FR2979055A1 - Suture implant system for repairing soft tissue e.g. tendon, has suture including end strands, where stress exerted in proximal direction on one of end strands of suture brings fixing device and implant close to each other - Google Patents

Abstract

The system (100) has an implant (110) with an elongated body between distal and proximal ends. A suture includes two end strands (176a, 176b) connected by a central part (161). A fixing device (180) is connected to the implant and the suture. The central part of the suture forms a proximal arc (162) in the fastening device, and a distal arc (172) cooperating with the implant, where stress (T178) exerted in a proximal direction (D2) on one of the end strands brings the proximal and distal arcs close to each other, and brings the fixing device and the implant close to each other. An independent claim is also included for a method for preparing a pre-operative suture implant system.

Description

The invention relates to a suture implant system. The field of the invention is that of suture implants for the repair of a soft tissue, for example a muscle, tendon or ligament to be attached to a bone. In some injuries or trauma, ligaments, tendons, and other soft tissues often become detached from the bones with which they are associated. As a result, it becomes necessary to re-attach the soft tissue to the bone to facilitate healing.

In known manner, the surgeon may have various devices for attaching the soft tissue to the bone, such as screws, staples, bugs, nails, or even a single suture. Advantageously, a suture implant may be anchored in the patient's bone at the desired point of re-attachment of the soft tissue, allowing fixation of a surgical suture. Such a suture implant can be inserted into a bone cavity prepared for this purpose, or be self-tapping. After insertion into the bone, the implant can be held in position by external elements, for example threads, ribs, or protrusions of various types. These external elements provide tensile strength so that the implant is rigidly held in position during healing. Also, such an implant may include an eyelet, bar, or other element for attachment of the suture. Thus, the free ends of the suture extend out of the bone, pass through or around the soft tissue, and are used to secure the soft tissue to the bone. However, some known suture implants, while effective in attaching soft tissue to bone, have many disadvantages. In practice, the surgeon must first knot the suture in order to obtain adequate fixation of the soft tissue to the bone. Achieving an arthroscopic knot causes the surgeon to waste valuable time during the surgical procedure and requires significant skill. In order to tie the suture, an interface between the suture and the soft tissue must first be established via an arthroscopic suture passage. This usually involves introducing an additional instrument into the patient's body and increasing the duration of the surgery. In addition, surgeons are often forced to use different implants to effectively reproduce the anatomical imprint of the soft tissue, which also increases the duration of the surgical invention and the risks of complication.

EP-A-0 908 143 discloses a suture implant for attachment of tissue to bone. The implant includes a body whose proximal end has an opening through which a suture passes to form a loop in the body. Both ends of the suture also pass through a soft tissue holding device, such as a disc, plate, or pin. Upon insertion of the implant through the soft tissue and into the bone, the holding device contacts the soft tissue on the opposite side of the implant, thereby exerting compressive stress on that soft tissue. The object of the present invention is to improve existing suture implants. To this end, the subject of the invention is a suture implant system comprising: at least one implant with an elongate body between a distal end and a proximal end, at least one suture which has two connected end strands by a median portion cooperating with the implant, and at least one fastener connected to the implant by the suture.

This suture implant system is characterized in that the medial portion of the suture forms a proximal arch in the fixation device and a distal arc cooperating with the implant, so that a tension exerted in the proximal direction on one or on the end strands of the suture approximates, on the one hand, the proximal arch and the distal arch and, on the other hand, the fixation device and the implant.

Thus, the invention provides an improved suture implant system, with one or more implants combined with one or more tissue fixation devices. In practice, each fastening device can be easily energized and without the need for the realization of a node. The system according to the invention is therefore adapted to carry out an anatomical impression restoration in a simple and reproducible manner. This system eliminates arthroscopic suture and knotting, while providing easy manipulation to the surgeon. Finally, the system is easily adaptable to different anatomies and different thicknesses of soft tissue. According to other advantageous features of the system according to the invention, taken separately or in combination: the or each fixing device comprises: a first face and a second opposite face, these two faces being preferably substantially planar, a through cavity opening on each of the two faces, at least two grooves formed at the first face, on either side of the through cavity, and in each of the grooves, a through orifice which opens on the second face. The proximal arc formed in the fixing device comprises: a rectilinear part arranged in the grooves on the side of the first face, two traversing parts arranged in the respective through orifices, and two connecting parts which extend out of the device of fixing on the side of the second side. The system comprises at least one additional suture which is distinct from the wire having the proximal arch and the distal arch and which passes through at least one additional through-hole in the fixation device, in particular the system comprises two wires additional suture each passing through two additional through holes. The system also comprises means for locking the suture in the implant, these locking means being movable relative to the implant while being permanently joined with the implant. - The locking means are adapted to selectively lock and unlock the suture relative to the implant, in particular adapted to immobilize the distal arc relative to the implant without performing node. - The body of the implant has an inner cavity which is open towards the proximal end and not open towards the distal end, and the locking means are at least partially arranged in this inner cavity. - The locking means comprise a first ring and a second ring, each ring having a flat annular face opposite to a corresponding flat annular face of the other ring, these rings being adapted to slide against each other at the level of planar annular faces and to cooperate by blocking the distal arch with respect to the implant. The suture extends along a suture path with each end strand of the suture that extends both through a separate through hole in the attachment device, through an interior space delimited in each of the rings and through a through cavity which is formed in the fixing device and which is distinct from the through holes. - The locking means are adapted to allow movement of the suture in a first direction when a tension is exerted on the suture in that first direction and to block the movement of the suture in a second direction different from the first direction. The system comprises a plurality of implants and / or a plurality of fixation devices that are connected by at least one suture.

