Urethral support system

ES2 394 751 Τ3

DESCRIPTION

Urethral support system

This invention relates to a system for the treatment of pelvic floor abnormalities; in particular female urinary incontinence. In particular, the invention provides a stabilization system that facilitates the temporary adjustment of tension and position.

Urinary incontinence is an involuntary release of urine when abdominal pressure increases from sneezing, coughing or exercise, for example, it is not transmitted evenly to the proximal urethra, resulting in urine "leaks". Moderate urinary incontinence is inconvenient and can be a social and hygienic problem, while severe urinary incontinence can be disabling. Urinary incontinence occurs in women and is caused, for example, by hypermobility of the bladder neck and proximal urethra (excessive downward and twisting movement of the bladder neck) or by an intrinsic deficiency of the sphincter.

Urinary incontinence affects a large number of women and, consequently, various approaches have been developed to treat female urinary incontinence. Those skilled in the art will be familiar with solutions ranging from pelvic floor exercises to surgical techniques such as Burch colposuspension procedures or Stamey endoscopic procedures, in which sutures are placed to elevate the bladder neck.

A known procedure places a support, for example a loose sling, under the urethra. It is generally understood that this treatment alleviates urinary incontinence by occluding the intermediate urethra (eg, at the time of elevated abdominal pressure when coughing or the like).

Document US2008 / 0021263 discloses an implantable mechanical device for applying traction to organs or anatomical tissues to reposition them during and after a surgical procedure.

WO2007 / 059199 discloses a support member, such as a sling for urinary incontinence, tissue anchors, filamentary elements to associate the support member with the anchors, and introducer needles to place the anchors in the patient.

WO2007 / 149555 discloses methods and devices that provide support for a part of the urethra or rectum or anus, to alleviate urinary or fecal incontinence.

Document US2004 / 231678 discloses a sling for the treatment of urinary incontinence consisting of a band comprising a middle part and two end parts that form a self-fixing system.

US6042534 discloses a urethral suspension sling comprising biocompatible material having an elongated shape adapted for urethral suspension.

Document US2005 / 004576 discloses self-anchoring lanyards and installation mechanisms for use with them, in the selective positioning of a lanyard in a position within the body.

Document US2005 / 278037 discloses an implant for the treatment of cystocele, rectocele and / or vaginal vault prolapse, including a support body and two upper and lower suspension stabilizers.

WO02 / 30293 discloses a surgical implant for supporting the urethra, comprising a suburethral support suspended between two soft tissue anchors.

Problems associated with the surgical correction of support mechanisms that have failed include under correction and over correction. The surgeon must determine the degree of support necessary to properly lift and support the urethra to properly address the urinary incontinence problem. This determination must be made both pre-operatively and intra-operatively and post-operatively. Too little elevation causes urinary incontinence to remain, although the degree of incontinence may be reduced. Too high an elevation can result in a voiding dysfunction (reduced ability or inability to void), leading to prolonged catheterization, and the need for post-operative correction.

The incidence of postoperative urinary retention due to postoperative obstruction can be high several weeks after surgery, and several patients have persistent postoperative urinary retention. Symptomatic detrusor muscle instability represents the bladder's response to increased output resistance caused by an inappropriately tensioned sling. The incidence of postoperative irritative symptoms that are secondary to detrusor muscle instability can be unacceptably high. Proper tensioning of the sub-urethral support, ie, the sling, minimizes persistent incontinence and voiding dysfunction. However, proper tensioning during surgery is difficult to assess and is frequently excessive or insufficient once the patient has assumed a normal posture and movement post2

ES2 394 751 Τ3 operatively. Methods and devices for immediate and short-term post-operative adjustment of the tension of the sub-urethral support member, i.e. the sling, are needed for the treatment of urinary incontinence in order to mitigate associated post-operative complications. with improper sling tension.

One of the problems identified and solved by the invention disclosed herein is that the appropriate immediate and short-term postoperative tensioning of a patient's sub-urethral support can minimize the discomfort, persistent incontinence, and voiding dysfunction that often complicate prior art methods and devices for the therapy of pelvic floor abnormalities, including urinary incontinence. The invention described below is related to a system and a method that allows the fine adjustment of a urethral support member, that is, the tension of the sling, immediately post-operatively and for days and up to a week, instead of hours after the sling has been implanted in the patient. Consequently, at least one objective in accordance with the invention described herein is to provide a system and method that mitigate post-operative complications associated with insufficient or excessive tension of an implanted sub-urethral sling for the therapy of urinary incontinence. or other dysfunctional or structural abnormalities of the pelvic floor.

In one aspect, the invention relates to a supplemental stabilization system for stabilizing the urethra. The stabilization system has a first elongated braided member and a second elongated braided member, each elongated braided member comprising an absorbable flexible material having a length extending from a first end to a second end in one embodiment, the elongated braid being free. second end of each braided member. The system for stabilizing the urethra also has a first stabilizer and a second stabilizer. In one embodiment, the first stabilizer is attached to the first end of the first elongated braided member. The second stabilizer is attached to the first end of the second elongated braided member.

In one embodiment, the elongated braided members are non-porous, that is, they do not have interstices such as small dimples, voids or holes for cellular integration. The width of each elongated braided member is in the range of 0.1 or 2 mm.

The supplemental stabilization system also has a first and a second suspension member and a support member. The support member has a first end and a second end. The first suspension member and the second suspension member each have a first end and a second end. The first end of each suspension member is attached to one end of the first or second stabilizer. The second end of each suspension member is attached to either the first end or the second end of the support member.

In one embodiment, the support member has a length that is shorter than either the first braided member or the second braided member. In one embodiment, the first braided member and the second braided member have a width that is in the range of about 0.8% to 20% of the width of the support member. Each of the first and second braided members can also have a longer length than the support member.

