JP5833563B2 - Patterned sling implant - Google Patents

Description

This application includes US Provisional Application No. 61 / 267,888 filed on December 9, 2009, US Provisional Application No. 61 / 291,385 filed on December 31, 2009, and November 23, 2010. All of which are hereby incorporated by reference in their entirety, and claim the priority and benefits of US Ser. No. 12 / 953,268, filed in.
The present invention relates generally to surgical methods and apparatus, and more particularly to surgically implantable sling devices and methods of forming and using the same.

  Pelvic health for men and women is an increasingly important medical field due, at least in part, to the mature population. Examples of common pelvic diseases include incontinence (feces and urine), pelvic tissue prolapse (eg, female vaginal prolapse), and pelvic floor disease.

  Urinary incontinence can be further classified as different types such as stress urinary incontinence (SUI), urge urinary incontinence, mixed urinary incontinence, among others. Urinary incontinence can be characterized by a loss or decrease in the ability to close the urethral sphincter as the bladder fills with urine. Male or female SUI generally occurs when a patient is physically under pressure.

  Over the years, many strategies have been implemented to provide mesh-type implants that can enhance the therapeutic support of each pelvic tissue. For example, slings and other implant devices that provide urethral or bladder neck support in treating patient urinary incontinence are known.

  Many of the implants developed to treat incontinence and other pelvic disorders are and continue to be constrained by the materials and geometry of existing stents and hernia implants. While objectively effective in their respective applications, such stents and hernia implants are inherently configured to address very different tissues. That is, the barrier, stiffness, and tissue compatibility and compatibility requirements required for hernia mesh or vascular stent-implants are needed to treat pelvic incontinence. The characteristics can be very different.

  Although these customary mesh implants have provided considerable benefits to those suffering from incontinence, there is still room for improvement. As a result, an implantable sling support that can be used to treat incontinence or other pelvic disorders and diseases, is inherently applicable, minimally invasive, and highly There is a desire for realization of a sling support that is effective.

  The present invention treats pelvic diseases such as incontinence (various forms such as fecal incontinence, stress urinary incontinence, urge incontinence, mixed incontinence) and other diseases caused by muscle or ligament weakness A sling implant and method for doing so is described. Some other uses include plastic surgery, hernia repair, and the provision of a support or platform for orthopedic repair and support. Embodiments of the implant may include a tissue support portion, one or more extensions, and one or more anchors. Certain embodiments may be configured as a single sling implant. The implant can be configured or formed in a generally elongated or rectangular shape, or can employ a number of other compatible configurations or shapes. The support portion may be positioned below and support a tissue or organ such as the urethra or bladder. The extension portion extends from the support portion so that each anchor or locking feature can be deployed for tissue fixation.

  In various embodiments, the implant may be formed by a plurality of patterned sections by molding, die casting, laser etching, laser cutting, extrusion, stamping, 3D printing, and the like. An implant cut or formed in such a pattern can be made of a polymer material to provide a lattice-like support structure consisting of a plurality of compartments. Unlike conventional implants that are woven or knitted, embodiments of the present invention are uniform, unitary structures.

  Each portion of the implant can be formed into a sinusoidal or another corrugated strut member to control and facilitate extension, expansion or contraction along a single or multiple axes. Hence, a controlled and specified distribution of stress, tension and compressive force is facilitated over a specific or confined area of the structure. In addition, each portion of the implant can be coated to provide additional control of spreading and prevent or promote tissue ingrowth.

  The implant can be configured to facilitate engagement and attachment of the implant to a target tissue site, with each region or portion including a locking specific structure. In addition to anchoring to internal tissue, it is also possible to extend one or more portions of the implant outward from the patient's incision or opening.

  For such implants, various anchors with or without extending tines can be defined, formed, or otherwise deployed. Each anchor can be integrally formed, cut or otherwise defined with respect to the implant. Each portion of the implant or anchor may collapse, fold, or otherwise deform to a certain degree to facilitate engagement with the introducer or needle device and / or tissue penetration or Fixing can be promoted.

