Surgical insert

Abstract

The present invention relates to a surgical insert (1) comprising a first layer (11), and a second layer (12), wherein the first layer and the second layer comprise orifices (111, 121) having an eight shape.

Description

[0001] Description

[0002] Title: Surgical insert

[0003] Technical field

[0004] [1] The present disclosure relates to a surgical insert, in particular a surgical insert comprising a first layer and a second layer comprising octomorphic shaped orifices.

[0005] Prior art

[0006] [2] Maxillofacial injuries are common injuries that mainly affect men and young people between 18 and 25 years old. They are mainly due to accidents on public roads, fights, accidents related to sports, and domestic accidents.

[0007] [3] In maxillofacial trauma, the areas mainly affected are the teeth, the nasal bones and the orbital structure, which is affected in more than 40% of cases due to its exposed position and very thin bone thickness. A fracture of the orbital structure can have functional consequences. Thus, there may be incarceration of the muscle and / or fat surrounding the eye, causing a difference in elevation between the two eyes (diplody). It can cause compression of the infraorbital nerve (V2) which passes under the orbital structure. This compression is responsible for sensory disturbances in the areas around the eye such as the cheek, nose, teeth and upper lip. It can also lead, in the case of a significant fracture or collapse of the orbital structure, to enophthalmos, a dystropia of the eyeball.Finally, a fracture of the orbital structure can also have aesthetic repercussions when it is associated with a fracture of the orbital rim, the nose or the zygomatic body by modifying the bony reliefs of the face.

[0008] [4] In cases where the fracture of the orbital frame is significant enough, it is necessary to reconstruct the orbital volume. This reconstruction must be strictly observed because complications, such as those mentioned above, may occur. In order for the eyeball to recover its normal function and positioning, the reconstruction must be precise and conform to the anatomy of the affected person's orbit, but it also requires repositioning of the intraorbital soft tissues.

[0009] [5] The advent of computer-assisted surgery has enabled many advances in cases of fractures requiring complex reconstructions of bone volume. In particular, it makes it possible to generate a virtual three-dimensional patient file faithfully reproducing the patient's specific anatomical bone structure. It is thus possible to have a faithful basis for reconstruction. It is particularly suitable for reconstructions of the orbital structure, a particularly complex area of ​​the human body and very different depending on the individual.

[0010] [6] The main objective of orbital structure reconstruction is to restore the shape and volume of the orbit specific to the anatomy of each patient. However, reduction of the thin bone fragments of the orbital floor is sometimes not sufficient or even impossible. It is therefore necessary to cover or fill the defect to avoid complications such as displacement of the tissues around the eye. Thus, the insertion of a biocompatible material, also called an orbital implant, is sometimes indicated depending on the size and location of the defect in order to support the tissues around the eye and to reshape the orbit. This orbital implant must, however, be adapted to the anatomy of each patient in order to function optimally.

[0011] [7] A first type of implant is a flat implant with manual shaping. To create it, the surgeon uses sterilized ABS (acrylonitrile butadiene styrene) replicas of the patient's skull to place and shape the implant to adapt it to the patient's anatomy. This implant almost completely respects the patient's anatomy and thus improves the precision of surgical repairs. However, this solution requires prerequisites: being able to manufacture and sterilize the patient's skull in ABS, desterilizing and resterilizing the implant, having the time to perform this operation and being in a structure that has access to this technology.

[0012] [8] A second solution is to design implants for most individuals by anatomically preforming an implant that covers the orbital floor and the medial wall. These implants have "average" dimensions, that is, their dimensions are not specific to an individual but are suitable for the different anatomical shapes of the orbit. These implants are available in two different sizes. They have allowed a clear improvement over standard implants. However, because fractures are not constant, in volume or location, and the anatomical shape of the orbital wall is very complex, they do not perfectly cover the orbital wall.

[0013] [9] There is therefore still a need for the design of an anatomically shaped orbital implant covering the lesion site adapted to each patient produced by rapid prototyping. The use of rapid prototyping will thus allow the optimization of the shape of the implant as well as the optimization of its internal structure in order to allow better circulation of fluids, bone recolonization and sufficient mechanical support properties.

[0010] There is also a need to design a material meeting the criteria of the specifications of a material used as a bone substitute but also those of a material capable of coming into close contact with the implant area and of being used as a substance release matrix.

[0014] Summary

[0015]

[0011] The present disclosure improves the situation.

[0016]

[0012] According to a first aspect, a surgical insert is provided comprising:

[0017] - a first layer, and

[0018] - a second layer, wherein the first layer and the second layer comprise orifices having an octomorphic shape.

[0019]

[0013] The surgical insert according to the first aspect of the invention has an internal architecture optimized for better circulation of fluids and bone regrowth. The first layer and the second layer allow the surgical insert to have sufficient mechanical support properties, in particular by a significant reduction in maximum stresses. This surgical insert can be used as a bone substitute, in particular for human or veterinary use. Its general shape can be adapted to result in an anatomically shaped bone implant. Thus, it can be used, for example, to replace a part of the skeleton such as the orbital floor, to serve as an osteosynthesis plate or to form a joint prosthesis.

[0020]

[0014] This surgical insert, or surgical implant, can also be used for human or animal surgery, particularly vertebrates. It can be implanted or replace all or part of the structures of the human or animal body, for example a limb, the skull, the trunk, etc. It can be used in particular in reconstructive surgery of the limbs (lower and upper), the face (including the jaws, the teeth) or the trunk (for example the spine). It can also be used in vascular, abdominal or digestive surgery.