In a particular embodiment, the urethral support system has a tensioner. The tensioner includes a mechanism for including and retaining 1 or 2 braided members and a mechanism for tightening and loosening the urethral support member, by mechanically exerting a linear or rotary force movement or by manual means.

In another aspect, which is not part of the invention, a method is described for stabilizing a urethral support member under the urethra to treat urinary incontinence, for example. According to this method, the surgeon introduces a urethral support stabilization system that includes a first elongated absorbable member and a second elongated absorbable member having a first end and a second end, and the urethral support member through an incision. on the vaginal wall. The first end of the system is introduced into the paraurethral space lateral to the urethra, through the subcutaneous tissue and through the skin of a first site. The second end of the system is introduced into the para-urethral space on the other side of the urethra, through the subcutaneous tissue on that side of the urethra, and through the skin in a second place. In one embodiment, the first and second locations are located on the skin of the abdomen. In another embodiment, the first and second locations are located on the perineal skin or the skin of the upper middle leg.

In an alternative method, the order of the tissues through which the urethral support system passes is the reverse of the previous order.

In one embodiment, the urethral support stabilization system further includes a stabilizer connectable to an elongated member. The method (which is not part of the invention) further comprises positioning the stabilizer in the soft tissue, for example in the soft tissue of the retro-pubic space, the soft tissue of the perineal space or the pre-pubic soft tissue. The stabilizer is located between an elongated absorbable member and the urethral support member. The length of the urethral support stabilization system between the stabilizer and the midpoint of the urethral support member is less than the distance between the urethra of the

ES2 394 751 Τ3 patient and the skin of the first place. According to the invention, the stabilizer is located in the pelvic soft tissue without penetrating the rectal sheath, in a vaginal to abdominal approach, or in the subcutaneous tissue of the perineal skin in a vaginal to perineal approach, or in the subcutaneous tissue of the pre-pubic skin in a vaginal to pre-pubic approach.

In one embodiment, the invention further includes a tensioner to be arranged on the abdominal perineal surface or on the pre-pubic skin, as may be the case. The tensioner has first and second ends and is attached to the first and second elongated members, respectively, after the elongated members emerge from the skin. Alternatively, the tensioner may consist of two independent tensioners, each of which can be attached to one of the first and second elongated members. The method (which is not part of the invention) further includes adjusting the tension in the support member by adjusting the tensioner. At any time up to ten days after the urethral support member has been implanted in the patient, tension is applied to the second end of the elongated member in the first location. In one embodiment, the surgeon applies the tension manually. Alternatively, tension can be applied to the elongated member and transmitted to the urethral support member by mechanical means, for example by mechanical movement of a rotary or linear force. The magnitude of the tension is sufficient to allow a remnant of the first end of the elongated member to retract under the skin after the remnant has been cut. The first end of the elongated member is cut while under tension, where the remainder of the first end is retracted under the skin.

In one embodiment of the method, applying tension to one or the other elongated member comprises advancing or withdrawing one or another stabilizer in the soft tissues of the patient. As used herein, removing a stabilizer in the soft tissues of the patient means moving the stabilizer back along the path in which the stabilizer was advanced, that is, in the reverse direction, without causing significant trauma to the soft tissue through. along the way and without applying more force, preferably less force than the force that was required to advance the stabilizer.

These and other objects, along with the advantages and features of the present invention disclosed herein, will become apparent with reference to the following description, the accompanying drawings, and the claims. Furthermore, it should be understood that the characteristics of the various embodiments described herein are not mutually exclusive and may exist in various combinations and permutations.

The foregoing and other objects, features, and advantages of the present invention disclosed herein, as well as the invention itself, will be more fully understood from the following description of the preferred embodiments and claims, when read in conjunction with accompanying drawings. The drawings are not necessarily to scale, the emphasis being generally placed instead on illustrating the principles of the invention.

Figure 1 illustrates a plan view of a urethral support system, according to an embodiment of the invention;

Figure 2A illustrates a side view of a first elongated member and a second elongated member of the urethral support system, in accordance with one embodiment of the invention;

Figure 2B illustrates various embodiments of the cross-sectional shape of the first and second elongated members, taken at 1B-1B of the urethral support system illustrated in Figure 1;

Figure 3A illustrates a front view and Figure 3B illustrates a perspective view of a stabilizer of the urethral support system, according to an embodiment of the invention;

Figure 4 illustrates a plan view of a urethral support system, including a first suspension member and a second suspension member, in accordance with another embodiment of the invention;

Figure 5A illustrates a top view of a urethral support member connected to a stabilizer at each end of the urethral support system, in accordance with one embodiment of the invention;

Figure 5B illustrates a side view of the urethral support member and stabilizer illustrated in Figure 5A;

Figure 6A illustrates a top view of a tensioner of the urethral support system, in accordance with one embodiment of the invention;

Figure 6B illustrates a side view of the tensioner illustrated in Figure 6A;

Figure 7A illustrates a perspective view of a tensioner of the urethral support system, according to another embodiment of the invention;

Figure 7B illustrates an exploded view of the tensioner illustrated in Figure 7A;

ES2 394 751 Τ3

Figures 7C-7E illustrate the steps for applying retention and applying tension to an elongated member, by means of the tensioner illustrated in Figure 7A;

Figure 8A illustrates a sagittal section and Figures 8B and 8C illustrate a cross section of the pelvic area illustrating the steps of the method for treating the pelvic floor, eg, for treating urinary incontinence;

Figure 9A illustrates a sagittal section taken at AA of Figure 9B; Y

Figure 9B illustrates a cross section of the pelvic area illustrating the steps of the method for treating the pelvic floor, eg, for treating urinary incontinence.

