Assembly for sub-urethral support

ES 2 536 748 T3

DESCRIPTION

Systems and Devices for Treating Pelvic Floor Disorders

Background

Pelvic floor disorders are a class of abnormalities that affect the pelvic region of patients, affecting millions of women. The pelvic region includes various anatomical structures such as the uterus, rectum, bladder, and vagina. These anatomical structures are supported and held in place by a complex collection of tissues, such as muscles and ligaments. When these tissues are damaged, stretched, or otherwise weakened, anatomical structures in the pelvic region shift and in some cases protrude into other anatomical structures. For example, when the tissues between the bladder and the vagina are weakened, the bladder can shift and bulge into the vagina, causing a pelvic floor disorder called a cystocele. Other pelvic floor disorders include vaginal prolapse, vaginal hernia, rectocele, enterocele, uterocele, and / or urethrocele.

Pelvic floor disorders often cause or exacerbate female urinary incontinence (UI). One type of UI, called stress urinary incontinence (SUI), affects mostly women and is often caused by two conditions, intrinsic sphincter deficiency (ISD) and hypermobility. These conditions can occur independently or in combination. In ISD, the urinary sphincter valve, which is located inside the urethra, does not close properly (or coapts), causing urine to leak from the urethra during stressful activity. In hypermobility, the pelvic floor is distended, weakened, or damaged. When the affected woman sneezes, coughs, or otherwise tenses the pelvic region, the bladder neck and proximal urethra rotate and descend. As a result, the urethra does not close with a sufficient response time, and urine leaks through the urethra.

Pelvic floor and UI disorders, which are usually accompanied by significant pain and discomfort, are often treated by implanting a supportive sling or mesh in or near the pelvic floor area to support sagging anatomical structures. or displaced or more generally, to strengthen the pelvic region by stimulating tissue growth. Often times, stress incontinence treatments are done without treating pelvic floor disorders at all, potentially leading to an early recurrence of stress incontinence.

Existing systems, methods, and kits for treatment generally apply delivery devices to place a supportive surgical sling in a desired position in the pelvic region. However, some of these systems and methods require a medical surgeon to create multiple incisions and administer the implant using complex procedures. Additionally, many existing surgical implants are not sized or shaped to properly fit within a patient and treat pelvic floor disorders. Consequently, medical surgeons and patients need better surgical systems, methods and kits for the treatment of pelvic floor disorders and / or urinary incontinence.

US Patent Publication No. 2003/0191360 A1 describes a surgical implant and methods for supporting the urethra, which implant comprises: a suburethral support suspended between two soft tissue anchors that do not penetrate the lower abdominal wall and are attached to each side of the suburethral support. Soft tissue anchors retain each anchor in soft tissue, suspending each side of the suburethral support. The suburethral support passes under the urethra to support the urethra (118). The implant has uses that include the treatment of urinary incontinence and uterovaginal prolapse.

Summary

The present invention relates to a surgical implant assembly for the repair of the pelvic floor of a patient according to claim 1. Preferred embodiments are described in the dependent claims.

The invention generally relates to systems for treating pelvic floor and / or UI disorders through the use of a single incision surgical procedure. In a general single-incision technique, the surgeon makes an incision in the patient's vaginal wall and uses a single incision as the port of entry into the patient's pelvic floor region to provide implants to support the urethra, neck of the bladder, and / or pelvic floor. As explained in more detail below, the single incision approach can be used to insert, position, tension, and secure the implant without the need for additional incisions in the patient. In practice, the surgeon makes the single incision in the anterior vaginal wall of the patient and performs a bilateral dissection to the lower public branch on each side of the patient. The surgeon attaches a surgical implant to a delivery device, and then guides the device through the single incision and to a target tissue region within the retropubic space on a first side of the patient's pelvic region.

The implant is secured within the retropubic space by soft tissue anchors, flat ends on the implant, or both. In some embodiments, the surgeon attaches a first end of the surgical implant to the

ES 2 536 748 T3 delivery device first by attaching the first end of the surgical implant to a soft tissue anchor, and then by attaching the soft tissue anchor to the delivery device. The surgeon then secures the soft tissue anchor to the target tissue region and removes the delivery device, leaving the first end of the implant anchored to the target tissue region. In other embodiments, the surgical implant is directly attached to the delivery device, and includes flat end portions that are secured to the target tissue region. The surgeon then repeats this process at a second end of the implant to anchor the second end to a target tissue region at a contralateral position in the patient's retropubic space. In certain embodiments, the target tissue regions are located on the obturator membranes of the patient and the implant supports the urethra and / or bladder neck of the patient.

In some configurations, the surgeon makes implants that also extend to regions of the pelvic floor that are posterior to the bladder neck, and provide support for anatomical organs such as the bladder. To provide implants that provide both anterior and posterior support, the implant is secured to a plurality of target tissue regions on each side of the patient through a plurality of anchors or flat end portions on each side of the implant. In these configurations, the surgeon repeats the aforementioned process for each of the flat end portions or anchors. After providing the implant into the patient's retropubic space, the surgeon can tension the surgical implant using a tensioning tool inserted through the vaginal incision. Systems include surgical implants, soft tissue anchors that anchor surgical implants to a desired anatomical position, delivery devices and methods that deliver the anchors and implants through the single incision to desired anatomical positions, and tension devices that return to place and / or consider surgical implants after administration.

In one aspect, the systems include surgical implants that are sized, shaped, and constructed to treat various disorders of the pelvic floor. In certain embodiments, the implants are slings that are configured to extend below the urethra and / or bladder neck of the patient for the treatment of urinary incontinence. In other embodiments, the implants are larger and are configured to extend to and support regions posterior to the neck of the patient's bladder, including the base of the patient's bladder, or further into the posterior region of the pelvic floor to support others. organs.

In certain embodiments, the systems and methods include surgical implant assemblies for repairing the pelvic floor and / or for treating urinary incontinence in a patient.

In another aspect, the invention includes implantable surgical sling assemblies for the repair of the pelvic floor and / or for the treatment of urinary incontinence in a patient. An exemplary implantable surgical sling assembly includes a surgical implant having a first end for securing to a first obturator membrane of a patient and a second end for securing to a second obturator membrane of a patient. The assembly includes a first set of at least three soft tissue anchors for coupling to the first end of the implant and to secure it to the first obturator membrane, and a second set of at least three soft tissue anchors for coupling to the second end of the implant. and to secure it to the second sealing membrane.

The systems and methods also include sling end terminations that are soft tissue anchors.

In another unclaimed aspect, surgical techniques are disclosed for providing an implant to a patient. In one embodiment, the techniques include a single incision method of implanting a surgical implant in the pelvic floor region of a patient for pelvic floor repair. The exemplary method includes the steps of creating an incision in the patient's vaginal wall, attaching the implant to a delivery device, inserting the delivery device through the vaginal incision through the patient's external vaginal opening, and implanting and securing the implant within the pelvic floor region of the patient so that at least a portion of the sling extends to a position posterior to the neck of the patient's bladder. The implant can be coupled to soft tissue anchors that anchor in respective soft tissue regions, such as obturator membranes, of the patient, and additionally and / or alternatively may include flat end portions that secure the implant to the soft tissue regions. The methods can optionally include tensioning the implant. In one feature, the methods include coupling the implant to a delivery device having a shaft and a slidable cannula positioned around the shaft, inserting the delivery device through the external vaginal opening, inserting the delivery device through through the posterior vaginal incision to insert the delivery device through the external vaginal opening, align the axis with a first obturator membrane, slide the cannula distally along the axis, and secure the implant to the first obturator membrane.

In another unclaimed aspect, the surgical implants are delivered through a single vaginal incision and secured to the patient's obturator membranes. In particular, in accordance with an illustrative technique, a surgeon makes a single incision in a patient's vaginal wall, attaches the implant to one or more soft tissue anchors, attaches a soft tissue anchor to a delivery device, provides the anchor. of soft tissue to an obturator membrane through the single vaginal incision, and anchor the soft tissue anchor to the

ES 2 536 748 T3 sealing membrane. The surgeon repeats this process for any other anchors used, including an anchor for the contralateral side of the patient, while using the same vaginal incision to insert the anchors and implant.

During administration or after administration, the surgeon optionally tensiones the surgical implant. In one aspect, the implant is adjustably coupled to one or more soft tissue anchors, and the surgeon tensiones the surgical implant by adjusting the orientation of the implant relative to its soft tissue anchors.

In certain non-claimed embodiments, a method is provided for treating urinary incontinence in a patient. The method includes providing an implant having at least one flat end portion formed as a unitary body with the implant, creating an incision in the patient's vaginal wall, attaching an implant to a delivery device, inserting the delivery device through from the vaginal wall incision through the patient's external vaginal opening, guide the device to a position below the patient's epidermis, and secure, via at least a portion of flat ends, the implant to the soft tissue of the patient.

Brief description of the figures

These and other features and advantages will be more fully understood by the following illustrative description with reference to the accompanying figures, in which similar elements are marked with similar reference designations and which may not be drawn to scale.

Figure 1A shows a side view of the female pelvic region and exemplary placement of a surgical implant.

Figure 1B shows an oblique view of the pelvic region of the surgical implant of Figure 1A.

Figure 1C shows an anterior view of the pelvic region and surgical implant of Figure 1B.

Figure 2A shows a surgical implant having a central region and six extensions.

Figure 2B shows the surgical implant of Figure 2A having flat end portions on its extensions.

Figure 3 shows a surgical implant having a circular central region and four extensions.

Figure 4 shows a sized and molded rectangular surgical implant for pelvic floor repair.

Figure 5 shows a dimensioned and molded trapezoidal surgical implant for pelvic floor repair.

Figure 6 shows a surgical implant that includes a plurality of openings to stimulate tissue growth.

Figure 7A shows a surgical implant having a first set of strands and a second set of strands joined at points of intersection.

Figure 7B shows a close-up view of the surgical implant of Figure 7A.

Figure 8A shows the implant of Figure 7A with tapered flat end portions.

Figure 8B shows a close-up view of the implant of Figure 8A.

Figure 9 shows an implant having flat end portions that includes a single long strand and a plurality of short strands.

Figure 10 shows an implant having long strands and short strands, in which the long strands are oriented at a non-perpendicular angle to the short strands.

Figure 11A illustrates an exemplary extrusion technique for constructing a surgical implant similar to the surgical implant of Figure 10.

Figure 11B is a block diagram showing the steps of the exemplary technique illustrated in Figure 11A.

Figure 12 illustrates a surgical implant having three sets of strands bonded together at points of intersection.

Figure 13 illustrates a surgical implant fabricated using a method similar to the surgical implant of Figure 7A, but having a longer anteroposterior length.

Figure 14A illustrates a circular surgical implant that includes a first set of threads and a second set of threads joined at points of intersection, in which the implant is sized and molded to extend into posterior regions of the pelvic floor and to provide support. to anatomical structures such as the bladder.

Figure 14B shows the surgical implant of Figure 14A after selective removal of portions of the surgical implant.

Figure 15A shows an implant molded to interpolate beneath a urethra or bladder neck of a patient.

Figure 15B shows a clip used to mold the implant of Figure 15A.

Figure 16A shows a sling assembly that includes an implant and end caps to associate the implant to a delivery device and to anchor the implant to soft tissue.

Figure 16B illustrates an exemplary fabrication technique of the implant of Figure 16A.

Figure 17 shows an alternate configuration for an end termination having a top piece and a bottom piece.

Figure 18 shows an implant assembly including one implant and two end caps, where each end cap includes a ring and no limbs.

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Figure 19A shows a flexible end termination in a collapsed state.

Figure 19B shows the end termination of Figure 19A in an expanded state and interpolated with a shaft of a delivery device.

Figure 20 shows an implant assembly that includes an implant and two alternative tab-shaped end caps.

Figures 21A-D show exemplary soft tissue anchors with tabs.

Figure 21E shows a barbed anchor coupled to a portion of a surgical implant and anchored to an obturator membrane.

Figure 22A shows a soft tissue anchor with a smooth outer surface and no tabs.

Figures 22B-22C illustrate an exemplary technique for using the anchor of Figure 22A to anchor a surgical implant to an obturator membrane.

Figure 23 shows a molded soft tissue anchor shaped like an arrowhead.

Figure 24 shows the implant of Figure 2A and depicts alternative approaches for mating soft tissue anchors with implant strips.

Figure 25A illustrates a surgical implant coupled with soft tissue anchors by snap rings.

Figure 25B shows the snap rings of Figure 25A in stretched states.

Figure 26A shows an implant assembly that includes a surgical implant that engages soft tissue anchors via filaments.

Figure 26B shows the implant assembly of Figure 26A anchored within the pelvic region of a patient.

Figures 26C-D show an exemplary technique for thinking about the implant of Figure 26A.

Figure 26E shows a corner of the implant of Figure 26A after the tension technique by way of example.

Figure 26F shows the implant assembly of Figure 26B anchored within the pelvic region of a patient after tension.

Figure 26G shows an exemplary technique for loosening the implant of Figure 26A.

Figure 27 shows a delivery device having a movable shaft and a fixed cannula for providing an implant mount to the pelvic region of a patient.

Figure 28 shows a delivery device having a fixed shaft and a movable cannula to provide an implant mount to the pelvic region of a patient.

Figure 29 shows the delivery device of Figure 28 in an extended state.

Figure 30 shows the delivery device of Figure 28 having increment marks on its axis.

Figure 31A illustrates a transobturator single vaginal incision procedure for providing an implant sized and molded to extend across the back of the bladder neck and support the base of the bladder.

Figure 31B shows a transobturator single incision procedure similar to the procedure depicted in Figure 31A, for providing an alternative implant sized and molded to support the urethra and / or bladder neck.

Figures 32A-32C show a delivery device that includes a handle and a curved halo-shaped shaft.

Figures 33A-B show symmetrical delivery devices similar to the device of Figures 32AC, but having the curved axis arrangement in a plane that is not orthogonal to a plane of the handle.

Figure 34A shows an exemplary technique for providing an implant sized and molded to extend posterior to the bladder neck and support the base of the bladder using a transobturator vaginal single incision procedure.

Figure 34B shows aspects of a transobturator single incision procedure similar to the procedure presented in Figure 34A for providing an alternative implant sized and molded to support the urethra and / or bladder neck.

Figure 35A shows aspects of a transobturator single incision procedure to provide a flat-ended implant without soft tissue anchors.

Figure 35B shows aspects of a transobturator single incision procedure similar to the procedure depicted in Figure 35A for providing an implant sized and molded to treat pelvic floor disorders.

