FR3091988A1 - INSTRUMENTATION ALLOWING THE PLACEMENT, IN A BONE OR OTHER BODY TISSUE, OF AN ANCHOR CONNECTED TO AT LEAST ONE SUTURE WIRE - Google Patents

Abstract

The object concerned is an instrumentation (1) allowing the placement, in a bone or other body tissue, of an anchor connected to at least one suture thread, this instrumentation (1) comprising an instrument (5) called " cannula" and an instrument (7) called "insert". According to the invention, the handle (10) of the cannula (5) forms an open chamber on the proximal side, arranged coaxially with a longitudinal duct of the cannula (5) and communicating with this longitudinal duct; and the instrumentation (1) also comprises a support (6) having: - a longitudinal duct in which a rod (35) of the inserter (7) is capable of being engaged, - means for positioning the anchor on the support (6) facing this longitudinal duct formed by the support (6), and - a winding body, around which the suture thread (3) of the anchor (2) is adapted to be wound. Figure for abstract: Fig. 1

Description

INSTRUMENTATION PERMITTING THE PLACEMENT, IN A BONE OR OTHER BODY TISSUE, OF AN ANCHOR CONNECTED TO AT LEAST ONE SUTURE THREAD

The present invention relates to an instrumentation allowing the placement, in a bone or other bodily tissue, of an anchor connected to at least one suture thread.

The anchor can be single wire but also double wire, or flat braid. The term "thread" used for simplification in the present description must therefore be taken in a very general sense, as meaning a filiform element, which can be constituted by a single thread or by a braiding of several threads.

It is well known to reinsert a ligament or a tendon on a bone by means of an anchor implanted in this bone, the anchor being connected to one or more suture threads; once the anchor is in place, this or these threads are intended to cross the ligament or tendon to be reinserted and to be knotted so as to maintain this ligament or tendon in place on the bone during healing.

Such an anchor can be more or less cylindrical in shape and be metallic, or made of a plastic material or a resorbable material; it can be of the screw-on or impaction type, and has a suture thread or flat braid connected to it, or is crossed by a suture thread/braid, thus forming two strands of this suture thread/braid. Another anchor can also be of the so-called "wired" type, that is to say be constituted by a tubular sheath made of braided son, engaged on a suture thread; such an anchor is able to be engaged through a hole made in a bone wall then, when the two strands of the suture thread are pulled, to come and collect below the bone wall, thus forming a mass which prevents the return passage of the anchor through the hole. US Patent Publication No. 8,562,647 B2 describes an anchor of this type.

An instrumentation for inserting a wired anchor includes:
- an instrument called "cannula" comprising a manipulation handle and an access rod to the implantation site, this handle and this rod being pierced with a longitudinal duct;
- an instrument for drilling a hole in a bone, comprising a drilling rod capable of being engaged through said cannula; and
- an instrument called "insert", comprising a rod at the end of which is placed the anchor and a handle at the level of which the suture thread is wound so as to maintain this thread, or the strands of this thread, in a state of tension along this rod; this tension is necessary so that the thread or threads are not in the way during the insertion of the anchor through the cannula or that they do not risk getting caught at the time of this insertion.

In practice, the cannula is used to access the implantation site and the piercing instrument is inserted through this cannula to pierce the bone; once this bone has been drilled, the piercing instrument is removed and the inserter is inserted into the cannula and is used to drive the anchor through the hole and below the wall of the bone.

Such instrumentation is generally made up of disposable tools and therefore involves a relatively high cost of use. The dimensions of these tools lead to relatively large packaging boxes, which has a significant implication on the volume occupied by the storage of these boxes. Furthermore, in the case of wired anchors as mentioned above, the inserter comprises a distal fork for holding the anchor having two very fine branches, the resistance of which is reduced; a shock at the level of these branches can lead to a rupture of one of the branches, or of both branches, and therefore to a lack of maintenance of the anchor at the time of its insertion, which should lead to the use of a another inserter.