Figure 1 illustrates a urethral support system 20 in accordance with one embodiment of the invention. Referring to Figure 1, exemplary urethral support system 20 has multiple components including a complementary urethral support stabilization system 10, comprising a first elongated member 22 and a second elongated member 22. In one embodiment of the invention, the supplemental urethral support stabilization system 10 further includes at least one tensioner (not illustrated), alternatively two tensioners described below. In another embodiment, the supplemental stabilization system 10 includes a first elongated member 22 and a second elongated member 22 ', and a first stabilizer 24 and a second stabilizer 24'. Alternatively, the supplemental urethral support stabilization system 10 includes at least one tensioner, first and second elongated members 22, 22 ', and first and second stabilizers 24, 24'. The urethral support system 20 further includes a support member 26. In one embodiment, the urethral support system 20 further includes a first suspension member 23 and a second suspension member 23 '.

Figures 2A and 2B illustrate an embodiment of the complementary urethral support stabilization system 10 of the urethral support system 20, including the first elongated member 22 and the second elongated member 22 '. Referring to FIG. 2A, the first exemplary elongated member 22 and second exemplary elongated member 22 'are substantially identical and typically braided, that is, they are neither tape nor band-shaped. The material used to make the elongated member is absorbable, that is, biodegradable and does not act as a platform to allow ingrowth of patient tissues, eg fibrous tissue, into the material. Suitable materials include absorbable synthetic polymers, lactides, glycolides, caprolactone, copolymers, or combinations of the foregoing, for example. In one embodiment, the material used to make the elongated member is solid, for example monofilaments without interstices such as pores, dimples or spaces, for example, that would allow cellular integration into the material, i.e. not a mesh, braid , knitted fabric, or woven material. In another embodiment, the material used can be braided.

Each of the first elongated member 22 and second elongated member 22 'is longer or as long as the urethral support member 26 (described in more detail below). The elongated member embodiments made from monofilaments lack the protruding ends of the mesh, knit, or fabric, or braided materials, and therefore slide more smoothly in the soft tissue forward (advance) in a direction, or backwards (retreat) in the opposite direction. In one embodiment, each of the first elongated member 22 and second elongated member 22 'includes a first end 30 and a second end 32. In one embodiment, the second end 32 is free, while the first end 30 is attached to another part of the urethral support system 20.

Referring to Figure 2B, typically, the first elongated member 22 and the second elongated member 22 'of the supplemental urethral support stabilization system 10 have a cross-sectional width in the range of about 0.1 to 2.0 millimeters. . The cross-sectional shape of the first 22 and second 22 'elongated members can be round, oval, triangular, or rectangular, for example. In one embodiment, the elongated braid-like members 22, 22 'are flexible enough to be knotted. The elongated members may be coated with a slippery absorbable, i.e., biodegradable material, for example, proteins, polysaccharides, hydrophilic polymers, wax, hydrogel, silicone, silicone rubber, PTFE, PBA, ethyl cellulose, or the like, to facilitate the sliding of the elongated limb in soft tissues. The length of each of the first and second elongated members is in the range, for example about 6-18 cm, preferably 7-16 cm. The thin braid-like feature of the elongated member is advantageous over the prior art, because the elongated members according to the invention do not allow ingrowth of the patient's tissue and slide in two directions, i.e. forward and backward. more easily than prior art urethral support sling systems that use wide flat tape members to promote ingrowth of the patient's tissues, and they cannot be dislodged without causing significant tissue trauma after operative placement.

Figures 3A and 3B illustrate an example of stabilizer 24 of the complementary system 10 for stabilizing the urethral support of the urethral support system 20, according to an embodiment of the invention. Referring to Figure 3A, exemplary stabilizer 24 is a flat, elongated, substantially rectangular or oval tab, which includes a radius 51 at distal end 52, and is flat at proximal end 54 opposite distal end 52. Alternatively, stabilizer 24 is substantially cylindrical (not shown) rather than flat, or

ES2 394 751 Τ3 stabilizer 24 may include a radius 51 at proximal end 54, as well as distal end 52. Sides 56 of stabilizer 24 include multiple radii 50, or flat ridges, eg 2-6 flat ridges, more preferably 1-2 a flat shoulder, that is, a radius. Aside from the "ridges", all sides of the stabilizer are devoid of protrusions that may increase drag or substantially impede free passage of stabilizer 24 into soft tissue. The length of stabilizer 24 is in the range of about 0.8 to 2.0 cm. The width of the stabilizer at its widest point is in the range of about 2 to 4 mm, preferably 3 mm. The thickness of the stabilizer is in the range of about 100 to 400 microns, preferably 200 microns.

Continuing with reference to Figures 3A and 3B, in one embodiment of the invention, the illustrated stabilizer 24 example includes a through hole 58 at distal end 52, extending from one surface 60 to the other surface 62 of the stabilizer 24. In one embodiment, through hole 58 functions as an eyelet to which the first end of the elongated member (not shown) can be knotted to connect the stabilizer to the elongated member. Multiple ridges 50 along the sides 56 of stabilizer 24 allow gradual movement of stabilizer 24 as it is pulled through the patient's fascia by the surgeon, during implantation of the urethral support system 20 illustrated in FIG. 1. Gradual movement assists the surgeon during the implantation process, increasing the "feel for it" when implanting.