  The sling implant material and compartment structure may be configured to promote flexibility while still providing optimal implant strength and tissue support. In addition, the stable geometric and dimensional attributes of the implants are flexible so that they can be easily positioned and deployed while avoiding undesirable bowing or bunching of the implants. A device is provided. Such a configuration facilitates a sling implant that can remain substantially in a predetermined plane during deployment and tissue fixation.

  The sling implant, or portions thereof, can be adapted to provide the desired accommodation, stress distribution, anchoring, stability, variable elongation, and the like.

1 is a perspective view of a unitary patterning sling implant having a locking specific structure extending generally laterally according to an embodiment of the present invention. FIG. FIG. 2 is a plan view of the unitary patterned sling implant of FIG. FIG. 3 is a partially enlarged view of a portion of the unitary patterned sling implant of FIG. FIG. 3 is a partially enlarged view of a particular structure for anchoring a single patterned sling implant, a transition area and an extension portion according to an embodiment of the present invention. 1 is a perspective view of a unitary patterning sling implant having a locking specific structure extending generally laterally according to an embodiment of the present invention. FIG. FIG. 6 is a plan view of the unitary patterned sling implant of FIG. FIG. 7 is a partially enlarged view of a portion of the unitary patterned sling implant of FIG. 6. FIG. 3 is a partially enlarged view of a particular structure for anchoring a single patterned sling implant, a transition area and an extension portion according to an embodiment of the present invention. 1 is a perspective view of a unitary patterning sling implant having a planar extending locking specific structure according to an embodiment of the present invention. FIG. FIG. 10 is a plan view of the unitary patterned sling implant of FIG. 9. FIG. 11 is a partially enlarged view of a portion of the unitary patterned sling implant of FIG. 1 is a perspective view of a unitary patterning sling implant having a planar extending locking specific structure according to an embodiment of the present invention. FIG. FIG. 13 is a plan view of the unitary patterned sling implant of FIG. 12. FIG. 14 is a partially enlarged view of a portion of the unitary patterned sling implant of FIG. 13. 1 is a perspective view of a unitary patterning sling implant having a planar extending locking specific structure according to an embodiment of the present invention. FIG. FIG. 16 is a plan view of the unitary patterned sling implant of FIG. 15. FIG. 17 is a partially enlarged view of a portion of the unitary patterned sling implant of FIG. 1 is a perspective view of a unitary patterning sling implant having a planar extending locking specific structure according to an embodiment of the present invention. FIG. FIG. 19 is a plan view of the unitary patterned sling implant of FIG. FIG. 20 is a partially enlarged view of a portion of the unitary patterned sling implant of FIG. 19. It is a figure which shows the typical sling introduction tool which concerns on embodiment of this invention. It is a figure which shows the typical sling introduction tool which concerns on embodiment of this invention. FIG. 6 shows various patterned compartment configurations and spacer elements for a sling implant according to an embodiment of the present invention. FIG. 6 shows various patterned compartment configurations and spacer elements for a sling implant according to an embodiment of the present invention. FIG. 6 shows various patterned compartment configurations and spacer elements for a sling implant according to an embodiment of the present invention. FIG. 6 shows various patterned compartment configurations and spacer elements for a sling implant according to an embodiment of the present invention. FIG. 6 shows various patterned compartment configurations and spacer elements for a sling implant according to an embodiment of the present invention. FIG. 6 shows various patterned compartment configurations and spacer elements for a sling implant according to an embodiment of the present invention. FIG. 6 shows various patterned compartment configurations and spacer elements for a sling implant according to an embodiment of the present invention. FIG. 6 shows various patterned compartment configurations and spacer elements for a sling implant according to an embodiment of the present invention. FIG. 6 shows various patterned compartment configurations and spacer elements for a sling implant according to an embodiment of the present invention. FIG. 6 shows various patterned compartment configurations and spacer elements for a sling implant according to an embodiment of the present invention. FIG. 6 shows various patterned compartment configurations and spacer elements for a sling implant according to an embodiment of the present invention. FIG. 6 shows various patterned compartment configurations and spacer elements for a sling implant according to an embodiment of the present invention. FIG. 3 shows various dehiscence zones, structures and methods for a sling implant according to an embodiment of the present invention. FIG. 3 shows various dehiscence zones, structures and methods for a sling implant according to an embodiment of the present invention. FIG. 3 shows various dehiscence zones, structures and methods for a sling implant according to an embodiment of the present invention. FIG. 3 shows various dehiscence zones, structures and methods for a sling implant according to an embodiment of the present invention. FIG. 3 shows various dehiscence zones, structures and methods for a sling implant according to an embodiment of the present invention. FIG. 3 shows various dehiscence zones, structures and methods for a sling implant according to an embodiment of the present invention. FIG. 3 shows various dehiscence zones, structures and methods for a sling implant according to an embodiment of the present invention. FIG. 3 shows various dehiscence zones, structures and methods for a sling implant according to an embodiment of the present invention. FIG. 3 shows various dehiscence zones, structures and methods for a sling implant according to an embodiment of the present invention. FIG. 3 shows various dehiscence zones, structures and methods for a sling implant according to an embodiment of the present invention. FIG. 3 shows various dehiscence zones, structures and methods for a sling implant according to an embodiment of the present invention. FIG. 3 shows various dehiscence zones, structures and methods for a sling implant according to an embodiment of the present invention. FIG. 3 shows various dehiscence zones, structures and methods for a sling implant according to an embodiment of the present invention. FIG. 3 shows various dehiscence zones, structures and methods for a sling implant according to an embodiment of the present invention. FIG. 3 shows various dehiscence zones, structures and methods for a sling implant according to an embodiment of the present invention. FIG. 3 shows various dehiscence zones, structures and methods for a sling implant according to an embodiment of the present invention.

