WO2024047318A1

WO2024047318A1 - Surgical insert

Info

Publication number: WO2024047318A1
Application number: PCT/FR2023/051319
Authority: WO
Inventors: Francine Monchau; Olivier CARPENTIER; Gwenaël RAOUL
Original assignee: Universite D'artois; Universite De Lille; Centre Hospitalier Universitaire De Lille; Institut National de la Santé et de la Recherche Médicale; Ecole Nationale Supérieure Mines-Télécom Lille-Douai; Junia
Priority date: 2022-09-01
Filing date: 2023-08-31
Publication date: 2024-03-07
Also published as: WO2024047317A1

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

Title: Surgical insert

Technical area

[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.

Prior art

[2] Maxillofacial trauma is a common trauma that mainly affects men and young people between 18 and 25 years old. They are mainly due to accidents on public roads, fights, accidents linked to the practice of sport, and domestic accidents.

[3] In maxillofacial trauma, the areas mainly affected are the teeth, the nasal bones as well as the orbital structure, which is affected in more than 40% of cases due to its exposed position and its very thin thickness. bone. A fracture of the orbital structure can lead to functional consequences. Thus, an incarceration of the muscle and/or fat surrounding the eye may appear, causing a difference in elevation between the two eyes (diplodia). It can cause compression of the infra-orbital nerve (V ₂ ) which passes under the orbital structure. This compression is responsible for sensitivity disorders in 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.

[4] In cases where the fracture of the orbital frame is quite significant, it is necessary to reconstruct the orbital volume. This reconstruction must be rigorously respected because complications, such as those mentioned above, may appear. In order for the eyeball to regain its normal functioning and positioning, the reconstruction must be precise and conform to the anatomy of the affected person's orbit but must also be accompanied by a repositioning of the intra-soft tissues. orbital.

[5] The appearance of computer-assisted surgery has enabled numerous advances in fractures requiring complex reconstructions of bone volume. In particular, it makes it possible to generate a virtual patient file in three dimensions faithfully reproducing the patient's specific anatomical bone structure. It is thus possible to have available a reliable basis for the 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.

[6] The main objective of reconstructing the orbital structure is to reconstruct the shape and volume of the orbit specific to the anatomy of each patient. However, reduction of thin bone fragments from 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 tissue displacement 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. However, this orbital implant must be adapted to the anatomy of each patient in order to function optimally.

[7] A first type of implant is a manually shaped flat implant. To achieve this, the surgeon uses replicas of the patient's skull sterilized in ABS (acrylonitrile butadiene styrene) to place and model the implant in order 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: to be able to manufacture and sterilize the patient's skull in ABS, to desterilize and re-sterilize the implant, to have the time to carry out this operation and to be in a structure that has access to this technology. .

[8] A second solution is to design implants for most individuals by anatomically preforming an implant covering the orbital floor and medial wall. These implants have “average” dimensions, that is to say, 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 allowed a clear improvement compared to standard implants. However, because the 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.

[9] There is therefore still a need for the design of an anatomically shaped orbital implant covering the site of the lesion 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. [10] 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 being used as a substance release matrix.

Summary

[11] This disclosure improves the situation.

[12] According to a first aspect, a surgical insert is proposed comprising:

- a first layer, and

- a second layer, in which the first layer and the second layer comprise orifices having an octomorphic shape.

[13] 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 ensure that the surgical insert has sufficient mechanical support properties, in particular by a significant reduction in maximum stresses. This surgical insert can be used as a bone substitute, particularly 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, serve as an osteosynthesis plate or form a joint prosthesis.

[14] This surgical insert, or surgical implant, can also be used for human or animal surgery, in particular 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, teeth) or the trunk (for example the spine). It can also be used in vascular, abdominal or digestive surgery.

