ES2870903T3 - An implantable support - Google Patents

Abstract

An implantable support adapted to treat urinary incontinence, the implantable support comprising: a support material (22) configured to support a urethra when implanted in a patient; sutures (24) engaged with the support material (22); and anchor assemblies (26), wherein each anchor assembly (26) is engaged with a respective one of each of the sutures (24); wherein each of the sutures (24) is threaded through the respective anchoring assembly (26) and the support material (22), to form a continuous closed suture loop characterized by the implantable support comprising the conduits (29 ) and the rear end portions of each suture (24), which are brought into contact and held within a respective one of the conduits (29), and at least the ends of the suture (24) being welded together to form a rupture pad (30) that maintains the ends of the continuous closed suture loop in an organized fashion, until the continuous closed suture loop separates at the rupture pad (30).

Description

DESCRIPTION

An implantable support

Background

Some surgical implants are fixed in place with one or more knots of suture. Other surgical implants, for example cloth or mesh holders, are fixed in place with an anchor attached to a suture, where the suture is tied against the holder. These surgical implants are usefully used to treat male or female incontinence, prolapse of the pelvic organs, and reconstruction of areas of tissue.

Document US2011 / 297161 discloses a method for treating prolapse of a vagina which comprises securing a base of a Y-shaped support to the tissue by inserting an anchor into the tissue, wherein the support may comprise a first anchor coupled to the base by means of a first interconnecting member and a second anchor coupled to the base by means of a second interconnecting member.

WO2013 / 006866 discloses an implantable support member having at least one adjustment portion that can be manipulated to adjust a length or tension of the support member, after placement of the support member anchors. The support member can be manipulated to provide intermediate urethral support for treating urinary incontinence.

Improved surgical implant fixation devices and methods would be welcomed by patients and healthcare professionals.

Summary

The invention relates to an implantable support adapted to treat urinary incontinence according to the appended claims.

Brief description of the drawings

The accompanying drawings are included to provide a further understanding of the embodiments and are incorporated into and constitute a part of this specification. The drawings illustrate the embodiments and together with the description serve to explain the principles of the embodiments. Other embodiments and many of the intended advantages of the embodiments will be readily appreciated as they are better understood with reference to the following detailed description. Items in the drawings are not necessarily to scale with each other.

Figure 1 is a plan view of one embodiment of a tissue anchor system that includes a support material, an anchor assembly, and an introducer.

Figure 2 is a plan view of an embodiment of the support material illustrated in Figure 1. Figure 3 is a schematic plan view of the support material illustrated in Figure 2 superimposed on a different support material.

Figure 4 is a perspective view of one embodiment of the introducer illustrated in Figure 1.

Figure 5 is a perspective view of the introducer illustrated in Figure 4.

Figure 6 is a perspective view of an end portion of a cannula of the introducer illustrated in Figure 4.

Figure 7 is a plan view, Figure 8 is a profile view, and Figure 9 is a cross-sectional view of the introducer cannula illustrated in Figure 4.

Figure 10A is a perspective view and Figure 10B is a profile view of one embodiment of the anchor assembly illustrated in Figure 1.

Figure 11 is a perspective view of one embodiment of the anchor assembly illustrated in Figure 1.

Figure 12 is a profile view of one embodiment of the anchor assembly illustrated in Figure 1.

Figure 13 is a plan view of one embodiment and Figure 14 is a profile view of one embodiment of anchor assemblies suitable for use with the tissue anchoring system illustrated in Figure 1.

Figure 15 is a perspective view of one embodiment of an anchor suitable for use with the tissue anchor system illustrated in Figure 1.

Figure 16 is a plan view and Figure 17 is a bottom view of the anchor illustrated in Figure 15.

Figure 18A is a cross-sectional view of the front end portion of the anchor and Figure 18B is a cross-sectional view of the rear end portion of the anchor.

Figures 19-20 are perspective views of the anchor illustrated in Figure 15 ejected into soft tissue from the cannula illustrated in Figure 6.

Figures 21A-21C are schematic views of the anchor illustrated in Figure 15 rotated into engagement with the tissue.

Figures 22A-22K are schematic views of embodiments of a process for implanting the tissue anchor system illustrated in Figure 1 in a person to treat urinary incontinence.

Detailed description

In the following detailed description, reference is made to the accompanying drawings, which form a part of this specification, and in which specific embodiments in which the invention may be practiced are shown by way of illustration. In this regard, directional terminology, such as "up", "down", "in front", "behind", "front", "back", etc., is used with reference to the orientation of the Figure (s). (s) to describe. Because the components of the embodiments can be placed in a number of different orientations, the directional terminology is used for illustrative purposes and is in no way limiting. It is to be understood that other embodiments can be used and structural or logical changes can be made without departing from the scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.

The features of the various example embodiments described in this application are suitable and are intended to be combined with each other, unless specifically stated otherwise.

Anterior means "forward" or "in front" and posterior means "backwards" or "behind". With respect to the surfaces of an organ in the human body, the anterior surface of an instrument inserted into the organ will face the belly and the posterior surface will face rearward toward the spine.

Endpoint means a location closer to the end and end part means that segment adjacent and near the end of an object. For example, two opposite ends of an object are both equidistant from a midpoint of the object and between the midpoint and each end of the object is an end portion of the object.

Soft tissue is a tissue other than bone. Soft tissue is not bone.

The embodiments provide a tissue anchor that has a geometric asymmetry and asymmetric mass distribution along a length of the anchor that causes the anchor to rotate to a stable configuration within the tissue.

The embodiments provide a tissue anchoring system having an anchor that will either be durably anchored within periosteal tissue covering a bone surface, or will be durably anchored within dense fibrous tissue where muscle inserts into bone. . An anchor thus anchored is suitable for suspending support material or is useful for implanting devices in the human body.

The embodiments provide a tissue anchor system that includes an introducer that is configured to deliver an anchor to an intracorporeal tissue site. The introducer includes a cannula that allows placement of an anchor at a landmark within the deep tissue of an incision site, which may be outside the surgeon's field of view. The anchor is configured to be secured within the cannula so that it does not rotate or fall out of the cannula during insertion into tissue. A length of suture is provided that is attached to the anchor, where the suture can be tied or otherwise terminated itself outside of the incision site and then subsequently directed to the intracorporeal landmark.

The embodiments provide describes a tissue anchoring system provided for treating male urinary incontinence that is advantageously implanted through a single incision formed in the patient. A first anchor is anchored to the tissue of a first obturator foramen of the patient, and a second anchor is anchored to the tissue of a second obturator foramen of the patient to secure the patient to the bottom of the support material. A third anchor is provided to anchor a first prepubic arm to the periosteal tissue on one side of the pubic symphysis, and a fourth anchor is provided to anchor a second prepubic arm of the support material to the periosteal tissue on the other side of the pubic symphysis. Each of the anchor assemblies includes a suture extending from an anchor, and the surgeon is instructed to properly terminate or tighten the suture to capture the support material between a knot formed in the suture and the anchor implanted within the tissue. The surgeon, guided by experience and the instructions provided with the tissue anchoring system, follows a routine of first centering and fixing the underside of the support material with respect to the obturator foramen using properly tensioned knots tied in the suture. Subsequently, the surgeon centers and fixes the part top of the support material near an upper part of the pelvis on each side of the pubic symphysis. Some aspects of the tissue anchoring system include a separate plication mechanism provided to absorb the slack in the tension of the support material on the urethral tissue.

Some incontinence treatment devices have multiple arms, including some form of arms that pass through the obturator foramen (called transobturator arms) and other arms that are implanted anterior to the pubic bone (called prepubic arms). A first set of tools is used to position the transobturator arms and a second different set of tools is used to position the prepubic arms. The prepubic arms are inserted into a first incision and channeled into the anterior part of the pelvis to exit the skin of the abdomen through a second incision and the respective third incision.

In contrast, the embodiments of the system described in this specification provide a support material that can be implanted into the patient through a single incision with anchoring assemblies that do not create a second or other incisions / openings in the skin. The system avoids the use of transobturator arms and additional tools that channel the prepubic arms under the skin. The system is easier to implant compared to a four-arm or six-arm support, and it reduces the amount of time the patient is in the operating room.