  Referring generally to FIGS. 1-50, various embodiments of a patterned sling implant 10 and method are shown. In general, the implant 10 can include a support portion 12, one or more extension portions 14, and one or more locking features 16. Each extension 14 includes a material configuration that extends from the support portion 12 to a respective locking specific structure 16. The various parts of the implant 10 may be constructed from a polymer material, for example, into a molded structure that is generally planar, or from a thin, generally planar thin film or thin body material. Can be cut out. Examples of acceptable polymeric materials that can be utilized in configuring or forming the implant system 10 and its components include polypropylene, polyethylene, fluoropolymer, or similar biocompatible materials.

  Various implants 10, structures, specific shapes and methods detailed herein are described in U.S. Patent 7,500,945, U.S. Patent 7,407,480, U.S. Patent 7,351,197, U.S. Patent 7,347,812, U.S. Patent No. US Patent No. 7,025,063, US Patent No. 6,691,711, US Patent No. 6,648,921, US Patent No. 6,612,977, International Patent Publication No.WO 2008/057261, International Patent Publication No. Many known implants and repair devices (e.g., for men and women), including those disclosed in Publication No. 2010/0261955, U.S. Publication No. 2002/151762 and U.S. Publication No. 2002/147382 It is contemplated for use with specific shapes and methods. Thus, each of the disclosures identified above is hereby incorporated by reference in its entirety.

  Referring generally to FIGS. 1-20, various embodiments of a sling implant 10 are shown. Portions of implant 10, such as support portion 12 and extension portion 14, can be formed or patterned by a polymer molding process to create a single, uniform, non-woven or non-woven device or construct. Other embodiments may already be formed from a single, uniform thin or thin film by laser cutting, stamping, stamping, and similar techniques. In certain incontinence sling embodiments of the implant, the support portion 12 allows the extension portion 14 to extend outward to nearby muscles, ligaments, or other tissues for anchoring, ( It may be configured and shaped to be positioned under and support the urethra or bladder (including the bladder, urethra, bladder neck, middle urethra, or the proximal end of the urethra). The implant can also be used to support pelvic tissue such as vaginal tissue, perineal tissue, coccyx, levator ani, levator hiatus, and rectum.

  The various lengths, widths, and other dimensional characteristics of the implant, portions and components can be varied greatly. In an exemplary embodiment, the implant width can be anywhere from about 5 mm to 15 mm and the length between the ends can be about 6-15 cm.