[0021] Brief description of the drawings

[0022]

[0015] Other characteristics, details and advantages will appear on reading the detailed description below, and on analyzing the attached drawings, in which:

[0023]

[0016] [Fig. 1] schematically shows a top view of an octomorphic orifice;

[0024]

[0017] [Fig- 2] schematically shows a top view of octomorphic shaped orifices arranged in a triangular pattern;

[0018] [Fig. 3] schematically shows a top view of octomorphic shaped orifices arranged in a square pattern;

[0025]

[0019] [Fig. 4] schematically shows a top view of octomorphic shaped orifices arranged in a hexagonal pattern;

[0026]

[0020] [Fig. 5] schematically shows a top view of octomorphic shaped orifices arranged in a heterogeneous pattern;

[0027]

[0021] [Fig. 6] schematically shows a top view of an example of a surgical insert according to the invention, of square shape having fixing tabs at one of its sides;

[0028]

[0022] [Fig. 7] schematically shows a top view of an example of a surgical insert according to the invention, of round shape;

[0029]

[0023] [Fig. 8] schematically shows a top view of an example of a surgical insert according to the invention, of triangular shape with two zones of different porosity;

[0030]

[0024] [Fig. 9] shows the two faces of an example of a surgical insert according to the invention;

[0031]

[0025] [Fig. 10a] schematically shows a top view of a first layer of a surgical insert according to the invention;

[0032]

[0026] [Fig. 10b] schematically shows a top view of a second layer of the same surgical insert as Fig. 10a;

[0033]

[0027] [Fig. 11] schematically shows an example of a surgical insert according to the invention, in three dimensions comprising two layers separated from each other by a plurality of separators;

[0034]

[0028] [Fig. 12] schematically shows an example of a pillar with a straight longitudinal axis perpendicular to the mean plane of the first or second layer;

[0035]

[0029] [Fig. 13] shows the evolution of the weighting coefficient C2 as a function of the torsion angle 0 of the pillars of the surgical insert according to the invention;

[0036]

[0030] [Fig. 14] schematically shows an example of a pillar with a vertical longitudinal axis of helical shape with a torsion angle other than 0;

[0037]

[0031] [Fig. 15] shows the evolution of the weighting coefficient C3 as a function of the angle of inclination Q of the straight pillars of the surgical insert according to the invention;

[0038]

[0032] [Fig. 16] schematically shows an example of a pillar with a longitudinal axis having a non-zero angle of inclination Q relative to the vertical;

[0039]

[0033] [Fig. 17] shows schematically an example of a pillar with a curved axis;

[0040]

[0034] [Fig. 18] schematically shows an example of a pillar with a straight longitudinal axis of helical shape having pores at its lateral surface;

[0035] [Fig. 19] schematically shows an example of a section of a layer of the surgical insert according to the invention and having an orifice of octomorphic shape and transverse orifices of octomorphic shape;

[0041]

[0036] [Fig. 20] schematically shows an example of a surgical insert according to the invention, in three dimensions having three layers separated by a plurality of pillars with a vertical longitudinal axis of helical shape having pores at its lateral surface;

[0042]

[0037] [Fig. 21] shows an example of a Bézier curve or function;

[0043]

[0038] [Fig. 22] shows a distribution of octomorphic shaped orifices along a Bézier curve;

[0044]

[0039] [Fig. 23] is an enlargement of a portion of the Bézier curve of Figure 22 at an extremum;

[0045]

[0040] [Fig. 24] shows overlap sections induced by a homothetic duplication of the first layer leading to the second layer;

[0046]

[0041] [Fig. 25] shows octomorphic orifices arranged in a partial rectangular pattern;

[0047]

[0042] [Fig. 26] shows octomorphic orifices arranged partially along the contours of an octagon;

[0048]

[0043] [Fig. 27] shows an example of a surgical insert according to the invention and its limit box; and

[0049]

[0044] [Fig. 28] shows the simulation results of two inserts both having octomorphic shaped orifices, one having mechanical reinforcement, the other being without.

[0050] Detailed description

[0051]

[0045] The present invention relates according to a first aspect to a surgical insert which will be described subsequently with reference to Figures 1 to 28.

[0052]

[0046] The surgical insert 1 comprises:

[0053] - a first layer 11, and

[0054] - a second layer 12, in which the first layer 11 and the second layer 12 comprise orifices 111, 121 having an octomorphic shape.

[0055]

[0047] The term "octomorphic" refers to orifices having the shape of the number 8, that is to say an elongated shape with two lobes at the ends and a narrow central part.

[0056]

[0048] The octomorphic shape can be described as consisting of two end portions, each formed by a circle of radius n. The two end portions are connected to each other by a central portion formed by a circular fillet of radius r2 so that the width of the central portion is less than the width of the end portions equal to 2xri. Thus, the radius is a first radius of curvature of the octomorphic shape in the end portions and the radius r2 is a second radius of curvature of the octomorphic shape in the central portion.

[0057]

[0049] The octomorphic shape can further be described as a two-dimensional, oblong shape tapered to half its length and comprising two end portions and a tapered central portion. The octomorphic shape may have a curved contour, i.e. the contour has no angles. The two end portions may have a first radius of curvature n oriented towards the inside of the orifice. The tapered central portion may comprise a central area having a second radius r2 of curvature oriented towards the outside of the orifice.

[0058]

[0050] When it is mentioned that an orifice has an octomorphic shape, this means that a section of the orifice has such a shape. The section generally considered is a section parallel to the mid-plane of the surface from which the orifice extends.

[0059]

[0051] An “octomorphic orifice” will also be understood to mean an orifice that does not have an octomorphic shape due to the paving and sizing of the insert. That is to say, any orifice resulting from paving with octomorphic orifices followed by trimming to the desired shape of the insert is considered an octomorphic orifice.

[0060]

[0052] The octomorphic shape may comprise a center of symmetry in the constricted central portion. The octomorphic shape may have two axes of symmetry perpendicular to each other.

[0061]

[0053] Several parameters can be defined in order to characterize the layers 11, 12 and the orifices 111, 121:

[0062] - laughed the first ray of curvature,

[0063] - r2 the second radius of curvature

[0064] - L o the total length of the orifice 111, 121,

[0065] - to the total width of the orifice 111, 121,

[0066] - tc the central width of the central part of the orifice 111, 121,

[0067] - h the thickness of the surgical insert 1,

[0068] - L the length of the smallest side of the first and second layers 11, 12,

[0069] - (p the porosity of a layer being the ratio between the surface occupied by the orifices 111, 121 of the layer and the total surface of the layer 11, 12,

[0070] - e the minimum distance between two orifices 111, 121, and

[0071] - Fia force applied to insert 1.