The subject of the invention is also a process for the preoperative preparation of such a suture implant system, the system comprising means for locking the suture in the implant, the locking means comprising a first ring and a second ring. ring, these rings being adapted to slide against each other and to cooperate by blocking the distal arc relative to the implant. The method is characterized in that it comprises the following steps: a) each end strand of the suture passes through a separate through hole in the fixation device; b) the medial portion of the suture forms the proximal arch in the fixation device; c) the end strands pass through an interior space delimited in each of the rings; d) the end strands make a passage outside the first ring and in the interior space delimited by the second ring; e) the medial portion of the suture forms the distal arc cooperating with the implant via the locking means, the distal arc passing between the first ring and the second ring; and f) the end strands pass through a through cavity in the fastener and separate from the through holes. A method for implementing a suture implant system as mentioned above is also described. This method comprises at least one assembly phase of the system performed before a surgical operation. This assembly phase comprises the following steps: a1) passing the suture thread (s) through the fixation device (s) by forming at least one proximal arch in each fixation device; and b1) connecting at least one of the suture threads to the implant (s) forming at least one distal arc cooperating with each implant. Other advantageous features of the method, taken alone or in combination, are also described: In step b1), the distal arch or bows cooperate with means for locking the suture in the implant (s). The assembly phase also comprises a step c1) of passing the end strand (s) of each suture extending from the distal arch (s) through the or one of the fixation devices. . - The assembly phase also comprises a step d1) of passing the at least one end strand of at least one of the suture son through an insertion tool. The assembly phase also comprises a step e1) consisting, after step d1), in reversibly fixing the one or one of the fastening devices to the insertion tool. The method also comprises a phase of preparing a bone and / or at least one soft tissue intended to undergo a surgical procedure. The method also comprises a phase of insertion of at least one implant into the bone, during which the one or more fixation devices are located outside the bone, on the side of the soft tissue opposite the bone. During the insertion phase, a proximal arc is disposed in each fixation device and a distal arch cooperates with each implant. The method also includes a step of compressing the soft tissue against the bone, comprising exerting a tension in the proximal direction on the at least one end strand of at least one of the suture threads for approximating a the proximal arch or arches and the distal arch or arches and the fastener (s) and the implant (s). The invention will be better understood on reading the following description, which is given solely by way of nonlimiting example and with reference to the drawings in which: FIG. 1 is a perspective view of an implant system of FIG. suture according to a first embodiment of the invention, said implant system being shown in a use configuration with bone and soft tissue not shown; Figure 2 is an axial section of the implant system of Figure 1; Fig. 3 is an elevational view along arrow III in Fig. 1, showing the implant system in use configuration while bone and soft tissue are shown; Fig. 4 is a perspective view of the suture implant system according to the first embodiment, coupled to a syringe type insertion tool prior to use; Figures 5 to 10 are schematic representations of the suture implant system according to the first embodiment, illustrating its implementation according to different configurations of use; Figures 11, 12 and 13 are views, respectively similar to Figures 1, 2 and 3, a second embodiment of a suture implant system according to the invention; Fig. 14 is a perspective view of the suture implant system according to the second embodiment, coupled to a screwdriver type insertion tool prior to use; Figure 15 is a perspective view similar to Figure 1, of a third embodiment of a suture implant system according to the invention; and Figure 16 is a perspective view similar to Figure 1 of a fourth embodiment of a suture implant system according to the invention. Figures 1 to 10 show a first embodiment of a suture implant system 100.

As shown in particular in Figures 1 to 3, the system 100 comprises at least one implant 110, a pin 130, rings 140 and 150, a suture 160 and a fastener 180. These constituent elements of the system 100 are made in biocompatible materials, and are therefore suitable for use in a surgical setting, for implantation in the body of a patient by a surgeon.

Thereafter, a distal side or a distal direction D1 and a proximal or proximal direction D2 in the anatomical sense of the terms "distal" and "proximal" are considered when the system 100 is implemented. The implant 110 comprises an implant body 111 elongate along a longitudinal axis X110, between a distal end 112 shaped as a tip and a proximal end 118 provided with a plurality of wings or anchoring tabs 120. In particular, the end 112 is a tip of self-insertion of the implant 110 into a bone cavity. Between the ends 112 and 118, the median part of the body 111 comprises a first cylindrical surface 113 and a second cylindrical surface 114, the diameter of which is smaller than the diameter of the first cylindrical surface 113. Inside the body 111 is delimited a cylindrical cavity 119, which is open at the proximal end 118, between the tabs 120. On the distal side, that is to say opposite the end 118, the bottom of the cavity 119 has a cone-shaped corresponding to a drilling hole of this cavity 119 in the body 111. The surface 114 is traversed by two orifices 115 and 116, which are diametrically opposed with respect to the axis X110 and which open each outside the body 111 and inside the cavity 119. Preferably, the implant 110 is made of a metal or metal alloy, in particular a nickel-titanium alloy of the nitinol type, which is a known shape-memory alloy. for its excellent properties of elasticity, strength and physiological and chemical biocompatibility with the human body.

