Implants, assemblies, and methods for manufacturing such implants or assemblies

Abstract

Disclosed is an implant for in vivo implantation comprising an assembly of two or more structural elements (3, 4) movable relative to one another. Each structural element (3, 4) is partially or completely porous and includes a porous portion (5, 6) having a matrix (7, 8) of open cells (51, 61). The first matrix (7) of a first structural element (3) includes a first overlapping portion (50) in form-closed connection with a second overlapping portion (60) of a second matrix (8) of a second structural element (4) of the structural elements, through which the first overlapping portion extends. The overlapping portions (50, 60) are movable relative to one another to change the combined shape of the overlapping portions.

Description

Technical Field

[0001] The present invention relates to implants, assemblies, and methods of manufacturing such implants or assemblies.

Background Art

[0002] Various implants for in vivo implantation in non-human animals such as humans or livestock animals, such as dental implants, spinal cages, artificial hip joints, etc., are known. Depending on the type of surgery and application, such implants may be adjustable in shape, for example, to expand after insertion through a relatively small incision in the patient's body, to adapt to the shape of the target bone during surgery, or to be adjusted during recovery, for example, to adjust for bone regrowth. Various types of implants with adjustable shapes are known.

[0003] As a first example, expandable bone substitute implants such as expandable spinal fixation implants are known in the art. For example, Patent Document ① discloses an expandable angulatable intervertebral cage. These cages include components of upper and lower plates connected by a connecting expansion or adjustment mechanism, allowing the cage to change its size and angle as needed. The expandability of such implants allows for the placement of potentially large implants through small openings in the patient's body, and selective expansion in one or more selected directions provides the advantage of increasing the height of the implant.

[0004] Note: There seems to be a missing number in the reference to "Patent Document ①" in the original text. It should be replaced with the correct patent document number for accurate translation.As a second example, implants that replace skeletal structures are known. Depending on various symptoms such as tumor growth or trauma, it may be necessary to remove one or part of a bone, such as a vertebra. Expandable implants may also be useful to replace long bones or parts of appendages such as the legs and arms, or ribs or other bones that are generally longer than their width. Examples include any of the femur, tibia, fibula, humerus, radius, ulna, phalanges, clavicle, and ribs. Here, expandable implants can help restore appropriate load to the anatomical structure and achieve more secure fixation of the implant. For example, from Patent Document 2, a mesh is known that can be shaped to fit into a non-uniform space and provide a scaffold for cell regeneration.

[0005] Another example is the existence of expandable stents, such as self-expanding stents and balloon-expanding stents. Balloon-expanding and self-expanding stents are typically delivered in cylindrical form using a catheter-based delivery system, compressed to a smaller diameter, and placed in the target blood vessel to be treated. Once placed in the desired location within the blood vessel of the body, these devices are allowed to expand by balloon to the desired diameter or to "self-expand." They typically consist of metal arranged in rows of crosshatch, woven, or interconnected structures.

[0006] However, as is clear from the above overview, a common drawback is that achieving expandability or adaptability in the shape of the implant requires highly specific solutions for each type and application of the implant. [Prior art documents] [Patent Documents]

[0007] [Patent Document 1] International Publication No. 2018 / 002720 [Patent Document 2] European Patent Application Publication No. 3181273 [Overview of the project]

[0008] The present invention provides implants, assemblies, and methods for manufacturing such implants or assemblies as described in the accompanying claims.

[0009] Specific embodiments of the present invention are described in the dependent claims.

[0010] These and other aspects of the present invention will become apparent from the embodiments described below and will be explained by reference to the embodiments described below. [Brief explanation of the drawing]

[0011] Further details, aspects, and embodiments of the present invention are described by reference to the drawings, merely as examples. In the drawings, similar reference numerals are used to identify similar or functionally similar elements. Elements in the drawings are illustrated for clarity and ease of understanding and are not necessarily drawn to scale. [Figure 1] This is a schematic perspective view showing an example of one embodiment of a constitutive assembly. [Figure 2] This is a schematic cross-sectional side view illustrating another example of one embodiment of a constitutive assembly. [Figure 3] This is a schematic cross-sectional side view illustrating another example of one embodiment of a constitutive assembly. [Figure 4] This is a schematic cross-sectional side view illustrating an example of one embodiment of a constitutive assembly in two different states. [Figure 5] This is a schematic cross-sectional side view illustrating the details of an example of one embodiment of a constitutive assembly. [Figure 6] This is a schematic cross-sectional top view illustrating another example of one embodiment of an implant. [Figure 7] This is a schematic perspective view showing an example of one embodiment of a constitutive element suitable for a constitutive assembly. [Figure 8] This is a schematic perspective view illustrating another example of one embodiment of a constitutive element suitable for a constitutive assembly. [Figure 9] A perspective view schematically showing an example of an implant in which a structural assembly is used. [Figure 10] A perspective view schematically showing an example of a structural element suitable for a stent. [Figure 11] A perspective view schematically showing another example of a structural element suitable for a stent. [Figure 12] A top view schematically showing an example of a stent that can use the elements of FIGS. 10 and 11. [Figure 13] A cross-sectional view schematically showing an example of an embodiment of a structural assembly. [Figure 14] A perspective view schematically showing a type of unit cell suitable for a structural assembly. [Figure 15] A perspective view schematically showing a type of unit cell suitable for a structural assembly. [Figure 16] A perspective view schematically showing a type of unit cell suitable for a structural assembly. [Figure 17] A perspective view schematically showing a type of unit cell suitable for a structural assembly. [Figure 18] A perspective view schematically showing a type of unit cell suitable for a structural assembly. [Figure 19] A diagram schematically illustrating a manufacturing apparatus suitable for manufacturing an implant or an assembly. [Figure 20] A flowchart of a method for manufacturing a dental implant that can use the example of FIG. 19.