[0072]

[0054] Figure 1 shows a top view diagram of an orifice 111, 121 of octomorphic shape. Thus, length is understood to mean a dimension taken in a direction extending between the two lobes, the direction corresponding in particular to one of the axes of symmetry if present. Width is understood to mean a dimension perpendicular to the length. The thickness of the surgical insert is understood to be a distance between the two end faces of the insert in the direction of superposition of the layers. Unless otherwise indicated, the average of the thickness on the insert is understood to be the distance between two orifices is taken between the centers of these orifices.

[0073]

[0055] The total length, L o , can be between 200 pm and 50 mm. In some cases (e.g. for orbital floors), this length is preferably

[0074] 200 pm to 2 mm. In other cases (e.g. for osteosynthesis plates), this length is preferably 10 to 50 mm.

[0075]

[0056] The ratio of the total length, L o , over the total width, t o , can be understood between

[0076] 1.8 and 2.2, preferably between 1.9 and 2.1, preferably between 1.95 and 2.05, for example 2.

[0077]

[0057] The ratio between the first radius of curvature, ri, and the second radius of curvature, r2, may be between 1.3 and 1.7, preferably between 1.4 and 1.6, preferably between 1.45 and 1.55, for example 1.5.

[0078]

[0058] The ratio between the total width, t o , and the central width, t c , may be between 1.3 and 1.7, preferably between 1.4 and 1.6, preferably between 1.45 and 1.55, for example 1.5.

[0079]

[0059] The preferred value of a parameter depends on the case studied and is generally a function of the maximum force which will be exerted on the insert 1 once in place and also of the general shape of the insert 1 which will condition the distribution of the stress resulting from the loading.

[0080]

[0060] The octomorphic orifices 111, 121 may be arranged at the layer 11, 12 according to a particular pattern. The pattern may be locally partial, that is to say that octomorphic orifices 111, 121 are missing. This pattern may be chosen from a triangular pattern, a square pattern, a hexagonal pattern or a heterogeneous pattern. The pattern may also be chosen so that the octomorphic orifices 111, 121 draw the contours of a geometric shape, in particular a regular one, such as a triangle, a rectangle, a square, a pentagon, a hexagon, etc. A triangular pattern is a pattern in which the center of each orifice 111, 121 is located at a vertex of a triangle. A square pattern is a pattern in which the center of each hole 111, 121 is at a vertex of a square. A hexagonal pattern is a pattern in which the center of each hole 111, 121 is at a vertex of a hexagon.A heterogeneous pattern is a pattern in which the center of each orifice 111, 121 is arranged randomly. The distribution of the orifices according to a particular pattern does not predict the angular orientation of each of the orifices around its center. Thus, the orientation can be homogeneous (identical angular orientation for all the orifices), centrifugal (different angular orientations for the orifices so that their lengths are collinear with a line connecting the center of the orifice to the center of the pattern) or heterogeneous (at least two orifices having different angular orientations).

[0081]

[0061] An example of a heterogeneous pattern can be described using a Bézier curve or function (see figure 21) defined by a set of control points whose number is n and at least equal to 2, P o , Pi, ..., P n -i. The parametric representation is as follows: where the B's -1are Bernstein polynomials:

[0082] In such a pattern, the center on ri are arranged on the Bézier curve (see figure 22). Preferably, between two consecutive extrema of the Bézier curve, a single octomorphic orifice is arranged.

[0083]

[0062] Furthermore, the shortest measurable distance d between the contours of two octomorphic orifices is greater than 0, preferably greater than 50 pm, still preferably greater than 100 pm, still preferably greater than 200 pm. Thus, the octomorphic orifices are disconnected.

[0084]

[0063] Preferably, if n Q is the total number of centers Q(t0), Q(ti), ... of circle of radius and ti the parametric coefficient corresponding to the i ème center Q(tj), then for i of

[0085] 2 to n Q , we define Qi, Q2 and Q3 as follows: Pj, or the (i— 1 ) ème center ; , s °it the i ème center ; x Pj, the point located between (i— 1 ) ème center and the i ème center.

[0086] We also define a point with coordinates (x c ; (c) as follows: and the following radius:

[0087] R c = c) 2 + (A / 1C ) 2 ; with :

[0088] (x k ; yk) being the coordinates of point Qk; then, the arrangement of the centers of the circles of radius is preferably chosen so that Rc yx (2 x ri + d); where y is a safety coefficient chosen between 4 and 8, preferably 6 (see figure 23).

[0089] This condition ensures that the minimum distance condition between two octomorphic orifices is respected.

[0090]

[0064] Figures 2, 3, 4 and 5 respectively show a top view diagram of octomorphic shaped orifices arranged in a triangular, square, hexagonal and heterogeneous pattern. In the case of the triangular pattern of Figure 2, the square pattern of Figure 4 and the hexagonal pattern of Figure 4, the orientation of the orifices is homogeneous. Figure 25 shows a top view diagram of octomorphic shaped orifices arranged in a partial rectangular pattern. It can be seen in Figure 25 that the octomorphic shaped orifices fit into the nodes MR1 ​​of a rectangular mesh MR but that other nodes MR2 of this mesh are not occupied by an octomorphic shaped orifice. Figure 26 shows a top view diagram of octomorphic shaped orifices arranged partially along the contours of a hexagon. Figure 22 shows a top view diagram of octomorphic shaped orifices arranged in a heterogeneous pattern described by a Bézier curve.

[0091]

[0065] The porosity of the layers 11, 12 may be from 0.1 to 0.93, preferably from 0.4 to 0.8.