One approach to treating urinary incontinence places a support under the urethra and directs the arms upward from the support next to the bladder along a U-shaped pathway. A significant advance over the U-shaped pathway was provided by Dr. Emmanuel Delorme as described in his US Patent No. 6,638,211 and included placing the arms of a support through the obturator foramen along a V-shaped pathway. This application provides Another advance in pelvic anatomy support by recognizing that support material can be firmly attached to periosteal tissue through the use of an anchoring system. The anchoring system allows the surgeon to place the bracket within the patient and directly fix the bracket to the periosteal tissue that is present on the outside of the pelvic bone. This approach eliminates needles and other tools that channel the arms of a holder through tissue. The anchoring system described in this application is compatible with a single true incision (only one) formed in the patient.

Figure 1 is a plan view of one embodiment of a tissue anchor system 20 (the system 20). System 20 is illustrated in a form useful for delivery to an end-patient facility and includes a support material 22, sutures 24 engaged with support material 22, an anchor assembly 26 engaged with each of the sutures 24 and a set of Introducers 28.

Support material 22 is provided to support the urethra when implanted in the patient. Suitable materials for the support material 22 include autograft material (the patient's own tissue), allograft material (tissue from a cadaver), xenograft material (tissue from another species), or synthetic materials such as woven fabrics, fabrics knitted fabrics, meshes, nonwovens, meshes, fibrillated fibers or spun and fibrillated fibers. In some embodiments, the support material 22 is manufactured to include voids (pores) configured to allow ingrowth of tissue within the support material 22. The pores are generally larger, on average, than 75 gm. A suitable support material 22 is a knitted polypropylene mesh, where each strand of the mesh is woven from a polypropylene filament.

Sutures 24 are threaded or otherwise engaged with support material 22. Each suture 24 is threaded or otherwise engaged with an anchor assembly 26. A suitable suture 24 is fabricated from a single polypropylene monofilament which is threaded through both the anchor assembly 26 and the support material 22 to form a continuous closed suture loop. In one embodiment, the rear end portions of each suture 24 are brought together and held within a conduit 29, and at least the ends of suture 24 are welded together (heat welded or ultrasound welded) to holding the ends of the continuous closed suture loop in an organized manner until the surgeon wishes to break the suture 24 at the point of the weld. In one embodiment, the weld is a rupture pad 30 that is formed by crushing the ends of suture 24 into a flat structure that is more brittle and easier to break than is suture 24 itself. 30 maintains suture 24 in an organized manner until the surgeon wishes to access the free ends of suture 24 and tie a knot. In one embodiment, the welded tear pad 30 is formed through the ends of the suture 24 and through the conduit 29. The conduit 29 advantageously allows the surgeon to identify which suture thread is associated with which part of the holder 22 and also handles sutures in an organized package for ease of handling during implantation of holder 22.

Anchor assembly 26 includes an insertion tab 40 that is removably secured to an anchor 42. Anchor 42 includes a body 44, a tissue engaging flap 46 attached to body 44, and an eyelet 48 formed in the flap. tissue attachment 46. Suture 24 is threaded through eyelet 48 and is gathered / secured in rupture pad 30. Insertion tab 40 provides a comfortable handle for the surgeon or surgical staff to manipulate anchor 42. The length of the anchor 42 is in a range of approximately 4-20mm, which may present a small area to grasp when a person is wearing surgical gloves. Insertion tab 40 allows the surgeon or surgical staff to manipulate anchor 42 comfortably when loading anchor 42 into introducer 28.

The introducer assembly 28 includes a first tool 28a for passing an anchor 26 to the patient's right lateral obturator membrane and a second tool 28b for passing a second anchor 26 to the patient's left lateral obturator membrane. Each of the introducers 28a, 28b includes a cannula 50 that extends from a handle 52, and an ejection mechanism 54 that includes a button 56 that communicates with a rod / cable disposed within the cannula 50. Movement of the button 56 in a distal (forward) direction moves the rod / cable in a distal direction, which acts on the anchor 42 to eject the anchor out of the cannula 50. The introducers 28a, 28b have a "dominant hand" depending on whether anchor 42 is in a left or right obturator foramen. However, each introducer 28a or 28b is equally suitable for inserting one of the anchors 42 into the periosteal tissue.

An optional plication mechanism 70 engages with the support material 22. The plication mechanism 70 functions to pick up any slack that may occur in the support 22 after implantation.

Figure 2 is a plan view of four anchor assemblies 42a, 42b, 42c, 42d that include an insertion tab 40 and engaged with support material 22. Anchors 42 are positioned between support 22 and the patient's body. , and the conduits 29 and rupture pads 30 are located between the bracket 22 and the surgeon. Thus, with respect to the support 22, the anchors 42 are located posteriorly (distal to the surgeon) and the conduits 29 / rupture pads 30 are located anteriorly (proximal to the surgeon).

Each of the four anchor assemblies 42a, 42b, 42c, 42d engages the support material 22 via a respective suture 24a, 24b, 24c, 24d, where each suture 24a, 24b, 24c, 24d penetrates the support 22 in more than one location. In the illustrated embodiment, each suture 24a, 24b, 24c, 24d penetrates support 22 at two locations. The effectiveness of the compression provided by the support 22 to elevate and compress the urethra was studied and it was determined that the multiplicity of penetrations of the support 22 via the suture 24 as illustrated in Figure 2 provides optimal support for the urethra. For example, two penetration points for sutures 24a, 24b on each side of base 60 (four total penetrations for two sutures 24a, 24b) provide excellent suspension of base 60 between the obturator foramen when bracket 22 is implanted Two penetration points oriented on a diagonal line from an interior location of an arm 62, 64 toward an exterior corner of each arm 62, 64 for each suture 24c, 24d have been determined to provide excellent tension to support 22 when implanted. .

The support material 22 includes a base 60 associated with a first anchor 42a that is provided to be anchored in a first obturator membrane and a second anchor 42b that is provided to be anchored in a second obturator membrane of the patient. Support material 22 further includes a first prepubic arm 62 associated with a third anchor 42c that is provided to be anchored within the periosteal tissue on one side of the pubic symphysis, and a second prepubic arm 64 associated with a fourth anchor 42d that is provided. to be anchored within the periosteal tissue on the other side of the pubic symphysis. Support material 22 is provided to the hospital or surgeon in an instruction package for use and includes each of four anchors 42a-42d engaged with support material 22 via one of the respective sutures 24a-24d.

In one embodiment, a plication mechanism 70 is engaged with the support material 22. The plication mechanism 70 is provided to allow the surgeon to remove slack from a central region of the support material 22 after the base 60 and the prepubic arms 62, 64 have been secured to the tissue. In one embodiment, the plication mechanism 70 is a single strand of polypropylene suture that is wound in a three-circle configuration (a snowman configuration). When force is applied to the free ends 72, 74 of the plication mechanism 70, each of the circles in the three-circle configuration contracts to remove slack from the center portion of the support material 22. The ends 72, 74 to the plication mechanism can be welded onto a rupture pad, or tied with a suitable knot to tension the support material 22 against the urethral tissue. The surgeon may remove the plication mechanism 70 from the holder 22 after implantation if it is determined that the holder material 22 is laid as desired on the tissue. In one embodiment, the plication mechanism 70 includes a conduit 71 provided to manage the loose ends of the plication suture.

Single incision male sling - SIMS

One approach to attaching a bracket 22 in the treatment of male urinary incontinence is made with reference to Figures 1 and 2. The patient is placed in a soft lithotomy position with the buttocks on the edge of the table. A French Foley catheter 14 is inserted. A single incision (one and only one) (approximately 4-6 cm) is made vertically into the perineal tissue 1 cm anterior to the anus. The surgeon is instructed to dissect downward and isolate the ventral bulbous urethra while keeping the bulbospongiosus muscle intact. The surgeon is instructed to expose the bulbospongiosus muscle and lower the central tendon 2 cm to provide urethral mobility and allow re-approximation of the sling. The surgeon is instructed to dissect sufficiently to accommodate the entire bracket 22 and to incorporate a wound retractor.