Mode for Carrying Out the Invention

[0012] The embodiments of the present invention that are illustrated can, in most cases, be implemented using electronic components and circuits known to those skilled in the art. Therefore, the details are not described in any broader range than what is considered necessary for the understanding and evaluation of the concepts underlying the present invention, and are not described so as not to obscure the teachings of the present invention or to distract from the teachings of the present invention.

[0013] Referring to FIG. 1, an example of an assembly 2 is shown there. The assembly 2 can be used in an implant 1 for in vivo implantation, such as, for example, those illustrated in FIGS. 9 - 12 or another implant. The assembly 2 includes two or more component parts 3, 4 that are movable relative to each other as shown in FIG. 1 by arrows. Each component part 3, 4 includes a porous portion 5, 6 (consisting of in this example) that is partially or completely porous and has a matrix 7, 8 of open cells 51, 61. For clarity, only the matrix is shown in FIG. 1, but it will become apparent that the elements 3, 4 may include other parts as shown, for example, in FIGS. 2 and 3.

[0014] In the example shown, in each of the matrices 7, 8, the rows have the same length, similar to columns, and thus the matrix has a cuboid shape. In this example, the open cells 51, 61 are similarly cuboids and more specifically cubes. However, the open cells 51, 61 may have different shapes as will be described in more detail below. The rows and columns may have different lengths such that the matrices 7, 8 have one or more non-planar sides and / or such that some sides are not perpendicular or parallel to other sides, such as in a parallelepiped shape.

[0015] The first matrix 7 of the first constituent element of constituent element 3 includes at least the first overlapping portion 50 which is in a form-closed connection with the second overlapping portion 60 of the second matrix 6 of the second constituent element of constituent element 4, the first overlapping portion 50 extending through the second overlapping portion 60. In this respect, the term "form-closed" refers to the German term "Formschluss," which is a connection between at least two connected elements formed by the interlocking shapes of the elements, and the connection cannot be broken by a lack of connecting force. In other words, in the case of a form-closed connection, the shapes of the connected elements are of a different nature, such that the connection cannot be broken without deforming the shape.

[0016] As indicated by the arrows in Figure 1, the overlapping portions 50 and 60 are movable relative to each other, changing the combined shape of the overlapping portions 50 and 60. For example, the combined shape can be expanded by moving the overlapping portions away from each other in a translational manner, contracted by moving the overlapping portions toward each other in a translational manner, or slightly tapered by rotating the overlapping portions.

[0017] Thus, the shape can be changed in various ways, and therefore, the assembly can be easily adapted to a wide variety of applications, rather than requiring specific solutions to modify the shape for a particular application. Although an assembly of biocompatible materials for in vivo implant applications is described below as an example, the structure of the assembly is also suitable for other applications, such as building materials. For example, the assembly may be scaled and dimensionally determined for other applications, for example, to several cubic decimeters or more. In such cases, the assembly can be made of non-biocompatible materials, such as weathering steel or other alloy steels.

[0018] In this example, changes in the combined shape of the overlapping portions 50 and 60 also change the combined shape of matrices 7 and 8. The first matrix 7 further includes a protruding portion 70 which may be movable to protrude more or less from the second matrix 8. As in this example, the second matrix may also include a protruding portion 80 which may be movable to protrude more or less from the first matrix 7. The overlapping portions 50 and 60 are movable to move the assembly from a first state to a second state. In the first state, the protruding portion 70 protrudes less from the second matrix than in the second state. In the second state, the protruding portion can be moved by rotation and / or translation in a direction away from the second matrix relative to the first state. Thus, to give a few examples, the shape of the implant can be adjusted, for example, to expand to fill the gap between the implant and the bone, or to tapere slightly to align the sides of the implant with the surface.

[0019] Alternatively, as illustrated in Figure 13, one of the matrices 7 and 8 can be incorporated inside the other matrix. In such a case, the matrices can move relative to each other by a movable form closed connection, for example, the incorporated matrix 7 can move the portion of the constitutive element 3 protruding from the other matrix 8, as indicated by the arrow. In this example, the protruding portion is a rod that forms a mechanical connection with matrix 7, but it is clear that more complex shapes may be used, and the protruding portion may be connected to the matrix by a joint.