More specifically, the anchoring tabs 120 comprise four tabs 121, 122, 123 and 124 which are distributed diametrically at 90 degrees around the axis X110. In the configuration of use of FIGS. 1 to 3, each of the tabs 120 has a curved profile, which is substantially parallel to the axis X110 at the end 118 and which progressively deviates from the axis 100 in s away from this end 118. In a configuration before use, as shown in Figure 4, the tabs 120 are not deployed and extend in the extension of the body 111. As shown in Figure 2, the pin 130 is positioned in the orifices 115 and 116 through the cavity 119 of the implant 110, when the rings 140 and 150 are also arranged in this cavity 119, in the manner detailed below. The pin 130 comprises a cylindrical body 132 which extends along a longitudinal axis Y130 between, on the one hand, a first end 134 formed at the head and, on the other hand, a second end 136 having an actuating orifice by a tool not shown. By way of example, this orifice has a hexagonal or cylindrical profile and makes it possible to deform the end 136 in order to lock the pin 130 in the implant 110. As shown in FIGS. 1 to 3, the rings 140 and 150 present profiles. identical rings. The ring 140 delimits an interior space 144 with a distal inner portion 146 and a proximal inner portion 148. The ring 140 has two substantially planar annular faces, with the face 142 facing the tabs 121 and 124 when the ring 140 is positioned in the implant 110. The ring 150 delimits an interior space 154 with a distal inner portion 156 and a proximal inner portion 158. The ring 150 has two substantially planar annular faces, with the face 152 facing the tabs 122 and 123 when the ring 150 is positioned in the implant 110. Alternatively not shown, the respective annular profiles of the rings 140 and 150 may be different.

In practice, the rings 140 and 150 are positioned in the cavity 119 of the implant 110 while being parallel to each other, with the planar faces 142 and 152 facing each other. The pin 130 is then introduced into the orifice 115 by its end 136, then through the spaces 144 and 154 to exit through the orifice 116. Finally, the head 134 bears against the outer surface 114. Preferably, the diameters of the body 132 and the orifices 115 and 116 are provided with a tight fit, so as to prevent accidental translation of the body 132 in or out of these orifices 115 and 116. In other words, the pin 130 is blocked by pressure in the orifices 115 and 116. Thus, the pin 130 limits the displacement of the rings 140 and 150 relative to the implant 110, in the cavity 119 and out of this cavity 119 at the proximal end 118.

More specifically, the rings 140 and 150 are locked in axial translation in the implant 110 by the pin 130, with the distal portions 146 and 156 which are capable of going up in the proximal direction D2 in the cavity 119 to abut against the body 132. During an axial translation in the distal direction D1, the rings 140 and 150 abut against the bottom of the cavity 119. Whatever the direction D1 or D2 of translation of the rings 140 and 150 according to the X110 axis, the plane faces 142 and 152 slide against each other. On the other hand, the pin 130 constitutes an obstacle to the rotation of the rings 140 and 150 around the axis X110. The device 180 for securing the suture 160 has a wafer shape symmetrical with respect to a median axis X180. This plate 180 is flattened on a proximal face 181 and a distal face 182, while it is substantially rounded on at least a portion of its outer edge 183. A cavity 186 centered on the axis X180 is delimited in the wafer 180, passing through this wafer 180 between the planar faces 181 and 182. The cavity 186 has a square profile with slightly rounded corners. An axis Z180 extends along the greatest length of the wafer 180, this axis Z180 being perpendicular to the axis X180, parallel to the faces 181 and 182 and closer to the face 181 than the face 182. Two grooves 184a and 184b are provided at the face 181, on either side of the cavity 186 and the axis X180, along the axis Z180. These grooves 184a and 184b open into the cavity 186 but not to the edge 183. In particular, two orifices 185a and 185b are formed in each of the grooves, respectively 184a and 184b, which pass through the plate 180 parallel to the axis X180 to unclog on the face 182. These orifices 185a and 185b, or eyelets, open into the respective grooves 184a and 184b but do not communicate with the cavity 186. These orifices 185a and 185b are provided for the passage of the suture 160 through the plate 180, as detailed below. In variant not shown in Figures 1 to 10, the wafer 180 may have a different arrangement. For example, the positioning and / or the dimensions of the grooves 184a and 184b may be different. In another example, the wafer 180 may comprise four parallel grooves in them, which extend on either side of the cavity 186. In another example, the wafer 180 may include through holes 185a and 185b but not grooves 184a and 184b. In another example, the wafer 180 may have several other through orifices similar to the orifices 185a and 185b. In another example, the ratio between the greatest length and the shortest length of the wafer 180 may be different, in particular the wafer 180 may be more elongated. Preferably, the wafer 180 is made of polyetheretherketone thermoplastic "PEEK", polylactic acid "PLLA", polyglycolic acid "PGA", polyethylene with a high molar mass "PE-UHPM", or a titanium-based metal alloy such as than the grade "TiCoAI4V" or "Ti6A114V". The suture 160 is elongated and flexible, with a medial portion 161 connecting two end strands 176a and 176b provided with respective ends 178a and 178b. The suture 160 is preferably made of biocompatible polymer material. By way of non-limiting example, the wire 160 may be a braided suture of size # 2 USP made of high molecular weight polyethylene material "PE-UHPM", known under the designation "UHMWPE" or "Ultra-high- molecular-weight polyethylene "in English. When it is used in the system 100, the middle part 161 of the suture 160 forms, on the one hand with the wafer 180, a first arch 162 situated on the proximal side and whose curvature is oriented in the distal direction D1 and on the other hand with the rings 140 and 150 so as to cooperate with the implant 110, a second arc 172 located on the distal side and whose curvature is oriented in the proximal direction D2. The assembly of the various elements 110, 130, 140, 150, 160 and 180 of the system 100 is carried out during a preoperative preparation phase, that is to say before the surgeon uses this system 100 in the system. part of a surgical operation. Therefore, only the manipulations directly related to the operation are performed by the surgeon, thus avoiding a waste of time. In particular, the suture 160 extends along a suture path defined below.