  Repeated sections or patterns of the implant 10 generally form a lattice structure. Each part of the implant 10 is cut into a sinusoidal, other corrugated, or undulating strut 15 pattern to control expansion or contraction along single or multiple axes. Thus, the desired pattern density can be defined with an overall reduced surface area, and the distribution and shaping due to the applied load can be controlled. The ability to mold, form or cut each strut 15 into a sinusoidal or similar shaped, infinite array, can better fit or mimic the anisotropic behavior of physiological tissue An implant 10 is provided. The various patterned implant configurations, specific structures and methods disclosed in U.S. Patent Application No. 12 / 953,268, filed November 23, 2010, are included in whole or in part with embodiments of the present invention. And is incorporated herein by reference in its entirety. A controlled and specified stress distribution is facilitated over a specific or larger area of the implant 10. In various embodiments, the thin film or unitary configuration of the implant can have a thickness T of about 0.127 mm to 0.508 mm (about 0.005 inch to 0.020 inch) and the strut 15 is about 0.127 mm to 0.305 mm. It may have a width W (approximately 0.005 inches to 0.012 inches). Other configurations, shapes and sizes for the various portions of the implant 10 may also be employed to facilitate and facilitate deployment, use and support of the implant 10 disclosed herein.

  In certain embodiments, such as depicted in FIGS. 1-8, the plurality of patterned struts 15 intersect or intersect at a repetitive fixed joint 24 to define a compartmental cavity 26. A generally pinwheel-like design is defined that includes a static strut line 20 and a second angular strut line 22. The thickness, size and spacing of each strut 15 can be modified to create an implant 10 with different surface area and compartment density attributes. Each strut 15 may have a uniform or variable width or thickness, may include apertures, or may be, for example, L-shaped, straight, or other simple or complex shapes and patterns It may include a predetermined shape and / or pattern. Unique strut 15 design aspects and compartmentalized patterns can be included within a single implant 10 to provide different areas with different stress, load distribution or compression characteristics. Other strut 15 design embodiments and patterns may also be employed to achieve the functionality described and depicted herein.

  The dimensional design of the implant strut 15 can be set to promote targeted strength and flexibility. For example, the material width in the fixed joint portion 24 is appropriately larger than the material width W of each strut 14 in the middle of each joint portion, thereby allowing a large strength in each joint portion. The strengthened and widened joint 24 can cope with and absorb larger stresses or torques due to implant positioning, twisting, and general manipulation. Conversely, the thinner strut portion in the middle of each joint 24 facilitates greater flexibility and controllability of the implant 10 during positioning and device operation. This flexibility is also an implant 10 that can be appropriately conformed to the patient's unique anatomy, lying flat against the anatomy, so that an optimal support distribution, An implant 10 that provides tissue ingrowth and similar properties is also realized. Other dimensional ranges and characteristics are contemplated for each strut and strut portion embodiment, depending on the particular application, strength, flexibility, stress distribution, or other performance requirements of the implant.

  Additional advantages are provided by the uniform nonwoven design aspect of the implant 10 and the targeted strength region (eg, fixed joint). That is, a flexible but powerful implant 10 is provided while still maintaining low surface area, low inflammatory response, low scarring, and high density.

  The patterned sling implant 10 also provides advantages over a conventionally knitted or woven mesh in terms of pressure area and reaction to longitudinal elongation stress. Conventionally knitted or woven mesh implants may tend to exhibit a positive Poisson effect or ratio by being compressed, narrowed, rounded, or folded during longitudinal stretching. . Conversely, the sinusoidal, pinwheel-like compartment and strut shape of the patterned implant 10 of the present invention may exhibit a negative Poisson effect or ratio. In particular, as the implant 10 is loaded or stretched (eg, at each end, anchor, corner corner, or on a planar surface), the strut and compartment structures resist compression. With moderate expansion together, it can provide a stable, generally planar surface for tissue or organ support. The combination of each strut and each fixed joint promotes this negative Poisson effect.

