress incontinence (SUI), compulsive incontinence, mixed incontinence. Urinary incontinence may be characterized by impaired or reduced ability to keep the urethra sphincter closed when the bladder is full of urine. Generally, male or female tension incontinence (SUI) occurs when the patient is physically stressed.

Various means of providing a mesh implant suitable for improving the support of each pelvic tissue for therapeutic purposes have been practiced over the years. For example, sling and other implant devices are known that provide support for the urethra or bladder neck with the treatment of a patient's urinary incontinence.

Many of the implants for promoting incontinence and other pelvic disease treatments have inherent material and geometry limitations of conventional stents and hernia implants. These applications are objectively effective for each application, but these stents and hernia implants are of course constructed to treat very different things. That is, the essential barrier, rigidity, and tissue fusion and compatibility requirements of the hernia mesh or vascular stent may be very different from those required to treat incontinence of the pelvis.

These traditional mesh implants have provided incredible benefits to patients suffering from incontinence, but there is still room for improvement. Accordingly, there is a desire to obtain a unique, at least invasive, highly effective mesh support 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 incontinence, tension incontinence, incontinence incontinence, mixed incontinence, etc.) and other diseases resulting from weakening of muscles or ligaments. Other uses include plastic surgery supports, hernia repair, and ortho repairs and supports. An embodiment of an implant may include a tissue support, one or more extensions and one or more anchors. Some embodiments may consist of a single sling implant. Implants may generally be constructed or formed in elongate or rectangular form, or may have a number of other compatible configurations or configurations. The support is positioned and supported under the tissue or organ such as the urethra or bladder. The extension extends from the support so that the anchor can be deployed for tissue anchoring.

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

Portions of the implant may be formed of sinusoids or other waveform strut members to control and encourage extension, contraction or contraction along single or multiple axes. As such, the controlled and specified stress, tension, and compression distributions are facilitated along specific or localized areas of the construct. In addition, portions of the implant can be coated to further control expansion, and to protect or protect tissue in-growth.

The implant may be configured to include a fixation feature that facilitates the attachment and attachment of the implant to the desired tissue location by the region or portions. In addition to fixing to the 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, with or without tines, can be formed or provided in the implant. The anchor may be integrally formed on the implant or cut or otherwise formed. Portions or anchors of the implant can be collapsed, folded or deformed to some extent to facilitate coupling with the introducer or needle and / or to facilitate tissue penetration and fixation.

The material and cell configuration of the sling implants can be configured to promote flexibility while providing optimum implant strength and tissue bearing capacity. In addition, the stable geometric and dimensional properties of the implant provide a flexible device that can be easily positioned and deployed while avoiding undesirable bending or skipping of the implant. Generally, such a configuration encourages the sling implant to remain substantially flat during deployment and tissue fixation.

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

1 is a perspective view of a single pattern sling implant having a transverse extending and fixing characteristic according to an embodiment of the present invention.
Figure 2 is a top view of the single pattern sling implant of Figure 1;
Figure 3 is an enlarged view of a portion of the single pattern sling implant of Figure 1;
4 is a partial enlarged view of a fixation feature, a transition area and an extension of a single pattern sling implant according to an embodiment of the present invention.
5 is a perspective view of a single patterned sling implant having a transverse extending fixation feature according to this embodiment.
Figure 6 is a top view of the single patterned sling implant of Figure 5;
Figure 7 is an enlarged view of a portion of the single patterned sling implant shown in Figure 6;
Figure 8 is a partial enlarged view of a fixation feature, a transition area and an extension of a single patterned sling implant according to an embodiment of the present invention.
9 is a perspective view of a single patterned sling implant having a planar extending and securing feature according to an embodiment of the present invention.
Figure 10 is a top view of the sling implant shown in Figure 9;
11 is an enlarged view of a portion of the sling implant shown in Fig.
12 is a perspective view of a single patterned sling implant having a planar extending anchorage characteristic according to an embodiment of the present invention.
13 is a top view of the sling implant shown in Fig.
14 is an enlarged view of a part of the sling implant shown in Fig.
15 is a perspective view of a single patterned sling implant having a planar extending anchorage characteristic according to an embodiment of the present invention.
16 is a top view of the sling implant shown in Fig.
Figure 17 is an enlarged view of a portion of the sling implant shown in Figure 16;
18 is a perspective view of a single patterned sling implant having a planar extending and securing feature according to an embodiment of the present invention.
19 is a top view of the sling implant shown in Fig.
Figure 20 is an enlarged view of a portion of the sling implant shown in Figure 19;
21-22 illustrate an exemplary sling introduction device according to an embodiment of the present invention.
23-34 illustrate various patterned cell structures and spacer members for a sling implant according to an embodiment of the present invention.
35-50 illustrate various tear zones, structures and methods for sling implants according to embodiments of the present invention.