[0092]

[0066] The two layers are preferably parallel to each other.

[0093]

[0067] The porosity of a layer 11, 12 as well as the mechanical resistance of a layer 11, 12 are two quantities which evolve in opposite directions. When the porosity is included in the intervals defined above, the layer 11, 12 has an elastic limit stress of less than 830 MPa which is the conventional elastic limit (Rp0.2) of the TA6V titanium implant.

[0094]

[0068] The greater the porosity, the lighter the structure will be. Furthermore, the more fluid circulation will be improved. The mechanical resistance of the insert 1 decreases with increasing porosity.

[0095]

[0069] The octomorphic orifices 111, 121 may be arranged at the level of the layer 11, 12 and in at least one zone in a parallel manner, that is to say that the 8 forming these orifices 111, 121 are all oriented in the same direction in this zone. In certain cases, all the orifices 111, 121 of the layer 11, 12 are parallel to each other.

[0096]

[0070] The surgical insert 1 may further comprise a fixing tab 14 extending from one of the layers. The fixing tab 14 may have an oblong-shaped fixing 141, in particular with an orifice 142 also oblong connected to the first and / or second layers 11, 12 by a tab 143.

[0071] The surgical insert 1 may have different shapes, for example a square shape, a round shape or a triangular shape and more generally, any shape physiologically compatible with the reconstruction of a structure of the human body.

[0097]

[0072] Figures 6, 7 and 8 schematically show a top view of a surgical insert 1 respectively of square shape having fixing tabs at one of its sides, of round shape and of triangular shape. The insert 1 of triangular shape is shown with two zones of different porosity.

[0098]

[0073] The surgical insert 1 may have a truncated circle section shape on the apex side. Such a surgical insert is advantageous for the reconstruction of the floor of the orbit.

[0099]

[0074] The surgical insert 1 may be composed of a material chosen from a polymer, a metal, a ceramic or a composite; these materials being of medical grade.

[0100]

[0075] When the insert 1 is composed of a polymer, it may in particular be composed of polyetheretherketone, polylactic acid or their derivatives.

[0101]

[0076] When the insert 1 is composed of a metal, it may in particular be composed of titanium, a titanium alloy, stainless steel, a cobalt alloy (such as cobalt chrome), or tantalum.

[0102]

[0077] When the insert 1 is composed of a ceramic, this ceramic may be a bioglass or a bioceramic, in particular a phosphocalcic bioceramic, for example hydroxyapatite, tricalcium phosphate (TCP) and mixtures thereof.

[0103]

[0078] When the insert 1 is composed of a composite, it may in particular be composed of a bone cement.

[0104]

[0079] Generally speaking, the surgical insert 1 according to the invention can be produced from a patient scanner. For example, it can be composed of a polymer, metallic or bioceramic material before being covered with bone cement or be made exclusively of bone cement by rapid prototyping. The insert 1 is then washed to remove all residual traces: it is washed with ether then with water before being left to dry in the oven at 37°C for 24 hours. If an active ingredient is to be added, the insert 1 can be brought into contact with a drug before implantation for its biofunctionalization.

[0105]

[0080] According to one embodiment, the ratio L / h between the length L of the smallest side of the first 11 and second layers 12 and the thickness h of the surgical insert 1 is chosen to be greater than 20.

[0106]

[0081] Also, the thickness h of each layer can verify the relation: [Math. 1] min{l,L] h

[0107] 4

[0082] where I is the maximum width of the surgical insert and L is the maximum length of the surgical insert.

[0108]

[0083] In the following, we will describe the values ​​of the parameters in the case where the L / h ratio is greater than 20.

[0109]

[0084] The first radius of curvature may be greater than or equal to the first minimum radius of curvature r^ min of 345 pm and may be less than or equal to the first maximum radius of curvature i max defined by Math. 2.

[0110]

[0085] [Math. 2]

[0111]

[0086] where S is the total surface area of ​​insert 1, <p est la porosité totale de l’insert 1 , et N le nombre de pores octomorphes d'une couche.

[0112]

[0087] When the first radius of curvature is within the limits defined above, it allows good osteogenesis, that is to say it allows the formation and development of bone at the level of which it is inserted. The lower limit was determined by fluid mechanics, it is in agreement with the orifices used conventionally in bioceramics. To determine the upper limit, a parametric study on 190 cases by varying the geometric dimensions and the loads applied to the unit cell was conducted.

[0113]

[0088] The minimum distance between two orifices 111, 121 may be greater than or equal to 100 μm. The minimum distance between two orifices 111, 121 may be less than or equal to 4 times the first radius of curvature. If two orifices 111, 121 have a different size, then the minimum distance between two orifices 111, 121 may be less than or equal to 4 times the first radius of curvature of the larger orifice 111, 121. The lower limit determines the minimum load that the insert can support. The interval ensures the circulation of fluids.

[0114]

[0089] The thickness h of the insert 1 may be greater than or equal to the minimum thickness h min 100 pm and may be less than or equal to the maximum thickness h max defined by Math. 3.

[0115]

[0090] [Math. 3] ri + e

[0116] I h L max < — — - -| Q

[0117]

[0091] The only real maximum limit on the thickness of insert 1 is the biological limit, i.e. the size of insert 1 must be adapted to the area in which it is inserted and to the trauma it must repair. However, it may be advantageous for insert 1 to remain within the Kirch h off-Love assumptions. In which case, the maximum thickness must respect the relation Math. 3.

[0092] The admissible load is then defined by the relation Math. 4 whose parameters are given in Table 1.

[0118]

[0093] [Math. 4]

[0119]

[0094] The maximum permissible load supported by insert 1 can be determined using the Kirchoff-Love hypotheses as well as by the geometric parameters of insert 1 defined previously.

[0120]

[0095] [Table 1]

[0121]

[0096] The relationship between f(o) and a is shown in the following Table 2:

[0122]

[0097] [Table 2]

[0123]

[0098] These values ​​allow the best compromise between sizes and distributions of the orifices 111, 121. These values ​​allow for better circulation of fluids, better bone recolonization and sufficient mechanical support properties.

