WO2022171801A1 - Device for locking suture threads - Google Patents

Device for locking suture threads Download PDF

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Publication number
WO2022171801A1
WO2022171801A1 PCT/EP2022/053376 EP2022053376W WO2022171801A1 WO 2022171801 A1 WO2022171801 A1 WO 2022171801A1 EP 2022053376 W EP2022053376 W EP 2022053376W WO 2022171801 A1 WO2022171801 A1 WO 2022171801A1
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WO
WIPO (PCT)
Prior art keywords
distal
proximal
component
nut holder
locking member
Prior art date
Application number
PCT/EP2022/053376
Other languages
French (fr)
Inventor
Michel Collette
Original Assignee
Michel Collette
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Michel Collette filed Critical Michel Collette
Publication of WO2022171801A1 publication Critical patent/WO2022171801A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0482—Needle or suture guides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0485—Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409—Instruments for applying suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0414—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having a suture-receiving opening, e.g. lateral opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
    • A61B2017/0448—Additional elements on or within the anchor
    • A61B2017/0453—Additional elements on or within the anchor threaded elements, e.g. set screws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • A61B2017/0488—Instruments for applying suture clamps, clips or locks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A61B2017/061—Needles, e.g. needle tip configurations hollow or tubular

Definitions

  • the present invention relates to a device for tensioning and locking one or more surgical suture son.
  • Shearing with breaking of one strand of the thread on the other during the making of the knot can annihilate the entire process of suturing, the implementation of which is sometimes very delicate, for example in the case of weakened tissues.
  • This risk is even more penalizing when using a sophisticated suture system composed of wires fixed by construction on a small anchor implanted for example in the bone tissue (shoulder, knee, etc.).
  • the accidental breakage of one of the ropes during the making of the knot then annihilates the work carried out, imposes the abandonment of the anchor which has just been placed and therefore requires the reimplantation of a new anchor, with significant negative implications in terms of terms of time, cost, and sometimes, what is worse, lack of an alternative location.
  • the knot irreversibly fixes the tissue tension induced by the surgeon. Too low, the abutment pressure between the tissue edges may be mediocre, or even insufficient, thus prejudicing the healing potential tissue to be repaired. Too strong, the induced tension can lead to a phenomenon of strangulation or even shearing of the tissues located between the 2 strands, with not only the risk of damage to the adjacent tissues but also the risk of gradual and late relaxation of the induced tension in the knot when making it. If the knot is poorly made, the surgeon unfortunately has no choice but to cut it and start the maneuver again.
  • the cruciate ligament graft to the femur is a good example: the sutures or strips for fixing the graft have to pass through a bone tunnel of several centimeters, made through the external condyle, before emerging at the external cortical surface of the femur or will come to apply the button ensuring their fixing.
  • This long textile relay considerably increases the elasticity of the graft-fixation assembly, which has detrimental effects on the healing of the graft, widely recognized and described in the specialized scientific literature (Bungee-chord effect).
  • a first system consists in creating on the suture thread itself multiple pointed protuberances, in the shape of an arrowhead, so as to allow the passage of the thread in one direction only, the protuberances preventing it from sliding in the opposite direction.
  • this type of mechanism has several disadvantages. First, these specialty yarns are unable to resist slippage when subjected to high tensile forces, which inevitably greatly reduces their potential for use. Then, the application of the system is completely irreversible. Once the thread has been introduced, it is impossible to modify its path or withdraw it.
  • US Patent 9,924,939 describes another clamping-blocking system for the suture obtained by construction, by reintroducing a strand of the suture into the very thickness of the filament, which neutralizes the sliding of this strand during the setting. filament tension.
  • This device is now widely used, particularly in ligament reconstruction techniques by suspended grafting, despite the results of several biomechanical studies which clearly demonstrate a tendency to partial relaxation of the system under the effect of cyclic tensile stresses occurring in vivo after the placing the suture.
  • This system also suffers from the negative effects of the problem of elasticity of the textile relays described above. Finally, like shaving threads, the mechanism is completely irreversible. An unfortunate excess of traction during the installation of the device cannot be corrected except by starting the procedure from scratch after cutting the first rope.
  • the locking mechanism is obtained by the interaction of a male member introduced by force into a female receptacle and compressing the wire along its longitudinal path against the walls of said receptacle.
  • the present invention describes a mechanism for compressing the yarn perpendicular to its longitudinal path, which provides particularly effective slip resistance by means of a minimal transverse bulk, perfectly suited to delicate minimally invasive procedures.
  • the present system makes it possible to insert the wire quite freely, for example through the soft tissues, then possibly to use the same locking system at the 2 ends, even if these are relatively far apart. from each other, in order to induce a compression of the tissues included between the 2 blocking organs.
  • US Patent 8,323,315 gives a typical example. It indeed describes a device blocking the sliding of a suture loop by pulling on one of the strands, the other strand carrying with it a small hard organ (ball, knot etc.) fixed on it, coming to jam growing the suture at a canal narrowing created through the blocking anchor. We see immediately that this is indeed a "self-locking" type system on the suture, allowing no reversibility of the procedure. Another major drawback of this system stems from its own mechanism of action. It is in fact the same force which induces both the joining of the edges to be sutured and the interlocking of the components of the blocking system.
  • a high resistance to sliding of a locking member working by clamping can only be obtained by applying a significant interlocking or snapping force of the components of the locking anchor. Not only can this force be difficult to apply simply by pulling on a wire while the anchor itself is subjected to the supple movements of the adjacent soft tissues, but, even if this is achieved, this force can be entirely different from the one that should ideally be applied to the edges to be sutured to best promote its healing.
  • one of the characteristics which seems to us essential to the use of a locking system for a knotless suture, and which is lacking in the various systems described above is to be able to adjust separately and independently the tension on the tissues to be sutured on the one hand and the application of the locking force on the other hand.
  • the other characteristic no less important and also absent from these systems, is to be able, if necessary, to easily unlock the blocking system in order to modify the tissue tension when it seems inadequate, before definitively reapplying the blocking mechanism.
  • the main objective of the invention is to provide a device making it possible to finely adjust the tension on one or more strands of surgical suture threads or ropes for mooring a ligament or even strapping any structure. , then to fix the chosen tension by blocking the sliding of the thread(s) or rope(s) in an efficient and reproducible way, and this, avoiding the technique of knots, the risks and disadvantages of which have been mentioned above.
  • the second objective of the invention is to make the process reversible, that is to say to offer the possibility, if necessary, of easily unlocking the locking system, readjusting the tension in the suture or the suspension or strapping ropes and lock again the sliding of the wires in the new position.
  • the third objective of the invention is to be able, if necessary, to lock the sliding of the threads as soon as they emerge from the structure to be sutured, moored or strapped, even if the anchoring of the locking device is carried out remotely, so as to neutralize any untimely phenomenon of elasticity.
  • the system makes it possible to block threads in the immediate vicinity of the structure to be anchored while relying on a plane located at a distance, thus avoiding the negative phenomena of elasticity specific to intermediate textile relays .
  • the fourth objective of the invention is to provide a system that can be used not only on the surface, in a conventional manner, but also in the depth of the tissues without having to perform a surgical approach to the work area, thus meeting the requirements of the techniques minimally invasive, including endoscopic surgical techniques.
  • the system makes it possible, for example, to effectively block a rope with a minimum size of the blocking member which can even be between 1 and 2 millimeters. This constitutes one of the important characteristics of the invention which makes it possible to distinguish it from most of the competing systems in which the minimum size of the blocking member often varies between 5 to 10 mm.
  • the fifth objective of the invention is to provide a simple and rapid means of sectioning the threads close to their place of blocking, once the operation has been validated by the surgeon.
  • the sixth object of the invention is to provide a system which, with the necessary adjustments in size and shape of the components, is applicable both in fine procedures (eg meniscal suture), of small size, subject to low tensile forces, than in procedures exposing the components to high mechanical stresses (anchoring of ligament grafts).
  • the system also makes it possible, if necessary, to fix an insulated rope, without having to add an additional stopping means (staples or screws), as is the case with knotting fixing techniques. This is also what makes it possible to put a rope in tension then to arrange the locking points at a distance between, without the slightest risk of strangulation.
  • the seventh objective of the invention is to provide a system making it possible to put a rope under tension and then to block it using the same blocking device at both ends.
  • the present invention thus differs from most of the competing systems which require the installation of a prior anchoring point before tensioning and locking the thread.
  • the invention relates to a kit comprising:
  • a blocking device It comprises 3 main elements: i. A male component comprising a threaded rod and an enlarged head (screw); ii. A female component comprising a tapped hole (nut); iii. A washer that can move freely along the male shank of the screw, one of the components, either male or female being said to be proximal and comprising at one end an indentation enabling a torque to be applied to it by means of a screwdriver having the complementary indentation, and the other component being said to be distal and having a section external allowing to apply a couple to it by means of a complementary hollow section.
  • the distal component comprises means making it possible to lock it in rotation by means of a placing instrument, so as to be able to apply a tightening torque to it.
  • the tapped hole can be blind or through, provided that it allows the tightening of the device (i.e. in the case of a blind hole, its depth must be greater than the length of the screw)
  • the distal component is of a shape that easily allows its rotation to be blocked. It can for example be a classic hexagonal section.
  • the blocking element is preassembled, and a loop of thread is passed through the washer, so as to facilitate the subsequent threading of the suture thread.
  • the suture thread can also be passed in advance through the preassembled blocking element.
  • the distal component of the blocking member comprises a loop arranged at its distal end, making it possible to guide the suture thread as close as possible to the anchoring zone of the suture thread.
  • Said loop is preferably arranged on the central axis of the locking member, distal side.
  • a nut holder this is a tubular element whose lower or distal end has a compartment whose size and shape make it possible to accommodate the locking device and move it within the tissues.
  • the shape of the housing makes it possible in particular to block the rotation of the distal component.
  • the distal end also preferably includes one or more slots allowing the suture threads to exit the nut carrier with minimal friction when tensioning the suture.
  • the manipulation of the instrument is preferably carried out by means of a handle fixed transversely to the proximal part of the tubular element.
  • a screwdriver comprising a rod which is dimensioned so as to slide freely but with the least possible lateral play in the central channel of the nut holder and whose shape of the distal end (distal tip) corresponds to the impression made in the component proximal to the blocking member.
  • a handle, or knob At the proximal part of the instrument, there is a handle, or knob, allowing the rotational movement of tightening or loosening of the locking device (i.e. to screw the screw into the nut).
  • a wire cutter comprising a tubular segment sliding freely on the outer wall of the nut holder. The advance or withdrawal of the instrument on the tubular body of the thread cutter is carried out thanks to a small lever fixed to its proximal part.
  • the lower or distal end of said thread cutter is bevelled and finely sharpened so as to be able to easily cut the suture threads after they have been locked in the blocking member.
  • the wire cutter described above is advantageous, however, other cutting systems allowing distal cutting by guiding on the wire after removal of the nut holder and the screwdriver are possible.
  • the shank of the screwdriver comprises a threaded zone which is screwed in use into a corresponding threaded zone on an internal face of the tubular nut holder.
  • the threads of the screwdriver and of the tubular nut holder have a pitch and a direction similar or identical to the pitch and screwing direction of the locking member.
  • the length of the rod is advantageously adjusted so that the tip of the screwdriver fits into the female recess of the screw head while leaving sufficient free space between the base of the pusher and the handle of the screwdriver, allowing the play necessary for tightening the screw in the nut, on the one hand and the expulsion of the blocking member after tightening on the wire.
  • the nut holder comprises a gripping element and for holding the blocking member, this gripping element comprising a coaxial tube, sliding in the tubular element of the nut holder, and comprising at its distal end a set of leaf springs forming the compartment making it possible to accommodate the blocking element, the lengths of the gripping element and of the nut holder being adapted so as to be able to occupy an open position, where the spring blades, projecting from the tubular element of the nut holder are open and allow the easy positioning of the locking element, and a closed position where the tubular element of the nut holder exerts a radial compression on the leaf springs, closing them on the locking element and maintaining it firmly nt this one, both in rotation and in translation.
  • the distal part of the blocking member thus loses all capacity for movement, both rotational and translational, while the proximal part, of rounded shape, retains all freedom of rotational movement. axial, necessary for the screwing movement.
  • the gripping element comprises at its proximal part a transverse handle serving as counter support for the distal axial pressure exerted on the tubular element of the nut holder in order to close the spring blades around the blockage.
  • the nut holder also comprises a push-button which, once secured to the tubular element of the nut holder, makes it possible to easily apply to it the axial pressure necessary for its distal movement, which then causes the blades to close. spring around the blocking member
  • the proximal end of the gripping element comprises a rack cooperating with a corresponding rack inside a duct passing through the push button allowing the tubular element, during its distal movement, to increase and maintain the pressure of the leaf springs around the blocking device without the possibility of recoil.
  • said rack is arranged only on two opposite faces of the conduit passing through the push button and on two corresponding sides of the gripping element, so that a simple rotation of a quarter turn makes it possible to separate these two elements to release the blocking element.
  • the diameter of the screwdriver does not exceed 2 mm, preferably less than 1.5 mm.
  • the wire cutter described above is advantageous, however, other systems for the distal section of the wire using it as a guide are possible, after removal of the nut holder and the screwdriver.
  • the distal component of the blocking member may comprise a proximal extension, said extension comprising means for anchoring to a structure remote towards the proximal zone.
  • This extension is advantageously in tubular form, having at its proximal end a shoulder which can rest on a circular hole made in a suitable attachment structure. Holes made at the distal end of this tubular structure allow the passage of the suture thread(s).
  • proximal shoulder which takes place in the recess of the nut carrier in this case and therefore has the section necessary for the application of the screwing torque on the distal component.
  • the kit of the invention can advantageously also comprise a hollow needle (lumbar puncture needle) and a thread pass, comprising a thin handle and an end comprising a loop (advantageously lozenge-shaped) , made of a retractable metal wire with shape memory which can be passed through the needle channel and which deploys in use when it exits at a distal end of said needle channel.
  • a hollow needle lumbar puncture needle
  • a thread pass comprising a thin handle and an end comprising a loop (advantageously lozenge-shaped) , made of a retractable metal wire with shape memory which can be passed through the needle channel and which deploys in use when it exits at a distal end of said needle channel.
  • the suture thread(s) are passed through the washer, which is then engaged on the threaded rod of the male organ, the free (distal) end of the thread(s) going up along the threaded rod in the proximal direction; - the male and female components of the locking member are engaged one in the other without tightening, the washer sliding freely on the threaded rod and the wire(s) also being able to
  • the locking member provided with the wires is then introduced into the distal orifice of the nut holder by simple pressure and is held there by light tightening, the distal component being placed in the compartment, and the proximal component inside the holder nut;
  • a simultaneous movement of proximal traction on the threads and distal pressure on a handle of the nut holder causes the sliding of the blocking member on the suture threads to the place where they emerge from the tissue structure at suture;
  • the tension in the suture can then be finely adjusted either by accentuating the inverted wire-instrument force, which increases the tension in the suture, or by releasing it, which decreases the tension in the suture;
  • the wire is then reflected at 180° to return to the periphery of the male component of the blocking device. It then undergoes a second crushing zone between the upper face of the washer and the lower face of the screw head.
  • the wire therefore undergoes several cumulative friction interactions, two changes of traction axis (90°, 180°) and two crushing zones (lower face washer-upper face female component/ upper face washer-lower face head of male component screws). These cumulative friction zones provide the system with particularly effective slip resistance, frequently exceeding the breaking strength of the filament itself;
  • the section of the threads flush with the blocking device is obtained, for example, by a simple proximal to distal movement of the thread cutter (provided that this option is chosen) while maintaining the tension on the wires.
  • the yarn(s) can be cut in any other conventional manner.
  • edges of the various components are blunt, in order to avoid any risk of shearing of the wire when it is tensioned.
  • Figure 1 shows a perspective view of the isolated components of the locking member.
  • Figure 2 shows the 3 elements of the blocking member, hinged together (but not tight), as well as the path of the wires inside said member.
  • Figure 3 shows the same elements in the locked position.
  • Figure 4 shows a preferred form of locking element comprising a pre-assembled loop and a breakable rod.
  • Figure 5 shows a sectional view of a hollow sleeve provided at its distal part with a locking device located away from the attachment zone, which occurs proximally, away from the locking zone.
  • Figure 6 shows that it is possible to multiply the clamping interfaces by simply adding additional washers, when the mechanical tension conditions so require.
  • Figure 7 shows the same components as in Figure 5, in the locked position.
  • Figure 8 shows a nut carrier in its various aspects: longitudinal section (Figure 8a), side view ( Figure 8B), upper or proximal end (Figure 8c) and distal or lower end (Figure 8D)
  • Figure 9 shows a screwdriver, equipped with its wheel and the wire cutter.
  • Figure 10 shows a transparent view of various assembled ancillary instruments.
  • Figure 11 shows a close-up section of the distal end of the nut holder after fitting the locking member and the screwdriver, the wire cutter ready to cut the wire.
  • Figure 12 shows a schematic view of the joint of a right knee in the flexion position.
  • the dark gray area represents the medial meniscus with a longitudinal crack located at its posterior medial part. Only this area will be repeated in the following diagrams to illustrate the meniscal suture technique.
  • Figures 13 to 29 illustrate the different sequences of the tension-locking technique of the device described, applied to the meniscal suture.
  • the figure at the top of the page shows the meniscus in perspective.
  • the lower figure illustrates the same action schematically on a cross-sectional view of the same region.
  • Figure 30 illustrates the use of the blocking system applied to surgical reconstruction of the anterior cruciate ligament by suspension graft to the femur.
  • Figure 31 schematizes the use of the system to tension then lock a strapping wire arranged around a cracked structure.
  • Figure 32 describes one (among others) possible technical alternative based on the same principles with in particular the description of an annular-shaped stop corpuscle, allowing the introduction of the wire by lateral pressure after it has passed through through the wall of the knee.
  • Figures 33 a and b show distal elements of the blocking member comprising means for guiding the suture thread closer to the structure to be sutured.
  • Figure 34 shows a blocking element according to Figure 33a in use.
  • Figures 35 and 36 show a screwdriver and a tubular nut holder each having a threaded area.
  • Figure 37 shows the various separate ancillary elements in the case of a system according to the invention comprising a gripping element.
  • Figure 38 shows a transparent view of a push button adapted to the ancillary system of figure 37.
  • Figure 39 shows a front view and a side view and in transparency of an example of an ancillary system mounted, in the open position.
  • Figure 40 shows a front view and a side view and in transparency of an example of an ancillary system mounted, in the closed position.
  • Socket locking shoulder 10. Sectional view of the threaded male rod fixed to the bottom of the socket
  • Any tissue structure e.g. bone
  • site of a fracture to be repaired by cerclage e.g. bone
  • Suture arranged in the form of a circle in a state of tension.
  • Distal element of the blocking device comprising a positioning loop 60
  • Distal element of the blocking device comprising a centered positioning loop 61
  • the present invention relates to a device making it possible to lock the sliding of suture threads after having adjusted their tension in a fine and reversible manner if necessary, while avoiding the classic technique of knots.
  • Figure 1 shows the main element of the device, namely the blocking member, consisting of its 3 main elements
  • a head of rounded shape and variable thickness whose lower face, entirely flat, is joined at its center to the threaded rod and whose upper face, of variable shape (flat, convex, etc.), is dug with a cavity 1b, preferably hexagonal, making it possible to accommodate the end piece of the "hexagonal" type of corresponding size, of the screwdriver.
  • the edge located at the junction between the upper and lower face of the head 1a is advantageously blunted or chamfered so as to avoid any possibility of shearing of the wire when tightening the male member in the female member.
  • a "female" member 3 having a body of generally flattened shape, comprising a perfectly flat upper surface 3a, perforated at its center with a cylindrical orifice 3b passing right through and threaded over its entire extent.
  • the lower surface 3c has a preferentially convex shape so as to be entirely atraumatic for the adjacent tissues.
  • the peripheral contour 3d has a preferentially (but not necessarily) hexagonal shape, allowing it to fit into a female end piece of corresponding shape and size of the gripping tool, blocking its rotation during screwing and unscrewing movements.
  • the junction between the flat part and the peripheral part of the female member must be blunted or chamfered to avoid any risk of shearing of the wire.
  • a washer 2 flat member of rounded shape, perforated in its center with an orifice 2a of diameter greater than the diameter of the threaded rod 1c of the male member 1, so that it can slide freely and loosely on said stem and allow the suture threads 4 to slide very easily as long as the male and female components are not tight together.
  • Figure 2 shows the 3 components 1,2,3 of the blocking member as well as the path of the suture threads 4 after their introduction into said member.