Various embodiments of the patterned sling implant 10 and method are shown in Figures 1-50. Generally, the implant 10 can include a support 12, one or more extensions 14, and one or more fixtures 16. As shown in FIG. The extension 14 includes a material structure extending from the support 12 to each fixture 16. Various portions of the implant 10 may be constructed of a polymeric material, for example, 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.

The various implants 10, structures, features, and methods described in detail herein are disclosed in U.S. Patent Nos. 7,500,945, 7,407,480, 7,351,197, 7,347,812, 7,303,525, 7,025,063, 6,691,711, 6,648,921 and 6,612,977, International Publication Nos. WO2008 / 057261 and WO2007 / 097994 , And many known implants and repair devices (e.g., for males and females), including those disclosed in U.S. Patent Nos. 2010/0261955, 2002/151762, and 2002/147382 . The disclosures of the foregoing are, therefore, incorporated herein by reference in their entirety.

Referring to Figs. 1-20, an embodiment of various implants 10 is shown. The portions of the implant 10, such as the support 12 and the extension 14, may be formed or patterned by a polymer molding process to create a single homogeneous nonwoven or non-woven or non- . Other embodiments may be formed from a single homogeneous sheet or film through a process such as laser cutting, die cutting, stamping, and the like. In some incontinence slings embodiments of the prosthesis, the extensions 14 may extend to nearby muscles, ligaments, or other tissues for fixation, so that the support 12 may include a urethra or bladder (which may be a bladder, urethra, (Including any position of the mid-urethra or proximal end of the urethra) and support it. Implants can also be used to support pelvic tissue 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 an arbitrary portion may be 5 to 15 mm and the length from the end to the end may be 6 to 15 cm.

The repeating cells or patterns of the implant 10 form a lattice structure. Portions of the implant 10 may be formed of sinusoidal or other waveguides 15 to control elongation or compression along a single or multiple axes, to form a desired pattern density of the overall reduced surface area, to determine the distribution and shape of the applied load shaping. The ability to mold, shape or cut the post 15 in an almost infinite array of configurations, such as a sinusoidal curve, provides an implant 10 that can better fit or simulate the anisotropic behavior of the physiological tissue. Various patterned implant configurations, features, and methods disclosed in U.S. Patent Application No. 12 / 953,268, filed November 23, 2010, may be included herein in whole or in part, the entire contents of which are incorporated herein by reference . The controlled and intended stress distribution is improved along certain or more areas of the implant 10. [ In various embodiments, the film or single configuration of the implant may have a thickness (T) of about 0.005 to 0.012 inches, and the post 15 may have a width (W) of about 0.005 to 0.012 inches. Different configurations, shapes, and sizes for various portions of the implant 10 can be used to facilitate and facilitate the deployment, use, and support of the implant 10 described herein.

1-8, the patterned struts 15 may have a first angled intersection or intersecting at an iterative fixed intersection 24 to form a cellular void 26. In some embodiments, A generally angular strut line 20, and a second angled strut line 22 to form a general pinwheel pattern. The thickness, size, and spacing of the post 15 can be modified to produce an implant 10 having different surface area and cell density properties. The post 15 may have a uniform or varying width or thickness, may be tapered, may include apertures, and may have a defined shape and / or pattern, such as a sinusoidal, square, Triangles, elbows, straight lines, or other simple or complex shapes and patterns. A unique post 15 design and a cell pattern can be included within one implant 10 to provide regions with different stresses, load distributions or compression properties. Other strut 15 designs and patterns may also be used to have the functionality described herein.

The dimensional design of the implant struts 15 may be configured to promote the desired strength and flexibility. For example, the material width J at the stationary intersection 24 can be greater than the material width I of the post 14 in the middle of the intersections, allowing the strength to increase at the intersection. The reinforced and wide intersections 24, 34 can absorb and tolerate more tension or torque due to positioning, torsion, and general manipulation of the implant. Conversely, the narrowed support portions intermediate the intersections 24, 34 facilitate the flexibility and controllability of the implant 10 during positioning and manipulation. This flexibility will also allow the implant 10 to fit well into a unique patient ' s body structure and provide an optimal positioning of the body structure to provide optimal support distribution, tissue inward growth, and the like. Depending on the particular application, strength, flexibility, tensile distribution, or other performance requirements of the implant, other dimensional ranges or ratios for the support or support parts are expected.

