WO2014177801A2

WO2014177801A2 - Device for fixing at least one suture thread in bone

Info

Publication number: WO2014177801A2
Application number: PCT/FR2014/051020
Authority: WO
Inventors: Denis Clement; Matthieu VIVEAU; Nicolas BONNEVIALLE; Jean-Charles Le Huec; Bruno Zipoli; Vincent MARTINEL
Original assignee: S.B.M.
Priority date: 2013-05-03
Filing date: 2014-04-29
Publication date: 2014-11-06
Also published as: FR3005257B1; WO2014177801A3; FR3005257A1

Abstract

The invention relates to a device for fixing at least one suture thread in bone, said suture thread being able to be connected to at least one soft tissue, said device comprising at least one anchoring element (2) with a continuous inner bore, and at least one pin (20) designed so as to be able to pass through and slide axially within the inner bore of the anchoring element, characterized in that it comprises at least one reamer (30), and in that the pin (20) comprises a shank (22) designed to be able to pass through and slide axially within the inner bore of the reamer, and a head (24) designed to be able to penetrate the bone and entrain said suture thread in a movement in at least a distal direction, and to be able to free said suture thread in at least a proximal direction, counter to said distal direction.

Description

DEVICE FOR FIXING AT LEAST ONE SUTURE WIRE IN

A BONE BODY

The invention relates to a device for fixing a soft tissue, such as a tendon or a ligament, to a bone body.

In particular, the invention relates to a device for fixing at least one suture connected to a soft tissue in a bone body with the aid of an anchoring element.

The invention also relates to a device for placing an anchoring element in a bone body by an arthroscopic surgical technique.

Such a device may for example be used for the fixation of ligaments or tendons in the operations of the shoulder (for example for the reconstruction of the rotator cuff), the knee or the hip.

Throughout the text, "soft tissue" is understood to mean any part of the human or animal body formed of a set of similar cells fulfilling the same function and serving to support the structures or organs of the body. It can be in particular a ligament or a tendon.

EP 1 607 065 discloses a bone anchoring device for a soft tissue comprising a screwdriver, a guide wire passing through the screwdriver, a pin and a screw having a through-bore which can be predisposed to the distal end of the screwdriver for its insertion into a hole previously formed in a bone. Such a device involves the use of many tools and parts and requires to find the hole previously formed in order to set up the screw in the bone, this step can be very difficult to perform, particularly under arthroscopy. In addition, such a device does not allow to pierce the bone and set up the son of sutures simultaneously, prior to insertion of the screw.

Moreover, there are also known devices comprising a self-tapping screw predisposed on a screwdriver and a needle disposed inside the screw and whose tip protrudes from the head of the screw. Such devices do not require prior drilling of a bone before the establishment of the screw, the hole being directly made by screwing the needle and screw into the bone. The Needle having a diameter smaller than that of the screw is in fact essentially the screw which makes it possible to form the hole in the bone. The screw therefore undergoes significant compressive and shearing stresses when screwed into the bone. Such stresses can lead to deterioration and sometimes even rupture of the screw, forcing the operator to remove the damaged screw, to repeat the operation, making it unnecessary to attach the soft tissue to the bone or significantly decreasing the reliability of fixation of the soft tissue to the bone, while risking unnecessary damage to the bone.

The problem related to the existence of such mechanical stresses on the anchoring screw in a bone is all the more important in cases where an anchor screw is used formed of at least one resorbable material whose resistance mechanical may be less than that of another screw in partially absorbable material or not fully absorbable.

The aim of the invention is to overcome the drawbacks of the various devices of the state of the art and to propose a device for placing an anchoring element in a bone body enabling:

the use of an anchoring element formed of at least one resorbable material in the human body,

- Fixing a soft tissue to a bone body without requiring the realization of knots with soft tissue-related sutures,

- ease and speed of establishment of an anchoring element son connected to a soft tissue in a bone body, especially during arthroscopic surgical operations,

placing an anchoring element in a bone body without requiring an exact location of a hole previously formed in the bone body,

- Tensioning the soft tissue-related suture threads and maintaining the tension between making a hole in the bone body, placing the suture threads and placing the element into position. anchoring in the bone body, - The establishment of an anchoring element of resorbable material in a bone body without any non-resorbable material remains in the bone body at the end of an operation.

The invention also aims at providing such a device which is simple to manufacture and at a limited cost.

The invention also aims at providing such a device which comprises only a small number of parts and which makes it possible to simplify and reduce the duration of the surgical operations during which it is used.