[0020] As some examples, due to changes in shape, the parts attached to the overlapping parts 50, 60 can be moved relative to each other, for example, by moving away from each other and / or moving toward each other and / or rotating relative to each other. Thus, the assembly can be used as a joint or coupling or other mechanical connection between parts of an implant that must be movable relative to each other (i.e., movable by translation and / or rotation).

[0021] Furthermore, for example, if a tibial implant is placed in a wedge-shaped incision in the tibia from above the proximal region of the knee, its size may be expanded and its shape modified to fill the gap between the two surfaces. Next, the implant can be inserted into the incision, for example. After the implant is inserted into the tibial incision, the shape of the assembly is changed upward until the side of the implant contacts the incision surface. Next, the position of the components can be fixed. Also, for example, in a bifurcated stent, the shape can be changed by rotating the matrices relative to each other and rotating and moving the bifurcated ends relative to each other. Figure 9 shows an assembly 2 in which, for example, a first component is attached to a first plate 9 and a second component is attached to a second plate 10. Thus, the assembly forms a mechanical joint that allows plates 9 and 10 to move relative to each other. Thus, the plates can be placed so as to contact each other's surfaces and attached to each surface. Although a wide variety of attachments are possible, in this example, each plate has a body and slotted fingers that protrude at least partially away from the body in the same plane as the body. For example, screws can be inserted into the surface through the slots. In this example, although plates 9 and 10 are parallel to each other and face each other, it becomes clear that other orientations, such as oblique or perpendicular, are also possible.

[0022] In addition to its variable shape, the porous portion allows tissue to grow between the matrix. This allows, for example, the assembly to have osseointegration or to allow soft tissue to grow within the matrix. In other applications, such as when used in underwater structures in riverbeds or seabeds, sediment can be held inside the porous portion, and for example, the porous portion can provide a surface for invertebrates such as algae and mollusks to grow.

[0023] The constitutive elements can be implemented in any manner suitable for a particular implementation. As illustrated in Figure 2, at least one of the first and second constitutive elements may include solid portions 30, 40 attached to the overlapping portion. As shown in Figure 2, the solid portion may be separated from the overlapping portions 50, 60 of matrices 7, 8 by, for example, protruding portions 70, 80 of the matrix that protrude from the other matrix. The solid portion may also be part of a single integrated element that includes the matrix. Such an element has good mechanical strength.

[0024] Referring to Figure 3, the assembly or implant may further include a fixation device 11 for fixing the position and / or orientation of the first component relative to the second component. The fixation device may be adjustable in situ to adapt the shape of the implant to the object to which the implant may be provided. In this example, the fixation device is basic, including a nut 110 that extends through a slot in the first component and engages with a threaded hole 112 in the second component. By tightening the nut, the component elements 3, 4 are fixed in place. It will become clear that more complex fixations are possible, and that the fixation may be permanent or non-destructively releaseable. Depending on the specific application, for example, if it is necessary to bend the implant or otherwise adjust its shape while the implant is being used in vivo, movable mountings are similarly possible.

[0025] A form-closed connection may be any suitable type of form-closed connection. A form-closed connection may be permanent, meaning it cannot be released without destructively deforming the shape, or it may be temporary, meaning it can be released by non-destructively deforming the shape. In the example shown, a form-closed connection exists between an open cell of the first overlap and an open cell of the second overlap of the second matrix, with the first overlap extending through the open cell of the second overlap. In other words, the first matrix contains a number of connected open cells, each of which is form-closed but movable to one or more open cells of the second matrix. More specifically, in this example, the connected open cells of the first matrix extend through the second matrix, and more specifically, through the open cells of the second matrix, and are connected to the second matrix.

[0026] A form-closed connection between connected open cells is established in the following example: The first overlapping portion 50 includes the first open cell 51, the edge 52 of the first open cell 51 extending through the open surface 63 of the second open cell 61 of the second overlapping portion 60 and enclosing the edge 62 of the second open cell. Conversely, the second overlapping portion 60 includes the second open cell 61, the edge 62 of the second open cell 61 extending through the open surface 53 of the first open cell 51 of the first overlapping portion 50 and enclosing the edge 52 of the first open cell 51. Free space exists between the edges of the first and second open cells 51, 61 such that the connected cells can move relative to each other.

[0027] Depending on the specific application, the overlapping portions 50 and 60 may be movable relative to each other in one, two, or three dimensions. These portions may also be movable by translation and / or rotation. As a result, the constituent elements may have 1 to 6 degrees of freedom (DoF) of movement relative to each other. In this respect, the freedom of movement is, in principle, limited by the connections. However, if, for example, one or more, or all, of the matrices are deformable in one, two, or three dimensions, for example, elastically or plastically, the degrees of freedom extend beyond the limitations imposed by the connections.