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

The patterned implant 10 also provides advantages over conventional woven or knitted mesh in the compression region and longitudinal extension. Conventional woven or knitted mesh implants tend to compress and narrow during longitudinal stretching, indicating a positive Poisson effect or ratio. Conversely, the sinusoidal cell and stalk 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 (e.g., at ends, anchors, corners, or on a flat surface), the post and cell structures resist compression and are stable for tissue or organ support And is generally expanded to provide a flat surface. The combination of column and fixed intersection facilitates this negative Poisson effect.

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

Embodiments of the implant 10 may include one or more transition or transition regions 30, as shown in particular in Figures 4 and 8. Generally, this region 30 provides a material transition between the fixture features of the implant 10, such as the cell configuration of the support 12 and anchor, eyelet, for example. The transition region 30 may have various sizes, shapes and designs to provide increased strength and stress absorption / distribution for portions of the implant 10 that are pulled, pushed, and twisted during deployment and positioning of the implant 10 Lt; / RTI > An embodiment of the region 30 may include an arc or a straight member 30a extending into or from the extension 14 and the fixed portion 16. The member may be tapered into or out of the extension 14 or the fixture 16 to facilitate stress and tensile distribution so that the extension 15 or support 15 of the extension 14 or support 12, The structure can be protected from tearing, widening, or breakage of other materials. Moreover, this design provides useful flexibility and handling characteristics during deployment.

The embodiments of FIGS. 9-20 and 23-24 may be used to implant the implant 10 and / or the implant cell portions with various linear, angled and shaped struts 15 to form unique patterned cell configurations Show. In addition, the thickness, size and spacing of the struts 15 can be modified to form an implant 10 having different surface areas, void shape / size, and cell density properties. As shown in Figures 9, 12, 15 and 18, the support 12 may include a support portion 14 that is different from the extension portion 14 to facilitate support, reduce erosion and bunching, You can take a pattern or size configuration. As shown in Figs. 23-34, the holding cell patterns can be separated or symmetrically distributed by the various spacer members 15a. The width, length, shape, number and distribution of the spacer members 15a connecting the openings of the geometric shape can be modified to obtain desired mechanical properties. Using the principle of symmetry, a uniform (e.g., isotropic) implant 10 can be provided in the plane of the implant 10, regardless of the direction of applied stress. Alternatively, the implant 10 can be constructed such that the mechanical properties are along a selected axis (e.g., the support 12 or extension 14).

The implant 10 may also be used to provide a fixed portion 32 or other portion of the implant 10 or other portions of the implant 10 to provide a fixation point for the material or tissue that passes near the implant, And may be formed or cut to include, for example, teeth, branches, spines, angular portions, small and thin wisps, members, supports, stablizers and the like.

The formed or cut cell or pattern can be configured to optimize or increase tissue in vivo growth, improve the endurance load along a particular portion of the implant, and compensate for durability, elongation, tensile strength, and bowing resistance. The implant 10 (e.g., the support and extensions 12, 14) may include a plurality of protrusions that extend into the cell structure or strut 15 configuration of the implant. May be included in some or all of the cell openings 26 in which one or more projections are formed. The protrusions may extend along substantially the same plane as the implant 10 or across the backside. The projections can provide an increased load bearing and contact area without increasing the surface area of the implant 10 substantially.

The structure and design of the fixation portion 16 of the implant 10 can be largely changed according to the support requirement of the specific sling device (for example, Figs. 4, 6, 11, 14, 17, 20) and the insertion procedure. In certain embodiments, the anchoring portion 16 may include first and second end anchors 34, 36 extending from the implant 10.

Fixing portions 16, such as end anchors 34 and 36, are formed (e.g., molded), cut or otherwise formed integrally with a single implant 10. The fixation portion 16 may include a distal portion 40 that is pierced or mated with the patient's tissue and one or more elongate branches (e.g., angled, straight, curved, etc.) Barbs 42 may be included. The branches 42 may be deformed or flexible to compress or fold when a certain level of force is applied to the branches 42. Once tissue is engaged with the top of the branch 42 or force is applied from the bottom of the branch 42, the branch 42 is stretched and secured to the tissue. In an exemplary embodiment, the anchor width (e.g., from the tip to the tip) is about 4 to 8 mm and the anchor length (e.g., tip to tail) can be about 5 to 10 mm.

