Soft tissue reconstruction implants and methods of forming the same

Abstract

Specific embodiments herein relate to an implant for insertion into a patient's body for soft tissue reconstruction. The implant (200) comprises a plurality of unit cells (102) arranged to form a three-dimensional grid structure, the three-dimensional structure having an idle volume of the implant. The plurality of unit cells are arranged to form a porous network of a three-dimensional structure (101), wherein the three-dimensional structure is a reversibly compressible three-dimensional structure, and wherein the overall porosity of the three-dimensional structure of the implant is at least 50%.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the priority of European patent application No. 19195332.2 filed in the European Patent Office on September 4, 2019, the entire contents of which are hereby incorporated by reference into this case. Technical Field

[0003] Embodiments described herein relate to the field of implants, and in particular to implants suitable for soft tissue reconstruction to be inserted into a patient's body, as well as methods for forming implants, and to the use of implants for tissue reconstruction and / or tissue expansion. Background Art

[0004] Breast augmentation and reconstruction mammaplasty (mammaplasty) has been performed for decades and is a highly popular procedure performed worldwide. Although overall patient satisfaction is high, common long-term effects include breast tissue shrinkage, accelerated ptosis (i.e., descent), and breast creases. There is growing evidence that attributes this to the sustained loading and compressive forces induced by breast implants. For example, mechanical challenges that exceed the elastic capacity of breast tissue components ultimately lead to irreversible tissue stretching. Traditional silicone implants may be filled with an incompressible fluid and may induce heavy loads that cause tissue stretching. In addition, silicone implants may burst over time, leading to health problems and may result in the need for additional surgery. Some implants may include space-occupying structures that may be filled with fluid. For example, international patent application WO 2016 / 038083 and Transformation of Breast Reconstruction via Additive Biomanufacturing. Sci. Rep. 6, 28030 by Chhaya et al.; doi: 10.1038 / srep28030 (2016) disclose implants with a three-dimensional scaffold structure with voids, all of which are filled with space-occupying structures. The space-occupying structure is removably attached to the three-dimensional scaffold structure and is configured to prevent invasion of tissue and / or individual cells. After implantation of the implant (e.g., 6 to 8 weeks after implantation of the implant), in a second operation, the space-occupying structure is removed from the remainder of the implant and the implantation site. Summary of the invention

[0005] Various embodiments are directed to providing a lightweight implant that reduces prolapse in patients and alleviates adverse reactions to the implant.

[0006] The specific embodiments described herein relate to an implant for insertion into a patient. The implant comprises a plurality of unit cells arranged to form a three-dimensional grid structure, the three-dimensional structure comprising an idle volume of the implant. The plurality of unit cells are arranged to form a porous network of the three-dimensional structure, and the three-dimensional structure is a reversibly compressible three-dimensional structure, wherein the overall porosity of the three-dimensional structure (101) of the implant is at least 50%.

[0007] Various embodiments relate to another implant for insertion into a patient's body, wherein the implant comprises a porous three-dimensional scaffold structure, which includes an arrangement structure composed of unit cells, wherein the plurality of unit cells are arranged to form a porous network of a three-dimensional structure, wherein the average pore size of the plurality of unit cells of the three-dimensional structure is at least 0.5 mm.

[0008] Various embodiments relate to another implant for insertion into a patient. The implant comprises a three-dimensional porous scaffold structure comprising a plurality of hollow channels extending between a first outer surface region and a second outer surface region of the three-dimensional porous scaffold structure, wherein the porous scaffold structure comprises a surface-degradable polymer material. The first outer surface region is configured to face the chest wall of a patient receiving the implant, wherein the geometry of the second outer surface region represents the geometry of a breast to be constructed by the implant, and wherein the plurality of hollow channels are configured to align with Cooper's ligaments of the patient receiving the implant.

[0009] Various embodiments relate to a method for forming an implant. The method comprises sequentially printing layers to form a three-dimensional (3D) printed structure that defines a free volume of the implant to be formed, wherein each printed layer comprises a grid arrangement of two-dimensional unit cells, wherein the 3D printed structure has a porosity such that the 3D printed structure is compressible to at least 80% of its free volume.

[0010] Finally, the present invention also relates to a method for tissue reconstruction or tissue expansion, wherein the method comprises implanting an implant as defined herein into an individual. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The foregoing and other features of the present invention will become more apparent from the following description and the scope of the appended claims, taken in conjunction with the accompanying drawings. It should be understood that the drawings illustrate only several specific embodiments of the present invention and, therefore, should not be considered to limit the scope thereof. Through the use of the accompanying drawings, the present invention will be described in more detail so that the advantages of the present invention can be more easily ascertained, wherein:

[0012] FIG. 1A shows a diagram of an implant described in international patent application WO 2016 / 038083, comprising a space-occupying structure.

[0013] Figure 1B A diagram showing an implant of the present invention for insertion into a patient.

[0014] Figure 1C and 1D Schematic diagram showing the reversible compressibility of the spring-like unit cell and the reversible compressibility of the implant of the present invention.

[0015] Figure 2A A perspective side view showing an implant to be inserted into a patient's body.

[0016] Figure 2B A cross-sectional side view of the implant is shown showing the upper and lower end portions of the implant.

[0017] Figure 2C A top view (plan view) of a first outer surface area of ​​the implant is shown.

[0018] Figure 2D Shown is a top view of two sublayers that can intersect to form a unit cell.

[0019] Figure 2E A cross-sectional longitudinal side view showing the implant.

[0020] Figure 2F A perspective side view showing a lower end portion of a second outer surface region of an implant.