[0028] Alternatively or additionally, one or more, for example, all, matrices may be rigid for practical purposes. If all matrices are rigid, the degrees of freedom of movement are limited to those provided by the form closed connection. However, as illustrated in Figure 4, a series of three or more matrices can be connected in an arrangement such as a chain, such that the overall degrees of freedom of movement at the end of the chain is the sum of the degrees of freedom of movement of the directly adjacent matrices. Such movement may be translational, as on the left side of Figure 4, and / or rotational, as on the right side.

[0029] Other arrangements of three or more matrices are possible, as illustrated in Figure 6. In Figure 6, for example, constitutive assembly 2 includes a central matrix 4 connected to an outer matrix 3 on different sides. Matrices 3 and 4 are movable by translation and / or rotation, as illustrated by the arrows in Figure 6. Thus, the outer matrix 3 has a greater degree of freedom of movement relative to each other than the degree of freedom of movement between the individual outer matrices and the central matrix.

[0030] The matrices and constituent elements may be implemented in any manner suitable for a particular implementation. One or more matrices, preferably each, may be, for example, a single element and may be made from a single piece of material. This provides a strong matrix that can withstand the forces that occur during and after implantation. Alternatively, one or more matrices may be made from multiple pieces attached to one another, for example, when it is to be possible for the matrix of interest to collapse during use.

[0031] The first matrix may be made from the same one or more materials as the second matrix, for example. This makes it possible to manufacture both matrices simultaneously, for example, using additive manufacturing equipment. Alternatively, the first matrix may be made from a different material than the second matrix. This makes possible, for example, a rigid first matrix and a flexible second matrix. One, two or more, or all of the matrices may be non-degradable in vivo or in situ. This makes possible permanent structures that provide mobility, for example, joints between mechanical connections.

[0032] Alternatively or additionally, one, two or more, or all of the matrix components may be biodegradable in vivo. This makes it possible, for example, to place a temporary implant or an implant with temporary components without requiring surgery to remove the implant. Also, for example, a biodegradable matrix can fill the gap between the non-degradable matrix and the tissue that will regrow, such as bone. This makes it possible, for example, to place the implant in a space larger than the implant itself and to expand the implant so that the biodegradable matrix fills the space between the non-degradable matrix and the edge of the gap. The biodegradable matrix can then disappear while the gap is being filled, for example, by tissue regrowth.

[0033] In the example shown, the first overlapping portion 50 and the second overlapping portion 60, and more generally, the matrix, contain open cells of a three-dimensional array of n × p × q, where n, p, and q are positive integers of at least 2. For example, (n and p) or (p and q) or (q and n) or (p, q, and n) may have the same value or different values. Any of n, p, and q may be any value from the group including 2, 3, 4, 5, at least 10, at least 20, at least 50, at least 100, at least 200, at least 500, or at least 1000, depending on the particular implementation. The three-dimensional array of the first overlapping portion extends through the three-dimensional array of the second portion.

[0034] One or more of the matrices may be arrays of unit cells, the unit cells forming a symmetrical pattern that repeats along the main directions of three-dimensional space. This array then forms a lattice structure constructed by the repeated translational movement of the unit cells along the principal axes. As illustrated in the examples in Figures 1-8, one, two or more, or all of the matrices may be formed by arrays of open unit cells, and may also have a lattice structure defined by the open unit cells. In such cases, the second matrix may be movable along the lattice planes of the lattice structure of the first matrix, as illustrated in Figure 5 by dotted lines L1-L3. Some or all of the matrices may have the same unit cells and lattice structure, or the matrices may have different unit cells and / or lattice structures. In the examples shown, the lattice planes of the first matrix are parallel to the lattice planes of the second matrix. The grid planes of the first and second matrices are arranged alternately, and the distance between parallel planes of the first matrix is ​​greater than the thickness of the edges of cells of the second matrix that extend parallel to the grid planes (and vice versa, between the planes of the second matrix and the edges of the first matrix). In this way, there is some play in moving the matrices relative to each other.

[0035] One or more of the matrices may be formed by an array of two or more species of unit cells. These species may differ in one or more of the following: type, cell size, porosity (also called openness), regularity, and uniformity. For example, Figure 7 shows an example of a matrix in which the size of the unit cells varies, more specifically increasing from one side to the other. Thus, the matrix includes a first segment having smaller unit cells 51 and a second segment having medium-sized unit cells 51' that are larger than the smaller unit cells. The matrix further includes a third segment having larger unit cells 51'' that are larger than the medium-sized unit cells 51'. As will be described in more detail below, Figure 8 shows an example of a matrix having unit cells with different porosity and different openness.

[0036] Alternatively or additionally, one, two or more, or all of the matrices 7 and 8 may be formed by an array of single-type unit cells, for example, as in the example in Figure 1. Open cells, more specifically, unit cells may have one or more geometric shapes, such as polyhedra, including convex polyhedra. Figures 14-18 show some examples of suitable shapes for cells 51 and 61 in addition to the cuboid or cubic unit cells in Figure 1, the examples shown being a rhombic unit cell 512, a rhombic dodecahedron unit cell 513, a truncated cube unit cell 514, a truncated octahedron 515, and a rhombic octahedron unit cell 516. Unit cells may also be triple-periodic minimal surfaces (TPMS) or Voronoi structures.