The system 20 is suitable for use both in procedures where the surgeon dissects the bulbospongiosus muscle and in procedures where the surgeon does not dissect the bulbospongiosus muscle, as it depends on the surgeon's preference.

One of the anchors 42 is loaded into a hole in one of the introducers 28a, 28b following the arrow provided on the tab 40. The tab 40 is removed and discarded after the anchor 42 is inserted into the hole of the introducer 28. Anchors 42 are positioned in the obturator foramen following a transobturator (TO) trajectory known as a TO approach. Introducer 28 is directed through the incision using an inside-out technique to guide anchor 42 through the membrane over either the left or right obturator foramen. Begin the passage of the introducer 28 approximately 2 finger widths (approximately 4 cm) below the pubic arch. The shaft of the introducer 28 should be parallel to the ipsilateral ramus of the ischial pubis. Using the thumb, push the back of the introducer 28 past the ischial pubic ramus, advancing through the obturator membrane until a click is felt. Once the "snap" is felt, rotate an additional% turn (thumb glide should be up). Introducer 28 and anchor 42 can be repositioned in introducer 28 as desired by the surgeon until anchor 42 is physically expelled from introducer 28. The surgeon is instructed to deploy the anchor using thumb advance 56. Anchor 42 is inserted into the external obturator muscle. The surgeon is instructed to remove introducer 28, pull suture 24 to seat anchor 42 within tissue, and ensure integrity of the anchor.

Similarly on the contralateral side, a second of anchors 42 is loaded into introducer 28, and introducer 28 is directed through the incision to guide anchor 42 through the membrane over the other left or right obturator foramen. for insertion into that external obturator muscle.

The surgeon is instructed to center the bracket 22 in the bulbospongiosus muscle, using a retention suture if desired. The surgeon is instructed to retract the catheter from the glans penis. The surgeon is instructed to remove the conduit 29 from the suture 24 and to separate the ends of the suture separating the rupture pad 30. The surgeon is instructed to tie a single double knot in both TO sutures to secure the bracket 22 downward. within the tissue, taking care to keep the support 22 centered. The surgeon is instructed to drive the knot downward toward anchor 42, keeping bracket 22 centered, to firmly secure the posterior portion of the implant for optimal urethral reapproximation. The surgeon is instructed to tie additional single knots to lock the bracket 22 in place, followed by trimming and discarding the excess suture removed. In this configuration, the base 60 of the support 22 is suspended by the suture 24, with each suture 24 connected to an anchor 42 that engages the muscle of one of the opposing obturator foramen. The surgeon selects the desired amount of tension in the lateral suspension supporting the base 60, for example, by making a suitable knot in the suture 24 to secure the base 60.

Arms 62, 64 are raised to tension support 22 against the bulbospongiosus muscle. While holding arms 62, 64 in tension, a third anchor is loaded into introducer 28, and introducer 28 is directed through the incision to guide anchor 42 below periosteal tissue, but above bone. Specifically, the surgeon is instructed to position the tip of the introducer 28 perpendicular to the tissue and gently press down to make contact with the pubic bone, sliding along the bone in order to maintain contact with the patient's ipsilateral shoulder during approximately 1.5 cm, then allow the needle to rotate away from the bone, followed by pushing the anchor 42 approximately 1 cm further. Introducer 28 and anchor 42 can be repositioned in introducer 28 as desired by the surgeon. The surgeon is instructed to deploy anchor 42 from introducer 28 using thumb advance 56 and counter-rotate to remove introducer 28 leaving anchor 42 within the dense fibrous tissue of the periosteum. The surgeon is instructed to pull suture 24 to seat anchor 42 within tissue to ensure integrity of the anchor. Suture 24 attached to anchor 42 is pulled and anchor 42 rotates or commutes to fully engage anchor 42 in a lateral orientation relative to the entry line of introducer 28 into the periosteal tissue. Anchor 42 engages the periosteal tissue to hold the support in tension against the urethral complex. The fourth anchor is loaded into introducer 28, and introducer 28 is directed through the incision to guide anchor 42 through into and below the periosteal tissue on the contralateral side of the patient's pubic symphysis. The surgeon is instructed to remove the conduit (s) from the suture (s) 24 followed by tying a single double knot in the sutures 24 to hold the bracket 22 in compression against the urethra. The knots are tightened to secure and stretch the anterior portion of the support 22 over the urethra to provide optimal compression. Additional knots are tied to lock in place, trim, and discard excess suture. The surgeon can perform a flexible cystoscopy to ensure proper coaptation of the urethra is achieved.

In this approach, support 22 is secured and suspended by sutures 24 between opposing obturator foramina and held in tension against the bulbospongiosus muscle of the urethra by anchoring two anchors 42 within the periosteal tissue on opposite lateral sides of the pubic symphysis. If the surgeon decides that additional concentration of the support 22 on the urethra is desired, the surgeon will use the plication mechanism 70 to absorb any slack in the mid-region of the support 22 to ensure proper elevation and support of the urethra.

Figure 3 is a plan view of support material 22 superimposed on a four-arm support. In this example, the four-arm brace is in the shape of the Coloplast Virtue® male sling available from Coloplast Corp., Minneapolis, MN, which is known to be useful in treating male urinary incontinence. The support material 22 has less material than this and other four-arm supports. The four-arm support includes a first transobturator arm (TO arm), a second TO arm, and a first prepubic arm opposite a second prepubic arm. The four-arm stand has a lateral dimension that extends along the TO arms of approximately 18 inches (45 cm) and a longitudinal dimension extending between the prepubic arms of approximately 12 inches (30 cm). In contrast, the backing material 22 has a base 60 with a width or base dimension of between 1.27 cm (0.5 inches) to 3.18 cm (1.25 inches), which is much smaller ( approximately 43 cm (17 inches) smaller) than the material between the first and second TO arms of the four-arm stand. The first and second prepubic arms 62, 64 of the support material 22 extend between 5.08 and 7.62 cm (2-3 inches), which is much shorter than the 30 cm (12 inches) extension of the Prepubic arms provided by the four-arm support. The relatively smaller support material 22 has been found to support the male urethra, as well as the larger four-arm support when implanted through a single incision and when secured by anchors 26 and the system 20 described herein. description.

Figure 4 is a perspective view of introducer 28a. The cannula 50 extends from the handle 52 and terminates at an end 80. The button 56 of the ejection mechanism 54 is located on the handle. In one embodiment, button 56 is curved with an arc that extends over an outer portion of handle 52, allowing the surgeon to manipulate button 56 when using introducer 28 to position anchor 42 in both a transobturator pass ( deployment of the anchor within the TO tissue) as in a prepubic pass (deployment of the anchor within the periosteal tissue). That is, when introducer 28 is used in a transobturator pass (eg, on both the right and left sides of the patient), the button 56 is conveniently positioned for operation by the surgeon's thumb. When the introducer 28 is then used in a prepubic pass to position the prepubic arms, the extended and sculpted button 56 is also conveniently and ergonomically positioned for the surgeon to manipulate with one hand.

End 80 is formed into an end portion 82 of cannula 50. In one embodiment, end portion 82 of cannula 50 is formed to have a constant outer diameter. In one embodiment, the end portion 82 of the cannula 50 is formed to have a tapered outer diameter that tapers from a first diameter D1 to a second diameter D2, where the diameter D2 is less than the diameter D1.

In one embodiment, ejection mechanism 54 includes a wire / rod located within cannula 50 and connected to button 56. Movement of button 56 moves the wire / rod within cannula 50. When anchor 42 (Figure 1) inserted into end 80 of cannula 50, movement of button 56 in a distal direction ejects anchor 42 in a distal direction out of cannula 50.

The cannula 50 can be straight or curved.

In one embodiment, end portion 82 is formed as a circular arc all within the same plane such that end portion 82 is neither helical nor spiral.

In one embodiment, the end portion 82 is formed as a circular arc in a helical spiral. For example, end portion 82 extends between a first segment 84 and end 80, and the helical coil of end portion 82 is formed such that end 80 is distally outward and away from the end. first segment 84.

Figure 5 is a perspective view of one embodiment of the introducer 28a where the end portion 82 is formed as a circular arc within the same P-plane. In one embodiment, the end portion 82 is oriented at 90 degrees. relative to a straight segment 86 of cannula 50.