  • the suture threads 4 remain perfectly slidable within the blocking member when it is in this state of configuration.
  • Figure 3 shows the same components but this time in the locking position of the suture threads 4.
  • Figure 4a shows the same components, in a pre-assembled version in which a wire loop 56 is placed in advance in the washer 2 so as to facilitate the threading of the suture thread into the washer.
  • the user just has to pass the suture thread through the loop 56 and pull on the free strands 57 to pass the suture thread through the washer 2.
  • Figure 4 b shows a small blocking member provided with its wire loop 56 and a prehensile rod 65 facilitating its handling.
  • this prehensile rod 65 comprises at its base a groove 66 facilitating its breaking once placed in the ancillary means.
  • Figure 5 illustrates one of the possible technical variants of the locking device of the present invention, responding to particular situations where the ideal zone 12 for locking the wires is located at a distance from the ideal zone 12' of the anchoring of the blocking device.
  • This situation arises when the structure to be anchored or sutured is adjacent to an anatomical structure of low mechanical quality such as for example the spongy bone 5'.
  • a standard blocking device would require allowing the wires 4 to travel through the entire tissue space located between the levels 12 and 12' before finding a strong anchor area.
  • Such a device is necessarily accompanied by the formation of a long textile relay (distance between levels 12 and 12') the elasticity of which leads to the negative consequences that we have already mentioned above.
  • the locking member comprises a hollow sleeve 11 comprising an elongated body of tubular shape 6, a proximal upper end and a distal lower end.
  • the length and diameter of the tubular segment depend on the type of intervention performed and the condition of the anatomical structures.
  • the lower or distal end of the sleeve 11 is blind and on the bottom of the inner wall, in its center, is fixed a threaded rod 10 intended to articulate with the threaded female orifice of the nut 8.
  • a washer 2 slides freely and loosely on the threaded rod 10 of the sleeve 11.
  • the bottom of the sleeve 11 is also pierced with 2 orifices 13 allowing the passage of the wires 4 whose path is analogous to the path wires from the classical organ.
  • the sleeve 11 therefore first crosses the cortical bone 5 then the spongy bone 5′ deemed to be fragile and the widened rim 9 of the upper end of the sleeve finally stops it on the solid support. of the cortical bone 5 thus ensuring not only the solidity but also the rigidity of the assembly.
  • Figure 6 illustrates a possible technical variant of the same device, responding to the possible need to increase the slip resistance of the wires in the event that the importance of the tensile mechanical stresses so requires.
  • 2 additional washers 2 makes it possible to double the surface of the tightening interfaces (4 interfaces instead of 2 with a single washer). They are located between the underside of the nut and the upper washer (first interface), between the washers between them (second and third interface) and finally between the underside of the distal washer and the socket floor (fourth interface ), with a practically unchanged size of the device.
  • Figure 7 shows the same device (with a single washer) in the locking position of the wires 4.
  • the blocking device further comprises ancillary components of the system making it possible to arrange the blocking member appropriately.
  • a gripping element 67 comprising a tubular segment, a nut holder proper 85 and a pusher 75.
  • the gripping element 67 comprises a longitudinal tubular segment, a distal segment and a proximal segment.
  • the longitudinal segment of the gripping element comprises a hollow tube approximately 15 cm in length, the internal diameter of which (approximately 2.25 mm) is adjusted to allow the rod of the screwdriver 7, the diameter of which is 7, to slide freely. about 2mm. Being only subject to torsional stresses, the wall of this tube can be thin depending on the material used (eg: approximately 0.25 mm for a conventional metal such as I ⁇ NOC or aluminium).
  • the distal segment of the gripping element 67 comprises at least 3 or preferably 4 small curved spring blades 68 (15 to 20 mm in length for a thickness of 0.15 to 0.20 mm) arranged in a collar at the external face of the tube with a gap of approximately 90°, and which are for example welded or glued along its longitudinal axis, extending beyond its distal end by approximately 10 to 15 mm.
  • These small blades 68 are spontaneously deployed in the rest state by creating a virtual cavity in the shape of a basket or basket, intended to accommodate the blocking member.
  • These blades can also be formed by the deformation of segments of the end of the hollow tube, these segments being separated by longitudinal cutouts.
  • the tubular element 71 of the nut carrier 85 By sliding around the gripping element 67 in the direction of its distal end, gradually encloses the small blades 68 which close on each other, blocking any possibility of rotation of the female part of the blocking member while leaving free the rotary movement of its male part, thus allowing the remote application of the force torque applied to the handle 22 of the screwdriver.
  • a transverse handle 69 About 3 cm from the proximal end of the gripping element 67 and perpendicular to its longitudinal axis, there is a transverse handle 69 4 to 5 mm in diameter and 4 to 5 cm long, fixed in the middle on the gripping element 67.
  • this transverse handle 69 makes it possible to find the support necessary to resist the axial pressure which will be applied by the thumb on the pusher 75 , exactly like a syringe.
  • two small crenellated elements 70 approximately 15 mm long by a few millimeters wide are fixed to the external face of the gripping element, to the part immediately adjacent to the transverse handle 69.
  • the teeth of these small modules 70 are inclined by approximately 45°, like an arrowhead pointing in the direction of the proximal end of the gripping element 67.
  • These 2 elements are fixed at 180° relative to each other , the adjacent surfaces remaining smooth and devoid of relief.
  • the nut holder 85 itself comprises two distinct tubular segments, one distal 71 and the other proximal 72. They are welded and connected to each other but have a shape, a size and a function different.
  • the distal tubular segment 71 has a distal orifice through which the spring blades 68 of the gripping element 67 will penetrate when it is mobilized distally and a proximal orifice in connection with the proximal tubular segment.
  • the length of the distal tubular element 71 is preferably equal to the portion of the gripping element 67 located distal to its transverse handle.
  • the minimum internal diameter of this section must allow it to slide freely around the gripping element 67 (thickness of the spring plates included). If, for example, the outside diameter of the gripping element with its spring blades is 3.2 mm, the inside diameter of tube 2 must be at least 3.5 mm. If the wall of the nut holder is 0.25 mm, the total diameter of this segment will be 4 mm, which allows it to be used easily for any minimally invasive procedure performed under endoscopy.
  • the proximal tubular segment 72 comprises a longitudinal segment of cylindrical shape, a distal end welded and in communication with the distal tubular segment 71 and an open proximal end which will be used to make the junction with the pusher.
  • a longitudinal slot 73 passes through the middle of the entire proximal tubular segment with the exception of the junction zone with the distal tubular segment described above. The thickness of the slot must be sufficient to allow the proximal segment to slide freely on the gripping element 67 until it comes to tie the transverse handle 69 of the gripping element.
  • the assembly of the instrument assumes that the base of the nut holder 67 is fitted onto the distal end of the gripping element 67, the movement of the nut holder 85 from distal to proximal stopping when the top of the longitudinal slot 73 made in the proximal segment 72 abuts on the transverse handle 69 of the gripping element 67.
  • the outer diameter of the proximal tubular segment 72 will therefore ultimately be 8 to 10 mm, corresponding to the sufficient thickness of the walls and the size of the cylindrical cavity intended for fitting the pusher 75.
  • the inner wall of the tubular segment at its proximal part comprises a female thread 74 over a height of 3 to 4 mm, intended to secure the nut holder 85 with the pusher 75, the base of the tubular segment of which will comprise a male thread 78 matching.
  • the pusher 75 comprises a wide and rounded proximal segment and a tubular-shaped distal segment.
  • the proximal segment comprises a convex proximal external face, preferably but not exclusively of semi-spherical shape, possibly hollowed out with a slight depression intended to accommodate effectively and comfortably the impression of the thumb which will exert the axial pressure on the instrument. in the distal direction. Opposite this convex face, the proximal segment also comprises a perfectly flat distal face in the center of which is implanted a cylindrical tubular segment 20 to 25 mm long, perpendicular to said surface.
  • a cylindrical cavity with a diameter slightly greater than the outer diameter of the gripping element 67 passes through the entire tubular segment of the pusher 75 and then extends over approximately 3/4 of its proximal part. This cavity allows the gripping element 67 to penetrate inside the pusher 75 when the latter moves distally. At the level of the proximal part of the pusher, the cylindrical cavity is then extended to its proximal end by a fine cylindrical channel 77 of diameter slightly greater than the diameter of the rod of the screwdriver 7. This small channel 77 therefore makes it possible to guide the rod of the screwdriver as far as the entrance to the central channel of the gripping element 67 in order then to reach the blocking member 1-2-3.
  • a male thread 78 of 2 to 3 mm has been created on the external face of the cylindrical tubular segment at the level of its junction with the proximal segment.
  • This thread 78 is intended to articulate with the corresponding female thread 74 existing at the level of the proximal end of the nut holder 85 so as to join the two parts together.
  • Two crenellated elements 76 identical to those described at the level of the base of the gripping element 67 are fixed longitudinally at 180° relative to each other at the level of the internal face of the distal portion of the distal tubular segment.
  • the orientation of the teeth of the respective slots of the gripping element 67 and of the pusher 75 has been reversed by 180° in order to allow the sliding of one over the other during the distal mobilization of the pusher 75.
  • a longitudinal slot of a length corresponding to that of the racks and 1 mm wide, crosses right through the wall of the cylindrical tubular segment passing through the middle of the smooth faces of the tube (at 90° in relation to the position of the racks).
  • the rod 7 consists of a cylindrical rod 7 and a handle 22 allowing it to be actuated.
  • the diameter of the rod 7 must be slightly less than the diameter of the inner channel of the gripping element 67 and of the proximal thin portion of the inner channel 77 of the pusher 75.
  • the rod ends in a tip whose the male relief corresponds to the female recess made in the screw head of the locking member (male part).
  • the instrumentation being specially adapted to the microelements, the shape of this tip will generally be similar to that of the micro screwdrivers which are used in microelectronics or in jewellery.
  • the length of the rod must be at least equal to the longest length of the nut carrier in the unlocked position, that is to say from the distal end of the claws in the open position to the base of the pusher. It is thanks to this characteristic that the screwdriver will be able to expel the locking member from the claws after disengagement of tubes one and two. As long as these 2 tubes remain engaged, the claws in the closed position effectively prevent any possibility of expulsion of the blocking member.
  • the shape and size of the screwdriver handle are adapted to the type of application in progress by best meeting ergonomic requirements. vs. The wire cutter.
  • the ancillary B mode is more particularly suitable for procedures requiring the use of large blocking devices, requiring the application of greater forces, especially when the nut carrier fitted with the locking device is working. in abutment on a hard organ (eg the bottom of a bone cavity) thus avoiding the risk of prematurely expelling the nut before the tightening process is completely completed.
  • the longitudinal segment is a hollow tube approximately 8 to 10 cm in length (which may vary depending on the type of procedure) whose outer diameter exceeds by 0.25 to 0.5 mm the largest diameter of the female component of the locking member used and whose diameter of the inner channel 16 is, over its entire length, except for a few mm of the distal segment 17, very slightly greater than the diameter of the screwdriver shaft, so as to allow said screwdriver to slide freely through the inner channel of the tube but guiding it precisely in its center.
  • this inner channel 16 is contiguous and coaxial with a hexagonal-shaped orifice 17 (cubicle) a few millimeters in height and with transverse dimensions identical to those of the female component of the blocking member, so as to be able to fit said member and move it without difficulty.
  • a hexagonal-shaped orifice 17 cubicle
  • a slot 19 has been made, approximately 1 mm wide by 5 to 6 mm high, thus allowing the wires to come out of the blocking member and to travel freely along the outer surface of the tube, in the direction of its proximal segment.
  • a handle 15 allowing said tube to be grasped and easily manipulated according to need. It consists of a segment of cylindrical shape with rounded ends, 6 to 8 mm in diameter and approximately 5 to 6 cm in length, fixed in the middle to the tube, perpendicular to its longitudinal axis.
  • the screwdriver (figure 9, left). It consists of a cylindrical rod 7 and a handle 22 allowing it to be actuated.
  • the rod with a diameter very slightly less than the diameter of the inner channel 16 of the nut holder, slides easily in this channel while remaining perfectly centered with respect to it.
  • the rod ends in a tip 23 whose male relief corresponds to the female indentation 1b made in the head of screw1 of the locking member (male part).
  • the rod is a 6-sided end fitting fitting into a hollow hexagonal indentation.
  • the length of the rod can vary according to the applications but it is adjusted so that the length (height) of the locking device (after tightening) combined with that of the screwdriver (after, complete fitting in the recess of the screw ) corresponds exactly to the length of the nut holder tube 18. Too long, even slightly, the rod could cause the blocking member to come out of its housing too early, before the screwing of the two components is complete and therefore the blocking of the wires is reached, too short, the handle or knob of the screwdriver would come up against the entrance of the nut holder, thus preventing the complete tightening of the blocking device and therefore the blocking of the wires.
  • the handle 22 may vary in shape and size depending on the current application. In the example of technique described below (meniscal suture), it is represented in the form of a simple roll.
  • the wire cutter ( Figure 9 on the right) It consists of a tubular member 27 of very thin thickness and of a length a few cm less than the length of the nut holder 18. It slides intimately and freely along the outer wall of the nut holder , by simple manual pressure on a small lever 26 fixed near its proximal end.
  • the lower end 28 of the wire cutter has been bevelled and finely sharpened so that the meeting of the cutting edge of the component with the wires put under tension beforehand causes the immediate cutting of these, like a guillotine.
  • Figure 10 shows the 3 ancillary instruments nested one inside the other.
  • the rod 7 of the screwdriver is seen by transparency through the wall 14 of the nut holder 18.
  • the wheel 22 of the screwdriver rests against the upper end of the nut holder.
  • the wire cutter 27 has been engaged and slides freely on the wall 14 of the nut holder.
  • Through the lateral slot 19 made in the lower end of the nut holder, the tip 23 of the screwdriver can be seen.
  • Figure 11 shows a close-up longitudinal section of the lower end of the nut holder 14 after loading the locking member in the sliding position 42 and inserting the screwdriver 7.
  • FIG. 12 represents the diagram of a joint of a right knee in a flexion position comprising the femur 29, tibia 30, fibula 31 and the external meniscus 32.
  • the internal meniscus 33, site of a meniscal tear 34 is shown in dark gray. Only this schematic element of the entire joint will be used repeatedly in all the following diagrams, illustrating the technique of meniscal suture by way of example among others of the possibilities of use of the blocking device, object of the present invention. .
  • Each of the stages of the technique is illustrated by a figure comprising two contiguous diagrams. The one on the left represents the different elements seen in perspective, from front to back, the one on the right represents the same action seen in section.
  • the operation begins (FIG. 13) with the introduction from front to back of a long hollow needle 38 (lumbar puncture needle) passing above the meniscal breach 34, crossing the entire wall of the knee and its various components, the capsule-ligament plane 37, the subcutaneous plane 36 and the cutaneous plane 35.
  • the needle thus reaches the outside of the knee in its postero-internal part.
  • the channel of the needle 38 (figure 14), then allows the introduction of a grommet, composed of a fine handle 39 and a lozenge-shaped end 40, made of a very fine retractable metal wire with memory of shape which unfolds as soon as it emerges from the channel of the needle.
  • This small corpuscle has a preferentially but not necessarily spherical shape. It could be made of compatible metal (titanium etc.), a rigid biocompatible material such as peek or another rigid bioabsorbable material. It has been published in the specialized literature that a similar blocking effect can be obtained by making one or more knots on the thread itself but, for convenience, the prior fixing of a stop corpuscle seems to us desirable. It should also be noted that the entire technique demonstrated below describes a meniscal suture made using a suture thread comprising 2 filaments, which obviously has strength advantages.
  • FIG. 16 Figure 16. The threads 4 are then tensioned while keeping the needle inside the knee. A tiny skin incision of 1 to 2 mm made with a scalpel allows the corpuscle 41 to cross the cutaneous plane 35 then to penetrate into the deep plane through the subcutaneous fatty plane 36, of low resistance, and finally to come to attach to the capsular fibrous plane 37 where it comes to rest.
  • Figure 17 The needle is then inclined by 25 to 30° so as to approach the upper surface of the meniscus 33 as perpendicularly as possible.
  • FIG. 18 The needle 38 is then reintroduced from front to back, first crossing the meniscal body 33 then the various components 37, 36 and 35 of the wall of the knee, carrying with it the suture threads 4 which therefore run along the outer wall of the needle during their path from front to back, thus emerge outside the knee at its postero-internal part then, after reflection of 180°, describe a reverse path from back to front at the within the needle to issue to the proximal part thereof.
  • Needle 38 is withdrawn from back to front and the threads, freed from the needle, are drawn to the outside of the knee by simply pulling on loop 4 made up of the 4 strands issuing from the inner postero part of the knee.
  • Figure 21 The empty needle 38 is then reintroduced from front to back below the meniscus 33, aiming at the cutaneous outlet zone of the suture threads lying free outside the knee in the posterolateral region. internal.
  • FIG. 22-23 This maneuver then makes it possible to reintroduce the thread guide in order to capture the free end of the suture threads 4 and reintroduce them into the knee.
  • This maneuver may require the performance of a second cutaneous micro-incision in order to allow the sutures 4 to migrate through the skin 35, cross the subcutaneous fatty layer 36 and abut against the fibro-ligamentous plane 37, like the corpuscle stop 41.
  • FIG. 24 The sutures 4 are recovered outside the knee but this time in front of it, by one of the arthroscopic approaches.
  • the wires are introduced into the blocking member 42, the components of which have been assembled beforehand but not tightened, according to the diagram described in FIG. 2. (NB: for reasons assembly of the male and female components can be done after first passing the wires through the washer and threading it on the male rod.)
  • the locking member then slides completely freely on the filaments .
  • FIG. 27 After having checked the adequate closure of the meniscal breach and if he is satisfied with it, the surgeon then only has to perform a few clockwise rotations applied to the knob 22 of the screwdriver which causes the clamping of the blocking member 43, completely locking the sliding of the threads 4. If at this time, the appearance of the suture is not satisfactory (tightening too great or, on the contrary, insufficient) it suffices to unscrew the blocking member a little, resume the tensioning operation on the wires to their level deemed optimal and screw the blocking member back on to bring it to its final locking position 43.
  • Figure 29 shows the end result of the suture. It can be seen that the small blocking body 43 will lodge in the inferior internal meniscal recess, where there is no risk of injuring the neighboring tissues. This is not the case for any technique ending in the formation of a knot on the upper surface of the meniscus, thus risking damage the articular cartilage of the overlying femoral condyle by repeated friction during flexion-extension movements.
  • Figure 30 clearly demonstrates that the thread locking device described by the present invention can be applied to situations radically different from those just illustrated with the meniscal suturing process.
  • this time it is a question of obtaining an anchorage that is both solid (exposed to several tens of kilos of traction) and rigid (by eliminating the parasitic phenomena of elasticity) of a ligament graft to a bone structure.
  • the diagram illustrates the inclusion of an anterior cruciate ligament graft 46 introduced into a bone pocket 45 made in the external femoral condyle 44.
  • Figure 30 shows how the hollow socket 11 makes it possible to lock the wires at level 12, in the immediate vicinity of the ligament graft while the socket is attached to a level 12' several centimeters away, thus avoiding the need for a long textile relay between these 2 levels, the elasticity of which is detrimental to the healing of the graft.
  • Figure 31 shows how the blocking device could be used to carry out, by strapping process, the reduction and maintenance in the reduction position of any anatomical structure that is the site of a crack or fracture.
  • Figure 31a shows the placement of a strapping rope 49 around a cracked structure 48.
  • Figure 31b shows the tensioning of the yarns through the locking member in sliding position 42, causing and consequently the reduction of the cracked structure.
  • Figure 31c illustrates the locking of the wires after reduction by tightening the locking member 43.
  • meniscal suturing technique described above constitutes one example among others of the possible applications of the locking device described by the present invention. There are many possible variants of the system and it is not possible to describe them exhaustively here.
  • FIG. 32 illustrates one of these variants making it possible to replace the grommet 39 with a simple filament loop 52, one of the strands of which passes inside the needle and the other along the needle ( Fig30a).
  • a simple filament loop 52 one of the strands of which passes inside the needle and the other along the needle ( Fig30a).
  • Such a device makes it possible very simply to bring a traction filament loop to the outside of the knee without the use of a grommet 39 whose main drawback lies in the diameter of the handle requiring the use of a needle large enough to allow its passage.
  • the filamentary loop can be made with an extremely fine wire, thus allowing the use of much finer needles and therefore much less traumatic for the tissues that it must cross (Ex: meniscus, wall of the knee etc.).
  • the filament loop offers several options.
  • FIG. 32 B illustrates, for example, the possibility of drawing a new suture filament 4 provided with a stop corpuscle 41 described above into the knee.
  • Another possibility described in FIG. 32c is that of using a stop corpuscle of the annular type 53, provided with a lateral opening 54 making it possible to introduce the wire 4 therein by lateral pressure taking advantage of the elasticity of the annular body. .
  • the suture thread4, section 55 of which can be seen in figure 32c, is then imprisoned inside the corpuscle and slides freely on the thread.
  • This device makes it possible, for example, to set up a second juxtaposed stitch using the same filament, then to stretch the 2 stitches together thanks to the sliding of the thread in the annular corpuscle and finally, to lock the assembly by means of a single blocking device.
  • the distal element of the blocking member preferably comprises a loop for guiding the suture thread placed at its distal end, so as to place the anchoring point of the blocking member optimally in relation to its position during tightening.
  • Figures 33 a and b show two alternatives in which the distal component 59,61 of the blocking member comprises at its distal end a positioning loop 60,62 of the suture thread 4.
  • a first strategy to avoid this problem is to provide the length of the stem of the screwdriver 7 so that it has just the length necessary for screwing the locking member (ie that the stem of the screwdriver 7 is similar or identical to the length of the nut holder 14 reduced by the length of the blocking element). In this case, the handle or the wheel 22 bears against the proximal end of the nut holder 14 before the screwdriver leaves the locking member of its housing.
  • Another advantage of using screw threads between the nut carrier and the screwdriver is to secure them during the operation, which allows the operator to position and screw the locking member in one go. hand, while the operator's other hand applies adequate tension to the suture.