The present invention aims to remedy these various drawbacks. Its objective is therefore to provide instrumentation with a lower cost of use than that of existing instrumentation, which can be contained in packaging boxes of smaller dimensions than the existing instrumentation, and does not have the disadvantage of include an inserter having a fragile distal fork.

The instrumentation concerned comprises, in a manner known per se:
- an instrument called "cannula" comprising a manipulation handle and an access rod to the implantation site, the cannula being pierced with a longitudinal conduit; and
- an instrument called "insert", comprising a rod allowing the anchor to be moved in this longitudinal conduit up to the level of the implantation site.

According to the invention,
the handle of the cannula forms a chamber arranged coaxially with said longitudinal duct of this cannula and communicating with this longitudinal duct; and
the instrumentation also comprises a support having:
- a longitudinal duct in which the rod of the inserter is capable of being engaged,
- means for positioning the anchor on the support, opposite this longitudinal duct of the support, and
- a winding body, around which the suture of the anchor is adapted to be wound;
said support is adapted to be placed in said chamber such that the longitudinal duct formed by the support is coaxial with the longitudinal duct formed by the cannula.

In practice, once the bone has been pierced, the support is placed in said chamber, which makes it possible to position the anchor facing the longitudinal conduit formed by the cannula and which makes it possible to position the suture thread, properly wound around the winding body; the stem of the inserter is then inserted through the longitudinal conduit formed by the support and then through the longitudinal conduit formed by the cannula and is used to bring the anchor through the hole made in the wall of the bone and below this wall.

Thanks to the design according to the invention, the inserter no longer has, as according to the prior art, wires protruding at the level of a handle that this inserter comprises for its manipulation, so that the inserter according to the invention is easier to handle than the inserter according to the prior art. The unwinding of the suture thread during the displacement of the anchor by means of the inserter, is carried out from the winding body and inside the handle of the cannula, therefore in optimal conditions and without any risk of discomfort for the practitioner.

In addition, the positioning of the anchor at the level of the aforementioned support allows the inserter to have a distal end devoid of a fragile fork as according to the prior art, given that the anchor is no longer positioned on this end. distal. The risk of having to use another inserter when this fork is broken is thus eliminated.

The cannula and the inserter according to the invention can be reusable instruments, which makes it possible to significantly reduce the cost of implanting an anchor, due to the savings in material thus achieved. The support, for its part, has a structure that is simple and inexpensive to produce, which it is in particular possible to manufacture by molding a synthetic material, and can therefore be disposable.

Preferably, the support is formed by two parts intended to be engaged one inside the other, namely an internal part forming said longitudinal duct of the support, said positioning means and said winding body, and a hollow external part capable of receiving said internal part inside it, a peripheral wall of this external part coming opposite said winding body when the internal part is engaged in the external part and making it possible to ensure the maintenance of the suture thread in its state of winding around the winding body.

Thus, when the internal part is engaged in the external part, the support constitutes an assembly which can be easily placed in said chamber of the cannula, without any risk of the wire unwinding. In addition, the external part forms an envelope around the wire and the anchor, which makes it possible to perfectly protect this wire and this anchor with regard to any risk of contamination which may result from manual contact by the practitioner.

The internal part and the external part can comprise means for mounting the internal part on the external part, with retention of this internal part on this external part, so that these two parts are assembled together and that they form a homogeneous whole, similar to a cartridge. This assembly can be sterilized in this state of assembly, with the anchor positioned on the internal part and the wire wound on the winding body in the aforementioned manner, and be delivered as a consumable for use with the cannula and the inserter.

This same external part and the cannula can comprise means for positioning the support in said chamber, for example in the form of a flange having a dimension adjusted to the cross section of said chamber. The positioning of the longitudinal duct formed by the support, in this chamber, coaxially to the longitudinal duct of the cannula, is thus perfectly ensured.

The external part and the cannula can also comprise means for mounting the support in said chamber, with retention relative to the cannula, for example in the form of a bayonet system. This system can in particular be in the form of lugs projecting from the wall of the outer part and of grooves made in the proximal part of the handle, for receiving these lugs.

