FR2622430A1 - Surgical staple for immediate fixation of artificial ligaments and accessory instrument for its implantation in the bone - Google Patents

Abstract

The present invention relates to a novel surgical staple for immediate fixation of artificial ligaments. This staple is characterised in that, on the one hand, the body 2 of the staple comprises over its entire height and along its axis a bore 3 of diameter substantially equal to the spacing of the two arms 4, whose internal opposite faces each have an identical protrusion 8 in the form of bosses, and, on the other hand, a cylindrical piece 9, one of whose bases is plane and comprises hollowed-out gripping means 11 for an adapted accessory system, has a diameter and a height such that the said piece 9 can penetrate the bore 3 of the staple body by its rounded base which thus comes, in contact with the bosses 8, progressively to separate the two arms 4, making the staple irremovable when it is implanted.

Description

 The present invention relates to a new surgical clip for immediate fixation of artificial ligaments as well as an ancillary instrument for its implantation in the bone, in particular under arthroscopy.

 Numerous executions of surgical staples intended for osteosynthesis and for the fixation of artificial ligaments are already known, all these staples block the free ends of the ligaments implanted in the bone thus ensuring minimal mechanical strength of the joint in the waiting for a biological fixation of the ligament on the bone or in the bone.

 This rehabitation of the ligament by the bone requires, for these reasons, slow rehabilitation and, at the very least, a period of rest sufficient for a secure and permanent anchoring of the newly implanted ligament.

To reduce these drawbacks, a new type of surgical clip has been devised, the implantation of which is carried out on the artificial ligament at the entrance to a perforated tunnel in the notch of the bone to receive the implant.
In this way, the ligament is mechanically blocked in the bone to which it is joined as soon as it enters the notch, its free end, passing through said tunnel, being conventionally fixed at the exit.

 We then understand the whole advantage of such a solution, which virtually excludes the entire period of convalescence while awaiting rehabitation of the ligament by the bone, which in this case. normally takes place in the implantation tunnel without being disturbed by the stresses exerted by said ligament. generating micro-vibrations which delay, at the very least, osteosynthesis.

 To obtain such a result requires a particular staple, blocking, for sure, the ligament in the notch of the bone; we therefore imagined a staple whose action is similar to a vice which comes by clamping crush the ligament against the wall of the bone tunnel until a deformation of said wall making impossible any retraction of the ligament.

 To this end, this surgical clip comprising a body of preferably cylindrical shape from which two substantially parallel lateral legs originate, disposed opposite each other at a spacing greater than the diameter of the ligament, extending collinearly to the axis of the body, their lateral faces. external in the extension of the external lateral face of the body, is characterized in that, on the one hand, the body of the staple has on its top its height and along its axis a bore of diameter substantially equal to the spacing of the two legs, the internal faces of which face each other have an identical protuberance in the form of substantially hemispherical bosses, arranged facing each other, approximately two thirds of the length of said legs from their ends. bosses which are such that the distance between their apices is less than the diameter of the bore and on the other hand, a cylindrical part of which one of the bases is planar and has hollow gripping means for a suitable ancillary system, the other base being rounded in preferably hemispherical shape, has a diameter and a height such that said part can penetrate into the bore of the staple body by its rounded base which thus comes. in contact with the bosses, gradually spread the two legs, making the clip unbreakable when it is implanted, and block the ligament in its reception tunnel made in the bone, until the upper face of the part is flush the body of the clip to which it is secured by appropriate means. Thus described, the clip according to the invention performs two technical functions on the one hand, its penetration into the bone. straddling the tunnel receiving the ligament, is made irreversible since the # two legs. after having crossed the cortex of the bone, are removed by the placement of the cylindro-ogival part which, on the other hand, radially perforates the tunnel to block the artificial ligament previously implanted in the same tunnel.

 Advancement of the cylindro-ogival part in the body of the staple is advantageously ensured by screwing said part inside the axial bore of the staple tapped for this purpose Incidentally, the ends of the staple are bevelled in such a way that the cutting edges determined by the bevels are in line with the external lateral faces of the legs; thus the cutting plane of the bevels tilts from the cutting edges towards the axis of the staple, which tends to open the two legs when the staple is pressed into the notch convex of the bone so as to surely overlap the ligament and to ensure a pre-separation of the same legs.