[0124]

[0099] With regard to the non-uniform patterns of orifices 111, 121, a person skilled in the art will be able to carry out a verification of the mechanical behavior of the insert 1 by a final numerical analysis in order to validate the size and distribution of the orifices 111, 121 proposed.

[0125]

[0100] The first layer 11 may have a porosity greater than the porosity of the second layer 12. The ratio of the maximum length of the orifices 111 of the first layer 11 Li and the maximum length of the first orifices 121 of the second layer 12 L2 may be greater than 1.4, preferably it is greater than 1.4 and less than 3.2.

[0126]

[0101] The first layer 11 has the objective of being directly in contact with the bone structure. Thus, preferably, the first layer 11 is made of a material biocompatible with osteoblasts to integrate with the bone tissue without risk of formation of fibrous tissue. The second layer 12 has the objective of supporting the tissues or organs. Thus, preferably, it has a smooth and low-porosity surface in order to avoid infections.

[0127]

[0102] The second layer 12 may have a keying device.

[0128]

[0103] The second layer 12 may have two zones, a first zone 122 with orifices 1221 having a first maximum length L2 and a second zone 123 with second orifices 1231 having a second maximum length. The ratio between the first maximum length l_3 and the second maximum length l_2 may be between 1.6 and 2, preferably between 1.7 and 1.9, preferably between 1.75 and 1.85, for example 1.8.

[0129]

[0104] The ratio between the maximum length of the orifices 111 of the first layer Li and the first maximum length L2 may be between 1.4 and 1.8, preferably between 1.5 and 1.7, preferably between 1.55 and 1.65, for example 1.6.

[0130]

[0105] The ratio between the maximum length of the orifices 111 of the first layer Li and the second maximum length l_3 may be between 2.8 and 3.2, preferably between 2.9 and 3.1, preferably between 2.95 and 3.05, for example 3.

[0131]

[0106] The first zone 122 with a lower porosity makes it possible to increase the stability of the insert 1. This denser zone 122 can also be useful for the surgeon when placing the insert 1 in the damaged area. Indeed, the octomorphic orifices 121 having a smaller size can serve as a foolproof device to know the direction of positioning of the insert 1.

[0132]

[0107] This bi-layer structure allows fluids to circulate easily through the insert 1 in order to avoid any stagnation and / or risk of infection.

[0133]

[0108] Figure 9 shows the two faces of an example of such a bilayer structure. Figures 10a and 10b show respectively a top view of the first layer 11 and a top view of the second layer 12.

[0134]

[0109] The total porosity of insert 1 is calculated using the following formula:

[0135]

[0110] [Math. 5]

[0136]

[0111] where (ptot is the total porosity of the surgical insert 1, (pi is the porosity of the first layer 11, <p2est la porosité de la deuxième couche 12, Si est la surface totale de la première couche 11 et S2est la surface totale de la deuxième couche 12. Pour une couche donnée, la porosité est le ratio entre la surface occupée par les orifices octomorphes et la surface totale de la couche.

[0137]

[0112] Preferably, the insert 1 has a total porosity greater than or equal to 0.6 and less than or equal to 0.93. Preferably, the insert 1 has a ratio between the total surface area occupied by the orifices of a layer and the total surface area of ​​this layer greater than or equal to 0.09 and less than or equal to 0.92.

[0138]

[0113] When the pattern of the orifices is a hexagonal pattern, the ratio between the total surface area occupied by the orifices of a layer and the total surface area of ​​this layer is greater than or equal to 0.1 11 and less than or equal to 0.923.

[0139]

[0114] According to another embodiment, the L / h ratio is less than 4. Subsequently, the characteristics will be described in the case of an L / h ratio less than 4. Furthermore, the fluid flows are then generally complex.

[0140]

[0115] The second layer 12 may have two zones, a first zone 122 with orifices 1221 having a first maximum length L2 and a second zone 123 with second orifices 1231 having a second maximum length. The ratio between the first maximum length l_3 and the second maximum length l_2 may be between 1.6 and 2, preferably between 1.7 and 1.9, preferably between 1.75 and

[0141] 1.85, for example 1.8.

[0142]

[0116] In the case of octomorphic orifices 111 distributed according to a heterogeneous pattern described by a Bézier curve on the first layer 11, the arrangement of the octomorphic orifices 121 on the second layer 12 may correspond to a homothetic duplication of the arrangement of the octomorphic orifices 111 of the first layer 11. That is to say that the orifices undergo a translation and a rotation (duplication) then a homogeneous scaling (homothetic). This homothetic duplication can be described by the following formulas: with :

[0143] Mi(x,y,z), the coordinates of the centers of the octomorphic orifices of the first layer; M2(x,y,z), the coordinates of the centers of the octomorphic orifices of the second layer;

[0144] X, the value of the translation along the main vector X;

[0145] Y, the value of the translation along the main vector Y;

[0146] Z, the value of the translation along the main vector Z;

[0147] 0, the rotation angle along the main Z axis; and SE, the scaling coefficient.

[0148]

[0117] There may be a single set of orifices 121 of the second layer 12 or several sets of orifices 121 of the second layer 12 differing from each other by the rotation angle θ and / or the scaling coefficient SE. Thus, from an orifice 111 of the first layer 11, there may be 1, 2, 3, 4 orifices 121 of the second layer 12, or more.

[0118] Preferably, the homothetic duplication induces a minimum overlap section SR of 0.2 mm 2 between the orifice 111 of the first layer 11 and the orifice 121 of the second layer 12 which results therefrom (see figure 24). Still preferably, the overlap is at most a quarter of the surface of the orifice 111 of the first layer 11.

[0149]

[0119] A plurality of separators 15 may be arranged between the first layer 11 and the second layer 12.