Brief description of the drawings

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

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

[17] [Fig- 2] schematically shows a top view of octomorphic shaped orifices arranged in a triangular pattern; [18] [Fig. 3] schematically shows a top view of octomorphic shaped orifices arranged in a square pattern;

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

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

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

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

[23] [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 porosities;

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

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

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

[27] [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;

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

[29] [Fig. 13] shows the evolution of the weighting coefficient C ₂ as a function of the twist angle 0 of the pillars of the surgical insert according to the invention;

[30] [Fig. 14] schematically shows an example of a pillar with a vertical longitudinal axis of helical shape with a twist angle different from 0;

[31] [Fig. 15] shows the evolution of the weighting coefficient C ₃ as a function of the angle of inclination Q of the straight pillars of the surgical insert according to the invention;

[32] [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;

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

[34] [Fig. 18] schematically shows an example of a pillar with a right longitudinal axis of helical shape having pores at its lateral surface; [35] [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;

[36] [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 of vertical longitudinal axis of helical shape having pores at its lateral surface;

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

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

[39] [Fig. 23] is an enlargement of part of the Bézier curve of Figure 22 at an extremum;

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

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

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

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

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

detailed description

[45] 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.

[46] The surgical insert 1 includes:

- a first layer 11, and

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

[47] We call “octomorphic” orifices having the shape of the number 8, that is to say an elongated shape with two lobes at the ends and a constricted central part.

[48] The octomorphic shape can be described as consisting of two end parts, each formed by a circle of radius n. The two end parts are connected together by a central part formed by a circular fillet of radius r ₂ so that the width of the central part is less than the width of the parts of ends equal to 2xri. Thus, the radius is a first radius of curvature of the octomorph shape in the end parts and the radius r ₂ is a second radius of curvature of the octomorph shape in the central part.

[49] The octomorphic shape can further be described as a two-dimensional shape, oblong constricted to half its length and includes two end parts and a central constricted part. The octomorphic shape can have a curved contour, that is to say the contour does not have angles. The two end parts may have a first radius of curvature n oriented towards the inside of the orifice. The constricted central part may comprise a central zone having a second radius r ₂ of curvature oriented towards the outside of the orifice.

[50] 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 mean plane of the surface from which the orifice extends.

[51] We will also understand as “octomorphic shaped orifice” an orifice not having the octomorphic shape due to the paving and the dimensioning of the insert. That is to say, any orifice resulting from paving with octomorph-shaped orifices followed by trimming to the desired shape of the insert is considered an octomorphic orifice.

[52] The octomorphic shape may include a center of symmetry in the constricted central part. The octomorphic shape can have two axes of symmetry perpendicular to each other.

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

- laughed the first radius of curvature,

- r ₂ the second radius of curvature

- L _o the total length of the orifice 111, 121,

- to the total width of the orifice 111, 121,

- t _c the central width of the central part of the orifice 111, 121,

- h the thickness of the surgical insert 1,

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

- (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,

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

- Fia force applied to insert 1.

[54] Figure 1 shows a top view diagram of an orifice 111, 121 of octomorphic shape. Thus, by length we understand 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. By width we mean a dimension perpendicular to the length. The thickness of the surgical insert is understood as a distance between the two extreme faces of the insert in the direction of superposition of the layers. Unless otherwise indicated, we mean the average thickness on the insert. The distance between two orifices is taken between the centers of these orifices.

[55] The total length, L _o , can be between 200 pm and 50 mm. In certain cases (for example for orbital floors), this length is preferably

200 pm to 2 mm. In other cases (for example for osteosynthesis plates), this length is preferably 10 to 50 mm.

[56] The ratio of the total length, L _o , to the total width, t _o , can be between

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

[57] The ratio between the first radius of curvature, ri, and the second radius of curvature, r ₂ , can 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.

[58] The ratio between the total width, t _o , and the central width, t _c , can 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.

[59] 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 on the general shape of the insert 1 which will condition the distribution of the stress resulting from loading.

[60] The orifices 111, 121 of octomorphic shape can be arranged at the level of the layer 11, 12 according to a particular pattern. The pattern can be locally partial, that is to say that orifices 111, 121 of octomorphic shape are missing. This pattern can be chosen from a triangular pattern, a square pattern, a hexagonal pattern or a heterogeneous pattern. The pattern can also be chosen so that the orifices 111, 121 of octomorphic shape draw the contours of a geometric shape, in particular regular, 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 at a vertex of a triangle. A square pattern is a pattern in which the center of each orifice 111, 121 is at a vertex of a square. A hexagonal pattern is a pattern in which the center of each orifice 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 following 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 be 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).