First, the suture 160 is assembled with the wafer 180. For this purpose, as shown in Figures 1 and 2, the two free ends 178a and 178b of the strands 176a and 176b each pass through a hole 185a or 185b , so that the median portion 161 of the wire 160 forms the first arc 162 at the wafer 180. Specifically, this arc 162 comprises a straight portion 164 stretched along the axis Z180 in the grooves 184a and 184b, two through portions 165a and 165b arranged in the respective orifices 185a and 185b, and two connecting parts 166a and 166b which extend out of the wafer 180 on the side of the face 182, in particular in the direction of the implant 110. Then, the ends 178a and 178b of the strands 176a and 176b pass through the rings 140 and 150, preferably before these rings 140 and 150 are arranged in the cavity 119 of the implant 110 and locked by the pin 130. In this case, the faces 142 and 152 rings 140 and 150 are in. supported on the axis X180 between the parts 148 and 158. The ends 178a and 178b make a first passage through the interior spaces 144 and 154 of the rings 140 and 150, then a second passage through the space delimited between the parts 148 and 158, that is to say outside the ring 140 but in the interior space 154 delimited by the ring 150.

Thus, the middle portion 161 of the wire 160 forms, from the two suture strands 176a and 176b, the second arc 172 in the rings 140 and 150. More specifically, this arc 172 comprises a curved portion 173 connecting a portion 174 in contact with the portion 148 of the ring 140 and a portion 175 in contact with the portion 158 of the ring 150.

Finally, the rings 140 and 150 are introduced into the cavity 119 and then locked axially by the pin 130, being connected to the wafer 180 by the wire 160. In other words, the suture wire 160 cooperates with the implant 110 through the pin 130 and the rings 140 and 150. In addition, the two strands 176a and 176b of the suture 160 extend along the axis X180 in the proximal direction D2, with a slight deviation from the portion 175 of the arc 172. More specifically, these two strands 176a and 176b through the cavity 186 of the wafer 180, this cavity 186 being divided into two spaces 187 and 188 by the arc 162. Preferably, the strands 176a and 176b pass together through one of the spaces 187 and 188, such as the space 187 in Figures 1 to 3. The strands 176a and 176b terminate at the respective ends 178a and 178b, which are then free and accessible from side of the face 181 of the plate 182. As can be seen in FIG. the strands 176a and 176b and the ends 178a and 178b can be disposed through an insertion tool IT1. Next, the system 100 is attached to this tool IT1 to facilitate its manipulation by the surgeon. The IT1 tool of the "syringe" type shown in this FIG. 4 comprises a body IT11, an actuating handle IT12 and a hollow rod IT13 which ends with an end IT14. In practice, the ends 178a and 178b are inserted into the IT13 rod at its IT14 end, then through the IT13 rod and the IT11 body to exit through the IT12 handle. The end IT14 is fixed in the cavity 186 of the wafer 180 and holds the implant 110 in an insertion configuration. Subsequently, the system 100 and, if appropriate, the tool IT1, can be sterilized in packaged form of a kit directly usable by the surgeon. The detailed operation of the system 100 is detailed below. In practice, as shown in particular in FIG. 3, the system 100 is used to reattach a soft tissue A to a bone B. This bone B comprises a spongy portion B1 and a peripheral portion B2, with a through-orifice B3 formed between a internal face B4 and an outer face B5 of the peripheral portion B2. The soft tissue A comprises a flexible mass A1, an outer surface A2 and an inner surface A3 intended to bear against the outer face B5 of the bone B.