Figure 6 is a perspective view of one embodiment of the cannula 50 prior to inserting the anchor 42. The cannula 50 includes a hole 90 that is sized to receive the body 44 of the anchor 42 and a slot 92 that is dimensioned to receive tissue engagement flap 46 from anchor 42. In one embodiment, end 80 of cannula 50 bends inward toward hole 90 to form an ejection chute that is similar to a ski ramp in a jump. skiing. In one embodiment, the end 80 of the cannula 50 forms an inwardly bending point, where the point is on a side of the cannula 50 opposite a slot 92 location. The bent end 80 provides several advantages, including preventing cannula 50 from sinking into bone when cannula 50 is inserted below periosteal tissue and causing anchor 42 to lift and toggle away from cannula 50 when anchor 42 is ejected from cannula 50. In a In one embodiment, hole 90 is a circular hole having essentially a constant inside diameter. Other geometries are acceptable for the shape of the hole 90.

In one embodiment, the slot 92 is provided with side walls 94a, 94b that are parallel to each other. Anchor 42 is relatively small compared to the human hand. The tab 40 is provided to allow the healthcare worker to manipulate the anchor 42 and insert the anchor into the cannula 50. After the body 44 of the anchor is inserted into the cannula 50, the tab 40 is dislodged from the anchor 42. tab 40 is discarded. Body 44 of anchor 42 is sized to frictionally engage hole 90 and tissue engagement flap 46 is sized to frictionally engage groove 92 so that anchor 42 does not come out of cannula 50 until it is actively and intentionally ejected by the surgeon operating the ejection mechanism 54 (Figure 5).

It is desirable to frictionally engage the anchor 42 in the cannula 50 of the introducer 28. The geometry of the hole 90 and the slot 92 can be modified to promote frictional engagement between cannula 50 and anchor 42.

Figure 7 is a plan view, Figure 8 is a profile view, and Figure 9 is an end view of one embodiment of a cannula 51 having a tapered outer diameter and a tapered groove 92 '.

Figure 7 is a plan view of cannula 51 having a slot 92 'modified to increase frictional engagement with anchor 42 illustrated in Figure 1.

Figure 7 illustrates an embodiment in which the slot 92 'narrows. The slot 92 'narrows by having the side walls of the slot 92' tapered with an angle T. In one embodiment, the angle T is 4 degrees and the side walls converge the width of the slot 92 'from 1, 1mm to 0.890mm. Tapered groove 92 'ensures positive engagement with anchor 42. In this example, the inner diameter of hole 90' is 1.6mm and the outer diameter of the cannula is 2.2mm.

Figure 8 is a profile view of cannula 51, and Figure 9 is an end view within the bore of cannula 51. In one embodiment, the outer diameter of cannula 51 is tapered from a first outer diameter OD1 measured at a proximal portion down to a second outer diameter OD2 measured at a distal portion, where the first outer diameter OD1 is larger than the second outer diameter OD2. The pointed end of cannula 51 does not bend to provide the ski slope that is provided by cannula 50 (Figure 6).

Figure 10A is a perspective view and Figure 10B is a profile view of anchor assembly 26. Anchor 42 of anchor assembly 26 includes a longitudinal midpoint M located at the center of the length of anchor 42 as measured along the longitudinal axis B between the ends 102, 106. A portion of the leading end 100 of the anchor 42 extends from the midpoint M to a leading end 102, and a portion of the trailing end 104 extends from the midpoint M to an end rear end 106. The front end portion 100 connects to the rear end portion 104 at the midpoint M. A vertical axis A bisects the length of the anchor between the front end 102 and the rear end 106 and thus cuts the midpoint M.

Anchor 42 has a geometric asymmetry in which anchor 42 has more area at the front end portion 100 (i.e., the left-hand side of axis A) than at the rear end portion 104 (i.e., the A-side). to the right of axis A). Anchor 42 also has an asymmetric mass distribution with respect to axis A. In one embodiment, a longitudinal central axis B is drawn and intersects vertical axis A. In one embodiment, the mass distribution of the anchor 42 is asymmetric with respect to the A axis (that is, weighted more towards the leading end portion 100) and is also asymmetric with respect to the B axis (that is, weighted more above the B axis). In this example, the center of mass CM is ahead of axis A toward end 102 and above axis B. The center of mass CM of anchor 42 is not necessarily located at the geometric midpoint M.

Tissue coupling flap 46 is positioned asymmetrically at anchor 42 with respect to midpoint M. In one embodiment, tissue coupling flap 46 is positioned along the front end portion 100 of anchor 42 to provide anchor 42 with geometric asymmetry associated with leading end portion 100. In one embodiment, anchor 42 includes a barrel 110 located at the forward end portion of anchor 42 to provide anchor 42 with an asymmetric mass distribution with relative to the midpoint M. The barrel 110, in combination with the tissue engagement fin 46 contributes to a mass distribution for the anchor 42 that is predominantly distributed forward at the anchor 42, for example, along the portion of the leading end 100. The barrel 110 and eyelet 48 provided in the tissue engaging flap 46, in cooperation with the asymmetric distribution of mass forced forward, p they allow the anchor 42 to commute, or rotate, or move to ensure engagement when inserted into tissue.

The tissue engaging flap 46 includes a leading edge 120 and a trailing edge 122, and the anchor 42 includes a leading surface 130 located at the leading end portion 110 and the trailing surface 132 located at the trailing end portion 104. In In one embodiment, the insertion tab 40 is removably secured to the leading edge 120 of the tissue engagement flap 46. The insertion tab 40 includes a marker or other indicia 134 to provide visual guidance to surgical personnel that is useful when anchoring assembly 26 is loaded into cannula 50 of introducer 28 (Figure 1). After body 44 and barrel 110 of anchor 42 are inserted into cannula 50 of introducer 28, insertion tab 40 is disconnected (dislodged) from anchor 42. Anchor 42 is retained within cannula 50 and is prepares for insertion into tissue.

Figure 10B illustrates an embodiment in which the tissue engagement flap 46 is triangular with a first side integrated into the leading end portion 100 of the body 44, a leading side (eg, leading edge 120) connected between the anterior tip 102 and a vertex V and a posterior side (eg, the trailing edge 122) connected between the vertex V and the rear end portion 104 of the body 44, with the vertex V located outside the longitudinal axis B.

When anchor 42 is inserted into tissue, the surgeon is instructed to provide a pulling force to suture 24 (Figure 1) that engages eyelet 48, and this pulling force rotates anchor 42 to engage the edge anterior 120, posterior edge 122, and posterior surface 132 in a stable position within the tissue.

Anchor 42 is asymmetrical both geometrically and has an asymmetric mass distribution, both of which cause anchor 42 to rotate, so front end 102 rotates clockwise (for example) to engage edges 120, 122 and surface 132 with the tissue. Anchor 42 is configured for insertion into the periosteal tissue covering the bone. The bone provides a barrier or a hard surface that prevents the anchor 42 from penetrating the bone. The bone, however, also provides a surface that may not be conducive to rotation or switching of the anchor 42, since the bone is essentially immobile. The geometric asymmetry and asymmetric mass distribution of the anchor 42 has been found to be adequate to allow the anchor 42 to rotate and switch over a short distance as the surgeon applies a pulling force to the suture that is engaged with the eyelet. 48. Other anchors having geometric symmetry and geometric mass distribution have been found to not rotate, or rotate less slowly and over a greater distance, which may have the effect of the anchor not fully engaging the tissue and make it possible to withdraw from the anchor or to protrude out of its insertion point into the tissue. In contrast, anchor 42 has been found to provide rapid turning and switching that provides excellent tissue engagement within a short engagement distance when the surgeon provides force to suture 24 that is engaged with eyelet 48.