[0021] Figure 2G A perspective top view (plan view) of a second outer surface area of ​​the implant is shown.

[0022] Figure 3A Shown is a perspective side view of an implant having multiple surface filling portions.

[0023] Figure 3B Shown are perspective side and top views of the implant, including the surface filling columns.

[0024] Figure 4A and 4B The implant is shown in a perspective longitudinal side view and a perspective top view, respectively.

[0025] Figure 5 A perspective top view of an implant of the present invention is shown.

[0026] Fig. 6A Graphical illustration showing the performance of c-values ​​representing implant softness.

[0027] Figure 6B Schematic diagram showing the forces acting on an implant.

[0028] Figure 6C(i) to (iii) show an overestimation of the compressibility of the implant and the volume of the implant.

[0029] Fig.6D (i) to (iii) show the effect of skin tension on the implant shape after insertion into the patient.

[0030] Fig. 6E A perspective view of the implant shown herein is shown, which has the form of a buttocks implant.

[0031] Fig. 7A Diagram showing the implant after insertion into a patient.

[0032] Figure 7B Diagram showing the patient's breast anatomy to be created with the implant.

[0033] Figure 7C Display represents the forces acting on the breast.

[0034] Fig.7D Histological images showing regenerated breast tissue.

[0035] Fig. 7E Diagram showing the Cooper's ligament forces acting on one ligament of an implant.

[0036] Figure 7F Schematic diagram showing the internal forces acting on breast tissue.

[0037] Figure 8 A flow chart showing a method for forming an implant.

[0038] Fig.9A A schematic diagram of the bottom of the implant used in the animal studies described herein is shown, with the dimensions of the implant indicated.

[0039] Fig. 9B Shown is a side view of the implant used in the animal studies described herein, with the dimensions of the implant indicated.

[0040] Fig. 9C Magnetic resonance imaging (MRI) images of minipigs from treatment group 3 described herein are shown, wherein Fig.9A and 9B The implant shown is inserted therein. Fig. 9C MRI images were taken two weeks after implant insertion.

[0041] Fig.9D Display and Fig. 9C MRI images of the same minipig, taken 4 weeks after implantation.

[0042] Fig. 10AA reproduction of the histological image of Figure 4 of Chhaya et al. (supra 2016) showing areas of chronic inflammation characterized by lymphatic structures following implant / scaffold implantation in minipigs as described in Chhaya et al. and WO 2016 / 038083.

[0043] Fig. 10B Shown is a histological image of Figure 4 of Chhaya et al. (supra 2016) showing the composition of the tissue infiltrated within the pores of the implants of the present invention used in the animal studies described herein. Fig. 10B The minipigs described herein were shown to have no signs of chronic inflammation following implantation of the implant / scaffold of the present invention.

[0044] Figures 11A to 11E Schematic diagram showing a soft tissue reconstruction implant used to reconstruct the pectoralis major muscle or chest area of ​​a patient's body.

[0045] Figures 12A to 12C Schematic diagram showing a soft tissue reconstruction implant used to reconstruct the zygomatic area (or cheek) of a patient's body.

[0046] Figures 13A to 13B Schematic diagram showing a soft tissue reconstruction implant used to reconstruct the testicular area of ​​a patient's body.

[0047] Figures 14A to 14C Display Combination Figures 1B to 10B More details of the implants described. DETAILED DESCRIPTION

[0048] In the following detailed description, with reference to the accompanying drawings, specific embodiments in which the claimed subject matter can be practiced are shown by way of icons. These embodiments are described in sufficient detail to enable those skilled in the art to practice the subject matter. The description of these embodiments is sufficiently detailed to enable those skilled in the art to practice the subject matter. It should be understood that the various embodiments, although different, are not necessarily mutually exclusive. For example, the specific features, structures, or characteristics described herein in connection with a specific embodiment may be implemented in other specific embodiments without departing from the spirit and scope of the claimed subject matter. References to "one specific embodiment" or "specific embodiments" in this specification mean that the specific features, structures, or characteristics described in connection with the specific embodiment are included in at least one implementation covered by this specification. Therefore, the use of phrases such as "one specific embodiment" or "in a specific embodiment" does not necessarily mean the same specific embodiment. In addition, it should be understood that the position or arrangement / arrangement of individual elements in each disclosed specific embodiment may be modified without departing from the spirit and scope of the claimed subject matter. Therefore, the following detailed description should not be construed as limiting, and the scope of the subject matter is limited only by the appended claims, properly interpreted, and the scope of the appended claims encompasses all equivalents. In the drawings, the same reference numerals refer to the same or similar elements or functions throughout the several views, and wherein the elements are not necessarily drawn to scale with each other, but rather individual elements may be enlarged or reduced to make it easier to understand the elements in the context of this specification.

[0049] As used herein, "on", "to", "between", and "on" may refer to the relative position of one layer to other layers. A layer "on" or "over" another layer may be directly in contact with the other layers, or may have one or more intervening layers. A layer "between" layers may be directly in contact with the layers, or may have one or more intervening layers.

[0050] Figure 1B A diagram is shown of an implant 100 of the present invention for insertion into a patient.

[0051] The implant 100 includes a plurality of unit cells 102 arranged to form a three-dimensional grid structure 101. The three-dimensional structure 101 includes an idle volume of the implant 100. The plurality of unit cells 102 are arranged to form a porous network of the three-dimensional structure 101, and the three-dimensional structure 101 is a reversibly compressible three-dimensional structure.