To do this, the invention relates to a device for fixing at least one suture in a bone body, said suture being able to be connected to at least one soft tissue, said device comprising:

at least one anchoring element having a through internal bore,

at least one pin adapted to be able to traverse and slide axially in the internal bore of the anchoring element,

characterized in that it comprises at least one reamer adapted to form at least one hole in said bone body, said reamer having an internal bore,

and in that the spindle comprises a rod and a head, the spindle rod being adapted to be able to traverse and slide axially in the internal bore of the reamer and the spindle head being adapted to be able to:

o penetrate the bone body,

o causing said suture to move in at least one direction of the spindle, said distal direction, from a proximal end of the spindle to the spindle head, and to release said suture into at least one a direction of movement of the spindle, said proximal direction, opposite to said distal direction.

A device according to the invention thus makes it possible both to form a hole in a bone body to which a soft tissue such as a ligament or tendon must be fixed and to set up an anchoring element, such as a screw anchoring, in the hole previously formed so as to fix or wedge (s) suture (s) between the anchoring element and the bone body. The reamer having an internal bore, it can be threaded around the pin so as to form a hole in a bone body and to position at least one suture in the hole simultaneously and in a single step. Once a hole has been formed in the bone body, the reamer can be removed from the bone body while leaving the pin holding the suture (s) in place in the hole. Since the pin of the pin can slide axially both in the internal bore of the reamer and in the internal bore of the anchoring member, the pin allows not only to maintain the wire (s) ) suture in position and tension in the hole formed in the bone body but also to keep the exact position of the hole formed in the bone body and to set up the anchoring element easily by guiding it into the hole.

A device according to the invention thus makes it possible to immobilize a soft tissue near a bone in a simple, fast and reliable manner, while allowing only the anchoring element and the suture thread (s) to remain in the bone. the bone body at the end of the surgical procedure.

The reamer is an instrument for forming a hole of the desired shape and size in a bone body. Throughout the text is meant by "reamer" of a device according to the invention, any instrument for forming a hole in a bone body by a rotational movement (reamer type tap for example) and / or translation (reamer needle type, for example).

The reamer is chosen according to the bone to be pierced and the type of anchor used. The reamer makes it possible to form a hole adapted to allow relatively easy insertion of the anchoring element while keeping the anchoring element at least partially in contact with the bony walls of the hole without the anchoring element is likely to move once put into place in the bone. Preferably, the reamer is adapted to form a hole whose axial and radial dimensions are similar to or slightly smaller than the axial and radial dimensions of the anchoring element to be put in place. In particular, advantageously and according to the invention, the reamer is adapted to form, in said bone body, at least one hole having a diameter and a length that are substantially identical or slightly smaller than the diameter and the length of the hole. the anchor element. Thus, the anchoring element can be put in place in the hole formed in the bone body without the risk of subjecting it to excessive stresses that would be likely to damage it, but while allowing that once inserted into the hole, the anchor is held in place by slight bone compression.

The reamer is adapted to slide longitudinally (in both directions) around the spindle rod when the spindle is disposed within the reamer. Thus, the reamer has a cannulated body and can be threaded around the pin shaft and removed from the pin, once the hole in the bone formed for example.

The body of the reamer may have any external shape to form a hole in a bone body. Advantageously and according to the invention, the reamer has a tubular cannulated body having an internal diameter greater than or equal to the diameter of the rod of the spindle.

Advantageously and according to the invention, the reamer has a distal portion adapted to form a hole for inserting the anchoring element without having to exert too much pressure while allowing to retain the anchoring element in position , against the bone wall of the hole, once in place. In particular, the reamer of a device according to the invention has a distal portion having a length equal to (or substantially identical to) the length of the anchoring element to be inserted (identical, slightly greater or slightly lower). In particular, the reamer of a device according to the invention has a distal portion having a nominal diameter less than or equal to the nominal diameter of the anchoring element to be put in place in the hole formed using said reamer. In this way, the anchoring element can be easily set up, without forcing, while allowing it to be held in place in a durable manner, which also makes it possible to hold the sutures in the hole and thus the soft tissue to the bone.

The reamer of a device according to the invention may have a smooth or at least partially partially threaded external surface. The reamer of a device according to the invention may have a slightly pointed and tapered distal end or a distal portion of constant external diameter. When he presents a body externally smooth, it can be used as a needle to form a hole in a bone body, by positioning the distal end of the reamer against the bone body and exerting pressure on the reamer so as to penetrate the bone body (with or without rotation or screwing movement) or by impaction using an impactor. If it has at least partially a threaded portion, the reamer can be used as a tap and the hole is formed by exerting both a pressure against the bone body and a rotational movement (screwing). Advantageously and according to the invention, the reamer has at least one threaded external portion adapted to penetrate into the bone body. Advantageously and according to the invention, the distal portion of the reamer is at least partially threaded. The presence of such an external threaded portion makes it possible in particular to facilitate the formation of the hole in the bone body when the hardness of the bone is greater.