Figure 36 shows exemplary placement of a surgical implant with straps secured to target tissue regions of obturator membranes, levator ani muscles, and sacrospinal ligaments.

Detailed description of exemplary embodiments

The invention generally relates to systems for treating pelvic floor and / or UI disorders using single vaginal incision surgical approaches to provide surgical implants to the patient's pelvic and / or suburethral floor and retropubic space. Implants are secured to soft tissues within the patient's retropubic space by flat end portions of the implant, by one or more soft tissue anchors attached to the implant, or both. Illustrative devices, systems, and methods of the invention are described below in the following order. First, surgical implants sized, molded, and constructed to treat UI and / or repair the pelvic floor are described. Second, soft tissue anchors are disclosed which, in certain embodiments, secure surgical implants to a desired anatomical position, such as

ES 2 536 748 T3 obturator membranes, along with methods for coupling soft tissue anchors to surgical implants. Third, devices are described to provide the anchors and the implants desired anatomical appositions in the patient's retropubic space, such as obturator membranes, together with tensioning devices and methods that reposition and / or tension the surgical implant after implantation. administration. Fourth, exemplary non-claimed methods are disclosed for implanting and positioning and securing exemplary implants within a pelvic region of the patient using a single vaginal incision surgical technique.

First, surgical implants sized, molded, and constructed to treat UI and / or repair the pelvic floor are described. The surgical implants described herein are adapted to be secured within the retropubic space of the patient. Implants support anatomical structures in the pelvic region and more generally strengthen the tissue of the pelvic region. In one aspect, surgical implants physically support anatomical structures in the pelvic region by providing hammock-like physical support to anatomical structures such as the urethra, bladder neck, bladder, uterus, and other vessels and structures. To physically support an anatomical structure, surgical implants are sized and molded to support the anatomical structure. In another aspect, surgical implants indirectly strengthen surrounding tissue by stimulating tissue growth. Surgical implants can be constructed to include openings or interstices in which tissue growth can occur, or are otherwise envisioned to be constructed of a material that stimulates tissue growth. Therefore, surgical implants can be sized, shaped, and constructed to support anatomical structures and strengthen tissue in the pelvic region.

Returning to the Figures, Figures 1A-1C show an exemplary surgical implant 2 that is positioned within and secured within the pelvic region 1 of a patient through the use of the procedures described herein. document. Figures 1A-1C show surgical implant 2 having lateral edge 2a, anterior edge 2b, and posterior edge 2c, and which have been sized, molded, and positioned to support urethra 4, bladder 6, and neck of the bladder 5 (the region that adjoins the urethra 4 and that the bladder 6), of the patient by means of soft tissue anchors 20a-20f. In particular, Figure 1A shows a side view and Figure 1B shows an oblique view of the pelvic region 1. As shown, the implant 2 is placed in the tissue region directly below the urethra 4 and the bladder neck 5 with the soft tissue anchors 20a-f anchored in the obturator membranes of the patient, the lateral edge 2a placed on one side of the urethra 4, bladder neck 5, and bladder 6, and the anterior border 2b placed under the urethra 4 to help strengthen this region of tissue in part to treat UI and / or urethrocele. The posterior edge 2c of the depicted surgical implant 2 also extends to a position that is posterior 12 to the neck of the bladder 5, to support tissue near the posterior region 6a of the bladder 6 and the lower region 8a of the uterus 8 to assist in the treatment of other pelvic floor disorders including cystocele, uterine prolapse, enterocele, rectocele, and / or vaginal prolapse. However, since various tissue regions of the pelvic region are interconnected, strengthening one tissue region often treat disorders that affect other tissue regions.

Figure 1C shows an anterior view of the pelvic region 1 with the anterior edge 2b of the implant 2 as described above. Exemplary surgical implant 2 forms a hammock-like support under urethra 4, bladder neck5, and bladder 6. Surgical implant 2 is held in position with the six soft tissue anchors 20a-f that they are anchored to the respective sealing membranes 22a and 22b with three such anchors on each side. An obturator membrane is a thick fascial membrane and is placed laterally on each side of the pelvic region. The plugging membrane is a convenient support structure for soft tissue anchors, such as soft tissue anchors 20a-f, partly because it is strong, and partly because it is large and thus provides lateral, anterior, anchor positions. and / or posterior (in fact, the obturator membrane is prolonged by the obturator foramen, the largest foramen in the skeleton).

In the embodiment depicted, anchors 20a-f are coupled to surgical implant 2 and are directly anchored to sealing membranes 22a and 22b. However, in alternative embodiments, the anchors 20a-f are anchored in muscle tissue located laterally beyond the plugging membranes 22a and 22b. In other embodiments, the implant 2 does not extend the entire length between the obturator membranes 22a and 22b, known as the obturator obturator length, but instead engages the anchors 20a-fa through filaments or rings that distance the implant. 2 beyond the anchors 20a-f and are anchored in the sealing membranes 22a and 22b. In yet other embodiments, implant 2 is not anchored to obturator membranes 22a and 22b, but instead is anchored to other soft tissue regions in the retropubic space, such as the tendinous arch region of the levator ani muscle, such as is discussed below.

Implant 2 can be sized and molded to achieve a desired fit in the patient. Figure 2A shows an exemplary surgical implant 30 of the type shown in Figures 1A-1C having a trapezoidal shaped central region 30a and six extension strips 32a-f. In other embodiments, the central region 30a is rectangular. In certain embodiments, implant 30, including strips 32a-f, extends to at least a length 34 that extends between or beyond a first obturator membrane and a second obturator membrane of the patient, also known as the obturator length. relative to the patient's obturator. Therefore, when the strips 32a-fa are provided through the single vaginal incision, the strips 32a-c are attached to a first obturator membrane through soft tissue anchors directly coupled to the strips 32a-c, and the

Strips 32d-f are attached to the contralateral obturator membrane through soft tissue anchors directly coupled to strips 32d-f, as illustrated with respect to Figures 1A-C.

In alternative embodiments, strips 32a-f are secured to other target tissue regions in the patient's retropubic space, such as the patient's sacrospinal ligaments or the levator ani muscles. By way of example, strips 32a and 32d can be extended to target regions of the sacrospinal ligament, strips 32b and 32e can be extended to target regions near the tendon arch of the levator ani muscle, and strips 32c and 32f can be extended to target regions of the plugging membranes. Each of the strips 32a-f can have varying lengths in order to reach their respective target tissue regions.

In certain embodiments, the strips 32a-f of the implant 30 have flat end portions that directly secure one or more of the strips 32a-f to a target tissue region. Figure 2B shows the implant 30 of Figure 2A, with flat end portions at the end of each of the strips 32a-f. In an exemplary technique, these portions are formed first by forming flat ends around the edges of implant 30, and then selectively blending portions of implant 30 to form the uncrushed end portions. More particularly, implant 30 is first cut from the woven sheet exposing fibrous protrusions, or flat ends, around the edges of implant 30. The uncrushed end portions are then formed by any process that smoothes, round, or removes the protrusions, leaving the ends flat around the ends of the strips 32a-f. In one embodiment, the edges of the implant 30 at the non-crushed end portions are heat fused. In another exemplary technique, the flat ends on implant 30 are formed from a tape of unstressed tissue ends having approximately the dimensions of implant 30 as depicted in Figure 2B. The smooth sides of the tape are then cut to produce the frayed edges or sharp protrusions of the flat end ends of the strips 32a-f. In either technique, the flat ends are fiber ends of the implant, and the flat end ends of the strips 32a-f form a unitary body with the implant 30.

Figure 3 shows an alternative, unclaimed configuration of a surgical implant 60 for use to support a pelvic region. As shown, implant 60 has a circular central region 62 and four radially extending extension strips 64a-d. Strips 64a and 64c are designed to extend to a patient's obturator membrane, and strips 64b and 64d are designed to extend to the patient's contralateral obturator membrane. The circular central region 62 is suitable for supporting various anatomical structures, including, for example, the base of the bladder. Strips 64a-d can be coupled with soft tissue anchors to anchor to respective sealant membranes, as will be discussed below. The implant 60 shown is a woven mesh; however, a similarly shaped nonwoven implant is discussed below with flat-ended strips to anchor to target tissue regions.

As indicated in relation to implant 30 of Figure 2A, the strips 64a-64d must also be configured to extend to and secure to other target tissue regions in the retropubic space of the patient. In one embodiment, the strips 64c-64d extend to the target tissue regions of the patient's obturator membranes, and the strips 64a-64b extend to the target tissue regions near the tendon arch of the levator ani muscle.

The implants of Figures 2 and 3 described above have extensions / strips that can be expanded to the obturator relative to obturator length of the patients so that the extensions / strips can be secured directly to the respective obturator membranes, alone. (using, for example, flat ends) or in conjunction with soft tissue anchors. Figure 4 illustrates an alternative non-claimed stripless embodiment of a surgical implant 70, having a lateral length 72 and, in various embodiments, spanning varying distances between or beyond a first obturator membrane and the patient's contralateral obturator membrane. In certain embodiments the surgical implant 70 depicted does not span the full length of plug to plug of many patients, but, as discussed below, it engages with soft tissue anchors via long filaments that are attached to the implant. The depicted implant 70 has a lateral length 72 of between about 5 centimeters and about 8 centimeters. Alternatively, implant 25 may have a longer lateral length 72, such as greater than about 7 cm, greater than about 9 cm, or greater than about 10 cm, and therefore can be sized to span the entire length of the implant. obturator relative to the patient's obturator and directly coupled to soft tissue anchors that have been planned in the respective obturator membranes without the involvement of any filament.

The depicted implant 70 has an anteroposterior length 74 between approximately 2.5 centimeters and approximately 8 centimeters, which allows surgical implant 70 to extend below and provide brand-like supports to posterior versions of the region. pelvic, including, for example, the base of the bladder. In general, surgical implant 70 can have any desired anteroposterior length 74 to support other anatomical regions of the pelvic floor. For example, surgical implant 70 should have an anteroposterior length 74 between about 5 cm and about 2 cm and may be suitable to support one or both of the patient's urethra and bladder neck. Alternatively, surgical implant 70 may have an anteroposterior length 74 greater than about 3 cm, greater than about 5 cm, greater than about 7 cm, or greater than about 10 cm to support the urethra, neck of the

ES 2 536 748 T3 bladder and / or bladder of the patient.

Surgical implant 70 is a woven mesh having interstices between component fibers in which tissue growth can occur. Surgical implant 70 can be prepared from a wide variety of materials, and can be treated with a variety of therapeutic materials, which are discussed in more detail in the references mentioned herein.

The implants are also intended to be configured to have other desired shapes. Figure 5 shows a trapezoidal shaped surgical implant 90 similar to implant 30 of Figure 2A, but without extension strips. The illustrated surgical implant 90 has a length of the posterior base 92 between about 8 cm and about 11 cm, a length of the anterior base 94 between about 5 cm and about 7 cm, and an anteroposterior length 96 between about 5 cm and about 10 cm. Surgical implant 90 is shaped to have a wider posterior region 90a than anterior region 90b because posterior region 90a of surgical implant 90 supports larger posterior anatomical structures, such as the bladder, while anterior region 90b The implant 90 supports smaller anterior anatomical structures, such as the urethra and / or bladder neck.

As mentioned above, surgical implants are generally prepared with mesh materials that have interstices that promote tissue growth. Figure 6 illustrates a surgical implant 120 that additionally or alternatively includes a plurality of openings 122 that can be of varying sizes and that stimulate tissue growth. This and other exemplary surgical implants are discussed further in US Patent No. 6197036.

As noted, the mesh surgical implants described above can be woven. Implants can also be protected with a protective covering or sheath, as described in US Patent Application No. 11/202554 to help prevent woven implants from fraying, stretching, and / or otherwise fraying. damaged by stresses applied to the implant during administration. the sheath covers and protects the implant during delivery of the implant through the tissue, and is removed after delivery. Alternatively, the implant can be configured in protected arrangements that prevent fraying, stretching, and / or damage during delivery and tension of the implant.

Figures 7A-14B illustrate various exemplary surgical implants constructed in a non-woven configuration. In particular, Figure 7A shows a surgical implant 140 having a first end 140a, a second end 140b, a set of lateral strands 142, and a set of transverse strands 144, while Figure 7B shows a close-up view of the implant 140. Implant 140 includes points of attachment 146, in which lateral strands 142 cross each other and are fused or otherwise fixedly attached to transverse strands 144, and openings 148 defined by strands 142 and 144 and points attachment 146. Implant 140 can be sized to suit a particular application. For example, the depicted implant 140 has a lateral width 150 between about 6 cm and about 11 cm to extend laterally both between the obturator foramen of the patient and in an antero-posterior width 153 between about 0.5 cm and about 2 cm to give support for the urethra and / or bladder neck.

As shown in Figure 7B, in this illustrative embodiment, the lateral strands 142 are parallel to the longitudinal axis 158 of the implant, and the transverse strands 144 are substantially perpendicular to the lateral strands 142. Side strands 142 and cross strands 144 can be prepared from a wide variety of materials, including any of the biocompatible materials described herein or in the references mentioned herein. Side strands 142 and transverse strands 144 can be prepared from monofilament fibers and / or multifilament fibers. Strands 142 and 144 may include different respective materials that provide, for example, different tension and / or elasticity along a longitudinal axis 158 compared to a perpendicular axis 156. In certain embodiments, the lateral strands 142 prevent implant 140 from seizing. stretch laterally. In certain configurations, the side strands 142 and the transverse strands 144 have respective different colors. This can help a surgeon visually determine the orientation of surgical implant 140 as he administers and / or tensiones implant 140.

As mentioned above, implant 140 includes attachment points 146 where lateral strands 142 meet and intersect transverse strands 144. In one embodiment, the attachment is formed by a biocompatible adhesive. Alternatively, the bond is formed by fusing strands 142 and 144. In other embodiments, the bond of strands 142 and strands 144 is formed by molding, stamping, and / or laser cutting.

Implant 140 also includes openings 148, defined by strands 142 and 144, that promote tissue growth. The openings 148 can be substantially similar in size and shape. The depicted apertures 148 are basically rectangular, but may have other shapes, and in certain embodiments are parallelogram-shaped. The openings 148 may also be of varying sizes and shapes to encourage the formation of varying tissue growth patterns alongside varying regions of the implant 140 in accordance with the preference of the medical surgeon.