[0150]

[0120] Each separator 15 may be in the form of a pillar 15. Figure 11 shows a three-dimensional surgical insert comprising two layers separated from each other by a plurality of pillars of octomorphic section.

[0151]

[0121] The pillar 15 may have a longitudinal axis. This longitudinal axis may be straight (Figures 12, 14 and 16) or curved (Figure 17). When the longitudinal axis is straight, it may extend perpendicularly from the mean plane formed by the first layer 11 or by the second layer 12. It may also be understood to form a non-right angle with this mean plane. When the longitudinal axis is curved, it follows the curve of a parametric equation between the first layer 11 and the second layer 12.

[0152]

[0122] Each separator 15 among the plurality of separators 15 may have a cross-section that has an octomorphic shape as described above. Thus, the pillar 15 may be obtained by translation of the octomorphic shape along the longitudinal axis (Figures 12, 16). Alternatively, the pillar 15 may be obtained by a combination of translation and rotation of the octomorphic shape along the longitudinal axis so as to give the lateral surface of the pillar 15 a helical shape (Figure 14).

[0153]

[0123] In the case of a pillar 15 with a helical-shaped lateral surface, preferably, the number of rotations of the octomorphic shape between the first layer 11 and the second layer 12 may be 1 / 4+k, 1 / 2+k, 3 / 4+k or 1 +k, where k is a number greater than or equal to 0; for example 0, 1, 2, 3. In the case where the number of rotations is 1 / 4+k or 3 / 4+k, this means that the orientation of the octomorph at the second layer 12 is 90° (270°) from its orientation at the first layer 11. In the case where the number of rotations is 1 / 2+k or 1 +k, this means that the orientation of the octomorph at the second layer 12 is 180° (360°) from its orientation at the first layer 11.

[0154]

[0124] More generally, in the case where the pillar 15 is chosen as being a pillar 15 of helical shape with a torsion angle 0, said angle 0 can be between 0 and 180°, preferably less than 90°.

[0155]

[0125] The parametric equation for designing the helical-shaped pillar 15 is expressed below.

[0126] [Math. 6]

[0156] 5.440 x(t) = rx cos(t),y(O = rx sin(t), z(t) = — — — rxt

[0157]

[0127] where f and P are expressed in radians.

[0158]

[0128] The separators 15 are preferably sized to support the load and in particular to take up a normal compression force and resist buckling.

[0159]

[0129] In order to study the influence of the different parameters of the pillars 15 on the admissible load, the following parameters are defined, the extreme values ​​of which will be determined by a parametric analysis:

[0160] - H the height of the pillar 15 measured as the distance between the first layer 11 and the second layer 12,

[0161] - P the torsion angle of pillar 15, this angle is non-zero when pillar 15 is helical,

[0162] - Q the angle of inclination of pillar 15 for a straight pillar 15, and

[0163] - C the curve of a parametric equation for a curved pillar 15.

[0164]

[0130] Each pillar 15 among the plurality of pillars 15 may have a height greater than or equal to 3 mm. The height is considered perpendicular to the mean plane of the first or second layer. The maximum value H max the height of pillar 15 can respect the following formula:

[0165]

[0131] [Math. 7]

[0166] H max = 637,040 x F p -0 ' 493 xr?

[0167]

[0132] where F p is the total force that pillar 15 can support for a straight pillar 15, and is the first radius of curvature.

[0168]

[0133] The helical pillar 15 can support an admissible load increased by a factor C2 expressed by the formula Math. 8.

[0169]

[0134] [Math. 8]

[0170]

[0135] Figure 13 shows the evolution of the weighting coefficient as a function of the torsion angle 0. This weighting coefficient can be determined by parametric analysis. It can be seen that above 90°, the weighting coefficient C2 increases sharply.

[0171]

[0136] In the case where the pillar 15 is chosen as being a pillar 15 of straight axis with an angle of inclination 6, said angle Q can be between 0 and 85°, it is preferable to place a pillar 15 in mirror with an opposite angle so that the support is more effective. The angle of inclination is measured with respect to the normal to the mean plane formed by the first or second layer.

[0137] The pillar of straight axis can support an admissible load increased by a factor C3 expressed by the formula Math. 9.

[0172]

[0138] [Math. 9]

[0173] Fp m = C3F p , C3= O,OOOO680 3 +9.7110 2 - 0.03860 + 1.1782

[0174]

[0139] Figure 15 shows the evolution of the weighting coefficient C3 as a function of the inclination angle Q. This weighting coefficient can be determined by parametric analysis. It can be seen that the higher the inclination angle, the more the weighted force increases.

[0175]

[0140] Each pillar 15 may comprise through-orifices 151 at its lateral surface (figure 18). These through-orifices 151 make it possible to improve the circulation of fluids between the first 11 and the second layer 12. Indeed, the presence of the pillars 15 forces the fluids to bypass them, the orifices 151 thus allow a portion of the fluids to pass through the pillars 15, making the flow less complex.

[0176]

[0141] The ratio between the surface area of ​​the transverse orifices 151 and the lateral surface area of ​​the pillar 15 may be between 0.25 and 0.3.

[0177]

[0142] As illustrated in Figure 19, the orifices 111, 121 of the first layer and / or of the second layer may have a side wall formed in the thickness of the corresponding layer, and in which the first layer 11 and / or the second layer 12 comprises transverse orifices 112, 124 passing through with an octomorphic section as described previously and extending between the side wall of two orifices 111, 121 of the corresponding layer 11, 12. Alternatively, the transverse orifices 112, 124 may have a circular or oval section. These transverse orifices 112, 124 may be entirely within the thickness of the first layer 11 or the second layer 12 (e.g. the transverse orifices 112, 124 form channels) or on the surface thereof (e.g. these transverse orifices 112, 124 form free-surface channels). The two types of channels may coexist in the same insert 1.

