3D PRINTED IMPLANT WITH INTERNAL CHANNELS
20210267742 · 2021-09-02
Inventors
- Mohit Prashant Chhaya (Leipzig, DE)
- Arpita Desai (Leipzig, DE)
- Navid Khani (Leipzig, DE)
- Sara Lucarotti (Leipzig, DE)
Cpc classification
B33Y10/00
PERFORMING OPERATIONS; TRANSPORTING
B29C64/386
PERFORMING OPERATIONS; TRANSPORTING
A61F2002/0081
HUMAN NECESSITIES
B33Y50/00
PERFORMING OPERATIONS; TRANSPORTING
A61F2/0077
HUMAN NECESSITIES
A61L27/18
HUMAN NECESSITIES
C08L67/04
CHEMISTRY; METALLURGY
A61L27/18
HUMAN NECESSITIES
A61L27/58
HUMAN NECESSITIES
B33Y80/00
PERFORMING OPERATIONS; TRANSPORTING
C08L67/04
CHEMISTRY; METALLURGY
B29L2031/7532
PERFORMING OPERATIONS; TRANSPORTING
International classification
A61F2/00
HUMAN NECESSITIES
B29C64/386
PERFORMING OPERATIONS; TRANSPORTING
B33Y50/00
PERFORMING OPERATIONS; TRANSPORTING
Abstract
An implant for insertion into a patient is provided. The implant includes a three-dimensionally printed structure of layers. Each layer comprises an infill pattern of the three-dimensionally printed structure, the infill pattern of each layer comprising a set of infill lines. The implant includes a plurality of hollow channels. The layers are arranged on top of one another such that the plurality of hollow channels are formed within the implant, wherein the walls of each channel are formed by sections of the infill lines of a plurality of layers of the printed structure of layers. At least one hollow channel extends between a first outer surface of the implant and a second outer surface of the implant. At least one hollow channel is oriented in a direction which is tilted with respect to a reference axis perpendicular to the first outer surface of the implant.
Claims
1. Implant (16, 33, 52, 61, 62) for insertion into a patient, wherein the implant comprises: a three-dimensionally (3D) printed structure of layers (71, 72, 101), wherein each layer (71, 72) comprises an infill pattern (76, 77) of the three-dimensionally printed structure, the infill pattern (76, 77) of each layer comprising a set of infill lines; and a plurality of hollow channels (21) comprising walls, wherein the layers (71, 72) are arranged on top of one another such that the plurality of hollow channels (21) are formed within the implant, wherein the walls of each channel (21) are formed by sections of the infill lines of a plurality of layers of the printed structure of layers, wherein at least one hollow channel (21) of the plurality of hollow channels (21) extends between a first outer surface of the implant and a second outer surface of the implant, wherein the at least one hollow channel (21) is oriented in a direction (53) which is tilted with respect to a reference axis perpendicular to the first outer surface of the implant.
2. Implant of claim 1, wherein the first outer surface of the implant and the second outer surface are opposite-facing surfaces.
3. Implant of claim 1, wherein the first outer surface is parallel to a two-dimensional plane formed by a first layer of the three-dimensional (3D) printed structure.
4. Implant of claim 1, wherein the first outer surface is the largest planar surface of the implant.
5. Implant of claim 1, wherein an angle between a longitudinal axis of a channel and the reference axis lies between 10 degrees and 85 degrees.
6. Implant of claim 1, wherein the three-dimensionally (3D) printed structure of layers (71, 72, 101) comprises a first batch of layers and a second batch of layers, wherein the first batch of layers comprises odd-numbered layers of the three-dimensionally (3D) printed structure of layers, and wherein the second batch of layers comprises even-numbered layers of the three-dimensionally (3D) printed structure of layers, wherein the infill lines of the first batch of layers are oriented in a first direction, and wherein the infill lines of the second batch of layers are oriented in a second direction different to the first direction, wherein portions of the infill pattern of the odd-numbered layer of the first batch of layers are shifted with respect to portions of the infill pattern of a first infill layer of the first batch of layers.
7. Implant of claim 6, wherein portions of the infill pattern of the even-numbered layers of the second batch of layers are shifted with respect to portions of the infill pattern of a first infill layer of the second batch of layers.
8. Implant of claim 6 or 7, wherein a lateral offset value between a first infill line (102.sub.11) of a first odd-numbered layer and a first infill line (102.sub.31) of a second odd-numbered layer lies between 0% and 50% of a distance between the first infill line (102.sub.11) of the first odd-numbered layer and a second adjacent infill line (102.sub.12) of the first odd-numbered layer.