 An additional advantage of the staple according to the invention lies in its preferably cylindrical shape, easily miniaturizable allowing operation under arthroscopy, and therefore reducing the size of the incisions. It will be observed, in this regard, that the cylindrical shape of the clip fits perfectly with an ancillary instrument itself cylindrical and of the same section, one end of which has a neck which is advantageously threaded in step with the axial bore of the clip. while the other end is conventionally arranged for striking a hammer when the staple is implanted in the bone.

 In this way, the clip screwed at the end of the clip holder thus produced, is in its extension and can be introduced and guided, under arthroscopy for example, until the notch of the bone in which the tunnel has been previously perforated reception of the artificial ligament; the two legs of the staple are then placed on either side of the ligament just above the entrance to the tunnel, and introduced into the bone by striking on the head of the staple holder.

 When the body of the staple is fully inserted into the cortex of the bone, the stapler holder is unscrewed, removed and replaced by the cylindro-ogival part which is introduced into the bore of the staple, guided by a awl key arranged in the head of the cylindro-ogival part comprising hollow sides.

An embodiment of the present invention will be described below, by way of non-limiting example, with reference to the appended drawing in which
Figure 1 shows an elevational view of a clip according to the invention with its cylindro-ogival part in the unassembled position.

 FIG. 2 represents a bottom view of the clip according to the invention without its cylindro-ogival part.

 Figure 3 is an elevational view of the ancillary instrument, or staple holder, associated with the staple according to the invention, intended for the implantation of said staple and incidentally to the mounting of the cylindro-ogival part in the body of the same clip.

 Figure 4 is a vertical sectional view of the clip according to the invention in a first position representing in phantom the implantation in the bone before mounting of the cylindro-ogival part, and a second position representing in continuous line l implantation in the bone after assembly of the cylindro-ogival part coming to spread the legs of the staple and compress the ligament in its tunnel.

 Figure 5 is a perspective view of the clip and ligament assembly as it is mounted in the notch of the bone at the end of the intervention.

 The clip 1 according to the invention which is shown in Figures 1 and 2, comprises a cylindrical body 2 molded from a biocompatible material, comprising axially a through bore 3 of diameter "D" tapped over the entire height of the body 2. Arranged opposite, on either side of the axis of the body 2, perpendicular to the latter, two legs 4 extend over a height of approximately three times the height of the body 2; The legs 4, of substantially elliptical section, have external lateral faces 5 which come in line with the external lateral surface of the body 2. The thickness of the legs 4 is such that the distance between their internal lateral faces 6 is greater than the diameter "D". On each internal face 6, approximately 2/3 of the height of each leg 4 from its end 7, two protrusions in the form of bosses 8 substantially hemispherical are arranged opposite so that the distance of their vertices is less than the diameter "D" of the bore 3. The threaded bore 3 can receive a part 9 of material similar to that of the clip 1, of cylindrical shape comprising over a height of about two times that of body 2 a thread of the same pitch as that of the bore; the part 9 comprises, on one side, a hemispherical end 10 and, on the other, a flat face having a central well 11 with a hexagon socket intended to receive an awl key end for the screwing of the part 9 in the the bore 3 of the body 2 of the clip 1, when the latter has been implanted in a notch 12 of a bone 13, straddling a ligament 14 predisposed in a tunnel 15 in accordance with FIG. 5.

 For the implantation of the staple 1 in the bone 13, a staple holder 16. as shown in FIG. 3, can be used; the staple holder 16 comprises a cylindrical handle 17, of section identical to that of the body 2 of the staple 1 and of sufficient length to reach the notch 12 of the joint from outside the member.

 The staple holder 16 comprises, at one of its ends, a screw 18 of the same diameter and the same pitch as the part 9, extending along the axis of the staple holder over a height substantially equal to that of the body 2 of clip 1; the other end 19 of the staple holder 16 has a flattening intended for the hammer blow necessary to drive the staple 1. In this way one can secure the staple 1 to the staple holder 16 by screwing the screw 18 into the bore 3 of clip 1 which thus follows on from clip holder 16.