The reamer has a distal end adapted to penetrate the bone body. In particular, advantageously and according to the invention, the reamer has a tapered distal end. In other words, the distal end of the reamer may have a general tip shape facilitating its insertion into a bone body. In particular, advantageously and according to the invention, the reamer has, at its distal end, an entry chamfer, in particular a straight or rounded entry chamfer.

The reamer of a device according to the invention is adapted to be handled by a practitioner alone or with the aid of one or more complementary tools. Advantageously and according to the invention, the reamer has, at its proximal end, a handle, said handle being adapted to allow the handling of the reamer. The handle and the distal end of the reamer are connected by a median portion of variable length adapted in particular to the depth of the hole formed and / or the type of surgical operation in which it is used. The spindle of a device according to the invention comprises a rod adapted to be able to traverse and slide axially in the internal bore of the reamer, and a head adapted to be able to penetrate into the bone body and to drive the said suture in displacement in at least one distal direction and to be able to release said suture in at least one proximal direction opposite to said distal direction. The head of the spit is therefore adapted to drive the suture (s) towards the bone body in which a hole is formed, while allowing the suture thread (s) to be released, that is to say leaving the suture (s) in place in a hole in the bone by removing the pin from the hole in the bone.

On the other hand, the pin has a length greater than the depth of insertion of the pin into the bone to which the soft tissue is attached. The length of the pin therefore depends on the type of operation and the nature of the bone to which the soft tissue is to be attached. It may for example have a length of the order of 150 mm for a shoulder operation.

Advantageously and according to the invention, the spindle head is arranged to act as a stop for the distal end of the reamer in the longitudinal direction of the spindle rod (being substantially identical to the longitudinal direction of the spindle). reamer) and distally (from a proximal end of the spindle to the spindle head). Advantageously and according to the invention, the head of the spindle thus has at least one radial dimension greater than the smallest radial dimension of the distal end of the reamer. Thus, when the reamer is set up around the spindle, passing the open distal end of the reamer around the spindle stem from the proximal end of the spindle and the body of the reamer slides. axially towards the spindle head in the distal direction, the distal end of the reamer is stopped at the spindle head preventing the spindle head from penetrating into the internal bore of the reamer. In this way it is possible to precisely control the depth of insertion of the spindle head into the bone body. In particular, said abutment makes it possible to avoid penetrating the pin too deep into the bone unnecessarily while being certain that it penetrates sufficiently into the bone body, that is to say, so that the head of the bone pin is located outside the distal end of the reamer.

In addition, advantageously and according to the invention, the head of the spindle has a radial dimension smaller than the internal radial dimension of the anchoring element, that is to say less than the radial dimension of the internal bore. of the anchoring element. In particular, advantageously and according to the invention, the spindle head has a nominal diameter smaller than the diameter of the internal bore of the anchoring element. It is thus possible to remove the pin having served as a guide to the insertion of the anchoring element, once the anchoring element has been placed in the bone body. On the other hand, in an advantageous embodiment of a device according to the invention, the head of the spindle has a length greater than half the length of the anchoring element, in particular a length substantially identical to the length of the anchoring element to put in place. Thus, when the pin and reamer are inserted into a bone to which a soft tissue is to be attached, the pin head will stabilize the position of the pin in the bone even when the reamer is removed. The position of the spindle (and therefore the exact position of the hole formed with the reamer) remains unchanged after removal of the reamer and allows precise positioning of the anchor. The choice of such a length of the spindle head thus avoids angular displacement of the spindle rod around the spindle head. It is therefore not necessary to use another instrument to hold the pin in position when fixing a soft tissue to a bone body using a device according to the invention.

An anchoring element of a device according to the invention may be formed of any physiologically acceptable material, and in particular of any material adapted to be implanted in a human or animal bone body. In particular, an anchoring element of a device according to the invention is for example formed of at least one material chosen from polymeric materials, ceramic materials and metallic materials. The anchoring element is formed of at least one material selected from the group consisting of polymers, ceramics, metals and their composites. In particular, advantageously and according to the invention, the anchoring element is formed of at least one material chosen from the group consisting of polymers, ceramics and their composites.

An anchoring element of a device according to the invention may comprise at least one non-absorbable material and / or at least one partially absorbable material and / or at least one fully resorbable material. In particular, advantageously and according to the invention, the anchoring element of a device according to the invention is formed of at least one material, said resorbable or bio-resorbable material, adapted to be resorbed in contact with living tissue and be replaced at least partially by bone material. Thus, in a particularly advantageous embodiment of a device according to the invention, the anchoring element is formed of at least one resorbable material.