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Abstract

The present invention relates to a kit for locking suture thread(s) comprising: A) at least one locking member comprising: i. A male component (1) comprising a threaded rod (1c) and a widened head (1a); ii. A female component (3) comprising a tapped hole (3b); iii. At least one washer (2) freely movable along the threaded rod (1c) of the male component (1), one of the male or female components being said to be proximal and having at one end an indentation (1b) enabling a torque to be applied thereto by means of a screwdriver having the complementary indentation, and the other component being said to be distal and having an external section (3d) enabling a reverse torque to be applied to it by means of a complementary hollow section; B) a tubular nut holder (14) having a distal end (17) and a proximal end, the distal end (17) having a socket (21) for receiving the locking member (1, 2, 3) and moving it inside tissue, the shape of the socket (21) being configured to allow torque to be applied to the distal component of the locking member and the proximal end comprising gripping means (15) for guiding the nut holder and applying torque thereto; C) a screwdriver comprising a shank (7) comprising a distal end (23) and a proximal end (22), the shank being dimensioned to slide freely in the central channel of the nut holder, and the shape of the distal end (23) thereof corresponding to the indentation (1b) made in the proximal component of the locking member so as to be able to screw or unscrew the latter in or on the distal component of the locking member.

Description

DISPOSITIF DE BLOCAGE DE FILS DE SUTURE SUTURE LOCKING DEVICE
Objet de l'invention Object of the invention
[0001] La présente invention se rapporte à un dispositif permettant de mettre en tension et de verrouiller un ou plusieurs fils de suture chirurgicale. The present invention relates to a device for tensioning and locking one or more surgical suture son.
Etat de la technique [0002] En chirurgie, les techniques de réparation des tissus lésés ou de fermeture des plaies nécessitent la mise en œuvre de procédés permettant de rapprocher les tissus entre eux et de les maintenir ensuite accolés sous tension de manière à induire leur cicatrisation. Classiquement, cette technique s'effectue au moyen d'un fil de suture dont un brin traverse chacun des tissus à suturer et ressort en sens inverse à quelque distance du point de pénétration, les 2 brins du fil étant ensuite noués entre eux sous tension de manière à maintenir l'accolement des tissus pendant la phase de cicatrisation. Bien qu'étant universellement utilisés en chirurgie, les nœuds ne sont cependant pas dénués d'inconvénients ou même de risques bien connus des chirurgiens : STATE OF THE ART [0002] In surgery, the techniques for repairing damaged tissues or for closing wounds require the implementation of processes making it possible to bring the tissues together and then to keep them joined under tension so as to induce their healing. . Conventionally, this technique is carried out by means of a suture thread, one strand of which passes through each of the tissues to be sutured and comes out in the opposite direction at some distance from the point of penetration, the 2 strands of the thread then being tied together under tension of so as to maintain tissue adhesion during the healing phase. Although being universally used in surgery, knots are however not devoid of disadvantages or even risks well known to surgeons:
Le cisaillement avec rupture d'un brin du fil sur l'autre lors de la réalisation du nœud peut annihiler tout le processus de suture dont la mise en place est parfois très délicate, par exemple en cas de tissus fragilisés. Ce risque est encore plus pénalisant lorsqu'on utilise un système sophistiqué de suture composé de fils fixés par construction sur une petite ancre implantée par exemple dans le tissus osseux (épaule, genou etc.). La rupture accidentelle d'un des filins lors de la réalisation du nœud annihile alors le travail réalisé, impose l'abandon de l'ancre qui vient d'être posée et nécessite donc la réimplantation d'une nouvelle ancre, avec importantes implications négatives en termes de temps, de coût, et parfois, ce qui est pire, d’absence de zone alternative d’implantation. Shearing with breaking of one strand of the thread on the other during the making of the knot can annihilate the entire process of suturing, the implementation of which is sometimes very delicate, for example in the case of weakened tissues. This risk is even more penalizing when using a sophisticated suture system composed of wires fixed by construction on a small anchor implanted for example in the bone tissue (shoulder, knee, etc.). The accidental breakage of one of the ropes during the making of the knot then annihilates the work carried out, imposes the abandonment of the anchor which has just been placed and therefore requires the reimplantation of a new anchor, with significant negative implications in terms of terms of time, cost, and sometimes, what is worse, lack of an alternative location.
Le nœud fixe de manière irréversible la tension tissulaire induite par le chirurgien. Trop faible, la pression d’accolement entre les berges tissulaires peut être médiocre, voire insuffisante, portant ainsi préjudice au potentiel de cicatrisation du tissu à réparer. Trop forte, la tension induite peut entraîner un phénomène d’étranglement ou encore de cisaillement des tissus situés entre les 2 brins, avec, non seulement risque de dommages pour les tissus adjacents mais encore risque de relâchement progressif et tardif de la tension induite dans le nœud lors de sa confection. Si le nœud est mal réalisé, le chirurgien n’a malheureusement pas d’autre choix que de le sectionner et de recommencer la manœuvre. The knot irreversibly fixes the tissue tension induced by the surgeon. Too low, the abutment pressure between the tissue edges may be mediocre, or even insufficient, thus prejudicing the healing potential tissue to be repaired. Too strong, the induced tension can lead to a phenomenon of strangulation or even shearing of the tissues located between the 2 strands, with not only the risk of damage to the adjacent tissues but also the risk of gradual and late relaxation of the induced tension in the knot when making it. If the knot is poorly made, the surgeon unfortunately has no choice but to cut it and start the maneuver again.
• Lorsque la distance entre les 2 brins de suture augmente, Le nœud comporte un risque croissant d'étranglement accidentel des structures anatomiques situées entre les brins (étranglement vasculaire ou nerveux). Ce risque interdit donc pratiquement l'usage de sutures à nouer en mode percutané dans les zones anatomiques à risque. La réalisation de points de suture dans ce type de zones entraîne donc souvent la mise en œuvre de techniques chirurgicales plus invasives, nécessitant un abord chirurgical classique avec dissection préalable des tissus mous sus-jacents au plan tissulaire à suturer. • When the distance between the 2 suture strands increases, the knot carries an increasing risk of accidental strangulation of the anatomical structures located between the strands (vascular or nervous strangulation). This risk therefore practically prohibits the use of sutures to be tied in percutaneous mode in the anatomical zones at risk. The production of stitches in this type of area therefore often leads to the implementation of more invasive surgical techniques, requiring a conventional surgical approach with prior dissection of the soft tissues overlying the tissue plane to be sutured.
• La réalisation de points de suture situés en profondeur par rapport au plan cutané nécessite soit la réalisation d'un abord chirurgical classique plus invasif, soit le recours à des instruments spéciaux (pousse-nœud...etc.) qui rendent la technique beaucoup plus délicate avec risques non négligeables de rupture accidentelle du fil ou de réalisation imparfaite du nœud (défauts de serrage etc.) avec les conséquences négatives exposées ci-dessus. • The realization of stitches located deep in relation to the cutaneous plane requires either the realization of a more invasive classic surgical approach, or the use of special instruments (knot pushers...etc.) which make the technique much more more delicate with significant risks of accidental breakage of the thread or imperfect realization of the knot (tightening faults etc.) with the negative consequences explained above.
• Il arrive que les fils de suture d’une structure tissulaire à réparer doivent cheminer à travers un plan tissulaire intermédiaire d’épaisseur non négligeable avant de trouver un plan ou une surface suffisamment solide pour pouvoir y réaliser le nœud d’ancrage. La greffe de ligament croisé au fémur en est un bon exemple : les fils ou bandelettes de fixation de la greffe ont à traverser un tunnel osseux de plusieurs centimètres, réalisé à travers le condyle externe, avant de déboucher à la surface corticale externe du fémur ou viendra s’appliquer le bouton assurant leur fixation. Ce long relais textile augmente considérablement l’élasticité du montage greffe-fixation ce qui entraîne des effets préjudiciables à la cicatrisation de la greffe, largement reconnus et décrits dans la littérature scientifique spécialisée (Bungee-chord effect). • It happens that the suture threads of a tissue structure to be repaired must travel through an intermediate tissue plane of considerable thickness before finding a plane or a surface solid enough to be able to make the anchoring knot there. The cruciate ligament graft to the femur is a good example: the sutures or strips for fixing the graft have to pass through a bone tunnel of several centimeters, made through the external condyle, before emerging at the external cortical surface of the femur or will come to apply the button ensuring their fixing. This long textile relay considerably increases the elasticity of the graft-fixation assembly, which has detrimental effects on the healing of the graft, widely recognized and described in the specialized scientific literature (Bungee-chord effect).
• Enfin, la réalisation classique d'un nœud n'est possible que si la suture comporte deux brins. La fixation d’un brin de suture isolé, principalement en profondeur, nécessite le plus souvent de réaliser un abord chirurgical complémentaire afin d’implanter un moyen d'arrêt quelconque (agrafe, vis etc..) permettant de l’y fixer. [0003] Divers mécanismes ont été proposés pour éviter l’usage de nœuds. • Finally, the classic realization of a knot is only possible if the suture has two strands. The fixing of an isolated suture strand, mainly in depth, most often requires carrying out an additional surgical approach in order to implant any stopping means (clip, screw, etc.) allowing it to be fixed there. [0003] Various mechanisms have been proposed to avoid the use of nodes.
[0004] Un premier système consiste à créer sur le fil de suture lui-même de multiples protubérances pointues, en forme de pointe de flèche, de manière à permettre le passage du fil dans un seul sens, les protubérances l’empêchant de coulisser dans le sens inverse. Outre un coût d’utilisation nettement plus élevé que les filaments standards, ce type de mécanisme comporte plusieurs inconvénients. Tout d’abord, ces fils spéciaux sont incapables de résister au glissement lorsqu’ils sont soumis à des forces tensionnelles élevées, ce qui forcément réduit considérablement leur potentiel d’utilisation. Ensuite, l’application du système est totalement irréversible. Une fois le fil introduit, la modification de son trajet ou son retrait sont impossibles. [0004] A first system consists in creating on the suture thread itself multiple pointed protuberances, in the shape of an arrowhead, so as to allow the passage of the thread in one direction only, the protuberances preventing it from sliding in the opposite direction. In addition to a significantly higher cost of use than standard filaments, this type of mechanism has several disadvantages. First, these specialty yarns are unable to resist slippage when subjected to high tensile forces, which inevitably greatly reduces their potential for use. Then, the application of the system is completely irreversible. Once the thread has been introduced, it is impossible to modify its path or withdraw it.
[0005] Le brevet US 9,924,939 décrit un autre système de serrage-blocage de la suture obtenu par construction, en réintroduisant un brin de la suture dans l’épaisseur même du filament, ce qui neutralise le coulissement de ce brin lors de la mise en tension du filament. Ce dispositif est aujourd’hui largement utilisé notamment dans les techniques de reconstruction ligamentaire par greffe suspendue et cela malgré les résultats de plusieurs études biomécaniques qui démontrent clairement une tendance au relâchement partiel du système sous l’effet des contraintes tensionnelles cycliques survenant in vivo après la pose de la suture. [0006] Ce système souffre par ailleurs des effets négatifs du problème d’élasticité des relais textiles décrits plus haut. Enfin, comme les fils à barbe, le mécanisme est totalement irréversible. Un excès malencontreux de traction lors de la mise en place du dispositif ne peut être corrigé sauf en reprenant à zéro la procédure après section du premier filin. [0005] US Patent 9,924,939 describes another clamping-blocking system for the suture obtained by construction, by reintroducing a strand of the suture into the very thickness of the filament, which neutralizes the sliding of this strand during the setting. filament tension. This device is now widely used, particularly in ligament reconstruction techniques by suspended grafting, despite the results of several biomechanical studies which clearly demonstrate a tendency to partial relaxation of the system under the effect of cyclic tensile stresses occurring in vivo after the placing the suture. [0006] This system also suffers from the negative effects of the problem of elasticity of the textile relays described above. Finally, like shaving threads, the mechanism is completely irreversible. An unfortunate excess of traction during the installation of the device cannot be corrected except by starting the procedure from scratch after cutting the first rope.
[0007] Enfin il existe divers procédés de blocage par serrage du fil lors de son passage à travers une ou plusieurs ancres éventuellement couplées entre elles. [0007] Finally, there are various methods of blocking by clamping the wire as it passes through one or more anchors possibly coupled together.
[0008] Le plus souvent, le mécanisme de blocage est obtenu par l’interaction d'un organe mâle introduit en force dans un réceptacle femelle et comprimant le fil selon son trajet longitudinal contre les parois dudit réceptacle. En pratique, cela signifie que l’accroissement de résistance au glissement ne peut être obtenu qu’au prix de l’augmentation de l'épaisseur des parois de du réceptacle femelle afin qu’elles puissent résister à une pression plus élevée, ce qui provoque donc inévitablement l’augmentation de son encombrement transversal. En revanche, la présente invention décrit un mécanisme de compression du fil perpendiculairement à son trajet longitudinal ce qui procure une résistance au glissement particulièrement efficace moyennant un encombrement transversal minimal, convenant parfaitement aux interventions délicates mini invasives. Most often, the locking mechanism is obtained by the interaction of a male member introduced by force into a female receptacle and compressing the wire along its longitudinal path against the walls of said receptacle. In practice, this means that the increased slip resistance can only be achieved at the cost of increasing the thickness of the walls of the female receptacle so that they can withstand higher pressure, which causes therefore inevitably the increase in its transverse size. On the other hand, the present invention describes a mechanism for compressing the yarn perpendicular to its longitudinal path, which provides particularly effective slip resistance by means of a minimal transverse bulk, perfectly suited to delicate minimally invasive procedures.
[0009] Par ailleurs, beaucoup de systèmes nécessitent la mise en place préalable d'un organe de blocage quelconque (vis, douille etc.) au sein d'un tissu solide tel que le tissu osseux avant de pouvoir y réaliser l'ancrage du fil. [0009] Furthermore, many systems require the prior positioning of any blocking member (screw, sleeve, etc.) within a solid tissue such as bone tissue before being able to anchor the thread.
[0010] Le présent système permet au contraire d'insérer le fil tout à fait librement, par exemple à travers les tissus mous, puis d’utiliser éventuellement le même système de blocage aux 2 extrémités, mêmes si celles-ci sont relativement éloignées l'une de l'autre, afin de d’induire une compression des tissus inclus entre les 2 organes de blocage. [0010] On the contrary, the present system makes it possible to insert the wire quite freely, for example through the soft tissues, then possibly to use the same locking system at the 2 ends, even if these are relatively far apart. from each other, in order to induce a compression of the tissues included between the 2 blocking organs.
[0011] Beaucoup de procédés existants procurent un système de serrage de type autobloquant. Ils ne peuvent en effet progresser que dans le sens de l'accroissement et jamais du relâchement. Cela signifie que si, par erreur, un excès de serrage a été appliqué au système, il n'est pas possible de revenir en arrière pour modifier le niveau de tension exercée sur la suture. [0011] Many existing methods provide a self-locking type clamping system. In fact, they can only progress in the direction of growth and never of relaxation. This means that if, by mistake, excess tightening has been applied to the system, it is not possible to go back and change the level of tension exerted on the suture.
[0012] Le document brevet US 8,323,315 en donne un exemple caractéristique. Il décrit en effet un dispositif bloquant le coulissement d’une anse de suture par traction sur l’un des brins, l’autre brin entraînant avec lui un petit organe dur (bille, nœud etc...) fixé sur lui, venant coincer de plus en plus la suture au niveau d’un rétrécissement canalaire créé à travers l’ancre de blocage. On voit tout de suite qu’il s’agit là effectivement d’un système de type "auto-bloquant " sur la suture, n’autorisant aucune réversibilité de la procédure. Un autre inconvénient majeur de ce système découle de son propre mécanisme d’action. Il s’agit en effet de la même force qui induit à la fois l’accolement des berges à suturer et l’emboitement des composants du système de blocage. Une forte résistance au glissement d’un organe de blocage travaillant par serrage ne peut être obtenue qu’en appliquant une importante force d’emboitement ou d’encliquetage des composants de l’ancre de blocage. Non seulement cette force peut être difficile à appliquer par simple traction sur un fil alors que l’ancre est elle-même soumise aux mouvements souples des tissus mous adjacents, mais, même si l’on y parvient, cette force peut être entièrement différente de celle qui devrait idéalement être appliquée sur les berges à suturer pour favoriser au mieux sa cicatrisation. En d’autres termes, une des caractéristiques qui nous parait essentielle à l’usage d’un système de blocage d’une suture sans nœud, et qui fait défaut aux différents systèmes décrits ci- dessus, c’est de pouvoir régler séparément et indépendamment la tension sur les tissus à suturer d’une part et l’application de la force de blocage d’autre part. L’autre caractéristique non moins importante et absente également de ces systèmes, est de pouvoir, si nécessaire, déverrouiller aisément le système de blocage afin de modifier la tension tissulaire lorsqu’elle semble inadéquate, avant de réappliquer définitivement le mécanisme de blocage. US Patent 8,323,315 gives a typical example. It indeed describes a device blocking the sliding of a suture loop by pulling on one of the strands, the other strand carrying with it a small hard organ (ball, knot etc.) fixed on it, coming to jam growing the suture at a canal narrowing created through the blocking anchor. We see immediately that this is indeed a "self-locking" type system on the suture, allowing no reversibility of the procedure. Another major drawback of this system stems from its own mechanism of action. It is in fact the same force which induces both the joining of the edges to be sutured and the interlocking of the components of the blocking system. A high resistance to sliding of a locking member working by clamping can only be obtained by applying a significant interlocking or snapping force of the components of the locking anchor. Not only can this force be difficult to apply simply by pulling on a wire while the anchor itself is subjected to the supple movements of the adjacent soft tissues, but, even if this is achieved, this force can be entirely different from the one that should ideally be applied to the edges to be sutured to best promote its healing. In other words, one of the characteristics which seems to us essential to the use of a locking system for a knotless suture, and which is lacking in the various systems described above, is to be able to adjust separately and independently the tension on the tissues to be sutured on the one hand and the application of the locking force on the other hand. The other characteristic, no less important and also absent from these systems, is to be able, if necessary, to easily unlock the blocking system in order to modify the tissue tension when it seems inadequate, before definitively reapplying the blocking mechanism.
[0013] La possibilité de déverrouiller aisément le système de blocage afin de modifier la tension tissulaire lorsqu’elle semble inadéquate, avant de réappliquer définitivement le mécanisme de blocage constitue pour nous un autre avantage majeur du système de l’invention décrit ci-après. The possibility of easily unlocking the blocking system in order to modify the tissue tension when it seems inadequate, before definitively reapplying the blocking mechanism constitutes for us another major advantage of the system of the invention described below.
Objectif de l’invention Purpose of the invention
[0014] Le principal objectif de l’invention est de fournir un dispositif permettant de régler finement la tension sur un ou plusieurs brins de fils de suture chirurgicale ou de filins d’amarrage d’un ligament ou encore de cerclage d’une structure quelconque, puis de fixer la tension choisie en bloquant le coulissement du ou des fils ou filins de façon efficace et reproductible, et cela, en évitant la technique des nœuds dont les risques et inconvénients ont été cités plus haut. The main objective of the invention is to provide a device making it possible to finely adjust the tension on one or more strands of surgical suture threads or ropes for mooring a ligament or even strapping any structure. , then to fix the chosen tension by blocking the sliding of the thread(s) or rope(s) in an efficient and reproducible way, and this, avoiding the technique of knots, the risks and disadvantages of which have been mentioned above.
[0015] Le deuxième objectif de l’invention est de rendre le procédé réversible, c’est- à-dire offrir la possibilité si nécessaire de déverrouiller aisément le système de blocage, réajuster la tension dans la suture ou les filins de suspension ou cerclage et verrouiller à nouveau le coulissement des fils dans la nouvelle position. [0015] The second objective of the invention is to make the process reversible, that is to say to offer the possibility, if necessary, of easily unlocking the locking system, readjusting the tension in the suture or the suspension or strapping ropes and lock again the sliding of the wires in the new position.
[0016] Le troisième objectif de l’invention est de pouvoir, si nécessaire, verrouiller le coulissement des fils dès leur issue de la structure à suturer, amarrer ou cercler, même si l’ancrage du dispositif de blocage s’opère à distance, de manière à neutraliser tout phénomène intempestif d’élasticité. Soit, lorsque les structures anatomiques l’exigent, le système permet de bloquer des fils au voisinage immédiat de la structure à ancrer tout en s’appuyant sur un plan situé à distance, évitant ainsi les phénomènes négatifs d’élasticité propres aux relais textiles intermédiaires. The third objective of the invention is to be able, if necessary, to lock the sliding of the threads as soon as they emerge from the structure to be sutured, moored or strapped, even if the anchoring of the locking device is carried out remotely, so as to neutralize any untimely phenomenon of elasticity. Either, when the anatomical structures require it, the system makes it possible to block threads in the immediate vicinity of the structure to be anchored while relying on a plane located at a distance, thus avoiding the negative phenomena of elasticity specific to intermediate textile relays .
[0017] Le quatrième objectif de l’invention est de fournir un système utilisable non seulement en superficie, de façon conventionnelle, mais également dans la profondeur des tissus sans devoir réaliser un abord chirurgical de la zone de travail, répondant ainsi aux exigences des techniques mini-invasives, notamment les techniques chirurgicales endoscopiques. [0018] Le système permet par exemple de bloquer efficacement un filin moyennant un encombrement minimum de l’organe de blocage pouvant même se situer entre 1 et 2 millimètres. Ceci constitue une des caractéristiques importantes de l’invention qui permet de la distinguer de la plupart des systèmes concurrents dont la taille minimum de l’organe de blocage varie souvent entre 5 à 10 mm. [0017] The fourth objective of the invention is to provide a system that can be used not only on the surface, in a conventional manner, but also in the depth of the tissues without having to perform a surgical approach to the work area, thus meeting the requirements of the techniques minimally invasive, including endoscopic surgical techniques. [0018] The system makes it possible, for example, to effectively block a rope with a minimum size of the blocking member which can even be between 1 and 2 millimeters. This constitutes one of the important characteristics of the invention which makes it possible to distinguish it from most of the competing systems in which the minimum size of the blocking member often varies between 5 to 10 mm.
[0019] Le cinquième objectif de l’invention est de fournir un moyen simple et rapide de section des fils à proximité de leur lieu de blocage, une fois l’opération validée par le chirurgien. [0019] The fifth objective of the invention is to provide a simple and rapid means of sectioning the threads close to their place of blocking, once the operation has been validated by the surgeon.
[0020] Le sixième objectif de l’invention est de fournir un système qui, moyennant les ajustements nécessaires de taille et de forme des composants, soit applicable aussi bien dans les procédures fines (ex. suture méniscale), de petite taille, soumises à des forces tensionnelles faibles, que dans des procédures exposant les composants à des sollicitations mécaniques élevées (ancrage de greffes ligamentaires). [0020] The sixth object of the invention is to provide a system which, with the necessary adjustments in size and shape of the components, is applicable both in fine procedures (eg meniscal suture), of small size, subject to low tensile forces, than in procedures exposing the components to high mechanical stresses (anchoring of ligament grafts).
[0021] Le système permet aussi, si nécessaire, de fixer un filin isolé, sans devoir ajouter un moyen d’arrêt supplémentaire (agrafes ou vis), comme c’est le cas avec les techniques de fixation par nouage. C’est ce qui permet également de mettre un filin en tension puis de disposer les points de blocage à une distance éloignée entre, sans le moindre risque d’étranglement. [0021] The system also makes it possible, if necessary, to fix an insulated rope, without having to add an additional stopping means (staples or screws), as is the case with knotting fixing techniques. This is also what makes it possible to put a rope in tension then to arrange the locking points at a distance between, without the slightest risk of strangulation.
[0022] Le septième objectif de l’invention est de fournir un système permettant de mettre un filin en tension puis de le bloquer en utilisant le même dispositif de blocage aux 2 extrémités. La présente invention se distingue ainsi de la plupart des systèmes concurrents qui nécessitent la mise en place d’un point d’ancrage préalable avant la mise en tension et le blocage du fil. The seventh objective of the invention is to provide a system making it possible to put a rope under tension and then to block it using the same blocking device at both ends. The present invention thus differs from most of the competing systems which require the installation of a prior anchoring point before tensioning and locking the thread.
Résumé de l’invention Summary of the invention
[0023] l’invention concerne un kit comprenant : [0023] the invention relates to a kit comprising:
A) un organe de blocage Il comprend 3 éléments principaux : i. Un composant mâle comprenant une tige filetée et une tête élargie (vis) ; ii. Un composant femelle comprenant un trou taraudé (écrou) ; iii. Une rondelle pouvant se déplacer librement le long de la tige mâle de la vis, l’un des composants, soit mâle soit femelle étant dit proximal et comprenant à une extrémité une empreinte permettant de lui appliquer un couple au moyen d’un tournevis ayant l’empreinte complémentaire, et l’autre composant étant dit distal et ayant une section externe permettant de lui appliquer un couple au moyen d’une section creuse complémentaire. A) a blocking device It comprises 3 main elements: i. A male component comprising a threaded rod and an enlarged head (screw); ii. A female component comprising a tapped hole (nut); iii. A washer that can move freely along the male shank of the screw, one of the components, either male or female being said to be proximal and comprising at one end an indentation enabling a torque to be applied to it by means of a screwdriver having the complementary indentation, and the other component being said to be distal and having a section external allowing to apply a couple to it by means of a complementary hollow section.
[0024] De façon plus générale, le composant distal comprend des moyens permettant de le bloquer en rotation au moyen d’un instrument pose, de façon à pouvoir lui appliquer un couple de serrage. [0024] More generally, the distal component comprises means making it possible to lock it in rotation by means of a placing instrument, so as to be able to apply a tightening torque to it.
[0025] Le trou taraudé peut être borgne ou traversant, pour autant qu’il permette le serrage du dispositif (i.e. dans le cas d’un trou borgne, sa profondeur doit être supérieure à la longueur de la vis) [0025] The tapped hole can be blind or through, provided that it allows the tightening of the device (i.e. in the case of a blind hole, its depth must be greater than the length of the screw)
[0026] L’empreinte du composant proximal est de forme quelconque tel qu’une fente, une empreinte « n pans » (classiquement hexagonale pour n=6 et tournevis 6 pans, tel qu’une clef «Allen», ou 4 pans pour un tournevis « Robertson »), Torx™, cruciforme, .... [0026] The imprint of the proximal component is of any shape such as a slot, an "n-sided" imprint (classically hexagonal for n=6 and 6-sided screwdriver, such as an "Allen" key, or 4-sided for a "Robertson" screwdriver), Torx™, Phillips, ....
[0027] De même, le composant distal est d’une forme qui permet aisément d’en bloquer la rotation. Il peut par exemple s’agir d’une classique section hexagonale. [0027] Similarly, the distal component is of a shape that easily allows its rotation to be blocked. It can for example be a classic hexagonal section.
[0028] Avantageusement, l’élément de blocage est préassemblé, et une boucle de fil est passée dans la rondelle, de façon à faciliter l’enfilage subséquent du fil de suture. [0028] Advantageously, the blocking element is preassembled, and a loop of thread is passed through the washer, so as to facilitate the subsequent threading of the suture thread.
[0029] En cas de taille minime (inférieur à 2mm) de l’organe de blocage, l’adjonction d’un petit bâtonnet préhensile prolongeant l’élément distal, à briser après introduction du fil, facilite grandement la manipulation de l’objet et sa mise en place dans un instrument de pose. [0029] In case of minimal size (less than 2 mm) of the blocking member, the addition of a small prehensile rod extending the distal element, to be broken after introduction of the wire, greatly facilitates the manipulation of the object and its placement in a setting instrument.
[0030] De façon alternative, le fil de suture peut aussi être passé d’avance dans l’élément de blocage préassemblé. [0030] Alternatively, the suture thread can also be passed in advance through the preassembled blocking element.
[0031] Avantageusement, le composant distal de l’organe de blocage comprend une boucle disposée à son extrémité distale, permettant de guider le fil de suture au plus près de la zone d’ancrage du fil de suture. Ladite boucle est, de préférence disposée sur l’axe central de l’organe de blocage, côté distal. B) Des instruments ancillaires : [0031] Advantageously, the distal component of the blocking member comprises a loop arranged at its distal end, making it possible to guide the suture thread as close as possible to the anchoring zone of the suture thread. Said loop is preferably arranged on the central axis of the locking member, distal side. B) Ancillary instruments:
[0032] Ils ont pour but de pouvoir déplacer l’organe de blocage à l’intérieur des tissus, réaliser ensuite le mouvement de serrage ou desserrage des éléments de l’organe de blocage et, optionnellement, de sectionner les fils de suture une fois le processus de verrouillage terminé. [0032] Their purpose is to be able to move the blocking member inside the tissues, then perform the tightening or loosening movement of the elements of the blocking member and, optionally, to cut the suture threads once the locking process completed.
[0033] Ils comprennent les éléments suivants : a. Un porte écrou : il s’agit d’un élément tubulaire dont l’extrémité inférieure ou distale comporte une logette dont la taille et la forme permettent d’accueillir l’organe de blocage et de le déplacer au sein des tissus. La forme de la logette permet en particulier de bloquer la rotation du composant distal. L’extrémité distale comprend aussi, de préférence, une ou des fentes permettant aux fils de suture de sortir du porte écrou avec une friction minimale lors de la mise sous tension de la suture. La manipulation de l’instrument s’effectue de préférence par l’intermédiaire d’une poignée fixée transversalement à la partie proximale de l’élément tubulaire. b. Un tournevis comportant une tige qui est dimensionnée de façon à coulisser librement mais avec le moins de jeu latéral possible dans le canal central du porte écrou et dont la forme de l’extrémité distale (embout distal) correspond à l’empreinte réalisée dans le composant proximal de l’organe de blocage. À la partie proximale de l’instrument, se trouve une poignée, ou molette permettant d’imprimer le mouvement rotatoire de serrage ou desserrage de l’organe de blocage (i.e. de visser la vis dans l’écrou). Optionnellement un coupe-fil comprenant un segment tubulaire coulissant librement sur la paroi externe du porte écrou. L’avancée ou le retrait de l’instrument sur le corps tubulaire du coupe-fil s’effectue grâce à un petit levier fixé à sa partie proximale. L’extrémité inférieure ou distale dudit coupe-fil est taillée en biseau et finement aiguisée de manière à pouvoir sectionner aisément les fils de suture après qu’ils aient été verrouillés dans l’organe de blocage. [0033] They include the following elements: a. A nut holder: this is a tubular element whose lower or distal end has a compartment whose size and shape make it possible to accommodate the locking device and move it within the tissues. The shape of the housing makes it possible in particular to block the rotation of the distal component. The distal end also preferably includes one or more slots allowing the suture threads to exit the nut carrier with minimal friction when tensioning the suture. The manipulation of the instrument is preferably carried out by means of a handle fixed transversely to the proximal part of the tubular element. b. A screwdriver comprising a rod which is dimensioned so as to slide freely but with the least possible lateral play in the central channel of the nut holder and whose shape of the distal end (distal tip) corresponds to the impression made in the component proximal to the blocking member. At the proximal part of the instrument, there is a handle, or knob, allowing the rotational movement of tightening or loosening of the locking device (i.e. to screw the screw into the nut). Optionally a wire cutter comprising a tubular segment sliding freely on the outer wall of the nut holder. The advance or withdrawal of the instrument on the tubular body of the thread cutter is carried out thanks to a small lever fixed to its proximal part. The lower or distal end of said thread cutter is bevelled and finely sharpened so as to be able to easily cut the suture threads after they have been locked in the blocking member.
[0034] Le coupe fil décrit ci-dessus est avantageux, néanmoins, d’autres systèmes de coupes permettant une coupe distale en se guidant sur le fil après retrait du porte- écrou et du tournevis sont envisageables. [0034] The wire cutter described above is advantageous, however, other cutting systems allowing distal cutting by guiding on the wire after removal of the nut holder and the screwdriver are possible.
[0035] De préférence, la tige du tournevis comprend une zone filetée se vissant en utilisation dans une zone filetée correspondante sur une face interne du porte écrou tubulaire. Avantageusement les filets du tournevis et du porte écrou tubulaire ont un pas et un sens similaire ou identique au pas et sens de vissage de l’organe de blocage. [0036] De préférence, la longueur de la tige est avantageusement ajustée pour que la pointe du tournevis vienne s’emboîter avec l’empreinte femelle de la tête de vis tout en laissant un espace libre suffisant entre la base du poussoir et la poignée du tournevis, autorisant le jeu nécessaire au serrage de la vis dans l’écrou, d’une part et l’expulsion de l’organe de blocage après serrage sur le fil. [0035] Preferably, the shank of the screwdriver comprises a threaded zone which is screwed in use into a corresponding threaded zone on an internal face of the tubular nut holder. Advantageously, the threads of the screwdriver and of the tubular nut holder have a pitch and a direction similar or identical to the pitch and screwing direction of the locking member. [0036] Preferably, the length of the rod is advantageously adjusted so that the tip of the screwdriver fits into the female recess of the screw head while leaving sufficient free space between the base of the pusher and the handle of the screwdriver, allowing the play necessary for tightening the screw in the nut, on the one hand and the expulsion of the blocking member after tightening on the wire.
[0037] Dans un mode préféré de l’invention, particulièrement adapté_aux sutures de tissus mous, potentiellement fragiles et nécessitant éventuellement l’application d’organe de blocage de petite taille (inférieur à 2mm), le porte écrou comprend un élément de préhension et de maintien de l’organe de blocage, cet élément de préhension comprenant un tube coaxial, coulissant dans l’élément tubulaire du porte-écrou, et comprenant à son extrémité distale un ensemble de lames de ressort formant la logette permettant d’accueillir l’élément de blocage, les longueur de l’élément de préhension et du porte écrou étant adaptées de façon à pouvoir occuper une position ouverte, où les lames ressort, dépassant du l’élément tubulaire du porte écrou sont ouvertes et permettent le positionnement aisé de l’élément de blocage, et une position fermée où l’élément tubulaire du porte écrou exerce une compression radiale sur les lames ressorts, refermant celles-ci sur l’élément de blocage et maintenant fermement celui-ci, tant en rotation qu’en translation. [0037] In a preferred mode of the invention, particularly suitable for suturing soft tissues, which are potentially fragile and possibly require the application of a small blocking member (less than 2 mm), the nut holder comprises a gripping element and for holding the blocking member, this gripping element comprising a coaxial tube, sliding in the tubular element of the nut holder, and comprising at its distal end a set of leaf springs forming the compartment making it possible to accommodate the blocking element, the lengths of the gripping element and of the nut holder being adapted so as to be able to occupy an open position, where the spring blades, projecting from the tubular element of the nut holder are open and allow the easy positioning of the locking element, and a closed position where the tubular element of the nut holder exerts a radial compression on the leaf springs, closing them on the locking element and maintaining it firmly nt this one, both in rotation and in translation.
[0038] En raison de sa forme, généralement hexagonale, la partie distale de l'organe de blocage perd ainsi toute capacité de mouvement, aussi bien rotatoire que translatoire, tandis que la partie proximale, de forme arrondie, conserve toute liberté de mouvement rotatoire axial, nécessaire au mouvement de vissage. [0038] Due to its generally hexagonal shape, the distal part of the blocking member thus loses all capacity for movement, both rotational and translational, while the proximal part, of rounded shape, retains all freedom of rotational movement. axial, necessary for the screwing movement.
[0039] Avantageusement, l'élément de préhension comporte à sa partie proximale une poignée transversale servant de contre appui à la pression axiale distale exercée sur l'élément tubulaire du porte écrou en vue de refermer les lames de ressort autour de l'organe de blocage. [0039] Advantageously, the gripping element comprises at its proximal part a transverse handle serving as counter support for the distal axial pressure exerted on the tubular element of the nut holder in order to close the spring blades around the blockage.
[0040] De préférence, le porte écrou comprend aussi un bouton-poussoir qui, une fois solidarisé avec l'élément tubulaire du porte écrou, permet de lui appliquer aisément la pression axiale nécessaire à son déplacement distal, lequel provoque alors la fermeture des lames de ressort autour de l'organe de blocage [0040] Preferably, the nut holder also comprises a push-button which, once secured to the tubular element of the nut holder, makes it possible to easily apply to it the axial pressure necessary for its distal movement, which then causes the blades to close. spring around the blocking member
[0041] Avantageusement, l’extrémité proximale de l’élément de préhension comprend une crémaillère coopérant avec une crémaillère correspondante à l’intérieur d’un conduit traversant le bouton poussoir permettant à l'élément tubulaire, lors de son mouvement distal, d'augmenter et de maintenir la pression des lames de ressort autour de l'organe blocage sans possibilité de recul. [0042] De préférence, ladite crémaillère n’est disposée que sur deux faces opposées du conduit traversant du bouton poussoir et sur deux côtés correspondants de l’élément de préhension, de façon à ce qu’une simple rotation d’un quart de tour permette de désolidariser ces deux éléments pour libérer l’élément de blocage. Advantageously, the proximal end of the gripping element comprises a rack cooperating with a corresponding rack inside a duct passing through the push button allowing the tubular element, during its distal movement, to increase and maintain the pressure of the leaf springs around the blocking device without the possibility of recoil. [0042] Preferably, said rack is arranged only on two opposite faces of the conduit passing through the push button and on two corresponding sides of the gripping element, so that a simple rotation of a quarter turn makes it possible to separate these two elements to release the blocking element.
[0043] Avantageusement, le diamètre du tournevis ne dépasse pas 2mm, de préférence inférieur à 1,5mm. [0043] Advantageously, the diameter of the screwdriver does not exceed 2 mm, preferably less than 1.5 mm.
[0044] Le coupe fil décrit ci-dessus est avantageux, néanmoins, d’autres systèmes de section distale du fil en l’utilisant comme guide sont envisageables, après retrait du porte-écrou et du tournevis. [0044] The wire cutter described above is advantageous, however, other systems for the distal section of the wire using it as a guide are possible, after removal of the nut holder and the screwdriver.
[0045] Lorsque le point d’ancrage est distant de la zone de suture, le composant distal de l’organe de blocage peut comprendre un prolongement proximal, ledit prolongement comprenant des moyens d’ancrage à une structure distante vers la zone proximale. Ce prolongement est avantageusement sous forme tubulaire, présentant à son extrémité proximale un épaulement pouvant prendre appui sur un trou circulaire pratiqué dans une structure d’accrochage adéquate. Des orifices pratiqués à l’extrémité distale de cette structure tubulaire permettent le passage du ou des fils de suture(s). When the anchor point is remote from the suture zone, the distal component of the blocking member may comprise a proximal extension, said extension comprising means for anchoring to a structure remote towards the proximal zone. This extension is advantageously in tubular form, having at its proximal end a shoulder which can rest on a circular hole made in a suitable attachment structure. Holes made at the distal end of this tubular structure allow the passage of the suture thread(s).
[0046] Avantageusement, c’est l’épaulement proximal qui prend place dans la logette du porte écrou dans ce cas et présente donc la section nécessaire à l’application du couple de vissage sur le composant distal. [0046] Advantageously, it is the proximal shoulder which takes place in the recess of the nut carrier in this case and therefore has the section necessary for the application of the screwing torque on the distal component.
[0047] Dans des cas particuliers d’interventions, le kit de l’invention peut avantageusement comprendre aussi une aiguille creuse (aiguille à ponction lombaire) et un passe-fil, comprenant un fin manche et une extrémité comprenant une boucle (avantageusement losangique), faite d’un fil métallique rétractable à mémoire de forme que l’on peut passer dans le canal de l’aiguille et qui se déploie en utilisation à sa sortie à une extrémité distale dudit canal de l’aiguille. Ces deux éléments permettent de récupérer des fils de sutures dans un structure distante du point d’entrée de l’intervention. In particular cases of interventions, the kit of the invention can advantageously also comprise a hollow needle (lumbar puncture needle) and a thread pass, comprising a thin handle and an end comprising a loop (advantageously lozenge-shaped) , made of a retractable metal wire with shape memory which can be passed through the needle channel and which deploys in use when it exits at a distal end of said needle channel. These two elements make it possible to recover suture threads in a structure distant from the entry point of the intervention.
[0048] Le mode d’action du système de blocage se résume donc comme suit :The mode of action of the blocking system can therefore be summarized as follows:
- après la réalisation de la suture, le ou les fils de sutures sont passés dans la rondelle, qui est ensuite engagée sur la tige filetée de l’organe mâle, l’extrémité libre (distale) du ou des fils remontant le long de la tige filetée dans la direction proximale ; - les composants mâle et femelle de l’organe de blocage sont engagés l’un dans l’autre sans serrage, la rondelle coulissant librement sur la tige filetée et le(s) fil(s) pouvant aussi - after completion of the suture, the suture thread(s) are passed through the washer, which is then engaged on the threaded rod of the male organ, the free (distal) end of the thread(s) going up along the threaded rod in the proximal direction; - the male and female components of the locking member are engaged one in the other without tightening, the washer sliding freely on the threaded rod and the wire(s) also being able to
- l’organe de blocage muni des fils est alors introduit dans l’orifice distal du porte écrou par simple pression et y est maintenu par léger serrage, le composant distal étant disposé dans la logette, et le composant proximal à l’intérieur du porte écrou ; - the locking member provided with the wires is then introduced into the distal orifice of the nut holder by simple pressure and is held there by light tightening, the distal component being placed in the compartment, and the proximal component inside the holder nut;
- Ie(s) fil(s) s’échappe(nt) par la ou les fente(s) latérale(s) de l’extrémité distale du porte- écrou et cheminent le long de la paroi externe de celui-ci ; - the wire(s) escape(s) through the lateral slot(s) of the distal end of the nut holder and run along the outer wall of the latter;
- Un mouvement simultané de traction proximale sur les fils et de pression distale sur une poignée du porte-écrou provoque le coulissement de l’organe de blocage sur les fils de suture jusqu’à l’endroit où ils font issue de la structure tissulaire à suturer ; - A simultaneous movement of proximal traction on the threads and distal pressure on a handle of the nut holder causes the sliding of the blocking member on the suture threads to the place where they emerge from the tissue structure at suture;
- La tension dans la suture peut alors être finement réglée soit en accentuant la force inversée fil-instrument, ce qui augmente la tension dans la suture, soit en la relâchant, ce qui diminue la tension dans la suture ; - The tension in the suture can then be finely adjusted either by accentuating the inverted wire-instrument force, which increases the tension in the suture, or by releasing it, which decreases the tension in the suture;
- Lorsque la tension dans la suture atteint le niveau souhaité, il suffit de serrer la vis dans l’écrou, pour verrouiller le coulissement des fils. Le mouvement de vissage ferme en effet l’espace entre les deux composants mâle et femelle de l’organe de blocage, la rondelle servant à dévier le fil de sa trajectoire correspondant à l’axe de traction. Si l’on considère le trajet du (ou des) fil(s), on voit que, en partant de la zone tissulaire, le fil longe d’abord la face externe du composant femelle de l’organe de blocage. Il s’infléchit ensuite à 90° pour rejoindre l’orifice central de la rondelle. Lors du serrage des composants, le fil se trouve à ce moment écrasé une première fois entre la face inférieure de la rondelle et la face supérieure du composant femelle. Le fil se réfléchit ensuite à 180° pour regagner la périphérie du composant mâle de l’organe de blocage. Il subit alors une deuxième zone d’écrasement entre la face supérieure de la rondelle et la face inférieure de la tête de vis. En résumé, le fil subit donc plusieurs interactions de friction cumulées, deux changements d’axe de traction (90°, 180°) et deux zones d’écrasement (face inférieure rondelle-face supérieure composant femelle/ face supérieure rondelle-face inférieure tête de vis composant mâle). Ces zones de friction cumulées procurent au système une résistance au glissement particulièrement efficace, dépassant fréquemment la résistance à la rupture du filament lui-même ; - When the tension in the suture reaches the desired level, simply tighten the screw in the nut to lock the sliding of the threads. The screwing movement in fact closes the space between the two male and female components of the locking device, the washer serving to deflect the wire from its trajectory corresponding to the axis of traction. If we consider the path of the thread(s), we see that, starting from the tissue zone, the thread first runs along the external face of the female component of the blocking member. It then bends 90° to join the central hole of the puck. During the tightening of the components, the wire is at this moment crushed a first time between the lower face of the washer and the upper face of the female component. The wire is then reflected at 180° to return to the periphery of the male component of the blocking device. It then undergoes a second crushing zone between the upper face of the washer and the lower face of the screw head. In summary, the wire therefore undergoes several cumulative friction interactions, two changes of traction axis (90°, 180°) and two crushing zones (lower face washer-upper face female component/ upper face washer-lower face head of male component screws). These cumulative friction zones provide the system with particularly effective slip resistance, frequently exceeding the breaking strength of the filament itself;
- Une fois le blocage terminé, si le chirurgien s’avère insatisfait du degré tensionnel imprimé dans la suture, il lui suffit de dévisser légèrement les composants afin de libérer le coulissement des fils, de corriger le réglage tensionnel de la suture et de reverrouiller le système en le revissant. - Once the blocking is complete, if the surgeon proves to be dissatisfied with the degree of tension imprinted in the suture, he simply has to unscrew the components slightly in order to release the sliding of the threads, to correct the tension adjustment of the suture and to relock the system by screwing it back on.
- La procédure étant définitivement validée, la section des fils au ras de l’organe de blocage s’obtient, par exemple, par un simple mouvement proximal vers distal du coupe- fil (pour autant que cette option soit retenue) en maintenant la tension sur les fils. - The procedure being definitively validated, the section of the threads flush with the blocking device is obtained, for example, by a simple proximal to distal movement of the thread cutter (provided that this option is chosen) while maintaining the tension on the wires.
[0049] De façon alternative, le ou les fils peuvent être coupés de toute autre manière conventionnelle. Alternatively, the yarn(s) can be cut in any other conventional manner.
[0050] Les zones de frictions cumulées obtenues par compression du fil sur les deux faces de la rondelle permet d’obtenir une force de blocage élevée, même lorsque la taille de l’organe de blocage est extrêmement réduite. Pour obtenir une force similaire par compression du fil selon son axe longitudinal, il faut nécessairement augmenter l’épaisseur des parois de l’organe de blocage afin de résister à la pression, ce qui forcément augmente son diamètre final. [0050] The cumulative friction zones obtained by compression of the wire on both sides of the washer make it possible to obtain a high locking force, even when the size of the locking member is extremely small. To obtain a similar force by compression of the wire along its longitudinal axis, it is necessary to increase the thickness of the walls of the blocking member in order to resist the pressure, which necessarily increases its final diameter.
[0051] Avantageusement, les arrêtes des différents composants (vis, écrou, rondelle, à l’exception du coupe-fil) sont émoussées, afin d’éviter tout risque de cisaillement du fil lors de sa mise en tension. [0051] Advantageously, the edges of the various components (screw, nut, washer, with the exception of the wire cutter) are blunt, in order to avoid any risk of shearing of the wire when it is tensioned.
Brève description des figures Brief description of figures
[0052] La figure 1 représente une vue en perspective des composants isolés de l’organe de blocage. [0052] Figure 1 shows a perspective view of the isolated components of the locking member.
[0053] La figure 2 montre les 3 éléments de l’organe de blocage, articulés entre eux (mais non serrés), ainsi que le trajet des fils à l’intérieur dudit organe. [0053] Figure 2 shows the 3 elements of the blocking member, hinged together (but not tight), as well as the path of the wires inside said member.
[0054] La figure 3 montre les mêmes éléments en position de verrouillage. Figure 3 shows the same elements in the locked position.
[0055] La figure 4 montre une forme préférée de l’élément de blocage comprenant une boucle préassemblée et une tige fracturable. [0055] Figure 4 shows a preferred form of locking element comprising a pre-assembled loop and a breakable rod.
[0056] La figure 5 représente une vue en coupe d’une douille creuse munie à sa partie distale d’un dispositif de blocage situé à distance de la zone d’accrochage, laquelle se produit proximalement, à distance de la zone de verrouillage. [0056] Figure 5 shows a sectional view of a hollow sleeve provided at its distal part with a locking device located away from the attachment zone, which occurs proximally, away from the locking zone.
[0057] La figure 6 montre qu’il est possible de multiplier les interfaces de serrage par simple adjonction de rondelles supplémentaires, lorsque les conditions mécaniques tensionnelles l’exigent. [0058] La figure 7 montre les mêmes composants qu’à la figure 5, en position de verrouillage. [0057] Figure 6 shows that it is possible to multiply the clamping interfaces by simply adding additional washers, when the mechanical tension conditions so require. Figure 7 shows the same components as in Figure 5, in the locked position.
[0059] La figure 8 représente un porte écrou sous ses différents aspects : coupe longitudinale (figure 8a), vue latérale (figure 8B), extrémité supérieure ou proximale (figure 8 c) et extrémité distale ou inférieure (figure 8D) Figure 8 shows a nut carrier in its various aspects: longitudinal section (Figure 8a), side view (Figure 8B), upper or proximal end (Figure 8c) and distal or lower end (Figure 8D)
[0060] La figure 9 représente un tournevis, muni de sa mollette et le coupe fils. [0060] Figure 9 shows a screwdriver, equipped with its wheel and the wire cutter.
[0061] La figure 10 montre une vue en transparence de différents instruments ancillaires assemblés. [0061] Figure 10 shows a transparent view of various assembled ancillary instruments.