9. Implant of claim 6 or 7, wherein a lateral offset value between a first infill line (102.sub.11) of a first odd-numbered layer and a first infill line (102.sub.31) of a second odd-numbered layer lies between 50% and 100% of a distance between the first infill line (102.sub.11) of the first odd-numbered layer and a second adjacent infill line (102.sub.12) of the first odd-numbered layer.
10. Implant of claim 1, wherein the plurality of hollow channels converges towards a predefined region (97) at the first outer surface or at the second outer surface of the implant.
11. Implant of claim 10, wherein the predefined region (97) is a point of a convergence located beyond the first outer surface or beyond the second outer surface of the implant.
12. Implant of claim 1 or 10, wherein at least one hollow channel is a tapered channel.
13. Implant of claim 12, wherein the tapered channels are configured such that a size of openings of the channels on a bottom surface of the implant is in the range of 5-10 mm and the size of the openings of the channels on a top surface of the implant is in the range of 0.5-5 mm.
14. Implant of claim 1, wherein at least one hollow channel of the plurality of hollow channels comprises a first opening at the first outer surface of the implant and a second opening at the second outer surface of the implant.
15. Implant of claim 1, wherein at least one hollow channel of the plurality of hollow channels comprises a tilted portion and at least one non-tilted portion, wherein the non-tilted portion of the channel comprises one or more outer-most layers of the implant.
16. Implant of claim 15, wherein the non-tilted portion of the at least one hollow channel is located between an opening of the channel at the first outer surface of the implant or at the second outer surface of the implant, and the tilted portion of the at least one hollow channel.
17. Implant of claim 1, wherein more than two hollow channels of the plurality of hollow channels may be tilted with respect to the reference axis by the same angle.
18. Implant of claim 1, wherein at least 10% of the hollow channels of the plurality of hollow channels may be tilted with respect to the reference axis by the same angle.
19. Implant of claim 1, wherein the three-dimensionally (3D) printed structure of layers (71, 72, 101) comprises a first batch of layers and a second batch of layers, wherein the first batch of layers comprises odd-numbered layers of the three-dimensionally (3D) printed structure of layers, and wherein the second batch of layers comprises even-numbered layers of the three-dimensionally (3D) printed structure of layers, wherein a first wall of a hollow channel is formed by sections of a plurality of odd-numbered layers of the first batch of layers, and wherein a second wall of the hollow channel is formed by sections of a plurality of even-numbered layers of the first batch of layers.
20. Implant of claim 1, wherein the infill pattern of each layer is bound by a perimeter (78), such that when the layers are arranged on top of one another, the implant has a 3D form.
21. Implant of claim 1, wherein the infill pattern of each layer comprises a print material meandering continuously from a start point (74) of the layer to an end point of the layer (75).
22. A method for forming an implant, the method comprising: sequential printing layers to form a three-dimensionally (3D) printed structure, wherein each layer is printed according to an infill pattern, the infill pattern of each layer comprising a set of infill lines, wherein the layers (71, 72) are printed on top of one another such that a plurality of hollow channels (21) comprising walls are formed within the implant, wherein the walls of each channel (21) are formed by sections of the infill lines of a plurality of layers of the printed structure of layers, wherein at least one hollow channel (21) of the plurality of hollow channels extends between a first outer surface of the implant and a second outer surface of the implant, wherein the at least one hollow channel (21) is oriented in a direction (53) which is tilted with respect to a reference axis perpendicular to the first outer surface of the implant.
23. The method of claim 22, further comprising: of a layer to be formed at a first height, wherein the first pore is represented by a first line segment; and specifying a pore dimension of a second pore of a layer to be formed at a second height, wherein the second pore is represented by a second line segment, the first pore and the second pore belonging to the same channel to be formed.
24. The method of claim 23, further comprising determining a point of convergence of the channels to be formed by calculating a first orientation line by connecting left end points of a first line segment and a second line segment; calculating a second orientation line by connecting right end points of the first line segment and the second line segment, the direction vector lying on the second orientation line; and calculating an intersection of the first and second orientation lines to determine the point of convergence of the channels to be formed.
25. The method of claim 24, wherein the point of convergence lies outside the first outer surface or outside the second outer surface of the implant to be formed.