The stabilizer 24 including the ridges along the sides, as described above, has at least the advantage over prior art stabilizers that the stabilizer 24 can undergo a reversible transition in tissue, i.e., the movement in tissues in two directions: (i) forward along the path of the respective elongated member to which stabilizer 24 is attached, and (ii) backward along the path already taken by stabilizer 24. Consequently, stabilizer 24 allows fine positional adjustment by transitioning the stabilizer 24 forward or backward, for example, by pulling in either direction during and after positioning the urethral support system 20 in the tissues of the patient. Furthermore, the stabilizers of the supplemental stabilization system 10 help to support the urethral support member under the urethra in a correct position. Furthermore, stabilizers according to the invention are not easily palpable, or may not be palpable through the vagina. The stabilizers and / or the complementary stabilization system, according to the invention, are positioned in the soft tissue with a suitable tensile force to counteract dislocation due, for example, to coughing or straining, or by other examples of augmentation. intra-abdominal pressure, until adequate integration of the patient's soft tissue with the implanted urethral support system takes place. Typically, the time frame required for integration of the urethral support member is from about 24 hours to about seven days.

The stabilizer according to the invention differs structurally and functionally from prior art devices, in that prior art devices are typically serrated, pointed or have rough surfaces which, once in soft tissue, cannot be easily removed. along the path already taken by the device. In contrast, the stabilizer according to the invention can be removed along the path already taken in the tissue with minimal trauma to the soft tissue, and allows forward or rearward repositioning of the urethral support member. In particular, the stabilizer according to the invention allows the adjustment of the tension of the urethral support member by transmitting the tension to the urethral support member through the stabilizer, after the stabilizer has been introduced into the tissues of the patient. Because the stabilizer can be moved forward (forward) or backward (backward), the stress transmitted to the urethral support member can be reduced as well as increased, a feature that is not present in urethral support systems or prior art methods for treating urinary incontinence.

Referring back to Figure 1, the example of the first stabilizer 24 is attached to the first end 30 of the first elongated member 22, and the second stabilizer 24 'is attached to the first end 30 of the second elongated member 22' of the complementary system 10 of stabilization of the urethral support. The stabilizer may be attached to the elongated member by any means known in the art, for example by knotting the elongated member to the stabilizer through the through hole of the stabilizer, for example, or by thermal bonding, ultrasonic bonding, application of an adhesive, chemical bonding. or by molding the stabilizer-elongated member combination so that the stabilizer and elongated member form a single integrated piece.

Referring to Figure 4, in one embodiment, the urethral support system 20 further includes a first suspension member 23 and a second suspension member 23 'that connect the first stabilizer 24 to one end of the urethral support member 26. , and the second stabilizer 24 'at the other end of the urethral support member, respectively. Suspension members 23 can be, for example, a strip such as for example a polymer strip. Suspension members may be attached to support member 26 and / or stabilizers 24, 24 'by crimping, thermal bonding, chemical bonding, ultrasonic bonding, adhesive, or formed as an integrated unit with the stabilizers and / or the member of urethral support.

Each of the examples of the first suspension member 23 and second suspension member 23 'illustrated in Figure 4 have an elongated member having a length in the range of about 1 to 3 cm, preferably about 1 to 2 cm. The width of each of the suspension members is typically 11mm at the end adjacent to the mesh, decreasing to 2mm at the end adjacent to the stabilizer.

ES2 394 751 Τ3

In another embodiment, referring again to Figure 1, the suspension members 23, 23 'examples form an integrated part of the urethral support member 26 and taper toward the stabilizers 24,

24 ', respectively. Alternatively, urethral support member 26 is attached directly to stabilizers 24, 24 'without a suspension member (see Figures 5A-5B).

Figures 5A and 5B illustrate a urethral support member 26, such as a sling, in accordance with one embodiment of the invention. Exemplary urethral support member 26 is a flat, band, or tape-shaped implant. According to one embodiment, the support member 26 is a mesh comprised of threads. The length of the support member 26 is in the range of about 6 to 20 cm, preferably 7 to 16 cm, more preferably 8 to 14 cm, preferably 12 cm or 8 cm in length. The width of the urethral support member 26 may be in the range of about 6 to 15 mm, preferably 8 to 13 mm, more preferably 11 mm in width. The weight of the urethral support member 26 is in the range of about 10 to 30 g / m², preferably 15 to 25 g / m², more preferably 18 to 20 g / m², and most preferably 19 g / m² Exemplary embodiments of the mesh urethral support member are described in US Serial Nos. 10 / 473,825 and 10 / 398,992, corresponding to publication numbers US 7594921 and US 6960160, respectively incorporated by reference herein. memory. The mesh threads of the urethral support member 26 are in the range of about 150 to 600 microns in diameter. The threads are arranged so that they form a regular net and are spaced apart so that for a diamond-shaped net configuration, there is a gap of between 2 to 5 mm between the points where the threads of the mesh interact each. In a hexagonal net configuration, the space is between 2 to 5 mm between the opposite points of the diagonals where the threads of the mesh interact.

It is preferable to space the threads as far apart as possible to allow blood to pass through the implant and reduce the mass of the implant, while providing the mesh with sufficient tensile strength and elasticity to be effective. It can therefore be appreciated that considerable variability can be achieved in the maximum spacing between the threads, depending on the material from which the threads are comprised and the network design in which the threads are arranged.

In one embodiment, the threads are arranged in a diamond-shaped mesh pattern. However, any design that provides appropriate tensile strength and elasticity can be used. For example, a hexagonal lattice design can be used.

Ideally, in order to reduce the overall mass of the urethral support member, the threads should be as narrow in diameter as possible, while still providing adequate tensile strength and elasticity to the mesh. The threads of the mesh include at least two filaments arranged to interact so that pores are formed between the filaments. The pores formed between the filaments are about 50 to 200 microns, allowing such separation to give rise to fibroblasts by growth. By growing fibroblasts, the implant is secured in place within the body. In addition, and importantly, the adequate size of the pores allows the implant to act as a platform to promote the deposition of new tissue from the patient that promotes the integration of the urethral support member in the soft tissues of the patient.