[0062] La figure 11 montre une coupe en gros plan de l’extrémité distale du porte écrou après emboîtement de l’organe de blocage et du tournevis, le coupe-fil prêt à couper le fil. [0062] Figure 11 shows a close-up section of the distal end of the nut holder after fitting the locking member and the screwdriver, the wire cutter ready to cut the wire.
[0063] la figure 12 représente une vue schématique de l’articulation d’un genou droit en position de flexion. La zone grisée foncée représente le ménisque interne avec une fissuration longitudinale située à sa partie postéro interne. Seule cette zone sera répétée dans les schémas qui vont suivre afin d’illustrer la technique de suture méniscale. [0063] Figure 12 shows a schematic view of the joint of a right knee in the flexion position. The dark gray area represents the medial meniscus with a longitudinal crack located at its posterior medial part. Only this area will be repeated in the following diagrams to illustrate the meniscal suture technique.
[0064] Les figures de 13 à 29 illustrent les différentes séquences de la technique de tension-verrouillage du dispositif décrit, appliquée à la suture méniscale. La figure située en haut de page montre le ménisque en perspective. La figure du bas illustre la même action schématisée sur une vue en coupe de la même région. [0064] Figures 13 to 29 illustrate the different sequences of the tension-locking technique of the device described, applied to the meniscal suture. The figure at the top of the page shows the meniscus in perspective. The lower figure illustrates the same action schematically on a cross-sectional view of the same region.
[0065] La figure 30 illustre l’utilisation du système de blocage appliqué à une reconstruction chirurgicale du ligament croisé antérieur par greffe de suspension au fémur. [0065] Figure 30 illustrates the use of the blocking system applied to surgical reconstruction of the anterior cruciate ligament by suspension graft to the femur.
[0066] La figure 31 schématise l’utilisation du système pour mettre en tension puis verrouiller un fil de cerclage disposé autour d’une structure fissurée. [0066] Figure 31 schematizes the use of the system to tension then lock a strapping wire arranged around a cracked structure.
[0067] La figure 32 décrit une (parmi d’autres) alternative technique possible reposant sur les mêmes principes avec notamment la description d’un corpuscule d’arrêt de forme annulaire, permettant l’introduction du fil par pression latérale après son passage à travers la paroi du genou. [0067] Figure 32 describes one (among others) possible technical alternative based on the same principles with in particular the description of an annular-shaped stop corpuscle, allowing the introduction of the wire by lateral pressure after it has passed through through the wall of the knee.
[0068] Les figures 33 a et b représentent des éléments distaux de l’organe de blocage comprenant des moyens de guidage du fil de suture au plus près de la structure à suturer. [0069] La figure 34 représente un élément de blocage selon la figure 33a en utilisation. Figures 33 a and b show distal elements of the blocking member comprising means for guiding the suture thread closer to the structure to be sutured. [0069] Figure 34 shows a blocking element according to Figure 33a in use.
[0070] Les figures 35 et 36 représentent un tournevis et un porte écrou tubulaire présentant chacun une zone filetée. Figures 35 and 36 show a screwdriver and a tubular nut holder each having a threaded area.
[0071] La figure 37 montre les différents éléments ancillaires séparés dans le cas d’un système selon l’invention comprenant un élément de préhension. Figure 37 shows the various separate ancillary elements in the case of a system according to the invention comprising a gripping element.
[0072] La figure 38 montre une vue en transparence d’un bouton poussoir adapté au système ancillaire de la figure 37. [0072] Figure 38 shows a transparent view of a push button adapted to the ancillary system of figure 37.
[0073] La figure 39 montre une vue de face et une vue de profil et en transparence d’un exemple de système ancillaire monté, en position ouverte. [0073] Figure 39 shows a front view and a side view and in transparency of an example of an ancillary system mounted, in the open position.
[0074] La figure 40 montre une vue de face et une vue de profil et en transparence d’un exemple de système ancillaire monté, en position fermée. [0074] Figure 40 shows a front view and a side view and in transparency of an example of an ancillary system mounted, in the closed position.
Légende des figures Legend of figures
1. Composant mâle de l’organe de blocage. 1. Male component of the locking device.
1a : tête de l’organe mâle. 1a: head of the male organ.
1b : orifice hexagonal de la tête de l’organe mâle. 1b: hexagonal hole in the head of the male organ.
1c : tige filetée de l’organe mâle. 1c: threaded rod of the male organ.
2. Rondelle. 2. Washer.
3. Composant femelle de l’organe de blocage. 3. Female component of the locking device.
3a : partie supérieure (proximale) du composant femelle en forme d’écrou de section hexagonale. 3a: upper (proximal) part of the female component in the form of a hexagonal section nut.
3b : orifice central fileté de l’organe femelle 3b: central threaded hole of the female component
3c : partie distale à convexité inférieure du composant femelle3c: lower convex distal part of the female component
4. Fil de suture 4. Suture thread
5. Os cortical solide propice à l’accrochage de la douille. 5b os spongieux fragile5. Solid cortical bone conducive to socket attachment. 5b brittle cancellous bone
6. Paroi de douille 6. Socket wall
7. Tige du tournevis 7. Screwdriver shaft
8. Ecrou de forme oblongue 8. Oblong shaped nut
9. Epaulement de blocage de la douille 10. Vue en coupe de la tige mâle filetée fixée sur le fond de la douille 9. Socket locking shoulder 10. Sectional view of the threaded male rod fixed to the bottom of the socket
11. Douille d’ancrage du fil de suture (forme de réalisation de l’élément mâle de l’organe de blocage) 11. Suture anchor socket (form of the male element of the blocking member)
12. Ligne de niveau où se produit le verrouillage des fils 12. Level line where interlocking of threads occurs
12’. Ligne de niveau où se produit l’accrochage de la douille 12'. Level line where socket hooking occurs
13. Orifice d’entrée des fils dans la douille 13. Wire entry hole in socket
14. Corps tubulaire du porte écrou. 14. Tubular body of the nut holder.
15. Poignée du porte écrou. 15. Nut holder handle.
16. Canal de passage du tournevis. 16. Screwdriver channel.
17. Logette hexagonale du porte écrou (support de l’organe de blocage). 17. Hexagonal housing of the nut carrier (blocking device support).
18. Porte-écrou 18. Nut holder
19. Fente longitudinale de la partie distale du porte écrou destinée au passage des fils. 19. Longitudinal slot of the distal part of the nut holder intended for the passage of the wires.
20. Extrémité supérieure (proximale) du porte écrou. 20. Upper (proximal) end of the nut carrier.
21. Extrémité inférieure (distale) du porte écrou. 21. Lower (distal) end of the nut carrier.
22. Poignée (ou mollette) du tournevis. 22. Handle (or wheel) of the screwdriver.
23. Embout du tournevis. 23. Screwdriver tip.
24. Extrémité supérieure du coupe-fil 24. Thread cutter upper end
25. Orifice supérieur du corps tubulaire du coupe-fil. 25. Upper hole in the tubular body of the thread cutter.
26. Levier de mise en action du coupe- fil. 26. Thread cutter activation lever.
27. Paroi extérieure de forme cylindrique du coupe- fil. 27. Cylindrical outer wall of wire cutter.
28. Extrémité inférieure biseautée et tranchante du coupe- fil. 28. Beveled and sharp bottom end of wire cutter.
29. Fémur 29. Femur
30. Tibia 30. Tibia
31. Péroné 31. Fibula
32. Ménisque externe 32. External meniscus
33. Ménisque interne 33. Internal meniscus
34. Déchirure méniscale. 34. Meniscal tear.
35. Plan cutané 35. Cutaneous plane
36. Plan sous-cutané. 36. Subcutaneous plane.
37. Plan fibre ligamentaire. 37. Ligament fiber plan.
38. Aiguille creuse. 38. Hollow needle.
39. Passe-fil 39. Grommet
40. Embout losangique du passe-fil 40. Diamond grommet tip
41. Corpuscule d’arrêt des fils 41. Thread stopper corpuscle
42. Organe de blocage assemblé, en position coulissante. 43. Organe de blocage assemblé, en position de verrouillage des fils. 42. Assembled blocking device, in sliding position. 43. Assembled blocking device, in wire locking position.
44. Condyle fémoral externe 44. External femoral condyle
45. Logette osseuse d’insertion de la greffe de ligament croisé antérieur. 45. Bone pocket for insertion of the anterior cruciate ligament graft.
46. Greffe de ligament croisé antérieur. 46. Anterior cruciate ligament graft.
47. Toit osseux de l’échancrure inter-condylienne. (Ligne de Blumensaat) 47. Bony roof of the intercondylar notch. (Blumensaat line)
48. Structure tissulaire quelconque (ex : os), siège d’une fracture à réparer par cerclage. 48. Any tissue structure (e.g. bone), site of a fracture to be repaired by cerclage.
49. Fil de suture disposée en forme de cercle à l’état de relâchement. 49. Suture arranged in the shape of a circle in the loose state.
50. Fil de suture disposée en forme de cercle à l’état de tension. 50. Suture arranged in the form of a circle in a state of tension.
51. Anse de fil 51. Wire loop
52. Filament tracteur 52. Tractor Filament
53. Corpuscule d’arrêt annulaire 53. Annular stop corpuscle
54. Ouverture latérale 54. Side opening
55. Section de fil vue en gros plan 55. Wire section seen close-up
56. Boucle d’enfilage du fil de suture 56. Suture Threading Loop
57. Brins libres de la boucle d’enfilage 56 57. Free ends of the threading loop 56
58. Ligne de niveau où se produit l’accrochage de la douille 58. Level line where socket hooking occurs
59. Elément distal de l’organe de blocage comprenant une boucle de positionnement 60 59. Distal element of the blocking device comprising a positioning loop 60
60. Boucle de positionnement de l’élément distal de l’organe de blocage 60. Positioning loop of the distal element of the blocking device
61. Elément distal de l’organe de blocage comprenant une boucle centrée de positionnement 61 61. Distal element of the blocking device comprising a centered positioning loop 61
62. Boucle de positionnement centrée 62. Centered Positioning Loop
63. Zone filetée de la tige de tournevis 63. Screwdriver shaft threaded area
64. Zone filetée du porte écrou tubulaire 64. Threaded area of the tubular nut holder
65. Tige de support fracturable 65. Fractured Support Rod
66. Zone de fracture 66. Fracture Zone
67. Elément de préhension 67. Gripper
68. Lames ressort 68. Leaf springs
69. Poignée transversale de l’élément de préhension 69. Cross handle of the gripping element
70. Crémaillère de retenue de l’élément de préhension 70. Gripper retaining rack
71. Elément tubulaire du porte écrou 71. Tubular element of the nut carrier
72. Partie proximale du porte écrou 72. Proximal part of the nut carrier
73. Ouvertures latérales 73. Side openings
74. Pas de vis 74. No screws
75. Bouton poussoir 76. Crémaillère 75. Push Button 76. Rack
77. Canal central 77. Center Channel
78. Pas de vis 78. No screws
79. Plan de coupe AA 80. Plan de coupe BB 79. Section AA 80. Section BB
81. Plan de coupe CC 81. CC cut plane
82. Vue du dessus de la coupe BB 82. BB Cut Top View
83. Vue du dessus de la coupe AA 83. Top view of cup AA
84. Vue du dessus de la coupe CC 85. Porte écrou 84. CC cup top view 85. Nut carrier
86. Coupe fil 86. Thread cutter
Description détaillée de l’invention Detailed description of the invention
[0075] La présente invention concerne un dispositif permettant de verrouiller le coulissement de fils de suture après avoir réglé leur tension de manière fine et réversible si nécessaire, tout en évitant la technique classique des nœuds. The present invention relates to a device making it possible to lock the sliding of suture threads after having adjusted their tension in a fine and reversible manner if necessary, while avoiding the classic technique of knots.
[0076] La figure 1 représente l’élément principal du dispositif, à savoir l’organe de blocage, constituée de ses 3 éléments principaux [0076] Figure 1 shows the main element of the device, namely the blocking member, consisting of its 3 main elements
- un organe « mâle » 1 comprenant : - a "male" member 1 comprising:
- une tige 1c de forme cylindrique, filetée, de hauteur et calibre variable selon l’application envisagée et de diamètre adapté au calibre de l’orifice fileté de l’organe femelle. - a stem 1c of cylindrical shape, threaded, of variable height and caliber depending on the intended application and of diameter adapted to the caliber of the threaded orifice of the female member.
- une têtela de forme arrondie et d’épaisseur variable dont la face inférieure, entièrement plane est jointe en son centre à la tige filetée et dont la face supérieure, de forme variable (plane, convexe etc...) est creusée d’une cavité 1b, préférentiellement hexagonale, permettant d’accueillir l’embout de type « six pans » de taille correspondante, du tournevis. - a head of rounded shape and variable thickness whose lower face, entirely flat, is joined at its center to the threaded rod and whose upper face, of variable shape (flat, convex, etc.), is dug with a cavity 1b, preferably hexagonal, making it possible to accommodate the end piece of the "hexagonal" type of corresponding size, of the screwdriver.
L’arête située à la jonction entre la face supérieure et inférieure de la tête 1a est avantageusement émoussée ou chanfreinée de manière à éviter toute possibilité de cisaillement du fil lors du serrage de l’organe mâle dans l’organe femelle. - un organe « femelle »3 possédant un corps de forme généralement aplatie, comprenant une surface supérieure3a, parfaitement plane, perforée en son centre d’un orifice 3b de forme cylindrique le traversant de part en part et fileté sur toute son étendue. La surface inférieure 3c à une forme préférentiellement convexe de manière à être entièrement atraumatique pour les tissus adjacents. Le contour périphérique 3d a une forme préférentiellement (mais pas obligatoirement) hexagonale, permettant son emboîtement dans un embout femelle de forme et de taille correspondante de l’outil préhensile, bloquant sa rotation lors des mouvements de vissage et dévissage. Comme pour l’organe mâle, la jonction entre la partie plane et la partie périphérique de l’organe femelle doit être émoussée ou chanfreinée pour éviter tout risque de cisaillement du fil. The edge located at the junction between the upper and lower face of the head 1a is advantageously blunted or chamfered so as to avoid any possibility of shearing of the wire when tightening the male member in the female member. - a "female" member 3 having a body of generally flattened shape, comprising a perfectly flat upper surface 3a, perforated at its center with a cylindrical orifice 3b passing right through and threaded over its entire extent. The lower surface 3c has a preferentially convex shape so as to be entirely atraumatic for the adjacent tissues. The peripheral contour 3d has a preferentially (but not necessarily) hexagonal shape, allowing it to fit into a female end piece of corresponding shape and size of the gripping tool, blocking its rotation during screwing and unscrewing movements. As for the male member, the junction between the flat part and the peripheral part of the female member must be blunted or chamfered to avoid any risk of shearing of the wire.
- une rondelle 2 : organe plat de forme arrondie, perforée en son centre d’un orifice 2a de diamètre supérieur au diamètre de la tige filetée 1c de l’organe mâle 1 , de telle sorte qu’elle puisse coulisser librement et lâchement sur ladite tige et laisser coulisser très facilement les fils de suture 4 aussi longtemps que les composants mâles et femelles ne sont pas serrés entre eux. - a washer 2: flat member of rounded shape, perforated in its center with an orifice 2a of diameter greater than the diameter of the threaded rod 1c of the male member 1, so that it can slide freely and loosely on said stem and allow the suture threads 4 to slide very easily as long as the male and female components are not tight together.
[0077] La figure 2 représente les 3 composants 1,2,3 de l’organe blocage ainsi que le trajet des fils de suture 4 après introduction de ceux-ci au sein de dudit organe. Les fils de suture 4 restent parfaitement coulissants au sein de l’organe de blocage lorsqu’il se trouve dans cet état de configuration. [0077] Figure 2 shows the 3 components 1,2,3 of the blocking member as well as the path of the suture threads 4 after their introduction into said member. The suture threads 4 remain perfectly slidable within the blocking member when it is in this state of configuration.
[0078] La figure 3 représente les mêmes composants mais cette fois en position de verrouillage des fils de suture 4. [0078] Figure 3 shows the same components but this time in the locking position of the suture threads 4.
[0079] La figure 4a montre les mêmes composants, dans une version préassemblée dans laquelle une boucle de fil 56 est disposée à l’avance dans la rondelle 2 de façon à faciliter l’enfilage du fil de suture dans la rondelle. Dans cette configuration, il suffit à l’utilisateur de passer le fil de suture dans la boucle 56 et de tirer sur les brins libres 57 pour faire passer le fil de suture dans la rondelle 2. [0079] Figure 4a shows the same components, in a pre-assembled version in which a wire loop 56 is placed in advance in the washer 2 so as to facilitate the threading of the suture thread into the washer. In this configuration, the user just has to pass the suture thread through the loop 56 and pull on the free strands 57 to pass the suture thread through the washer 2.
[0080] La figure 4 b montre un organe blocage de petite taille muni de sa boucle passe fil 56 et d’un bâtonnet préhensile 65 facilitant sa manipulation. Avantageusement, ce bâtonnet préhensile 65 comprend à sa base une rainure 66 facilitant sa rupture une fois disposé dans les moyens ancillaires. [0080] Figure 4 b shows a small blocking member provided with its wire loop 56 and a prehensile rod 65 facilitating its handling. Advantageously, this prehensile rod 65 comprises at its base a groove 66 facilitating its breaking once placed in the ancillary means.
[0081] La figure 5 illustre une des variantes techniques possibles du dispositif de blocage de la présente invention, répondant aux situations particulières ou la zone idéale 12 de verrouillage des fils se situe à distance de la zone idéale 12’de l’ancrage de l’organe de blocage. Cette situation se présente lorsque la structure à ancrer ou suturer est adjacente à une structure anatomique de faible qualité mécanique comme par exemple l’os spongieux 5’. Dans ce cas, il est souhaitable pour la solidité du dispositif d’accrocher l’organe de suspension sur une structure anatomique solide telle que l’os cortical 5. Un dispositif de blocage standard nécessiterait de laisser les fils 4 parcourir tout l’espace tissulaire situé entre les niveaux 12 et 12’ avant de trouver une zone d’ancrage solide. Un tel dispositif s’accompagne nécessairement de la formation d’un long relais textile (distance entre les niveaux 12 et 12’) dont l’élasticité entraîne les conséquences négatives que nous avons déjà mentionnées plus haut. [0081] Figure 5 illustrates one of the possible technical variants of the locking device of the present invention, responding to particular situations where the ideal zone 12 for locking the wires is located at a distance from the ideal zone 12' of the anchoring of the blocking device. This situation arises when the structure to be anchored or sutured is adjacent to an anatomical structure of low mechanical quality such as for example the spongy bone 5'. In this case, it is desirable for the solidity of the device hang the suspension member on a solid anatomical structure such as the cortical bone 5. A standard blocking device would require allowing the wires 4 to travel through the entire tissue space located between the levels 12 and 12' before finding a strong anchor area. Such a device is necessarily accompanied by the formation of a long textile relay (distance between levels 12 and 12') the elasticity of which leads to the negative consequences that we have already mentioned above.
[0082] Dans l’exemple illustré en coupe sur la figure 5, l’organe de blocage comprend une douille creuse 11 comprenant un corps allongé de forme tubulaire 6, une extrémité supérieure proximale et une extrémité inférieure distale. La longueur et le diamètre du segment tubulaire dépendent du type d’intervention réalisée et de l’état des structures anatomiques. L’extrémité inférieure ou distale de la douille 11 est borgne et sur le fond de la paroi intérieure, en son centre, est fixée une tige filetée 10 destinée à s’articuler avec l’orifice femelle fileté de l’écrou 8. Comme dans l’organe de blocage classique, une rondelle 2 coulisse librement et lâchement sur la tige filetée 10 de la douille 11. Le fond de la douille 11 est également percé de 2 orifices 13 permettant le passage des fils 4 dont le trajet est analogue au trajet des fils de l’organe classique. Lors de sa mise en place, la douille 11 traverse donc en premier lieu l’os cortical 5 puis l’os spongieux 5’ réputé fragile et le rebord élargi 9 de l’extrémité supérieure de la douille l’arrête enfin sur le support solide de l’os cortical 5 assurant ainsi non seulement la solidité mais également la rigidité du montage. In the example illustrated in section in Figure 5, the locking member comprises a hollow sleeve 11 comprising an elongated body of tubular shape 6, a proximal upper end and a distal lower end. The length and diameter of the tubular segment depend on the type of intervention performed and the condition of the anatomical structures. The lower or distal end of the sleeve 11 is blind and on the bottom of the inner wall, in its center, is fixed a threaded rod 10 intended to articulate with the threaded female orifice of the nut 8. As in the conventional locking member, a washer 2 slides freely and loosely on the threaded rod 10 of the sleeve 11. The bottom of the sleeve 11 is also pierced with 2 orifices 13 allowing the passage of the wires 4 whose path is analogous to the path wires from the classical organ. When it is put in place, the sleeve 11 therefore first crosses the cortical bone 5 then the spongy bone 5′ deemed to be fragile and the widened rim 9 of the upper end of the sleeve finally stops it on the solid support. of the cortical bone 5 thus ensuring not only the solidity but also the rigidity of the assembly.
[0083] La figure 6 illustre une variante technique possible du même dispositif, répondant à la nécessité éventuelle d’augmenter la résistance au glissement des fils au cas où l’importance des contraintes mécaniques tensionnelles l’exigerait. On voit ainsi que l’adjonction de 2 rondelles supplémentaires 2 permet de doubler la surface des interfaces de serrage (4 interfaces au lieu de 2 avec une rondelle unique). Ils se situent entre la face inférieure de l’écrou et la rondelle supérieure (première interface), entre les rondelles entre elles (deuxième et troisième interface) et enfin entre la face inférieure de la rondelle distale et le plancher de la douille (quatrième interface), moyennant un encombrement pratiquement inchangé du dispositif. On remarquera que, grâce au mécanisme de blocage perpendiculaire à l’axe du fil, cet accroissement à la résistance au glissement ne nécessite nullement d’augmenter l’épaisseur des parois de l’implant comme c’est le cas dans tous les dispositifs visant à bloquer le fil selon son axe longitudinal. [0083] Figure 6 illustrates a possible technical variant of the same device, responding to the possible need to increase the slip resistance of the wires in the event that the importance of the tensile mechanical stresses so requires. We can thus see that the addition of 2 additional washers 2 makes it possible to double the surface of the tightening interfaces (4 interfaces instead of 2 with a single washer). They are located between the underside of the nut and the upper washer (first interface), between the washers between them (second and third interface) and finally between the underside of the distal washer and the socket floor (fourth interface ), with a practically unchanged size of the device. It will be noted that, thanks to the blocking mechanism perpendicular to the axis of the wire, this increase in resistance to sliding does not in any way require increasing the thickness of the walls of the implant as is the case in all devices aimed at to block the wire along its longitudinal axis.
[0084] La figure 7 montre le même dispositif (avec rondelle unique) en position de blocage des fils 4. [0085] Selon un des modes préférés de l'invention, le dispositif de blocage comprend en outre des composants ancillaires du système permettant de disposer adéquatement l’organe de blocage. [0084] Figure 7 shows the same device (with a single washer) in the locking position of the wires 4. [0085] According to one of the preferred embodiments of the invention, the blocking device further comprises ancillary components of the system making it possible to arrange the blocking member appropriately.
MODE ANCILLAIRE A a. L’ensemble porte écrou (Fig. 37) ANCILLARY MODE A a. The nut holder assembly (Fig. 37)
[0086] Il se compose de 3 éléments distincts : un élément de préhension 67 comprenant un segment tubulaire, un porte écrou proprement dit 85 et un poussoir 75. [0086] It is made up of 3 distinct elements: a gripping element 67 comprising a tubular segment, a nut holder proper 85 and a pusher 75.
[0087] L’élément de préhension 67 comprend un segment tubulaire longitudinal, un segment distal et un segment proximal. The gripping element 67 comprises a longitudinal tubular segment, a distal segment and a proximal segment.
[0088] Le segment longitudinal de l’élément de préhension comprend un tube creux d'environ 15 cm de longueur dont le diamètre intérieur (environ 2,25 mm) est ajusté pour laisser coulisser librement la tige du tournevis 7 dont le diamètre est d'environ 2 mm. N'étant soumis qu’à des contraintes de torsion, la paroi de ce tube peut être mince selon le matériau utilisé (ex : 0,25 mm environ pour un métal classique tel que de IΊNOC ou de l’aluminium). [0088] The longitudinal segment of the gripping element comprises a hollow tube approximately 15 cm in length, the internal diameter of which (approximately 2.25 mm) is adjusted to allow the rod of the screwdriver 7, the diameter of which is 7, to slide freely. about 2mm. Being only subject to torsional stresses, the wall of this tube can be thin depending on the material used (eg: approximately 0.25 mm for a conventional metal such as IΊNOC or aluminium).
[0089] Le segment distal de l’élément de préhension 67 comprend au moins 3 ou préférentiellement 4 petites lames de ressort incurvées 68 (15 à 20 mm de longueur pour une épaisseur de 0,15 à 0,20mm) disposées en collerette à la face externe du tube avec un écart d’environ 90°, et qui sont par exemple soudées ou collées selon son axe longitudinal, en dépassant son extrémité distale de 10 à 15 mm environ. Ces petites lames 68, dont l'extrémité distale est repliée en griffe, sont spontanément déployées à l'état de repos en créant une cavité virtuelle en forme de panier ou de corbeille, destinée à accueillir l'organe de blocage. Ces lames peuvent aussi être formée par la déformation de segments de l’extrémité du tube creux, ces segments étant séparés par des découpes longitudinales. The distal segment of the gripping element 67 comprises at least 3 or preferably 4 small curved spring blades 68 (15 to 20 mm in length for a thickness of 0.15 to 0.20 mm) arranged in a collar at the external face of the tube with a gap of approximately 90°, and which are for example welded or glued along its longitudinal axis, extending beyond its distal end by approximately 10 to 15 mm. These small blades 68, the distal end of which is folded into a claw, are spontaneously deployed in the rest state by creating a virtual cavity in the shape of a basket or basket, intended to accommodate the blocking member. These blades can also be formed by the deformation of segments of the end of the hollow tube, these segments being separated by longitudinal cutouts.