[61] 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" ^-1 are Bernstein polynomials:

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 placed.

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

[63] Preferably, if n _Q is the total number of centers Q(t ₀ ), Q(ti), ... of circle of radius and ti the parametric coefficient corresponding to the i ^th center Q(tj), then for i of

2 to n _Q , we define Qi, Q ₂ and Q ₃ as follows: Pj, i.e. the (i— 1) ^th center; , ^is the i ^th center;

^x Pj, i.e. the point located between the (i—1) ^th center and the ^ith center.

We also define a point with coordinates (x _c ; yc) as follows:

and the following radius:

R _c = c) ² + (A/ _1C ) ² ; with :

(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).

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

[64] 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 octomorph-shaped orifices arranged in a partial rectangular pattern. We can see in Figure 25 that the octomorph-shaped orifices are inserted into the MR1 nodes of a rectangular mesh MR but that other nodes MR2 of this mesh are not occupied by an octomorph-shaped orifice. Figure 26 shows a top view diagram of octomorphic shaped holes 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.

[65] The porosity of layers 11, 12 can be from 0.1 to 0.93, preferably from 0.4 to 0.8.

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

[67] 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 within the intervals defined above, the layer 11, 12 has an elastic limit stress less than 830 MPa which is the conventional elastic limit (Rp0.2) of the TA6V titanium implant.

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

[69] The orifices 111, 121 of octomorphic shape can 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 area. In certain cases, all the orifices 111, 121 of the layer 11, 12 are parallel to each other.

[70] The surgical insert 1 may further comprise a fixing tab 14 extending from one of the layers. The fixing tab 14 may have a fixing 141 of oblong shape, in particular with an orifice 142 also oblong connected to the first and/or second layers 11, 12 by a tongue 143. [71] The surgical insert 1 can 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.

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

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

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

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

[76] 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 chromium), or of tantalum.

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

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

[79] 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 by bone cement or be made exclusively of bone cement by rapid prototyping. Insert 1 is then washed to eliminate any residual traces: it is washed with ether then with water before being dried in the oven at 37° C for 24 hours. If an active ingredient wants to be added, insert 1 can be brought into contact with a drug before implantation for its biofunctionalization.

[80] 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 greater than 20.

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

4 [82] where I is the maximum width of the surgical insert and L is the maximum length of the surgical insert.

[83] In the following, we will describe the parameter values in the case where the L/h ration is greater than 20.

[84] 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.

[85] [Math. 2]

[86] where S is the total surface area of insert 1, <p is the total porosity of insert 1, and N is the number of octomorphic pores in a layer.

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

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

[89] 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.

[90] [Math. 3] r-i + e

^I h ^L max < — — - -| Q

[91] The only real maximum limit of 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 which he 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 Math relationship. 3. [92] The admissible load is then defined by the relation Math. 4 whose parameters are given in table 1.

[93] [Math. 4]

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

[95] [Table 1]

[96] The relationship between f(o) and a is presented in the following table 2:

[97] [Table 2]

[98] 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.

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

[100] 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 L ₂ can be greater than 1.4, preferably it is greater than 1.4 and less than 3.2.

[101] The first layer 11 aims to be in direct contact with the bone structure. Thus, preferably, the first layer 11 is made of a material biocompatible with osteoblasts to integrate into the bone tissue without risk of formation of fibrous tissue. The second layer 12 aims to support support tissues or organs. Therefore, preferably, it has a smooth and not very porous surface in order to avoid infections.

[102] The second layer 12 may have a key.

[103] The second layer 12 may have two zones, a first zone 122 with orifices 1221 having a first maximum length L ₂ 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 can be between 1.6 and 2, preferably between 1.7 and 1.9, preferably between 1.75 and 1.85, for example 1.8.