Various embodiments of the anchor fixing portion 16 may also include a barrel or bodysection 46, as shown in Figs. The fuselage portion 46 may include an interior lumen 48 adapted to selectively engage an insertion or introduction tool (e.g., an insertion needle tip). 1-8, the anchor fixture 16 may extend transversely from the extension 14 side of the sling implant 10. These anchor anchor designs reduce the insertion force while increasing the desired fixation force within the tissue. As shown in FIGS. 9-20, the anchor fixing portion 16 may extend therefrom along the same plane as the extension 14 of the sling implant 10.

An embodiment of the anchor fixing portion 16 as shown in Figures 9-10 may be manufactured with relatively thin (e.g., compared to the thickness of the support 12 and extension 14) anchors 34,36. Or cut. As shown in Figs. 15-20, the anchors 34 and 36 can form two mirror symmetry portions 37a and 37b. The mirror symmetry portions 37a and 37b can be folded with respect to the central portion 39 so as to form a three dimensional anchor so that the needle or other introduction device can be moved to the other portion of the central portion 39 or the fixing portion 16, May be attached to the portion 16 (e.g., hole 39a).

The fixation portion 16 may include various holes, slits, lumens, barrels, clips, snaps, structures, or areas that facilitate selective engagement or connection with a needle or other introduction device. In addition, the fixation portion 16 may be integrally formed with or separately from the implant 10 or the extension portion 14. [

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

Various embodiments of the implant 10 may include markings or markings to mark the line or area to aid in deployment, positioning, and adjustment. In addition, measures or features such as scoring, indenting, squeezing, etc. along one or more portions of the implant 10 may be included 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 fabricate or form the implant 10. Portions of the implant 10 provide additional dilatation control and may be coated to promote or protect tissue atrioventricular growth. The material surface or surfaces of the implant 10 or cell can be smooth or rough to improve mechanical or tissue atrio-growth characteristics.

The ability to make or cut the support and the extensions 12, 14, or other parts of the implant 10 in an almost infinite number of configurations provides an implant that can better control or mimic the anisotropic behavior of the physiological tissue do. Or it can provide a sling implant 10 with significantly fewer surfaces than conventional mesh implants.

These configurations for the patterned sling implants 10 help to keep the implant flat or on a predetermined plane or position during deployment, which allows the physician to more easily position it, and may cause pain syndrome, erosion or the like .

By adjusting the density of the cell pattern in the embodiment of the implant 10 of the present invention, it is possible to adjust the elongation, load or strength characteristics of the implant 10 according to a specific need or support requirement. Moreover, one or more materials may be used to construct the implant 10 to further control the desired load and stress characteristics, such as, for example, bonding different polymers such as polypropylene, PEEK, PET, PTFE, PGA, PLA . The polymer may also be combined with a metallic member to alter the strength and elongation profile of the implant 10. A stronger material will allow a method to selectively control the performance characteristics of the implant 10 by more quickly stressing from a larger load area. Moreover, a polymer or metal frame may be provided along the perimeter or other selected areas of the implant 10 to provide additional strength or rigidity characteristics.

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

Another embodiment of the implant 10 includes a precise cutting device process (e.g., using a DPSS laser system) to cut into a single piece of film or sheet polymer material with the implant 10 and stalk 15 features and designs, ≪ / RTI > Or the characteristic portions and portions of the implant can be stamped into this single film or sheet material stock.

35-50, various implants 10 and methods of forming these portions are disclosed to facilitate a preferred or intended tear region. Thus, the implant 10 may include portions that can be removed by a physician or other user, depending on the patient's unique anatomical structure, surgical requirements, and the like. Generally, a direct extrusion or 3-D printing method is used to produce the structure or configuration of the implant 10 for polymer extrusion or printing to form the tier region 50. These tiered regions 50 allow structures that can be separated in a controlled manner. This is useful when the structure or part of the implant 10 is not needed and can be removed without or with a cutting tool. As such, if a cutting tool is used and some damage to the structure or structure of the implant 10 is desired, it can be avoided.

The direct extrusion or 3D printing method forms the above structure by sliding the thermosetting plastic above the melting point into a small orifice or nozzle arrangement 54 and drawing it out, as shown in Figures 46-48. The extruded hot plastic is provided to the surface (e.g., struts, films, etc.) of the implant to "drawn" or form a tier structure so that the extrudate can be applied to a portion of the implant 10, A support, a structure or a characteristic portion 52 is formed. Adhesive strength can be controlled to create a zone for a predetermined tearing by controlling how the extrudate adheres to previously extruded or formed material. These regions or tier structures / pillars 52 can be increased in size or thickness if more force is required to facilitate tearing, i.e., separation, and less separation or tearing force is required, .