[0052] The three-dimensional mesh structure 101 may be a mesh-like structure. For example, the implant 100 may include a plurality of lines configured to form a mesh-like structure. Each unit cell 102 of the plurality of unit cells 102 may include intersecting (or, for example, crossing) lines of the plurality of lines that form and / or define a single unit cell 102 (such as forming a wall that surrounds each unit cell), and / or each unit cell 102 may be formed by intersecting (or, for example, crossing) lines of the plurality of lines that form and / or define each unit cell 102 (such as forming a wall that surrounds a single unit cell). The plurality of lines may form and / or constitute an overall mesh-like three-dimensional mesh structure 101. The intersecting lines may be arranged so that each unit cell 102 formed by the intersecting lines may include or may refer to a pore having a pore size. Therefore, the plurality of intersecting lines may form or define a plurality of pores of the unit cell 102. For example, the intersection lines may form or define the geometry (e.g., shape, dimension / size, pore size) of a single unit cell 102 (e.g., each unit cell 102) of the three-dimensional structure 101. A plurality of unit cells 102 may be arranged to form a porous network of the three-dimensional structure 101. The porous network may refer to (and / or may include) pores of the plurality of unit cells 102 within the three-dimensional structure 101.

[0053] The unit cell 102 may be the smallest and most basic unit of the three-dimensional grid structure 101. The intersection lines of the plurality of lines may be configured to form a plurality of repeated unit cells 102, and the repeated unit cells form the three-dimensional grid structure 101. For example, the unit cell 102 is repeated in at least (equal to or greater than) 80% (or, for example, at least 90%, or, for example, at least 95%) of the idle volume of the entire three-dimensional grid structure 101. Therefore, the grid structure 101 may include a plurality of adjacent (e.g., directly adjacent) unit cells, and the unit cells are connected to each other in the entire grid structure 101.

[0054] The idle volume of implant 101 (cm 3) may be the volume of the implant 101 before the implant 101 is inserted into the patient's body. The idle volume of the implant 101 may be the volume of the implant 101 when only one outer surface of the implant 101 is subjected to an external force. For example, when the implant 101 is resting on (or in contact with) a carrier surface (such as a table, or, for example, a board). For example, a first outer surface of the implant may be in contact with the carrier surface, and a second (opposite) outer surface may be free of any compressive force. In other words, the idle volume of the implant 101 may be the volume of the implant 101 when no reverse compressive force acts on the implant surface. When a (physical or mechanical) compressive force acts on more than one outer surface of the implant 101, the implant 101 may be compressed to at least 80% (or, for example, at least 70%, or, for example, at least 60%, or, for example, at least 50%, or, for example, at least 30%, or, for example, at least 20%, or, for example, at least 10%) of its idle volume. Compressible to at least 80% means that the implant can reach a volume of 80% or less of its idle volume (due to compression). For example, the idle volume of the implant 101 can be derived based on the build volume (desired or required volume) of the breast to be built by the implant 101. The implant 101 can be configured to be at least compressible to the build volume so that the implant contains or reaches the build volume of the breast after insertion into the patient.

[0055] Individual / single unit cells 102 of the plurality of unit cells 102 may be spring-like unit cells. The spring-like unit cells may be compressed to at least 80% of their original volume (or, for example, at least 70%, or, for example, at least 60%, or, for example, at least 50%, or, for example, at least 30%, or, for example, at least 20%, or, for example, at least 10%). As used herein, compressible to at least 80% means compressible to 80% or less of their original volume. The spring-like unit cells may be reversibly compressible. By being reversibly compressible, each unit cell 102 may recover or return to its original (idle) volume after the compressive force is removed (even at the same ambient pressure and temperature). The reversibly compressible spring-like unit cells may be configured to recover to at least 80% of their original volume (or, for example, at least 90%, or, for example, at least 95%, or, for example, at least 98%, or, for example, up to 100%) after the compressive force applied to the implant 101 is removed. As used herein, recovering to at least 80% means being able to recover to 80% or more of its original volume.

[0056] Figure 1C and 1D Schematic showing the reversible compressibility of the spring-like unit cell 102 and the reversible compressibility of the implant 100 .

[0057] The three-dimensional structure 101 can be a reversibly compressible three-dimensional structure comprising a plurality of reversibly compressible unit cells 102. The spring-like implant 100 can provide shape stability. If a force 103 is applied to the implant, the spring-like implant 100 can be deformed, and when or after the force is released, the implant 100 can restore its shape. The ability of the implant 100 to restore its shape can avoid pore blockage and / or avoid any additional force on the chest cavity, which may cause damage to the patient's tissue and / or lungs. The implant 100 can be a soft tissue reconstruction implant (i.e., an implant used for and / or suitable for soft tissue reconstruction).

[0058] like Figure 1C As shown, the reversibly compressible structure of the implant 100 and the reversibly compressible unit cells 102 can transfer forces acting in one direction (such as opposite / reverse compression forces 103 along the z-axis) to a different direction, such as a vertical direction 104 (such as along the x-axis).

[0059] like Figure 1D As shown, once the compressive force 103 is released (indicated by the change in direction of arrow 103), the energy stored in the process may act in the opposite direction to when the compressive force 103 was applied (indicated by the change in direction of arrow 104). This may help to rebound the shape of the implant 100 and restore its original shape (e.g., at least 80% of its idle volume).

[0060] The individual spring-like unit cells 102 may be reversibly compressed in at least one Cartesian direction, and / or in three Cartesian directions. Figure 1C and 1D The unit cell 102 is shown to be compressible in the z-axis direction, and it will be appreciated that the spring-like unit cell 102 may be reversibly compressible in three Cartesian directions and / or in any direction in three-dimensional space.

