FR2800595A1 - Rotating shoulder muscle cap reinforcement is made from supple layer of biocompatible material with curved lateral edges - Google Patents

Abstract

The reinforcement (1) consists of a supple layer (2) of woven or mesh filaments of a biocompatible material, bounded by a short transverse distal edge (3), a longer transverse proximal edge (4) and two convex curved lateral edges (5, 6). The layer has an elastic stretch capacity of 10 - 20 per cent and is pre-formed so that it adapts to the natural shape of the shoulder muscle cap. It has lengthwise reinforcing zones (7 - 10) produced by over-sewing which allow it to be cut to the required width, and is equipped with suture threads and needles.

Description

The present invention relates to surgical devices and methods for repairing rotator cuff lesions of a shoulder.

The skeleton of the shoulder consists of the scapula, clavicle, the superior end of the humerus, and the upper part of the lateral wall of the thorax. The upper end of the humerus comprises three projections, an internal projection or head of the humerus which articulates on the scapula, an external projection or trochiter with three facets of insertion for the supraspinous muscles, under- spiny and small round, and an anterior or trochinous projection which serves as an attachment to the subscapularis muscle.

The muscles of the headdress are the supraspinous and sub-spinal muscles, the subscapularis and the small round. The distal tendon portions of these muscles merge with each other to form a cap overlying the humeral head. These muscles are superficially covered by the deltoid muscle, whose proximal insertion is located on the anterior edge of the clavicle, the outer edge of the acromion, and the posterior edge of the spine of the scapula.

The role of the shoulder cuff muscles is essential in the mobility of the shoulder because they allow certain movements of elevation and rotation. They also have a role coapteur by preventing the humeral head to rise during the contraction of the deltoid muscle.

The tendons of the shoulder cuff can break in a pure traumatic way, like other tendons of the body. But it can also be a degenerative rupture of a pathological tendon, weakened.

The tendon rupture may be more or less extensive, reaching one or more tendons. Thus, the importance of the rupture from front to back and the degree of tendino-muscular contraction determine a more or less important orifice opening the humeral head, this perforation ending up at the most with a totally disheveled head.

Restorative surgery of the cuff involves suturing or reinserting the tendons on their humeral insertion. When reinsertion is performed, the principle is to brighten the edges of the rupture and the bone surface and put them in contact to obtain healing. The assembly is provided by usually transosseous son. The contact between tendon and bone surface of reinsertion is more or less easy to obtain according to the size of the rupture, and according to the retraction and the flexibility of the tendon. These elements also influence the tension at the suture area. If the tension is too great, there is a risk of localized necrosis, and therefore of iterative rupture or suture release.

Various technical devices are proposed when the retraction is important or when the suture may be under tension. These are usually advancements, transfers or muscle flaps.

It has also been proposed, in EP 0 423 297, a synthetic reinforcement prosthesis in the form of a flat strip having a rear heel to be fixed on the trochiter and extending linearly or by at least two divergent branches towards the top of the cap for to attach to the tendon or tendons. The prosthesis is fixed on the one hand by the distal end in the form of a heel, and on the other by the ends of the band or bands, extremities consisting of a semi-rigid or flexible mass which may comprise holes. ligature. This material requires the availability of tape stock of different widths to accommodate the size of the capping area to be repaired. It appears that the fixing of the prosthesis by its two ends is not sufficiently effective in some cases, and the prosthesis is not structured to allow fixation distributed along its length. Also, the installation of the prosthesis is not easy, because its shape is not well suited to match the convex contour of the shoulder cap.

The problem proposed by the present invention is to design a new reinforcement device for treating the rupture or weakening of the rotator cuff of a shoulder, which in itself has a shape and a dimension that can be adapted to the size of the zone. to repair, and which has a structure for a more efficient and reliable fastening. Another object of the invention is to ensure easy attachment to the cap while avoiding a maximum extra thickness of the system could lead to a sub-acromial conflict.

Another object is to provide a type of fixation allowing a distribution of stresses along the tendon to be repaired.

Another object is to provide a device in which the distal bone fixation is independent of the re-insertion of the tendon, to protect and relieve the re-insertion area.

Another object is to provide a structure for colonization by scar tissue and integration of the material within the tendon.

To achieve these objects as well as others, a reinforcing device according to the invention for treating rupture or weakening of the rotator cuff of a shoulder comprises a flexible sheet of biocompatible material, limited a small distal transverse edge, by a large rim proximal transverse, and two convex curved lateral edges, and having a plurality of longitudinal reinforcing zones connecting the small distal transverse edge and the large proximal transverse edge and laterally spaced apart from each other.

According to a preferred embodiment, the flexible sheet is made of woven or mesh yarns, and has an elastic expansion capacity of 10 to 20 $.

Good results can be obtained by producing the flexible sheet using a high tenacity polyethylene terephthalate yarn.

