Partial trabecular bone elements for augmentation or bone filling

Abstract

An element (100, 200, 300) for augmentation or bone filling, comprising at least one first outer layer portion (101) having a trabecular lattice of metallic material, and further comprising at least one reinforcing inner layer (103) of metallic material having a plurality of channel structures (104) with an arrangement of corresponding channel openings (105) surrounded by edges that are in structural contact with the at least one first outer layer portion (101).

Description

[Technical Field]

[0001] FIELD OF THE INVENTION The present invention relates to elements for augmentation or bone filling. Generally, the present invention relates to devices that can be implanted within the body, such as components for prostheses or artificial replacements of body parts. [Background technology]

[0002] For implantation of a femoral head prosthesis, it may be necessary to deal with an implantation site that has scarce bone, for example due to disease, injury, or wear from previous surgery.

[0003] Therefore, in the context of femoral head prostheses, it is known to provide porous reinforcing devices or elements designed to fill the void left by the defective bone. Similarly, bone fillers are synthetic adjuvants that provide an osteoconductive matrix to facilitate surgery or implantation.

[0004] However, prior art solutions are not sufficiently effective in providing augmentation or bone filling and therefore can be improved. Summary of the Invention [Problem to be solved by the invention]

[0005] It is an object of the present invention to provide a device for effective augmentation or bone filling.

[0006] A further object of the present invention is to allow for a reduction in the total weight of the augmentation or bone filling with comparable effectiveness.

[0007] A further object of the present invention is to meet the manufacturing constraints of augmentation or bone filling in a qualitatively better way.

[0008] A further object of the present invention is to provide an augmentation or bone filling material with adequate mechanical strength.

[0009] A further object of the present invention is to provide an augmentation or bone filling having structural and functional characteristics that make it possible to overcome the drawbacks of the prior art. [Means for solving the problem]

[0010] The solution underlying the present invention is to provide an augmentation or bone filling component with one or more outer layers or "skins" made of trabecular bone material, such as titanium, aimed at promoting bone integration or cementation of the femoral head. Preferably, the outer layer or layers have a constant thickness. A regular reinforcing inner structure associated with the outer layer or layers allows for a reduction in the overall weight, thereby maintaining the mechanical stability of the component.

[0011] Such reinforcing internal structures are preferably at least partially hollow and configured to allow for more effective cleaning from process powders, particularly in the context of single-step additive manufacturing.

[0012] According to the solution, an element for augmentation or bone filling is provided, comprising at least one first outer layer portion with a trabecular lattice of metallic material and further comprising at least one reinforcing inner layer of metallic material, the reinforcing inner layer having a plurality of channel structures with an arrangement of corresponding channel openings surrounded by edges that are in structural contact with the at least one first outer layer portion with the trabecular lattice.

[0013] Advantageously, the elements of the present invention allow for a reduction in the total weight of the augmentation or bone fill.

[0014] Advantageously, the elements of the invention make it possible to maintain the manufacturing constraints for augmentation or bone filling, in particular to be produced entirely and at the same time in a qualitatively better way by additive manufacturing.

[0015] Advantageously, elements of the present invention avoid powder becoming trapped within the porous structure of the trabecular lattice, allowing for better removal of powder in the manufacturing process.

[0016] Advantageously, the elements of the invention make it possible to provide an augmentation or bone filling with increased mechanical strength.

[0017] Advantageously, the elements of the present invention also entail physiological and / or psychological benefits for the end user (the patient receiving the augmentation or bone filling) who obtains a light and cumbersome solution.

[0018] Preferably, the trabecular lattice of the element has porous cells with a first dimension, and the channel structure has a channel equivalent diameter with a second dimension larger than the first dimension of the trabecular porous cells. Furthermore, preferably, the channel structure has corresponding through-channel cavities. In this way, particularly in the case of additive manufacturing, powder or other manufacturing residues can advantageously pass through the trabecular lattice and be easily evacuated through the channel structure, especially with the aid of gravity. In this way, advantageously, a cleaning effect contributes to providing a high-quality element.

[0019] Preferably, the channel structures are adjacent and substantially aligned, in particular defining a honeycomb structure, so as to contribute to the mechanical strength of the element.