[0090] En coulissant autour de l’élément de préhension 67 en direction de son extrémité distale, l’élément tubulaire 71 du porte écrou 85 enferme progressivement les petites lames 68 qui se referment les unes sur les autres en bloquant toute possibilité de rotation de la partie femelle de l’organe de blocage tout en laissant libre le mouvement rotatoire de sa partie mâle, permettant ainsi l'application à distance du couple de force appliqué sur le manche 22 du tournevis. [0091] À 3 cm environ de l'extrémité proximale de l’élément de préhension 67 et perpendiculairement à son axe longitudinal, se trouve une poignée transversale 69 de 4 à 5 mm de diamètre et d'une longueur de 4 à 5 cm, fixée en son milieu sur l’élément de préhension 67. En y accrochant par exemple l'index et le médium, cette poignée transversale 69 permet de trouver l'appui nécessaire pour résister à la pression axiale qui sera appliquée par le pouce sur le poussoir75, exactement à la manière d'une seringue. Enfin, deux petits éléments crénelés 70 d'environ 15 mm de longueur sur quelques millimètres de largeur sont fixés à la face externe de l’élément de préhension, à la partie immédiatement adjacente à la poignée transversale 69. Les dents de ces petits modules 70 sont inclinées d’environ 45°, à la manière d'une pointe de flèche orientée en direction de l'extrémité proximale de l’élément de préhension 67. Ces 2 éléments sont fixés à 180° l'un par rapport à l'autre, les surfaces adjacentes restant lisses et dépourvues de relief. By sliding around the gripping element 67 in the direction of its distal end, the tubular element 71 of the nut carrier 85 gradually encloses the small blades 68 which close on each other, blocking any possibility of rotation of the female part of the blocking member while leaving free the rotary movement of its male part, thus allowing the remote application of the force torque applied to the handle 22 of the screwdriver. About 3 cm from the proximal end of the gripping element 67 and perpendicular to its longitudinal axis, there is a transverse handle 69 4 to 5 mm in diameter and 4 to 5 cm long, fixed in the middle on the gripping element 67. For example by hooking the index and the medium there, this transverse handle 69 makes it possible to find the support necessary to resist the axial pressure which will be applied by the thumb on the pusher 75 , exactly like a syringe. Finally, two small crenellated elements 70 approximately 15 mm long by a few millimeters wide are fixed to the external face of the gripping element, to the part immediately adjacent to the transverse handle 69. The teeth of these small modules 70 are inclined by approximately 45°, like an arrowhead pointing in the direction of the proximal end of the gripping element 67. These 2 elements are fixed at 180° relative to each other , the adjacent surfaces remaining smooth and devoid of relief.
[0092] Le porte écrou 85 proprement dit, comprend deux segments tubulaires distincts, l'un distal 71 et l'autre proximal 72. Ils sont soudés et connectés l'un à l'autre mais ont une forme, une taille et une fonction différente. The nut holder 85 itself comprises two distinct tubular segments, one distal 71 and the other proximal 72. They are welded and connected to each other but have a shape, a size and a function different.
[0093] Le segment tubulaire 71 distal comporte un orifice distal par lequel pénétreront les lames de ressort 68 de l’élément de préhension 67 lorsqu'il sera mobilisé distalement et un orifice proximal en connexion avec le segment tubulaire proximal. La longueur de l’élément tubulaire distal 71 est de préférence égale à la portion de l’élément de préhension 67 située distalement par rapport à sa poignée transversale. Le diamètre intérieur minimal de cette section doit lui permettre de coulisser librement autour de l’élément de préhension 67 (épaisseur des lamelles de ressort comprises). Si par exemple le diamètre extérieur de l’élément de préhension avec ses lames de ressort est de 3,2 mm, le diamètre intérieur du tube 2 devra être au minimum de 3,5 mm. Si la paroi du porte écrou est de 0,25 mm, le diamètre total de ce segment sera de 4 mm ce qui permet de l'utiliser aisément pour toute intervention mini invasive réalisée sous endoscopie. The distal tubular segment 71 has a distal orifice through which the spring blades 68 of the gripping element 67 will penetrate when it is mobilized distally and a proximal orifice in connection with the proximal tubular segment. The length of the distal tubular element 71 is preferably equal to the portion of the gripping element 67 located distal to its transverse handle. The minimum internal diameter of this section must allow it to slide freely around the gripping element 67 (thickness of the spring plates included). If, for example, the outside diameter of the gripping element with its spring blades is 3.2 mm, the inside diameter of tube 2 must be at least 3.5 mm. If the wall of the nut holder is 0.25 mm, the total diameter of this segment will be 4 mm, which allows it to be used easily for any minimally invasive procedure performed under endoscopy.
[0094] Le segment tubulaire proximal 72 comporte un segment longitudinal de forme cylindrique, une extrémité distale soudée et en communication avec le segment tubulaire distal 71 et une extrémité proximale ouverte qui sera utilisée pour réaliser la jonction avec le poussoir. The proximal tubular segment 72 comprises a longitudinal segment of cylindrical shape, a distal end welded and in communication with the distal tubular segment 71 and an open proximal end which will be used to make the junction with the pusher.
[0095] Il est percé d'une cavité cylindrique s'étendant sur toute l'étendue longitudinale du segment à l'exception de la jonction avec le segment tubulaire distal. Le diamètre intérieur de cette cavité cylindrique est ajusté pour laisser coulisser librement le segment tubulaire du poussoir qui sera décrit au paragraphe suivant. Une fente longitudinale 73 traverse en son milieu l'entièreté du segment tubulaire proximal à l'exception de la zone de jonction avec le segment tubulaire distal décrit précédemment. L'épaisseur de la fente doit être suffisante pour permettre au segment proximal de coulisser librement sur l’élément de préhension 67 jusqu’à venir cravater la poignée transversale 69 de l’élément de préhension. L’assemblage de l'instrument suppose en effet que l'on emboîte la base du porte écrou 67 sur l'extrémité distale de l’élément de préhension 67, le mouvement du porte écrou 85 de distal à proximal s'arrêtant lorsque le sommet de la fente longitudinale 73 pratiquée dans le segment proximal 72 bute sur la poignée transversale 69 de l’élément de préhension 67. Le diamètre extérieur du segment tubulaire proximal 72 sera donc en finale de 8 à10 mm, correspondant à l'épaisseur suffisante des parois et à la taille de la cavité cylindrique destinée à l'emboîtement du poussoir 75. It is pierced with a cylindrical cavity extending over the entire longitudinal extent of the segment with the exception of the junction with the distal tubular segment. the inside diameter of this cylindrical cavity is adjusted to allow the tubular segment of the pusher which will be described in the following paragraph to slide freely. A longitudinal slot 73 passes through the middle of the entire proximal tubular segment with the exception of the junction zone with the distal tubular segment described above. The thickness of the slot must be sufficient to allow the proximal segment to slide freely on the gripping element 67 until it comes to tie the transverse handle 69 of the gripping element. The assembly of the instrument assumes that the base of the nut holder 67 is fitted onto the distal end of the gripping element 67, the movement of the nut holder 85 from distal to proximal stopping when the top of the longitudinal slot 73 made in the proximal segment 72 abuts on the transverse handle 69 of the gripping element 67. The outer diameter of the proximal tubular segment 72 will therefore ultimately be 8 to 10 mm, corresponding to the sufficient thickness of the walls and the size of the cylindrical cavity intended for fitting the pusher 75.
[0096] Enfin, la paroi intérieure du segment tubulaire à sa partie proximale comporte un filetage femelle 74 sur une hauteur de 3 à 4 mm, destiné à solidariser le porte écrou 85 avec le poussoir 75 dont la base du segment tubulaire comportera un filet mâle 78 correspondant. Finally, the inner wall of the tubular segment at its proximal part comprises a female thread 74 over a height of 3 to 4 mm, intended to secure the nut holder 85 with the pusher 75, the base of the tubular segment of which will comprise a male thread 78 matching.
[0097] Le poussoir 75 comprend un segment proximal large et arrondi et d'un segment distal de forme tubulaire. The pusher 75 comprises a wide and rounded proximal segment and a tubular-shaped distal segment.
[0098] Le segment proximal comprend une face externe proximale convexe, préférentiellement mais pas exclusivement de forme semi-sphérique, éventuellement creusée d'une légère dépression destinée à accueillir efficacement et confortablement l'empreinte du pouce qui exercera la pression axiale sur l'instrument en direction distale. À l'opposé de cette face convexe, Le segment proximal comporte par ailleurs une face distale parfaitement plane au centre de laquelle est implanté un segment tubulaire cylindrique de 20 à 25 mm de long, perpendiculairement à ladite surface. [0098] The proximal segment comprises a convex proximal external face, preferably but not exclusively of semi-spherical shape, possibly hollowed out with a slight depression intended to accommodate effectively and comfortably the impression of the thumb which will exert the axial pressure on the instrument. in the distal direction. Opposite this convex face, the proximal segment also comprises a perfectly flat distal face in the center of which is implanted a cylindrical tubular segment 20 to 25 mm long, perpendicular to said surface.
[0099] Une cavité cylindrique de diamètre légèrement supérieur au diamètre extérieur de l’élément de préhension 67 traverse tout le segment tubulaire du poussoir 75 et se prolonge ensuite sur les 3/4 environ de sa partie proximale. Cette cavité permet à l’élément de préhension 67 de pénétrer à l'intérieur du poussoir 75 lorsque celui-ci se déplace distalement. Au niveau de la partie proximale du poussoir, la cavité cylindrique se prolonge ensuite jusqu'à son extrémité proximale par un fin canal cylindrique 77 de diamètre légèrement supérieur au diamètre de la tige du tournevis 7. Ce petit canal 77 permet donc de guider la tige du tournevis jusqu'à l'entrée du canal central de l’élément de préhension 67 pour atteindre ensuite l'organe de blocage 1-2-3. Un pas de vis mâle 78 de 2 à 3 mm a été créé à la face externe du segment tubulaire cylindrique au niveau de sa jonction avec le segment proximal. Ce pas de vis 78 est destiné à s'articuler avec le filet femelle 74 correspondant existant au niveau de l'extrémité proximale du porte écrou 85 de manière à solidariser les deux pièces. Deux éléments crénelés 76 identiques à ceux décrits au niveau de la base de l’élément de préhension 67 sont fixés longitudinalement à 180° l'un par rapport à l'autre au niveau de la face interne de la portion distale du segment tubulaire distal. L'orientation des dents des créneaux respectifs de l’élément de préhension 67 et du poussoir 75 a été inversée de 180° afin de permettre le glissement des unes sur les autres lors de la mobilisation distale du poussoir75. Lorsque le crénelage du poussoir chevauche celui de l’élément de préhension, le poussoir peut donc cheminer distalement en bloquant toute possibilité de retour en direction proximale. Afin de faciliter l'emboîtement des 2 pièces, une fente longitudinale, de longueur correspondante à celle des crémaillères sur 1 mm de large, traverse de part en part la paroi du segment tubulaire cylindrique en passant par le milieu des faces lisses du tube (à 90° par rapport à la position des crémaillères). A cylindrical cavity with a diameter slightly greater than the outer diameter of the gripping element 67 passes through the entire tubular segment of the pusher 75 and then extends over approximately 3/4 of its proximal part. This cavity allows the gripping element 67 to penetrate inside the pusher 75 when the latter moves distally. At the level of the proximal part of the pusher, the cylindrical cavity is then extended to its proximal end by a fine cylindrical channel 77 of diameter slightly greater than the diameter of the rod of the screwdriver 7. This small channel 77 therefore makes it possible to guide the rod of the screwdriver as far as the entrance to the central channel of the gripping element 67 in order then to reach the blocking member 1-2-3. A male thread 78 of 2 to 3 mm has been created on the external face of the cylindrical tubular segment at the level of its junction with the proximal segment. This thread 78 is intended to articulate with the corresponding female thread 74 existing at the level of the proximal end of the nut holder 85 so as to join the two parts together. Two crenellated elements 76 identical to those described at the level of the base of the gripping element 67 are fixed longitudinally at 180° relative to each other at the level of the internal face of the distal portion of the distal tubular segment. The orientation of the teeth of the respective slots of the gripping element 67 and of the pusher 75 has been reversed by 180° in order to allow the sliding of one over the other during the distal mobilization of the pusher 75. When the serration of the pusher overlaps that of the gripping element, the pusher can therefore travel distally, blocking any possibility of returning in the proximal direction. In order to facilitate the interlocking of the 2 parts, a longitudinal slot, of a length corresponding to that of the racks and 1 mm wide, crosses right through the wall of the cylindrical tubular segment passing through the middle of the smooth faces of the tube (at 90° in relation to the position of the racks).
[0100] Lorsque les crémaillères 76,70 se chevauchent, la pression axiale exercée sur le poussoir en direction proximale entraîne donc le déplacement distal du porte écrou sans possibilité de retour en arrière. Celui-ci enferme et resserre progressivement les griffes de l’élément de préhension autour de l’organe de blocage, bloquant ainsi toute capacité de mouvement rotatoire et translatoire de sa partie femelle, tandis que le mouvement rotatoire axial de sa partie mâle reste entièrement libre. Le tournevis peut alors être introduit afin de d'appliquer le couple de serrage nécessaire au blocage du fil. Une fois le serrage achevé, il suffit de faire pivoter le poussoir de 90° pour désengager les crémaillères respectives de l’élément de préhension 67 et du poussoir 75 et permettre le retrait de l'ensemble poussoir-porte écrou, restés solidaires grâce au pas de vis de jonction entre les 2 pièces. [0100] When the racks 76,70 overlap, the axial pressure exerted on the pusher in the proximal direction therefore causes the distal movement of the nut carrier without the possibility of turning back. This encloses and gradually tightens the claws of the gripping element around the blocking member, thus blocking any capacity for rotary and translational movement of its female part, while the axial rotary movement of its male part remains entirely free. . The screwdriver can then be introduced in order to apply the tightening torque required to lock the wire. Once the tightening is complete, it suffices to rotate the pusher by 90° to disengage the respective racks from the gripping element 67 and the pusher 75 and allow the removal of the pusher-nut holder assembly, which have remained integral thanks to the pitch of junction screws between the 2 parts.
[0101] Contrairement à la plupart des systèmes de l’art antérieur, la présente instrumentation permet la mise en place et le verrouillage à distance d'un organe de blocage de taille extrêmement réduite (1 ,5 à2mm) analogue aux micro-dispositifs utilisés en micro-électronique ou en bijouterie. b. Le tournevis. [0101] Unlike most systems of the prior art, this instrumentation allows the remote installation and locking of an extremely small blocking member (1.5 to 2 mm) similar to the micro-devices used in micro-electronics or jewelry. b. The screwdriver.
[0102] Il se compose d'une tige cylindrique 7 et d'un manche 22 permettant de l'actionner. Le diamètre de la tige 7 doit être légèrement inférieur au diamètre du canal intérieur de l’élément de préhension 67 et de la portion fine proximale du canal intérieur 77 du poussoir 75. À sa partie distale 23, la tige se termine par un embout dont le relief mâle correspond à l'empreinte femelle réalisée dans la tête de vis de l'organe de blocage (partie mâle). L'instrumentation étant spécialement adaptée aux microéléments, la forme de cet embout sera généralement semblable à celle des micro tournevis que l'on utilise en microélectronique ou en bijouterie. La longueur de la tige doit être au moins égale à la plus grande longueur du porte écrou en position de déverrouillage, c'est-à-dire depuis l'extrémité distale des griffes en position d'ouverture jusqu'à la base du poussoir. C'est grâce à cette caractéristique que le tournevis sera en mesure d'expulser l'organe de blocage hors des griffes après désengagement des tubes un et deux. Aussi longtemps que ces 2 tubes restent engagés, les griffes en position de fermeture empêchent en effet toute possibilité d'expulsion de l'organe de blocage. [0102] It consists of a cylindrical rod 7 and a handle 22 allowing it to be actuated. The diameter of the rod 7 must be slightly less than the diameter of the inner channel of the gripping element 67 and of the proximal thin portion of the inner channel 77 of the pusher 75. At its distal part 23, the rod ends in a tip whose the male relief corresponds to the female recess made in the screw head of the locking member (male part). The instrumentation being specially adapted to the microelements, the shape of this tip will generally be similar to that of the micro screwdrivers which are used in microelectronics or in jewellery. The length of the rod must be at least equal to the longest length of the nut carrier in the unlocked position, that is to say from the distal end of the claws in the open position to the base of the pusher. It is thanks to this characteristic that the screwdriver will be able to expel the locking member from the claws after disengagement of tubes one and two. As long as these 2 tubes remain engaged, the claws in the closed position effectively prevent any possibility of expulsion of the blocking member.
[0103] La forme et la taille du manche de tournevis sont adaptées au type d'application en cours en répondant au mieux aux exigences d'ergonomie. c. Le coupe fil. [0103] The shape and size of the screwdriver handle are adapted to the type of application in progress by best meeting ergonomic requirements. vs. The wire cutter.
[0104] Il est constitué d'un organe tubulaire de faible épaisseur et de longueur inférieure à la portion distale du porte écrou. Il coulisse librement autour de la paroi extérieure du tube 2. On l'actionne par un petit levier situé à sa partie proximale. Son extrémité biseautée et finement aiguisée permet en le poussant distalement de sectionner le fil maintenu en tension proximale, à la manière d'une guillotine. [0104] It consists of a thin tubular member of shorter length than the distal portion of the nut carrier. It slides freely around the outer wall of the tube 2. It is actuated by a small lever located at its proximal part. Its bevelled and finely sharpened end allows, by pushing it distally, to cut the wire held in proximal tension, like a guillotine.
MODE ANCILLAIRE B. [0105] Le mode ancillaire B convient plus particulièrement aux procédures nécessitant l'utilisation d'organes de blocage de grande taille, nécessitant l'application de forces plus importantes, spécialement lorsque le porte écrou muni de l'organe blocage travaille en butée sur un organe dur (exemple le fond d'une logette osseuse) évitant ainsi le risque d'expulser prématurément l'écrou avant que le processus de serrage ne soit complètement achevé. ANCILLARY B MODE [0105] The ancillary B mode is more particularly suitable for procedures requiring the use of large blocking devices, requiring the application of greater forces, especially when the nut carrier fitted with the locking device is working. in abutment on a hard organ (eg the bottom of a bone cavity) thus avoiding the risk of prematurely expelling the nut before the tightening process is completely completed.
Il comprend les éléments suivants : a. Le porte écrou 18 représenté à la figure 8. Il s’agit d’un organe de forme tubulaire comprenant un segment longitudinal 14, une extrémité proximale 20 et une extrémité distale 21. It includes the following elements: has. The nut carrier 18 shown in Figure 8. It is a tubular shaped member comprising a longitudinal segment 14, a proximal end 20 and a distal end 21.
[0106] Le segment longitudinal est un tube creux d’environ 8 à 10 cm de longueur (pouvant varier selon le type de procédure) dont le diamètre extérieur excède de 0,25 à 0,5mm le plus grand diamètre du composant femelle de l’organe de blocage utilisé et dont le diamètre du canal intérieur 16 est, sur toute sa longueur, sauf sur quelques mm du segment distal 17, très légèrement supérieur au diamètre de la tige du tournevis, de manière à laisser coulisser ledit tournevis librement à travers le canal intérieur du tube mais en le guidant précisément en son centre. Dans son segment distal 21, ce canal intérieur 16 est contigu et coaxial à un orifice de forme hexagonale 17 (logette) de quelques millimètres de hauteur et de dimensions transversales identiques à celles du composant femelle de l’organe de blocage, de manière à pouvoir emboîter ledit organe et le déplacer sans difficultés. [0106] The longitudinal segment is a hollow tube approximately 8 to 10 cm in length (which may vary depending on the type of procedure) whose outer diameter exceeds by 0.25 to 0.5 mm the largest diameter of the female component of the locking member used and whose diameter of the inner channel 16 is, over its entire length, except for a few mm of the distal segment 17, very slightly greater than the diameter of the screwdriver shaft, so as to allow said screwdriver to slide freely through the inner channel of the tube but guiding it precisely in its center. In its distal segment 21, this inner channel 16 is contiguous and coaxial with a hexagonal-shaped orifice 17 (cubicle) a few millimeters in height and with transverse dimensions identical to those of the female component of the blocking member, so as to be able to fit said member and move it without difficulty.
[0107] Enfin, au niveau du segment distal 21, passant par le centre du tube à travers tout son diamètre et selon son axe longitudinal, a été réalisée une fente 19 d’environ 1mm de largeur sur 5 à 6 mm de hauteur permettant ainsi aux fils de sortir de l’organe de blocage et cheminer librement le long de la surface extérieure du tube, en direction de son segment proximal. [0107] Finally, at the level of the distal segment 21, passing through the center of the tube through its entire diameter and along its longitudinal axis, a slot 19 has been made, approximately 1 mm wide by 5 to 6 mm high, thus allowing the wires to come out of the blocking member and to travel freely along the outer surface of the tube, in the direction of its proximal segment.
[0108] A 2-3 cm de l’extrémité proximale du tube 14 est fixée une poignée 15 permettant de saisir ledit tube et le manipuler aisément selon les besoins. Elle est constituée d’un segment de forme cylindrique aux extrémités arrondies de 6 à 8 mm de diamètre et d’environ 5 à 6 cm de longueur, fixé en son milieu sur le tube, perpendiculairement à son axe longitudinal. [0108] At 2-3 cm from the proximal end of the tube 14 is fixed a handle 15 allowing said tube to be grasped and easily manipulated according to need. It consists of a segment of cylindrical shape with rounded ends, 6 to 8 mm in diameter and approximately 5 to 6 cm in length, fixed in the middle to the tube, perpendicular to its longitudinal axis.
[0109] Au niveau de l’extrémité proximale, perpendiculaire à l’axe longitudinal du tube, se trouve l’orifice d’entrée 20 du canal de guidage de la tige du tournevis. [0109] At the level of the proximal end, perpendicular to the longitudinal axis of the tube, is the inlet 20 of the guide channel for the rod of the screwdriver.
[0110] Au niveau de l’extrémité distale 21, également perpendiculaire à l’axe longitudinal du tube, se trouve l’entrée 17 de l’orifice hexagonal destiné à accueillir le contour hexagonal de l’organe de blocage (partie femelle). b. Le tournevis (figure 9, à gauche). Il se compose d’une tige cylindrique 7 et d’un manche 22 permettant de l’actionner. La tige, de diamètre très légèrement inférieur au diamètre du canal intérieur 16 du porte-écrou, coulisse aisément dans ce canal en restant parfaitement centré par rapport à lui. A sa partie distale, la tige se termine par un embout 23 dont le relief mâle correspond à l’empreinte femelle 1b réalisée dans la tête de vis1 de l’organe de blocage (partie mâle). De manière préférée mais non exclusive, il s’agit d’un embout 6 pans s’emboîtant dans une empreinte creuse de forme hexagonale. La longueur de la tige peut varier selon les applications mais elle est ajustée de telle sorte que la longueur(hauteur) de l’organe de blocage (après serrage) cumulée avec celle du tournevis (après, emboîtement complet dans l’empreinte de la vis) corresponde exactement à la longueur du tube porte-écrou 18. Trop longue, même légèrement, la tige pourrait faire sortir l’organe de blocage trop tôt de sa logette, avant que le vissage des deux composants ne soit achevé et donc que le blocage complet des fils ne soit atteint, trop courte, la poignée ou molette du tournevis viendrait buter sur l'entrée du porte écrou empêchant ainsi le serrage complet de l'organe de blocage et donc le blocage des fils. At the level of the distal end 21, also perpendicular to the longitudinal axis of the tube, is the inlet 17 of the hexagonal orifice intended to accommodate the hexagonal outline of the blocking member (female part). b. The screwdriver (figure 9, left). It consists of a cylindrical rod 7 and a handle 22 allowing it to be actuated. The rod, with a diameter very slightly less than the diameter of the inner channel 16 of the nut holder, slides easily in this channel while remaining perfectly centered with respect to it. At its distal part, the rod ends in a tip 23 whose male relief corresponds to the female indentation 1b made in the head of screw1 of the locking member (male part). Preferably but not exclusively, it is a 6-sided end fitting fitting into a hollow hexagonal indentation. The length of the rod can vary according to the applications but it is adjusted so that the length (height) of the locking device (after tightening) combined with that of the screwdriver (after, complete fitting in the recess of the screw ) corresponds exactly to the length of the nut holder tube 18. Too long, even slightly, the rod could cause the blocking member to come out of its housing too early, before the screwing of the two components is complete and therefore the blocking of the wires is reached, too short, the handle or knob of the screwdriver would come up against the entrance of the nut holder, thus preventing the complete tightening of the blocking device and therefore the blocking of the wires.
[0111] Le manche 22 peut varier en forme et en taille selon l’application en cours. Dans l’exemple de technique décrite plus loin (suture méniscale), il est représenté sous la forme d’une simple mollette. Le coupe fil. (Figure 9 à droite) Il est constitué d’un organe tubulaire 27 de très faible épaisseur et de longueur inférieure de quelques cm à la longueur du porte-écrou 18. Il coulisse intimement et librement le long de la paroi extérieure du porte- écrou, par simple pression manuelle sur un petit levier 26 fixé à proximité de son extrémité proximale. L’extrémité inférieure 28 du coupe fil a été biseautée et finement aiguisée de sorte que la rencontre du bord tranchant du composant avec les fils mis préalablement sous tension provoque la section immédiate de ceux-ci, à la manière d’une guillotine. The handle 22 may vary in shape and size depending on the current application. In the example of technique described below (meniscal suture), it is represented in the form of a simple roll. The wire cutter. (Figure 9 on the right) It consists of a tubular member 27 of very thin thickness and of a length a few cm less than the length of the nut holder 18. It slides intimately and freely along the outer wall of the nut holder , by simple manual pressure on a small lever 26 fixed near its proximal end. The lower end 28 of the wire cutter has been bevelled and finely sharpened so that the meeting of the cutting edge of the component with the wires put under tension beforehand causes the immediate cutting of these, like a guillotine.
[0112] La figure 10 montre les 3 instruments ancillaires emboîtés l’un dans l’autre. La tige 7 du tournevis est vue par transparence à travers la paroi 14 du porte écrou 18. La molette 22 du tournevis repose en butée sur l’extrémité supérieure du porte écrou. Le coupe fil 27 a été engagé et coulisse librement sur la paroi 14 du porte écrou. À travers la fente latérale 19 réalisée dans l’extrémité inférieure du porte écrou, on distingue l’embout 23 du tournevis. [0113] La figure 11 montre une coupe longitudinale en gros plan de l’extrémité inférieure du porte écrou 14 après chargement de l’organe de blocage en position de coulissement 42 et introduction du tournevis 7. Figure 10 shows the 3 ancillary instruments nested one inside the other. The rod 7 of the screwdriver is seen by transparency through the wall 14 of the nut holder 18. The wheel 22 of the screwdriver rests against the upper end of the nut holder. The wire cutter 27 has been engaged and slides freely on the wall 14 of the nut holder. Through the lateral slot 19 made in the lower end of the nut holder, the tip 23 of the screwdriver can be seen. [0113] Figure 11 shows a close-up longitudinal section of the lower end of the nut holder 14 after loading the locking member in the sliding position 42 and inserting the screwdriver 7.