 The clip 1 is then implanted, as shown in phantom in FIG. 4, in the cancellous part 131 of the bone 13 until it is flush with the cortex 132 of the bone 13, the legs 5 overlapping the tunnel 15 comprising the artificial ligament 14. The ends 7 of the legs 5 of the clip 1 are cut in a bevel so that during penetration into the bone 13, the legs 4 tend to move apart, that is to say that the oblique planes 71 of the ends 7 come from the internal walls 6 to join the external lateral faces 5 and form in their extension a sharp part 72.

 The sgrafe holder 16 is then unscrewed from the body 2 of the staple 1 and the part 9 is then introduced and screwed into the bore 3 for example by means of the same staple holder 16 provided with an end piece 20 with hexagon advantageously provided in the extension of screw 18.

 When the rounded end 10 of the part 9 meets the bosses 8 on the legs 5 of the clip 1, these move apart in the cancellous part 131 of the bone 13 making the clip completely unstoppable; the progression of the piece 9 finally crushes the ligament 14 in the bottom of the tunnel 15 until a total blocking of said ligament 14 in the bone 13.

 The artificial ligament 14 firmly locked at the entrance of the tunnel 15 in the notch 12 of the bone 13, can be rehabilitated by the bone inside said tunnel 15 where it can reside without constraint the time necessary for 1 ' osteosynthesis without keeping the joint at rest.

Claims (6)

 1.- Surgical clip comprising a body of preferably cylindrical shape from which two substantially parallel lateral legs originate, disposed opposite each other at a distance greater than the diameter of the ligament by extending collinearly to the axis of the body, their external lateral faces coming in the extension of the external lateral face of the body, characterized in that, on the one hand, the body (2) of the clip comprises over its entire height and along its axis a bore (3) of diameter substantially equal to the spacing of the two legs (4), the internal faces of which face each other have an identical protuberance (8) in the form of substantially hemispherical bosses, disposed facing each other, approximately two thirds of the length of said legs (4) to be counted their ends, bosses (8) which are such that the distance between their vertices is less than the diameter of the bore and on the other hand, a cylindrical part (9) one of the bases of which is planar and has hollow x gripping means (11) for a suitable ancillary system, the other base being rounded in preferably hemispherical shape (10), has a diameter and a height such that said part (9) can penetrate into the bore (3) of the staple body by its rounded base (10) which thus comes into contact with the bosses (8), gradually spreading the two legs (4), making the staple unbreakable when it is implanted, and locking the ligament (14 ) in its reception tunnel (15) formed in the bone, until the upper face of the part (9) is flush with the body (2) of the clip to which it is secured by appropriate means.  2.- surgical clip according to claim 1 characterized in that on the one hand the bore (3) of the body (2) of the clip (1) is tapped and, on the other hand, the part (9) is threaded not even as the bore (3) over its entire cylindrical part so that said part (9), by screwing into the bore (3), comes first to spread the legs (4) of the clip 1 pre-installed in the bone (13) straddling the tunnel (15) thus making it unbreakable and then crushing the ligament (14) to block it against the wall of said tunnel (15).  3.- surgical clip according to any one of the preceding claims, characterized in that the ends (7) of the two legs (4) of the clip (1) are bevelled by a progressive reduction (71,72) of said ends (7) from their internal faces (6), the cutting edges (72) which result therefrom being in the extension of the external lateral faces (5) of the legs 4.  4. Surgical clip according to any one of the preceding claims, characterized in that the part (9) comprises, on the side of its planar face, a central well (11) with four or hexagon socket so as to receive an awl key intended for mounting of said part (9).  5. Ancillary instrument associated with the clip according to any one of the preceding claims, characterized in that it consists of a cylindrical part (17) of the same diameter as the body (2) of the clip (1). , of a sufficient height for easy access and handling, comprising, on one side a screw (18) with the pitch of the bore (3) of the body (2) of the clip (1) and of the same height that the latter so as to be able to assemble them, and on the other side, a flattening (19) suitable for striking a hammer provided for implanting the clip (1) in the bone (13).  6. Ancillary instrument according to claim 5 characterized in that in the axial extension of the screw (18) extends a tip (20) with four or six regular sides corresponding to the hollow sides of the well (11) of the part ( 9) allowing the transport, guidance and screwing of said part (9) in the clip (1).