Absorbable polymeric materials that can be used to prepare an anchoring element of a device according to the invention are chosen especially from polylactic acid (PLA or lactic acid polymer), for example poly-D, L-acid. -lactic (PDLLA), poly-D-lactic acid (PDLA) or poly-L-lactic acid (PLLA), polyglycolic acid (PGA or glycolic acid polymer), polyhydroxybutyrate (PHB), polycaprolactone (PCL), polydioxanone (PDO), their copolymers and their mixtures. In a particularly advantageous variant of a device according to the invention, the anchoring element comprises at least one polymer chosen from poly-L-lactic acid and a copolymer of L-lactic acid and D-acid, L-lactic (PLDL).

An anchoring element of a device according to the invention may also be formed of at least one nonabsorbable polymer material such as polyetheretherketone (PEEK).

The absorbable or non-absorbable ceramic materials that can be used to prepare an anchoring element of a device according to the invention are for example chosen from calcium phosphates, in particular tricalcium phosphate, hydroxyapatite and their mixtures.

In a particularly advantageous embodiment of a device according to the invention, the anchoring element is formed of a material prepared on the basis of polylactic acid (PLA) and a tricalcium phosphate (β-TCP per example).

Moreover, in addition to at least one pin, at least one reamer and at least one anchoring element, a device according to the invention may also comprise a gripping tool of the anchoring element having a handle and a distal end adapted to can be engaged in the head of the anchoring element, so as to be able to handle and drive the element anchor. Thus, in a particularly advantageous variant of a device according to the invention, the proximal end of the gripping tool has a distal end forming a cavity complementary to the internal bore of the anchoring element.

In particular, such a gripping tool of the anchoring element has, at its proximal end, a handle allowing it to be taken in hand and directed by an operator. The handle of the gripping tool and the distal end of the gripping tool are connected by a rod of variable length and adapted to the establishment of the anchoring element in the bone body using the spindle . In particular, the distal end of the gripping tool has a length substantially identical to the length of the anchoring element and a nominal diameter substantially identical to the nominal diameter of the internal bore of the anchoring element. The distal end of the gripper may be smooth or for example have longitudinal grooves. In particular, the gripping tool is formed of a screwdriver. A device according to the invention may therefore comprise a screwdriver having a handle and a distal end forming a cavity complementary to the internal bore of the anchoring element.

A device according to the invention may comprise several anchoring elements of different sizes and, if necessary, several pins and several reamers with dimensions adapted to be used with the various anchoring elements.

In a first variant embodiment, a device according to the invention may for example comprise a spindle, a reamer and one or more anchoring elements that can be used with said spindle and said reamer. In another variant embodiment, a device according to the invention may comprise several anchoring elements of different sizes and several pins (two or more) and several reamers (two or more), in particular pins and reamers with dimensions adapted to those of each type of anchor element.

Each spindle, each reamer and each gripping tool of a device according to the invention may be disposable single-use type or can be sterilized and reused. Advantageously and according to the invention, a device according to the invention comprises at least one reamer adapted to be sterilized and reused later.

The invention extends to a method of fixing at least one suture in a bone body, said suture being capable of being connected to at least one soft tissue, wherein:

at least one pin is provided in the internal bore of a reamer adapted to form at least one hole in said bone body, the pin having a rod adapted to be able to traverse and slide axially in the internal bore of the reamer,

at least said suture is arranged at the spindle head, the spindle head being adapted to be able to:

o penetrate the bone body,

o causing said suture to move in at least one direction of the spindle, said distal direction, from a proximal end of the spindle to the spindle head, and to release said suture into at least one a direction of movement of the pin, said proximal direction, inverse of said distal direction,

at least one hole is formed in said bone body,

once the hole has been formed, the reamer is removed by holding the pin and said suture in the bone body,

at least one anchoring element is provided having an internal bore through the spindle rod,

said anchoring element is inserted into the hole formed in said bone body so that the anchoring element holds said suture in the bone body, and

the pin is withdrawn through the internal bore of the anchoring element.

Such a method not only makes it possible to form a hole in a bone by simultaneously disposing, in a single step, at least one suture connected to a soft tissue, such as a tendon or a ligament, but also to put in place a simple and fast way an anchoring element, such as an anchor screw, in the hole formed in the bone, so as to hold the suture thread (s) in the bone by wedging, and thus reliably attach the soft tissue to the bone.

The invention also relates to a device and a method characterized in combination by all or some of the characteristics mentioned above or below.