The implant 110 is inserted into the bone B through the orifice B3, preferably using the tool IT1, with the elements 130, 140 and 150 which hold the middle part of the suture 160 relative to at the implant 110. The shape of the tip 112 facilitates the insertion of the implant 110 in the cancellous portion B1. In addition, the configuration of the tabs 120 and the properties of the constituent material of the implant 110, which is preferably a shape memory alloy, promote the anchoring of this implant 110 in the bone B. Indeed, the legs 120 are initially folded along the axis X180, in the extension of the body 111, and unfold away from this axis X180 when the implant 110 is in place in the cancellous portion B1. Then, the surgeon can actuate the IT12 handle to cause the deployment of the tabs 120, while manipulating the ends 178a and 178b of the wire 160, to release the system 100. In particular, the plate 180 can be unhooked from the insertion rod IT13 exerting a stress of tension on the ends 178a and 178b. The wafer 180 is then suspended above the implant 110, the bone B and the tissue A. At this stage, a tension T178 is exerted on the strand (s) 176a and 176b and / or on the end (s) 178a. and 178b of the suture 160 in the proximal direction D2.

As shown in FIGS. 2 and 3, the tension T178 exerted on the ends 178a and 178b is transmitted to the arc 172, then to the arc 162, and finally to the plate 180. The tabs 120 abut against the face B4 of the bone, while the wafer 180 compresses the soft tissue A against the bone B. At the arc 172, a first reaction voltage T175 exerted by the portion 175 of the wire 160 on the portion 158 of the ring 150 tends to move this ring 150 in the direction D2, while a second reaction voltage T174 exerted by the portion 174 of the wire 160 on the portion 148 of the ring 140 tends to move the ring 140 in the direction D2. Thus, the rings 140 and 150 tend to abut against the pin 130, while the middle portion 161 of the wire 160 slides between the rings 140 and 150 in the direction of the tension T178. At the level of the arc 162, the sliding of the wire 160 generates a tension T162 exerted essentially by the rectilinear part 164 on the wafer 180, in the grooves 184a and 184b, in the distal direction D1. The tension T162 tends to move the wafer 180 in this direction D1, until the face 182 comes to bear against the surface A2 of the fabric A. If the tension T178 increases in intensity, the tension T162 increases in response and the wafer 180 compresses the soft tissue A against the peripheral portion B2 of the bone B, with the surface A3 in contact with the face B5. Furthermore, it is noted that the voltages T178, T175, T174 and T162 are directed along the axes X110 and X180, which are substantially aligned during the implementation of the system 100.

When the compression of the tissue A against the bone B is satisfactory, the middle portion 161 is locked between the rings 140 and 150 at the arc 172, so that the wire 160 is locked in position and that the spacing between the arcs 162 and 172 along the axis X110 remain substantially constant. At the level of the arc 172, the presence of the parts 173, 174 and 175 prevents the ring 140 from rising as high as the ring 150 in the direction D2, while this ring 150 abuts against the pin 130. in other words, the elements 130, 140 and 150 are securing means of the suture 160 in the implant 110, which may be referred to as a "two-ring locking set". The rings 140 and 150 are movable relative to the implant 110 in the cavity 119, while being permanently joined with the implant 110 because of the presence of the pin 130. These locking means are configured to selectively block and releasing the suture 160 relative to the implant 110, in particular configured to immobilize the second arc 172 of the suture 160 relative to the implant 110 without performing a knot.