[0020] Preferably, the channel structures are partially divergent from one another so as to follow the inclined contour surface of the element. Advantageously, in this way, a better cleaning effect as described above and possibly a better load transfer through the element is obtained. In particular, advantageously, the channel structures are aligned along the main stress direction of the element.

[0021] Preferably, the element further comprises at least one second outer layer portion having a trabecular lattice of metallic material and associated with a plurality of channel structures, advantageously in this way improving the cementation or bone integration of the femoral head prosthesis.

[0022] Preferably, the element further comprises at least one third outer layer portion having a bulk thin film shell of metallic material configured to at least partially surround the element laterally, the third outer layer portion being particularly suited for contact with soft tissue.

[0023] Advantageously, the element is particularly suitable for being entirely and simultaneously manufactured by additive manufacturing, so as to obtain structural continuity between the at least one first outer layer portion and the at least one reinforcing inner layer, thereby improving the mechanical performance of the element. In particular, advantageously, the element is entirely made of metal by means of additive manufacturing. Preferably, the metallic material comprises titanium to improve biocompatibility.

[0024] Further features and advantages of the present invention will become apparent from the following detailed description of embodiments thereof, given by way of non-limiting example, and from the claims which form a part hereof. [Brief explanation of the drawings]

[0025] [Figure 1] 1 shows a three-dimensional view of a first embodiment of the present invention; [Figure 2] 1 shows a further three-dimensional view of the first embodiment of the present invention; [Figure 3] 1 shows a top perspective view of a first embodiment of the present invention. [Figure 4] 1 shows a bottom perspective view of a first embodiment of the present invention. [Figure 5] 1 shows a top view of a first embodiment of the present invention. [Figure 6] 1 shows a perspective cross-sectional view of a first embodiment of the present invention. [Figure 7] The first section of FIG. [Figure 8] The second section of FIG. [Figure 9] 1 shows a perspective top view of a second embodiment of the present invention. [Figure 10] 1 shows a further perspective top view of a second embodiment of the present invention; [Figure 11] 2 shows a perspective cross-sectional view of a second embodiment of the present invention. [Figure 12] 2 shows a cross-sectional view of a second embodiment of the present invention. [Figure 13] 1 shows a top view of a third embodiment of the present invention. [Figure 14] A cross-sectional view of FIG. 13 is shown. [Figure 15] 1 illustrates a first application example of the present invention. [Figure 16] A second application example of the present invention will be illustrated. DETAILED DESCRIPTION OF THE INVENTION

[0026] In different drawings, similar elements are designated by similar reference numerals. Often, when one drawing contains more similar elements, only one or some of them are designated by their respective reference numerals for the purpose of improving readability, and it is understood that the others are also included in the discussion.

[0027] [Detailed explanation] The elements of the present invention are intended for augmentation or bone filling applications. This description will focus on elements for reinforcement, but it is intended that similar solutions are applicable to elements for bone filling.

[0028] FIG. 1 shows a three-dimensional view of an embodiment of an element 100, which is in particular an element for reinforcement, while FIG. 2 shows a further three-dimensional view of the element 100 with a slightly different graphical representation of the trabecular bone portions.

[0029] The element 100 comprises an outer layer portion 102 having a trabecular lattice intended for osseointegration or artificial bone cement fixation. The trabecular lattice is made of a metallic material. Generally, the portion having the trabecular lattice is specifically intended to contact a bone surface.

[0030] The element 100 further comprises at least one reinforcing inner layer having a multi-channel structure, which is barely visible in the above figures and will be described in more detail below. The reinforcing inner layer is made of a metallic material.

[0031] The element according to the invention can be obtained in particular by means of additive manufacturing techniques, preferably using the SLM (Selective Laser Melting) process, which represents an enabling reference technique, or alternatively using the EBM (Electron Beam Melting) process.

[0032] A specific embodiment of the element according to the invention provides a manufacturing process that is a metal addition process of powder bed fusion, in particular E-PBF (Electron Beam Powder Bed Fusion) and L-PBF (Laser Powder Bed Fusion).

[0033] This element is a metallic material, in particular containing titanium.

[0034] 3 shows a top perspective view of element 100 with outer layer portion 102 visible, as further described below. In this and the next figure, the graphical representation of the trabecular bone portion is slightly different from the previous figure.