ES 2 536 748 T3

The implants described herein are configured to secure within the soft tissues within the retropubic space of the patient. In one aspect, implant 140 includes flat end portions 152a and 152b, in which transverse strands 144 extend beyond the extension of lateral strands 142 along perpendicular axis 156, and a flat endless portion 162 at where the length of the transverse strands 144 is basically equal to the extension of the lateral strands 142 along the perpendicular axis 156. As shown in Figure 7B, the flat end portions 152a and 152b are formed from a plurality of flat ends 160. The flat ends 160 interact with surrounding tissue to resist, and optionally prevent, implant movement and therefore securing implant 140 in place until tissue growth occurs through openings 148. For example, flat end portions 152a and 152b can be placed directly within an obturator foramen, thereby securing the implant within the obturator foramen without requiring the use of anchors at the ends of the implant. Each of the flat ends 160 may extend beyond an extension of the lateral strands 142 between about 0.5 mm and about 1 mm, between about 1 mm and about 2 mm, between about 2 mm and about 3 mm, between about 3mm to about 4mm, about 4mm to about 5mm, or about 5mm to about 1cm. In certain embodiments, the flat ends 160 are basically rigid. For example, they can be prepared from monofilament or multifilament strands with sufficient rigidity to secure implant 140 to target soft tissue regions without requiring the use of soft tissue anchors.

The implant 140 also includes an uncompressed end portion 162 in which the length of the transverse strands 144 is substantially equal to the extension of the lateral strands 142 along the perpendicular axis 156. The uncompressed end portion 162 provides a large support area for an anatomical structure. In certain embodiments, a surgeon places the unstressed end portion 162 in sensitive anatomical structures such as the urethra, bladder neck, and / or bladder, while the flat end portions 152a secure the implant 140 in place, resulting in This results in a decrease in irritation to the supported structures.

In one exemplary technique, a manufacturer forms implant 140 by first laying strands 142 and 144 using one or more joining methods described above, then shaping flat end portions 152a-b, and then shaping the end portion without crushing 162. To form flat end portions 152a-b, the manufacturer first manufactures implant 140 with two additional side strands, represented by dashed lines 142a and 142b, that are configured as the outermost strands in side strand set 142. Next , the manufacturer shortens the transverse strands 144 to the outer side strands 142a and 142b and removes the long outer strands 142a and 142b to expose the flat ends 160. The flat ends 160 are therefore ends of the transverse strands 144 that form the implant 140, and the implant 144 and its strands 144 with flat ends 160 form a unitary body. In one exemplary method, the transverse strands 144 are shortened by heat fusion, and in others they are shortened by trimming or cutting. Next, to form the uncrushed end portion 162, a manufacturer hot melts, cuts, trims, or otherwise shortens the transverse strands 144 to the outermost strands 142c and 142d of the remaining strands and sides 142. strands 142 and 144 are individually bonded, strands 142 and 144 can be cut as desired without causing the implant to fray.

The flat end and uncrushed end portions of an implant can be sized to achieve a desired anatomical fit and to reduce the level of invasion caused by the implant. Figures 8A and 8B show the implant 140 of Figures 7A and 7B with the flat end portions 152a and 152b that have been tapered along the perpendicular axis 156 by cutting or otherwise shortening the flat end portions 152a- b to reduce the delivery profile of the implant 140. A delivery profile refers to the maximum cross-sectional area of ​​a corridor through the patient's anatomy that is necessary for the delivery of implant 140. The delivery profile can be affected by one or more of a number of factors, which include the diameter of the administration needles, shafts, and / or dilators, implant width, and width of the protective sheath.

Smaller delivery profiles can be beneficial because they can result in less invasive implant delivery procedures. An implant having the smaller profile illustrated in Figures 8A-B can be delivered using a delivery device with smaller dimensions, such as a smaller shaft or needle, which can reduce trauma to the patient and damage less tissue. . However, implants with larger profiles, such as implant 140 as shown in Figures 7A and 7B, can more securely anchor within the patient's anatomy and provide more controlled operation during administration. and the surgeon can select an implant that has a delivery profile that is suitable for the patient. The antero-posterior width of the flat end portion 162 has not been narrowed and thus provides a wide bearing area for an anatomical structure.

Figure 9 shows an alternative implant embodiment with an even more reduced delivery profile. As shown, each of the flat end portions 152a and 152b includes a single side strand 170 having terminal portions 170a and 170b. Flat ends are formed from transverse strands 172 attached to side strand 170 in a perpendicular orientation. In an example application, a surgeon

ES 2 536 748 T3 uses a delivery device with a fork shaped tip to provide, place, and / or adjust the placement of the implant 140. The surgeon interpolates the teeth of the shaped tip to have around the long strand closely from terminal portion 170a, for example, in regions 174a and 174b. The fork-shaped tip abuts one of the transverse strands 172a and the surgeon pulls or drags the implant 140 in a desired direction. In this embodiment, if one or both of the flat end portions 152a and 152b is twisted around the longitudinal axis 158 during administration or placement, tissue growth in surrounding tissue regions can be seen substantially unaffected. Therefore, the surgeon need not avoid twisting the implant 140 during administration.

Implants can also be shaped when necessary to achieve desired elasticity and elongation properties. Figure 10 shows an exemplary implant 180 having lateral strands 182 and transverse strands 184, flat end portions 186a and 186b, and a non-crushed end portion 188, Implant 180 is similar to implant 140 of Figure 7A, except that the transverse strands 184 are oriented at an opposite and non-perpendicular angle 190 relative to the lateral strands 182, so that the implant 180 includes apertures 192 that are essentially diamond-shaped. The orientation of the transverse strands 184 thus allows the implant 180 to be stretched in the transverse direction 194 without damaging the implant 60. More particularly, during implantation or use, when stretching or transverse tension is applied along the width antero-posterior 194, the transverse strands 184 move and orient themselves perpendicular to the lateral strands 182. This increases the anteroposterior width 194 which allows implant 180 to absorb transverse stress without damaging implant 180.

Figure 11A illustrates an exemplary extrusion technique for constructing a surgical implant 210 similar to surgical implant 180 of Figure 10, and Figure 11B illustrates a block diagram of the technique. In the art, a fabricator first extrudes and fuses two sets of strands, and then cuts the resulting structure to size and shape implant 210,

More particularly, a manufacturer first extrudes the first set of strands 212 (step 230) at a first angle relative to the longitudinal axis 214. To do so, in one embodiment, the manufacturer pushes and / or draws a raw material of the material. implant through an extrusion mold that includes respective openings for each of the first set of strands 212. The openings are arranged in a circular configuration and are oriented at the first angle relative to the longitudinal axis 214 so that the first set of strands form a tube of parallel strands.

Next, the manufacturer extrudes a second set of strands 216 (step 232) at a second angle with respect to longitudinal axis 214. To do so, in one embodiment, the manufacturer pushes and / or draws a raw material of the implantation through a second exclusion mold that includes respective openings for each of the second set of strands 216. These openings are also placed in a circular configuration and are oriented at the second angle relative to the longitudinal axis 214, so that the second set of strands forms a tube of the parallels and intersects the first set of strands 212 in a plurality of attachment points 218. The manufacturer then fuses the first set of strands 212 with the second set of strands 216 (step 234) at attachment points 218, thereby forming a substantially continuous tube.

Next, the manufacturer cuts implant 210 to an appropriate length along longitudinal axis 214 (step 235) and cuts implant 210 longitudinally along a side wall of the tube (step 236) to open the tube in a shape. flat. In certain embodiments, the cuts in the side wall allow the first set of strands 212 or the second set of strands 216 to be oriented parallel to the longitudinal axis 214 of the implant. This results in a configuration similar to that shown in Figure 10, in which the long strands 182 are parallel to the longitudinal axis 181 of implant 180. As mentioned, such orientation helps reduce stretching in the direction lateral during delivery of implant 210. In other embodiments, the number of strands is increased or decreased to alter the diameter of the tubular shape in order to vary the size of the final configuration of the implant. Finally, the surgeon optionally cuts the implant to a desired size and shape (step 238), and optionally forms flat ends as described above (step 240). Optionally, the surgeon may also attach one or more soft tissue anchors to the implant, as described herein.

The implants described above with reference to Figures 7A-11B include two sets of strands, which in illustrated embodiments include a first set of long strands and a second set of short strands. In alternative embodiments, additional sets of strands can be included to provide additional strength, tension, or elasticity properties. Figure 12 illustrates a portion of any exemplary surgical implant 250 that has three sets of threads - a first transverse set 252, a second side set 254, and a third cross-oriented set 256. The threads within each set they are basically parallel and in certain embodiments remain in different respective layers. Each layer is oriented at a different angle to longitudinal axis 257 and is fixedly attached to at least one other layer. As shown, the strands from each of the sets 252, 254, and 256 are joined to strands in one or both of the other two sets to form a plurality of intersection points 258 having strands from all or more of the fused, fused, or otherwise joined sets use methods that have been discussed

ES 2 536 748 T3 above.

The implants that have been described with respect to Figures 7A-12 are sized and molded to support anatomical structures such as the urethra and / or bladder neck of the patient. Similarly, constructed implants can be sized and molded to support other anatomical structures and extend to other pelvic regions. Figure 13 illustrates a surgical implant 280 constructed similarly to implant 140 of Figure 7A, but sized and molded similarly to implant 70 of Figure 4. In particular, implant 280 has a longer anteroposterior length 282 than implant 140, which allows implant 280 to support posterior regions of the pelvic region, such as tissue regions posterior to the neck of the patient's bladder. and below the base of the patient's bladder. In addition, the depicted surgical implant 280 has a smaller side length 284 than the side length of the surgical implant 140 in Figure 7A, so that the implant 280 does not span the entire length of the obturator relative to the patient's obturator. Instead, as discussed below, surgical implant 280 is coupled to soft tissue anchors that are spaced from implant 280 by long filaments 286 that span the remainder of the plug-to-plug length when soft tissue anchors are anchored to the respective sealing membranes. Although not shown, one or more of the edges of surgical implant 280 may include flat ends as described above. In one of the exemplary embodiments, the flat ends are optional, particularly when soft tissue anchors are used to anchor the surgical implants to the respective sealing membranes.

Figures 14A-B illustrate alternative exemplary surgical implants 300 and 310 that are sized and molded to extend to posterior regions of the pelvic floor and to support anatomical structures such as the bladder. Implant 310 depicted in Figure is sized and molded in the same way as implant 60 in Figure 3, but is manufactured in accordance with the nonwoven configuration previously described in connection with Figures 7A-12. Illustrative implant 300 in Figure 14A is circular and has a center 302, a first set of strands 304 formed as concentric circles of increasing radii around the center 302, and a second set of strands 306 extending radially from the center 302. The implant 300 includes flat ends 308, but in alternate embodiments, the implant portions may have uncrushed ends as described above.

In an exemplary fabrication technique, a manufacturer selectively removes portions of the surgical implant 300 depicted in Figure 14A to construct the surgical implant 310 of Figure 14B. In particular, portions 303a-303d are removed by cutting, trimming, fusing, laser cutting, or using other similar methods. removal of portions 303a-303d shortens some of the radial strands 306a-306d, and optionally leaves them without flat ends. Similarly, the removal of portions 303a-303d leaves the concentric circular strands 304 in segments 304a-304d, which are depicted as having flat ends. Thus, the resulting implant 310 includes an uncompressed central portion 314 with multiple radially extending flat end extensions 316a-d. The central uncompressed end portion 314 shown is circular to support various anatomical structures including, for example, the base of the bladder. The radially extending flat end portions 316a-d can be extended and anchored to the respective sealant membranes alone or in conjunction with soft tissue anchors, as will be discussed below.

Implants that have been discussed above generally lie flat when not in use. However, in one aspect, the implants described herein can be pre-molded to fit and fit around desired anatomical positions. For example, Figure 15A shows an implant 320 that is pre-sized and molded to fit and support some of the urethra and / or bladder neck. Implant 320 includes an indented portion 322 that is designed to interpose below the bladder neck and / or urethra, to prevent implant 320 from placing undue stress on the bladder neck and / or urethra.

In an exemplary technique, indented portion 322 is formed by gathering and compressing portion 322 of implant 320 using a clip 324 shown in Figure 15B that is aligned along the anteroposterior direction 328 of implant 320. In particular, the surgeon squeezes the clamps 326a and 326b together and opens the clip 324, then places the portion 322 of the implant 320 in the clip 324, releases the clamps 326a and 326b to close the clip, and then bends the ends 320a and 320b on the respective clamps 326a and 326b. After waiting for a sufficient period of time for implant 320 to maintain its folded configuration after removing clip 324, the surgeon opens the clip and releases implant 320, which is then molded as illustrated in Figure 15A.

The larger pelvic floor implants described above, including those sized and molded to extend and support a patient's bladder, can be pre-molded in the same way using larger 324 clips, or using multiple 324 clips or multiple single clip 324 uses at various positions along implant 320. The depicted indented portion 322 is extended in the anteroposterior direction 328, but in other embodiments, the indented portion 322 may also be extended in a lateral direction 330. This can be done, after forming the indented portion 322 as described.

ES 2 536 748 T3 above, gathering and compressing a portion of implant 320 with clip 324 aligned along lateral direction 330 of implant 320.

The implants described above can be constructed from a variety of materials. There are many possible mesh materials, and the implant can be made, alternatively or in combination, of other types of materials. Exemplary mesh materials include, for example, synthetic materials, natural (eg, biological) materials, or a combination thereof. The mesh can be manufactured from any number of biocompatible materials, such as nylon, silicone, polyethylene, polyester, polyethylene, polyimide, polyurethane, polypropylene, fluoropolymers, copolymers thereof, combinations thereof, or other suitable synthetic materials. . The material can be, for example, a biodegradable synthetic material. The term "biodegradable", as used herein, refers to the property of a material to dissolve in the body. Such materials can also be absorbed into the body, that is, they are bioabsorbable.

Suitable bioabsorbable synthetic materials include, without limitation, polylactic acid (PLA), polyglycolic acid (PGA), poly-L-lactic acid (PLLA), human dermis, and decellularized animal tissue. Human tissues can be obtained, for example, from cadaveric human tissue or engineered human tissue. Animal tissues can be obtained, for example, from porcine, sheep, bovine, and equine tissue sources. The material can be omnidirectional material, a material that has equivalent tensile strength from any direction, such as the pericardium or dermis. Alternatively, the material can be an oriented material, a material that has only one direction when the tensile strength of the material is highest. Targeted materials can include rectus fascia and / or fascia lata, as well as oriented synthetic materials.