Preferably, the blocking means is configured to allow the suture 160 to be displaced in the proximal direction D2 when the tension T178 is exerted on the ends 178a and 178b in that direction and to block the movement of the suture 160 in one direction. different from the proximal direction D2, in particular a direction transverse to this direction D2. Thus, the cooperation of the rings 140 and 150 and the suture 160 prevents uncontrolled sliding of the tissue A. The ends 178a and 178b remain accessible to the surgeon to complete the operation. The surgeon is able to quantify, during this operation, the compression of tissue A, which was not possible with existing suture implant systems. Tissue compression A is completed by attaching and / or cutting strands 176a and 176b of suture 160. For example, suture strands 176a and 176b may be cut at ends 178a and 178b using a chisel or a cutter. Also, the suture strands 176a and 176b may be incorporated into a repair set, of the double-column type, with suture bridges or in a trans-osseous equivalent. Thus, the surgeon obtains a reliable and reproducible healing set, without passage of suture or knot. Different implants can be used to perform anatomical footprint restoration. When the restoration of this anatomical impression is made, the dimensions of the impression depend on the dimensions of the wafer 180. By way of example, this impression may have a length of the order of 8 and 10 millimeters in the direction of the Z180 axis, a width of the order of 4 to 5 millimeters transverse to the axes X180 and Z180, and a thickness of about 1.5 millimeters considered between the A2 and A3 surfaces along the axis X180. The complete course of a surgical operation is detailed below in connection with FIGS. 5 to 10, thus making it possible to illustrate various configurations of use of the system 100. By way of example, this operation corresponds to a repair of the rotator cuff of the shoulder, that is to say a RTCR or "rotator cuff repair" in English. The rotator cuff is a set of muscle tendons located in the shoulder joint, which plays an important role in the stabilization of the glenohumeral joint. Figure 5 shows the complete detachment of the soft tissue A from the associated bone B, following a tear A6. Parts A2 and B5 face the surgeon, while the surgeon assesses the anatomical imprint of the soft tissue A. The surgeon proceeds to the preparation of the bone B, at the location of reattachment of the tissue (s) A on the B5 side, then assesses the mobility of the tear A6. Figure 6 shows the next step of determining and marking an insertion site A8 of the implant 110, using a needle or a spinal probe not shown. Piercing of bone B is performed by the surgeon at the insertion site A8, thereby forming an orifice analogous to port B3 of FIG. 3. At this stage, a single staple or a single point of connection or Traction suture can be placed through the loose soft tissue to help approximate and reduce the A6 tear. Figure 7 shows the anatomical impression restoration, inserting an implant 110 into bone B following a "trans-tendon" approach, during a single insertion step. By way of example, anatomical impression restoration concerns the rotator cuff of the shoulder, and bone B is a humerus. The implant 110 may be introduced through a 1 centimeter incision made by the surgeon near the margin of the anterolateral acromion. The surgeon may use a mallet to gently strike the implant 110 at the point of attachment of the tissue A, corresponding substantially to the insertion site A8, until the compression of the tissue A against the bone B begins. The elements 110, 140, 150 and 172 are not shown in FIG. 7 for purposes of simplification. The implant 110 is masked behind the rotator cuff and the bone B. In practice, the implant 110 is connected to the wafer 180, through the arc 162 formed in the wafer 180 and the arc 172. performed at the level of the rings 140 and 150. The wafer 180 is loaded with a wire 160 of active suture. Stretching the strands 176a and 176b, in particular at their respective ends 178a and 178b, as previously described with reference to FIGS. 2 and 3, a suitable compression of the fabric A against the bone B is thus achieved.

The strands 176a and 176b can be cut using a chisel or cutter when the repair is complete. The surgical operation is entirely performed without passing suture and without additional node. Thanks to the system 100, the soft tissue A is fixed and included on the bone B without knot. FIG. 8 shows a particular use configuration 100 'of the system 100, when this system 100 includes two implants 110 and a suture 160 cooperating with a wafer 180. The lateral implant 110 is shown in FIG. the medial implant 100 is masked behind the rotator cuff and the bone B. The strands 176a and 176b are placed in the medial implant 110, not shown, to create a repair construct that can be tensioned laterally to complete Restoration. In this case also, the strands 176a and 176b can be cut using a chisel or a cutter when the repair is complete. The surgical operation is entirely performed without passing suture and without additional node. Thanks to the system 100, the soft tissue A is fixed and included on the bone B without knot. FIG. 9 shows a particular use configuration 100 "of the system 100, when this system 100 includes three implants 110 and three sutures 160 cooperating with a wafer 180". Two lateral implants 110 are shown in FIG. 9, while the medial implant 110 is masked behind the rotator cuff and the bone B. The wafer 180 "has certain differences with the wafer 180 previously described. large dimensions, while the healing assembly can be tensioned laterally to complete the repair.Using doubly loaded active auxiliary suture threads 160 and the 180 "wafer, a suture bridge technique known in itself can be implemented to achieve maximum compression of fabric A. FIG. 10 shows an alternative use configuration 100 "'of system 100, with five implants 110 connected to two wafers 480 by a single wire 160. Three lateral implants 110 and two Platelets 480 are shown in Figure 10, while two medial implants 110 are masked behind the rotator cuff and B-bone. n is described below in connection with Figure 16. The ends 178a and 178b of the wire 160 are tied together, but without requiring an arthroscopic node.

In Figures 11 to 14 is shown a second embodiment of a suture implant system 200 according to the invention.

Some constituent elements of the system 200 are identical to the constituent elements of the system 100 of the first embodiment, described above, and bears the same reference numeral. This is the pin 130, the rings 140 and 150, the suture 160 and the wafer 180. In particular, this wafer 180 is a device for fixing the suture 160 in an implant 210, which is different of the implant 110 of the first embodiment. This implant 210 comprises an implant body 211 provided with a threaded outer surface 220. The body 211 of the implant 210 is elongate along a longitudinal axis X 210, between a distal end 212 shaped in point and a substantially flat proximal end 218 at which a cylindrical cavity 219 emerges, with a middle portion 213. The threaded surface 220, formed on the outside of the body 211, has a thread diameter which is substantially constant towards the proximal end 218 and the middle portion 213 and decreasing towards the distal end 212. The middle portion 213 is traversed by the two orifices 215 and 216, provided to receive the pin 130.