[104] The ratio between the maximum length of the orifices 111 of the first layer Li and the first maximum length L ₂ can 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.

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

[106] The first zone 122 with 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 zone. Indeed, the octomorphic orifices 121 having a smaller size can serve as a key to knowing the direction of positioning of the insert 1.

[107] This bilayer structure allows fluids to circulate easily through insert 1 in order to avoid any stagnation and/or risk of infection.

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

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

[110] [Math. 5]

[111] where (ptot is the total porosity of the surgical insert 1, (pi is the porosity of the first layer 11, <p ₂ is the porosity of the second layer 12, Si is the total surface of the first layer 11 and S ₂ is the total surface area of the second layer 12. For a given layer, the porosity is the ratio between the surface area occupied by the octomorphic orifices and the total surface area of the layer.

[112] 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 surface total 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.

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

[114] 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.

[115] The second layer 12 may have two zones, a first zone 122 with orifices 1221 having a first maximum length L ₂ 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 can be between 1.6 and 2, preferably between 1.7 and 1.9, preferably between 1.75 and

1.85, for example 1.8.

[116] 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 can correspond to a homothetic duplication of the arrangement of the orifices octomorphs 111 of the first layer 11. That is to say that the orifices undergo a translation and a rotation (duplication) then a homogeneous scaling (homothety). This homothetic duplication can be described by the following formulas:

with :

Mi(x,y,z), the coordinates of the centers of the octomorphic orifices of the first layer; M ₂ (x,y,z), the coordinates of the centers of the octomorphic orifices of the second layer;

X, the value of the translation following the main vector X;

Y, the value of the translation following the main vector Y;

Z, the value of the translation following the main vector Z;

0, the angle of rotation along the main axis Z; and SE, the scaling coefficient.

[117] 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 differentiating from each other by the angle of rotation 0 and/or the coefficient of rotation. SE scaling. Thus, from an orifice 111 of the first layer 11, there can be 1, 2, 3, 4 orifices 121 of the second layer 12, or more. [118] 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 from it (see figure 24) . Still preferably, the covering is worth a maximum of a quarter of the surface of the orifice 111 of the first layer 11.

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

[120] Each separator 15 can 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.

[121] The pillar 15 may have a longitudinal axis. This longitudinal axis can be straight (figures 12, 14 and 16) or curved (figure 17). When the longitudinal axis is straight, it can extend perpendicularly from the average plane formed by the first layer 11 or by the second layer 12. It can also be understood as forming a non-right angle with this average 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.

[122] Each separator 15 among the plurality of separators 15 may have a cross section which has an octomorphic shape as described above. Thus, pillar 15 can be obtained by translation of the octomorphic shape along the longitudinal axis (Figures 12, 16). Alternatively, the pillar 15 can 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).

[123] In the case of a pillar 15 with a lateral surface of helical shape, preferably, the number of rotations of the octomorphic shape between the first layer 11 and the second layer 12 can 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 octomorphic shape at the level of the second layer 12 is at 90° (270°) from its orientation at the level of 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 octomorphic shape at the level of the second layer 12 is 180° (360°) from its orientation at the level of the first layer 11.

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

[125] The parametric equation making it possible to design the pillar 15 of helical shape is expressed below. [126] [Math. 6]

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

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

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

[129] In order to study the influence of the different parameters of the pillars 15 on the admissible load, we define the following parameters whose extreme values will be determined by a parametric analysis:

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

- P the angle of twist of pillar 15, this angle is non-zero when pillar 15 is helical,

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

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

[130] 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 average plane of the first or second layer. The maximum value H _max of the height of pillar 15 can respect the following formula:

[131] [Math. 7]

H _max = 637.040 x F _p ^-0 ' ⁴⁹³ xr?

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

[133] The helical pillar 15 can support an admissible load increased by a factor C ₂ expressed by the formula Math. 8.

[134] [Math. 8]

[135] Figure 13 shows the evolution of the weighting coefficient as a function of the twist angle 0. This weighting coefficient can be determined by parametric analysis. We thus see that above 90°, the weighting coefficient C ₂ increases significantly.