Description
BRIEF DESCRIPTION OF DRAWINGS
[0055]
[0056]
[0057]
[0058]
[0059]
[0060]
[0061]
[0062]
[0063]
[0064]
[0065]
[0066]
[0067]
[0068]
[0069]
DETAILED DESCRIPTION OF THE INVENTION
[0070] In
[0071] In
[0072] A schematic channel 21 of the implant 16 (marked by a dashed circle) is shown on the left side of
[0073] In 3D printing, the layers of printed material are stacked on top of one another. Therefore, the easiest and fastest way to create porosity is to print constant channels in the z-direction, i.e. channels having the same cross-section at any level (height) of the channel. Such configurations of implants have been shown in
[0074] In the right column, an implant 33 according to various embodiments is shown with a form corresponding to the projected form 31. As can be seen from the different views, the channels 21 extend from the bottom surface of the implant 33 to its top surface and are slanted/skewed. In other words, the orientation of the channels 21, denoted by the second arrow 38 does not coincide with the print direction which is denoted by the first arrow 37, such that the first arrow 37 representing print direction forms and angle with the second arrow 38 representing the orientation of the channels 21 with the angle being different from zero. The orientation of the channels may be chosen according to need, i.e. in accordance with a preferred site of fat injection and/or in accordance with mechanical requirements of the implant 16. As can be seen by comparing the side views 36 of the conventional implant 32 and the implant 33 according to various embodiments, the top openings 27 of the latter do not overlay the bottom openings 28 of the channels 21 when viewed from top in the direction corresponding to the print direction, i.e. the first arrow 37.
[0075] In
[0076]
[0077] In addition to the slant, the channels 21 are tapered, i.e. have a form which was already explained in detail based on
[0078] As already described above, the exemplary embodiment of the implant 52 shown in
[0079] Oriented pores/channels in an implant which is a printed porous structure may be further advantageously used to reduce the stiffness of the overall structure in the printing direction. The angle of orientation or the angle of convergence, i.e. the angle between the xy-plane (plane of printing) and the orientation direction or the focus direction, respectively, makes that stiffness tunable. In general, the smaller the angle of convergence, the softer the structure. This concept is further exemplified in
[0080] As already outlined above, the implant according to various embodiments is manufactured by sequential printing of the layers. In
[0081] After the second layer 72 has been printed on top of the first layer 71, a third layer is deposited on the second layer. The third layer (not shown in
[0082] Further provided herein is a method for generating a printing path of a 3D printer for printing a porous object comprising channels extending through the porous object, such as the 3D implant described herein. The channels of the porous object are formed by pores comprised by layers printed during the manufacture of the porous object. The generated printing path comprises a set of path points along which the printing nozzle of the 3D printer is moved in order to print the layers of material, one by one, to ultimately manufacture the 3D implant.
[0083] In a first step, the method for generating a printing path according to various embodiments comprises decomposing the 3D model of the porous object (3D object) into a set of layers, each layer comprising a contour of the 3D model at a corresponding height of the 3D model, the height being aligned with the print direction. The first step may thus include infill of the 3D model into slices, each slice representing a printing layer. During printing, each layer is manufactured by extruding print material from the printer's nozzle along a printing path. Usually, the individual planes are parallel to the print surface on which the 3D object is printed which is assumed to correspond to the xy-plane. The layers are manufactured by extruding print material on top of each other in the print direction which is assumed to correspond to the z-direction. The overall extrusion of the layers generally takes place in a crisscross pattern, such that filaments of one layer are extruded on the filaments of the previous layer at a certain angle, most commonly 90°. The aim of this first step of the method which corresponds to the design/planning phase is the generation of layers, each layer containing the contour of the 3D model at a corresponding height of the 3D model. The structure of the inside of each layer is a design parameter and may be chosen later on according to needs of the respective application.
[0084] In a further step the method includes intersecting one or more layers in the set of layers with a set of infill lines, wherein the distance between the infill lines for each layer is set to correspond to the dimension of the pores in that layer in a direction perpendicular to the infill lines. By intersecting a layer with a set of infill lines, the layer is segmented into stripes, with two opposing sides simply corresponding to portions of two adjacent infill lines and the other two opposing sides representing portions of the contour of the layer. The infill lines preferably correspond to representations of portions of material which are extruded during the printing process. The two opposing sides representing portions of the contour of the layer may be approximated by straight lines during the printing process, wherein the straight lines extend between the corresponding edges of the stripe. In some embodiments, the infill lines may be equidistant, thus leading to homogenously sized pores within the layer.