Other aims, features and advantages of the invention appear on reading the following description of one of its preferred embodiments given by way of non-limiting example, and which refers to the appended figures in which:

FIG. 1 is a schematic view of a device according to the invention according to a first embodiment,

FIG. 2 is a view in longitudinal section of an exemplary embodiment of a reamer of a device according to the invention,

FIG. 3 is a schematic view of a reamer and a spindle of a device according to the invention, the reamer having a stop device in the locked position,

- Figure 4 is a schematic view of a reamer and a spindle of a device according to the invention, Γ reamer having a stop device in the unlocked position,

FIG. 5 is a view in longitudinal section of an exemplary embodiment of a gripping tool on which is predisposed an anchoring element of a device according to the invention,

FIG. 6 is a longitudinal sectional view of an exemplary embodiment of a gripping tool and an anchoring element engaged around the spindle of a device according to the invention,

FIGS. 7a to 7h are schematic views illustrating the use of a device according to the invention,

- Figure 8 is a schematic view of a device according to the invention according to a second embodiment.

The device 1 according to the invention shown in FIG. 1 illustrates a first embodiment according to the invention. The device 1 comprises: a bone anchoring screw 2 making it possible to fix by binding at least one suture connected to a soft tissue in a bone,

a screwdriver 10 making it possible to direct the anchoring screw,

a pin 20, and

a reamer 30 making it possible to form a hole in a bone to which a soft tissue such as a ligament or a tendon is to be attached by means of the suture thread (s).

The bone anchoring screw 2 of a device according to the invention as shown in FIG. 1 has a threaded body of tubular shape comprising an internal through bore of dimensions adapted to allow the screw to be able to slide longitudinally around the stem of the invention. the pin 20. In this way the pin 20 can serve as a guide for the insertion of the anchoring screw 2 in a hole previously formed in the bone.

Pin 2 has a rod 22 and at its distal end a tapered head 24. The rod 22 of the spindle is adapted to be axially traversable and slidable in the internal bore of the reamer 30 in both directions (in a direction of insertion of the spindle into the reamer, by inserting the spindle rod at the end of the spindle). distal end of the reamer and in a direction opposite to the direction of insertion). The shaft of the spindle has a length adapted to always be able to protrude from the surface of the bone to which the soft tissue is attached, so that it can be easily handled and removed from the bone once the element has been removed. anchor set up. The head 24 of the spindle is adapted to pierce a bone and penetrate the bone body. The spindle head is slotted so as to be able to drive a suture moving in at least one direction of movement of the spindle 20, said distal direction, from a proximal end of the spindle to the spindle head, while allowing to release the suture in a proximal direction of displacement of the pin 20, inverse of the distal direction.

Nevertheless, other structural embodiments than a slot may be provided to allow the spindle head to perform this function: a hook shape (in lateral projection or formed in a hollow recess radially), or throat (for example in V), or a groove formed in hollow, or a clamp ... The spindle head has for example a length equal to the length of the anchoring element, for example a length of 10 mm.

In addition, the head 24 of the spindle 20 is adapted to be able to traverse and slide axially in the internal bore of the anchoring element. In this way, the pin can be removed from the bone body once the screw 2 is put in place and that it holds the suture (s) by wedging it (s) -ci between the anchor screw and the bone. The spindle head has a diameter slightly smaller than the diameter of the inner bore of the anchor.

The reamer 30 is a tool for forming a hole in the bone body in which then will be attached the suture (s) (s) connected to the soft tissue using the anchoring screw 2.

As seen in Figure 2, the reamer 30 has a tubular cannulated body and a conical distal portion on which opens the internal bore through the reamer. The body of the reamer is cannulated so that the distal portion of the reamer can be threaded about the pin shaft 20 through an open distal end 37 of the reamer. The reamer 30 can therefore slide longitudinally around the rod of the spindle. In the variant embodiment shown in FIG. 2, the distal end 37 of the reamer comprises a right-entry chamfer (forming an angle that can for example be 30 ° to 55 ° with respect to the longitudinal direction of the reamer ). It is of course also possible to use a reamer having a simple tubular cannulated body of constant external diameter and whose distal end is not tapered (variant not shown).

The reamer 30 has a distal portion 35 adapted to form at least one hole in the bone body. The distal portion 35 of the reamer has a threaded portion 36. The distal portion 35 of the reamer is adapted to form a hole whose dimensions correspond to those of the anchoring screw 2. The distal portion 35 of the reamer therefore has a diameter at least substantially equal to the diameter of the anchoring screw 2 so as to allow easy insertion of the anchoring screw while allowing jamming of the anchor screw in bone (that is, without significant free space between the outer surface of the anchor screw and the bone wall). In addition, the distance between the distal end 37 of the reamer 30 and the end of the threaded portion of the reamer 30 (on the proximal side of the reamer, that is to say on the reamer handle side) is substantially equal to the length of the screw.

The reamer 30 also has, at its proximal end, a handle 32 allowing it to be easily directed and manipulated by an operator. The handle 32 and the distal end 35 of the reamer are connected by a medial portion 34.