Suitable materials from which the mesh can be made are sufficiently inert to avoid foreign body reactions when retained in the human body for long periods of time and have suitably easy handling characteristics for placement under the urethra at the desired location. of the body. The mesh can be easily sterilized to prevent the introduction of infection when the mesh is implanted in the human body.

For example, the filaments can be formed from biocompatible material. In one embodiment, the filaments are formed from polyester, where each polyester filament is about 0.09mm in diameter. Suitable materials from which the filaments can be formed also include polypropylene.

The filaments of the yarns can be knitted together using warp knitting to reduce the possibility of the filaments and yarns fraying. The fine warp knit fabric of the filaments provides a urethral support member that is flexible in handling, which can be easily cut into different shapes and dimensions. As the yarns are formed using the warp knit fabric, the possibility of fraying of the edge of the urethral support member after production or cutting of the mesh is reduced.

Other methods of reducing filament fraying after the mesh is cut or produced include heat treatment, laser treatment or the like, to seal the edges of the mesh.

The mesh can be provided in any shape or size and cut to the appropriate dimensions as required.

It can be appreciated that cutting the mesh will produce an unfinished edge. Due to the dispersed nature of the threads that make up the mesh and their narrow diameter, the unfinished edge does not suffer from the same problems as the

ES2 394 751 Τ3 edges of prior art meshes.

In other words, the edge produced is neither rough nor jagged, thereby increasing the likelihood of mesh edge extrusion in situ or the possibility of infection.

An advantage of the mesh of the present invention is that it allows substantially less foreign material to be left in the body than conventional mesh for pelvic region repair.

However, to improve handling, the mesh described above can be treated using an absorbable coating. The absorbable coating includes, for example, a layer of absorbable material that is thicker than the threads of the mesh. For example, the thickness of the mesh of absorbable material can be around 1 to 2 mm. The threads of the mesh may be fully embedded in the absorbable liner, such that the outer surface of the mesh is fully covered with the absorbable material, covering the entire urethral support member.

Consequently, in this embodiment, the urethral support member does not have voids or holes on its surface to reduce the likelihood that the mesh threads will become clogged with bacteria prior to mesh implantation. In addition, the absorbable coating makes the mesh more substantial and less flexible so that it can be manipulated more easily by the surgeon.

In an alternative embodiment, the absorbable coating includes a layer of absorbable material applied to one face of the mesh, such that the mesh has a first face on which the absorbable material has been applied and a second face on which the absorbable material has not been applied. the absorbable material has been applied, so that the first and second faces and each one of them have different characteristics.

It is also conceivable that the surgical implant is provided with improved surgical handling qualities in a range of other various methods. Such methods include releasable bonding of the mesh to a support strip.

The support strip can be formed of plastic material and is adhered to a surgical implant using a releasable adhesive.

Similar to the absorbable coating, the support strip makes the mesh more substantial and less flexible so that it is more easily handled by the surgeon. Following proper mesh placement, the support strip can be removed from the mesh, the mesh being retained in the body and the support material can be removed by the surgeon. The application of the support strip to the mesh means that the mesh benefits from a reduced mass, but the mesh and the support strip together confer the characteristics required for surgical manipulation.

In a further embodiment, the mesh filaments can be comprised of two-component microfibers or composite polymers. These technologies provide the implant with a dual phase technology.

Two-component microfibers comprise a core and a surface material. The surface material can be reabsorbed by the tissues in which it resides in a matter of hours, while the core material remains in the body for a longer period to allow ingrowth of the tissue.

Suitable bicomponent microfibers include a non-absorbable part of polypropylene and a part of absorbable polylactic acid, for example.

The surface material is present during the surgical procedure when the mesh is being inserted and is positioned in the soft tissues of the patient, and provides the mesh with desirable characteristics for surgical manipulation. After implantation into the patient's body, typically a few hours later, the surface material is absorbed by the body, leaving only the core material of the filaments in the body. The filament core material has a low extraneous mass compared to prior art meshes or mesh when it also includes the surface material.

The mesh of the urethral support member can be formed from composite polymers. As described for two-component microfibers, composite polymers provide urethral support implants with dual-phase technology. A first face of the mesh has particular characteristics such as flexibility and elasticity, while a second face of the mesh provides the mesh with characteristics that enhance surgical handling of the mesh, such as strength and robustness. The mesh ends in an unfinished edge. This mesh is not likely to cause the same problems as the rough and jagged edges of the prior art mesh, due to the fact that it has fewer yarns, smaller diameter filaments, and the treatment of the mesh with an absorbable coating that protects the fabric from mesh during implantation, when damage is most likely to occur.

In a further embodiment, the mesh has perimeter threads. Typically, the mesh is circular or similar in

ES2 394 751 Τ3 its shape and, therefore, the perimeter wire can be generally referred to as a circumferential wire. A thread runs around the circumference of the oval shape of the mesh. In another embodiment, several circumferential threads may be present, each circumferential thread being capable of extending over one side of the oval mesh, ie about half the circumference of the mesh. In another embodiment, the circumferential threads are arranged concentrically and each one extends around the mesh at a different radial location.

An outer circumferential thread extending around the perimeter of the mesh, as well as other circumferential threads, are disposed inward of the outer circumferential thread which forms a perimeter spaced at a certain distance. The distance between adjacent circumferential members can vary and in this example is 20mm.

The transverse threads extend from the center of the oval mesh to points on the perimeter of the mesh. In this example, four transverse threads are laid across the diameter of the mesh, dividing the mesh into eight angularly equal parts.