[0085] In a further step of the method, the printing path is formed for the one or more layers (which has been “sliced” in the previous step) on the basis of the intersections between the set of infill lines and the contour of the corresponding layer. In that sense, the infill lines may be also referred to as searching lines as they are used to search for the intersections thereof with the contour of the layer. Preferably, the printing path of a given layer may consist of the intersections arranged in such an order that, during printing of the 3D object, the nozzle will be moved along the printing path in a meandering manner, from one intersection to the next, and extrude print material continuously from a start point to an end point of the layer. It is noted that while a respective layer substantially comprises the contour and the calculated intersections all lie on the contour of the layer, the material layer of the 3D object which is extruded on the basis of the calculated intersections may comprise an intermittent representation of the contour of the layer and an infill comprising straight lines of print material (which correspond to infill lines), as shown in
[0086] In a further step of the method, the previous two steps (i.e. infilling the layers and forming printing paths) are performed with regard to one or more layers lying on those layers which have been processed so far (previously) and using a set of infill lines for that purpose which are arranged at an angle, preferably at 90°, to the set of infill lines that have been used for the layers processed so far (previously). The separation of the layers of a 3D object into two two batches of layers reflects the criss-cross nature of the printing process. It is noted that the criss-cross pattern is formed by repeatedly depositing one or more (a) infill lines in a first direction, then depositing one or more (b) infill lines in another direction, the other direction oriented at an angle, preferably 90°, to the first direction, and then by repeating the process at least one time, preferably multiple times. In that manner, by adjusting the number of layers in each batch, the height of the walls of the pores may be varied from one layer to the next. In the special case of a=b, the criss cross pattern is formed by an infill pattern of the 3D model, where every other infill line is oriented in the first direction, with single infill lines being arranged in between and oriented in the second direction being different from the first direction (see
[0087] According to further embodiments of the method, in case of constant channels (see
[0088] According to further embodiments of the method, a first line of the set of lines used for a layer of one batch of layers may be laterally offset with respect to a first line of the set of lines used for an adjacent layer. This may also be the case for all the other lines in the sets used for adjacent layers. The position of the first infill line in a respective layer may correspond to the intersection line between a boundary plane of the 3D model and a plane in which the layer is embedded. The 3D model may be bound by three boundary planes, wherein one plane may correspond to the plane in which the bottom layer of the 3D model is embedded. The cross-sectional shape of the confining region of the 3D model may be triangular, e.g. when viewed in the xz-plane in the 3D model representation coordinate system.
[0089] According to further embodiments, the method may further include steps aiming at determining a confining region for the 3D model. Accordingly, the method may further include intersecting the representation of the 3D model of the porous object with a plane to form a working plane and performing subsequent steps in the working plane. The working plane, without loss of generality, may correspond to the xz-plane in the 3D model representation coordinate system, with the origin of the coordinate system being located at the projection of the center of mass of the 3D model on the bottom surface or at the center of the bottom layer of the 3D model, for example. The method may further include specifying a pore dimension of a first pore in a layer at a first height, preferably at a base (bottom surface) of the 3D model, represented by a first line segment (which lies in the working plane). The method may further include specifying a pore dimension of a second pore in a (different) layer of the porous object at a second height of the 3D model, represented by a second line segment (which also lies in the working plane), the first pore and the second pore belonging to the same channel. The pore dimensions of the first and second pores may correspond to the distances between the lines used for infill of the respective layers. The method may further include calculating a first orientation line by connecting left end points of the first and second line segments and calculating a second orientation line by connecting right end points of the first and second line segments. The method may further include calculating an intersection of the first and second orientation lines. That intersection corresponds to a point of convergence of walls associated with the respective pores in the case of non-constant channels, i.e. diverging or converging channels. The point of convergence lies above the xy-plane for converging channels or below the xy-plane for diverging channels, with the base or bottom layer of the 3D model being embedded in the xy-plane. The method may further comprise choosing a main orientation line which corresponds to that one of the first and second orientation lines which has a smaller distance to the center of the base of the 3D model or to the projection of the center of mass on the base of the 3D model. The method may further include varying the slope of the main orientation line to determine a first boundary line and a second boundary line, both running through the intersection (point of convergence) and being tangential to the 3D model. Both the first and the second boundary lines may each be expanded to a corresponding boundary plane (tangential plane) which is arranged at an angle, e.g, perpendicularly, to the xz-plane. Finally, the method may include confining the region in which intersections between the contour of a layer and the set of infill lines are determined to the region bound by the intersection between a plane comprising that respective layer and the first and second tangential planes.
[0090] In the following, an exemplary embodiment of the method will be described. In
[0091] In addition to the user defined geometric information {G} with regard to the outer shape of the 3D model 81 channel direction vector {right arrow over (V.sub.d)}, the present method may receive the following input parameters from a user:
[0092] D.sub.n: diameter of the nozzle of the 3D printer,
[0093] LT: layer thickness, i.e. thickness of the strands of the material deposited by the nozzle, with the boundary condition LT<D.sub.n,
[0094] Pore.sub.b: pore size at the base of the 3D model 81,
[0095] Pore.sub.u: pore size at a user defined height h.sub.u,
[0096] h.sub.u: user defined height at which the pore size Pore.sub.u is specified.
