A device for the mechanical fixation of connective tissue in an animal.

Abstract

Mechanical fixation device for connective tissue of an animal. Mechanical fixation device (1) of a first connective tissue (11) of the body of an animal, in particular the human body or the body of a mammal, to a second connective tissue (12) of that body, the mechanical fixation device (1) comprising: - an interface piece (2), - at least one element (3, 6; 7, 8) for fixing the interface piece (2) to a second connective tissue (12) of that body, and - at least one removable fixing element (9) for a thread (4) to the interface piece (2). Figure for the abstract: 1

Description

Title of the invention: Mechanical fixation device for connective tissue of an animal.

[0001] The invention relates to a device for mechanically fixing a first connective tissue, such as a muscle, of the body of a mammal or more generally of an animal, to a second connective tissue of that body, such as a muscle, bone, tendon, or ligament. The invention further relates to a method for positioning and configuring the aforementioned fixing device.

[0002] In the surgical field, particularly in reconstructive or plastic surgery, it is sometimes necessary to implement methods to tighten a muscle or group of muscles. Such an intervention is time-consuming. Furthermore, it is often difficult to make fine adjustments to muscle tension during or after surgery, in a subsequent surgical procedure.

[0003] The object of the invention is to provide a device for the mechanical fixation of a first connective tissue of an animal's body to a second connective tissue of that same animal's body, and a method for configuring and positioning such a device, remedying the above-mentioned drawbacks and improving upon devices and methods known in the prior art. In particular, the invention proposes a simple device that makes the aforementioned surgical procedures more practical and faster.

[0004] The invention relates to a device for mechanically attaching a first connective tissue of an animal's body, particularly the human body or the body of a mammal, to a second connective tissue of that body. The mechanical attachment device comprises: - an interface piece, - at least one element for attaching the interface piece to a second connective tissue of that body, and - at least one removable fixing element for a wire to the interface piece.

[0005] The interface piece may be a plate, in particular: - a flat or nearly flat plate, or - a convex plate, or - a concave plate, or - a warped plate.

[0006] At least one fastening element of the interface part may include a through hole for a fastening screw.

[0007] The device may include at least one element for permanently attaching a wire to the interface piece.

[0008] At least one permanent wire fixing element may include a wire knotting hole.

[0009] At least one removable wire fastening element may include a locking element such as, for example: - a flap, tab, or cover, hinged or pivoted on the interface piece, or - a cork.

[0010] At least one removable fastening element can be arranged to tighten the thread when traction is applied to the strand of thread connected to the first connective tissue.

[0011] At least one removable fastening element can be arranged to release the wire when traction is applied to the distal end of the wire.

[0012] The invention also relates to a method for setting up and configuring a mechanical fastening device defined previously. The method comprises: - a step of fixing the interface piece to a second connective tissue of an animal's body, in particular the human body, - a step of fixing a thread to a first connective tissue of an animal's body, and - a step of removably fixing the thread to the interface piece.

[0013] The method may include: - a step of releasing the thread, in particular by pulling on a distal end of the thread, and - a step of re-removable attachment of the wire to the interface piece, in particular by releasing the tension exerted on a distal end of the wire.

[0014] The attached drawing represents, by way of example, two embodiments of a fastening device according to the invention.

[0015] Fig. 1 represents a first embodiment of a mechanical fixation device for a first connective tissue.

[0016] Fig. 2 represents the first embodiment of the fixation device implanted on a patient.

[0017] Fig. 3 represents a second embodiment of a mechanical fixation device for a first connective tissue.

[0018] Fig. 4 represents the second embodiment of the fixation device implanted on a patient.

[0019] Fig. 5 is a perspective view of a first embodiment of a removable wire fixing element, a wire being fixed by the element.

[0020] Fig. 6 is a cross-sectional view of the first embodiment of a removable wire fixing element along plane AA of Fig. 5.

[0021] Fig. 7 is a perspective view of a second embodiment of a removable wire fixing element, without wire fixed by the element.

[0022] Fig. 8 is a perspective view of the second embodiment of a removable wire fixing element, a wire being fixed by the element.