[136] 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 inclination angle is measured relative to the normal to the average plane formed by the first or second layer. [137] The right axis pillar can support an admissible load increased by a factor C ₃ expressed by the formula Math. 9.

[138] [Math. 9]

Fp ^m = C ₃ F _p , C ₃ = O.OOOO680 ³ + 9.7110 ² - 0.03860 + 1.1782

[139] Figure 15 shows the evolution of the weighting coefficient C ₃ 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 factored force increases.

[140] Each pillar 15 may include through holes 151 at its side 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. In fact, 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.

[141] The ratio between the surface of the transverse orifices 151 and the lateral surface of the pillar 15 can be between 0.25 and 0.3.

[142] As illustrated in Figure 19, the orifices 111, 121 of the first layer and/or 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 or the second layer 12 comprises transverse orifices 112, 124 with an octomorphic cross-section as described above 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 can be entirely in the thickness of the first layer 11 or the second layer 12 (/.e. the transverse orifices 112, 124 form channels) or on the surface thereof (/.e . these transverse orifices 112, 124 form channels with a free surface). The two types of channels can coexist in the same insert 1.

[143] 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

[144] In the case where, as in the insert 1 in three dimensions, 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 help the circulation of fluids. They are arranged so as to connect the orifices 111, 121 of the first layer 11 and the second layer 12 between them. The desired number of interconnections N is located 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 layer 11, 12 corresponding. Too few interconnections can result in

“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, for its part, the risk of multiplication of “dead channels” by leaving the fluid the possibility of finding a clearly preferential route.

[145] 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 .

[146] The plurality of pillars preferably comprises transverse holes at the side surface of the insert.

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

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

[149] The surgical insert can also include a mechanical reinforcement 16 (see Figure 27). The mechanical reinforcement 16 takes up the bending, torsion and compression forces so that the layers 11, 12 of the insert 1 do not suffer deterioration. In addition, the mechanical reinforcement 16 must not hinder the fixing of the insert 1.

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

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

[152] 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 in diameter thickness is preferably provided around this orifice 161.

[153] Such mechanical reinforcement 16 is advantageous when the insert fits into a bounding box BB of dimensions a, b, c of which c is the smallest dimension, at least one of following conditions is met:

- c > 10 or - c > 10. [154] A BB limit box for a set of points in three dimensions is defined as the parallelepiped box having the smallest volume and capable of containing the set of points (see figure 27).

[155] 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.

[156] Among the particular agents, the following can be cited: bacteriophages and phage lysines. Bacteriophages have the ability to target bacteria integrated into a biofilm on the surface of the surgical insert. Phage lysines are hydrolytic enzymes.

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

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

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

[160] Among the antibiotics, the following can be cited: gentamicin, rifampicin (e.g. Rifadine®), ceftriaxone, quinolones such as fluoroquinolones (e.g.

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 makes it possible to release locally, e.g. at the site at risk of colonization, a high concentration of antibacterial agents. Combinations of antibiotics can be advantageously used, such as: rifampicin/tetracycline (notably Minocycline®) and chlorhexidine/silver sulfadiazine.

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

[162] Among the anti-oncotics, we can mainly cite 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. [163] Among the activators of bone adhesion and healing, we can cite growth factors and collagen, but also mesenchymal stem cells.

[164] Other biological materials can also be added to the surgical insert.

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

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

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

[168] [Table 3]

[169] The orifices have the dimensions shown in the table below. And the properties are shown in Table 5. [170] [Table 4]

[171] [Table 5]

[172] Example 2: Surgical insert with mechanical reinforcement

[173] Figure 28 shows the simulation results of two inserts both having octomorph shaped holes. One 1a does not have mechanical reinforcement (black bars) and the other 1a has mechanical reinforcement 16 (gray bars). The bars represent the maximum displacement simulated in the case where the insert is subjected to a bending force F, traction Tr or torsion To. The values are normalized by the values obtained for insert 1a without mechanical reinforcement. We notice that the maximum displacement is less when applying the three types of force for the insert 1b with mechanical reinforcement compared to that without mechanical reinforcement.