[0061] Figures 2A to 2G Different views of an implant 200 of the present invention are shown to be inserted into a patient's body. The implant 200 may include a combination of Figures 1B to 1D One or more or all of the features of implant 100 described, as well as various other features.

[0062] Figure 2AA perspective side view of an implant 200 is shown. The three-dimensional structure 101 of the implant 200 may include an arrangement of layers 126. The arrangement of layers 126 may include (or may be) a plurality of transverse layers 126 (e.g., parallel to the xy plane), which are arranged one after another in the z-axis direction (e.g., vertical direction). For example, the implant 200 may be formed by sequentially printing each layer 126 to form a three-dimensional (3D) printed support structure 101. Arrow 117 represents the sequential printing direction (e.g., in the z-axis direction) of the continuous layers 126. Each transverse layer 126 of the arrangement of layers 126 may include a two-dimensional grid arrangement structure consisting of a plurality of two-dimensional unit cells 102. The sequential arrangement (using printing) of each layer 126 stacked on top of each other may result in the formation of a three-dimensional structure 101, wherein the edges (or peripheries) of the plurality of layers 126 define the shape and / or geometry of the second outer surface region 106.

[0063] The three-dimensional structure 101 of implant 200 can comprise first outer surface area 105 and second (different and / or opposite) outer surface area 106.It is understandable that outer surface area can refer to (or can be) the outermost surface, outermost layer and / or outermost contour of implant 200.Outermost surface and outermost contour can be formed by one or more layers or one or more lines.Outer surface area can refer to (or can be) the group (for example, single outermost layer, or for example outermost multiple layers) that the outermost layer of implant 200 constitutes.Outer surface area can refer to the outward surface of implant 100.

[0064] The first outer surface region 105 of the implant 200 may include or may have a first surface curvature. The first outer surface region 105 of the implant 200 may be the largest planar (or, for example, flattest) surface of the implant. For example, the first outer surface region 105 may be the flattest surface of the implant and / or the surface having the least (or smallest) amount of curvature. Figure 2C As shown, the first outer surface region 105 of the implant 200 can be parallel to a two-dimensional (xy) Cartesian plane. Alternatively or optionally, the best fit plane of the first outer surface region 105 can be parallel to a two-dimensional (xy) Cartesian plane.

[0065] The second outer surface area 106 of implant 200 may include or may have a second surface curvature that is different from the first surface curvature. The second surface curvature may be greater than the first surface curvature. The second outer surface area 106 of implant 200 may be adjacent to (such as adjoining) the first outer surface area 105 of implant 200 at a periphery 107 (such as periphery) of the first outer surface area 105. For example, the second outer surface area 106 of implant 200 may adjoin the first outer surface area 105, wherein the periphery 107 of the first outer surface area 105 may be a shared edge (or interface / interface) between the first outer surface area 105 and the second outer surface area 106.

[0066] The second outer surface region 106 may have a geometry (e.g., shape, curvature, size) that represents the geometry of the patient's breast to be constructed using the implant 200. For example, the second outer surface region 106 may include an upper portion 109 and a lower portion 111. The upper portion 109 may have the geometry of the upper portion of the breast to be constructed using the implant 200. The upper portion of the breast may be the area of ​​the breast above the patient's nipple area toward the patient's head. The lower portion 111 may have the geometry of the lower portion of the breast to be constructed using the implant 200. The lower portion of the breast may be the area of ​​the breast below the patient's nipple area toward the patient's feet. The upper portion 109 and the lower portion 111 may meet (or coincide) at an apex region 112 of the second outer surface region 106. The location (or position) of the apex region 112 on the second outer surface region 106 of the implant may be based on (and / or may coincide with) the location (or position) of the nipple / areola of the breast to be constructed using the implant 200.

[0067] Figure 2B A cross-sectional side view of the implant 200 is shown. The figure shows the upper end portion 109 and the lower end portion 111 of the implant 200.

[0068] In the cross-sectional side view, the first outer surface region 105 can be regarded as a straight line extending along (such as parallel to) the Cartesian x-axis (such as -x to +x). For example, the slope of the first outer surface region 105 can be zero. Generally speaking, the (surface) curvature of the upper end portion 109 of the second outer surface region 106 and the (surface) curvature of the lower end portion 111 can be greater than the (surface) curvature of the first outer surface region 108, respectively. Alternatively, the curvature of the upper end portion 109 of the second outer surface region 106 can be less than or equal to the Da curvature of the first outer surface region. According to the size and shape required for the implant 200, the contour and shape of the upper end portion 109 and the lower end portion 111 of the second outer surface region 106 can be controlled.

[0069] The curvature and / or profile of the upper portion 109 and the lower portion 111 may be based on controlling at least one of the projection / protuberance height, height, and width (indicated by boxes) of each of the plurality of segments of the second outer surface region 106. The plurality of segments may be defined based on a plurality of points (e.g., p1 to p7) on the second outer surface region 106. Each segment may be located between two points of the second outer surface region 106. At the same time, the distance between the points and the number of points may be selectively controlled.