Examples of biodegradable polymers, which can be used to form tubular mesh 100, in addition to those noted above, include, without limitation, polylactic acid, polyglycolic acid, and copolymers and mixtures thereof, such as poly (L- lactide) (PLLA), poly (D, L-lactide) (PLA), polyglycolic acid [polyglycolide (PGA)], poly (L-lactide-co-D, L-lactide) (pLlA / PLA), poly (L -lactide-co-glycolide) (PLLA / PGA), poly (D, L-lactide-co-glycolide) (PlA / PGA), poly (glycolide-co-trimethylene carbonate) (PGA / PT-MC), poly (D, L-lactide-co-caprolactone) (PLA / PCL), and poly (glycolide-co-caprolactone) (PGA / PCL) ; polyethylene oxide (PEO); polydioxanone (PDS); polypropylene fumarate; polydepsipeptides, poly (ethyl glutamate-co-glutamic acid), poly (tert-butyloxycarbonylmethyl glutamate); polycaprolactone (PCL), poly (hydroxy butyrate), polycaprolactone co-butylacrylate, polyhydroxybutyrate (PHBT), and polyhydroxybutyrate copolymers; polyphosphazenes, poly (phosphate ester); maleic anhydride copolymers, polyiminocarbonates, poly [(97.5% dimethyl trimethylene carbonate) -co- (2.5% trimethylene carbonate)], cyanoacrylate, hydroxypropylmethylcellulose; polysaccharides, such as hyaluronic acid, chitosan, alginates, and regenerated cellulose; poly (amino acids) and proteins, such as gelatin and collagen; and blends and copolymers thereof.

The systems, devices, and methods described herein can be combined with other techniques to treat UI and / or pelvic floor disorders. For example, while the implants described herein are suitable for use in the single vaginal incision procedure, such implants can also be used in multiple incision procedures such as those described in US Patent Publications. United States No. 2005/0245787, No. 2005/0250977, No. 2005/0075660, United States Patent No. 6911003, and other systems. In certain embodiments, the meshes used to support the urethra and / or pelvic organs may include, as a whole or on a fiber-to-fiber basis, a release agent for patient tissues. An illustrative agent is a tissue growth factor that stimulates, when applied to the patient's tissues in a pharmaceutically acceptable amount, growth of well-organized collagen tissue, such as scar tissue growth, preferably in large quantities. According to one characteristic, the agent may or may not block or delay the dissolving capacity of the biodegradable materials. This can be controlled by selecting different methods for loading the implant agent. The tissue growth factor can include natural and / or recombinant proteins to stimulate a tissue response so as to increase collagen tissue such as tissue tissue growth. Exemplary growth factors that can be used include, but are not limited to, platelet-derived growth factor (PDGF), fibroblast growth factor (FGF), transforming growth factor-beta (TGF-beta). , vascular endothelial growth factor (VEGF), Activin / TGF and sex steroids, bone marrow growth factor, growth hormone, insulin-like growth factor 1, and combinations thereof. The agent can also include a hormone, including, but not limited to, estrogens, steroid hormones, and other hormones that stimulate the growth of appropriate collagen tissue such as scar tissue. The agent also includes stem cells or other suitable cells derived from the host patient. These cells can be fibroblasts, myoblasts, other precursor cells to mature into appropriate tissues. In addition to applying active pharmaceutical agents, passive agents can also be applied to stimulate tissue growth. For example, titanium sputtering or chromium sputtering can be used.

In various illustrative embodiments, the agent can include one or more therapeutic agents. Therapeutic agents can be, for example, anti-inflammatory agents, including steroidal or non-steroidal anti-inflammatory agents, analgesic agents, including narcotic and non-narcotic analgesics, local anesthetic agents, antispasmodic agents, growth factors, gene-based therapeutic agents, and combinations of the same.

ES 2 536 748 T3

Exemplary steroidal anti-inflammatory therapeutic agents (glucocorticoids) include, but are not limited to, 21-acetoxyprephnenolone, aalclomethasone, algestone, amicinonide, beclomethasone, betamethasone, budesonide, chloroprednisone, clobetasol, cloredisolone, clobetasol, cloredisolone, cortisolone, clobetasol, cloredisolone, cortivazole, deflazacort, desonide, deoximetasone, dexamethasone, diflorasone, diflucortolone, difluprednate, enoxolone, fluazacort, fluchloronide, flumethasone, flunisolide, fluocinolone acetonide, fluocinonide, fluocortin butyl, fluocortolone, fluorometholone, fluperolone acetate, fluprednidene acetate, fluprednisolone, flurandrenolide, fluticasone propionate, formocortal, halcinonide, halcinonide, halogenated sodium hydroxide, halogenated sodium hydroxide, halcinolone acetate, halcinatebonacortone lotion, halcinolone acetate, halobetabometolone hydrochloride, halogenated sodium hydroxide , mazipredone, medrisone, meprednisone, methylprednisolone, mometasone furoate, paramethasone, prednicarbate, prednisolone, prednisolone 25-diethylaminoacetate, prednisone sodium phosphate, prednisone, prednival, prednylidene, rimexolone, thixocortal, triamcinolone, triamcinolone acetonide, triamcinolone benetonide, triamcinolone hexacetonide, and pharmaceutically acceptable salts of the same.

Exemplary non-steroidal anti-inflammatory therapeutics include, but are not limited to, aminoarylcarboxylic acid derivatives such as enfenamic acid, etofenamate, flufenamic acid, isonixin, meclofenamic acid, mephanamic acid, niflumic acid, talniflumate, terofenamate, and tolfenamic acid; Arylacetic acid derivatives such as acemetacin, alclofenac, amphenac, bufexamac, cinmethazine, clopirac, diclofenac sodium, etodolac, felbinac, phenclofenac, phenchlorac, phenclofenac acid, fenthiazac, glucamethazine, ibucophenazine, isopacopheic acid, indomelacophenazine, isopacopheic acid, indomelacophenazine , proglumethacin, sulindac, thiaramide, tolmetin, and zomepirac; arylbutyric acid derivatives such as bumadizone, butbufen, fenbufen, and xenbucine; arylcarboxylic acids such as clidanac, ketorolac, and tinoridine; arylpropionic acid derivatives such as aminoprofen, benoxaprofen, bucoloxic acid; carprofen, fenoprofen, flunoxaprofen, flurbiprofen, ibuprofen, ibuproxamo, indoprofen, ketoprofen, loxoprofen, miroprofen, naproxen, oxaprozin, picetoprofen, pyrprofen, pranoprofen, protizinic acid, and tofenic acid, supprofenic acid; pyrazoles such as diphenamizole and epirizole; pyrazolones such as apazone, benzopiperilone, feprazone, mofebutazone, morazone, oxyphenbutazone, phenibutazone, pipebuzone, propiphenazone, ramifenazone, suxibuzone and thiazolinobutazone; salicylic acid derivatives such as acetaminosalol, aspirin, benorylate, bromosaligenin, calcium acetylsalicylate, diflunisal, etersalate, fendosal, gentisic acid, glycol salicylate, imidazole salicylate, lysine acetylsalicylate, mesalamine 1-salicylate salicylate, morphine salicylate , olsalazine, parsalmide, phenyl acetylsalicylate, phenyl salicylate, salacetamide, o-acetic acid salicylamine, salicylsulfuric acid, salsalate and sulfasalazine; thiazinecarboxamides, such as droxicam, isoxicam, piroxicam, and tenoxicam; others, such as εacetamidocaproic acid, s-adenosylmethionine, 3-amino-4-hydroxybutyric acid, amixethrin, bendazac, benzydamine, bucoloma, diphenpyramide, ditazole, emorphazone, guaiazulene, nabumetone, nimesulide, orgotein, paraffin, oxaximerole, proquazone, proxazole, and tenidap; and pharmaceutically acceptable salts thereof.

Exemplary narcotic analgesic therapeutics include, but are not limited to, alfentanil, allylprodin, alphaprodin, anileridine, benzylmorphine, bezitramide, buprenorphine, butorphanol, clonitacene, codeine, methylcodeine bromide, codeine phosphate, codeine desomorphine, codeine sulfate, codeine sulfate, dextromoramide, dezocine, diampromide, dihydrocodeine, dihydrocodeinone enolacetate, dihydromorphine, dimenoxadol, dimefeptanol, dimethylthiambutene, dioxafethyl butyrate, dipipanone, eptazocine, ethoheptazine, ethylmethylthiambutene, ethylmorphine, etonitazene, fentanyl, hydrocodone, hydromorphone, hydroxypetidine, isomethadone, ketobemidone, levorphanol, lofentanyl, meperidine, meptazinol, metazocine, methopholiphine, normevorone, normetazocine, methophanomorphine, normetazinol, normethylenedone, hydrochloride, methaphenolphine, normorphine, norpipanone, opium, oxycodone, oxymorphone, papaveretum, pentazocine, fenadoxone, phenazocine, pheoperidine, piminodine, pyritramide, proheptazine, promedol, properidine, propyram, propoxyphene, rumifentanil, sufentanil, tilidine, and pharmaceutically acceptable salts thereof.

Exemplary non-narcotic analgesic agents that can be combined with the implants of the invention include, but are not limited to, aceclofenac, acetaminophen, acetaminosalol, acetanilide, acetylsalicylsalicylic acid, alclofenac, alminoprofen, alloxyprine, aluminum bis (acetylsalicylate) , aminochloroxenoxazine, 2 amino-4-picoline, aminopropylone, aminopyrine, ammonium salicylate, amtholmethine guacil, antipyrine, antipyrine salicylate, anthraphenine, apazone, aspirin, benoxylate, benoxaprofen, benzpiperilone, benzydamine, bermoprofen, brofenac, p-bromoacetanilide, 5-bromosalicylic acid acetate, bucetin, bufexamacus, bumadizone, butacetin, calcium acetylsalicylate, carbamazepine, carbiphene, carsalazine, chloralicylic acid choline, cincofen, ciramadol, clomethacin, cropropamide, crotetamide, dexoxadrol, diphenamizole, diflunisal, dihydroxyaluminum acetylsalicylate, dipyrocetyl, dipyrone, emorphazone, enfenamic acid, epirizole, etersalate, etenzamide, ethoxazene, etodolac, felbinac, fenoprofen, floctaphenine, flufenamic acid, fluoresone, flupirtine, fluprocuazone, flurbiprofen, phosphosal, gentisic acid, glafenin, ibufenac, inzophenopromethane, isophenophene, imidazole, indocophomethate, ketoprofen, ketorolac, p-lactofenetide, lefetamine, loxoprofen, lysine acetylsalicylate, magnesium acetylsalicylate, metotrimeprazine, metdeolin, miroprofen, morazone, Morpholine salicylate, naproxen, nefopam, niphenazone, 5'-nitro-2'-propoxyacetanilide, parsalmide, perisoxal, phenacetin, phenazopyridine hydrochloride, phenol, phenopyrazone, phenyl acetylsalicylate, salicylate, phenylene, phenylpyrine, propoxyacetyl, pipebu- dyl propacetamol, propiphenazone, proxazole, quinine salicylate, ramifenazone, rimazolium methylsulfate, sallacetamide, salicin, salicylamide, o-acetic acid salicylamide, salicylsulfuric acid, salsalt, salverine, symmetride, sodium salicylate, sulfamipyrine, suprofen, talniflumate, tenoxicam, terofenamate, tetradrine, tinoridine,

ES 2 536 748 T3 tolfenamic acid, tolpronine, tramadol, viminol, xenbucine, zomepirac, and pharmaceutically acceptable salts thereof.

Exemplary local anesthetic therapeutic agents include, but are not limited to, ambucain, amolanone, amylocaine hydrochloride, benoxyinate, benzocaine, betoxycaine, biphenamine, bupivacaine, butacaine, butaben, butanilicaine, butetamine, butoxycaine, carticaine chlorohydrate, procahydrate. , cocaethylene, cocaine, cyclometaine ,dracaine hydrochloride, dimethisoquine, dimethocaine, diperadone hydrochloride, dichlonine, ecgonidine, ecgonine, ethyl chloride, beta-eucaine, euprocin, phenalcomine, fomocaine, hexylcaine hydrochloride, hydroxytetracaine, isobutyl p-aminobenzoate, leucinocaine mesylate, levoxadrol, lidocaine, mepivacaine, methylcaine, metabutoxycaine, methyl chloride, myrtecaine, parecaine, naetoxicaine, chloroxycaine, parecaine, naetoxicaine phenacaine, phenol, piperocaine, pyridocaine, polidocanol, pramoxine, prilocaine, procaine, propanocaine, proparacaine, propipocaine, propoxicaine hydrochloride, pseudococaine, pyrrocaine, ropavacaine, salicylic alcohol, tetracaine hydrochloride, tolicaine, trimecaine, zolamine, and pharmaceutically acceptable salts thereof.

Exemplary antispasmodic therapeutics include, but are not limited to, alibendol, ambucetamide, aminopromazine, apoatropine, bevonium methylsulfate, bietamiverine, butaverine, butropium bromide, n-butylscopolammonium bromide, caroverimetropin, cinnamon bromide, cinnamon bromide clebopride, coniin hydrobromide, coniin hydrochloride, cyclonium iodide, diphemerin, diisopromin, dioxafethyl butyrate, diponium bromide, drdeenin, emepronium bromide, ethaverine, pheclemine, phenalamide, phenoverine, fenpipran, fenpiverinium bromide, fentonium bromide, flavoxate, flopropione, gluconic acid, guaiactamine, hydramitrazine, hymechromone, leiopyrrole, mebeverine, moxaverine, naphiverine, octamylamine chlorine, octaverine chloride, phenanthine chloride, pentaverine , floroglucinol, pinaverium bromide, piperilate, pipoxolane hydrochloride, pramiverine, prifinium bromide, properidine, propivan, propiromazine, prozapine, racefemin, rociverine, spasmolitol, stilonium iodide, sultroponium, thimmonium iodide, tiquizium bromide, thyropramide, trepibutone, trichromyl, trifolium, trimebutine, n, n-1-trimethyl-3,3-diphenylpropylamine, tropenzyl, trospium chloride, bromide and pharmaceutically acceptable salts thereof.

Having described various surgical implants sized, molded, and constructed to repair UI and / or the pelvic floor, and exemplary methods of construction, the inventors now describe soft tissue anchors that can optionally be used to secure surgical implants to a desired anatomical position, such as obturator membranes, and methods for coupling the soft tissue anchors to the surgical implants. In practice, as mentioned above, surgical implants are inserted and placed in a desired position within the pelvic region of the patient through a single incision in the vaginal wall of the patient and thereafter anchored to regions soft tissue such as plugging membranes.