Figure 11 is a perspective view of anchor assembly 26 oriented to illustrate crush rib 140 located along a lower edge of anchor 42 on a side opposite tissue engagement fin 46. In one embodiment , the crushing rib 140 extends from the front end portion 100 rearwardly to the rearward end portion 104. A suitable height of the crushing rib 140 is in a range of 0.5-4 mm, preferably 1-3 mm. The crushing rib 140 is provided to ensure positive frictional engagement of the anchor 42 with the cannula 50 (Figure 1) of the introducer 28. The crushing rib 140 can be deformed and is configured to be pressed toward the body of the anchor 42 when anchor 42 is inserted into a cannula. The crush rib 140 occupies any excess space within the cannula, with the excess material from the crush rib 140 compacted to fit within the cannula by friction fit. The 1-3 mm height of the crush rib 140 allows the rib to compact to size as it is inserted into the cannula.

Suitable materials for making anchor assembly 26 include polymers in general, metals and metal alloys, composites, fiber-reinforced composites, and other materials suitable for molding or extrusion. In one embodiment, anchor assembly 26 is manufactured from polypropylene. Other polyolefins or polymers are suitable.

Anchor 42 of anchor 26 simply has a length extending from front end 102 to rear end 106 in a range of 2-30mm, preferably 5-25mm, and more preferably 10-20mm. A suitable anchor length has been determined to be approximately 11mm from leading end 102 to trailing end 106.

Figure 12 is a profile view of anchor assembly 26, Figure 13 is a bottom view of an embodiment of an anchor assembly 226, and Figure 14 is a profile view of an embodiment of an assembly. anchor 326. Anchor assembly 26 provides insertion tab 40 removably connected to leading edge 120 of anchor 42. Anchor assembly 226 includes a perpendicular insertion tab 240 secured to a side surface of anchor 42. The assembly Anchor 326 includes an insert tab 340 located on the trailing edge 122 of anchor 42. The outer surface of the insert tabs 40, 240, 340 may include a textured gripping surface, such as a dotted surface or other suitably structured surface. increase friction when surgical personnel manipulate the anchor assembly with gloved hands.

Figure 15 is a perspective view, Figure 16 is a plan view, and Figure 17 is a bottom view of anchor 42 without insertion tab 40. Leading edge 120 tapers to converge to line 121 or surface narrow 121 which allows anchor 42 to more easily penetrate into tissue.

Tissue engagement fin 46 extends away from body 44. In one embodiment, tissue engagement fin 46 has a triangular shape with a longer side X of the triangle parallel to the longitudinal axis BB of anchor 42, and sides shorter Y and Z meeting an angle F, the three sides X, Y, Z of the triangle defining a geometry of the tissue coupling flap 46.

Tissue engagement flap 46 is configured to grip tissue and cause anchor 42 to rotate for stable engagement and anchor in tissue. One embodiment provides the tissue engaging flap 46 with a uniform width or thickness. In one embodiment, the interior portions of the X-Y-Z triangle are filleted or thinned, so that the perimeter of the X-Y-Z triangle is thicker in width than the interior area of the X-Y-Z triangle.

The crush rib 140 extends longitudinally along a portion of the lower surface of the anchor 42. The crush rib 140 is provided as a radially extending flange, wherein the flange has a width ranging from 0, 1-0.5mm and a height in a range of 0.5-4mm, preferably 1-3mm. In one embodiment, crush rib 140 includes a tapered leading edge and a tapered trailing edge. The crushing rib 140 is useful for retaining the anchor 42 in the cannula 50 of the tool. introducer 28 (Figure 1) until deployment of anchor 42 begins. Crush rib 42 is sufficiently deformable when engaged with cannula 50 to allow anchor 42 to snap fit into cannula 50 while also allowing anchor 42 is ejected from the tool.

Figure 16 is a plan view of anchor 42. Leading edge 120 tapers to converge to line 121 or shoulder 121.

In one embodiment, the leading edge 120 tapers or tapers from a pinnacle or vertex V of the anchor 42 toward the body 44 and the trailing edge 122 tapers or tapers from the apex / pinnacle of the anchor 42 toward the body 44 In one embodiment, leading edge 120 includes sloped surfaces 123, 125 that extend from line 121 toward first and second side surfaces 127, 129 of tissue engagement flap 46. Line 121 and sloped surfaces 123, 125 of leading edge 120 are configured to facilitate simple cutting or drilling through tissue during insertion and rotation of anchor 42 within tissue. The configuration of leading edge 120, which includes line 121 and sloped surfaces 123, 125, provides leading edge 120 with a reduced thickness (width) relative to the thickness of fin 46 at first and second side surfaces 127, 129, which helps the flap 46 to slide through or pierce the tissue.

In one embodiment, an upper portion 131 of the tissue engaging flap 46 has a generally cusp configuration with a base of the cusp located toward the trailing edge 122 of flap 46 and with the two sides of the triangle meeting. at the line 121 of the anterior face 52. The cusp top 131 is configured to help provide a smooth transition of the anterior edge 120 between the line 121 and the first and second side surfaces 123, 125.

In one embodiment, the trailing edge 122 of the tissue engagement flap 46 has a blunt configuration and may include a flat surface. Trailing edge 122 is configured to provide increased engagement with tissue, such that anchor 42 has improved resistance against removal of tissue once it is implanted in place.

Referring to Figure 17, the front surface 120 of the anchor 42 integrates with and angles away from the barrel 110 to terminate at the anterior end 102. The bottom view of the anchor 42 illustrates that the front surface 130 is heart-shaped to as the wider barrel 110 tapers toward the front end 102.

In one embodiment, a width W3 of the tissue attachment flap 46 corresponds to the width W2 of the rear end portion 104 of the body 44. In one embodiment, the width W3 of the tissue attachment flap 46 it is greater along one or more of the X, Y, Z sides of the triangular shape (Figure 15) than at defined positions within the triangular area. That is, in one embodiment, the wall thickness of the tissue engaging flap 46 is thinner "within" the boundaries of the triangle than at one or more of the edges of the triangular shape.

In one embodiment, the tissue engaging fin 46 overlaps the leading end portion 100 of the body 44 including the protruding barrels 110. The protruding barrels 110 are formed as a pair of radial barrels 110 extending from the body 44 in a radial direction perpendicular to the direction of the fin 46.

In one embodiment, the tissue engagement flap 46 is moved toward the anterior end 102 with respect to the midpoint M of the body 30 (located on the axis A-A in Figure 10). In one embodiment, the tissue attachment flap 46 is positioned asymmetric to the midpoint M. In one embodiment, the tissue attachment flap 46 is displaced such that an entirety of the tissue attachment flap 46 is at the leading end portion 100. In one embodiment, a majority, but less than all of the tissue engagement flap 46 is located at the leading end portion 100. In one embodiment, the point The middle M of the body 44 is positioned at a transition between the leading end portion 100 and the rear end portion 104. In one embodiment, the eyelet 36 for receiving a length of suture extends across the entire width W3 of tissue coupling flap 46.

Figure 18A is a cross-sectional view of the leading end portion 100 of the anchor 42 and Figure 18B is a cross-sectional view of the rear end 104 portion of the anchor 42.

In one embodiment, the first and second projections 110 combine with the leading end portion 100 of the body to provide the tissue anchor 42 with a circular cross section.

The tissue anchoring system 20 described above is useful for anchoring the support material relative to the tissue, particularly in the treatment of urinary incontinence. Examples provide placement of anchor 42 in tissue, which may include ligaments, fatty tissue, connective tissue, and other general soft tissue. It has been discovered that the support material useful in the treatment of male urinary incontinence can be implanted through a single incision (one and only one) using the introducer 28 and the anchor 42 described in this specification in the placement of the anchor. 42 within the periosteal tissue over the pelvic bone and other anchors in the membrane of the transobturator foramen.

One approach to attaching a bracket 22 in the treatment of male urinary incontinence is made with reference to Figures 1 and 2. The base 60 of bracket 22 is secured to the patient by engaging an anchor 42 in the external obturator muscle of each obturator foramen and the suture 24 having been extended from each anchor 42 to the support 22. In this manner, the support 22 is suspended between the opposing obturator foramina. The arms 62, 64 of the support 22 are raised to tension the support against the bulbospongiosus muscle, and while keeping the arms 62, 64 in tension, two other anchors 42 are secured within the periosteal tissue, one on each side of the pubic symphysis of the patient. In this approach, support 22 is secured and suspended by sutures between opposing obturator foramina and held in tension against the bulbospongiosus muscle of the urethra by anchoring two anchors 42 between the periosteal tissue and bone on opposite lateral sides of the urethra. the pubic symphysis. Anchors 42 anchored between periosteal tissue and bone are positioned as described below in Figures 19-21C.