[0070] The Cartesian z-axis may be located at (e.g., directly at) the vertex region 112 of the second outer surface region 105 (e.g., at x=0). The upper portion 109 of the second outer surface region 106 may be located in the -x region, and the lower portion 111 of the second outer surface region 106 may be located in the +x region. In general, the segments of the upper portion 109 may have a positive slope relative to the x-axis and the z-axis. Point p4 (e.g., the midpoint of the vertex region 112) defining the vertex region 112 may be located at x=0. The segments of the upper portion 109 that are closer to the vertex region 112 (e.g., closer to point 4) may have a smaller slope, such as a slope close to zero. For example, segments p3 to p4 may have a smaller slope than segments p2 to p3, and segments p2 to p3 may have a smaller slope than segments p1 to p2. In general, the segments of the lower portion 111 may have a negative slope relative to the x-axis and the z-axis. The segmentation closer to apex region 112 (as closer to point 4) of lower end portion 111 can have less slope, as slope is close to zero.For example, segmentation p4 to p5 can have the slope less than segmentation p5 to p6.Depending on the required shape or geometry of implant 200, the sub-segmentation of lower end portion 111 can have positive slope (as the sub-segmentation between segmentation p6 to p7).In this way, the curvature of the lower end portion 111 of second outer surface region 106 may seem to be greater than the curvature of the upper end portion 109 of second outer surface region 106.

[0071] Figure 2C A top view (plan view) of the first outer surface region 105 of the implant 200 is shown.

[0072] In top view, the first outer surface region 105 may be circular or oval. The first outer surface region 105 may include (or may refer to) a first layer 126 of the layer arrangement structure. Figure 2C As shown, each transverse layer 126 may include an arrangement structure composed of two-dimensional unit cells 102. The two-dimensional unit cells 102 may be rhombus (or diamond or rhombus) unit cells.

[0073] Figure 2D Shown is a top view of two sub-layers 136A, 136B, which may intersect to form a unit cell.

[0074] Each transverse layer 126 of the unit cell may include a first sublayer 136A (or a first group of sublayers) having lines 128 along a first direction and a second sublayer 136B (or a second group of sublayers) having lines 129 along a second direction, the second direction being different from the first direction. The lines of each sublayer may be a portion of a continuous sublayer line that winds continuously from a starting point S of the sublayer to an end point E of the sublayer. For example, the lines 128 of the first sublayer 136A may be a portion of a continuous sublayer line 138 that winds continuously from a starting point S of the first sublayer 136A to an end point E. For example, the lines 129 of the second sublayer 136B may be a portion of a continuous sublayer line 139 that winds continuously from a starting point S of the second sublayer 136B to an end point E. The intersecting lines that form the unit cell may be straight lines, or the lines may be sinusoidal curves, wherein the unit cell may have a "free form" shape. The lines 128, 129 within each individual sub-layer 136A, 136B may be parallel to each other (e.g., the acute angles between the lines within the sub-layer or between the best fit lines of the sine curve may be within + / - 5°). The multiple lines 128 of the first sub-layer and the multiple lines 129 of the second sub-layer may intersect at the intersection point or intersection area to form a two-dimensional grid arrangement structure composed of two-dimensional unit cells of the subsequent layer 126. The two-dimensional unit cells 102 of each layer 126 of the stacked layer arrangement structure may form a three-dimensional grid structure 101.

[0075] like Figure 2C As shown, each unit cell 102 of the transverse layer 126 may include or may be formed by intersection lines 128, 129 originating from adjacent sub-layers 136A, 136B, thereby defining the pore size of the unit cell 102. For example, two adjacent (and parallel) lines 128 of the first sub-layer 136A may intersect with two adjacent (and parallel) lines 129 of the second (adjacent) sub-layer 136B. The area of ​​the unit cell surrounded by the intersection lines may be a rhombus (or diamond, or rhombus). In some examples, the minimum angle j between the two intersection lines of the unit cell may be 5° to 90° (or, for example, 10° to 80°, or, for example, 30° to 60°).

[0076] Each two-dimensional unit cell 102 has a pore size that defines the size of the unit cell 102. The pore size w of a unit cell 102 of a layer may be the minimum dimension (or width) of a pore, such as the minimum distance of the pore measured between two lines (such as opposing lines) defining the unit cell 102.

[0077] The three-dimensional structure 101 of the implant 200 may be composed of a plurality of unit cells 102 having different pore size ranges. Figure 2CAs shown, the first layer 126 may be the outermost layer at the first outer surface region 105. Therefore, the pore size of the unit cell 102 may also be the surface pore size of the surface pores (openings) of the first outer surface region. The (minimum) surface pore size w of the plurality of unit cells (at) the first outer surface region 105 of the implant 200 may be at least (e.g., equal to or greater than) 2 mm (or, for example, at least 6 mm, or, for example, at least 8 mm). The surface pore size of at least 80% (or, for example, at least 70%, or, for example, at least 80%) of the unit cells 102 (at) the first outer surface region 105 may be at least 2 mm (or, for example, at least 0.75 mm, or, for example, at least 1 mm).

[0078] The size of the openings (e.g., surface pore size) on the surface of the implant 200 may vary, depending on their location on the implant 200. The (average) surface pore size of the openings in the first outer surface region 105 of the three-dimensional structure may be at least (e.g., equal to or greater than) 10% (or, for example, at least 25% greater, or, for example, at least 30% greater, or, for example, at least 35% greater) greater than the (average) surface pore size of the openings in the second outer surface region 106 of the three-dimensional structure 101. In addition, or as desired, the (average) surface pore size at the first outer surface region 105 may be greater than the (average) surface pore size at the lower end portion 111 of the second outer surface region 106 and greater than the (average) surface pore size at the upper end portion (109) of the second outer surface region 106.