The mesh of this embodiment can be formed from the materials that have been described above. Depending on the material chosen, the mesh can be woven, knitted or extruded in one piece, or the individual or grouped yarns can be extruded separately and joined together.

In another embodiment, the meshes may have angled sides. A mesh according to this embodiment has a structure similar to that described above. However, the mesh has a perimeter member with angled sides. In addition, it may have cross members arranged only to extend towards the perimeter of the mesh, rather than all of them being across the diameter of the mesh. This provides a more uniform structure. More specifically, the mesh has a cross member that extends along the axis of symmetry, a cross member that bisects the axis of symmetry, and four additional cross members that extend from the axis of symmetry to the perimeter of the mesh.

In addition to the pores arranged by combination of filaments that form the yarns, the pores can be arranged in polypropylene rings positioned at the intersection of the circumferential and transverse members.

Alternatively, the pores can be formed by spacing the cross members, for example pores 50 to 200 micron in size, suitable to allow tissue ingrowth between the cross members.

Continuing with reference to Figures 5A and 5B, the urethral support member 26 has a first end 40 and a second end 42. In one embodiment, the length of the urethral support member 26 is shorter than the length of either between the first elongated member 22 and the second elongated member 22 '. For example, the length of the urethral support member 26 is about 5-100%, preferably about 5-60%, more preferably 5-30%, and most preferably 5-20% of the length of either. between the first elongated member 22 or the second elongated member 22 '. The width of each elongated member may be in the range of about 0.1-30%, 0.8-20%, 1-20%, or 5-10% of the width of the urethral support member, for example.

Continuing with reference to Figures 5A and 5B, in one embodiment, the first end 40 of the urethral support member 26 is attached to the first stabilizer 24, and the second end 42 of the urethral support member 26 is attached to the second stabilizer. 24 '. The end of the urethral support member may be attached to either of the first or second stabilizers by ultrasonic welding, heat bonding, chemical bonding, an adhesive, or by mechanical means such as a clamp, a hook and eye, a suture, a stem. and a slot, for example. The attachment of the ends of the urethral support member to the first or second stabilizers may be permanent or a reversible attachment.

With reference to Figures 6A and 6B, in an embodiment according to the invention, the urethral support system 20 further comprises a tensioner 50. Any of the tensioners described herein may be reversibly attached to the skin of the patient. patient, for example by means of an adhesive. Either tensioner can consist of two parts, one that can be attached to the second ends of the first elongated braided member and one that can be attached to the second end of the second elongated member.

The example tensioner 50 illustrated in Figures 6A and 6B is typically substantially flat to rest close to the skin, thereby preventing it from inadvertently dislodging. The shape can be whatever is suitable, such as round, rectangular or oval, as illustrated in Figure 6A. The length of the tensioner is in the range of about 1 to 6 cm, preferably 3 to 6 cm, 1 to 3 cm, or 1-4 cm. The width is in the range of about 1 to 4 cm, and the depth is in the range of about 0.5 to 3 cm. When the tensioner consists of two parts, as described above, the tensioner will typically comprise two flat, button-like discs. These can be in any suitable shape.

ES2 394 751 Τ3

At each end of the tensioner 50 illustrated in Figures 6A and 6B, a hole 52, 52 ', more preferably two holes at each end of the tensioner 50, extend from the upper surface 56 through the body of the tensioner 50 toward the lower surface. 57 of the tensioner 50. The diameter of each hole 52, 52 'is sufficient to easily accommodate the second end 32 of the elongated member 22, 22' of the complementary stabilization system 10 of the urethral support system 20. In one embodiment, the diameter of each hole 52, 52 'is in the range of about 5mm or less, preferably 3mm. A plurality of smaller diameter holes 54, 54 ', disposed for example linearly at each end of tensioner 50, extend from upper surface 56, through lower surface tensioner body 57, at both ends of tensioner 50. The diameter of the holes 54, 54 'is smaller than that of the holes 52, 52' to allow the second end of the elongated member 22, 22 'to be pinched or interlocked when the elongated member is pulled from what emerges from it through the larger holes 52, 52 'in the upper surface 56 of the tensioner 50, over the smaller holes 54, 54', thereby pinching, clamping or locking the second end 32 of the elongated member 22 of the tensioner 50.

As an alternative to the embodiment of tensioner 50 described above, an adhesive may be used alone or in concert with the holes to join second end 32 of elongated member 22 to tensioner 50. In yet another embodiment, tensioner 50 may include only one hole 52.

Referring to Figures 7A -7C, in an alternative embodiment, the tensioner comprises a rotary device to provide the mechanical advantage of a rotary force movement to adjust the tension of the sub-urethral support member. The illustrative rotary force tensioner 60, which is illustrated in a mounting configuration in Figure 7A and in exploded form in Figure 7B, includes a wheel 62 and a sprocket 63. Wheel 62 is rotatably locked to sprocket 63, for example by a clamp 64, preferably two clamps 64, positioned opposite each other on rim 65 of sprocket 63. At least one ridge 66 is positioned perpendicular to the long axis of gear 63 on collet 64 and projects toward the center of gear 63.

Referring now to Figures 7C-E, wheel 62 includes at least one door 67 located on the perimeter of wheel 62. Door 67 is a wedge-shaped portion, partially spaced from outer edge 70 of wheel 62. Second end 32 of elongated member 22 passes between door 67 and inner flange 68 of wheel 62. Since wheel 32 is manually rotatable on the teeth of sprocket 63, by turning the knob 71 indicated by arrow 69 in FIG. 7D, door 67 is compressed by flange 66 against internal flange 68, and member Elongated 22 is locked within tensioner 50 between door 67 and inner flange 68 of wheel 62, as illustrated in FIG. 7E.