[0035] 4 shows a perspective bottom view of element 100. Element 100 includes at least one first outer layer portion 101 having a trabecular lattice of metallic material. Typically, at least one first outer layer portion 100 having a trabecular lattice occupies at least 45% of the surface of each side of the element. In this example, the trabecular portion occupies substantially the entire surface of the corresponding side.

[0036] Figure 5 shows a top view of element 100, where two cross sections VI and VIII are observed, Figure 6 shows a perspective view of element 100 along cross section VI, and Figure 7 shows a plan view of element 100 along cross section VI.

[0037] In these figures, and particularly inside the exemplary box 10 of FIG. 7, it is possible to observe that the element 100 comprises at least one first outer layer portion 101 having a trabecular lattice of metallic material.

[0038] The element 100 further includes at least one reinforcing inner layer 103 of a metallic material. The reinforcing inner layer 103 has a plurality of channel structures 104. The channel structures 104 are arranged with respective channel openings 105 surrounded by edges that are in structural contact with the at least one first outer layer portion 101.

[0039] In particular, for elements 100 made entirely and simultaneously from metal material by additive manufacturing, not only is there structural contact between the channel structure 104 and the first outer layer 101, but there is also structural continuity between at least one first outer layer 101 and at least one reinforcing inner layer 103.

[0040] Preferably, the trabecular lattice of the first outer layer portion 101 and the trabecular lattice of the further region comprising the trabecular lattice have porous cells with a first dimension.

[0041] The channel structure 104 has a channel equivalent diameter with a second dimension larger than a first dimension of the porosity of the trabecular lattice. Simply stated, the channel structure 104 is larger in the diameter or transverse direction than the porosity or dimensional characteristics of the cells of the trabecular lattice. In this way, it becomes easier to expel powder that may be weakly attached or processing residue, for the benefit of better de-powdering in the context of additive manufacturing.

[0042] Preferably, the channel structures 104 are adjacent and substantially aligned. In this preferred example, the channel structures define a honeycomb structure having hexagonal cells, it being understood that different cell contours other than hexagonal (e.g., circular, elliptical, polygonal) are possible. Thus, "channel equivalent diameter" means the diameter associated with a circular contour that inscribes or circumscribes the contour of the channel structure 104, as closely as possible.

[0043] In a particularly advantageous embodiment, as can be observed in this example, the channel structures 104 partially diverge from one another to follow the sloped contour surface of the element 100. In particular, the sloped contour surface of the element 100 is determined based on an evaluation of the anatomical structure with which the element 101 is associated. By "partially diverging" is meant that the respective axes are not parallel to one another and therefore diverge, and possibly the equivalent diameter of each channel structure 104 is not constant but diverges.

[0044] Generally, the contour of the element 101 may be anatomically designed so that at least one side has a slope of 0° to 40°. This particular design ensures open channels in the appropriate load area, determined based on consideration of the anatomical structure or the geometrical consequences of the femoral head prosthesis, while simultaneously optimizing the load distribution on the outer layer of the trabecular bone, resulting in an extended reinforcement structure. In particular, the channel structure 104 is preferably aligned along the main stress direction of the element 101.

[0045] The reinforcing inner layer 103 preferably has a regular structure that minimizes the amount of material required for structural stability to obtain minimum weight and material cost. While the geometry of the channel structure 104 can vary widely, a common feature of preferred channel structures is an array of hollow cells formed between thin walls. The hollow cells preferably have columnar and hexagonal shapes. A reinforcing inner layer 103, such as a honeycomb structure, provides a structured material with minimal density, relatively high out-of-plane compression properties, and out-of-plane shear properties. This allows for primary stability and secondary fixation, as well as adequate mechanical properties due to the internal honeycomb, while also being extremely lightweight.

[0046] In the preferred embodiment depicted herein, the channel structures 104 comprise respective through-channel cavities.

[0047] In possible variations not shown, the element may comprise an additional reinforcing inner layer with bulk reinforcement that crosses the channel structure so that the element defines blind channel cavities. These possible variations may provide the element with better strength, even though cleaning from powders or manufacturing residues may potentially be more complicated and may involve the use of physical and / or chemical post-treatments.