In general, soft tissue anchors are biocompatible structures that are fixed or interoperably connected to an implant and adjusted to anchor them to the pelvic tissue of the patient. In certain embodiments, the soft tissue anchors are sling housings formed directly and / or adapted as end terminations around the ends of the implant, and in others, the soft tissue anchors and the implant are separate elements that can be assembled. to form an implant assembly. In addition, the anchors can be directly coupled to a surgical implant, or indirectly coupled to the implant through, for example, filaments or rings that distance the anchors from the surgical implant. Soft tissue anchors can be adjustably attached to the surgical implant to allow the surgeon to tension the implant after anchoring in the patient. Soft tissue anchors can include tabs that anchor to the plugging membrane, or they can be smooth, in which case the surgeon positions the anchor to act as a mechanical stop and prevent disengagement of the plugging membrane. Soft tissue anchors can also be bioabsorbable and absorbed into the surrounding tissue after implantation in the pelvic region of the patient.

Figures 16A-16C depict an unclaimed implant assembly 400 having soft tissue anchors that are configured as housings around the ends of a surgical implant 401 that are anchored to the implant and coupled to the implant with delivery devices.

More particularly, as shown in Figure 16A, implant assembly 400 includes housings 402 and 404 which are end terminations formed and / or fitted around the end of mesh implant 401 that taper beyond the end of the implant. 401 around which they form and / or adapt. The end termination 402 includes a ring or opening 416 and first and second legs 412 and 414 extending radially from the opening 416. The opening 416 is sized and molded to be enveloped by a delivery device, such as, for example, the distal end of a shaft, needle, or dilator of any of the delivery devices described below. The assembly 400 also includes an end termination 404 that is similar to the end termination 402. In particular, the end termination 404 includes branches 406 and 408 that extend radially from the opening 410. In operation, a surgeon places opening 416 (or 410) over the tip of a shaft of a delivery device and slides opening 416 underneath the tip until opening 416 abuts against a step, anchor, or another stopping mechanism, as will be discussed in more detail below. Apertures 410 and 416 include internal surfaces 410a and 416a that, in certain embodiments, taper to interpose with the tip of a delivery device.

ES 2 536 748 T3

The apertures 410 and 416 depicted are coplanar with the implant 401. As a result, the implant assembly

400 has a low management profile. As mentioned above, delivery profile refers to the maximum cross-sectional area of ​​a corridor through the patient's anatomy that is necessary for implant placement, and smaller delivery profiles are beneficial at least in part. because they reduce tissue damage during instant administration. In addition, the openings 410 and 416 can have any shape, including square, triangular, oval, other preferred shapes. The openings 410 and 416 can also be of any size, and in particular can be configured to engage with shafts or needles of varying dimensions.

The limbs at the end termination 402 and 404 are sized and molded to wrap around and join implant 401 to help anchor implant 401 within the patient. More particularly, referring to the end termination 402, the branches 412 and 414 extend radially from the respective opening 416 and meet at an angle 418. In certain embodiments, the end cap 402 is flexible so that the angle 418 can increase or decrease after application of an appropriate mechanical pressure. By way of example, if implant 401 passes through tissue in a forward direction 420, branches 412 and 414 interact with tissue to reduce angle 418. If implant 401 passes through tissue in a backward direction 422, limbs 412 and 414 are pushed outward through tissue to increase angle 418. Thus, variable angle 418 facilitates movement of implant 401 in the forward direction 420, and prevents movement of the mesh strip 401 in the backward direction 422. In certain embodiments, the angle 418 can vary between about 0 degrees and about 90 degrees, and in other embodiments it can vary up to more than about 90 degrees. The angle 418 formed between branches 412 and 414 can vary, as can the flexibility of the termination of end 402. These properties are generally chosen to suit the route of administration and position for anchoring the particular implant, as well as the condition being treated.

In addition, the configuration of the V-shaped limbs 412 and 414 acts to wrap around a patient's tissue to resist removal once the implant assembly 400 is implanted. The shown limbs 412 and 414 extend beyond of the width 401a of implant 401 to provide additional wrapping with tissue, but in other illustrative embodiments it may be of any length, and may extend beyond the width 401a of implant 401. The characteristics described herein with respect to the termination of the 402 end can also be applied to the termination of the 404 end.

The end cap can be attached to the implant by gluing, stapling, welding, molding, other methods. Figure 16B shows an embodiment in which end caps 402 and 404 are molded into implant 401. In an exemplary fabrication technique, a manufacturer inserts one end 401b of the implant

401 in a mold (not shown) that has corridors or cavities molded as the end termination 402 (ie, includes ring-like shaped cavities 416 and branches 412 and 414). The manufacturer then injects a curable material, such as a curable biocompatible plastic, into the mold. After curing the curable material, the fabricator decouples the mold and implant 401, and then trims, melts, or otherwise removes excess casting material 419. The process is repeated for the other 401c side of implant 401 to form the end cap 404, the manufacturer then trims, melts, or otherwise removes excess mesh corners 401d, 401e, 401f, and 401g implant 401.

Figure 17 illustrates an end cap similar to end caps 402 and 404, but does not need to be molded directly into an implant. This end termination includes a top piece 420 and a bottom piece 422. The bottom piece 422 includes two legs 424 and 426 that are V-shaped and an opening 428 located between the shaped legs. of V 424 and 426. Top piece 420 is shaped to align with bottom piece 422, and in particular includes two legs 429 and 430 that have a V shape and an opening 432 located between the shape legs. V 429 and 430. Top piece 420 further includes a plurality of openings or cavities (not shown) that align with a plurality of projections 434 that are designed to interpose within the openings or cavities. In operation, a manufacturer secures an implant 401 between the top piece 420 and the bottom piece 422 by placing one end of the implant 401 b between the top piece 420 and the bottom piece 422. Projections 434 pass through interstitial spaces between implant 401 filaments and snap-fit ​​into corresponding openings or cavities (not shown) in top piece 420. In addition to or as an alternative to the use of projections 434 and corresponding openings or cavities, a fabricator may secure the top piece 420 and the bottom piece 422 by gluing, heat bonding, molding, or otherwise. thus joining the upper part 420 and the lower part 422 to each other and / or to the implant 401.

In alternative configurations, the end terminations are provided without radial extension legs. Figure 18 shows an implant assembly 440 that includes an implant 442 and two end caps 444 and 446 formed as respective openings without branches. One manufacturer attaches end caps 444 and 446 to implant 442 using any of the methods described above. In the depicted implant assembly 440, the corners of implant 442 are cut off at positions 442a, 442b, 442c, and 442d.

ES 2 536 748 T3

Figures 19A and 19B show an alternative end cap 450 that is flexible and is prepared from softer material, such as a soft durometer biocompatible material, than the end caps described above. End cap 450 can be attached to a surgical implant using any of the methods described herein with respect to other end cap embodiments. As shown in Figure 19A, the end termination 450 includes an opening 452, a first limb 454, and a second limb 456. The first limb 454 and the second limb 456 which are V-shaped, and the opening 452 It rests in a plane that is perpendicular to the plane that extends through the first and second branches 454 and 456. This perpendicular orientation results in the distal end of shaft 458 aligning with the implant (not shown), and may be preferred by a surgeon for the delivery of an implant. Since the end cap 450 is made of relatively soft material, the ring 452 is in a collapsed state when the end cap 450 is at rest, as shown in Figure 19A. In use, a surgeon attaches end termination 450 to a delivery device (not shown) by sliding aperture 452 around an axis 458 of the delivery device as depicted in Figure 19B. Opening 452 expands as shaft 458 is pushed into opening 452, expanding opening 452 into a substantially circular configuration. The surgeon administers the end cap 450 to a target tissue region, and retracts the shaft 458 to disengage the axis 458 from the end cap 450. The surgeon then retracts the shaft 458, the opening 452 returns to the collapsed state which is illustrated in Figure 19A. The collapsed state provides a lower profile for the end cap 450 after the end cap 450 is implanted. As mentioned above, low profile implant mounts can lessen damage to surrounding tissues.

Figure 20 shows another unclaimed embodiment of an implant assembly 460 having an alternate low profile of end caps 463 and 464 that remain substantially in the plane of the implant 466. The end cap 464 includes a tab-shaped region 468 , an opening 470 positioned within the tongue-shaped region 468, and branches 472 and 474 extending radially from the opening 470. The depicted aperture 470 is small (ie, in certain embodiments less than about 2mm in diameter), and is sized to engage a narrow needle of a delivery device. In other embodiments, opening 470 is sized to allow a surgeon to thread a filament through it. The filament can be coupled to a separate soft tissue anchor as described in connection with other embodiments herein. In the same way as the limbs described in relation to Figure 16A mentioned above, limbs 472 and 474 anchor implant 466 to soft tissue. In an exemplary fabrication technique, a surgeon dips implant 466 into a curable plastic to form the end cap 468. The manufacturer then trims the plastic to create the tab shape 468 and optional branches 472 and 474, and drills a hole through the plastic to create the opening 470. However, in alternative embodiments, the manufacturer may preform the termination. end 464 and subsequently press fit, glue, sew, or otherwise bond to implant 466.

The alternate end termination 463 also includes a tab-shaped region 473 but does not include an opening. Instead, the end termination 463 includes a conical projection 475. The conical projection 475 is designed to interpolate around the distal end of a shaft of the delivery device, such as needle 477. In operation as a surgeon interpolates needle 477 with projection 475 and draws implant 466 toward a target tissue region. The projection 475 need not be conical, and in certain embodiments it is pyramidal.

As mentioned above, in certain embodiments, the soft tissue anchors and the implant are separate elements that are assembled as an implant assembly. Figures 21A-D illustrate exemplary soft tissue barbed anchors that may be used for this purpose. In Figure 21A, anchor 500 includes a through opening 502, a body 504, and two rows of radial projections, or tabs 506. The through opening 502 is coupled to a shaft of a delivery device by fitting around the shaft, as will be discussed below. The depicted through-opening 502 extends axially entirely through the body 504 of the anchor 500. In other embodiments, the body 504 includes a passageway that extends axially from the proximal end 500b of the anchor 500 only partially toward the distal end 500a of anchor 500.

The tabs 506 are relatively short (eg, less than about 2 millimeters in length) and relatively wide (eg, between about 1 millimeter and about 2 millimeters in width / diameter). Furthermore, they have relatively flat terminal ends 508. The tabs 506 are also flexible. When a surgeon inserts the anchor 500 into a plugging membrane, the tabs 506 flex and compress against the body 504 of the anchor 500 to allow passage at least partially through the plugging membrane. After insertion into the plug membrane, the tabs 506 expand radially from the body 504 and thereby resist backward movement through the plug membrane, thereby preventing the anchor 500 from disengaging from the plug. sealing membrane.

Figure 21B shows an alternative embodiment of an anchor 510, having a through opening 512, a body 514, and two rows of radial projections 516. The projections 516 are relatively long (e.g., greater than or equal to about 2 millimeters in diameter). length) and relatively wide (for example, between about

ES 2 536 748 T3 millimeter and approximately 2 millimeters in width / diameter), compared to anchor 500 in Figure 21A.

Figure 21C shows another embodiment of an anchor 520 having a body 522, an axially extending through opening 524, and radial projections 526. Anchor 520 is similar to anchors 500 and 510 of Figures 21A and 21B, respectively, except that radial projections 526 have tip-shaped rather than flat terminal ends, in contrast to projections 506 and 516. The spike-shaped projections 526 prevent the rearward forces that can be applied to the anchor 520, since the projections 526 strike more firmly on and in court with the tissue of the sealing membrane and thus prevent disengagement of the anchoring 520 of the sealing membrane. In particular, the projections have an initial width at a base 530 comparable to the width of the projections 506 and 516, and are similar in length to that of the projections 506.

Figure 21D shows another illustrative anchor 540, including a 542 relatively long body (eg, between about 2.5 centimeters and about 3.5 centimeters) and five rows of relatively long radial projections 544 (eg, greater than about 5 millimeters). ). As in the case of the examples described above, anchor 540 includes a radially extending passageway 546.

Figure 21E shows the tab anchor 540 coupled to a portion of a surgical implant 550 and anchored to an obturator membrane 552. In operation as a surgeon directs anchor 540 partially (as illustrated) or fully through the membrane obturator 552 using a delivery device and / or method to be discussed below. The tabs 544 on the anchor 540 engage with the sealing membrane 552 and inhibit the retraction of the anchor 540 out of the membrane 552 after insertion. Next, a surgeon optionally directs anchor 540 further to obturator membrane 552 to tension associated surgical implant 550. Long body 542 is beneficial in part because the surgeon can direct anchor 540 various distances through obturator membrane 552, corresponding to various stresses of implant 550. When surgeon directs anchor 540 fully through obturator membrane 552 , the surgical implant 550 is directed through the obturator membrane 552. The implant 550 may have flat ends to engage with and anchor the obturator membrane 552. The surgeon may then extend or retract a portion of the implant 550 through the obturator membrane 552 to tension the implant 550. In certain embodiments, the implant 550 does not engage the soft tissue anchor 540 and has anchored itself. to the sealing membrane 552.

Figure 22A illustrates a soft tissue anchor 560 without tabs. In particular, the soft tissue anchor 560 has a smooth outer surface 562. Like the anchors shown in Figures 21A-E, the anchor 560 includes a through opening 564 that fits around the axis of a locking device. administration, as discussed below. The depicted through opening 564 extends axially entirely through the anchor 560. In other embodiments, anchor 560 includes a passageway that extends axially from proximal end 560b of anchor 500 only in part toward distal end 560a of anchor 560.

Figures 22B-22C illustrate an exemplary technique for using anchor 560 to anchor a surgical implant 566 to a membrane plug 568. In particular, a surgeon forms an opening 570 within the plug membrane 568 using, for example, a needle or a dilator. Next, the surgeon attaches anchor 560 to implant 566 using methods discussed below. The surgeon then directs anchor 560 through opening 570. When back tension is applied to implant 566, anchor 560 pivots to a horizontal orientation, shown in Figure 22C, and is aligned with obturator membrane 568, and this horizontal orientation prevents anchor 560 from disengaging from the membrane. shutter 568.

Figure 23 illustrates an alternative soft tissue anchor 570 shaped like an arrowhead. More particularly, anchor 570 includes a point 572 at a distal end, a cylindrical shaft 574 at a proximal end, and wings 576a and 576b at a distal end of cylindrical shaft 574. Anchor 570 further includes a slot 578 positioned longitudinally along it. along the cylindrical shaft 574 and a cross bar 580 that bridges the slot 578. In an exemplary technique, a surgeon attaches anchor 570 to a filament by interpolating the filament through slot 578 and threading the filament around crossbar 580.

As mentioned above, soft tissue anchors are attached to surgical implants in various ways. In certain embodiments, such as with pelvic floor repair, the implants have long lateral widths or laterally extending branches or regions of extension, which directly engage the surgical implant. In others, they distance themselves far from the surgical implants. In either case, the anchors can be fixedly attached, or they can be attached adjustably so that a surgeon can think of the implant.