[0037] The average size of open cells can range from 0.1 to 0.8 mm, for example, from 0.05 mm to 1 mm, or from 0.25 mm to 0.75 mm. Depending on the specific implementation, cells may have different or the same size (for example, if the size is distributed according to a Gaussian or normal distribution). For example, at least 90% of the cells may have a size of 0.1 to 0.8 mm.

[0038] The porous portions 5 and 6 of the constituent elements 3 and 4 can be of any suitable type, and the first matrix 7 and the second matrix 8 may include or consist of, for example, open-cell solid forms. The forms may be made of, for example, biocompatible metals and may be open-cell metallic forms. Such forms may be, for example, self-forming structures and may form cells in a three-dimensional network. The open-cell metallic forms may be, for example, mesh solid forms, as shown in the example. The forms may also be regular or probabilistic forms. In the figure, for example, the form is a regular mesh form. The matrices may include or consist of a single type of metallic form, or similarly, they may include or consist of mixtures of forms, such as a mixture of mesh forms and partially or completely closed cells, such as closed-cell forms. For example, the mixture may consist of 50% or more mesh forms and 50% or less closed cells, and may have, for example, 90% or more mesh forms. For example, the mixture may have 99% or more mesh foam and 1% or less (but obviously not 0%) closed cells.

[0039] As illustrated in Figure 8, the porosity of one, two or more, or all of the matrices 7 and 8 may differ in one or more directions, such as increasing or decreasing. The increase or decrease may be stepwise or gradual. Porosity may increase or decrease monotonically in a certain direction, as in Figure 8, or porosity may fluctuate, increasing and decreasing (repeatedly) in the direction of fluctuation. In Figure 8, porosity changes in only one direction (e.g., length), but it becomes clear that the change can be applied in other ways (e.g., in two non-parallel directions or three perpendicular directions), such as from outside to inside, or along the longitudinal axis. The matrix may have, for example, one or more highly porous layers (or n×p×q segments) that may be more porous (and / or have larger (average) pore sizes), and one or more less porous layers (or n×p×q segments) that are less porous and / or have smaller pore sizes than the highly porous layers. This allows for, for example, the presence of low-porosity portions that are relatively rigid but still porous, while osseointegration is improved by the high-porosity portions. Thus, the rigidity of the constitutive elements can be adjusted in one or more directions.

[0040] For example, a highly porous layer may have a porosity of less than one of the groups including 95%, 85%, and 75%, or at least one of the groups including 70%, 80%, 90%, and less than 100%, or an equal porosity thereto. A low-porosity layer may have a porosity of at least 10%, at least 20%, at least 30%, at least 40%, for example at least 50%, at least 55%, or (naturally) greater than 0%. A low-porosity layer may have a porosity of a specific proportion smaller than that of a highly porous layer, for example at least one of the groups including 10%, 20%, and 30%, or an equal porosity thereto.

[0041] As shown, in these examples, the matrix also has pores on at least part of its open surface or on the outside, as well as a porous interior. In this example, the outer pores are located on the entire surface, and the matrix is ​​open on all sides. The porous interior is in fluid communication with the outer pores, allowing bone growth into the porous interior. For example, the internal and external pores can form an integrated network of porous cells. The porous outer surface of the matrix may have an openness of, for example, at least 5%, for example at least 10%, preferably at least 50%, for example at least 80%. The openness is, of course, less than 100%, and may be, for example, 90% or less, for example less than 70%. The openness is defined as the ratio of the total area of ​​the unclosed portions of the outer pores occupied on the outer surface to the total area of ​​the outer surface.

[0042] The assembly may be part of any type of implant for which matrix movement is suitable. Such implants may, for example, be sterilized and supplied in sterile packaging. The implant may be selected from the group including, for example, permanent prostheses, temporary prostheses, orthopedic implants, dental implants, spinal cages, stents, and combinations of two or more of such types. The implant may be an implant for in vivo implantation in one or more animals selected from the group including, for example, non-human animals, humans, domesticated animals, pets, and livestock.

[0043] Figures 10 and 11 show, as an example, portions 101 and 102 of a branched stent, such as a stent 100, more specifically for a coronary bifurcation lesion. As shown, each portion includes a tubular matrix having a hollow interior and an open end. Figure 10 shows a straight tube, and Figure 12 shows a curved tube. As illustrated in Figure 12, portions 101 and 102 can be connected to obtain a stent, such that the matrix has overlapping portions 50 and 60 having a form-closed connection. More specifically, portions 101 and 102 may be connected to each other at the respective connecting ends of the tubular shape. For example, two portions can be connected and extended in the same direction away from the overlapping portion to form a Y-shaped or T-shaped stent, as illustrated in the upper part of Figure 12. For example, two curved tube portions 102 can be connected in the manner shown in the example in the upper part of Figure 12. Alternatively, a curved tube portion 102 and a straight tube portion 101 may be connected in the manner illustrated in the lower left part of Figure 12. As illustrated on the right side of Figure 12, portions 101 and 102 may also be connected so as to extend in opposite directions away from overlapping portions 50 and 60. In such cases, a C-shaped stent can be obtained, for example.