[0097] At least a subset of the user defined parameters may be used to calculate the point of convergence of walls which define the channels of the 3D model 81. This will be explained on the basis of
[0098] After the nature of the channels has been determined, the 3D model 81 of the porous object shown in
[0099] In the next step illustrated in
[0100] In more detail, the 3D object 81 is presented as set of S layers 101, {L.sup.s}.sub.s=1, . . . , S, and each layer L.sup.s at the respective height of h contains geometrical information G, primarily the form of the contour of the layer (circular, oval, etc). Each layer L.sup.s can be defined as a set of contours, L.sup.s={CO.sub.q.sup.s}, q=1, . . . , Q Each contour CO.sub.q.sup.s is a closed curve which represents the external boundaries of the 3D model 81 at the level of the respective layer L.sup.s. The deposition of print material over layer s is represented by the preferably parallel infill lines {l.sub.a.sup.s}, a=1, . . . , A. As already mentioned, the distance between the infill lines l.sub.a.sup.s is set to correspond to the size of the pores of a respective layer at the corresponding height h.sub.s. The starting position of the first line l.sub.1.sup.s may be defined by the intersection line of a tangential plane with a plane in which the respective layer is embedded. This aspect will be explained in more detail later on. An ordered set of points {P.sub.t.sup.s}, t=1, . . . , T is generated for path planning of the 3D printing by arranging the intersections 104 in an ordered manner, as already explained. These points P.sub.t.sup.s form the printing path which the nozzle of the 3D printer follows during 3D printing.
[0101] In case of non-constant channels, i.e. convergent or divergent channels, the size of pores changes gradually from one layer to the next. At the same time, the number of pores is equal for all the layers L.sup.s, also in the case of constant channels.
[0102] The number of infill lines 102 should be as small as possible in order to reduce the required computational time. In order to do so, the relevant region in which the infill lines 102 are arranged can be restricted, e.g. by calculation of two bounding planes. The calculation of the bounding planes is explained in
[0103] The scenario for convergent channels is analogous to the one shown in
[0104] The pore size Pore.sub.s at any s-th layer 101 can be defined by first calculating the number of pores N in the first layer (bottom layer):
N=(X.sub.max−X.sub.min)/Pore.sub.b
[0105] Then, by using the calculated number of pores N, which for reasons of consistency remains constant for all the layers of the 3D model, the pore size Pore.sub.s at the s-th layer can be determined:
Pore.sub.s=(X.sub.max−X.sub.min).sup.s/N
[0106]
[0107] The implant 1330 comprises a three dimensionally (3D) printed structure of layers 101. Each layer 101 comprises an infill pattern (as described in connection with
[0108] The first outer surface 138 of the implant may be the largest planar (flat) surface of the implant. For example, the first outer surface 138 may be a flattest surface of the implant and/or surface with the least amount of curvature. The first outer surface 138 may be the bottom surface, which may be the surface of the implant facing, or closest to the chest-wall of the patient after insertion into the patient. The first outer surface of the implant may be parallel to a two-dimensional (x-y) plane formed by a first layer (or one or more layers) of the three-dimensional (3D) printed structure. The cross-sectional side view of
[0109] Additionally, or optionally, the second outer surface 139 may be a non-coincident (e.g. non-intersecting) surface to the first outer surface 138. The second outer surface 139 may be a side surface of the implant, or a top surface of the implant. Optionally, the first outer surface 138 of the implant and the second outer surface 139 may be opposite-facing surfaces. For example, the first outer surface of the implant may be a bottom surface, and the second outer surface may be a top surface. Optionally, the second outer surface 139 may be a curved surface of the implant. A channel 21 (or a projection, or extension of the channel 21) may terminate at the second outer surface 139, defining a point of intersection between the channel 21 and the second outer surface 139. A tangential plane at the point of intersection between the channel 21 and the second outer surface 139 may be non-parallel to the x-y plane.
[0110] The tilt-to-reference angle, a, may be defined as the angle between the reference axis 137 and the central longitudinal axis 141 of a channel 21. The reference axis 137 may be perpendicular to the x-y planes of the layers (e.g. perpendicular to majority of the layers, e.g. perpendicular to more than 50% of the layers). For example, the reference axis 137 may be parallel to the z-axis. For example, the reference axis 137 may be perpendicular to a plane formed by the first outer surface 138 of the implant. The tilt-to-reference angle, a, may lie between 10 degrees and 85 degrees (or e.g. between 45 degrees and 85 degrees), in the cross-sectional side view of the implant 1330, the cross-sectional side view being perpendicular to the x-y plane.