The outer part may further comprise means forming a foolproof device making it possible to ensure the correct positioning of said support in the chamber.

The instrumentation according to the invention can be used with all types of known anchors, said support comprising anchor positioning means suitable for the type of anchor to be used. This instrumentation is however particularly intended to be used with a so-called "wired" anchor as mentioned above; in such a case,
said anchor positioning means consist of notches provided at the distal end of the support, in a direction transverse to the longitudinal duct formed by the support, these notches being dimensioned so as to receive the anchor in them;
the support and the inserter form means for angular positioning of the inserter with respect to the support so as to orient the distal end of this inserter for bearing against the anchor.

In particular, the distal end of the stem of the inserter can be flattened, so that the inserter forms a transverse edge for bearing against the anchor, and said positioning means consist of flats arranged on the support and corresponding flats arranged on the inserter, the coming into coincidence of these respective flats determining a precise angular position of the inserter allowing the engagement of the inserter in the longitudinal duct formed by the support.

Furthermore, the cannula can form, at the outlet of the longitudinal duct that this cannula presents in said chamber, a conical wall coaxial with the axis of this duct. This wall forms a guide making it possible to direct the anchor and the distal end of the inserter towards said longitudinal duct, and thus making it possible to overcome any fault in perfect coaxial alignment of the longitudinal duct formed by the support with the longitudinal duct formed by the cannula.

The invention will be well understood, and other characteristics and advantages thereof will appear, with reference to the appended schematic drawing, which represents, by way of non-limiting example, a preferred embodiment of the invention. In this drawing:
is a side view of an instrument called "cannula", of a subassembly called "support", and of an instrument called "insert", these elements being represented in this order in this figure, from left to right ;
is a perspective view of the cannula and the support, the cannula being cut longitudinally along its longitudinal axis;
is a perspective view of the support, from a first angle; an internal part that this support comprises is shown in the extended position with respect to an external part that this support also comprises;
is a view of a detail of FIG. 3, on an enlarged scale;
is a view of the support similar to Figure 3, from another angle;
is a view of a detail of FIG. 5, on an enlarged scale;
is a view of the support in perspective, with the engagement of said internal part in said external part, these parts being cut longitudinally over a portion corresponding to a quarter of the circumference of these parts;
is a side view of the cannula, in longitudinal section, during a first stage of use; a portion of bone in which a hole is made is also visible on the left of this figure;
is a view of the cannula similar to FIG. 8, after positioning the support in the cannula;
is a view of the cannula similar to FIG. 9, in perspective, after engagement of the inserter in a longitudinal duct that the support comprises; this view shows an anchor, hitherto positioned on the support, being moved by means of the inserter;
is a view of the instrumentation according to an alternative embodiment, in perspective, and
is a view of the cannula according to this embodiment, in perspective from another angle.

FIG. 1 represents instrumentation 1 for inserting a medical anchor connected to at least one suture thread, this anchor being intended to be implanted in a bone, or other body tissue, to reattach an anatomical structure to this bone, in particular for reinsert a ligament or tendon on this bone.

The anchor in question is visible in particular in Figures 5 to 7; in the example shown, it is of the so-called "wired" type, described in particular by patent publication No. US 8,562,647 B2, that is to say that the anchor 2 consists of a tubular sheath made of braided son, engaged on the suture 3 to which this anchor 2 is connected. As is well known, such an anchor 2 is capable of being engaged through a hole provided in a bone wall then, during traction exerted on the two strands of wire 3 extending on either side of the anchor 2, to come to collect below this bone wall, thus forming a mass which prevents the return passage of the anchor 2 through the hole.

As visible in Figure 1, the instrumentation 1 comprises an instrument 5, called "cannula", a support 6 and an instrument 7, called "insert". The instrumentation 1 also comprises various other instruments not shown, well known in themselves, in particular an instrument for drilling the aforementioned hole in the bone, comprising a rod capable of being engaged through the cannula 5, which is terminated by a bone drill bit.