[0044] Because of the movable form-closed connection, the free ends of the connected tubular sections can move relative to each other. Thus, for example, the free ends of a branched stent can be moved toward or away from each other, or, in the case of a C-shaped stent, the curvature can be adapted.

[0045] Typical dimensions of a stent can range from 5 mm to 50 mm in length (although other sizes are possible depending on the blood vessel or tube in which the stent will be placed). For example, lengths may be 8 mm or more, 15 mm or more, etc. Lengths may also be less than 40 mm, for example, less than 30 mm, etc. A suitable range for length is 8 to 38 mm. The diameter of the tube may be, for example, 2 to 10 mm. The minimum diameter may be, for example, 2.25 mm or more, 3 mm or more, etc. The maximum diameter may be, for example, less than 8 mm, less than 5 mm, 4 mm or less, etc.

[0046] The implants or assemblies described above, or further described in the section titled "Claims," ​​may be manufactured, for example, by using additive manufacturing techniques or by using a hybrid technique of additive and subtractive manufacturing. Such intermediate products may be formed by forming continuous layers of material under computer control, for example by selective laser melting or SLM. Figure 19 schematically shows a selective laser melting machine 200 suitable for use in forming intermediate products.

[0047] As shown, the SLM machine 200 in this example includes a laser 201 that generates a laser beam 203 that scans a powder bed 204 of selectively meltable material via a scanning optical system 203. These lasers direct the laser beam onto the exposed uppermost layer of the bed 204 according to a computer program that uses data representing a model of a dental implant as input, under the control of a computer, i.e., a programmable device that controls the optical system 203.

[0048] As can be seen more clearly on the right side of Figure 19, the laser selectively melts the top layer of powder in the molten region 300. After sintering the top layer in those regions, a new top layer can be applied. In this example, the powder bed 204 can be lowered by moving the building plate of the object, i.e., the plate 208 on which the intermediate product rests, in this example, downwards using the piston 207. The new top layer can be applied by moving the pile of powder upwards using the delivery piston 205 and covering the top surface by transferring the powder protruding over the edge of the delivery system with the roller 206. As shown in Figure 12, this continuous application of powder layers and the localized sintering of the powder result in a stacking of patterned layers of sintered material that forms the object.

[0049] Once the final layer is sintered, the object can be removed from plate 208, and the unsintered material can be removed. The intermediate product may then undergo post-processing, such as heat treatment for stress relief and tempering.

[0050] The SLM process has proven to enable the manufacture of complex structures in a manner that requires little to no post-processing. In particular, it allows for the manufacture of constitutive elements (or at least matrices 7, 8) as a single, form-closed and immediately movable relative to one another, without requiring further etching or removal of material to separate the matrices from each other. In the case of applications in implants, the surface roughness of the product is ideal for bone growth, and therefore it is further believed that the intermediate product is already suitable for use in the final product without requiring further surface treatment. However, it becomes clear that further steps may be applied before the product is transported, for example, to attach other parts of the implant to the assembly or to sterilize the product.

[0051] As another example, the manufacturing apparatus may be a casting apparatus, and the manufacturing process may include casting matrices 7, 8. In such a case, a portion of the first constituent element including the first overlapping portion, or the entirety of the first constituent element, can be cast in a mold having solids and voids of a first pattern corresponding to the first matrix. (During casting, it becomes apparent that the voids can be filled before casting with a material that disappears, for example, by melting, evaporating, or by other means.) This first casting may include filling the voids with the material of the first matrix. As a result, the pattern will include the first pattern, but will have voids and solids filled with the first matrix material. Next, a portion of the solids of the first pattern can be dissolved (i.e., dissolved in a suitable solvent, or melted and discharged like wax) to obtain solids and voids of a second pattern corresponding to the second matrix. For example, the solids corresponding to the second pattern may have a different composition from the other solids, for example, having a lower melting point and therefore being removed by heating while holding the other solids. Preferably, this process is resisted by the material of the first matrix, for example, by using a solvent in which the material is insoluble, or by melting the solid at a temperature below the melting temperature of the material. Next, the second overlapping portion can be cast, which may include filling the voids of the second pattern with the material of the second matrix. Then, the solid of the second pattern can be melted (i.e., by melting in a suitable solvent, or by melting and draining in the same way as wax) to obtain the first and second matrices having a form-closed connection.

[0052] The manufacturing process can use data representing a model of the implant or assembly. In such cases, the data can be loaded into a data processing device, such as an embedded control system or another type of computer that performs computer control, and the data processing device operates to control the formation by the manufacturing equipment to obtain the shape according to the data. The model can be obtained in any form suitable for a particular implementation. The design may be stored in a tangible data carrier so that data that can be loaded into a computer representing a model of the implant or assembly is stored therein.