[0023] Fig. 9 is a cross-sectional view of the second embodiment of a removable wire fixing element along plane AA of Fig. 8.

[0024] A first embodiment of a mechanical fastening device 1: - of at least one first connective tissue 11 of an animal's body, particularly the human body or the body of a mammal, - to at least a second connective tissue 12 of this same body is described below with reference to figures 1 and 2.

[0025] Regardless of the embodiment and variant, at least one first connective tissue may in particular be or comprise: - a muscle, and / or - a fascia, and / or - a tendon, and / or

[0026] - cartilage, and / or - the dermis, and / or - the hypodermis.

[0027] Regardless of the embodiment and variant, the at least one second connective tissue may in particular be or comprise: - a muscle, and / or - a fascia, and / or - a tendon, and / or

[0028] - cartilage, and / or - a ligament, and / or - a bone, and / or - a periosteum, and / or - a perichondrium.

[0029] This fixation device allows tension or pre-stress to be applied to the first connective tissue 11 or to different first connective tissues 11. This makes it possible to perform aesthetic, therapeutic, or reconstructive treatments on a patient's body. In particular, it allows for modifying the facial expression of a patient with facial hemiplegia. It also allows for the support or suspension of organs, such as breast tissue, buttock muscles, or abdominal muscles. It also allows, in particular, the correction of muscle hernias.

[0030] The mechanical fastening device 1 comprises: - an interface piece 2, - at least one element 3, 6 for fixing the interface piece 2 to the second connective tissue 12 of this body, and - at least one removable fixing element 9 for a wire 4 to the interface piece 2.

[0031] Preferably, the interface piece 2 can be a plate, in particular: - a flat or nearly flat plate, or - a convex plate, or - a concave plate, or - a left-handed plate.

[0032] The mechanical fastening device 1 may further include: - at least one first mechanical bonding thread 4 intended to be fixed to the first connective tissue 11 or to several first connective tissues 11, and - at least one first needle 5.

[0033] In [Fig. 1], the first four wires 4 are shown.

[0034] Each mechanical connecting wire may include: - a proximal end 41 fixed, in particular knotted, to the interface piece 2, and - a distal end 42 fixed, in particular knotted, to a first needle 5.

[0035] The interface piece 2 can have any shape. Its function is to provide an interface between: - a first connective tissue 11 or several first connective tissues 11 on which it will exert a tensile force or forces, and

[0036] - a second connective tissue 12 or several second connective tissues 12 to which it will be fixed so that this / these second fabric(s) can mechanically take over the tensile force.

[0037] The interface piece is preferably rigid in the sense that, under normal use—that is, when the device 1 is fixed to the body and when the aforementioned forces are applied to the interface piece—no significant deformation of the interface piece is visible to the naked eye. This does not preclude the interface piece from being flexible before its attachment to the body or for achieving a removable attachment of a wire 4 by deforming a region of the interface piece 2.

[0038] In the first embodiment, the interface part 2 is a plate, in particular: - a flat or nearly flat plate, or - a convex plate, or - a concave plate, or - a left-handed plate. Alternatively, the interface piece 2 can be annular in shape. In both cases, the perimeter of the interface piece can be any geometric shape, including: - of a circle, - of ellipsis, - of triangle, - of a rectangle, or - of square.

[0039] In the first embodiment, the interface piece 2 is a circular plate.

[0040] The interface piece 2 can be made of a biocompatible material, by example : - made of surgical-grade stainless steel, or - in titanium alloy, or other or - made of plastic or synthetic material, or - made of ceramic material.

[0041] The interface piece 2 can perform another complementary function. In particular, the interface piece 2 can perform a prosthetic function. The interface piece 2 can therefore be a prosthesis, in particular a bioprosthesis, or a prosthetic component, in particular a bioprosthesis component.

[0042] The interface piece 2 can be adapted to the morphology of the body to which it is to be attached or can be designed for the morphology of the body to which it is to be attached. For example, measurements can be taken on the body and the interface piece can be custom-made. The interface piece can, in particular, be produced for this purpose by three-dimensional printing (3D printing).