Thus, the device 1 makes it possible to form a hole and to position the sutures in the hole simultaneously. To do this, after having passed the suture threads connected to the soft tissue in the slot of the head 24 of the spindle 20, and when the reamer is threaded around the pin of the spindle, the assembly formed by pin 20, sutures and reamer 30 in the bone at the desired location by pressure and / or impaction on the handle 32 of the reamer until the front of the threaded portion 36 is flush the bone. The reamer 30 is then screwed into the bone until the threaded portion 36 of the reamer has fully penetrated the bone.

As seen in FIGS. 3 and 4, the medial portion 34 of the reamer 30 comprises a button 33 for controlling an abutment mechanism controlling the advance of the head 24 of the spindle 20 to the distal end 35. the reamer 30. In a first position, said locking position, and that the button 33 controlling the stop mechanism is for example in the retracted position, the position of the pin 20 is fixed relative to the reamer 30. This mechanism stop means comprises for example a sliding device substantially orthogonal to the longitudinal direction of the reamer in an opening formed in the thickness of the middle portion 34 of the reamer 30. In the locking position the device is in the retracted position in said opening formed in the thickness of the middle portion 34 of the reamer 30 and bears on the spindle rod so as to prevent any translation of the spindle into the reamer in the direction p roximal (from the distal end 35 of the reamer to the handle 32 of the reamer). And in the unlocked position the sliding device is in the extended position of said opening formed in the thickness of the middle portion 34 of the reamer 30, so as to allow longitudinal displacement of the pin 20 in the reamer 30. This mechanism makes it possible to leave a space between the head 24 of the spindle 20 and the distal end 35 of the reamer 30. The distance thus left fixed between the head 24 of the spindle 20 and the distal end 35 of the reamer is substantially equal to the length of the threaded portion 36 of the reamer 30. In a second position, said unlocking position, the button 33 controlling the stop mechanism is for example in the extended position and the spindle 20 is free to move longitudinally in the internal bore of the reamer 30.

A device according to the invention further comprises at least one cannulated screwdriver having a distal end 16 adapted to be engaged in the internal bore of the screw. The screwdriver also has, at its proximal end, a handle 12 allowing it to be directed and easily handled by an operator. The handle 12 and the distal end 16 of the screwdriver 10 are connected by a medial portion 14. In FIGS. 5 and 6, the screw 2 is disposed on the distal end 16 of the screwdriver 10. The cannulated screwdriver 10 also has a bore internally adapted to allow the rod 22 of the pin 20 to pass axially through and slide in the internal bore of the screwdriver 10. Thus, the diameter of the internal bore of the screwdriver 10 is preferably greater than or equal to the diameter of the rod 22 of pin 20.

Figures 7a to 7h illustrate the various steps of a method of attaching at least one suture in a bone body, said suture being connected to at least one soft tissue, for example a ligament (not shown). In a first step illustrated in FIG. 7a, the reamer 30 is prepared with the pin 20 disposed inside the internal bore of the reamer 30 and the suture (s) are passed inside the reamer 30. the slit formed in the head 24 of the spindle 20. In a second step illustrated in FIG. 7b, the reamer 30 is brought together with the button 33 in the locked position, the spindle 20 and the suture threads of the location chosen for fix the ligament to the bone and pierce the bone to form a hole that can receive the screw 2. To do this, the tip of the pin is brought into contact with the surface of the bone, the whole formed by the reamer 30 and the spindle 20 being disposed substantially orthogonal to the outer surface of the bone (another configuration with a different angle being of course possible), then pressure is exerted (without rotation required), in particular using the handle 32 of the reamer 30 to penetrate the head of the spindle and the distal end of the reamer 30 into the bone until that the threaded portion 36 of the reamer 30 is flush with the surface of the bone. In a third step illustrated in FIG. 7c, the suture threads are tensioned. The sutures directly connected to the ligament are those that are pressed against the surface of the bone (upwards in FIGS. 7b to 7h).

Then, in a fourth step illustrated in FIG. 7d, the stop mechanism of the reamer 30 is unlocked by means of the button 33 and the threaded portion 36 of the reamer 30 is screwed into the bone so as to penetrate more deep in the bone. This is enabled by the fact that the distance previously left between the head 24 of the spindle 20 and the distal end 35 of the reamer is equal to the length of the threaded portion 36 of the reamer 30. When the threaded portion 36 the reamer 30 is fully screwed into the bone, the distal end 35 of the reamer comes into contact with the head 24 of the spindle 20. The hole thus formed has a size (length and diameter) at least substantially identical to the size (length and diameter) of the screw 2. And, in a fifth step illustrated in FIG. 7e, the reamer 30 is removed while holding the pin 20 in place. The device 1 according to the invention therefore has the advantage of allowing to remove the reamer while keeping in place the suture son in the hole formed in the bone, the pin 20 remaining in place.