Figure 19 illustrates the cannula 50 of the introducer 28 inserted into the soft tissue along a path of the cannula and guided along the pelvic bone and into the periosteal tissue. Neither cannula 50 nor anchor 42 enter the bone. Anchor 42 has been inserted into hole 90 and retained in slot 92 with insertion tab 40 (Figure 1) removed. Suture 24 engages anchor 42 via eyelet 48 and exits through the incision made within the tissue. In this way, the surgeon is in control of anchor 42 by placing tension on suture 24, and also by having anchor 40 frictionally engaged within cannula 50. In one example, end 80 of cannula 50 is bent upward. toward the hole 90 to reduce the possibility that the end 80 will sink or scratch the bone.

Figure 20 illustrates the anchor 42 ejected a partial distance out of the hole 90 of the cannula 50 by the ejection mechanism 54. In one example, the ejection mechanism 54 is a piano wire connected to the button 56, in which the The cable is rigid in axial compression and is suitable for pushing the anchor 42 out of the cannula 50 and is still flexible in a radial direction to allow the cable to bridge the curvature of the introducer needle or cannula 50. Suitable ejection mechanisms 54 include piano wire, stranded wire, or flexible wire made of metal or plastic.

With further reference to Figure 1, the button 56 of the ejector mechanism 54 has been moved forward in a distal direction, resulting in the cable pushing the rod forward in a distal direction. A surface of the rod pushes against the trailing edge 132 of anchor 42 to eject anchor 42 out of cannula 50 and into soft / connective tissue. Suture 24 and proximal portion of cannula 50 extend out of the incision toward the surgeon. The anterior end 102 and the anterior surface 130 of the anchor 42 are sized and configured to slide between the periosteal tissue and over the bone (but not on the surface of the bone). The bent end 80 of the cannula 50 prevents the cannula 50 from sinking into the bone and lifts the anchor 42 away from the bone and initiates the rotation or switching of the anchor 42. The bent end 80 of the cannula 50 provides a ramp 80, and movement of the anchor out of the cannula 50 causes the anchor 42 to rotate away from the path of the cannula.

Figure 21A illustrates anchor 42 ejected out of cannula 50. Bent tip 80 directs anchor 42 in an upward direction toward periosteal tissue. Anchor 42 is rotated out of the cannula path (anchor 42 tilts upward). In one example, anchor 42 has two rotational motions: one is rotated / tilted up out of the cannula's path and the second is rotated (or rolled) on the longitudinal axis of anchor 42. Cannula 50 is removed from the cannula. tissue after anchor 42 has been ejected. The surgeon controls the orientation of anchor 42 while maintaining control of suture 24. Referring further to Figure 1, suture 24 engages support material 22 and includes flattened rupture pad 30.

Figure 21B illustrates that the cannula 50 has been removed from the tissue, leaving the anchor 42 within the periosteal tissue above the bone. Suture 24 is extended away from anchor 42 out of the incision via the cannula and back toward the surgeon.

Figure 21C illustrates a plan view of the anchor 42 with an orientation after a pulling force has been applied to the suture 24. Pulling the suture 24 in a direction away from the patient rotates the anchor 42 to place a length of the anchoring 42 transverse to the path of the cannula. Anchor 42 engages periosteal tissue on the bone surface; in this sense, the anchor 42 is located between the bone and the surface of the skin, therefore located within the periosteal tissue.

The surgeon has directed a forced pull on suture 24 to rotate anchor 42. The geometric asymmetry of anchor 42 and the asymmetric mass distribution along the length of anchor 42 encourages the anchor to rotate to a stable configuration in the that the anterior edge 120, the posterior edge 122 and the posterior surface 132 engage with the tissue and resist further movement of the anchor toward the opening formed in the skin by the cannula 50. The surgeon has thus forcibly engaged the anchor 42 within the periosteal tissue in an orientation in which the anchor resists displacement or movement. Suture 24 extends anchor 42 into support material 22 (Figure 1). Anchor 42 thereby engages tissue and suture 24 engages support material 22. The surgeon has controlled anchor 42 with suture 24, and in preparation for tying a suitable suture knot he separates suture 24 at two free ends breaking rupture pad 30. Suture 24 is tied with a knot suitable to retain support material 22 in the location desired by the surgeon.

Anchor 42 has been found to engage periosteal tissue in such a forceful and durable manner that a polypropylene suture 24, such as that commonly used in the treatment of incontinence, will fail and dislodge before anchor 42 disengages from the tissue. That is, the polypropylene suture 24 has been designed to be the weak link of the system 20, such that the anchor 42 engages tightly with the periosteal tissue to allow the surgeon to apply whatever force they desire and secure the tissue material. support 22. Suture 24 will break before anchor 42 can be removed from the tissue, contributing to a superior anchoring connection. The surgeon is familiar with the amount of force that can be applied to the polypropylene suture.

The procedure described above places the anchor and the periosteal tissue covering the pelvis. System 20 is suitable for positioning anchor 42 at other locations, for example, through the membrane of the obturator foramen. In such a procedure, the cannula is directed through the single incision formed in the patient, around the ischial pubic ramus and into the membrane covering the obturator foramen. One suitable cannula of this type includes the cannula 50 described in Figure 5 having the curved section 82. The ejection mechanism 54 is used to deploy the anchor 42 in the membrane or muscle formed on the obturator foramen. Suture 24 is used to fully engage anchor 42 within tissue before the surgeon fixes support material 22 by knotting and suture 24.

A suitable example method of placing an anchor within tissue includes directing cannula 50 of introducer 28 into tissue; pushing anchor 42 out of cannula 50; removing the cannula 50 from the tissue and leaving the anchor 42 within the tissue; applying a pulling force to suture 24 that is connected to anchor 42 to engage anchor 42 with tissue; breaking the bond that is formed at suture 24 at rupture pad 30 to produce two free ends of suture 24; and tying a knot in the suture 24 to secure the anchor 42, or the anchor 42 and the support material 22, in the position desired by the surgeon and indicated in the instructions for use of the system 20.

An advantageous embodiment of system 20 includes providing the surgeon with improved control over when and where anchor 42 is placed. For example, it is sometimes experienced that when an anchor is delivered into tissue via an introducer, the tissue has a capacity insufficient to retain the anchor. This phenomenon is experienced when the needle is directed into fatty tissue, after which the surgeon realizes that the fatty tissue will not be able to properly retain the anchor to treat male incontinence. The system 20 provides a solution by allowing the surgeon to direct the cannula 50 into the tissue to determine if the tissue is suitable to receive the anchor, and allowing the surgeon to remove both the cannula 50 and the anchor 42 if the surgeon determines that the tissue does not it is ideal for the application. System 20 allows the surgeon to direct the cannula to another location within tissue prior to ejecting anchor 42 out of cannula 50 with ejection mechanism 54. System 20 provides the surgeon with improved control in that anchor 42 does not drop out. cannula 50 until the surgeon activates ejection mechanism 54.

A suitable example method of anchoring an example support material suitable for treating male urinary incontinence will now be described with reference to Figure 1 in Figure 2. A member of the surgical staff grasps the anchor assembly 26 by the insertion tab. 40 and inserts anchor 42 into cannula 50. Insertion tab 40 is subsequently removed from anchor 42. Suture 24 engages eyelet 48 of anchor 42 and support material 22. The surgeon directs cannula 50 to the tissue location of interest and ejects anchor 42 by activating button 56 of ejection mechanism 54. The surgeon removes cannula 50 from tissue and applies a retraction force to suture 24 that rotates and engages anchor 42 with tissue . Support material 22 is placed in the desired location, rupture pad 30 is pulled apart to provide suture 24 with two free ends, and the surgeon fixes support material 22 at the desired location. It should be noted that the surgeon also has the option of lightly tying a fastening stitch to hold the support material 22 in place until the other anchors are deployed.