The implant 210 does not have anchoring tabs, because this function of anchoring in a bone B is provided by the threaded surface 220. The implementation of the system 200 is similar to that of the system 100, detailed above, except that the implant 210 is screwed into the bone B until soft tissue compression A begins, as shown in FIG. 13. The tension T178 exerted on the ends 178a and 178b of the thread 160 then allows the surgeon to compress the tissue A against the bone B, in a controlled manner, by means of the wafer 180. As shown in FIG. 14, the system 200 can be fixed to an IT2 tool, prior to the surgical procedure, in order to facilitate its manipulation by the surgeon. The tool IT2 of the screwdriver type represented in this FIG. 14 comprises an actuating handle IT21 with an end IT22 provided with an orifice, as well as a hollow rod IT23 which ends with an end IT24. In practice, the ends 178a and 178b of the strands 176a and 176b are inserted into the rod IT23 at its end IT24, then through the rod IT23 and the handle IT21 to come out at the other end IT22 of the screwdriver IT2. The end IT24 is fixed in the cavity 186 of the wafer 180 and holds the implant 210 in an insertion configuration. At this stage, the system 200 and, if necessary, the IT2 screwdriver, can be sterilized in packaged form of a kit directly usable by the surgeon. Subsequently, the screwdriver IT2 makes it possible to easily introduce the threaded implant 210 through the orifice B3 formed in the bone B, as shown in FIG. 13.

In Figure 15 is shown a third embodiment of a suture implant system 300 according to the invention.

Some constituent elements of the system 300 are identical to the constituent elements of the systems 100 and 200 described above, and bear the same reference numerals. This is the implant 210, the pin 130, the rings 140 and 150, and the suture 160.

In contrast, the system 300 includes a fastener 380, which is different from the wafer 180 of the first embodiments. In particular, this device 380 has a disc shape, with a rounded edge 383. The disc 380 is provided with flat faces 381 and 382 and a through cavity 386 centered on an axis X380. Grooves 384a and 384b extend along an axis Z380 at the face 381, on either side of the cavity 386. Orifices 385a and 385b passing through the disk 380, from the respective grooves 384a and 384b to the face 382. Thus, the anatomical impression made on the soft tissue A by the disk 380 has smaller dimensions, in comparison with the plate 180. In FIG. 16 is shown a fourth embodiment of a system of FIG. suture implant 400 according to the invention. Some constituent elements of the system 400 are identical to the constituent elements of the systems 100, 200 and 300 described above, and bear the same reference numerals. This is the implant 210, the pin 130, the rings 140 and 150, and the suture 160.

On the other hand, the system 400 comprises a platelet-shaped fastener 480 which has certain differences with the wafer 180 of the first and second embodiments. In particular, wafer 480 has four additional through-holes for the passage of four additional shank strands 160, i.e. wafer 480 has a total of six orifices 485a, 485b, 485c, 485d, 485e. and 485f for passage of the suture strands 160. The orifices 485a and 485b are formed in grooves 484a and 484b, while the orifices 485b to 485f are distributed around a central cavity 486 and a Z480 axis. Alternatively, the wafer 480 may comprise a different number of through orifices, for example four through orifices aligned along the Z480 axis.

In practice, the system 400 comprises at least one suture 491 or 492, similar but distinct from the suture 160. The number of wires 160, 491, 492 and the like that can be integrated in the system 400 depends on the number of orifices 485a 485f formed in the wafer 480. In Figure 16, the wire 491 comprises two strands 491a and 491b connected by an arc 491c, while the wire 492 comprises two strands 492a and 492b connected by an arc 492c. The orifices 485c and 485e are traversed by the lateral suture strands 491a and 491b of the wire 491, while the orifices 485d and 485f are traversed by the lateral suture strands 492a and 492b of the wire 492. The central suture strands 166a, 166b , 176a and 176b passing through the orifices 485a, 485b and the cavity 486 are used to energize the arches 162 and 172, while the strands 491a, 491b, 492a and 492b passing through the additional orifices 485c, 485d, 485e and 485f may be used to achieve a complex healing set. For example, the strands 491a-492b may cooperate with the soft tissue and / or adjacent soft tissues and / or be connected to other implants adjacent to the implant 210, similarly to the configurations illustrated in Figures 9 and 10.

Each wire 491 or 492 may be incorporated into the implant system 400 without the need for suture or arthroscopic tying. In this case, a chisel, a cutter or a cutting plier is the only instrument necessary to achieve a stable and reproducible healing set. Multiple implants 110 or 210 may be used to achieve any desired suture configuration.

In a variant that is not shown, the suture fixation device (s) and / or the suture implant (s) and / or the securing means of the suture relative to the implant may have different designs. Preferably, surgical kits ready for use are made available to the surgeon. These surgical kits may correspond to different configurations of use of the suture implant system according to the invention, with a variable number of elements and / or elements of different designs. Thus, the system according to the invention can be used for a wide variety of surgical applications, such as the repair of wrists, Achilles tendons, biceps tendons, acromioclavicular joints, with possible insertion of surgical patches.