[0048] This embodiment of the element 100 has at least one second outer layer portion 102 comprising a trabecular lattice of metallic material.

[0049] At least one second outer layer portion 102 is arranged opposite at least one first outer layer portion 101 already described with respect to the reinforcing inner layer 103, thereby forming a sandwich structure as it were.

[0050] A second channel opening 106 corresponding to the plurality of channel openings 104 is further surrounded by a second end in structural contact with the at least one second outer layer portion 102 .

[0051] Preferably, the element 100 further comprises at least one third outer layer portion 107 having a bulk thin film shell of metallic material configured to at least partially surround the element 100 transversely to the reinforcing inner layer 103 .

[0052] Preferably, the element 100 further comprises at least one fourth outer layer portion 108 of trabecular metal material configured to at least partially surround the element 100 transversely to the inner reinforcing layer 103 .

[0053] Furthermore, the element 100 preferably further comprises a bulk protrusion profile 109 on the surface opposite the at least one first outer layer portion 101. In particular, the bulk protrusion profile 109 is configured for secure locking engagement with a further femoral head prosthesis component in an augmentation application. For example, for engagement with a negative shape of the component, e.g., a tibial plate in the case of a knee, the bulk protrusion profile 109 can be applied to create the required positive shape.

[0054] On the contrary, the application of the elements for bone filling does not provide for the presence of a bulk protruding profile.

[0055] FIG. 8 shows a further plan view of element 100 along cross section VIII.

[0056] As can be seen, element 100 comprises at least one hole 110 configured for the insertion of a connection point screw for a connection point to an additional prosthetic femoral head component in an augmentation application, or for a connection point to bone in the case of bone filling.

[0057] As a non-limiting example, the dimensions of element 100 are: - First outer layer 101: thickness 1.2 to 2.0 mm - Second outer layer 103: thickness 1.2 to 2.0 mm - Reinforcement inner layer 103: height 6~16mm - Channel structure 104: Wall thickness of approximately 1.0 mm -Channel opening 105: equivalent diameter 3.5~4.0mm -Channel opening 106: equivalent diameter 3.5~4.0mm -Third outer layer 107: thickness 1.0 to 2.0 mm may be.

[0058] FIG. 9 shows a perspective top view of a second embodiment of element 200.

[0059] Similar to that described with reference to the embodiment of element 100, the reinforcing element 200 comprises at least one first outer layer portion 101 having a trabecular lattice and at least one reinforcing inner layer 103 having a plurality of channel structures 104 with an array of channel openings 105 each surrounded by an end that is in structural contact with the at least one first outer layer portion 101.

[0060] Element 200 therefore corresponds to element 100 already described. It is noteworthy that element 200 does not have the second outer layer portion mentioned above, and the channel structure 104 is directly visible on the element.

[0061] In the embodiment of element 200, the channel structure is configured to fit directly onto the prosthetic head surface, preferably by means of the majority of the protruding contour 109.

[0062] Figure 10 shows a further perspective top view of element 200, where cross section XI is viewed. Figure 11 shows a perspective view of element 200 along cross section XI, and Figure 12 shows a plan view of element 200 along cross section XI.

[0063] In these figures, it can be seen that in the element 200 made entirely and simultaneously of metal material by additive manufacturing, there is structural continuity between the at least one first outer layer portion 101 and the at least one reinforcing inner layer 103.

[0064] Figure 13 shows a top view of the third embodiment of element 300, where cross section XIV is viewed. Figure 14 shows a plan view of element 300 along cross section XIV.

[0065] Similar to that described with reference to the embodiment of element 100, the reinforcing element 300 comprises at least one first outer layer portion 101 having a trabecular lattice and at least one reinforcing inner layer 103 having a plurality of channel structures 104 with an array of corresponding channel openings 105 surrounded by ends that are in structural contact with the at least one first outer layer portion 101.

[0066] Element 300 thus corresponds to element 100 already described. Note that in element 300, there are no channel structures 104 that partially diverge from one another; instead, they are parallel to one another. In particular, the axes of each of the channel structures 104 are parallel to one another, and presumably the equivalent diameter of each channel structure 104 is also constant along its axial extension.