Figure 24 illustrates a surgical implant 580, similar to surgical implant 30 depicted in Figure 2A, with soft tissue anchors 582-587 directly coupled to respective of strips 590-595. In certain embodiments, the anchors are fixedly coupled to the respective strips, as depicted with respect to the

ES 2 536 748 T3 soft tissue anchors 582-584. Ends 582a, 583a, and 584a of anchors 582-584 are attached to respective ends 590a, 591a, and 592a of strips 590-592 by gluing, heat bonding, tying, other permanent attachment methods.

In other embodiments, the anchors are adjustably coupled to the respective straps, as shown with respect to soft tissue anchors 585-587. As shown, the 593-595 mesh strips are threaded through buckles or openings in the 585-587 anchors, which expose the 593a, 594a, and 595a free ends of the mesh strips that have been fully threaded through anchors 585-587. The surgeon can pull the free end 595a to veneer the mesh strips 595 through the anchor 587 and increase the length of the exposed free end 595a. as a result, the tension applied by strip 595 to surgical implant 580 will increase. The surgeon can think of implant 580 in the same way by adjusting the other mesh strips.

As mentioned above, certain surgical implants can be used by way of example that do not extend the total length of the obturator relative to the patient's obturator. In such cases, the soft tissue anchors can be indirectly attached to the surgical implant, for example, through filaments or rings that distance the anchors beyond the surgical implant to extend the anchor points. Figure 25A illustrates a surgical implant 600 coupled with soft tissue anchors 602 and 604 via snap rings 606 and 608. Rings 606 and 608 couple their respective anchors to the implant via a set of through openings. More particularly, ring 606 engages anchor 602 by threading through openings 614 and 616 in soft tissue anchor 602, and engages surgical implant 600 by threading through apertures 610 and 612 into the surgical implant. 600. Similarly, ring 608 engages soft tissue anchor 604 by threading through openings 622 and 624 in soft tissue anchor 604, and engages surgical implant 600 by threading through openings 618 and 620 into the surgical implant 600. As mentioned above, woven surgical implants can be stretched and damaged due to stresses during implant delivery. Drastic rings 606 and 608 stretch to absorb lateral stresses, thereby preventing damage to implant 600 during delivery.

Additionally, elastic rings 606 and 608 adjust for short-term and / or long-term changes in the changing anatomy of the patient to prevent damage to the surgical implant 600. For example, when the patient sneezes, coughs, or jumps, the muscles of the pelvic region can contract and anatomical structures can be displaced. Anatomical structures can also be displaced for long periods of time due to the changing anatomy of the patient due to, for example, weight gain or weight loss. In such cases, snap rings 606 and 608 are stretched to absorb the stresses caused by these short-term and long-term changes, thereby avoiding changes that can damage surgical implant 600. Figure 25b shows snap rings 606 and 608 in stretched states.

Figures 26A-G illustrate an alternate embodiment of an implant assembly 630 having a surgical implant 632 that spans past and engages with soft tissue anchors 634, 636, 638, and 640 through filaments 642, 644 , 646, and 648. As will be discussed, the spacing of soft tissue anchors 634, 636, 638, and 640 from implant 632 can be adjusted to tighten the implant, and to allow soft tissue anchors 634, 636, 638, and 640 reach various target tissue regions in the patient's retropubic space.

The surgical implant 632 shown is similar to the surgical implant 70 of Figure 4, and the soft tissue anchors 634, 636, 638, and 640 shown are similar to the soft tissue anchor 570 of Figure 23. More particularly, as shown shown in Figure 26A, filament 642 is threaded through a first opening 650 in implant 632, through an opening 652 in anchor 634, and through a second opening 654 in implant 632. Two ends 642a and 642b of filament 642 are encircled by a slidable filament lock mechanism 656 into an adjustable size loop. Similarly, implant 632 engages soft tissue anchor 636 through strand 644, strand lock 660, and openings 666, 668, and 670, to soft tissue anchor 640 through strand 648, filament lock mechanism 662, and openings 672, 674, and 676, and to soft tissue anchor 638 through filament 646, filament lock mechanism 664, and openings 678, 680, and 682. Figure 26B shows implant 632 after anchoring of soft tissue anchors 634, 636, 638, and 640 to sealing membranes 639 and 641. In place of the filament locking mechanism 660, 662, 664, and 656, They can use other fasteners with adjustable straps, such as slip knots.

Filaments 642, 644, 646, and 648 in conjunction with filament locking mechanisms 660, 662, 664, and 656 allow a surgeon to adjustably tension implant 632 within the pelvic region of the patient. More particularly, once the surgeon delivers implant 632 to a target tissue region, such as the plugging membranes as depicted in Figure 26B, the surgeon tightens surgical implant 632 and / or adjusts its length or width using the filament locking mechanisms 660, 662, 664, and 656 and drawing the implant corners 632a, 632b, 632c, and 632d towards the respective anchors 634, 636, 638, and 640. In particular, as depicted in Figures 26C-D, a surgeon holds a tensioning tool 700 with one hand and one or both ends of filament 642a and 642b with the other hand. Tension tool 700 includes a handle 700a, a shaft 700b that extends distally from the handle, and a curved, loop-shaped, or hook-shaped tip 700c to a distal end of shaft 700b oriented at an angle. towards the axis 700b. The 700c tip of the

ES 2 536 748 T3 Tension Tool 700 is sized and molded to engage and engage with the 656 filament lock mechanism and to decipher the 656 filament lock mechanism along the 642 filament to adjust the distance from the corner of implant 632a to anchor 634 (secured to a target tissue region) and thereby tensioning and / or using the length and / or width of the implant mount.

In an exemplary technique, the surgeon supports the tip 700c of the tension tool 700 against the proximal end 656a of the filament locking mechanism 656. The filament locking mechanism 656 may be external to the patient, within the canal vaginal, or beyond the vaginal incision and into the patient's pelvic region. When the locking mechanism of filament 656 is beyond the vaginal incision, the surgeon will insert the tension tool 700 through the same vaginal incision. Next, as shown in Figure 26D, the surgeon pushes tension tool 700 in a distal direction 706 toward the corner of implant 632a while pulling one or both ends of filament 642a and 642b in a proximal direction. 708 past the corner of implant 632a. The ends of the filament 642a and 642b can remain outside the patient, within the vaginal canal, or beyond the vaginal incision. If the ends of the filament 642a and 642b are not accessible by hand, the surgeon may use forceps or other suitable instruments to grasp the ends of the filament 642a and 642b. The filament locking mechanism 656 is then slid in a distal direction 706 along the filament 642 and towards the corner of the implant 632a. In certain embodiments, the filament locking mechanism 656 is configured to slide in one direction (ie, fiscally 706) and not in a rearward direction (ie, proximally 708). The same can be applied if slip knots are used (ie slip knots can be one-way slip knots).

The filament locking mechanism 656 then abuts against the corner of the implant 632a and draws the corner of the implant 632a towards the anchor 634 which increases the tension of the implant 632. Figure 26E represents the corner of the implant 632a, the anchor 634 , the locking mechanism of filament 656, and filament 642 after such an exemplary tensioning technique. The surgeon then repeats this process for implant corners 632b, 632c, and 632d until implant 632 is adequately tensioned. Figure 26F depicts implant 632 after the surgeon has tensioned all four corners 632a-d. Although the depicted implant 632 attaches four anchors to the respective corners 632a-d, the implant 632 can also be attached to anchors on sides or edges of the implant 632 that are spaced from the corners 632a-d.

The surgeon can also loosen implant 632 using filament locking mechanisms 660, 662, 664, and 656. An exemplary technique is depicted in Figure 26G, in which a surgeon holds tension tool 700 and supports tip 700c facing proximal end 656b of filament locking mechanism 656. The surgeon pulls the tensioning tool in a proximal direction 708, and as a result the locking mechanism of filament 656 slides proximally along filament 642. The corner of implant 632a is then released to slide in a proximal direction 708 Along filament 642, the surgeon then repeats this process to implant corners 632b-d until implant 632 is properly loosened to a desired tension.

Although the tension and loosening technique depicted was described with reference to anchors 634, 636, 638, and 640 that anchor to the respective sealing membranes 639 and 641, anchors 634, 636, 638, and 640 can also be coupled with other target tissue regions in the patient's retropubic space. For example, in an alternative embodiment, anchors 634 and 636 anchor to the sacrospinal ligament or levator ani regions of target tissue of the patient, although anchors 638 and 640 anchor to target tissue regions of the obturator membranes. of patient 639 and 641.

Having described various exemplary surgical implants, and systems and methods for anchoring the implants within the patient and tensioning the implants once the implants are anchored, various exemplary devices for use in inserting the implants are described below. surgical implants through a single vaginal incision. In certain embodiments, delivery devices include a handle and a shaft that extends distally from the handle to engage a soft tissue anchor. In certain configurations, the delivery devices include moving parts that allow a surgeon to control the release of the soft tissue anchor from the delivery device, measure the placement position of the soft tissue anchors, and / or view the appropriate lengths. of an implant for use in a particular patient. Delivery devices are generally molded so that a surgeon can guide a distal end of the delivery device through the patient's vaginal opening, through the vaginal incision, and into a patient's obturator membrane. In certain embodiments, the delivery device also involves molding to extend through the vaginal incision to the contralateral obturator membrane, and in others the surgeon provides a second device that has an opposite curvature to extend through the incision. vaginal and the contralateral obturator membrane. In certain exemplary techniques, soft tissue anchors secure the implant to target tissue regions, while in others, the flat end portions of the implant secure the implant to target tissue regions.

More particularly, Figure 27 shows an unclaimed delivery device 800 for delivery of an implant assembly to the pelvic region of a patient. Delivery device 800 includes handle 802, cannula 804 extending distally from handle 802, and movable shaft 806.

ES 2 536 748 T3

The handle 802 includes a proximal end 808 and a distal end 810. The handle 802, as shown, is basically straight and tapers basically inward from the proximal end 808 to a distal position 812. The distal portion 810 of the 802 tapers outward from distal position 812 to prevent a hand of the medical surgeon from sliding distally while grasping handle 802.

The cannula 804 has a proximal end 804a and a distal end 804b, and extends distally from a more distal end 814 of the handle 802. The cannula 804 is basically straight, but this need not be the case. In alternative embodiments, it can include any combination of curved sections and straight sections, and can be extended in one, two, or more planes. Shaft 806 is interpolated within cannula 804 and mechanically coupled to a proximal end of a slider 816 on / within handle 802. A surgeon can slide slider 816 axially into the slot to retract and extend shaft 806 in and out. outside of cannula 804. With shaft 806 extended, a more distal end 820 of cannula 804 forms a projecting portion 822.

In operation, a surgeon slides slider 816 distally and thereby extends shaft 806 to an extended position. The surgeon then interpolates a tissue anchor, such as the tissue anchors described above, at the distal end of shaft 806. The surgeon then inserts the distal end of the delivery device 800 with the tissue anchor into the patient's body, eg, through the vaginal wall incision in accordance with the illustrative procedure. The surgeon advances the device until the anchor is positioned in a target tissue region such as an obturator membrane. The surgeon then retracts slider 816 to retract shaft 806 into cannula 804 and out of the tissue anchor. In certain embodiments, the tissue anchor abuts against the projecting portion 822 of the delivery device 800 and thereby engages the shaft 806 when the shaft 806 retracts into the cannula 820. The surgeon removes the delivery device 800 of the patient and thus leaves the tissue anchor in place and anchored in the target tissue region. The anchor can be attached to an implant that engages the one or more soft tissue anchors. The surgeon can repeat the procedure for the other soft tissue anchors with the same or a different delivery device.

According to the illustrative embodiment, when shaft 806 is in an extended position, the exposed distal section of shaft 806 is between about 2 centimeters and about 4 centimeters in length. In other illustrative embodiments, it is between about 1 centimeter and about 3 centimeters in length. In further illustrative embodiments, the tapered distal section of shaft 806 has an outer diameter between about 0.076 centimeter and about 0.127 centimeter. In an illustrative embodiment, it has an outer diameter of approximately 0.102 centimeters. In accordance with other configurations, the outer diameter of cannula 804 at distal end 820 is between about 0.178 centimeters and about 0.3 centimeters. In one embodiment, the outer diameter of this portion of the cannula is approximately 0.2 centimeters. According to one configuration, the total distance from the distal end 814 of the handle 802 to the most distal tip 806a of the shaft 806, with the shaft extended is between about 7 centimeters and about 20 centimeters. In other configurations, the total distance is between approximately 8 centimeters and approximately 12 centimeters.

Alternatively, the delivery devices can include a fixed axis and a movable cannula positioned around the fixed axis. Figure 28 shows such a delivery device 900 and an implant assembly 920. Delivery device 900 includes handle 902, needle / shaft 910 extending directly from handle 902, push switch 904 distal to handle 902, and cannula 906 positioned around shaft 910 and extending distally from the handle. push switch 904.

Shaft 910 is generally linear at its proximal end 910a, and curves toward its distal end 910b. However, in other embodiments, shaft 910 can be straight, can include any combination of curved sections and straight sections, and / or can be extended in one, two, or more planes. When the delivery device 900 is inserted through the vaginal incision and using an obturator membrane, a straight shaft can facilitate access for a surgeon to more posterior regions of an obturator membrane, while a more curved shaft can facilitate access. to more anterior regions of a sealing membrane. In certain embodiments, the shaft may have a shorter length than the depicted shaft 910 which may provide a surgeon with better control. In certain embodiments, shaft 910 has a diameter between about 0.191 centimeter and about 0.508 centimeter, di in certain embodiments it is about 0.272 centimeter. The shaft 910 includes a tip 916. The tip 916 can be sharp and is adapted to incise and / or dissect human tissue, or blunt and is adapted for dissection and / or blunt dilation of human tissue. In certain embodiments, the tip is blunt in order to avoid damage to sensitive structures such as organs, nerves, and arteries, as will be discussed below.

Push switch 904 comprises polymeric materials and is mechanically coupled to cannula 906. Cannula 906 is shorter in length than shaft 910, and when switch 904 is in the retracted state, as shown in Figure 28 , shaft 910 is exposed at its distal end 910b. In certain embodiments, the exposed portion of shaft 910 is slightly longer than about half the length of implant assembly 920 so that implant assembly 920 remains external to the body during initial placement of shaft 910.