  As shown in FIGS. 1-3, the support portion 12 may exhibit physical and design properties that promote tissue or organ support and reduce or eliminate adverse erosion. In certain embodiments, the support portion 12 may be reasonably wider than each extension portion 14. Each relatively narrow extension portion 14 may facilitate flexibility and positioning of the implant 10 within the patient's body without impairing the size and effectiveness of the support portion 12. In other embodiments, the support portion 12 is one or more apertures 13 that can reduce tissue erosion and promotes tissue ingrowth, flexibility, and support for the tissue. An aperture 13 may be included.

  Embodiments of the implant 10 may include one or more transition portions or sections 30, particularly as shown in FIGS. In general, each zone 30 provides a material transition between the compartmental configuration of the extension 14 and a particular structure, such as for anchoring the implant 10, such as an anchor, eyelet, or the like. The transition zone 30 employs various sizes, shapes and design aspects to provide greater strength and stress absorption / distribution for each portion of the implant 10 that is pulled, pressed and twisted during deployment and positioning of the implant 10. Can be provided. Embodiments of section 30 may include an arcuate or straight member 30a that extends outwardly from extension portion 14 to locking portion 16 or vice versa. Each member is tapered toward the extension portion 14 or the locking portion 16, or vice versa, so that each strut 15 and the compartmental structure of the extension portion 14 or the support portion 12 is torn, torn, Alternatively, stress and tension distributions can be facilitated so that they are protected from other material failures. Such a design aspect further provides suitable flexibility and operational characteristics during deployment.

  The embodiments of FIGS. 9-20 and FIGS. 23-34 have implants 10 having a variety of linear and angled struts 15 to define a unique patterned compartment configuration and / or Or illustrates the implant section. Again, the thickness, size, shape and spacing of each strut 15 can be modified to create an implant 10 with different surface area, void or pore shape / size, and compartment density attributes. As shown in FIGS. 9, 12, 15 and 18, the support portion 12 employs a different pattern or size configuration than the extension portion 14 to facilitate support and reduce erosion and rounding. Or similar matters may be promoted. As shown in FIGS. 23 to 34, the strut section patterns can be separated by various spacer elements 15a or distributed symmetrically. The width, length, shape, number and distribution of spacer elements 15a connecting each geometrical gap can be varied to achieve the desired mechanical properties. Using the principle of symmetry, an implant 10 can be provided that mechanical properties are uniform in the plane of the implant 10 regardless of the direction of applied (eg, isotropic) stress. Alternatively, the implant 10 (such as the support portion 12 or the extension portion 14) can be configured to have significantly different mechanical properties along a selected axis.

  In addition, the implant 10 may have certain edges or other parts such as teeth, tines, tongues, angled parts, tufts, members, struts, stabilizing members, or other similar An edge-specific structure 32, such as a specific structure, that provides a capture point for material or tissue passing in the vicinity of the implant, or of auxiliary tissue anchoring means during or after deployment of the implant 10. It may be formed or cut out so as to include an edge-specific structure 32 that plays a role.

  Each shaped or cut-out section or pattern is designed to optimize or enhance tissue ingrowth, promote load bearing along selected portions of the implant, and provide stiffness, elongation, tensile strength and warpage. Alternatively, it can be configured to compensate for rounding resistance. The implant 10 (eg, portions 12, 14) may include a plurality of ridges or protrusions located generally extending within the compartment structure or strut 15 of the implant 10. One or more protrusions may be included in any or all of the compartment voids within a given compartment void 26. Each protrusion may extend along substantially the same plane as the implant 10 or in a direction perpendicular to the plane. Each protrusion may provide a number of load bearing points and contact points without significantly increasing the surface area of the implant 10.

  The structure and design aspects of the anchoring specific structure 16 of the implant 10 is dependent on the specific implantation and support of the specific sling device (eg, FIGS. 4, 8, 11, 14, 17, and 20). Depending on the requirements, it can vary greatly. In certain embodiments, anchor portion 16 may include first and second end anchors 34, 36 extending from implant 10.