38-50, some methods of controlling the bond strength of the area 50 may be used to control the amount of physical overlap (PO) between the new extrudate (N) and the previous crushed material (P) And controlling the time to place the heated extrusion nozzle on the previous material P to cause significant re-melting and bonding flow of the new extrudate N and the previous material P. The adhesive strength also changes the number of strands or bonds that make up the post (e.g., Figs. 41-45, 49-50) and bridges the new extrudate N to the previous material P ). ≪ / RTI > As shown in Figures 47-50, bridging occurs when the nozzle device 54 is pressurized with a previous material P to remelted and flow the bovine portion with a thin bridge that bonds to the new extrudate N . Other well-known manufacturing methods and techniques, such as extrusion, molding, printing, and the like, can be used to form predetermined tier regions 50 in the portions of the implant 10.

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

Examples of exemplary insertion tools are shown in Figures 21-228. Each tool 60 may include a handle 62, a needle 64, and a coupling distal tip 66. The handle 62 is in communication with the distal tip 66 and is operable to selectively control engagement and / or disengagement of portions (e.g., anchor 16) and distal tip 66 of the implant 10 Device 63 as shown in FIG. The needles 64 may be spiral, straight, or curved to name a few. A portion of the needle 64, such as the needle tip 66, is secured to the anchor fixture 60 to protect it from undesirable tissue contact or penetration during initial deployment and positioning of the implant 10 (e.g., prior to targeted fixation of the tissue) And one or more barb guides adapted to receive or receive one or more branches 42 of the barb 16.

Embodiments of the present invention may be inserted into a patient to treat incontinence, such as urinary incontinence. The tool 60 (e.g., the needle 64) may be inserted through an incision providing access to the pelvic region. The incision may be, for example, an incision in the vaginal incision (in the case of the female body), perineal incision (in the male body), rectum or hip, medial femur or groin, The needle 66 is connected to the first site (e.g., anchor 34) of the fixture 16 and is positioned at a desired location to secure the fixture 16 to a target tissue, such as in an obtrurator foramen. . The other part of the fixing part 16 (for example, the anchor 36) can be laterally expanded and fixed to the other side of the supported organs (for example, in the closing hole). The support 12 may then be adjusted and tensioned against the supported organ / tissue (e.g., urethra or bladder) as needed.

The various components, structures, features, materials, and methods of the implant 10 can have numerous configurations and applications shown and described in the foregoing references. It is contemplated that various methods and tools for introducing, deploying, fixing and manipulating implants to treat incontinence (e.g., male and female), such as those disclosed in the foregoing references, are also contemplated for use in the present invention.

All patents, patent applications, and publications cited herein are hereby incorporated by reference in their entirety, including references contained in the cited patents, applications and publications.

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

A support (12) comprising a plurality of strut members (15) spaced from and joined to a plurality of fixed intersections (24) and formed along a first plane;
First and second extensions 14;
At least one securing portion (16) integrally formed on at least one of the first and second extensions (14) and having at least one flexible branch (42) adapted to be secured to the soft tissue of the patient; And
The method of any one of the preceding claims, wherein the at least one fixation portion (16) and the first portion of the implant (10) are dimensioned to facilitate stress or tension distribution between the at least one fixation portion (16) and one of the first and second extensions (30) extending between one of the first and second extensions (14) and each including a plurality of arcuate members (30a) curved inward toward the at least one fixed portion (16);
≪ / RTI > A single, patterned implant for treating a patient ' s incontinence. The implant according to claim 1, wherein said at least one fixation portion (16) extends laterally from a first plane of said support (12). 2. The implant according to claim 1, wherein said at least one fixation portion (16) extends in a plane with respect to a first plane of the support (12). 4. The implant according to claim 3, wherein the at least one fixation portion (16) is equal in thickness to at least one of the first and second extensions (14). The implant according to claim 1, wherein said at least one fixation portion (16) comprises two opposed end anchors. The implant according to claim 1, wherein the plurality of strut members (15) have a sinusoidal shape so as to form a plurality of leaflet cell configurations.
delete 2. The implant of claim 1, wherein said at least one fastener (16) comprises an lumen (48) adapted to receive a distal tip (66) of a needle tool (60). The implant according to claim 1, wherein the plurality of strut members (15) comprises at least one side fixing part (32) extended to provide engagement with tissue. The implant according to claim 1, wherein the support (12) is wider than the first and second extensions (14). delete delete delete delete delete delete delete delete delete delete

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