In one aspect, the invention relates to a kit for the treatment of urinary incontinence. In one embodiment, the kit includes a urethral support stabilization system. The urethral support stabilization system includes first and second elongated members; a first and second stabilizers, and optionally a urethral support member, for example a mesh sling. In one embodiment, each of the elongated members comprises an absorbable non-porous material, without interstices that would allow internal cell growth. In another embodiment, each of the stabilizers comprises a substantially flat member with multiple radii, that is, projections such as those described above projecting from the edge of the flat surface. The stabilizer may further comprise a through hole at one end. In another embodiment, the kit of the invention may further include a tensioner that includes a hole to pinch the end of an elongated member or an adhesive to adhere it to an elongated member.

In another aspect, a method of providing urethral support in a patient is disclosed, such as for the therapy of female urinary incontinence, for example, and / or uterus-vaginal prolapse. Referring to Figures 8A through 8C, in one embodiment of the method, the surgeon takes a vaginal to abdominal skin approach, making an incision in the vaginal wall 08 to provide a site for the introduction of the urethral support system 20, described above, in the para-urethral area, that is, contiguous to the urethra. The complementary stabilization system 10 of the invention that includes the first elongated member 22 driven by the second end 32 or free end, is passed through the vaginal incision, around one side of the urethra 114, through the soft tissue retro-pubic space 112, behind pubic bone 102, through rectum sheath 104, subcutaneous tissue 118 and abdominal skin 106, to emerge on the surface of the abdominal skin 106 in an abdominal first place. According to one embodiment, the first end 30 of the first elongated member 22 of the complementary stabilization system 10 is pre-attached to the first stabilizer 24. Alternatively, the first end 30 of the first elongated member 22 of the complementary stabilization system 10 is attaches to the first stabilizer 24 during the surgical procedure. In yet another embodiment, the elongated member and the stabilizer may be separable.

In one embodiment, the first stabilizer 24 is positioned in the soft tissue of the retro-pubic space 112, while the elongated member 22 emerges from the abdominal skin 106. The first stabilizer 24 is positioned in the retro-pubic space, ie that is, it does not pass through any of the intermediate tissues, that is, the rectum sheath, the subcutaneous tissue and the skin, between the retro-pubic space and the surface of the skin.

The first end 40 of the urethral support member 26 is pre-attached to the first stabilizer 24. Alternatively, 10

ES2394751-3 The first end 40 of the urethral support member 26 may be attached and detached from the first stabilizer 24 during the surgical procedure. A portion of the urethral support member 26, eg, a first portion extending from approximately the midpoint to one end of the urethral support member, is positioned on the side of the urethra 114 through which the first member passes. elongated 22.

This process is repeated with the second elongated member 22 ', the second stabilizer 24', and the support member 26 on the other side of the urethra 114. As with the first stabilizer 24, the second stabilizer 24 'is positioned in the retro-pubic space, but in a different place than the first stabilizer 24. The second stabilizer 24 'does not pass through any intermediate tissue, ie the rectum sheath, subcutaneous tissue and skin, between the retro-pubic space and the skin surface. After the introduction of the second elongated member 22 'and the second stabilizer 24', the remainder of the urethral support member 26 is positioned under the urethra 114 with one end of the support member on one side of the urethra 114 and the other end of the support member on the other side of urethra 114.

In one embodiment, the first stabilizer 24 and the second stabilizer 24 'cannot extend very much into the intermediate tissues between the retro-pubic space and the skin surface, because the length of the urethral support member 26 from its midpoint under the urethra to one end of the urethral support member and the length of the suspension member, if one is used, which is positioned on one side of the urethral support member to which the stabilizer is attached, it is shorter than the distance between the urethra and the rectum sheath.

Referring to Figure 8B, after the second elongated member 22 'emerges in a second abdominal location, the position of the urethral support member 26 under the urethra is adjusted and stabilized by applying tension through the supplemental stabilization system 10. to one, or the other, or both of the first elongated member 21 and the second elongated member 22 '. The tension can be applied manually, that is, by hand without mechanical aids, or by a system that includes mechanical aids such as the mechanical application of a movement of a rotary or linear force and, in addition, can measure and regulate the applied tension. . Tension is transmitted from the elongated members to the first and second stabilizers 24, 24 '. For example, by applying tension by pulling the first elongated member 22 at its second end 32, the first stabilizer 24 advances through the soft tissue, while the second stabilizer 24 'is drawn through the soft tissue, along the path and taken by the second stabilizer 24 '.

Referring to Figure 8C, in one embodiment of the method, the supplemental stabilization system 10 further includes the tensioner 50, for example the tensioner 50 described above with respect to Figures 6A and 6B. The example tensioner 50 is attached to the free ends 32, 32 ', of the first and second elongated members 22, 22', respectively, emerging through, for example, the abdominal skin 106. The tension of the urethral support member 26 is adjusted by applying tension to the second end 32, 32 ', respectively, of the first and second elongated members 22, 22'. The urethral support member 26 can be displaced from one side to the other because it can be pulled back and forth in the soft tissues of the stabilizer 24, 24 'illustrated in Figures 3A and 3B, in contrast to devices of the art. anterior that have obstructing tips, hooks, barbs, or other projections to prevent the device from being pulled out of the soft tissue along the entry path.

In another embodiment, the surgeon takes a vaginal to perineal approach. The perineum corresponds to the outlet of the pelvis inferior to the pelvic diaphragm (levator ani and coccygeus muscle). The limits of the perineum are provided by the pubic arch and the arcuate pubic ligament, the tip of the coccyx, and on each side of the lower branch of the pubis and the ischium and the sacrotuberous ligament. A line joining the anterior parts of the ischial tuberosities divides the perineum into two parts, the posterior anal triangular part and the smaller anterior urogenital triangle.