Claims (12)

1. suture implant system (100; 100 '; 100 "; 100"'; 200; 300; 400), comprising: at least one implant (110; 210) with an elongated body (111; 211) between a distal end (112; 212) and a proximal end (118; 218), at least one suture (160) having two end strands (176a, 176b) connected by a medial portion (161) cooperating with the implant (110), and at least one fixation device (180; 180 "; 380; 480) connected to the implant (110) by the suture (160), characterized in that the medial portion (161) suture (160) forms a proximal arch (162) in the fixation device (180) and a distal arc (172) cooperating with the implant (110), so that a tension (T178) exerted in the proximal direction (D2) on one or both end strands (176a, 176b) of the suture (160) brings the proximal (162) and distal (172) arches closer to one another and, on the other hand, the fastening device (180; 180 "; 380; 480) and the implant (110; 210). 2. Suture implant system according to claim 1, characterized in that the or each fixing device (180; 180 "; 380; 480) comprises: a first opposite face (181) and a second face (182); these two faces being preferably substantially planar, a through cavity (186) opening on each of the two faces (181, 182), at least two grooves (184a, 184b) formed at the first face (181), from and other of the through cavity (186), and in each of the grooves (184a, 184b), a through hole (185a, 185b) which opens on the second face (182). 3. A suture implant system according to claim 2, characterized in that the proximal arch (162) formed in the fixation device (180; 180 "; 380; 480) comprises: - a rectilinear part (164) arranged in the grooves (184a, 184b) on the side of the first face (181), - two through portions (165a, 165b) arranged in respective through-holes (185a, 185b), and - two connecting portions (166a, 166b). ) which extend out of the fastener (180) on the side of the second face (182). 4. A suture implant system according to one of the preceding claims, characterized in that it comprises at least one additional suture (491, 492) which is distinct from the wire (160) comprising the proximal arch ( 162) and the distal arc (172) and which passes through at least one additional through-hole (485c, 485d, 485e, 485f) in the fastener (180; 180 "; 380; 480), including the system (400) comprises two additional sutures (491, 492) each passing through two additional through-holes (485c, 485d, 485e, 485f). 5. A suture implant system according to one of the preceding claims, characterized in that it also comprises means (130, 140, 150) for locking the suture (160) in the implant (110; 210), these locking means being movable relative to the implant while being permanently assembled with the implant. Suture implant system according to claim 5, characterized in that the locking means (130, 140, 150) are adapted to selectively lock and unlock the suture (160) relative to the implant (110). 210), in particular adapted to immobilize the distal arch (172) relative to the implant without performing a knot. 7. A suture implant system according to one of claims 5 or 6, characterized in that the body (111; 211) of the implant (110; 210) has an inner cavity (119; 219) which is opening towards the proximal end (118; 218) and not opening towards the distal end (112; 212), and in that the locking means (130, 140, 150) are at least partially arranged in this internal cavity ( 119; 219). 8. A suture implant system according to one of claims 5 to 7, characterized in that the locking means (130, 140, 150) comprise a first ring (140) and a second ring (150), each ring (140; 150) having a planar annular face (142) opposite a corresponding planar annular face (152) of the other ring, said rings (140, 150) being adapted to slide against each other at the planar annular faces (142, 152) and to cooperate by blocking the distal arc (172) relative to the implant (110; 210). A suture implant system according to claim 8, characterized in that the suture (160) extends along a suture path with each end strand (176a, 176b) of the suture (160). which extends both through a separate through hole (185a, 185b) in the fastening device (180), through an interior space (144, 154) defined in each of the rings (140, 150), and through a through cavity (186) which is formed in the fastener (180) and which is separate from the through holes (185a, 185b). The suture implant system according to one of claims 5 to 9, characterized in that the locking means (130, 140, 150) are adapted to allow movement of the suture (160) in a first direction. (D2) when a tension (T178) is exerted on the suture in this first direction and to block the movement of the suture in a second direction different from the first direction. 11. A suture implant system according to one of the preceding claims, characterized in that it comprises a plurality of implants (110; 210) and / or a plurality of fixation devices (180; 180 "; 380; 480) which are connected by at least one suture (160; 160, 491, 492). 12. A method of preoperative preparation of a suture implant system (100; 100 '; 100 "; 100"'; 200; 300; 400) according to one of claims 1 to 11, the system comprising means for blocking (130, 140, 150) the suture (160) in the implant (110; 210), the locking means (130, 140, 150) comprising a first ring (140) and a second ring (150); ), said rings (140, 150) being adapted to slide against each other and to cooperate by blocking the distal arc (172) relative to the implant (110; 210), the method being characterized in that it comprises the following steps: a) each end strand (176a, 176b) of the suture (160) passes through a separate through hole (185a, 185b) in the fastener (180); b) the medial portion (161) of the suture (160) forms the proximal arch (162) in the fixation device (180); c) the end strands (176a, 176b) pass through an interior space (144, 154) defined in each of the rings (140, 150); d) the end strands (176a, 176b) pass outside the first ring (140) and into the interior space (154) delimited by the second ring (150); e) the medial portion (161) of the suture (160) forms the distal arc (172) cooperating with the implant (110) through the locking means (130, 140, 150), the bow distal (172) passing between the first ring (140) and the second ring (150); and f) the end strands (176a, 176b) pass through a through cavity (186) in the fastener (180) and separate from the through holes (185a, 185b).