[0114] La figure 12 représente le schéma d’une articulation d’un genou droit en position de flexion comprenant le fémur 29, tibia 30, le péroné 31 et le ménisque externe 32. Le ménisque interne 33, siège d’une déchirure méniscale 34 est représenté en gris foncé. Seul cet élément schématique de l’articulation entière sera utilisé de manière répétitive dans tous les schémas qui vont suivre, illustrant la technique de suture méniscale à titre exemplatif parmi d’autres des possibilités d’utilisation du dispositif de blocage, objet de la présente invention. Chacune des étapes de la technique est illustrée par une figure comportant deux schémas contigus. Celui de gauche représente les différents éléments vus en perspective, d'avant en arrière, celui de droite représente la même action vue en coupe. [0114] FIG. 12 represents the diagram of a joint of a right knee in a flexion position comprising the femur 29, tibia 30, fibula 31 and the external meniscus 32. The internal meniscus 33, site of a meniscal tear 34 is shown in dark gray. Only this schematic element of the entire joint will be used repeatedly in all the following diagrams, illustrating the technique of meniscal suture by way of example among others of the possibilities of use of the blocking device, object of the present invention. . Each of the stages of the technique is illustrated by a figure comprising two contiguous diagrams. The one on the left represents the different elements seen in perspective, from front to back, the one on the right represents the same action seen in section.
[0115] L’intervention commence (figure 13) par l’introduction d’avant en arrière d’une longue aiguille creuse 38 (aiguille à ponction lombaire) passant au-dessus de la brèche méniscale 34, traversant toute la paroi du genou et ses différents composants, le plan capsulo-ligamentaire 37, le plan sous-cutané 36 et le plan cutané 35. L’aiguille parvient ainsi à l’extérieur du genou dans sa partie postéro-interne. Le canal de l’aiguille 38 (figure 14), permet alors l’introduction d’un passe-fil, composé d’un fin manche 39 et d’une extrémité losangique 40, faite d’un très fin fil métallique rétractable à mémoire de forme qui se déploie dès son issue du canal de l’aiguille. Il permet ainsi de capturer aisément l’extrémité des 2 brins d’un fil de suture 4 comportant un corpuscule d’arrêt 41 fixé en leur milieu par construction. Ce petit corpuscule aune forme préférentiellement mais non obligatoirement sphérique. Il pourrait être fait de métal compatible (titane etc.) d’un matériau rigide biocompatible tel que le peek ou encore d’un autre matériau rigide biorésorbable. Il a été publié dans la littérature spécialisée qu’un effet de blocage similaire peut être obtenu en réalisant un ou plusieurs nœuds sur le fil lui-même mais, pour des raisons de commodité, la fixation préalable d’un corpuscule d’arrêt nous paraît souhaitable. Il est à noter également que toute la technique démontrée ci-après décrit une suture méniscale réalisée au moyen d’un fil de suture comprenant 2 filaments ce qui comporte évidemment des avantages de solidité. La même technique pourrait cependant être réalisée exactement de la même manière au moyen d’un seul brin de suture (ce qui est impossible si l’on doit terminer la suture par la technique classique de nouage). [0116] Figure 15. En retirant le passe-fil 39 d’arrière en avant à travers l’aiguille 38, il attire les fils 4 à travers la paroi du genou, puis à travers le canal de l’aiguille et les fils sont récupérés au niveau de l’orifice d’entrée proximale de I’aiguille38. The operation begins (FIG. 13) with the introduction from front to back of a long hollow needle 38 (lumbar puncture needle) passing above the meniscal breach 34, crossing the entire wall of the knee and its various components, the capsule-ligament plane 37, the subcutaneous plane 36 and the cutaneous plane 35. The needle thus reaches the outside of the knee in its postero-internal part. The channel of the needle 38 (figure 14), then allows the introduction of a grommet, composed of a fine handle 39 and a lozenge-shaped end 40, made of a very fine retractable metal wire with memory of shape which unfolds as soon as it emerges from the channel of the needle. It thus makes it possible to easily capture the end of the 2 strands of a suture thread 4 comprising a stop corpuscle 41 fixed in their middle by construction. This small corpuscle has a preferentially but not necessarily spherical shape. It could be made of compatible metal (titanium etc.), a rigid biocompatible material such as peek or another rigid bioabsorbable material. It has been published in the specialized literature that a similar blocking effect can be obtained by making one or more knots on the thread itself but, for convenience, the prior fixing of a stop corpuscle seems to us desirable. It should also be noted that the entire technique demonstrated below describes a meniscal suture made using a suture thread comprising 2 filaments, which obviously has strength advantages. The same technique could, however, be performed in exactly the same way using a single strand of suture (which is impossible if the suture must be terminated by the classic knotting technique). [0116] Figure 15. By withdrawing the grommet 39 from back to front through the needle 38, it draws the threads 4 through the wall of the knee, then through the needle channel and the threads are retrieved at the level of the proximal entry hole of the needle38.
[0117] Figure 16. Les fils 4 sont alors mis en tension tout en conservant l’aiguille à l’intérieur du genou. Une minime incision cutanée de 1 à 2 mm réalisée au bistouri permet au corpuscule 41 de traverser le plan cutané 35 puis de pénétrer dans le plan profond à travers le plan graisseux sous-cutané 36, de faible résistance, et enfin de venir s’accoler au plan fibreux capsulaire 37 où il s’immobilise. [0117] Figure 16. The threads 4 are then tensioned while keeping the needle inside the knee. A tiny skin incision of 1 to 2 mm made with a scalpel allows the corpuscle 41 to cross the cutaneous plane 35 then to penetrate into the deep plane through the subcutaneous fatty plane 36, of low resistance, and finally to come to attach to the capsular fibrous plane 37 where it comes to rest.
[0118] Figure 17. L’aiguille est ensuite inclinée de 25 à 30° de manière à aborder la surface supérieure du ménisque 33 le plus perpendiculairement possible. [0118] Figure 17. The needle is then inclined by 25 to 30° so as to approach the upper surface of the meniscus 33 as perpendicularly as possible.
[0119] Figure 18. L’aiguille 38 est alors réintroduite d’avant en arrière, traversant d’abord le corps méniscal 33 puis les différents composants 37, 36 et 35 de la paroi du genou, entraînant avec elle les fils de suture 4 qui longent donc la paroi externe de l’aiguille durant leur trajet d’avant en arrière, débouchent ainsi à l’extérieur du genou à sa partie postéro interne puis, après réflexion de 180°, décrivent un trajet inverse d’arrière en avant au sein de l’aiguille pour faire issue à la partie proximale de celle-ci. [0119] Figure 18. The needle 38 is then reintroduced from front to back, first crossing the meniscal body 33 then the various components 37, 36 and 35 of the wall of the knee, carrying with it the suture threads 4 which therefore run along the outer wall of the needle during their path from front to back, thus emerge outside the knee at its postero-internal part then, after reflection of 180°, describe a reverse path from back to front at the within the needle to issue to the proximal part thereof.
[0120] Figure 19-20. L’aiguille 38 est retirée d’arrière en avant et les fils, libérés de l’aiguille, sont attirés à l’extérieur du genou en tirant simplement sur la boucle 4 composée des 4 brins faisant issue à la partie postéro interne du genou. [0120] Figure 19-20. Needle 38 is withdrawn from back to front and the threads, freed from the needle, are drawn to the outside of the knee by simply pulling on loop 4 made up of the 4 strands issuing from the inner postero part of the knee.
[0121] Figure 21. L’aiguille vide 38 est ensuite réintroduite d’avant en arrière en dessous du ménisque 33 en visant la zone d’issue cutanée des fils de suture se trouvant libre à l’extérieur du genou dans la région postéro-interne. [0121] Figure 21. The empty needle 38 is then reintroduced from front to back below the meniscus 33, aiming at the cutaneous outlet zone of the suture threads lying free outside the knee in the posterolateral region. internal.
[0122] Figure 22-23. Cette manœuvre permet alors de réintroduire le passe-fil afin de capturer l’extrémité libre des fils de suture 4 et les réintroduire dans le genou. Cette manœuvre peut nécessiter la réalisation d’une seconde micro-incision cutanée afin de permettre aux fils 4 de migrer à travers la peau 35, traverser le plan graisseux sous- cutané 36 et venir buter sur le plan fibro-ligamentaire 37, comme le corpuscule d’arrêt 41. [0122] Figure 22-23. This maneuver then makes it possible to reintroduce the thread guide in order to capture the free end of the suture threads 4 and reintroduce them into the knee. This maneuver may require the performance of a second cutaneous micro-incision in order to allow the sutures 4 to migrate through the skin 35, cross the subcutaneous fatty layer 36 and abut against the fibro-ligamentous plane 37, like the corpuscle stop 41.
[0123] Figure 24. Les fils de suture 4 sont récupérés à l’extérieur du genou mais cette fois en avant de celui-ci, par une des voies d’abord arthroscopiques. Les fils sont introduits dans l’organe de blocage 42 dont les composants ont été préalablement assemblés mais non serrés, selon le schéma décrit à la figure 2. (NB : pour des raisons de facilité, l’assemblage des composants mâle et femelle peut se faire après avoir passé au préalable les fils dans la rondelle et en enfilant celle-ci sur la tige mâle.) L’organe de blocage coulisse alors tout à fait librement sur les filaments. [0123] Figure 24. The sutures 4 are recovered outside the knee but this time in front of it, by one of the arthroscopic approaches. The wires are introduced into the blocking member 42, the components of which have been assembled beforehand but not tightened, according to the diagram described in FIG. 2. (NB: for reasons assembly of the male and female components can be done after first passing the wires through the washer and threading it on the male rod.) The locking member then slides completely freely on the filaments .
[0124] L'autre alternative technique déjà mentionnée plus haut est d'utiliser l'organe de blocage déjà assemblé mais équipé d'une boucle de traction 56 (figure 4) qui permet d'attirer aisément les fils de suture 4 à travers l'organe de blocage. The other technical alternative already mentioned above is to use the locking member already assembled but equipped with a traction loop 56 (FIG. 4) which makes it possible to easily attract the suture threads 4 through the blocking device.
[0125] Figure 25-26. L’organe de blocage muni de ses fils est alors introduit dans l’extrémité inférieure du porte écrou (figure 26b). Il se trouve toujours à ce moment en configuration de coulissement, ce qui permet au porte-écrou déjà muni du tournevis, de guider l’organe de blocage en dessous du ménisque jusqu’au contact du plan capsulo- ligamentaire 37, au niveau même de l’issue des fils de suture. La traction proximale (d’arrière en avant) appliquée sur les fils de suture combinée à une pression distale (d’avant en arrière) appliquée sur les poignées 15 du porte écrou 18 provoque la mise en tension du fil de suture 4. La tension exercée sur les fils provoque ainsi l’accolement du ménisque 33 à sa périphérie capsulo-ligamentaire 37 en refermant la brèche méniscale 34. [0125] Figure 25-26. The locking device fitted with its wires is then introduced into the lower end of the nut holder (figure 26b). It is still at this time in the sliding configuration, which allows the nut holder already equipped with the screwdriver, to guide the locking member below the meniscus until it comes into contact with the capsulo-ligamentary plane 37, at the same level of the outcome of the sutures. The proximal traction (from back to front) applied to the suture threads combined with a distal pressure (from front to back) applied to the handles 15 of the nut holder 18 causes the tensioning of the suture thread 4. The tension exerted on the wires thus causes the attachment of the meniscus 33 to its capsulo-ligamentous periphery 37 by closing the meniscal breach 34.
[0126] Figure 27. Après avoir vérifié la fermeture adéquate de la brèche méniscale et s’il en est satisfait, il suffit alors au chirurgien d’effectuer dans le sens des aiguilles d’une montre quelques tours de rotation appliquée sur la molette 22 du tournevis ce qui entraîne le serrage de l’organe de blocage 43, verrouillant complètement le coulissement des fils 4. Si à ce moment, l’aspect de la suture n’est pas satisfaisant (serrage trop important ou, au contraire, insuffisant) il suffit de dévisser quelque peu l’organe de blocage, reprendre la manœuvre de tension sur les fils jusqu’à leur niveau jugé optimal et revisser l’organe de blocage pour l’amener à sa position définitive de verrouillage 43. [0126] Figure 27. After having checked the adequate closure of the meniscal breach and if he is satisfied with it, the surgeon then only has to perform a few clockwise rotations applied to the knob 22 of the screwdriver which causes the clamping of the blocking member 43, completely locking the sliding of the threads 4. If at this time, the appearance of the suture is not satisfactory (tightening too great or, on the contrary, insufficient) it suffices to unscrew the blocking member a little, resume the tensioning operation on the wires to their level deemed optimal and screw the blocking member back on to bring it to its final locking position 43.
[0127] Le processus étant définitivement validé (figure 28), il suffit alors de mettre les fils 4 en tension et de pousser le coupe-fil 27 par l’intermédiaire du petit levier 26 en direction de l’extrémité distale du porte écrou 28. La rencontre de l’extrémité biseautée tranchante du coupe-fil avec les fils tendus provoque immédiatement la section de ceux- ci. [0127] The process being definitively validated (figure 28), it is then sufficient to put the wires 4 under tension and to push the wire cutter 27 via the small lever 26 in the direction of the distal end of the nut holder 28 The encounter of the sharp bevelled end of the wire cutter with the taut wires immediately causes them to be cut.
[0128] La figure 29 montre le résultat final de la suture. On voit que le petit corps de blocage 43 va se loger dans le récessus sous méniscal interne inférieur, là où il n’existe aucun risque de blesser les tissus voisins. Cela n’est pas le cas de toute technique se terminant par la formation d’un nœud à la face supérieure du ménisque risquant ainsi d’endommager le cartilage articulaire du condyle fémoral sus-jacent par frottement répété lors des mouvements de flexion-extension. [0128] Figure 29 shows the end result of the suture. It can be seen that the small blocking body 43 will lodge in the inferior internal meniscal recess, where there is no risk of injuring the neighboring tissues. This is not the case for any technique ending in the formation of a knot on the upper surface of the meniscus, thus risking damage the articular cartilage of the overlying femoral condyle by repeated friction during flexion-extension movements.
[0129] La figure 30 démontre clairement que le dispositif de blocage de fils décrit par la présente invention peut s’appliquer à des situations radicalement différentes de celles qui vient d’être illustrée avec le processus de suture méniscale. Dans l’exemple décrit, il s’agit cette fois d’obtenir un ancrage à la fois solide (exposé à plusieurs dizaines de kilos de traction) et rigide (en supprimant les phénomènes parasites d’élasticité) d’une greffe ligamentaire à une structure osseuse. Le schéma illustre l’inclusion d’une greffe de ligament croisé antérieur 46 introduite dans une logette osseuse 45 réalisée dans le condyle fémoral externe 44. La figure 30 montre comment la douille creuse 11 permet de verrouiller les fils au niveau 12, à proximité immédiate de la greffe ligamentaire alors que la douille s’accroche sur un niveau 12’ distant de plusieurs centimètres, évitant ainsi la nécessité d’un long relais textile entre ces 2 niveaux, dont l’élasticité est préjudiciable à la cicatrisation de la greffe. [0129] Figure 30 clearly demonstrates that the thread locking device described by the present invention can be applied to situations radically different from those just illustrated with the meniscal suturing process. In the example described, this time it is a question of obtaining an anchorage that is both solid (exposed to several tens of kilos of traction) and rigid (by eliminating the parasitic phenomena of elasticity) of a ligament graft to a bone structure. The diagram illustrates the inclusion of an anterior cruciate ligament graft 46 introduced into a bone pocket 45 made in the external femoral condyle 44. Figure 30 shows how the hollow socket 11 makes it possible to lock the wires at level 12, in the immediate vicinity of the ligament graft while the socket is attached to a level 12' several centimeters away, thus avoiding the need for a long textile relay between these 2 levels, the elasticity of which is detrimental to the healing of the graft.
[0130] La figure 31 montre comment le dispositif de blocage pourrait être utilisé pour réaliser par procédé de cerclage la réduction et le maintien en position de réduction d’une structure anatomique quelconque siège d’une fissuration ou fracture. La figure 31a montre la mise en place d’un filin de cerclage 49 autour d’une structure fissurée 48. La figure 31b montre la mise en tension des fils à travers l’organe de blocage en position coulissante 42, provoquant la tension du fil et par conséquent la réduction de la structure fissurée. La figure 31c illustre le verrouillage des fils après réduction par serrage de l’organe de blocage 43. [0130] Figure 31 shows how the blocking device could be used to carry out, by strapping process, the reduction and maintenance in the reduction position of any anatomical structure that is the site of a crack or fracture. Figure 31a shows the placement of a strapping rope 49 around a cracked structure 48. Figure 31b shows the tensioning of the yarns through the locking member in sliding position 42, causing and consequently the reduction of the cracked structure. Figure 31c illustrates the locking of the wires after reduction by tightening the locking member 43.
[0131] Les dimensions de l’organe de blocage représenté à la figure 31 ont été volontairement agrandies afin de pouvoir visualiser le trajet des fils et le processus de blocage. Il est évident qu’en réalité, le système peut être appliqué avec un encombrement minimal du dispositif de blocage. The dimensions of the blocking member shown in Figure 31 have been deliberately enlarged in order to be able to visualize the path of the wires and the blocking process. It is obvious that in reality the system can be applied with a minimum bulk of the blocking device.
[0132] Il faut comprendre que la technique de suture méniscale exposée plus haut constitue un exemple parmi d’autres des applications possibles du dispositif de blocage décrit par la présente invention. Il existe de nombreuses variantes possibles du système et il n’est pas possible de les décrire ici de façon exhaustive. It should be understood that the meniscal suturing technique described above constitutes one example among others of the possible applications of the locking device described by the present invention. There are many possible variants of the system and it is not possible to describe them exhaustively here.
[0133] La figure 32 illustre toutefois une de ces variantes permettant de remplacer le passe-fil 39 par une anse filamentaire simple 52 dont un des brins passe à l’intérieur de l’aiguille et l’autre le long de l’aiguille (Fig30a). Un tel dispositif permet d’amener très simplement une anse filamentaire tractrice à l’extérieur du genou sans utilisation d’un passe-fil 39 dont l’inconvénient principal réside dans le diamètre du manche nécessitant l’utilisation d’une aiguille suffisamment large pour permettre son passage. À l’inverse, l’anse filamentaire peut être réalisée avec un fil extrêmement fin, permettant ainsi l’utilisation d’aiguilles beaucoup plus fines et donc beaucoup moins traumatisantes pour les tissus qu’elle doit traverser (Ex : ménisque, paroi du genou etc.). However, FIG. 32 illustrates one of these variants making it possible to replace the grommet 39 with a simple filament loop 52, one of the strands of which passes inside the needle and the other along the needle ( Fig30a). Such a device makes it possible very simply to bring a traction filament loop to the outside of the knee without the use of a grommet 39 whose main drawback lies in the diameter of the handle requiring the use of a needle large enough to allow its passage. Conversely, the filamentary loop can be made with an extremely fine wire, thus allowing the use of much finer needles and therefore much less traumatic for the tissues that it must cross (Ex: meniscus, wall of the knee etc.).
[0134] Une fois parvenue à l’extérieur du genou, l’anse filamentaire offre plusieurs options. [0134] Once outside the knee, the filament loop offers several options.
[0135] La figure 32 B illustre par exemple la possibilité d’attirer dans le genou un nouveau filament de suture 4 muni d’un corpuscule d’arrêt 41 décrit plus haut. Une autre possibilité décrite à la figure 32c est celle d’utiliser un corpuscule d’arrêt de type annulaire 53, muni d’une ouverture latérale 54 permettant d’y introduire le fil 4 par pression latérale en profitant de l’élasticité du corps annulaire. Le fil de suture4 dont on voit la section 55 à la figure 32c est alors emprisonné à l’intérieur du corpuscule et coulisse librement sur le fil. Ce dispositif permet par exemple de mettre en place un second point de suture juxtaposé en utilisant le même filament, de tendre ensuite les 2 points de suture conjointement grâce au coulissement du fil dans le corpuscule annulaire et finalement, de verrouiller l’ensemble au moyen d’un seul organe de blocage. FIG. 32 B illustrates, for example, the possibility of drawing a new suture filament 4 provided with a stop corpuscle 41 described above into the knee. Another possibility described in FIG. 32c is that of using a stop corpuscle of the annular type 53, provided with a lateral opening 54 making it possible to introduce the wire 4 therein by lateral pressure taking advantage of the elasticity of the annular body. . The suture thread4, section 55 of which can be seen in figure 32c, is then imprisoned inside the corpuscle and slides freely on the thread. This device makes it possible, for example, to set up a second juxtaposed stitch using the same filament, then to stretch the 2 stitches together thanks to the sliding of the thread in the annular corpuscle and finally, to lock the assembly by means of a single blocking device.
[0136] Il est apparu lors d’essais préliminaires que l’organe de blocage 1,2,3 présenté ci-avant avait tendance à tourner lorsqu’il était extrait du porte écrou. Cette rotation a pour effet de légèrement détendre la suture 4, surtout, lorsque l’élément distal de l’organe blocage est épais, et que soit il n’y a qu’un fil de suture 4, soit les fils de sutures ne sont pas symétriques autour de l’organe de blocage. Afin de remédier à cet inconvénient, l’élément distal de l’organe de blocage comprend de préférence une boucle de guidage du fil de suture disposé à son extrémité distale, de façon à disposer le point d’ancrage de l’organe de blocage de façon optimale par rapport à sa position lors du serrage. Les figures 33 a et b représentent deux alternatives dans lesquelles le composant distal 59,61 de l’organe de blocage comprend à son extrémité distale une boucle de positionnement 60,62 du fil de suture 4. It appeared during preliminary tests that the locking member 1,2,3 presented above had a tendency to rotate when it was extracted from the nut holder. This rotation has the effect of slightly relaxing the suture 4, especially when the distal element of the blocking member is thick, and either there is only one suture thread 4, or the suture threads are not not symmetrical around the blocking device. In order to remedy this drawback, the distal element of the blocking member preferably comprises a loop for guiding the suture thread placed at its distal end, so as to place the anchoring point of the blocking member optimally in relation to its position during tightening. Figures 33 a and b show two alternatives in which the distal component 59,61 of the blocking member comprises at its distal end a positioning loop 60,62 of the suture thread 4.
[0137] Enfin, lors du positionnement et du serrage de l’organe de blocage, celui-ci doit être au plus près de la structure d’ancrage, et donc affleurer à l’extrémité distale du porte écrou 14. Ce faisant, il y a un risque que l’opérateur, en exerçant sur le tournevis 7 la pression nécessaire au vissage de l’élément proximal de l’organe de blocage dans l’élément distal, l’opérateur risque d’expulser prématurément l’organe de blocage 1 ,2,3 du porte écrou 14. Une première stratégie pour éviter ce problème est de prévoir la longueur de la tige du tournevis 7 de façon à ce que celui-ci ait juste la longueur nécessaire au vissage de l’organe de blocage (i.e. que la tige du tournevis 7 soit similaire ou identique à la longueur du porte écrou 14 réduite de la longueur de l’élément de blocage). Dans ce cas, le manche ou la molette 22 prend appui sur l’extrémité proximale du porte écrou 14 avant que le tournevis ne sorte l’organe de blocage de son logement. Finally, when positioning and tightening the locking member, the latter must be as close as possible to the anchoring structure, and therefore be flush with the distal end of the nut holder 14. In doing so, it there is a risk that the operator, by exerting on the screwdriver 7 the pressure necessary for screwing the proximal element of the blocking member into the distal element, the operator risks expelling the blocking member prematurely 1, 2, 3 of the nut carrier 14. A first strategy to avoid this problem is to provide the length of the stem of the screwdriver 7 so that it has just the length necessary for screwing the locking member (ie that the stem of the screwdriver 7 is similar or identical to the length of the nut holder 14 reduced by the length of the blocking element). In this case, the handle or the wheel 22 bears against the proximal end of the nut holder 14 before the screwdriver leaves the locking member of its housing.
[0138] Néanmoins, même lorsque la longueur du tournevis est optimisée, la course de l’élément proximal de l’organe de blocage par rapport à l’élément distal peut rendre le vissage compliqué. En effet, si le tournevis est disposé de façon optimale en début de serrage, l’élément proximal avance lors du vissage au point qu’il ne soit plus possible d’y appliquer un couple de serrage suffisant. Pour pallier à ce problème, il peut être avantageux de disposer un filet de vissage 63,64 sur la tige du tournevis 7 et sur la surface interne du porte-écrou 14 tel que représenté aux figures 35 et 36. En effet, dans ce cas, l’utilisation de pas de vissage similaires entre l’ensemble tournevis/porte écrou d’une part et l’ensemble organe de blocage d’autre part permet une mouvement simultané permettant un positionnement optimal du tournevis sans risque d’expulsion de l’organe de blocage de son logement. Nevertheless, even when the length of the screwdriver is optimized, the travel of the proximal element of the blocking member relative to the distal element can make screwing complicated. In fact, if the screwdriver is positioned optimally at the start of tightening, the proximal element advances during screwing to the point that it is no longer possible to apply sufficient tightening torque. To overcome this problem, it may be advantageous to have a screw thread 63,64 on the rod of the screwdriver 7 and on the internal surface of the nut holder 14 as shown in Figures 35 and 36. Indeed, in this case , the use of similar screwing pitches between the screwdriver/nut holder assembly on the one hand and the locking member assembly on the other hand allows simultaneous movement allowing optimal positioning of the screwdriver without risk of expulsion of the blocking device from its housing.
[0139] Un autre avantage de l’utilisation des filets de vissage entre le porte écrou et le tournevis est de les solidariser pendant l’opération, ce qui permet à l’opérateur de positionner et visser l’organe de blocage d’une seule main, tandis que l’autre main de l’opérateur applique la tension adéquate sur le fil de suture. [0139] Another advantage of using screw threads between the nut carrier and the screwdriver is to secure them during the operation, which allows the operator to position and screw the locking member in one go. hand, while the operator's other hand applies adequate tension to the suture.