Preferably, the flexible ply is preformed hollow in order to adapt to the natural convex shape of the upper face of the shoulder cap.

The longitudinal reinforcement zones may advantageously be constituted by a longitudinal overcast, allowing cutting without degradation of the flexible sheet along each longitudinal reinforcing zone in order to adapt the width of the flexible sheet to the size of the zone of reinforcement. shoulder cap to treat. Preferably, the flexible ply is associated suture son each having a first end shaped closed loop and a second end secured to an arcuate curved needle which extends.

According to an advantageous embodiment, the flexible sheet comprises at least one transverse yarn of different color superimposed close to and away from the large transverse side, and constituting a means for locating the start of the lateral fixation zone of the reinforcement on the cap. shoulder.

Other objects, features and advantages of the present invention will become apparent from the following description of particular embodiments, with reference to the attached figures, in which: FIG. 1 is a view of the outside face of a cap reinforcement of FIG. shoulder according to an embodiment of the present invention; FIG. 2 is a view of the inside face of the shoulder cap reinforcement of FIG. 1; FIG. 3 is an end view of the shoulder cap reinforcement of FIG. 1, showing its transverse profile; FIG. 4 illustrates the suture threads used for fixing the shoulder cap reinforcement of FIG. 1; - Figure 5 illustrates a shoulder during treatment, which is placed on a reinforcement according to the invention; FIG. 6 illustrates the reinforcement according to the invention, adapted to size and at the beginning of fixing on the shoulder cap; FIG. 7 illustrates the reinforcement being fastened; and - Figure 8 illustrates the reinforcement at the end of attachment to the shoulder cap.

In the embodiment illustrated in FIGS. 1 to 3, the reinforcing device 1 according to the invention comprises a flexible sheet 2 of biocompatible material, limited by a small distal transverse edge 3, by a large proximal transverse edge 4, and by two convex curved lateral edges 5 and 6.

The flexible sheet 2 may advantageously have a length L of about 60 to 75 mm, a width 1 or dimension of the large proximal transverse edge 4 of about 50 to 65 mm, a small distal transverse edge 3 whose length is from 10 to 20 mm. about.

According to the invention, the flexible ply comprises two extreme longitudinal reinforcing zones 7 and 8, respectively along each of one of the lateral edges 5 and 6.

The flexible ply further comprises two intermediate longitudinal reinforcing zones 9 and 10, distributed substantially at one-third and two-thirds of the width of the flexible ply, as illustrated in FIGS. 1 and 2.

The longitudinal reinforcing zones 7, 8, 9 and 10 connect the small distal transverse edge 3 and the large proximal transverse edge 4, being spaced apart from one another, and are for example constituted by a longitudinal overcast made in such a way that The user can cut the flexible sheet along each longitudinal reinforcing zone, without degradation of the sheet, in order to adapt the width of the flexible sheet 2 to the size of the area of the shoulder cap to be treated.

In Figure 3, the longitudinal reinforcing zones 7, 8, 9 and 10 are illustrated in extra thickness on the outer face 11, each in the form of a longitudinal strip sewn to apply. Such strips simultaneously make it possible to reduce the longitudinal elastic deformation of the flexible sheet 2.

For example, when the area of the shoulder cap to be treated is wide, use the entire flexible ply 2 as shown in the figures. Alternatively, it is possible to cut the flexible sheet 2 along the outer edge of the intermediate longitudinal reinforcing zone 9 to retain only the part of the sheet located between the intermediate longitudinal reinforcing zone 9 and the extreme longitudinal reinforcing zone 8. Another possibility is to cut the flexible sheet 2 along the respective outer edges of the two intermediate longitudinal reinforcing zones 9 and 10, retaining only the central portion of the flexible sheet 2 when the shoulder portion to be treated is narrow.

The flexible sheet 2 is advantageously made of woven or mesh yarns, and it has an elastic expansion capacity of 10 to 20%. It is advantageous to use a high tenacity polyethylene terephthalate yarn.

According to the invention, the flexible ply 3 is advantageously hollow preformed, as can be seen in FIG. 3, having an outer convex face 11 and an inner concave face 12, to better adapt to the natural convex shape of the face. upper shoulder cap.

flexible ply 2 is advantageously preformed into a hollow whose radius is 50 to 60 mm.

To facilitate laying, the flexible sheet 2 may advantageously comprise at least one transverse yarn 13 of different colors, which is distinguished from the color of the remainder of the sheet, serrated in the vicinity and set back from the large proximal and apparent transverse transverse edge. This transverse thread 13 marks the beginning of the lateral zone suitable for fastening the reinforcement to a shoulder cap.