Finally, in a sixth step illustrated in FIG. 7f, the screw 2 predisposed to the distal end 16 of the screwdriver 10 is approached using the pin 20 that remains in place as a guide. Thus, the pin 20 has also allowed to keep the exact position of the hole for the establishment of the screw 2. In a seventh step illustrated in Figure 7g, the screw 2 is inserted into the bone by screwing using 10. The screwdriver 10 and the spindle 20 can then be removed in turn leaving only the screw 2 holding the suture threads firmly attached to the soft tissue in place in the bone as shown in FIG. 7h. Sutures whose ends are not connected to the soft tissue can then be cut to the surface of the bone. It can thus be seen in FIG. 7h that the suture threads directly connected to the ligament are left upwards against the surface of the ligament. the bone, the sutures at the other end (free) having been cut close to the surface of the bone.

The device according to the invention shown in FIG. 8 illustrates a second embodiment according to the invention. The device thus comprises:

- a pin 20,

a reamer 40 making it possible to form a hole in a bone to which a soft tissue such as a ligament or a tendon is to be attached using at least one suture,

an anchor 4 or bone anchoring screw making it possible to fix by wedging the suture thread or sutures connected to the soft tissue in the bone, and

- A screwdriver 11 for directing the bone anchor.

The device shown in FIG. 8 differs from the device 1 in that the reamer has no threaded external portion, allowing the formation of a hole solely by impaction. The device also differs from the device 1 in that the anchoring element is formed of an anchor 4 in place of an anchor screw. In addition, the reamer 40 does not have a stop mechanism similar to the abutment mechanism 33 of the device 1. In the device, the distal end of the reamer 40 is adapted to abut the head of the spindle 20. For this the width of the spindle head 20 is slightly greater than the diameter of the distal end of the reamer 40.

The reamer 40 has a distal portion 45 adapted to form at least one hole in the bone body. The distal portion 45 of the reamer is adapted to form a hole whose dimensions correspond to those of the anchor pin 4. The distal portion 45 of Γ reamer therefore has a diameter at least substantially equal to the diameter of the anchor pin 4 so as to allow easy insertion of the pin 4 while allowing a wedging of the anchor screw in the bone (That is, without leaving significant free space between the outer surface of the ankle 4 and the bone wall).

The various steps of a method of fixing at least one suture in a bone body, said suture being connected to at least one tissue soft, using a device are similar to the steps illustrated in Figures 7a to 7h for the device 1.

In a first step, the reamer 40 is prepared with the pin 20 disposed inside the internal bore of the reamer 40 and the suture (s) is passed inside the slot formed in the head 24 of the spindle 20. In a second step, the reamer 40, the spindle 20 and the sutures of the chosen location are brought together to fix the ligament to the bone and the bone is pierced in order to form a hole that can receive the pin 4. To do this, the tip of the pin is brought into contact with the surface of the bone, the assembly formed by the reamer 40 and the pin 20 being disposed substantially orthogonal to the surface external of the bone (another configuration with a different angle being of course possible), then a pressure is exerted (without rotation necessary), in particular using the handle 42 of the reamer 40 to penetrate the head of the bone. the spindle and the distal end of the reamer 40 in the bone. The pressure exerted to penetrate the reamer 40 and the spindle 20 into the bone can be exerted progressively and continuously or by manual impaction or with the aid of an impactor.

In a third step, the reamer 40 is driven into the bone so as to form a hole of length substantially identical to the length of the pin 4. In particular, to precisely control the length of the hole formed, the reamer can be provided with a marking line between the distal portion 45 and a medial portion 44 of the reamer 40. As shown in FIG. 8, the reamer 40 may also have a chamfer between the distal portion 45 and the medial portion 44, the medial portion 44 having a diameter greater than the diameter of the distal portion 45. The reamer is inserted into the bone until the chamfer between the distal portion 45 and the medial portion 44 of the reamer 30 is flush with the surface bone (and / or that the marking line between the distal portion 45 and a medial portion 44 of the reamer 40 is flush with the surface of the bone).

The hole thus formed has a size (length and diameter) at least substantially identical to the size (length and diameter) of the peg 4. The suture threads are then preferably put into tension, the operator being able to pull their ends until the threads are slightly stretched. Then, in the next step, the reamer 40 is removed while holding the pin 20 in place. The device according to the invention therefore has the advantage of allowing to remove the reamer while holding in place the suture son in the hole formed in the bone, the pin 20 remaining in place.