As visible in Figures 1 and 2, the cannula 5 comprises a handling handle 10 and a rod 11 for access to the implantation site, connected to this handle 10. The rod 11 is pierced with a longitudinal conduit 12, intended to receive the aforementioned piercing instrument, and to receive the rod 35, described later, of the inserter 7.

The handle 10 forms a chamber 15 open at the level of the proximal end of this handle, arranged coaxially with said longitudinal duct 12 and communicating with this duct. On its proximal side, the handle 10 forms two diametrically opposed grooves 16 of a bayonet mounting system. At the distal end of chamber 15, handle 10 forms a conical wall 17 coaxial with the outlet of conduit 12 and communicating with this conduit; this wall 17 facilitates the guiding of the piercing instrument or of the rod 35 of the inserter 7 towards the duct 12 during the insertion of this piercing instrument or of this rod 35 through the cannula 5.

Referring to Figures 3 and 5, it appears that the support 6 is formed of two separate parts 20, 21, capable of being assembled to one another, namely an internal part 20 intended to be received in an external part 21.

The internal part 20 comprises an internal longitudinal duct 22, particularly visible in FIGS. 6 and 7, two distal notches 23 arranged in a direction transverse to this duct 22, and a body 24 for winding the suture thread 3; it also comprises a proximal flange 25 allowing it to bear against the proximal edge of the outer part 21, two diametrically opposed lugs 26, intended to be received with snap-fastening in corresponding notches 36 arranged in the proximal edge of the part 21, a distal ferrule 27 and a distal collar 28.

The longitudinal duct 22 is intended to receive the rod 35 of the inserter 7 by sliding; as seen in Figures 4 and 7, the inner part 20 forms two flats 30 at this conduit 22, diametrically opposed; the rod 35 of the inserter 7 forms corresponding flats 38, visible in FIGS. 1 and 10, which must be oriented angularly so as to be placed opposite the flats 30 to allow the rod 35 to be completely engaged in the duct 22, these flats 30, 38 thus forming means for determining a precise angular positioning of the inserter 7 relative to the support 6 to allow the engagement of the rod 35 in the duct 22 to be possible. Referring to Figure 1, it also appears that the flats 38 are oriented in a plane perpendicular to the plane in which extends a flattened distal transverse edge 35a provided at the distal end of the rod 35; with reference to Figures 3, 5 and 7, it also appears that the flats 30 extend in planes which are parallel to the transverse direction in which the notches 23 are arranged; thus, it is understood that, when the inserter 7, and therefore the rod 35, is in said determined angular position defined by the coming into coincidence of the respective flats 30 and 38, said flattened transverse edge 35a will be positioned so as to extend perpendicular to said transverse direction, and therefore perpendicular to the anchor 2 received in the notches 23; therefore, this edge 35a is placed in an ideal angular position to bear against the anchor 2 and push this anchor in the distal direction, as shown in Figure 10.

With particular reference to Figure 6, it appears that the anchor 2 is received in the notches 23, causing the middle part of this anchor 2 to extend across the conduit 22, these notches 23 being provided in the ferrule 27 which is formed at the distal end of the internal part 20. The notches 23 communicate with lateral grooves provided in the flange 28, and the lateral parts of the anchor 2 are also inserted into these grooves. It appears in Figure 6 that the proximal portions of the collar 28 which delimits these grooves are cut on the bias, so that these portions do not risk constituting attachment points for the strands of the suture thread 3 when these strands unwind. when moving the anchor 2 in the distal direction.

The body 24 has a cylindrical shape and receives, wound on it, the two strands of the suture thread 3.