[0111] The central longitudinal axis 141 of a channel 21 may be a central longitudinal axis of symmetry which may be a straight line lying at the mid-points of the infill-lines forming the walls 134 of the channel 21. Optionally, in the case of non-tapered channels, the central longitudinal axis 141 may be parallel to each of the walls 134 of the channel 21.
[0112] At least one hollow channel 21 (e.g. one or more hollow channels 21) extends between a first outer surface 138 of the implant and a second outer surface 139 of the implant. Optionally, more than 30% (or e.g. more than 50%, or e.g. more than 80%, or e.g. each) of the hollow channels 21 extends between the first outer surface 138 and the second outer surface 139. “Extending between the first outer surface 138 and the second outer surface 139” may be understood to include examples even if the channels 21 do not terminate directly at the surfaces. For example, “extending between the first outer surface 138 and the second outer surface 139” may include examples wherein the channels 21 terminate (one or more layers) before reaching the first outer surface 138 and the second outer surface 139, in other words, where the openings of the channels 21 are not necessarily formed at the outer-most layers of the implant. In some examples, it may be possible that the channel 21 includes a slanted (tilted) portion and at least one non-tilted portion. A non-tilted portion of the channel 21 may be a portion which is parallel to the reference axis (e.g. the tilt-to-reference angle is zero). For example, a (first) non-tilted portion may have an opening at the first outer surface of the implant. The tilted portion of the channel 21 may be located between the first non-tilted portion and optionally a second non-tilted portion having an opening at the second outer surface of the implant. A non-tilted portion of the channel 21 may be formed from one or more (e.g. a plurality) of the outer-most layers of the implant at the first outer surface of the implant or the second outer surface of the implant.
[0113] “Extending between the first outer surface 138 and the second outer surface 139” may also include examples, wherein at least one end of the channel terminates at an outermost layer of the implant. For example, a channel 21 may extend completely from the first outer surface 138 to the second outer surface 139. For example, the channel 21 originates at the first outer surface 138 and terminates at the second outer surface 139. It may further be understood that it is possible that not all the hollow channels 21 originate from the first outer surface 138 and terminate at the second outer surface 139. For example, it is possible that some of the channels 21 (or extrapolations of the channels) at the side of the implant do not originate at the first outer surface 138.
[0114] At least 10% (or e.g. at least 20%, or e.g, at least 30%, or e.g. at least 50%, or e.g. all) of the hollow channels of the plurality of hollow channels may be tilted with respect to the reference axis by the same tilt-to-reference angle. Hollow channels having the same tilt-to reference angle may be aligned in the same direction, and the magnitude of the tilt-to-reference angle may be the same. Alternatively or optionally, more than two hollow channels (or e.g. more than 3 hollow channels, or more than 5 hollow channels) of the plurality of hollow channels may be tilted with respect to the reference axis by the same tilt-to-reference angle. In the case of the tilted constant channels, the tilt-to-reference angle may be the same for each of the channels. In other words, all the hollow channels of the implant may be parallel to each other, ignoring deviations due to manufacturing imperfections.
[0115] Optionally, at least one hollow channel (or e.g. one or more or all of the hollow channels) may be a tapered channel. Optionally, the plurality of hollow channels may converge towards a predefined region at the first outer surface or at the second outer surface of the implant. In some embodiments, the predefined region may be point of convergence located directly on the first outer surface or directly on the second outer surface of the implant. Alternatively, the predefined region may be a point of a convergence located beyond (outside) the first outer surface or beyond (outside) the second outer surface of the implant. In other words, the point of convergence may be located outside the implant (as described in connection with
[0116]
[0117] The three-dimensionally (3D) printed structure of layers may include a first batch of layers and a second batch of layers. The first batch of layers may include odd-numbered layers of the three-dimensionally (3D) printed structure of layers, and the second batch of layers may include even-numbered layers of the three-dimensionally (3D) printed structure of layers.
[0118] The infill lines of the first batch of layers may be oriented in a first direction, and the infill lines of the second batch of layers may be oriented in a second direction different to the first direction. Portions of the infill pattern of the odd-numbered layer of the first batch of layers may be shifted with respect to portions of the infill pattern of a first infill layer of the first batch of layers. Additionally, or optionally, portions of the infill pattern of the even-numbered layers of the second batch of layers may be shifted with respect to portions of the infill pattern of a first infill layer of the second batch of layers.