  Locking features 16, such as end anchors 34, 36, can be formed (eg, molded), cut out, or otherwise defined integrally with the unitary implant 10. Anchor 16 extends distally 40 that can penetrate or otherwise engage tissue within the patient's body and to facilitate tissue fixation (e.g., angled, straight, curved, etc.). One or more tines or barbs 42 may be included. The tines 42 are generally bendable or deformable to allow for compressibility or collapse when a predetermined level of force is applied to the top of the tines 42. Once the tissue has captured the tip of each tine 42, or once a force has been applied from the underside of each tine 42, each tine 42 expands and settles against the tissue. In an exemplary embodiment, the anchor width (e.g., between the tip of the tines) can be about 4 mm to 8 mm, and the anchor length (e.g., from the tip to the tail) can be about 5 mm to 10 mm. .

  As shown in FIGS. 4 and 8, various embodiments of anchor 16 may further include a cylinder or body portion 46. The body portion 46 can include an inner lumen 48 that can be selectively engaged with an insertion or introduction tool (eg, an insertion needle tip). As shown in FIGS. 1-8, the anchor 16 may extend in a generally orthogonal direction from the plane of each extension 14 of the sling implant 10. Such anchor design aspects can also increase the desired retention force in the tissue while reducing the insertion force. As shown in FIGS. 9-20, the anchor 16 may extend outwardly from the same plane as each extension 14 of the sling implant 10, generally along that plane.

  The embodiment of the locking feature 16 as depicted in FIGS. 9-10 is formed into relatively thin anchors 34, 36 (eg, relative to the thickness of the support portion 12 or extension portion 14). Or can be cut out. As shown in FIGS. 15-20, anchors 34, 36 may define two portions 37a, 37b that are generally mirrored. The portions 37a, 37b are relative to the locking specific structure 16 at or near the central portion 39 or any other portion of the locking specific structure 16 (for example, in a specific shape, structure, or aperture 39a). A generally 3D anchor can be created by folding together around the central portion 39 so that a needle or other introducer device can be attached.

  Any of the locking specific structures 16 may include needles or other introducer devices by including various apertures, slits, inner holes, cylinders, clips, clasps, structures, or regions. Connection or selective engagement with can be facilitated or addressed. In addition, the locking feature 16 can be integrally formed with the implant 10 or extension 14 or can be separate and coupled thereto.

  In addition to the locking portion 16 depicted herein, other configurations are contemplated. For example, the anchors 34, 36 can be rotationally or pivotally secured to the sling implant 10.

  Various embodiments of the implant 10 may include marks or landmarks representing lines or compartments that assist in deployment, positioning and adjustment. In addition, along one or more portions of the implant 10, scoring, dip formation, collapse, and similar treatments or specific structures may be included to represent a cut or sized line or area.

  In addition to molding or laser cutting portions of the implant 10, stamping, stamping, 3D printing, and other methods and techniques can be used to form or define the implant 10. Each portion of the implant 10 can be coated to provide additional control over spreading and prevent or promote tissue ingrowth. The single or multiple material surfaces of the implant 10 or each compartment may be smooth or rough to promote mechanical or tissue ingrowth characteristics.

  The above-described function of forming or cutting the support and extension portions 12, 14, or other portions of the implant 10 into a substantially infinite array of predetermined shapes is better adapted to the anisotropic behavior of physiological tissue or An implant that can mimic it is provided. This may also provide a sling implant 10 that has a substantially smaller surface area than conventional mesh-type implants.

  These configurations for the patterned sling implant 10 maintain the implant in a generally flat or predefined plane or position during deployment, while further facilitating placement by the physician and pain Can help reduce the incidence of syndrome, erosion, etc.

  By setting the density of the compartment pattern for each embodiment of the implant 10 of the present invention, it is possible to adapt and adjust the stretch, load or strength characteristics of the implant 10 according to unique and support requirements. In addition, more than one type, such as combining various polymers such as polypropylene, PEEK, PET, PTFE, PGA, PLA, etc. to configure the implant 10 to further control the desired load and stress properties. Different types of materials can be used. Each polymer can also be combined with metallic elements to change the strength and elongation variation characteristics of the implant 10. Stronger materials allow for a way to selectively control the performance characteristics of the implant 10 by absorbing stress more quickly from larger load areas. Further, additional strength or stiffness characteristics may be achieved by deploying a polymer or metal frame or specific structure along the periphery of the implant 10 or other selected area.