One application of the example method above includes forming one and only one incision in the patient between the scrotum and the anus, and loading the anchor 42a into the cannula 50. The insertion tab 40 is separated from the anchor 42. The cannula 50 is inserts into the one and only one midline incision and is directed into the obturator foramen membrane. Ejecting mechanism 54 is manipulated to eject anchor 42a within the membrane of the obturator foramen. The cannula 50 is removed, for example, by following a path around a descending limb and out of the incision. The base 60 of the support material 22 is positioned at the bottom of the bulbar urethra and a holding stitch is placed with the suture 24. A similar approach is used on the contralateral side of the patient to place the anchor 42b in the membrane of the Opposite obturator foramen. The surgeon ties suture 24b to secure base 60 of support material 22 at a location inferior to the bulbar urethra. With the support material 22 in the desired position, the surgeon returns to the suture 24A, removes the fastening stitch, and ties a permanent knot to secure the base 60 of the support material 22.

The prepubic arms 62, 64 are raised to a location higher than the base 60 and a mark is made within the tissue with a marker pen to identify the location of the prepubic arms 62, 64. It is desirable that the support material 22 lift and compress the urethral tissue, and in one embodiment, the surgeon will place additional markings within the tissue at a location approximately 1 cm superior to each of the prepubic arms 62, 64, and 1 cm lateral to and outside of each of the prepubic arms 62, 64 (that is, the markings are "above and above" with respect to the arms). A suitable cannula is selected, and the anchor 42c is loaded into the cannula.

The cannula is directed into the periosteal tissue and the anchor 42c is expelled from the cannula into the periosteal tissue above the surface of the pelvic bone. The cannula is withdrawn and a force is applied to suture 24c to toggle and engage anchor 42c within tissue. With the prepubic arm 62 positioned in its desired position, the surgeon will lightly tie a holding stitch at suture 24c. A similar approach will be used on the contralateral side of the patient in which anchor 42d is positioned within the periosteal tissue via an introducer cannula, after which the cannula is removed and anchor 42d is rotated or moved in engagement with the tissue by applying a force to the suture 24d. The prepubic arms 64 will be placed in the desired position according to the instructions for use provided with the system 20, and the surgeon will make a permanent knot to secure the prepubic arm 64. The surgeon confirms the placement location of the prepubic arm 62, loosens the clamping stitch at suture 24c, and makes a permanent knot at suture 24c to secure the prepubic arm 62. In this manner, the prepublic arms 62, 64 are detached from the base 60 and secured to lift and compress the support material 22 against the urethra. If desired by the surgeon, plication mechanism 70 is adjusted to remove slack from a central region of support material 22 after base 60 and prepubic arms 62, 64 have been secured to tissue. The one and only incision is closed in a proper manner desired by the physician and the patient begins recovery.

Figures 22A-22K are schematic views of an exemplary process for implanting the tissue anchoring system illustrated in Figure 1 in a person to treat urinary incontinence.

In preparation for surgery, the patient is reclined in a lithotomy position, the sterile field is defined with appropriate coverage, and the patient's skin is appropriately prepared in accordance with the guidelines of the healthcare facility. The packaging containing the tissue anchor system 20 is opened and the instructions for use are available, for example, on a back table in the surgical room. The cannula 50 of the introducer 28 is sized to position each of the anchors 42 of the system 20 within the patient's tissue accessing a single incision 145. The single incision 145 is the one and only incision formed in the patient's skin. A useful incision is a midline incision formed between the scrotum and the anus of a male patient to provide an axis to the bulbous urethral complex. Some surgeons dissect the bulbospongiosus muscle to access the urethra, and system 20 is appropriate for this approach. Other surgeons do not dissect the bulbospongiosus muscle, but instead access the urethral complex, and system 20 is also appropriate for this approach. Typically a dilator of some type is used to force incision 145 into an expanded position that provides access to the pelvic triangle. The dilator is not illustrated, but the incision is illustrated as an expanded circumferential area.

Figure 22A is a schematic view of anchor 42b inserted into slot 92 of cannula 50. Anchors 42 are positioned between support 22 and the patient, allowing the anchors to be attached within the tissue and support to cover the bulbar urethral complex. Suture 24 is provided as a continuous suture loop that extends through eyelet of anchor 42b, a portion of base 60 of holder 22, and terminates at breakout tab 30 (see Figure 1). The conduit 29 of Figures 1-2 provided around a portion of the suture 24 to handle the suture assembly is optional.

Anchor 42b is a bit small and can be difficult for a person wearing surgical gloves to manipulate. Insertion tab 40 is provided to allow anchor 42b to be inserted into slot 92 of cannula 50. Hole 90 and slot 92 are sized to engage with and retain anchor 42 in cannula 50. Insertion tab 40 is subsequently removed from anchor 42 and discarded, leaving anchor 42 secured within cannula 50.

The following procedure will place the anchors 42b, 42a associated with the base 60 of the holder 22 in the opposing obturator foramina (OF) spaced from the patient. Anchor 42b is inserted into the OF on the right side of the patient and suture 24b is allowed to drag out of incision 145. Anchor 42a is inserted into the OF on the left side of the patient and suture 24a is also allowed to be drawn. pull out of incision 145. Bracket 22 is positioned and sutures 24b, 24a are tied off and terminated on bracket 22. Therefore, base 60 of bracket 22 is suspended by sutures 24b, 24a implanted in the OF muscle. Anchors 42c, 42d attached to the prepubic arms of support 22 are posteriorly attached to the periosteal tissue, and each suture 24c, 24d is secured after both anchors 42c, 42d are implanted, as described below.

Figure 22B is a schematic view of anchor 42b inserted into cannula 50. Insertion tab 40 has been discarded. In some cases, the anchor (s) are preloaded into a cannula and do not have a tab 40 that is discarded. Some examples of the cannula 50 include a distal end portion that is curved in the shape of a semicircle and curves appropriately for passage around the descending limb for insertion into the obturator foramen muscle OF.

Figure 22C is a schematic view of the right side introducer 28a (relative to the patient) inserted through incision 145 and directed in a path around the descending ischial pubic ramus (or, IR sciatic ramus). End 80 of cannula 50 follows a path from incision 145 around the IR and penetrates the membrane M of the obturator foramen OF to a location of the internal obturator muscle. Button 56 is activated to push anchor 42b out of cannula 50 and into internal obturator muscle. Introducer 28a is removed from incision 145. The surgeon applies force to suture 24 to switch anchor 42b to secure that the anchor fully engages with the medial obturator muscle. Base 60 of bracket 22 is directed through incision 145. Suture 24 connects to anchor 42b and is passed through bracket 22 and hangs freely out of incision 145. The surgeon may choose to fix base 60 using suture 24 and anchor 42b, however, experience has indicated that fixation of base 60 is preferable after second anchor 42a is placed.

Figure 22D is a schematic view illustrating the base 60 of the holder 22 positioned in a desirable position with the second anchor 42a inserted into the cannula 50 of the left side introducer 28b. Anchor 42a will be inserted into the left side of the patient using introducer 28b which is provided with a curvature that is opposite to the curvature of introducer 28a (the right side introducer). Insertion tab 40 has been removed from anchor 42a.

Figure 22E is a schematic view of the left-side introducer 28b inserted through incision 145, around the descending IR, and through membrane M covering the obturator foramen OF. Button 56 is moved to eject anchor 42a out of cannula 50 and into internal obturator muscle. Introducer 28b is removed. The surgeon pulls on suture 24 to switch anchor 42a in a lateral orientation within the muscle and to ensure that it is fully engaged with the internal obturator muscle. Suture 24 is allowed to descend through bracket 22 and incision 145 until secured by the surgeon.

With respect to an exemplary process of anchoring the anchor to tissue, and as the steps in Figure 22E illustrate, the second anchor is inserted into a hole in a second different cannula; the second different cannula is inserted into the incision and along a second cannula path into the tissue of an obturator foramen; the second anchor is expelled out of the hole of the second different cannula and into the tissue of the obturator foramen; the second suture is pulled in a direction away from the patient to rotate the second anchor to place a length of the second anchor transverse to the second path of the cannula; and the second continuous suture loop is broken, allowing a second knot to be made with the second suture to secure the bracket to the patient.