Claims

Revendications. Claims.
1. Kit de blocage de fil(s) de suture comprenant : 1. Suture thread(s) blocking kit comprising:
A) au moins un organe de blocage comprenant : i. Un composant mâle (1) comprenant une tige filetée (1c) et une tête (1a) élargie; ii. Un composant femelle (3) comprenant un trou taraudé (3b); iii. Au moins une rondelle (2) pouvant se déplacer librement le long de la tige filetée (1c) du composant mâle (1), les arrêtes externes de la ou les rondelles étant arrondies de façon à éviter de couper ou user le ou les fils de suture lors de leurs mouvements dans l’organe de blocage ; l’un des composant mâle ou femelle étant dit proximal et comprenant à une extrémité une empreinte (1b) permettant de lui appliquer un couple au moyen d’un tournevis ayant l’empreinte complémentaire, et l’autre composant étant dit distal et ayant une section externe (3d) permettant de lui appliquer un couple inverse au moyen d’une section creuse complémentaire ; A) at least one locking member comprising: i. A male component (1) comprising a threaded rod (1c) and an enlarged head (1a); ii. A female component (3) comprising a tapped hole (3b); iii. At least one washer (2) able to move freely along the threaded rod (1c) of the male component (1), the outer edges of the washer(s) being rounded so as to avoid cutting or wearing the thread(s) of suture during their movements in the blocking organ; one of the male or female component being said to be proximal and comprising at one end an imprint (1b) enabling torque to be applied to it by means of a screwdriver having the complementary imprint, and the other component being said to be distal and having a external section (3d) enabling a reverse torque to be applied to it by means of a complementary hollow section;
B) un porte écrou comprenant un élément tubulaire (14,85) comportant une extrémité distale (17) et une extrémité proximale, l’extrémité distale (17) comportant une logette (21) permettant d’accueillir l’organe de blocage (1 ,2,3) et de le déplacer au sein de tissus, la forme de la logette (21) étant configurée de façon à permettre d’appliquer un couple de rotation au composant distal de l’organe de blocage et l’extrémité proximale comprenant des moyens de préhension (15) permettant de guider le porte écrou et d’y appliquer un couple de rotation ; B) a nut holder comprising a tubular element (14,85) comprising a distal end (17) and a proximal end, the distal end (17) comprising a recess (21) making it possible to accommodate the locking member (1 ,2,3) and to move it within tissue, the shape of the pocket (21) being configured so as to make it possible to apply a rotational torque to the distal component of the blocking member and the proximal end comprising gripping means (15) making it possible to guide the nut holder and to apply a torque thereto;
C) un tournevis comprenant une tige (7) comprenant une extrémité distale (23) et une extrémité proximale (22) la tige étant dimensionnée de façon à coulisser librement dans le canal central du porte écrou et dont la forme de l’extrémité distale (23) correspond à l’empreinte (1b) réalisée dans le composant proximal de l’organe de blocage de façon à pouvoir visser ou dévisser celui-ci dans ou sur le composant distal de l’organe de blocage. C) a screwdriver comprising a rod (7) comprising a distal end (23) and a proximal end (22), the rod being dimensioned so as to slide freely in the central channel of the nut holder and the shape of the distal end ( 23) corresponds to the recess (1b) made in the proximal component of the blocking member so as to be able to screw or unscrew the latter into or on the distal component of the blocking member.
2. Kit selon la revendication 1 comprenant un ou des fils de suture. 2. Kit according to claim 1 comprising one or more sutures.
3. Kit selon la revendication 1 ou 2 comprenant un coupe fil de forme tubulaire, coaxial au porte écrou, et pouvant coulisser à l’extérieur du porte écrou, une arrête biseautée (28) à une extrémité distale dudit coupe fil étant configurée de façon à pouvoir couper, en utilisation, le ou les fils de suture (4). 3. Kit according to claim 1 or 2 comprising a wire cutter of tubular shape, coaxial with the nut carrier, and slidable outside the nut carrier, a beveled edge (28) at a distal end of said wire cutter being configured so to be able to cut, in use, the suture or sutures (4).
4. Kit selon l’une des revendications précédentes dans lequel l’organe de blocage est préassemblé, le fil de suture (4) étant passé dans la rondelle (2) de l’organe de blocage, ou, une boucle de fil (56) est prédisposée dans la rondelle (2) de l’organe de blocage pour faciliter le passage du fil de suture (4) dans la rondelle (2) sans désassembler la partie mâle de la partie femelle. 4. Kit according to one of the preceding claims, in which the blocking member is preassembled, the suture thread (4) being passed through the washer (2) of the blocking member, or a wire loop (56 ) is predisposed in the washer (2) of the locking member to facilitate the passage of the suture thread (4) in the washer (2) without disassembling the male part from the female part.
5. Kit selon l’une des revendications précédentes dans lequel l’élément tubulaire (14) du porte écrou comprend une ou des fentes (19) à son extrémité distale (21), de façon à permettre en utilisation le passage du ou des fils de sutures (4) en minimisant les force de frictions entre les fils (4) et le porte écrou. 5. Kit according to one of the preceding claims, in which the tubular element (14) of the nut holder comprises one or more slots (19) at its distal end (21), so as to allow the passage of the wire or wires in use. sutures (4) minimizing the friction force between the son (4) and the nut holder.
6. Kit selon l’une des revendications précédentes dans lequel l’organe de blocage comprend un prolongement proximal, ledit prolongement comprenant des moyens d’ancrage (9) à une structure distante (5) vers la zone proximale. 6. Kit according to one of the preceding claims, in which the locking member comprises a proximal extension, said extension comprising anchoring means (9) to a remote structure (5) towards the proximal zone.
7. Kit selon la revendication 6 dans lequel le prolongement proximal présente une forme tubulaire (6), comprenant à son extrémité proximale un épaulement (9) adapté à prendre appui sur un trou circulaire pratiqué dans une structure d’accrochage correspondante d’un tissu, des orifices (13) pratiqués à l’extrémité distale de cette structure tubulaire permettant le passage du ou des fils de suture(s). 7. Kit according to claim 6 wherein the proximal extension has a tubular shape (6), comprising at its proximal end a shoulder (9) adapted to bear on a circular hole made in a corresponding attachment structure of a tissue , orifices (13) made at the distal end of this tubular structure allowing passage of the suture thread(s).
8. Kit selon la revendication 7 dans lequel l’épaulement proximal (9) comprend la section externe permettant d’appliquer un couple au composant distal. 8. Kit according to claim 7 in which the proximal shoulder (9) comprises the external section allowing to apply a torque to the distal component.
9. Kit selon l’une des revendications précédentes, le porte écrou comprenant un élément de préhension (67) coaxiale et à l’intérieur de l’élément tubulaire (71) du porte écrou (85), ledit élément de préhension (67) comprenant à son extrémité distale des lames ressort (68) et pouvant coulisser à l’intérieur du porte écrou (85) entre un position ouverte où les lames ressorts (68) émergent largement du porte écrou (85) et une position fermée où les lames ressorts sont comprimées par l’orifice distal du porte écrou (85) les lames ressorts en position fermées formant la logette permettant de bloquer l’élément distal de l’organe de blocage (3,59). 9. Kit according to one of the preceding claims, the nut holder comprising a gripping element (67) coaxial and inside the tubular element (71) of the nut holder (85), said gripping element (67) comprising at its distal end leaf springs (68) and able to slide inside the nut holder (85) between an open position where the leaf springs (68) largely emerge from the nut holder (85) and a closed position where the blades springs are compressed by the distal orifice of the nut holder (85) the leaf springs in the closed position forming the housing allowing the distal element of the locking member (3,59) to be blocked.
10. Kit selon l’une des revendications précédentes dans lequel la section externe du composant distal de l’organe de blocage est un polygone régulier convexe ou étoilé. 10. Kit according to one of the preceding claims, in which the outer section of the distal component of the locking member is a regular convex or star-shaped polygon.
11. Kit selon la revendication 10 dans lequel la section externe du composant distal de l’organe de blocage est hexagonale. 11. Kit according to claim 10 wherein the outer section of the distal component of the locking member is hexagonal.
12. Kit selon l’une des revendications précédentes dans lequel la forme de l’empreinte du composant proximal de l’organe de blocage présente une section de polygone régulier convexe ou étoilé. 12. Kit according to one of the preceding claims, in which the shape of the imprint of the proximal component of the locking member has a section of a regular convex or star-shaped polygon.
13. Kit selon la revendication 11 dans lequel la section externe du composant proximal de l’organe de blocage est hexagonale. 13. Kit according to claim 11 wherein the outer section of the proximal component of the locking member is hexagonal.
14. Kit selon l’une des revendications précédentes dans lequel le composant distal (59,61) de l’organe de blocage comprend à son extrémité distale une boucle de positionnement (60,62) du fil de suture (4). 14. Kit according to one of the preceding claims wherein the distal component (59,61) of the locking member comprises at its distal end a positioning loop (60,62) of the suture thread (4).
15. Kit selon l’une des revendications précédentes dans lequel la tige du tournevis (7) comprend une zone filetée (63) se vissant en utilisation dans une zone filetée (64) correspondante du porte écrou tubulaire (14). 15. Kit according to one of the preceding claims, in which the rod of the screwdriver (7) comprises a threaded zone (63) which is screwed in use into a corresponding threaded zone (64) of the tubular nut holder (14).
PCT/EP2022/053376 2021-02-12 2022-02-11 Device for locking suture threads WO2022171801A1 (en)

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EP21156878 2021-02-12

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024069117A1 (en) * 2022-09-27 2024-04-04 Osteoweld Surgical Ltd Suture retainer and insertion tool

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WO1997030639A1 (en) * 1996-02-22 1997-08-28 Smith And Nephew, Inc. Suture collet
US20070167950A1 (en) * 2005-12-22 2007-07-19 Tauro Joseph C System and method for attaching soft tissue to bone
US20100070045A1 (en) * 2000-05-01 2010-03-18 Arthrosurface Incorparated System and Method for Joint Resurface Repair
FR2938745A1 (en) * 2008-09-12 2010-05-28 Tettra Marketing Llp TAP FOR PLACING A CAGE OF A FIXING DEVICE FOR LIGAMENTOPLASTY
US8323315B2 (en) 1998-12-30 2012-12-04 Depuy Mitek, Inc. Suture locking device
US9924939B1 (en) 2017-07-06 2018-03-27 Christian N. Anderson Self-cinching suture construct apparatus
US10743858B1 (en) * 2019-07-26 2020-08-18 Little Engine, LLC Flush anchor snap-off apparatus

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997030639A1 (en) * 1996-02-22 1997-08-28 Smith And Nephew, Inc. Suture collet
US8323315B2 (en) 1998-12-30 2012-12-04 Depuy Mitek, Inc. Suture locking device
US20100070045A1 (en) * 2000-05-01 2010-03-18 Arthrosurface Incorparated System and Method for Joint Resurface Repair
US20070167950A1 (en) * 2005-12-22 2007-07-19 Tauro Joseph C System and method for attaching soft tissue to bone
FR2938745A1 (en) * 2008-09-12 2010-05-28 Tettra Marketing Llp TAP FOR PLACING A CAGE OF A FIXING DEVICE FOR LIGAMENTOPLASTY
US9924939B1 (en) 2017-07-06 2018-03-27 Christian N. Anderson Self-cinching suture construct apparatus
US10743858B1 (en) * 2019-07-26 2020-08-18 Little Engine, LLC Flush anchor snap-off apparatus

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024069117A1 (en) * 2022-09-27 2024-04-04 Osteoweld Surgical Ltd Suture retainer and insertion tool

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