  As detailed herein, the various structures and components of the present invention can be integrally formed into a unitary body by a molding process. For example, an injection molding machine (such as a Milacron Roboshot S2000i 33B machine) with an internal vacuum / cooling line may be employed. In general, a dry resin such as polypropylene resin is maintained at elevated temperatures for several hours. In addition, the molding device can be heated. The mold vacuum line can then be started and the injection molding cycle initiated. As the mold cavity is filled, the device is cooled over a predetermined time interval. Upon completion, the mold is opened and member release is triggered by decompression. The mold is then closed and the cycle is repeated for additional injection molded implants. Other known molding processes and systems can be employed with the present invention.

  Other embodiments of the implant 10 are precision (for example, DPSS 266 laser system) to cut out each specific shape and design of the implant 10 and strut 15 in an already unitary thin film or thin body of polymer material. It can be formed or cut along the path of the cutting tool. Alternatively, each particular shape and portion of the implant can be stamped into such a single thin film or thin material.

  Referring generally to FIGS. 35 through 50, various implant 10 portions and methods of forming such portions are disclosed to facilitate a preferred or targeted dehiscence zone 50. FIG. Thus, the implant 10 may include portions that can be removed by a physician or other user according to the patient's unique anatomical configuration, surgical requirements, and the like. In general, direct extrusion or 3D printing methods are employed such that the polymer is extruded or printed onto the surface to produce the structure or configuration of the implant 10 that forms the cleavage zone 50. These cleavage zones 50 allow structures that can be pulled apart in a controlled manner. This is useful in applications where a portion of the structure or implant 10 is not necessary and can be removed with or without a cutter. Therefore, damage that may occur to the structure or portion of the implant 10 by using a cutter may be avoided if desired.

  As shown in FIGS. 46-48, the direct extrusion or 3D printing process produces the above structure by extruding a thermoplastic above the melting point from a small orifice or nozzle device 54. The extruded high temperature plastic is then “drawn” or otherwise provided on the surface of the implant (eg, struts, thin film, etc.) to produce a tear structure, where the extrudate is In the design embodiment or in a portion of the implant 10, a single thin dimension dehiscence strut, structure or specific shape 52 is formed. By controlling the manner in which the extrudate is bonded to the previously extruded or formed material, the bond strength can be controlled to create a pre-defined area for dehiscence. These zones 50 or cleavage structures / struts 52 can be increased in size or thickness when greater force is required to facilitate cleavage or separation, or even smaller separation or cleavage forces. Can be made relatively thin when desired.

  As shown in FIGS. 38 through 50, certain methods of controlling the bond strength of the zone 50 are as follows: the amount of physical overlap PO between the new extrudate N and the previously placed material P. And the time during which the heated extruder nozzle stays on the previously placed material P, causing considerable remelting of the material P and a combined flow to the new extrusion N The step of performing. Furthermore, by changing the number of twisting or bonding of the individual extrudates constituting the struts (for example, FIGS. 41 to 45, FIGS. 49 to 50), a new extrudate N can be added first. By bridging the material P placed on, the bond strength can be controlled. As shown in FIGS. 47 to 50, the bridging occurs when the nozzle device 54 is pressed into the previously placed material P to remelt it, causing its small portions to flow and This can be done when making a bridge of thin material to be bonded to the extruded product N. Other known extrusion methods, molding, printing, and other forming methods and techniques are also contemplated for use in defining a predetermined dehiscence zone 50 in each portion of the implant 10.

  The implant 10 described herein generally has a variety of different types of tools such as an insertion tool that is useful for engaging a tissue anchor and placing a long incontinence sling. It can be implanted in the patient's body through the use of surgical instruments. Various types of insertion tools are known, including those previously incorporated by reference, and these types of tools and their modifications can be used in accordance with the present invention to make the sling implant 10 Can be installed.