[0043] In this first embodiment, the at least one fastening element 3 comprises at least one second thread 3 and at least one second needle 5. The second thread 3 comprises: - a proximal end 31 fixed, in particular knotted, to the interface piece 2, and - a distal end 32 fixed, in particular knotted, to the second needle 5.

[0044] The use or installation and configuration of a device is described below. 1 as mentioned previously. The device put in place is illustrated in [Fig. 2].

[0045] The method of using device 1 or of setting up and configuring device 1 comprises: (a) a first step of fixing the interface piece 2 to the second connective tissue 12, (b) a second step of fixing all the wires 4 to the first connective tissue 11 or to several first connective tissues 11, or a second step of fixing one or some of the wires 4 to the first connective tissue 11 or to several first connective tissues 11 and optionally removing the unused mechanical bonding wire(s) 4, the second step comprising a removable fixing of one or more wires 4 to the interface piece 2.

[0046] In the first step (a), the interface piece is fixed by means of the second wire(s) 3 which is / are passed through the second connective tissue 12. The second wire(s) may / may have been previously knotted at their proximal ends 31 to the interface piece 2 at hole(s) 6. This / these second wire(s) may also be knotted, at their distal end(s) 32, at the level of the second connective tissue 12 or at a hole 6 provided in the interface piece 2. Alternatively, the second wire(s) may / may be fixed removably to the interface piece 2 via a removable fixing element 9.

[0047] In the second step (b), the interface piece 2 is attached to the first connective tissue(s) 12 by means of the first thread(s) 4 which is / are passed through the first connective tissue(s) 12. This first thread 4 or these first threads 4 are / are permanently attached to the interface piece 2 at their proximal ends 41, for example by tying the proximal ends 41 to holes 6 made in the interface piece 2. In addition, this first thread 4 or these first threads 4 are / are attached at their distal ends 42 to the interface piece 2 via one or more removable fastening elements 9. The first threads 4 are, for example, removably fixed by wedging and / or by butting.

[0048] In this first step and / or in this second step, if a surgeon uses a device 1 with too many first threads 4 and / or too many second threads 3, they can simply, in a first removal operation, remove (by cutting) the threads they do not wish to use. This removal operation can be performed before or after the other first and / or second threads have been fixed to the connective tissue(s). Alternatively, in this first step and / or in this second step, if a surgeon uses a device 1 with not enough first threads 4 and / or not enough second threads 3, they can simply, in a second addition operation, add some by fixing them (in particular by tying a knot) to the interface piece 2. This thread addition operation can be performed before or after the other first and / or second threads have been fixed to the connective tissue(s).

[0049] The first and second steps mentioned above can be carried out in any order. Preferably, however, the first step (a) is carried out before the second step (b). Alternatively, it is possible to attach the first threads alternately to the first fabric(s) and the second threads to the second fabric(s).

[0050] Initial operations to add thread(s) and / or subsequent operations to remove thread(s) can be performed during a second surgical procedure, staggered in time from the initial surgical procedure during which the fixation device was placed on the body, by For example, this could occur several months or years after the initial surgery. In such a case, one might: - add one or more first and / or second threads that were not placed during the first surgical procedure, and / or - remove one or more first and / or second threads put in place during the first surgical procedure.

[0051] Thanks to the removable fixation element 9, the tension and / or length of the first wire 4 can be finely adjusted during the initial surgical procedure. In particular, the surgeon can correctly adjust the tension of the first wire 4 by performing various fixation trials. The removable nature of the fixation element 9 makes these trials possible and practical to carry out. It should also be noted that these adjustments can be made not only during the initial surgical procedure, but also during a second surgical procedure performed at a later time relative to the initial surgical procedure during which the fixation device was placed on the body. These adjustments include a step of releasing the first wire 4 from the removable fixation element 9, followed by a step of re-removing and re-fixing the wire 4 to the interface piece 2.