[0067] FIG. 15 illustrates a first application of the element 100, and FIG. 16 illustrates a second application of the element 300 for reinforcement of a femoral head prosthesis.

[0068] The tibial augment 100 and the femoral augment 300 are assembled onto the tibial component 400 and the femoral component 500 through specific connecting screws 401 and 501, respectively.

[0069] The femoral augment 300 and tibial augment 100 elements are used to fill moderate sized bone defects with biomechanically stable components to support weight and assist functional movement, thereby helping to restore the anatomical joint line.

[0070] Reinforcements are typically modular and are considered an alternative solution to bone cement, autografts, and structural allografts for addressing bone loss.

[0071] The present invention combines design and process in an element of femoral head augmentation or bone filling.

[0072] Furthermore, the solution allows a reduction in the total weight of the femoral head prosthesis of about 50% with respect to the same solution obtained from a solid, thereby at the same time allowing a better quality of the manufacturing process.

[0073] It will be apparent that those skilled in the art can make further implementations and modifications of the present invention to meet their particular needs.

[0074] For example, the geometry of the elements is purely exemplary and is adapted to the type of femoral head prosthesis or implant.

[0075] Therefore, the above-described embodiments should be understood as being provided by way of non-limiting example.

Claims

1. An element (100, 200, 300) for augmentation or bone filling, comprising: at least one first outer layer portion (101) having a trabecular lattice of metallic material; at least one reinforcing inner layer (103) of a metallic material, said at least one reinforcing inner layer (103) having a plurality of channel structures (104) with an arrangement of corresponding channel openings (105) surrounded by edges in structural contact with said at least one first outer layer portion (101); An element comprising:

2. the trabecular lattice has porous cells having a first dimension; the channel structure (104) has a channel equivalent diameter in a second dimension that is greater than the first dimension; The element of claim 1.

3. 3. An element according to claim 1 or claim 2, wherein the channel structures (104) are adjacent and substantially aligned, in particular defining a honeycomb structure.

4. 4. The element of claim 3, wherein the channel structures (104) are partially divergent from one another to follow the inclined contour surface of the element (100, 200).

5. Element according to any one of claims 1 to 4, wherein the channel structure (104) is aligned along a major stress direction of the element (100, 200, 300).

6. Element according to any one of claims 1 to 5, wherein said channel structure (104) comprises a corresponding through-channel cavity.

7. 6. The element according to any one of claims 1 to 5, wherein said at least one reinforcing inner layer (103) further comprises bulk reinforcement material that crosses said channel structure (104), thereby defining a blind channel cavity.

8. and at least one second outer layer portion (102) having a trabecular lattice of the metal material and arranged opposite the at least one first outer layer portion (101) with respect to the reinforcing inner layer (103). a second end portion of the plurality of channel structures in structural contact with the at least one second outer layer portion; An element according to any one of claims 1 to 7.

9. 9. The element according to any one of claims 1 to 8, further comprising at least one third outer layer portion (107) having a bulk thin film shell of metallic material configured to at least partially surround the element (100, 200, 300) transversely to the reinforcing inner layer (103).

10. The element according to any one of claims 1 to 9, further comprising at least one fourth outer layer portion (108) of trabecular metal material configured to at least partially surround the element (100, 200, 300) transversely to the reinforcing inner layer (103).

11. further comprising a bulk protruding profile (109) of metallic material on an opposite surface of said at least one first outer layer portion (101); The bulk protrusion profile (109) is configured for mating connection with a further prosthetic head component (400, 500). An element according to any one of claims 1 to 10.

12. An element according to any one of claims 1 to 11, further comprising at least one hole (110) configured to receive a connection screw (401, 501) for connection to a further artificial femoral head component (400, 500) or directly to bone.

13. the metallic material is fabricated entirely simultaneously by additive manufacturing; There is structural continuity between at least said at least one first outer layer portion (101) and said at least one reinforcing inner layer (103). An element according to any one of claims 1 to 12.

14. Element according to any one of claims 1 to 13, wherein the at least one first outer layer portion (101) comprising the trabecular lattice of the metallic material occupies at least 45% of the surface of each side of the element (100, 200, 300).

15. Element according to any one of claims 1 to 14, wherein the metallic material comprises titanium.

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