In the vaginal-to-perineal approach, referring now to Figures 9A and 9B, the surgeon makes an incision in the vaginal wall 108 to provide an insertion site for the urethral support system 20 described above, in the para-urethral area. The complementary stabilization system 10 that includes the first elongated member 22 driven by the second end 32 or free end, is passed through the vaginal incision, around one side of the urethra 114, through the soft tissues of the space perineal 110, including the perineal muscles and into and behind the lower pubic ramus, but not through the obturator opening, through the subcutaneous tissue underlying the skin of the perineum 150, emerging on the perineal skin surface 150 in a first perineal location.

The first stabilizer 24 is positioned in the soft tissues of the perineal space 110, while the elongated member 22 emerges from the perineal skin 150. The first stabilizer 24 is positioned in the soft tissue of the perineal space 110, that is, the first stabilizer 24 it does not pass through the skin.

The first end 40 of the support member 26 is pre-attached to the first stabilizer 24. Alternatively, the first end 40 of the support member 26 may be attached and detached from the first stabilizer 24 during the surgical procedure. Support member 26 is positioned on the side of urethra 114 through which first elongated member 22 is passed.

ES2 394 751 Τ3

Referring to Figure 9B, this process is repeated with the second elongated member 22 ', the second stabilizer 24', and the support member 26 on the other side of the urethra 114. As with the first stabilizer 24, the second Stabilizer 24 'is positioned in the perineal space 110 at a different location than the first stabilizer 24. The second stabilizer 24' does not pass through the skin. Neither the first stabilizer 24 nor the second stabilizer 24 'are positioned above the endopelvic fascia. In addition, the urethral support system used for a vaginal-to-perineal approach does not extend through the abdominal wall or the obturator opening. Following the introduction of the second elongated member 22 'and the second stabilizer 24', the urethral support member 26 is positioned under the urethra 114 with one end of the urethral support member 26 on one side of the urethra 114 and the other end of the urethral support member 26 on the other side of urethra 114.

In one embodiment, the first stabilizer 24 and the second stabilizer 24 'cannot extend into the intermediate tissue between the perineal space and the skin surface, because the length of the urethral support member from its midpoint on one side of the urethra to one end of the urethral support member, and the length of the suspension member, if one is used, is less than the distance between the urethra and the perineal skin. Typically, in a vaginal to perineal approach, the length of the urethral support member from its midpoint on one side of the urethra to the suspension member on the other side of the urethra, if any is used, is in the range of about 3 to 6 cm, preferably 4 cm.

After the second elongated member 22 'emerges at a second location on the perineal skin, the position of the urethral support member 26 under the urethra is adjusted and stabilized by applying tension to either of the first 22 and second 22' elongated members. or both. The tension can be applied manually, that is, by hand, without mechanical aids or by a system that includes mechanical aids such as the mechanical application of a movement by a rotary or linear force and, in addition, can measure and regulate the applied tension. As previously discussed, stress is transmitted from the elongated members to the first and second stabilizers 24, 24 '. For example, by applying tension such as pulling the second end 32 of the first elongated member 22, the first stabilizer 24 advances through the soft tissue, while the second stabilizer 24 'is drawn through the soft tissue, along of the path already taken by the second stabilizer 24 '.

A first tensioner 50 is attached to the free end 32 of the first elongated member 22 of the supplemental stabilization system 10 that emerges through the perineal skin first. A second tensioner 50 is attached to the free end 32 'of the second elongated member 22' of the supplemental stabilization system 10, emerging through the perineal skin in a second location. The tension of the urethral support member 26 is adjusted by applying a tension to the first elongated member 22 and the second elongated member 22 '.

In one embodiment, the skin sites can be on the mid-thighs.

In another embodiment of the method, stabilizers 24, 24 'are located in the pre-pubic soft tissue and at the ends 32 of the first and second elongated members 22, 22' that emerge through the pre-pubic skin.

Alternatively, the route through the tissues can be reversed, for example, in an abdominal to vaginal approach, the urethral support system would pass through the tissues in the following order: abdominal skin, subcutaneous tissue first , rectal sheath, retro-pubic space, sub-urethral space, and finally through the vaginal incision. These steps would be repeated on the other side, starting in a second place on the abdominal skin.

In a perineal-to-vaginal approach, the urethral system would pass through the tissues in the following order: perineal skin first, subcutaneous perineal tissue, perineal muscles, sub-urethral space, and finally through the vaginal incision. The steps would be repeated on the other side, starting at the second perineal skin location.

Regardless of the surgical approach, according to the invention, intra-operative and post-operative adjustment of the urethral support member, for example adjustment of the tension applied to the urethral support member, can be performed up to one week, preferably 72 hours. after surgery. For example, in one embodiment of the method, the tensioner 50 is left in place for 1 to 7 days after implantation of the urethral support member 26. The ends 32 of the first and second elongated members 22, 22 'that emerge through the abdominal wall, the perineal skin, or the pre-pubic skin, as the case may be, are cross-cut by first applying tension to the free ends 32, 32 'to pull a portion of the elongated members 22, 22' adjoining the free end under the skin, through the skin, and to the surface of the skin. The part of an elongated member that was under the skin is cut so that the remainder of the elongated member, after cutting, which was under tension, recedes under the skin. The same process is repeated with the elongated member that emerges in the second abdominal, perineal, or pre-pubic place, as may be the case. The one or more tensioners are removed from the patient.

In a particular embodiment of the method, the vaginal incision is closed, for example, by suturing followed by adjusting the tension of the urethral support member, transmitting the tension from the elongated members through the stabilizers to the support member. urethral.