[0052] In a second embodiment described with reference to figures 3 and 4, the mechanical fastening device 1 differs in that: - the interface piece 2 is a rectangular plate, and - at least one fastening element 3 includes at least one hole 7 for the passage of a screw 8.

[0053] In this second embodiment, the mechanical fastening device 1 may also include second wires 3 or not include such wires.

[0054] In the described embodiment, at least one fixing element 3 comprises two screw holes 7 made in the interface plate 2. In [Fig.4], the screw heads 8 can be seen being screwed, for example into a bone 12.

[0055] Regardless of the embodiment and variant, the interface piece 2 may include several holes 6 for fixing wires 3, 4 at their proximal ends 31, 41. Regardless of the embodiment, the interface piece 2 may also include several holes 6 for fixing wires 3 at their distal ends 32.

[0056] In the first and second embodiments, four first wires 4 and two first wires 2 have been shown respectively. However, regardless of the embodiment and variant, the device 1 may include 1, 2, 3, 4, 5, 6, 7, 8, or 9 first wires 4 or more.

[0057] In the first embodiment, a second wire 3 is shown. However, in this first embodiment, regardless of the variant, the device 1 may include 2, 3, 4, 5, 6, 7, 8, or 9 second threads, or even more. As with the first threads, during use, if the surgeon uses a device with too many second threads, they can simply remove (by cutting) the second threads they do not wish to use. This removal operation can be performed before the remaining second threads are fixed to the interface or connective tissue.

[0058] In another embodiment not shown, the fastening may be mixed, that is to say that at least one fastening element 3 may comprise: - at least a second wire 3, and - at least one hole 7 for the passage of a screw 8.

[0059] Regardless of the embodiment and variant, the first and second threads may have any type of needle combination at their distal ends, in particular - curved needles as shown in figures 1 and 3, - straight needles, or - any combination of curved and straight needles.

[0060] Regardless of the embodiment and variant, wires 3, 4 can be: - absorbable, or - non-absorbable, or - any combination of absorbable and non-absorbable thread(s).

[0061] Regardless of the embodiment and variant, the at least one fastening element 3 may comprise any mechanical fastening means. Alternatively, to the means described above, the at least one fastening element 3 may comprise: - a clipping system for attaching to connective tissue, and / or - a tight-fitting or forced conformation in a conformation present or made on rigid connective tissue.

[0062] Regardless of the embodiment and variant, at least one fixing element of the interface part 2 may include a through hole 7 for a fixing screw 8.

[0063] Regardless of the embodiment and variant, the device may include at least one element 6 for permanently fixing a wire 4 to the interface piece 2.

[0064] Regardless of the embodiment and variant, at least one permanent wire fixing element 4 may include a wire knotting hole 6.

[0065] A first embodiment of a removable wire fixing element 9 is described below with reference to figures 5 and 6.

[0066] Removable fastener element 9 comprises: - an opening 21 or a hole 21 made in the interface element 2, and - a cover 91 or a plug 91 intended to plug the opening or hole while jamming the wire 4.

[0067] Preferably, the lid or cap comprises a head 93 and a body 94.

[0068] The removable fastening element 9 is put in place by passing the wire 4 through the opening, then by wedging the lid or cap into the opening. Preferably, the wire 4 is passed from one side of the opening and the lid or cap is put in place from a second side of the opening. Thus, when tension is applied to the wire 4, the forces tend to pull the cap or lid, in particular the body 94 of the cap, into the opening and / or increase the wedging of the wire 4, particularly between the head 93 of the cap and the interface piece 2.

[0069] Preferably, the sides 22 of the opening 21 and / or the surface 92 of the body 93 of the plug 91 may have non-smooth surfaces, in particular wavy or striated, which increase the friction forces on the wire 4 and improve the holding of the wire 4 in place.

[0070] Alternatively, the cap 91 or the cover 91 can be hinged on a surface of the interface part 2, in particular along an axis parallel to a surface of the interface part.

[0071] Alternatively, the plug 91 or the cover 91 may comprise several bodies 94, connected by the same head 93, allowing several openings 21 to be plugged simultaneously and thus several wires 4 to be jammed simultaneously.