[0053] Data representing an implant can be obtained by first generating a first model of a first constituent element on a data processing device, such as a computer on which computer-aided design software can be run. Similarly, a second model of a second constituent element can be generated on the same or a different data processing device. Next, data for the implant or assembly can be generated using the first and second models, which extend through the regions corresponding to the overlapping portions of the constituent elements. This data can then be transmitted to a manufacturing device.

[0054] The model can be designed by creating the first solid model of the first constituent element and the solid model of the second constituent element using a suitable computer-aided design (CDA) program such as SolidWorks or CATIA. Then, holes can be added to these models by adding a three-dimensional structure using software such as Autodesk Within Medical, Materize Magics, or Autodesk Netfabb Studio. This 3D structure can be created using the open unit cells described earlier, such as cuboid, rhombic, rhombic dodecahedron, and truncated octahedron cells.

[0055] Next, the two models can be combined to form the overall model. The combined model is then converted to a format suitable for 3D printing, such as the STL format.

[0056] Referring to Figure 20, as illustrated using blocks in the flowchart, the examples of assemblies and implants shown can be manufactured as illustrated therein by providing biocompatible material (block 90) and shaping the biocompatible material to obtain products or intermediate products (blocks 91-93). Biocompatible material can be shaped in various ways, such as by casting metal into a mold or by locally injecting gas to obtain a self-organizing porous structure.

[0057] The above-mentioned implant or assembly, and / or the portion following the heading "Claims," ​​can be manufactured as illustrated with the flowchart in Figure 20. The material can first be provided in the manufacturing apparatus, as illustrated with block 90 labeled "Providing Material." This material may be pre-formed, such as a block of metal or stone, or it may be unformed, such as a powder.

[0058] As illustrated using block 91, "Load Model," the manufacturing apparatus can receive data representing the implant or assembly to be manufactured.

[0059] As illustrated using block 92, “Generating Structures,” implants or assemblies can then be manufactured from materials according to data. These may be final products or intermediate products. For example, in the case of implants, the products may be at least sterilized and sterile-packaged after manufacturing, but other further processing may also be possible. For example, in the case of assemblies, other parts of the final product, such as mounting parts, can be added to the structure. These parts may be permanently attached or removable, and may be movable or immovable relative to the constituent assembly. Suitable modes of permanent and immovable attachment may be, for example, welding, bonding, or soldering.

[0060] In the foregoing, the present invention has been described with reference to specific examples of embodiments of the present invention. However, it will become apparent that various modifications and changes can be made therein without departing from the broader scope of the present invention as described in the appended claims.

[0061] For example, the overlapping matrix, or more generally, the implant, may be made of any suitable biocompatible material. The material may include, for example, metals, metal compounds, metal alloys, metal composites, polymers, ceramics, and combinations of materials from this group. Biocompatible materials may include metals from the group including titanium, tantalum, niobium, stainless steel, cobalt-chromium alloys, zirconia, or compounds, alloys, or composites thereof. Other suitable biocompatible materials may include polymers from the group including polyaryletherketones, polyetheretherketones, and polyetherketoneketones.

[0062] Similarly, where movement of an object (for example, relative to another object) is described, unless explicitly stated otherwise, this is a relative movement, and therefore, depending on the chosen reference frame, it becomes clear that the object may move relative to the observer while the other object is static, the other object may move while the object is static relative to the observer, or both objects may move relative to the observer, but in different ways.

[0063] Furthermore, where the term “data carrier” is used herein, it may refer to, for example, a tangible, non-temporary, computer-readable storage medium or a computer-readable transmission medium. These computer-readable media can be permanently, detachably, or remotely coupled to a computer. Computer-readable transmission media may include, to name a few, data transmission media such as wired or wireless transmission media.

[0064] Computer-readable storage media may include, for example, but are not limited to: magnetic storage media including disk and tape storage media; optical storage media such as compact disc media (e.g., CD-ROM, CD-R, etc.) and digital video disc storage media; non-volatile memory storage media including semiconductor-based memory units such as FLASH® memory, EEPROM, EPROM, ROM, etc.; ferromagnetic digital memory; MRAM; volatile storage media including registers, buffers or caches, main memory, RAM, etc.; and any number of these.

[0065] Furthermore, in the example, the matrix is ​​open on all sides. However, it will become clear that in some applications, one or more or all of the matrix may have one or more closed outer surfaces, and that, for example, some sides may be closed without any holes.

[0066] Furthermore, terms such as “front,” “rear,” “top,” “bottom,” “above,” and “below” in this specification and the claims are used for descriptive purposes, if any, and are not necessarily used to describe permanent relative positions. It should be understood that such terms are interchangeable under appropriate circumstances so that embodiments of the invention described herein may be operated in orientations other than those illustrated or otherwise described herein.

[0067] However, other modifications, variations, and alternatives are possible. Therefore, this specification and the drawings are to be considered illustrative rather than restrictive.