Finally, we approach the pin 4 predisposed on the distal end 17 of the screwdriver 11 using the pin 20 remained in place as a guide for its implementation. The pin 20 thus makes it possible to preserve the exact position of the hole for the placement of the pin 4. The pin 4 is then inserted into the bone using the screwdriver 11. The screwdriver has, at its proximal end, a handle 13 allowing it to be directed and easily handled by an operator. The handle 13 and the distal end 17 of the screwdriver 11 are connected by a medial portion 15. The screwdriver 11 and the spindle 20 can then be removed in turn, leaving only the peg 4 now firmly holding the sutures tied to the tissue soft in place in the bone body. Sutures whose ends are not connected to the soft tissue can then be cut to the surface of the bone.

The invention can be the subject of many variants. A device according to the invention may comprise several anchoring elements, several pins and several reamers In particular, one or more suture son may be used and several anchor screws may be fixed in the same bone body. The number of anchors used in the same bone body depends on the type of operation (the bones and soft tissues involved and the severity of the break in the bond between each bone and soft tissue). One to five anchor screws can for example be used in the same bone. When several anchoring elements are used in the same bone body, the same suture son may be connected to several anchoring elements, each wire is not necessarily necessarily directly connected to the soft tissue to be immobilized near the bone. A device according to the invention can be used to implement any knotless fastening technique of at least one soft tissue to a bone, for example a single or double row technique, but also for an insertion of the d element. anchorage in the medial row (under the soft tissue, that is, between the bone and the soft tissue partially covering the bone) or in lateral row (outside the soft tissue). On the other hand, it is also possible to use a device according to the invention with an anchoring element formed of at least one metallic material, for example an anchoring element formed of a titanium alloy such as Ti _O a V. the use of such an anchor element formed metallic material is particularly advantageous in cases where the dimensions of the anchoring element are very small or when the bone is very dense, and that Anchor element formed of polymer material could be damaged during insertion into the bone. The split spindle head can be replaced by any other structure allowing to perform the same functions (hook, furrow, groove, clamp, ...). The screwdriver and the spindle may be provided with a device such as a thumbscrew to secure them in translation to allow removal together. The spindle head can be equipped with a grommet for easy insertion of the wire into the slot.

Claims

1 / - Device for fixing at least one suture in a bone body, said suture being able to be connected to at least one soft tissue, said device comprising:

at least one anchoring element (2, 4) having a through internal bore,

at least one pin adapted to be able to cross and slide axially in the internal bore of the anchoring element,

characterized in that it comprises at least one reamer (30, 40) capable of forming at least one hole in said bone body, said reamer having an internal bore, and in that the pin (20) comprises a rod (22) and a head (24), the spindle rod being adapted to be able to traverse and slide axially in the internal bore of the reamer and the spindle head being adapted to be able to:

o penetrate the bone body,

o causing said suture to move in at least one direction of the spindle, said distal direction, from a proximal end of the spindle to the spindle head, and to release said suture into at least one a direction of movement of the spindle, said proximal direction, inverse of said distal direction.

21 - Device according to claim 1, characterized in that

The reamer (30, 40) is adapted to slide longitudinally around the spindle rod when the spindle is disposed within the reamer.

3 / - Device according to one of claims 1 or 2, characterized in that Γ reamer (30, 40) has a distal portion having a length equal to the length of the anchoring element (2, 4).

4 / - Device according to one of claims 1 to 3, characterized in that Γ reamer (30, 40) has a distal portion having a nominal diameter less than or equal to the nominal diameter of the internal bore of the element of anchorage.

5 / - Device according to one of claims 3 or 4, characterized in that the distal portion of the reamer is at least partially threaded. 6 / - Device according to one of claims 1 to 5, characterized in that the reamer (30, 40) has a tubular cannulated body.

Il - Device according to one of claims 1 to 6, characterized in that the reamer (30, 40) has, at its distal end, an inlet chamfer.

8 / - Device according to one of claims 1 to 7, characterized in that the reamer (30, 40) has, at its proximal end, a handle (32, 42).

91 - Device according to one of claims 1 to 8, characterized in that the head (24) of the spindle (20) is arranged to act as a stop for the distal end of the reamer (30, 40) in the longitudinal direction of the pin shaft and in said distal direction.

10 / - Device according to one of claims 1 to 9, characterized in that the head (24) of the spindle (20) has at least one radial dimension greater than the smallest radial dimension of the distal end of the reamer (30, 40).

11 / - Device according to one of claims 1 to 10, characterized in that the anchoring element (2, 4) is formed of at least one resorbable material.

12 / - Device according to one of claims 1 to 11, characterized in that it comprises a gripping tool (10, 11) of the anchoring element having a handle (12, 13) and a distal end (16 , 17) adapted to be engaged in the head of the anchoring element (2, 4).