[0072] A second embodiment of a removable wire fixing element 9 is described below with reference to figures 7 to 9.

[0073] The removable fixing element 9 includes a tab 95 or a flap 95 made on the interface piece 2. Simply, the tab 95 can be made by a simple U-shaped cut made in the interface piece 2, which is for example a plate.

[0074] The tab 95 is articulated on the interface piece 2 and returned to a rest position such as, for example, shown in [Fig. 7]. In the case of a tab cut out of the interface piece 2, the articulation is achieved by bending the tab 95.

[0075] The tab 95 includes an edge 98 which cooperates with an edge 28 of the interface piece to clamp the wire 4, as shown in Figures 8 and 9.

[0076] Advantageously, the interface piece 2 has an opening 96 adjacent to the tab 95. This opening 96 allows the wire 4 to pass through the interface piece, before being clamped by the tab 95. The opening can extend along a lateral wing of the U-shaped cutout.

[0077] Advantageously, the edge 98 may have a chamfer 97 to facilitate and improve the guidance of the wire 4 towards its clamping position by the tab 95. Indeed, the surgeon can pass the thread 4 through the opening 96, then pull the thread 4 into the chamfer 97, before wedging the thread 4 between the edges 98 and 28.

[0078] Regardless of the embodiment or variant, at least one removable wire fixing element 9 4 may include a locking element 91, 95, such as: - a flap 95 or a tab 95 or a cover 91 hinged or pivoted on the interface piece 2, or - a plug 91.

[0079] Regardless of the embodiment or variant, at least one removable fixing element 9 can be arranged to tighten the thread when traction is applied to the strand of thread connected to the first connective tissue 11.

[0080] Regardless of the embodiment or variant, at least one removable fastening element 9 can be arranged to release the thread when tension is applied to the thread strand not connected to the first connective tissue 11, i.e., when tension is applied to the distal end 42 of the thread 4. Furthermore, at least one removable fastening element 9 can be arranged to clamp the thread when tension is released on the thread strand not connected to the first connective tissue 11, i.e., when tension is released on the distal end 42 of the thread 4.

[0081] Regardless of the embodiment or variant, the interface piece 2 preferably has a thickness e of less than 2 mm or less than 1 mm or less than 0.8 mm or less than 0.5 mm.

[0082] In this document, a thread tied to a part is considered to be permanently attached to that part. Indeed, the thread must be cut to break this connection.

Claims

Demands

1. A mechanical fastening device (1) of a first connective tissue (11) of the body of an animal, in particular the human body or the body of a mammal, to a second connective tissue (12) of that body, the mechanical fastening device (1) comprising: - an interface piece (2), - at least one element (3, 6; 7, 8) for fastening the interface piece (2) to a second connective tissue (12) of that body, and - at least one removable fastening element (9) for a wire (4) to the interface piece (2).

2. Device according to claim 1, characterized in that the interface piece (2) is a plate, in particular: - a flat or substantially flat plate, or - a convex plate, or - a concave plate, or - a skewed plate.

3. Device according to any one of the preceding claims, characterized in that at least one fixing element of the interface part (2) includes a through hole (7) for a fixing screw (8).

4. Device according to any one of the preceding claims, characterized in that the device comprises at least one element (6) for permanently fixing a wire (4) to the interface piece (2).

5. Device according to the preceding claim, characterized in that at least one permanent wire fixing element (6) includes a wire knotting hole (6).

6. Device according to any one of the preceding claims, characterized in that at least one removable wire (4) fixing element (9) comprises a locking element (91; 95) such as for example: - a flap (95) or a tab (95) or a cover (91), hinged or pivoted on the interface piece (2), or - a plug (91).

7. Device according to claim 5 or 6, characterized in that at least one removable fastening element (9) is arranged to tighten the thread when a pull is exerted on a strand of thread connected to the first connective tissue (11).

8. A device according to any one of claims 5 to 7, characterized in that at least one removable fastening element (9) is arranged to release the wire (4) when a pull is applied to a distal end (42) of the wire (4).

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