Figure 22F is a schematic view of the bracket 22 guided through the incision with the base 60 held in a lateral orientation between the opposing plug foramina OF. The surgeon locates a desired orientation for base 60 and completes suture 24 connected to anchor 42b and completes suture 24 connected to anchor 42a. The surgeon applies an appropriate level of tension to the base 60 while completing the sutures 24. In this manner, the base 60 is suspended between the sutures 24 and a respective one of the anchors 42b, 42a. The prepubic arms 62, 64 rise on either side of the pubic symphysis PS.

Figure 22G is a schematic view of anchor 42d loaded into cannula 50 of left side introducer 28b. The insert tab 40 has been removed and discarded. The exemplary procedure allows placement of the prepubic arm anchors 42c, 42d with both the right side introducer 28a and the left side introducer 28b, as determined by surgeon's preference. Sometimes the surgeon will simply keep using the most recently used introducer (in this case, the introducer 28b of Figure 22E); at other times, the most recently used introducer is returned to a member of the surgical staff and the other introducer is used.

Figure 22H is a schematic view of introducer 28b inserted through incision 145 to attach prepubic arm 62 to the left side of the patient. End 80 of cannula 50 is inserted through the periosteal tissue PT. End 80 of cannula 50 is bent / angled or otherwise configured to allow the tip of the introducer to slide along the bone and avoid sinking into the bone below the periosteal tissue PT. Button 56 is manipulated to eject anchor 42d out of the cannula and under the periosteal tissue PT and above the bone. Introducer 28b is removed from the incision. The surgeon applies a pulling force to suture 24 that is connected to anchor 42d, and this force switches and rotates anchor 42d to a side position that fully engages anchor 42d with the periosteal tissue PT. Suture 24d extends from implanted anchor 42d, through the prepubic arm of bracket 22, and out of the incision for subsequent fixation.

With respect to an example process for anchoring the anchor to the tissue, and as the steps in Figure 22H are illustrated, another anchor is inserted into the hole of the same cannula 28b that was used in the placement of an anchor within the tissue of the obturator foramen, and this other anchor is inserted into the cannula and into the incision and along a second cannula path into the periosteal tissue. This other anchor is removed outside the cannula hole and into the periosteal tissue. The other suture attached to the other anchor is pulled in a direction away from the patient to rotate the other anchor to place a length of the anchor transverse to the second path of the cannula. The other continuous loop of suture is broken to allow a knot to be tied to secure the support over the periosteal tissue.

Figure 22I is a schematic view of the base 60 of the support 22 suspended between the obturator foramen OF with the prepubic arm 62 secured to the periosteal tissue PT on the left side of the patient by the anchor 42d. A fourth anchor 42c is inserted into cannula 50 of, in this case, introducer 28a. Again, insert tab 40 has been removed from anchor 42c and discarded.

Figure 22J is a schematic view of the introducer 28a inserted through the incision to secure the prepubic arm 64 on the right side of the patient. The end 80 of the cannula 50 is directed through the periosteal tissue PT. End 80 of cannula 50 will slide along the surface of the bone. When properly positioned between the periosteal tissue PT and the bone, button 56 is pushed forward to eject anchor 42c out of cannula 50. Introducer 28b is removed from the incision. The surgeon applies tension to suture 24 to switch, rotate, and engage anchor 42c within the periosteal tissue PT. At this point in the process, two anchors 42d, 42c are attached at the two prepubic arms and the associated sutures 24d, 24c extend from anchors 42d, 42c freely out of incision 145.

The surgeon both raises the prepubic arms 62, 64 in tension against the fixed base 60 and terminates the sutures 24d, 24c.

Figure 22K is a schematic view of the support 22 suspended between the obturator foramina OF and the anchors 42a, 42b and attached to the periosteal tissue PT by anchors 42c, 42d. Bracket 22 has been implanted through a single incision (one and only one). Implanted anchors 42 combine with sutures 24 to hold bracket 22 in place and to elevate and compress the bulbar urethral complex in the treatment of male urinary incontinence.

Although specific embodiments have been illustrated and described herein, those skilled in the art will appreciate that a variety of alternative and / or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present. invention. This application is intended to cover any adaptations or variations of the medical devices as described herein. Therefore, this invention is intended to be limited solely by its claims.

Claims (1)

1. An implantable support adapted to treat urinary incontinence, the implantable support comprising: a support material (22) configured to support a urethra when implanted in a patient; sutures (24) engaged with the support material (22); and anchor assemblies (26), wherein each anchor assembly (26) is coupled with a respective one of each of the sutures (24); wherein each of the sutures (24) is threaded through the anchor assembly (26) and the support material (22) respective, to form a continuous closed suture loop characterized by the implantable support that It comprises the ducts (29) and the parts of the posterior end of each suture (24), which are brought into contact and kept within a respective one of the conduits (29), and at least the ends of the suture (24) to form a rupture pad (30) that holds the ends of the suture loop closed continuous in an organized manner, until the continuous closed suture loop separates at the break (30). The implantable support of claim 1, wherein the anchoring assembly (26) comprises a body (44), a flap (46) extending from the body (44), with an eyelet (48) formed in the flap and the suture (24) passing through through the eyelet (48) of the fin (46), and an insertion tab (40) removably secured to the fin, where the insertion tab (40) is adapted to be removed from the fin prior to insertion of the anchor assembly (26) in the fabric. The implantable support of claim 2, wherein the fin (46) extends from the body (44) of the assembly anchor (26) in a first direction, and the anchor assembly (26) further comprises a pair of barrels radial lines (110) extending from opposite sides of the body (44) in a radial direction, perpendicular to the first direction. The implantable support of claim 1, wherein the support material (22) has a base (60) and arms (62, 64) extending from the base, where the arms include a first arm separated from a second arm by a central part of the support material (22). The implantable support of claim 1, wherein the support material (22) is a knitted mesh having open pores. 6. The implantable support of claim 1, wherein

the support material (22) is a material of a 7. The implantable support of claim 1, wherein

the support material (22) is a material from 8. The implantable support of claim 1, wherein

the support material (22) is a material of x 9. The implantable support of claim 1, wherein

the support material (22) is a synthetic material 10. The implantable support of claim 8, wherein the synthetic material (22) is a woven fabric, a fabric knitted, a woven mesh or a non-woven mesh. The implantable support of claim 1, wherein the support material (22) is manufactured so that include voids that are configured to allow tissue ingrowth within the support material. 12. The implantable support of claim 1, wherein the support material (22) is a polypropylene mesh. knitted, knitted from strands formed from a polypropylene filament. The implantable support of claim 1, wherein the support material (22) has a base (60) and arms (62, 64) extending from the base, and one of the sutures (24) is inserted through the base of the material of support. The implantable support of claim 1, wherein the support material (22) has a base (60) and arms (62, 64) extending from the base, and one of the sutures (24) is inserted through one of the arms of the support material. The implantable holder of claim 1, wherein the rupture pad (30) is thermally formed to be more brittle than a remaining part of the suture (24). 16. The implantable support of claim 1, wherein the anchor assembly (26) has a mass distribution asymmetric and an asymmetric geometry, with more mass located at a leading end portion of the set of anchor (26) than at a rear end portion of the anchor assembly. 17. The implantable support of claim 2, wherein the fin (46) extends from the body (44) of the anchor assembly (26) in a first direction, and the anchor assembly further comprises: a pair of radial barrels (110) extending from opposite sides of the body in a radial direction perpendicular to the first direction; and a crushing rib (140) formed between the pair of radial barrels (110) on a side of the body opposite the fin (46). 18. The implantable support of claim 1, further comprising: a plication mechanism (70) coupled with the central portion of the support material (22), the plication mechanism (70) being provided as a single strand of a second suture that is wound in a plurality of passes through the support material . The implantable holder of claim 1, wherein a first of the sutures (24) is inserted through a first lateral side of the support material (22), and the implantable holder further comprises: a second suture wound through a second lateral side of the support material and a second eyelet of a second anchor assembly, a third suture wound through a first arm of the support material and a third eyelet of a third anchor assembly, and a fourth suture wound through a second arm of the support material and a fourth eyelet of a fourth anchor assembly.