[0068] In the claims, no reference numerals enclosed in parentheses should be construed as limiting the claims. The term “including” does not exclude the existence of elements or steps other than those enumerated in the claims. Furthermore, indefinite articles such as “a” or “an” are defined as “one or more” when used herein. Also, the use of introductory phrases such as “at least one” and “one or more” in the claims should not be construed as meaning that the introduction of another claim element by the indefinite article “a” or “an” limits any particular claim having such introduced claim element to an invention having only one such element, even if the same claim includes the introductory phrase “one or more” or “at least one” and an indefinite article such as “a” or “an”. The same applies to the use of definite articles. Unless otherwise indicated, terms such as “first” and “second” are used to arbitrarily distinguish the elements represented by such terms. Thus, these terms are not necessarily intended to indicate a temporal or other priority of such elements. The mere fact that certain means are described in different claims does not mean that combinations of these means cannot be used advantageously.

[0069] List of reference numbers 1. Implant 2. Constitutive Assembly 3,4 Constituent elements 5,6 Porous part 7,8 Matrix 9,10 Plate 11 Fixation device 30,40 Solid parts 50,60 Overlapping part 51,61 Open Cells Edges of cells 52 and 62 53,63 Open surface 70,80 Protruding part 90 blocks 91 blocks 92 blocks 93 blocks 100 stents 101 Stent portion 102 Stent portion 110 Nut 111 slots 112 screw holes 200 SLM Machines 201 Laser 202 Laser beam 203 Scanning Optical System 204 Powder bed 205 Delivery Piston 206 Laura 207 Piston 208 Plate 300 molten area 511-516 Unit Cell Type

Claims

1. An assembly of at least two constitutive elements, wherein the at least two constitutive elements are movable relative to each other, and each constitutive element is at least partially porous and includes a porous portion having an open-cell matrix, A first matrix of the first constituent element among the constituent elements, which includes a first overlapping portion connected to at least a second overlapping portion of the second matrix of the second constituent element among the constituent elements, wherein the first overlapping portion and the second overlapping portion are movable relative to each other, thereby allowing the first constituent element and the second constituent element to move relative to each other; Includes, The first overlapping portion includes a first open cell, the first open cell having a shape with an edge and an open surface defined by the edge, the second overlapping portion includes a second open cell, the second open cell having a shape with an edge and an open surface defined by the edge, the edge of the first open cell extending through the open surface of the second open cell and enclosing the edge of the second open cell, the edge of the second open cell extending through the open surface of the first open cell and enclosing the edge of the first open cell, An implant for in vivo implantation, wherein the first overlapping portion comprises open cells of a three-dimensional array having at least two layers of the first open cells in each of the three dimensions, and the second overlapping portion comprises open cells of a three-dimensional array having at least two layers of the second open cells in each of the three dimensions.

2. The implant according to claim 1, wherein the overlapping portions are movable relative to each other in one, two, or three dimensions.

3. The implant according to claim 1 or 2, wherein the first matrix further includes a protruding portion, the protruding portion being movable so as to protrude more or less from the second matrix, and the overlapping portion being movable so as to move the assembly from a first state to a second state, in which case the protruding portion protrudes less from the second matrix than in the second state.

4. The implant according to claim 3, wherein in the second state, the protruding portion is translated and / or rotated in a direction away from the second matrix relative to the first state.

5. The implant according to any one of claims 1 to 4, wherein at least one of the first and second constituent elements further comprises a solid portion attached to the overlapping portion.

6. The implant according to any one of claims 1 to 5, wherein at least one of the matrices is formed by an arrangement of at least two types of unit cells, the types differing in at least one of type, cell size, porosity, regularity, and uniformity.

7. The implant according to any one of claims 1 to 6, further comprising a fixing device for fixing the position and / or orientation of the first constituent element relative to the second constituent element.

8. The implant according to claim 7, wherein the fixing device is adjustable in situ to adapt the shape of the implant to the object to which the implant is provided.

9. The implant according to any one of claims 1 to 8, wherein the implant is an implant of a type selected from the group including a permanent prosthesis, a temporary prosthesis, an orthopedic implant, a dental implant, a spinal cage, a stent, and a combination of at least two of such types.

10. An implant according to any one of claims 1 to 9 for in vivo implantation in at least one selected from the group including non-human animals, humans, domesticated animals, pets, and livestock.

11. A method for manufacturing an implant according to any one of claims 1 to 10, In the manufacturing apparatus, the steps include receiving data representing the implant, A method comprising the step of manufacturing the implant according to the aforementioned data.

12. A step of generating a first model of the first constitutive element, The steps include generating a second model of the second constitutive element, A step of generating data representing the implant in the region corresponding to the overlapping portion of the constituent elements, where the first model and the second model extend through each other; The steps include transmitting the data to the manufacturing apparatus, The method according to claim 11, including the method described above.

13. A program causing a programmable device to perform the manufacturing method according to claim 11 or 12, the program causing the device to generate a shape according to a model representing an implant according to any one of claims 1 to 10.

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