[0079] Although the rhombus (or diamond) unit cell 102 is shown in Figure 2CIt is understood that, as desired, the plurality of two-dimensional unit cells 102 may be polygonal unit cells. For example, the plurality of two-dimensional unit cells may be triangular unit cells, rhombus unit cells, rhombus unit cells, rectangular unit cells, parallelogram unit cells, and / or hexagonal unit cells. It is understood that, in the volume of the entire implant 200, the implant 200 may include more than one type of unit cells, such as a mixture of multiple unit cells. In one example, the implant 200 may mainly include rhombus unit cells (e.g., greater than 50%, or, for example, greater than 60%, or, for example, greater than 70%, or, for example, greater than 80% of the unit cells may be rhombus unit cells). Alternatively, as an alternative to two-dimensional unit cells, the unit cells 102 of the plurality of unit cells 102 may include (or may be) three-dimensional unit cells, having multiple planes. Each plane of the three-dimensional unit cell may define the pores and / or pore size of the three-dimensional unit cell 102. Generally speaking, each three-dimensional unit cell 102 may include at least four pores. For example, a tetrahedral three-dimensional unit cell may include at least four openings (or pores) formed by four triangular faces of the tetrahedral unit cell. For example, a hexagonal three-dimensional unit cell may include six openings (or pores) on corresponding six faces of the hexagonal unit cell.

[0080] The average thickness of the plurality of lines may be in the range of 0.1 mm to 5 mm (or in the range of 0.1 mm to 2 mm, or in the range of 0.5 mm to 1.5 mm). Thus, each sublayer 136A having lines oriented in a first direction may be separated from an adjacent (or continuous) sublayer 136A having lines oriented in the (same) first direction by a sublayer 136B having lines oriented in a second (different) direction. Thus, each sublayer 136A in the first direction may be separated from an adjacent (or continuous) sublayer 136A in the (same) first direction by a separation distance in the range of 0.1 mm to 5 mm (or, for example, in the range of 0.1 mm to 2 mm, or, for example, in the range of 0.5 mm to 1.5 mm). Likewise, each sub-layer 136B along the second direction may be separated from an adjacent (or consecutive) sub-layer 136B along the (same) second direction by a separation distance in the range of 0.1 mm to 5 mm (or, for example, in the range of 0.1 mm to 2 mm, or, for example, in the range of 0.5 mm to 1.5 mm). This may result in a layer arrangement with a loose space of the sub-layers that allows freedom of movement of the wires relative to each other (e.g., due to compression, stretching, translation).

[0081] Figure 2EA cross-sectional longitudinal (side view) of the first outer surface region 105 of the implant 200 is shown. The cross-sectional side view shows that a single layer of the layer arrangement structure can be configured such that the (two-dimensional) unit cells of the consecutive layers can form a plurality of hollow channels 118 extending between the first outer surface region 105 and the second outer surface region 106 of the three-dimensional structure 101. The cross-sectional side view shows the plurality of hollow channels 118 formed by the arrangement of the two-dimensional unit cells of the consecutive layers within the implant 200.

[0082] One or more channels 118 of the plurality of hollow channels may be configured to extend from the first outer surface region 105 toward the vertex region 112 of the second outer surface region 106 and / or the lower end portion 111 of the second outer surface region 106. In addition, or as required, one or more other channels 118 of the plurality of hollow channels may be configured to extend from the upper end portion 109 of the second outer surface region 106 toward the vertex region 112 and / or the lower end portion 111 of the second outer surface region 106. Optionally, the plurality of hollow channels may be parallel to each other (e.g., the acute angle between adjacent channel sidewalls may be within + / -5°). Alternatively, the plurality of hollow channels may converge toward a convergence region (or point), wherein the convergence region is located outside the first outer surface region 105 or the second outer surface region 106 of the three-dimensional structure. For example, the convergence point may be located above the vertex region 112 of the implant 200.

[0083] A plurality of hollow channels 118 may be inclined relative to the first outer surface region 105 of the implant 200. The acute angle of inclination k between the sidewall of the hollow channel 118 and the reference axis (such as the x-axis) may be less than 90 degrees, or, for example, less than 60 degrees, representing the first outer surface region. The reference axis may be based on the plane or line of the best fit of the first outer surface region 105. A plurality of hollow channels 118 may be composed of 5 to 1000 hollow channels (or, for example, 5 to 60 channels, or, for example, 8 to 20 channels). Each inclined channel may be formed by (or may include) a unit cell column derived from continuous layers 126 stacked above each other / on top of each other, or each inclined channel may include a unit cell column derived from continuous layers 126 stacked above each other / on top of each other. In the unit cells forming the unit cell column, the unit cells of the second layer may be laterally offset (in the x-axis direction) relative to the unit cells of the adjacent first layer.

[0084] The sidewalls of the unit cell column may be formed by a plurality of transverse lines (substantially parallel to the xy plane) vertically stacked in the z-axis direction and oriented in the same direction, wherein the lines forming the sidewalls are the lines of each unit cell forming the unit cell column. For example, a diamond-shaped unit cell column may be formed by a vertical stack of diamond-shaped unit cells, wherein the lines or walls that enclose (and define) each unit cell in layer 126 may be aligned with the lines or walls that enclose (and define) a subsequent unit cell in a subsequent layer. Thus, the wall of each unit cell of the unit cell column may form at least a portion of the sidewalls of the unit cell column. The individual unit cells of the unit cell column may be aligned / arranged such that within the same column, the unit cells of each successive layer may be laterally offset relative to the unit cells of the (directly) previous layer. The lateral offset value between the first unit cell and the second unit cell may be 0% to 50% (or such as 0% to 20%, or such as 5% to 10%) of the pore size of the unit cell. Optionally, within the same column, the unit cells of each layer may have the same lateral offset relative to the unit cells of the immediately preceding layer. Optionally, at least (e.g., equal to or greater than) 80% (or, for example, at least 70%, or, for example, at least 50%) of the unit cells (forming the same channel) of the same column may have the same pore size and the same pore shape. Alternatively, in the case of tapered channels, the unit cells forming the same channel may have different pore sizes (e.g., the pore size of the unit cells may decrease or increase toward one of the outer surface regions). Surface porosity and surface pores of different sizes are shown in Figure 2F and 2G .