The outer part 21 has a tubular shape, internally defining said cavity 37; in addition to the proximal notches 36 and this cavity 37 mentioned above, it comprises:
- A distal opening 45 allowing passage of the anchor 2 and the strands of wire 3, as well as the rod 35, through it;
- two diametrically opposed lugs 46, capable of cooperating with the grooves 16 to allow mounting of the support 6 on the cannula 5,
- a distal flange 47 allowing precise positioning of the distal end of the support 6 in the chamber 15, so that the conduit 22 is positioned coaxially with the conduit 12,
- Two diametrically opposed proximal bosses 48, located between the lugs 46 and the proximal edge of the outer part 21, which are part of a diameter greater than that of the chamber 15; these bosses 48 are mainly used to indicate that the support 6 has docked in the chamber 15 of the cannula 5;
- two diametrically opposed bosses 44, formed on the head 25, visible in FIGS. 3 and 5, which interfere with the proximal edge of the cannula 5 if the support 6 is not slid in the right direction, and thus constitute polarizers ; and
- two diametrically opposed windows 49, provided to visualize and optimize the mounting of the anchor wires or to indicate to the surgeon that the support 6 indeed contains an anchor.

Figure 7 shows the support 6 in the assembly state of the inner part 20 to the outer part 21, this assembly resulting from the snapping of the lugs 26 in the notches 36; the assembly thus has a homogeneous structure and is substantially in the form of a cartridge in which the anchor 2 and the wire 3 are perfectly positioned, with the wall of the outer part 21 protecting this anchor 2 and this wire 3 and ensuring the maintenance of the wire 3 in its state of winding on the body 24, while allowing the easy unwinding of the two strands of the wire 3 when the anchor 2 is pushed by means of the inserter 7.

Referring to Figure 1, it appears that the transverse distal edge 35a formed by the rod 35 of the inserter 7 has a slightly concave shape favoring its bearing around the anchor 2, and that this inserter 7 comprises a handling handle 50.

In practice, as appears with reference to Figures 8 to 10, the cannula 5 is first of all used to cross any soft tissues and then to access the implantation site; the aforementioned piercing instrument is then engaged through the duct 12 so as to pierce, through the cortex 100 and in the underlying spongy bone 101, a hole intended to receive the anchor 2; the piercing instrument is then removed, which corresponds to the situation shown in Figure 8; the support 6 is then placed in the chamber 15 while being retained on the cannula 5 by means of the bayonet system formed by the grooves 16 and the lugs 46, see FIG. 9; in this position, the anchor 2 is positioned slightly set back from the conical wall 17, with its middle portion facing the duct 12, as shown in this figure; the rod 35 of the inserter 7 is then engaged in the duct 22 and is slid therein until it meets the anchor 2, as can be seen in FIG. 10; a manual push on the handle 50 of the inserter 7 is then exerted so as to engage the anchor 2 and the strands of the wire 3 in the conduit 12 then, by impaction with a hammer, through the hole made in the cortex 100 , to the level of the spongy bone 101; the inserter 7 is then removed, as is the support 6, and traction is exerted on the strands of the wire 3 so as to carry out the positioning of the anchor 2 below the bone wall, in the manner described previously . The cannula 5 is finally withdrawn and the suture thread 3 is used to reinsert the tendon or the ligament on the bone.

Figures 11 and 12 show an alternative embodiment of the instrumentation 1 in which the cannula 5 has a longitudinal slot 60 extending over its entire length, both at the level of the handle 10 and at the level of the rod 11. As the shown in FIG. 12, this slot 60 makes it possible to extract the wire 3 outside the cannula 5, laterally, without removing the cannula from the first channel, which is useful in certain cases.

As appears from the foregoing, the invention provides an instrumentation 1 having decisive advantages, in particular those of having a lower cost of use than that of an existing instrumentation, of comprising instruments (cannula 6, inserter 7 ) reusable and only one instrument (the support 6) for single use, this instrument 6 thus being able to be contained in a sterile packaging box having smaller dimensions than the box in which a complete existing instrumentation is contained, and not presenting the disadvantage of including an inserter having a fragile distal fork.