Numerical references

[174] 1: surgical insert,

11: first layer,

111: orifices of the first layer,

112: transverse orifices of the first layer,

12: second layer,

121: orifices of the second layer,

122: first zone of the second layer,

1221: orifices of the first zone of the second layer,

123: second zone of the second layer,

1231: orifices of the second zone of the second layer,

124: transverse orifices of the second layer,

13: third layer,

131: orifices of the third layer,

14: fixing brackets,

15: plurality of separators, and

151: orifices of the plurality of separators.

Claims

[Claim 1] Surgical insert (1) comprising:

- a first layer (11), and

- a second layer (12), in which the first layer and the second layer comprise orifices (11 1, 121) having an octomorphic shape.

[Claim 2] Surgical insert according to claim 1, in which the octomorphic shape is a shape composed of two end parts, each formed by a circle of radius; the two end parts being connected together by a central part formed by a circular fillet of radius r ₂ so that the width of the central part is less than the width of the end parts.

[Claim 3] Surgical insert according to claim 1 or claim 2, in which 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 È _N where n.max is the first maximum radius of curvature of the orifices of the first layer, S is the total surface of a layer, <p is the ratio between the total occupied surface by the orifices and the total surface area of the first layer and N is the number of orifices in a layer.

[Claim 4] Surgical insert according to any one of claims 1 to 3, in which the ratio between the total surface occupied by the orifices of a layer and the total surface of this layer is greater than or equal to 0.09 and less or equal to 0.92.

[Claim 5] Surgical insert according to any one of claims 1 to 4, in which the orifices are arranged in a pattern chosen from a square pattern, a hexagonal pattern and a heterogeneous pattern.

[Claim 6] Surgical insert according to claim 5, in which the orifices are arranged in a heterogeneous pattern defined by a Bézier curve.

[Claim 7] Surgical insert according to claim 6, in which the arrangement of the orifices (121) of octomorphic shape of the second layer result from a homothetic duplication of the arrangement of the orifices (1 11) of octomorphic shape of the first layer.

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

[Claim 9] Surgical insert according to any one of claims 1 to 8, in which the first layer has a greater porosity than that of the second layer.

[Claim 10] Surgical insert according to one of claims 1 to 9, in which the orifices of the first layer have a total length and the orifices of the second layer have a total length; in which 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.

[Claim 11] Surgical insert according to one of claims 1 to 10, in which the second layer has a key (122).

[Claim 12] Surgical insert according to claim 11, in which the keying device is formed of two zones on the second layer, a first zone with orifices having a first total length and a second zone with second orifices having a second total length; in which 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 .

[Claim 13] 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.

[Claim 14] Surgical insert according to claim 13, in which the thickness h of each layer verifies the relationship:

[Math. 1]

where / is the maximum width of the surgical insert and L is the maximum length of the surgical insert.

[Claim 15] Surgical insert according to claim 13 or claim 14, wherein each of the plurality of separators is a pillar whose cross section has an octomorphic shape as described in claims 1 to 3.

[Claim 16] 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 average plane formed by the first layer and the second layer greater than or equal to 5 ° and less than or equal to 90°.

[Claim 17] 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 at 90°.

[Claim 18] A surgical insert according to any one of claims 13 to 17, wherein each of the plurality of posts includes transverse holes (151) at its side surface.

[Claim 19] Surgical insert according to any one of claims 1 to 18, in which the orifices of the first layer and/or the second layer have a side wall formed in the thickness of the corresponding layer, and in which 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.

[Claim 20] Surgical insert according to claim 15 or claim 19, in which each of the orifices of each layer has a section greater than or equal to 0.70 mm ² .

[Claim 21] Surgical insert according to any one of claims 1 to 20, being composed of a material chosen from a polymer, a metal, a ceramic or a composite.

[Claim 22] Surgical insert according to any one of claims 1 to 21, further comprising a fixing tab (14) extending from one of the first layers.

[Claim 23] Surgical insert according to any one of claims 1 to 22, further comprising a mechanical reinforcement (16).