  21 to 22 show a typical insertion tool. Each tool 60 may include a handle 62, a needle 64, and an engaging distal tip 66. The handle 62 is an activation mechanism 63 operatively connected to the distal tip 66 that can selectively control the engagement and / or disengagement of the distal tip 66 with respect to portions of the implant 10 (eg, the anchor 16 etc.). Can be included. Needle 64 can be helical, straight, or curved, to name a few options. A portion of the needle 64, such as the needle tip 66, is one or more barbs that can receive or abut one or more tines 42 of each anchor 16, such as prior to target tissue fixation. It may include a barb protector that may prevent adverse contact or penetration of tissue during the ten initial deployments and positioning.

  Each embodiment of the present invention can be implanted in a patient to treat incontinence such as urinary incontinence. A tool 60 (eg, needle 64) may be inserted through an incision that provides access to the pelvic region. The incision can be, for example, a vaginal incision (for a female anatomy), a perineal incision (for a male anatomy), or a rectum or buttocks area, medial thigh or inguinal area, pubic area And so on. The needle tip 66 is connected to one of the anchor identification structures 16 (e.g., anchor 34) and at a desired location for securing the anchoring identification structure 16 to the target tissue, such as in a closure hole. Can be placed. The other of each anchoring feature 16 (eg, anchor 36) can be deployed bilaterally (eg, against a closed hole) and anchored on the other side of the supported organ. If desired, the support portion 12 can then be adjusted and tensioned against a supported organ / tissue (eg, urethra or bladder).

  Each implant 10, their various components, structures, specific shapes, materials and methods may have a number of suitable configurations shown and described in each previously incorporated document. Also, various methods and tools for introducing, deploying, locking and manipulating implants to treat incontinence (eg, male and female) as disclosed in the previously incorporated references are used with the present invention. Is intended.

  As a result, all patents, patent applications and publications cited herein are incorporated in their entirety as if individually incorporated, and they are incorporated into each identified patent, patent application and publication. Documents incorporated in are included.

  Obviously, many modifications and variations of the present invention are possible in light of the teachings herein. It is therefore to be understood that within the scope of the appended claims, the present invention may be practiced otherwise than as specifically described herein.

Claims (9)

Non-woven simple long sling (10),
A support portion (12) including a plurality of strut members (15) coupled to and extending from a plurality of fixed joints (24), defined along a first plane The support part (12),
First and second extensions (14);
At least one tissue anchor (16) having one or more deformable tines (42) that can be secured to the soft tissue of the patient;
Extending from one of the first and second extension portions substantially along the same plane as the extension portion, the at least one tissue anchor (16), and the first and second extension portions (14). Extending between the at least one tissue anchor (16) and one of the first and second extension portions (14) to facilitate stress and tension distribution. A transition strength zone (30) including a plurality of long arcuate members (30a), each of the plurality of long arcuate members (30a) curved inward toward the at least one tissue anchor. And having a transition intensity zone (30),
The at least one tissue anchor (16) is integrally formed with the transition strength section and one of the first and second extensions (14);
With long sling (10),
A single patterned implant that treats patient incontinence.   The implant according to claim 1, wherein the at least one tissue anchor (16) extends in a direction substantially orthogonal from the first plane of the support portion (12).   The implant of claim 1, wherein the at least one tissue anchor (16) extends generally in the same plane as the first plane of the support portion (12).   The implant of claim 3, wherein the at least one anchor (16) has a thickness substantially equal to at least one of the first and second extension portions (14).   The implant according to claim 1, wherein the at least one anchor (16) comprises two end anchors positioned in opposition.   The implant according to claim 1, wherein the plurality of strut members (15) are sinusoidally shaped to define a plurality of pinwheel-like compartment shapes.   The implant of claim 1, wherein the at least one anchor (16) includes a body bore (48) capable of receiving a distal end (66) of the needle tool (60).   The implant of claim 1, wherein the plurality of strut members (15) include one or more edge retention features (32) that extend to provide tissue engagement.   The implant of claim 1, wherein the support portion (12) is substantially wider than the first and second extension portions (14).

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