[0085] Figure 2F A perspective side view of the lower end portion 111 of the second outer surface area is shown.

[0086] like Figure 2F and Figure 2AAs shown, the surface pore size w at the lower end portion 111 of the second outer surface region 106 may increase (stepwise, or, for example, stepwise, or, for example, layer by layer) from the lower end interface region 115 of the second outer surface region 106 toward the vertex region 112. The lower end interface region 115 may be an interface (or edge) region of the three-dimensional structure 101, where the lower end portion 111 of the second outer surface region 106 intersects a portion of the periphery 107 of the first outer surface region 105. For example, the surface pore size at the lower end portion 111 of the second outer surface region 106 may increase from 0.15 mm or 2 mm at the lower end interface region 115 to 6 mm, to 8 mm, to 9 mm, or to 10 mm toward the vertex region 112 of the second outer surface region 106. The direction of increase is indicated by arrow 116. Optionally, the surface pore size may be increased by 3 mm to 7 mm (or, for example, 3 mm to 6 mm, or 4 mm to 8 mm, as in the implants used in the experimental examples of the present application).

[0087] Figure 2G A perspective top view of the second outer surface region 106 of the implant 200 is shown.

[0088] like Figure 2G As shown, the apex region 112 is located between the upper portion 109 and the lower portion 111 (or at their interface). Figure 2G (and Figure 2A ), additionally or optionally, the (average) surface pore size at the first outer surface region 105 may be greater than the (average) surface pore size at the upper portion 109. The surface pore size at the upper portion 109 of the second outer surface region 106 may increase (stepwise, or, for example, stepwise, or, for example, layer by layer) from the upper interface region 114 toward the vertex region 112 of the second outer surface region 106. The direction of increase is indicated by arrow 113. The upper interface region 114 may be an interface (or edge) region of the three-dimensional structure 101, where the upper portion 109 of the second outer surface region 106 intersects a portion of the perimeter 107 of the first outer surface region 105. For example, the surface pore size of the upper portion 109 of the second outer surface region 106 may increase from 0.5 mm at the upper interface region 114 to 5 mm at the vertex region 112 of the second outer surface region 106. Optionally, the surface pore size may be increased from 0.5 mm to 4 mm (or, for example, 0.5 mm to 2 mm, or, for example, 0.8 mm to 2 mm, or, for example, 1 mm to 2 mm). The surface pore size at the upper portion 109 may be determined by (or may depend on) the contour line (e.g., Figure 4A and 4B The spacing between the above) is achieved.

[0089] The surface pores at (or within) the apex region may have an average surface pore size w in the range of 2 mm to 6 mm (or such as 2 mm to 4 mm, or such as 2 mm to 3 mm).

[0090] In general, at least 50% (or, for example, at least 70%, or, for example, at least 80%) of the three-dimensional structure 101 may have a surface pore size of at least 0.5 mm (or, for example, at least 0.75 mm, or, for example, at least 1 mm). The average surface pore size of the three-dimensional structure 101 may be at least 0.5 mm (or, for example, at least 0.75 mm, or, for example, at least 1 mm). The average surface pore size is calculated by adding the pore sizes of all number of openings on the outermost surface of the three-dimensional structure 101 and dividing it by the total number of openings on the outermost surface of the three-dimensional structure. At least 50% (or, for example, at least 70%, or, for example, at least 80%) of the surface pores of the three-dimensional structure 101 may have a surface pore area of ​​at least 0.75 mm 2 (or for example at least 1 mm 2 , or for example at least 3 mm 2 ). The surface pore area may be the area enclosed by the intersecting lines defining the surface pores.

[0091] Optionally, the pore sizes of the unit cells 102 within a layer may differ from one another. For example, in the case of tapered channels or converging channels, the unit cells within a layer may have the same shape but may have different pore sizes. Thus, the pore sizes of the unit cells at different locations of the implant 200 may differ from one another. For example, the pore sizes of the unit cells 102 within the body of the implant 200 (body pore size) may differ from one another, depending on the location of the unit cells 102 within the implant 200.

[0092] Figure 3A A three-dimensional perspective side view of an implant 200 having a plurality of surface filling portions 122 is shown. The figure shows a side view of the lower end portion 111 of the implant 200. The implant 200 may include a combination of Figures 1B to 2G One or more or all of the features described above, and various other features.

[0093] The surface filling portion 122 may occupy the openings (surface pores) at the outermost surface of the three-dimensional structure 101. Each surface filling portion 122 may include one or more filling lines 124, which are configured to at least partially fill one or more openings (surface pores) at the outermost surface of the three-dimensional structure 101. The one or more filling lines 124 of the surface filling portion 122 may be configured to connect a set of intersecting lines of the surface pores 123 defined at the outer surface area of ​​the three-dimensional structure (or at least partially fill the space between the set of intersecting lines). The surface pores that are at least partially filled may be such surface pores, that is, the filling lines occupy 50% to 99% (or, for example, 55% to 95%, or, for example, 80% to 95%) of the pore surface area. For example, two pores 123A and 123B may be considered to be at least partially filled, even if the surface area filling percentage of pore 123A is greater than that of pore 123B. Optionally, at least 20% (or, for example, at least 30%, or, for example, at least 40%) of the surface pores at the outer surface region of the three-dimensional structure 101 may be at least partially filled with the surface filling portion 122. Optionally, the surface filling portion 122 may be formed (or arranged) at the second outer surface region, while the first outer surface region may be free of the surface filling portion 122 (e.g., all the surface pores of the first outer surface region may be open).