[0178]

[0143] The number of transverse orifices 112, 124 may be greater than or equal to 4 and less than or equal to 8, for example 4, 5, 6, 7 and 8

[0179]

[0144] In the case where, as in the three-dimensional insert 1, the thickness of the insert 1 is of the order of magnitude of the smallest length of the insert 1, it is possible to add a network of transverse orifices 112, 124 of octomorphic shape in order to assist the circulation of fluids. They are arranged so as to connect the orifices 111, 121 of the first layer 11 and of the second layer 12 to each other. The desired number of interconnections N is around 6 to 8 interconnections. The number of interconnections is defined as being the number of transverse orifices 112, 124 extending from a single octomorphic orifice 111, 121 of the corresponding layer 11, 12. Too small a number of interconnections can lead to a

[0180] “clutter” creating excess pressure in the orifices 111, 121 of the first or second layer 11, 12 and too high a flow rate in the transverse orifices 112, 124. Too many transverse orifices 112, 124 can increase the risk of multiplication of “dead channels” by leaving the fluid the possibility of finding a clearly preferential path.

[0181]

[0145] When the layers of the insert comprise transverse orifices 112, 124, the section of each orifice 111, 121 of each layer 11, 12 is preferably greater than or equal to 0.7 mm. 2 and less than or equal to 1.2 mm 2 .

[0182]

[0146] The plurality of pillars preferably includes transverse holes at the side surface of the insert.

[0183]

[0147] The surgical insert may further comprise a third layer 13 comprising orifices 131 of octomorphic shape as described previously and separated from the first layer 11 or from the second layer 12 by a plurality of separators 15 as described previously (figure 20).

[0184]

[0148] The number of layers is in reality not limited and the surgical insert can comprise 4, 5, 6, 7, 8, 9, or even 10 layers and even more if necessary.

[0185]

[0149] The surgical insert may also comprise a mechanical reinforcement 16 (see figure 27). The mechanical reinforcement 16 absorbs the bending, torsion and compression forces so that the layers 11, 12 of the insert 1 do not undergo deterioration. In addition, the mechanical reinforcement 16 must not hinder the fixing of the insert 1.

[0186]

[0150] The mechanical reinforcement 16 may be continuous or discontinuous. In the latter case, the mechanical reinforcement 16 is composed of a plurality of reinforcement units.

[0187]

[0151] Preferably, the mechanical reinforcement 16 or each of the reinforcement units is an excess thickness of the surgical insert 1, in particular on one of the layers 11, 12 of the insert 1. This excess thickness is advantageously at least 1 mm. In addition, the mechanical reinforcement 16 or each of the reinforcement units are free of octomorphic orifices.

[0188]

[0152] In the case where an orifice 161 intended for the passage of fixing screws (in particular round or oblong) is provided through the mechanical reinforcement 16 or a reinforcement unit, a border 162 of at least 1 mm thickness is preferably provided around this orifice 161.

[0189]

[0153] Such a mechanical reinforcement 16 is advantageous when, the insert being inserted into a boundary box BB (in English bounding box) of dimensions a, b, c of which c is the smallest dimension, at least one of the following conditions is fulfilled:

[0190] - c > 10 or - c > 10.

[0154] A bounding box BB for a set of points in three dimensions is defined as the parallelepiped box having the smallest volume and which can contain the set of points (see figure 27).

[0191]

[0155] The surgical insert 1 can be used as a support in order to add at least one of particular agents and active ingredients in order to avoid the risk of infection. Thus, the octomorphic orifices 111, 121 can contain at least one of particular agents and active ingredients.

[0192]

[0156] Among the particular agents, the following may be mentioned: bacteriophages and phage lysins. Bacteriophages have the capacity to target bacteria integrated into a biofilm on the surface of the surgical insert. Phage lysins are hydrolytic enzymes.

[0193]

[0157] The active ingredients can be in liquid, hydrogel, cement, powder or microbead form. These forms all allow for prolonged release of the active ingredients inhibiting bacterial adhesion, biofilm formation and bacterial proliferation.

[0194]

[0158] Among the active ingredients, the following may be cited: anti-infectives, anti-oncotics and activators of adhesion and bone healing.

[0195]

[0159] Among the anti-infectives, the following can be mentioned: antibiotics and antifungals.

[0196]

[0160] Among the antibiotics, the following can be cited: gentamicin, rifampicin (eg Rifadine®), ceftriaxone, quinolones such as fluoroquinolones (eg

[0197] Ciprofloxacin® and Moxifloxacin®), amoxicillin, tetracyclines (e.g. Doxycycline® and Minocycline®), mixtures of trimethoprim and sulfamethoxazole (e.g. Bactrim® and Eusaprim®), clindamycin, linezolid (e.g. Zyvoxyd®), fusidic acid, chlorhexidine and silver sulfadiazine. The use of surgical inserts impregnated with antibiotics allows the local release, e.g. at the site at risk of colonization, of a high concentration of antibacterial agents. Combinations of antibiotics can be advantageously used, such as: rifampicin / tetracycline (notably Minocycline®) and chlorhexidine / silver sulfadiazine.

[0198]

[0161] Among the antifungals, the following can be mentioned: terbinafine, ketoconazole and amphotericin B.

[0199]

[0162] Among the anti-oncotics, the main ones that can be mentioned are anti-osteosarcoma anti-oncotics. Indeed, osteosarcoma is the most common malignant tumor originating in the bone. Examples of such anti-oncotics are: methotrexate, doxorubicin, cyclophosphamide, cisplatin, ifosfamide and etoposide.

[0163] Among the activators of bone adhesion and healing, the growth factors and collagen, but also mesenchymal stem cells, can be mentioned.

[0200]

[0164] Other biological materials may also be added to the surgical insert.

[0201]

[0165] Example 1: Two-layer surgical insert without separators

[0202]

[0166] In this example, a bilayer surgical insert 1 will be presented with two zones 122, 123 of different porosities in the second layer 12.

[0203]

[0167] A surgical insert 1 was produced by rapid prototyping. Figure 9 shows the two faces of the insert 1 and its properties are presented in the table below.