ES 2 536 748 T3

Implant assembly 920 includes implant 928 and anchors 926 and 922 coupled to implant 928. Anchors 926 and 922 are similar to anchor 560 of Figure 22a, but may be similar to any of the anchors described herein. . Anchors 926 and 922 include respective axial through holes. The internal diameter of anchor 926 is preferably sized and molded to fit around and slide against the external diameter of shaft 910. Anchor 926 slides proximally along axis 910 and abuts the distal end of push cannula 906. The external diameter of anchor 926 may be less than, greater than, or equal to the external diameter of the propeller cannula 906. The implant 928 further includes a center mark 924 that indicates the center, or mid-length, of the implant 924. In one use of the device 900, the center mark 924 of the implant is known directly below the urethra. However, in other embodiments, device 900 is used with longer meshes that include markings that are placed under other anatomical structures, such as, for example, the base of the bladder.

The cannula 906 includes a propellant mark 908 that indicates where the center mark 924 of the implant 928 will be placed after the implant 928 has been placed using the delivery device 900. In an exemplary mode of operation, when a surgeon delivers implant 928 using delivery device 900 with thruster switch 904 and cannula 906 retracted, the surgeon places thruster mark 908 under the urethra such that when the surgeon advances the thruster, the center mark 924 of implant 928 rests near or directly under the urethra. However, in embodiments where the implants include markings that indicate the position of the implant relative to another anatomical structure, such as the base of the bladder, the surgeon accordingly places the propellant marking 908 below that anatomical structure.

In operation, a surgeon attaches an anchor 926 of implant mount 920 to shaft 910. Anchor 926 slides proximally along shaft 910 and supports the distal end of driver cannula 906, the surgeon inserts shaft 910 into the body of the patient and guides tip 916 toward a target region while retracting switch 904. In certain embodiments, the surgeon advances the tip beyond the target region. The surgeon optionally calibrates its proximity to the target region but aligning the cannula mark 924 with an anatomical landmark such as the urethra. The surgeon advances switch 904 distally, thereby advancing the distal end of cannula 906 toward tip 916 of shaft 910. Figure 29 shows delivery device 900 of Figure 28 with propellant 904 in an extended state. As will be described below, in certain embodiments, the surgeon advances anchor 926 to a target region with the patient's anatomy without pushing anchor 926 off axis 910. Instead, after anchor 926 placement, the surgeon retracting device 900 in a rearward direction, which disengages anchor 926 from shaft 910.

In addition to the cannula marking 908, the device 900 may include other markings that guide the surgeon. To measure how far switch 904 and cannula 908 advance, in certain embodiments shaft 910 includes increment / measure marks 910a. The surgeon can use the gauge marks to gauge the distance from shaft tip 916 to the distal end of cannula 908. Figure 30 shows an alternate view of device 900 of Figure 29 with increment marks 910a etched on shaft 910. Marks 910a can be placed using other methods, such as placing a biocompatible ink or stain on shaft 910.

As described above, exemplary meshes, anchors, and delivery devices access soft tissue target regions, such as plugging membranes, through individual vaginal incisions. Exemplary surgical techniques for implanting the meshes will now be described. As illustrated herein, the procedure is practiced with meshes that are configured to support the urethra or bladder neck for the treatment of UI, and also with meshes that have longer anteroposterior widths to support the bladder, uterus, and / or other organs located within the patient's pelvic region.

Figure 31A illustrates an exemplary unclaimed single vaginal incision procedure for use of delivery device 900 to deliver implant assembly 981 for the treatment of a pelvic floor disorder. Exemplary implant assembly 981 is similar to implant assembly 630 of Figure 26A, and in particular includes an implant 980 similar to implant 632 of Figure 26A. Implant assembly 981 also includes three soft tissue anchors 982, 984, and 986 on one side of the implant, and three soft tissue anchors 988, 990, and 992 on a contralateral side. Anchors 982, 984, 986, 988, 990, and 992 are similar to anchor 500 of Figure 21A, and are attached to implant 980 using filaments and filament locking mechanisms similar to those described with reference to Figure 26A. .

In the exemplary technique, the patient is placed on an operating table in a position to provide access to the pelvic region. The surgeon can subject the patient to local anesthesia, regional anesthesia, and / or general anesthesia or sedation according to their preference. The surgeon then makes a transverse incision (not shown) in the patient's anterior vaginal wall and dissects the incision bilaterally according to his preference using, for example, surgical scissors. In certain embodiments, the surgeon bilaterally dissects the lower public branch on both sides of the patient. The surgeon then identifies a route of administration of the implant by palpating tissues in the pelvic region. The surgeon can palpate by inserting his finger through the vaginal incision and can identify anatomical structures such as the obturator foramen.

ES 2 536 748 T3

The surgeon then accesses the patient's pelvic region through a single incision to insert the implant into the patient's pelvic region and secure the implant within the region so that at least a portion of the implant is positioned posterior to the neck. of the bladder. To accomplish this, the surgeon first attaches anchor 982 to tip 916 of shaft 910, inserts the distal end of shaft 910 into the body through external vaginal opening 987, and then guides the distal end of shaft 910 through the vaginal incision into a 950 obturator membrane. The surgeon can palpate during administration if preferred. The surgeon can also use the posterior portion of the patient's pubic bone as an anatomical landmark to help guide the needle. The surgeon optionally secures implant 980 against shaft 910 during administration so that implant 980 does not obstruct the surgeon's view or route of administration using any suitable sterile securing means, such as a sterile elastic band or tie.

The surgeon then punctures the obturator membrane 950 with the tip 916 but soon stops the extension of a portion of the tip 916 or shaft 910 through the skin surface of the patient in the groin. The location of function within the obturator membrane 250 depends on the anchor being delivered. For example, the surgeon administers the anchor 982 through a sufficiently posterior region 950b of the obturator membrane 950 so that the implant assembly 981 extends to posterior regions of the patient's pelvic floor and provides posterior support, while delivering anchor 986 through an anterior region 950a of obturator membrane 950 such that implant assembly 981 is prolonged and supports anterior regions of the patient's pelvic floor (e.g., such that at least a portion implant 981 is extended to a position that is posterior to the patient's bladder neck). In certain embodiments, the surgeon generally administers the implant 980 along a pathway that prevents certain pelvic structures, such as the internal pudendal artery, the pudendal canal, the perineal nerve, the labial nerve, and other vascular structures and nervous.

The surgeon may hear and / or feel an explosion indicating that he has pierced the obturator membrane 950. The surgeon calibrates the length of the vaginal incision to the obturator 950 using the markings or indications (not shown) on the axis 910, using the marking 908 (not shown) on cannula 906, and / or by visual calibration of the length from the proximal end of anchor 982 to the vaginal incision to ensure that the length of implant 980 is appropriate for the patient. As mentioned above, in certain embodiments, implant 980 includes a visual mark that the surgeon places below a predetermined anatomical landmark, such as the urethra or bladder.

If necessary, the surgeon further advances shaft 910 to be close to, contact, apply pressure to, push (lift), or, in certain uses, pierce the epidermis (not shown) just beyond the obturator membrane 950 , without fully penetrating through the skin, until shaft 910 is in an appropriate position to deliver anchor 982. The surgeon can externally palpate the epidermis proximal to the obturator membrane to feel the shaft 910 pushing the epidermis and confirm its position. In certain embodiments the surgeon stops the extension of the tip 916 when reaching a position that is below the stratum corneum of the patient, while in other embodiments the surgeon stops the extension of the tip 916 to the epidermis. In certain embodiments the surgeon stops the tip 916 in the subcutaneous tissue or below the subcutaneous tissue and does not extend the tip 916 to the dermal layer.

In certain embodiments, the incision is made in the vagina in order to allow the inserted shaft to close, contact, apply pressure to, or push the skin into a position that is generally in line with the urethral meatus. The surgeon anchors anchor 982 to the obturator membrane, and retracts shaft 910, thereby disengaging shaft 910 from anchor 982, using methods discussed above.

The surgeon repeats this process for anchors 984 and 986, in each case administering the anchors through the same vaginal incision. The surgeon then repeats the process on the contralateral side, administering anchors 988, 990, and 992 to the obturator membrane 951 through the same vaginal incision. The surgeon also inserts the reaction 981 of the implant 980 through the vaginal incision. In certain embodiments region 981 is inserted after the surgeon inserts anchors 982, 984, and 986 on one side of the patient but before anchors 988, 990, and 992 are inserted on the other side. Once anchors 982, 984, 986, 988, 990, and 992 are delivered through the vaginal incision in the anterior vaginal wall and are extended to the respective obturator membranes 950 and 951, the entire implant 980 will have been delivered to through the vaginal opening 987 and through the vaginal incision, and therefore rests in a region anterior to the vaginal canal and provides support for the urethra, bladder, and / or neck of the bladder.

The order in which anchors 982, 984, 986, 988, 990, and / or 992 are administered to the surgeon may vary. In certain embodiments, the surgeon administers anchors in a posterior to anterior order so that the anterior portions of the implant do not obstruct or get in the way of the surgeon when administering the posterior anchors. Although cystoscopies are not required with the procedure described above, the surgeon may perform a cystoscopy to check for bladder damage detachment from the administration of any or all of the anchors. Also during administration, the surgeon optionally uses a pair of forceps or other suitable medical instrument to distance implant 980 from the urethra (not shown) d during

ES 2 536 748 T3 administration of one or more of the anchors to avoid excessive tension or stretching in the urethra. When complete, the surgeon reviews implant 980 to confirm that it is properly positioned in the organ that needs support, then sutures the vaginal incision.

For certain patients, the lateral length of implant 980 may be longer than the length of the obturator relative to the obturator of that patient. In these cases, the surgeon can leave equal lengths of the implant offset on the outer sides of the obturator membranes 950 and 951. As an example, if implant 980 has a lateral length of approximately 10 cm, then the patient with an obturator obturator length of approximately 7 cm will have approximately 1.5 cm of implants displaced on each side beyond the obturator membranes 950 and 951. Alternatively, the manufacturer may provide implants with various lateral lengths to accommodate various patients.

Device 900 and a similar delivery technique can be used to deliver non-woven implants discussed above (i.e., implant 140 of Figure 7A), and / or implants that do not extend to posterior regions of the patient's anatomy and that instead they are sized and shaped to treat urinary incontinence. Figure 31B illustrates the use of device 900 to deliver an implant 994 with a narrower anteroposterior width 994a that is designed to extend and support the urethra and / or bladder neck of the patient. Implant 994 is directly coupled to anchors 500 in Figure 21A. The surgeon uses a method of administration similar to that described with respect to Figure 31A, except that the surgeon only administers two soft tissue anchors 500. In either case, the surgeon extends the soft tissue anchors 500 into the soft tissue of the patient but stops a short length of the extension of the device portion through the surface of the patient's skin, as described above.

The surgical methods described above are non-limiting, non-claimed examples. Others will be apparent upon review of this disclosure. In certain alternative embodiments, the devices used to insert the implants are set forth in Figures 32A-34B. Figures 32A-C show another illustrative unclaimed delivery device 1060 that is sized and molded for transobturator placement of an implantable implant through the single vaginal incision, and may be used, without limitation, with any of the illustrative embodiments that are listed below. described in this document. More particularly, delivery device 1060 includes a handle 1062 with substantially straight first 1062a and second 1062b sections positioned substantially first and at an angle relative to each other, a transition portion 1065 extending out of a distal end 1063 of the handle 1062 that interpolates and extends axially out of the distal end 1063 of the second straight handle section 1062b, and a halo-shaped curved shaft 1064 extending from a distal end of transition portion 1065. Curved shaft 1064 includes a reduced diameter section 1064a at a distal end of shaft 1064 and an increased diameter section 1064b at a proximal end of shaft 1064. Increased diameter section 1064b and reduced diameter section 1064a are joined to form a ledge / ledge portion 1064c. In use, a surgeon attaches a soft tissue anchor to device 1060 requiring interpolation of the reduced diameter section 1064a of shaft 1064 through a passage opening of the soft tissue anchor. The enlarged diameter section 1064 should have a cross section with a diameter greater than the diameter of the through opening, and thus the protruding portion 1064c provides a stop or marble that prevents the anchor from sliding proximally along the axis. 1064. In certain embodiments, the increased diameter section 1064b and the reduced diameter section 1064a are manufactured from a unitary body. However, in other embodiments, the increased diameter section comprises a flexible sheath or cover that a surgeon will slide the reduced diameter section 1064a and around axis 1064.

In this embodiment, the first substantially straight section 1062a has a longitudinal axis 1067 that is normal to the plane of the curved axis 1064. However, the longitudinal axis 1067 can form any suitable angle relative to the plane of the curved axis (for example, approximately 10 , 20, 30, 45, 60, 70 or 80 degrees). By way of example, Figures 33A-B show two symmetrical devices 1040 and 1041 similar to the device 1060 of Figures 32A-C, but having alternate flat handles 1043, tapered tips 1046a at distal ends of curved shafts 1046, and have longitudinal axes 1042 which form angles 1044 of approximately 60 degrees with respect to the planes of the curved axes 1046.

Figure 34A shows an exemplary unclaimed technique for delivery of an implant using device 1041. Implant 1120 is similar to implant 30 of Figure 2A, except that implant 1120 includes a central region 1120a that is rectangular in instead of trapezoidal. Anchors 1122, 1124, 1126, 1128, 1130, and 1132, similar to anchor 500 in Figure 21A, directly engage strips 1120b, 1120c, 1120d, 1120e, 1120f, and 1120g of implant 1120.

In the exemplary technique, the patient is first positioned to provide access to the pelvic region. The surgeon may subject the patient to local anesthesia, regional anesthesia, and / or general anesthesia or sedation according to their preference. The surgeon then makes a transverse incision (not shown) in the patient's anterior vaginal wall and dissects the incision bilaterally according to his preference using, for example, surgical scissors. In certain embodiments, the surgeon bilaterally dissects the lower public ramus on both sides of the patient. The surgeon then identifies (optionally) a route of administration of the implant by palpating tissues in the pelvic region. The surgeon may feel to insert his finger through the incision

ES 2 536 748 T3 vaginal and can identify anatomical structures such as the obturator foramen.

Next, the soft tissue anchor 1122 is interpolated over the conical tip 1046a (not shown) of the delivery device shaft 1064. The surgeon grasps the handle 1043 and inserts the shaft portion of the delivery device 1046 with the anchoring 1122 through the vaginal incision. With a lateral movement, the medical surgeon passes the curved shaft 1046 past the ischiopubic branch 1140 and pierces the obturator membrane 1142.