[0119] Each odd-numbered layer of the plurality of layers of the 3D printed structure may include a first infill line 102.sub.y1 and a second infill line 102.sub.y2 which may be parallel to and directly adjacent to the first infill line 102.sub.y1, of the odd-numbered layer. By way of example, the odd-numbered layers may refer to layer 1, layer 3, layer 5 and so on, or generally by the formula layer n+2*(t), where t is an integer greater than or equal to 0. t may be, but is not limited to being, an integer which lines between 30 and 200, for example. As shown in
[0120] A lateral pore dimension (pore.sub.1) may be a distance 103 between a first infill line 102.sub.11 of the first odd numbered-layer (layer 1) and a second adjacent (directly subsequent) infill line 102.sub.12 of the first odd-numbered layer. The distance 103 may be measured in a direction (x-direction) perpendicular to a central longitudinal axis 131 of the first infill line 102.sub.11 of the first odd-numbered layer and/or to the central longitudinal axis 132 of the second infill line 102.sub.12 of the first odd-numbered layer. The central longitudinal axis 131 of the first infill line 102.sub.11 of the first odd-numbered layer may be an axis parallel to the length of the first infill line 102.sub.11 (e.g. parallel to the y-axis) of the first odd-numbered layer. The central longitudinal axis 132 of the second infill line 102.sub.12 of the first odd-numbered layer may be an axis parallel to the length of the second infill line 102.sub.12 of the first odd-numbered layer.
[0121] A lateral offset value, ov, may be defined as the smallest distance between the central longitudinal axis 131 of a first infill line of the first odd-numbered layer and a central longitudinal axis 133 of a first infill line 102.sub.31 of the second odd-numbered layer (e.g. layer n+2=3). The central longitudinal axis 133 of the first infill line 102.sub.31 of the second odd-numbered layer may be an axis parallel to the length of the first infill line 102.sub.31 (e.g. parallel to the y axis) of the second odd-numbered layer. The lateral offset value, ov, may be a dimension measured in a horizontal direction, parallel to the layer (e.g. parallel to the x-axis).
[0122] The lateral offset value, ov, may be larger than zero and less than 50% (or e.g. less than 30%, or e.g. less than 10%, or e.g. less than 5%, or e.g. less than 1%) of the pore size, 103 (or pore.sub.1), of the first pore of the first layer (layer 1), ignoring deviations due to manufacturing imperfections.
[0123] The infill lines 102 of the plurality of odd-numbered layer of the channel 21 may be arranged, so that the portion of an infill line 102.sub.11 of an odd-numbered layer (e.g. layer 1) forming part of the wall 134.sub.1 of the hollow channel 21, may be offset with respect to the nearest (or closest), parallel infill line 102.sub.31 of the adjacent odd-numbered layer (e.g. layer 3) forming part of the same wall 134.sub.1 of the same hollow channel 21 by the lateral offset value, ov. By way of example, a portion of an infill line of the n+2*(1) layer may be offset with respect to the nearest (or closest), parallel infill line of the n layer by the lateral offset value, ov. A subsequent odd-numbered layer, n+2*(2) may be offset with respect to the nearest parallel infill line of the n+2*(1) layer by the same lateral offset value. In the case of constant channels, the lateral offset value may be constant (or the same) for more than 80% of the layers of the implant, ignoring deviations due to manufacturing.
[0124] All the portions of the infill lines forming the same wall of the same hollow channel may have an accumulative (summative) lateral offset value with respect to the infill line of the first layer forming that wall. In the case of constant tilted channels, the accumulative lateral offset value may be a multiple of the lateral offset value between the directly subsequent odd numbered layers. For example, the first infill line of the n+2*(t) layer of the wall 134.sub.1 may have an accumulative lateral offset value of ((t−1)*ov) with respect to the first infill line 102.sub.11 of the first layer of the wall 134.sub.1. The infill lines may be arranged so that the accumulative lateral offset value of ((t−1)*ov) may be larger than or equal to the pore size, 103 (or pore.sub.1) of the first pore of the first layer only for integer values of t larger than 2 i.e. for odd-numbered layers 7, 9 and onwards. In this case, t may be, but is not limited to values, such as 2<t<8, or e.g. 4<t<20. In other words, for values of t smaller than or equal to 2, the accumulative lateral offset value ((t−1)*ov) may be less than the pore size, 103 (or pores), ignoring deviations due to manufacturing. Alternatively or optionally, in the case where the tilt-to reference angle is very small (e.g. less than 5 degrees), the accumulative lateral offset value of ((t−1)*ov) may be smaller than the pore size, 103, even for integer values oft larger than 2.