[0204]

[0168] [Table 3]

[0205]

[0169] The orifices have the dimensions shown in the table below. And the properties are shown in Table 5.

[0170] [Table 4]

[0206]

[0171] [Table 5]

[0207]

[0172] Example 2: Surgical insert with mechanical reinforcement

[0208]

[0173] Figure 28 shows the simulation results of two inserts both having octomorphic shaped orifices. One 1a has no mechanical reinforcement (black bars) and the other 1a has mechanical reinforcement 16 (grey bars). The bars represent the simulated maximum displacement in the case where the insert is subjected to a bending force F, tensile force Tr or torsion To. The values ​​are normalized by the values ​​obtained for insert 1a without mechanical reinforcement. It is noted that the maximum displacement is lower when applying the three types of force for insert 1b with mechanical reinforcement compared to that without mechanical reinforcement.

[0209] Digital references

[0210]

[0174] 1: surgical insert,

[0211] 11: first layer,

[0212] 111: orifices of the first layer,

[0213] 112: transverse orifices of the first layer,

[0214] 12: second layer,

[0215] 121: orifices of the second layer,

[0216] 122: first zone of the second layer,

[0217] 1221: orifices of the first zone of the second layer,

[0218] 123: second zone of the second layer,

[0219] 1231: orifices of the second zone of the second layer,

[0220] 124: transverse orifices of the second layer,

[0221] 13: third layer,

[0222] 131: orifices of the third layer,

[0223] 14: fixing legs,

[0224] 15: plurality of separators, and

[0225] 151: orifices of the plurality of separators.

Claims

Claims

1. Surgical insert (1) comprising: - a first layer (11), and - a second layer (12), wherein the first layer and the second layer comprise orifices (11 1 , 121 ) having an octomorphic shape.

2. A surgical insert according to claim 1, wherein the octomorphic shape is a shape composed of two end portions, each formed by a circle of radius; the two end portions being connected to each other by a central portion formed by a circular fillet of radius r2 so that the width of the central portion is less than the width of the end portions.

3. A surgical insert according to claim 1 or claim 2, wherein the first radius of curvature of the orifices of a layer is greater than or equal to 345 pm and less than or equal to the following formula: [Math. 2] r >l,max - ~ l ÈN where n.max is the first maximum radius of curvature of the holes in the first layer, S is the total surface area of ​​a layer, <p est le rapport entre la surface totale occupée par les orifices et la surface totale de la première couche et N est le nombre d’orifices d’une couche.

4. A surgical insert according to any one of claims 1 to 3, wherein the ratio of the total surface area occupied by the orifices of a layer to the total surface area of ​​that layer is greater than or equal to 0.09 and less than or equal to 0.

92.

5. A surgical insert according to any one of claims 1 to 4, wherein the orifices are arranged in a pattern selected from a square pattern, a hexagonal pattern, and a heterogeneous pattern.

6. A surgical insert according to claim 5, wherein the orifices are arranged in a heterogeneous pattern defined by a Bézier curve.

7. Surgical insert according to claim 6, in which the arrangement of the octomorphic shaped orifices (121) of the second layer results from a homothetic duplication of the arrangement of the octomorphic shaped orifices (111) of the first layer.

8. Insert according to claim 7, in which the homothetic duplication induces a minimum overlap section of 0.2 mm 2 between the octomorphic orifice of the first layer and that of the second layer.

9. A surgical insert according to any one of claims 1 to 8, wherein the first layer has a porosity greater than that of the second layer.

10. A surgical insert according to one of claims 1 to 9, wherein the orifices of the first layer have a total length and the orifices of the second layer have a total length; wherein the ratio of the total length of the orifices of the first layer and the total length of the first orifices of the second layer is greater than 1.

4.

11. Surgical insert according to one of claims 1 to 10, in which the second layer has a keying device (122).

12. A surgical insert according to claim 11, wherein the keying device is formed of two areas on the second layer, a first area with orifices having a first total length and a second area with second orifices having a second total length; wherein the ratio between the first total length and the second total length is between 1.6 and 2, preferably between 1.7 and 1.9, preferably between 1.75 and 1.85, for example 1.

8.

13. A surgical insert according to any one of claims 1 to 12, further comprising a plurality of separators (15) disposed between the first layer and the second layer.

14. Surgical insert according to claim 13, in which the thickness h of each layer satisfies the relationship: [Math. 1] where / is the maximum width of the surgical insert and L is the maximum length of the surgical insert.

15. A surgical insert according to claim 13 or claim 14, wherein each of the plurality of separators is a pillar having a cross-sectional shape as described in claims 1 to 3.

16. A surgical insert according to any one of claims 13 to 15, wherein each of the plurality of pillars has a longitudinal axis forming an angle with the midplane formed by the first layer and the second layer greater than or equal to 5° and less than or equal to 90°.

17. A surgical insert according to any one of claims 13 to 16, wherein each of the plurality of pillars is helical and has a twist angle greater than 0° and less than or equal to 180°, preferably less than or equal to 90°.

18. A surgical insert according to any one of claims 13 to 17, wherein each of the plurality of pillars comprises transverse holes (151) at its lateral surface.

19. A surgical insert according to any one of claims 1 to 18, wherein the orifices of the first layer and / or the second layer have a side wall formed in the thickness of the corresponding layer, and wherein the first layer and / or the second layer comprises transverse orifices of octomorphic shape as described in claims 1 to 3 and extending between the side wall of two orifices of the corresponding layer.

20. A surgical insert according to claim 15 or claim 19, wherein each of the orifices of each layer has a section greater than or equal to 0.70 mm 2 .

21. A surgical insert according to any one of claims 1 to 20, being composed of a material selected from a polymer, a metal, a ceramic or a composite.

22. A surgical insert according to any one of claims 1 to 21, further comprising a securing tab (14) extending from one of the first layers.

23. A surgical insert according to any one of claims 1 to 22, further comprising a mechanical reinforcement (16).

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