Claims (10)

Instrumentation (1) allowing the placement, in a bone or other body tissue, of an anchor (2) connected to at least one suture thread (3), the instrumentation (1) comprising:
- an instrument (5) called "cannula" comprising a handling handle (10) and a rod (11) for access to the implantation site, the cannula (5) being pierced with a longitudinal conduit (12); and
- an instrument (7) called "insert", comprising a rod (35) allowing the anchor (2) to be moved in this longitudinal conduit (12) up to the level of the implantation site;
characterized in that:
the handle of the cannula (5) forms a chamber (15) arranged coaxially with said longitudinal duct (12) of this cannula (5) and communicating with this longitudinal duct; and in that
the instrumentation (1) also comprises a support (6) having:
- a longitudinal duct (22) in which the rod (35) of the inserter (7) is capable of being engaged,
- means (23) for positioning the anchor (2) on the support (6), opposite this longitudinal duct (22) formed by the support (6), and
- a winding body (24), around which the suture thread (3) of the anchor (2) is adapted to be wound;
said support (6) is able to be placed in said chamber (15) in such a way that the longitudinal duct (22) formed by the support (6) is coaxial with the longitudinal duct (12) formed by the cannula (5) . Instrumentation (1) according to Claim 1, characterized in that the support (6) is formed by two parts (20, 21) intended to be engaged one inside the other, namely an internal part (20) forming the said longitudinal duct (22) of the support (6), said positioning means (23) and said winding body (24), and a hollow outer part (21) capable of receiving said inner part (20) inside it, a peripheral wall of this outer part (21) coming opposite said winding body (24) when the inner part (20) is engaged in the outer part (21) and making it possible to ensure the maintenance of the suture (3) in its state of winding around the winding body (24). Instrumentation (1) according to Claim 2, characterized in that the internal part and the external part (21) comprise means (26, 36) for mounting the internal part (20) on the external part (21), with retention of this internal piece on this external piece. Instrumentation (1) according to Claim 2 or Claim 3, characterized in that the external part (21) comprises means (47) for its positioning in the said chamber (15), for example in the form of a collar (47 ) having a dimension adjusted to the cross section of said chamber (15). Instrumentation (1) according to one of Claims 2 to 4, characterized in that the outer part (21) and the cannula (5) comprise means (16, 46) for mounting the support (6) in the said chamber ( 15), with retention relative to the cannula (5), for example in the form of a bayonet system. Instrumentation (1) according to one of Claims 2 to 5, characterized in that the external part (21) comprises means (44) forming an error-proof device making it possible to ensure the correct positioning of the said support (6) in the bedroom (15). Instrumentation (1) according to one of Claims 1 to 6, intended to be used with a so-called "wired" anchor (2), characterized in that:
said means for positioning the anchor (2) are constituted by notches (23) provided at the level of the distal end of the support (6), in a direction transverse to the longitudinal conduit (22) formed by the support (6) , these notches (23) being dimensioned so as to receive the anchor (2) in them;
the support (6) and the inserter (7) form means (30, 38) for angular positioning of the inserter (7) relative to the support (6) so as to orient the distal end of this inserter (7) for a bearing against the anchor (2). Instrumentation (1) according to Claim 7, characterized in that the distal end of the stem (35) of the inserter (7) is flattened, so that the inserter (7) forms a transverse edge (35a) of taking support against the anchor (2), and in that the said positioning means consist of flats (30) provided on the support (6) and corresponding flats (38) provided on the inserter (7) , the coming into coincidence of these respective flats (30, 38) determining a precise angular position of the inserter (7) allowing the engagement of the inserter (7) in the longitudinal conduit (22) formed by the support (6 ). Instrumentation (1) according to one of Claims 1 to 8, characterized in that the cannula (5) forms, at the level of the outlet of the longitudinal duct (12) which this cannula (5) presents in the said chamber (15), a conical wall (17) coaxial with the axis of this duct. Instrumentation (1) according to one of Claims 1 to 9, characterized in that the cannula (5) has a longitudinal slot (60) extending over its entire length, both at the level of the handle 10 and at the level of the rod 11, making it possible to extract the wire (3) outside the cannula (5), laterally.