For its fixation, the flexible ply 2 is associated with sutures 14, 15, 16 and 17 (FIG. 4), each having a closed loop end 18 and a second end integral with an arcuate curved needle 20. circle that prolongs it. The sutures 14 to 17 are advantageously four in number, that is to say one for each longitudinal reinforcing zone 7 to 10, and have a length of about 200 to 300 mm.

Preferably, the weaving of the yarns constituting the flexible sheet 2 is such that it forms a perforated grid, advantageously with apertures 30 of about two millimeters each and distributed in a pitch of about 4 to 7 mm. This promotes colonization by scar tissue, and integration of the material within the tendon.

Figures 5 to 8 illustrate the method of use of the previously described reinforcement, for its attachment to a shoulder cap to be treated.

In Figure 5, there is illustrated a shoulder cap 21 previously repaired by a conventional method. shoulder cap 21 is attached to the trochiter 22 by sutures 23 and 24 or by making a bone trench. The reinforcement 1 according to the invention is then presented on the shoulder cap to determine the necessary size. During the operation, the surgeon then cuts the reinforcement 1 with scissors, along the intermediate longitudinal reinforcing zones 9 and / or 10 if necessary, to adapt the reinforcement 1 the dimension of the pathological area of the shoulder cap to treat. For example, in FIG. 6, only the central zone of the reinforcement 1 has been retained. After positioning the reinforcement 1 on the shoulder cap 21, the surgeon begins fixing it by over-threading with the aid of the suture 14 along a first longitudinal reinforcing zone 10: the suture 14 is passed through the reinforcement 1 and a sufficient thickness of the cap, from the area of the transverse wire 13. The suture 14 is docked in proximal by passage in the closed loop 18, and then an overlock is performed as illustrated in Figure 7 taking the cap and the longitudinal reinforcing zone 10. In the embodiment illustrated in Figure 8, the reinforcement 1 is thus fixed on the shoulder cap 21 by two lateral surfaces 25 and 26 which ensure a distribution of constraints avoiding necrotizing points.

an overlock is preferably made on each longitudinal reinforcing zone which has been preserved for use. Thus, a reinforcement in which the totality of the surface has been preserved is fixed by four surties. When all the son are passed, their ends are placed under the reinforcement 1, position in which they can optionally be tied together or fixed by the clip 27 which ensures the distal attachment of the reinforcement to the outer face of the trochiter 22 previously brightened.

The present invention is not limited to the embodiments which have been explicitly described, but it includes the various variants and generalizations thereof within the scope of the claims below.

Claims (1)

<1> Reinforcing device (1) for treating the rupture or weakening of the rotator cuff (21) of a shoulder, characterized in that it comprises a flexible ply (2) made of biocompatible material, bounded by a small distal transverse edge (3), a large proximal transverse edge (4), and two convexly curved lateral edges (5, 6), and having a plurality of longitudinal reinforcing zones (7-10). ) connecting the small distal transverse edge (3) and the large proximal transverse edge (4) laterally spaced from each other. 2 - Device according to claim 1, characterized in that the flexible sheet (2) is of woven or mesh son, and has an elastic expansion capacity of 10 to 20 3 - Device according to one of claims 1 or 2, characterized in that the flexible ply (2) is made of high tenacity polyethylene terephthalate yarn. 4 - Device according to any one of claims 1 to 3, characterized in that the flexible web (2) is preformed hollow in order to adapt to the natural convex shape of the upper face of the shoulder cap (21). 5 - Device according to any one of claims 1 to 4, characterized in that the longitudinal reinforcing zones (7-10) consist of a longitudinal overcast allowing the cutting without degradation of the flexible sheet (2) along each longitudinal reinforcing zone (7-10) in order to adapt the width of the flexible ply (2) to the size of the shoulder coping zone to be treated. 6 - Device according to any one of claims 1 to 5, characterized in that to the flexible web (2) are associated suture son (14-17) each having a first end shaped closed loop (18) and a second end (19) integral with a needle (20) curved in a circular arc which extends it 7 Device according to claim 6, characterized in that the suture son (14-17) have a length of 200 to 300 mm about. 8 - Device according to any one of claims 1 to 7, characterized in that the flexible sheet (2) has a length (L) of about 60 to 75 mm, a width (1) or dimension of the large transverse transverse edge ( 4) from about 50 to about 65 mm, a small distal transverse edge (3) of about 20 mm, with two extreme longitudinal reinforcing zones (7, 8) each respectively along one of the lateral edges (5, 6), and with two intermediate longitudinal reinforcing zones (9, 10) distributed substantially at one-third and two-thirds of the width of the flexible ply (2). 9 - Device according to any one of claims 1 to 7, characterized in that the flexible web (2) comprises at least one transverse thread (13) of different color superimposed close to and away from the large proximal transverse edge (4) . 10 - Device according to any one of claims 1 to 9, characterized in that the flexible web (2) is preformed into a hollow whose radius is 50 to 60 mm.