The shaft of the delivery device 1046 is then withdrawn through the vaginal incision with a backward motion by the surgeon, leaving the anchor 1122 implanted in or through the plug membrane 1142 and optionally attached to the plug membrane 1142 as described above. The surgeon implants the anchor 1122 in a sufficiently posterior region 1142a of the obturator membrane 1142 so that the implant 1120 provides support to anatomical structures and posterior regions, such as the base of the bladder, in each case by administering the anchors through the same vaginal incision.

This process is repeated for anchors 1124 and 1126. The process is then repeated for anchors 1128, 1130, and 1132 to the contralateral obturator membrane 1146 with which there was a second delivery device (i.e., the delivery device 1040 symmetrical with the curvature of the opposite 1064 axis). As described above in connection with other exemplary techniques, the surgeon can perform cystoscopies during the procedure to check for damage to the bladder.

The curved halo-shaped shaft 1046 is beneficial at least in part because the surgeon can direct the 1046a around the ischio-pubic ramus with less movement of his arm, wrist, and / or hand to provide more precise placement of the anchors. The surgeon can palpate during administration if he prefers. The surgeon can also use the posterior portion of the patient's pubic bone as an anatomical landmark to aid in needle guidance. The curved halo-shaped shaft 1046 is also beneficial in part because it is modeled to avoid sensitive nerves and vascular structures that can be placed in tender from certain regions of the obturator membrane 1142. In some patients, these sensitive structures are more concentrated in regions sealing membrane 1142. Therefore, in certain embodiments, the surgeon administers anchors 1122, 1124, 1126, 1128, 1130, and 1132 to regions in the vicinity of obturator membranes 1142 and 1146 that are proximal to lower pubic bone structures, such as the inferior ramus of the pubis and the ramus of the ischium.

As in the case of delivery device 900, delivery devices 1040, 1041, and 1060 can be used to deliver the nonwoven implants discussed above (i.e., implant 140 of Figure 7a), and / or implants that do not extend into the posterior regions of the patient's anatomy and are instead sized and molded to treat urinary incontinence. Figure 34B illustrates the use of device 1041 to deliver a mesh implant 1048 with a relatively narrow antero-posterior width 1048a that is designed to extend and support the urethra and / or bladder neck of the patient. The surgeon uses a method of administration similar to that described in connection with Figure 34A, except that the surgeon only administers two soft tissue anchors 500 coupled to implant 1048. In addition, device 1041 includes an alternative handle configuration 1043 that includes grooves to provide the surgeon with a better grip on device 1041.

Figures 31A-B and Figures 34A-B illustrate non-claimed exemplary techniques for delivering implants that are secured to respective sealing membranes with soft tissue anchors. However, as mentioned above, in certain embodiments the implants are directly secured to the target tissue regions of the retropubic space using flat ends that are in the unitary body with the implant. Figures 35A-B depict exemplary flat-ended implants and techniques for administering and securing the implants.

In exemplary techniques involving soft tissue anchors discussed above in connection with Figures 31A-B and Figures 34A-B, the implant is coupled to soft tissue anchors, which are then coupled to a management device. However, when no soft tissue anchor is used, the implant is directly attached to the delivery device. Figure 35A depicts an implant 1102 directly coupled to the delivery device 1060 shown in Figures 32A-32C. The implant 1102 includes the flat end portions 1104a and 1104b at the respective ends of the implant 1102, and a non-flat end portion 1104c between the flat end portions 1104a and 1104b. The flat-ended implant 1102 can be manufactured using a similar technique to that described in connection with the flat-ended implant 30 of Figure 2B.

In use, the surgeon couples implant 1102 directly to delivery device 1060 by sliding reduced diameter portion 1064a through one of the interstices 1110 of implant 1102. In order for reduced diameter portion 1064a to fit through one of the interstices, in certain embodiments the reduced diameter portion 1064a has a diameter of less than about 1mm. The surgeon then follows the same steps as those described in connection with Figure 34B to guide the distal end of the device.

ES 2 536 748 T3 of delivery 1060 to the sealing membrane 1112b. However, instead of piercing a soft tissue anchor through the sealing membrane, the surgeon directs the reduced diameter portion 1064a of the device 1060 with at least part of the flat end portion 1104b through the sealing membrane 1112b. The delivery device 1060 is then removed through the vaginal incision leaving the flat-ended portion 1104b implanted in or through the obturator membrane 1112b. The surgeon then repeats this process to anchor the contralateral flat-ended portion 1104a to the contralateral obturator membrane 1112a.

The flat-ended implant 1102 is sized and molded to treat urinary incontinence to support the urethra and / or bladder neck of the patient. Flat-ended implants can also be used to treat other pelvic floor disorders. Figure 35B shows an oblique view of the pelvic region 1128 of a patient with an implant 1130 similar to implant 30 of Figure 2, but having the flat end strips 1130a-f. To administer implant 1130, the surgeon uses a method similar to that described in connection with Figure 35A to administer each of the flat end ends 1130a-c to a first sealing membrane 1132 and then administer each of the strips. with flat ends 1130d-fa a contralateral obturator membrane 1134.

As noted above, after placing a surgical implant, the surgeon tenses the implant to provide appropriate support to the anatomical structures of the pelvic region using the methods described above.

In addition to the obturator membranes, in certain alternative embodiments the surgeon anchors the implant to other anatomical structures. These structures include posterior or lateral tissues or muscles such as the sacrospinal ligament and the levator ani muscle. The sacrospinal ligament is a thin, triangular tissue that is attached at its cusp to the spine of the patient's ischium, and medially, through its broad base, to the lateral margins of the sacrum and coccyx in front of the sacrotuberous ligament. The sacrospinal ligament is a convenient position to anchor the mesh strips in the posterior regions of the pelvic floor to provide posterior support. The levator ani is a broad, thin muscle generally located on the side of the pelvis that is attached to the inner surface of the lower pelvis. It is a convenient position to anchor the mesh strips to provide lateral and / or posterior support and tension for a surgical implant.

More particularly, Figure 36 shows an exemplary position of a surgical implant 1142 in the pelvic region 1140 of a patient. The implant includes three sets of strips. The anterior set of strips 1142a-b anchors to the respective sealing membranes as discussed above in relation to other exemplary implant positions, and provides anterior support to the implant 1142. The lateral set of strips 1142b-c anchors to the respective target tissue regions 1144a and 1144b around the tendinous arch of the levator ani muscle and provides lateral support to the implant 1142. The posterior set of strips 1142e-f anchors to the respective target tissue regions 1146a and 1146b of the sacrospinal ligament and provides posterior support to the implant 1142. Each of the strips 1142a-f is anchored to the respective target tissue region via a soft tissue anchor 500 discussed in relation to Figure 21A. However, in other embodiments, strips 1142a-f have flat ends that anchor to respective target tissue regions.

An exemplary implantation technique is carried out in three phases. In a first phase, the surgeon inserts and secures the posterior straps 1142e-f in the sacrospinal ligament. In a second phase, the surgeon inserts and secures the lateral straps 1142c-d in the levator ani muscle. In a third phase, the surgeon inserts the anterior strips 1142a-ba through the obturator foramen and secures the strips in the obturator membranes or in the patient's tissues near the obturator canals.

More particularly, in the first phase, to insert strip 1142e, the medical surgeon makes an incision in an anterior vaginal wall of patient 1148. The incision can be dissected or lengthened as required to facilitate access of a delivery device to the target region 1146b. Next, the surgeon couples, preferably external to the body, the mesh strip 1142e with the delivery device 900 described above in relation to Figure 28 through the soft tissue anchor 500 (not shown) described in relation to Figure 21A.

The surgeon then inserts device 900 and attached mesh strip 1142e through the vaginal opening, into the vaginal canal, and through the vaginal incision. The surgeon guides the tip 916 of the device toward the target region 1146a of the sacrospinal ligament, and pierces and directs the mesh strip 1142e through the target region 1146a. The surgeon then retracts the device, leaving the strip 1142e anchored to the target region 1146a. For strip 1142e, as well as other strips 1142a-d and 1142f, the surgeon may use other devices having variable shaft lengths and curvatures in order to reach the appropriate region of target tissue through the vaginal incision.

The surgeon then administers the mesh strip 1142f through the vaginal opening and through the vaginal incision in a manner similar to 1142e. The vaginal incision can be dissected or lengthened as necessary to facilitate access of the delivery device 900 to the target region 1146b. The surgeon can use the

ES 2 536 748 T3 same delivery device 900 for administration of strip 1142f, or alternatively you can use a second delivery device 900.

In the second phase, the surgeon inserts the strips 1142d-e into the target regions 1144a and 1144b of the levator ani muscle. To insert strip 1142c, the surgeon first attaches delivery device 900 to mesh strip 1142c using a soft tissue anchor 500, and then inserts device 900 into the vaginal canal, and through the vaginal incision. The surgeon then pierces and directs the mesh strip 1142c through the target region 1144a of the levator ani muscle, and retracts the delivery device 900 using the methods discussed above. The surgeon similarly administers mesh strip 1142d to target region 1144b of the tendon arch of the levator ani muscle contralateral to target region 1144a using delivery device 900.

In a third phase, the surgeon inserts the anterior strips 1142a and 1142b through the obturator foramen and secures the strips to the respective obturator membranes or to the patient's tissues near the obturator canals using any of the exemplary methods and devices. discussed above.

In alternative embodiments, the implants can be sewn or sutured to the target tissue regions. In addition, the surgeon can use any operative combination of the techniques described above. For example, the surgeon can anchor any of the implants described herein to one side of the patient's retropubic space using soft tissue anchors, while anchoring the same implant to the contralateral side of the patient's retropubic space using portions of flat ends of the implant.

In accordance with another feature, the implants of the invention may include any suitable end portion, such as tissue dilators, anchors, and association mechanisms to associate the implant with the delivery devices described herein. The implants and other features described herein can be adapted for use in multiple incision procedures, such as, for example, US Patent Documents 2005/0245787, 2005/0250977, 2003/0220538, and 2004 / 0249473. They may also include other implants (ie, slings), sling assemblies, sling delivery approaches, sling assembly to delivery device association mechanisms, and sling anchor mechanisms. These and other characteristics with which the implants and kits of the invention can be used are disclosed in US Patent No. 6,042,534, entitled Stabilization Sling for Use in Minimally Invasive Pelvic Surgery, US Patent No. 6,755,781, entitled Medical Slings, US Patent No. 6,666,817, entitled Expandable Surgical Implants and Methods of Use Thereof, US Patent No. 6,042,592, entitled Thin Soft Tissue Surgical Support Mesh, US Patent No. 6,375,662, entitled Thin Soft Tissue Surgical Support Mesh, Patent Document US Patent No. 6,669,706, entitled Thin Soft Tissue Surgical Support Mesh, US Patent No. 6,752,814, entitled Minimally Invasive Pelvic Surgery Devices, US Patent Document Serial Number 10 / 918,123, entitled Surgical Slings, US Patent Application Document Serial Number 10 / 641,376, entitled Spacer for Sling Delivery System, Application Document for US Patent Serial Number 10 / 641,192, entitled Medical Slings, US Patent Document Serial Number 10 / 641,170, entitled Medical Slings, United States Patent Document Serial Number 10 / 640,838, entitled Medical Implant, United States Patent Application Document Serial Number 10 / 460,112, entitled Medical Slings, United States Patent Application Document with Serial Number 10 / 631,364, titled Bioresorbable Wrap for Surgical Sling Assembly, U.S. Patent Document Serial Number 10 / 092,872, titled Medical Slings, the United States Patent Application Serial Number 10 / 939,191, entitled Devices for Minimally Invasive Pelvic Surgery, the United States Patent Application Serial Number 10 / 774,842, entitled Devices for Minimally Invasive Pelvic Surgery, US Patent Application Serial Number 10 / 774,826, entitled Devices for Minimally Invasive Pelvic Surgery, US Patent Document Serial Number 10 / 015,114, entitled Devices for Minimally Invasive Pelvic Surgery, US Patent Application Serial Number 10 / 973,010, entitled Systems and Methods for Administration and Placement slings, U.S. Patent Application Serial Number 10 / 957,926, entitled Systems and Methods for Delivering a Medical Implant to an Anatomical Location in a Patient, United States Patent Application Serial Number 10 / 939,191, entitled Devices for Minimally Invasive Pelvic Surgery, the United States Patent Application document United States with Serial Number 10 / 918,123, entitled Surgical Slings, the United States Patent Application document Serial Number 10 / 832,653, Entitled Systems and Methods for the Administration and Placement of Slings, United States Patent Application Serial Number 10 / 642,397, Entitled Systems, Methods and Devices Related to the Administration of Medical Implants, the Patent Application document of the United States with Serial Number 10 / 642,395, entitled Systems, methods and devices related to the administration of medical implants, United States Patent Application Serial Number 10 / 642,365, entitled Systems, Methods and Devices Related to the Administration of Medical Implants, United States Patent Application Serial Number 10 / 641,487, entitled Systems , methods and devices

ES 2 536 748 T3 related to the administration of medical implants, the United States Patent Application document Serial Number 10 / 094,352, entitled System for implanting an implant and method therefor, the United States Patent Application document States with Serial Number 10 / 093,498, entitled System for implanting an implant and method therefor, United States Patent Application Serial Number 10 / 093,450, entitled System for implanting an implant and method therefor, United States Patent Application Serial Number 10 / 093,424, entitled System for implanting an implant and method therefor, United States Patent Application document with Serial Number 10 / 093,398, entitled System to implant an implant and method therefor, and the United States Patent Application document Serial Number 10 / 093,371, entitled System for implanting an implant and method therefor, United States Patent Document No. 6,197,036, entitled Pelvic Floor Reconstruction, United States Patent Document No. 6,691,711, entitled Pathology Correction Method urinary and gynecological including incontinence treatment, US Patent No. 6,884,212, entitled Implantable Article and Method, US Patent No. 6,911,003, Entitled Transobturator Surgical Articles and Methods, United States Patent Application Serial Number 10 / 840,646, entitled Method and Apparatus for Cystoceles Repair, United States Patent Application Document No. 10 / 834,943, entitled Procedure and Apparatus for Treating Pelvic Organ Prolapse, US Patent Application Serial Number 10 / 804,718, entitled Prolapse Repair, and US Patent Application Serial Number 11 / 115,655, entitled Surgical Implants and Related Methods. Variations, modifications, and other embodiments of what is described may be employed without departing from the spirit of the invention. More specifically, any of the system and device features described above or incorporated by reference may be combined with any other system or device features disclosed herein, and is within the scope of the contemplated invention. All operative combinations between a disclosed embodiment and any other embodiment are also contemplated. The scope of the invention is intended to be limited not by the present detailed description, but by the claims appended thereto.