[0125] The wall 134.sub.1 of a slanted channel 21 extending between the top surface of the implant and the bottom surface of the implant may be comprised of portions of the infill lines 102 from every odd-numbered layer. The wall 134.sub.1 may be formed by the infill lines of a plurality of odd-numbered layer of the channel 21, so that a portion of an infill line 102.sub.11 of an odd-numbered layer (e.g. layer 1) and a portion of a nearest (closest) parallel infill line 102.sub.31 of an adjacent (or directly subsequent) odd-numbered layer (e.g. layer 3) form part of the same wall 134.sub.1 of the same hollow channel 21. Similarly, a portion of a parallel infill line 102.sub.51 of an adjacent (or directly subsequent) odd-numbered layer (e.g. layer 5) forms part of the same wall 134.sub.1 of the same hollow channel 21.
[0126] Any of the walls of a hollow channel may be formed by a section of every other layer in the arrangement of layers forming the implant. A first wall 134.sub.1 of a hollow channel 21 may be formed from a portion of the first infill lines of the odd-numbered layers. A second wall 134.sub.2 of the hollow channel 21 may be formed from a portion of the second infill lines of the odd-numbered layers. The second wall 134.sub.2 may also be a wall of a second neighbouring (directly adjacent) hollow channel, which in the case of tilted constant channels, may be parallel to the first hollow channel.
[0127] Each even-numbered layer (e.g. layers 2, 4, 6 . . . 2*t) of the plurality of layers of the 3D printed structure may include a first infill line and a second infill line which may be parallel to and directly adjacent to the first infill line of the even-numbered layer. A third wall of the hollow channel 21 may be formed from a portion of the first infill lines of the even-numbered layers. A fourth wall of the hollow channel 21 may be formed from a portion of the second infill lines of the even-numbered layers of the plurality of layers.
[0128] In some other examples, a lateral offset value between a first infill line 102.sub.11 of a first odd-numbered layer and a first infill line 102.sub.31 of a second odd-numbered layer lies between 50% and 100% (e.g. between 55% and 95%) of a distance between the first infill line 102.sub.11 of the first odd-numbered layer and a second adjacent infill line 102.sub.12 of the first odd-numbered layer. An accumulative lateral offset value between a first infill line 102.sub.11 of an odd-numbered layer (e.g. an n+2*t layer) and the first infill line 102.sub.11 of the first odd-numbered layer may be larger than the distance between the first infill line 102.sub.11 of the first odd-numbered layer and the second adjacent infill line 102.sub.12 of the first odd-numbered layer, for values oft larger than or equal to 2.
[0129] It may be understood that the terms “odd-numbered layer” and “even-numbered layer” may refer to a single (i.e. one) layer, or it may also refer respectively to “odd-numbered sets of layers” and “even-numbered sets of layers”. In other words, the term “odd-numbered layer” may refer to one or more layers within the odd-numbered set of layers. Likewise, the term “even-numbered layer” may refer to one or more layers within the even-numbered set of layers.
[0130] It may be understood that the features of the implant (the 3D printed structure of layers, the infill pattern, the infill lines, the plurality of hollow channels, the walls of the channels, the odd-numbered layers, the even-numbered layers) described in connection with embodiments of
[0131]
[0132] One skilled in the art would readily appreciate that the present invention is well adapted to carry out the objects and obtain the ends and advantages mentioned, as well as those inherent therein. Further, it will be readily apparent to one skilled in the art that varying substitutions and modifications may be made to the invention disclosed herein without departing from the scope and spirit of the invention. The compositions, methods, procedures, treatments, and specific compounds described herein are presently representative of certain embodiments are thus exemplary and are not intended as limitations on the scope of the invention. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention are defined by the scope of the claims. The listing or discussion of a previously published document in this specification should not necessarily be taken as an acknowledgement that the document is part of the state of the art or is common general knowledge.
[0133] The invention illustratively described herein may suitably be practiced in the absence of any element or elements, limitation or limitations, not specifically disclosed herein. Thus, for example, the terms “comprising”, “including,” “containing”, etc. shall be read expansively and without limitation. Additionally, the terms and expressions employed herein have been used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the invention claimed. Thus, it should be understood that although the present invention has been specifically disclosed by exemplary embodiments and optional features, modification and variation of the inventions embodied herein may be resorted to by those skilled in the art, and that such modifications and variations are considered to be within the scope of this invention.
[0134] The invention has been described broadly and generically herein. Each of the narrower species and subgeneric groupings falling within the generic disclosure also form part of the invention. This includes the generic description of the invention with a proviso or negative limitation removing any subject matter from the genus, regardless of whether or not the excised material is specifically recited herein.
[0135] Other embodiments are within the following claims. In addition, where features or aspects of the invention are described in terms of Markush groups, those skilled in the art will recognize that the invention is also thereby described in terms of any individual member or subgroup of members of the Markush group.