[0094] Figure 3B A perspective side view and a top view of an implant 200 are shown having surface filler rows 125. The figures show the surface porosity of the implant 200.

[0095] Optionally, the ratio of filled surface pores (closed surface pores) to unfilled (open) surface pores at the second outer surface region may be 1:2. In this case, the surface porosity of the implant 200 before insertion into the patient's body may be defined. The surface porosity may represent (or may be) the void fraction or percentage (e.g., a measure / metric of empty space) of the outermost surface of the three-dimensional structure 101. By taking the total void space (m 2 ) (such as the total surface area of ​​the unfilled openings at the outermost surface of the 3D structure 101) divided by the total surface area (m 2), the surface porosity of the implant 200 can be determined. The surface porosity of the second outer surface area can be less than the overall porosity of the three-dimensional structure of the implant. The surface porosity of the second outer surface area can be (e.g., 0.8 times, or, for example, 0.5 times, or, for example, 0.2 times, or, for example, 0.1 times) the surface porosity of the first outer surface area. For example, the surface porosity of the second outer surface of the implant 200 can be 30% to 80% (or, for example, 40% to 70%, or, for example, 50% to 60%, or, for example, 54% to 66%). The overall porosity of the three-dimensional structure 101 of the implant 200 can be at least 80% (or, for example, at least 20%, or, for example, at least 50%, or, for example, at least 60%, or, for example, at least 70%, or, for example, at least 85%, or, for example, at least 90%). Optionally, the overall porosity of the implant can be 80% to 99%. The overall porosity may represent (or may be) the void fraction or percentage (e.g., a measure of empty space) of the implant 200 prior to insertion into the patient's body. By measuring the total void space (m 3 ) divided by the total volume (m 3 ), the overall porosity of the implant 200 can be determined.

[0096] The compressibility of the three-dimensional structure 101 of the implant can be based on (or, for example, proportional to) the overall porosity and / or total void space of the implant. For example, based on (or, for example, proportional to) the void space of the implant, the three-dimensional structure 101 can be compressed to a minimum compressible volume V C For example, a three-dimensional structure can be compressed into:

[0097] V c =V T -V V

[0098] Where V C is the volume of the compressed implant, V V is the volume of the void space, and V T is the total free volume of the scaffold. In other words, the implant is compressible to a volume that is based on (proportional to, or equal to) the volume of the void space.

[0099] The spring-like implant may be configured to recover at least 80% (e.g., equal to or greater than 80%) (or, for example, at least 90%, or, for example, at least 95%, or, for example, at least 98%, or, for example, up to 100%) of its original volume after the compressive force applied to the implant is removed.

[0100] The amount of recovery of the spring-like implant can depend on the amount of compression applied to the implant. For example, the implant can be compressed to 30% or less size in at least one compression direction. After the force is removed, the stent 101 can recover (rebound) to more than 80% of the size. Alternatively, the implant can be compressed to less than 80% of the size. After the force is removed, the stent 101 can recover to 85% or 90% or more of the initial protrusion height.

[0101] In addition, implants 100, 200 can be reversibly compressed in one or more axial directions (such as in two axial directions, such as the xy direction, or for example in three axial directions, such as the xyz direction) at the same time. Therefore, each of the implants in one or more axial directions (such as height, width, length, and / or protuberance height) can be compressed to 80% or less of its original size (or for example 70% or less, or for example 60% or less, or for example 50% or less, or for example 30% or less, or for example 20% or less, or for example 10% or less). The implant can be configured to restore to 80% or more of the original size (such as 90% or more, or for example 95% or more, or for example 98% or more, or for example 100%) in each of one or two or three axial directions.

[0102] Optionally, the plurality of surface filling portions may be arranged to form a plurality of surface filling columns 125 (or strips) located at the second outer surface region 106. The surface filling columns 125 may include a plurality of surface filling portions occupying a column of adjacent surface pores (e.g., openings). The surface filling columns may be arranged adjacent to the opening columns 135. The opening columns 135 may include (or may be) a column of surface pores without surface filling portions. Optionally, in the outer surface region (e.g., at the second outer surface region), the plurality of surface filling columns 125 and the plurality of opening columns 135 may be arranged alternately. Optionally, in the outer surface region, the plurality of surface filling columns and the plurality of opening columns may be arranged in a cross-shaped manner.

[0103] The surface filling columns 125 arranged at the lower end portion of the second outer surface region may at least partially cover or close the top openings of some channels of the implant 200. The surface filling columns 125 arranged at the upper end portion of the second outer surface region may include (or may form part of) the channel sidewalls of the plurality of hollow channels.

[0104] Figure 4A and 4B The implant 200 is shown in a longitudinal side view and a top view, respectively. The implant 200 may include a combination of Figures 1B to 3B One or more or all of the features described above, and various other features.

[0105] like Figure 4A and 4BAs shown, the multiple lines forming the three-dimensional structure 101 of the implant 200 may include multiple contour lines. The first group of contour lines 119 of the multiple lines may be arranged around the periphery 107 of the first outer surface area 105 (or, for example, around the periphery 107 of one or more layers of the first outer surface area 105). The first group of contour lines 119 may be completely (such as at least 90%, or, for example, at least 95%, or, for example, at least 99%, or, for example, 100%) arranged around the periphery 107 of the first outer surface area 105, such as forming a closed circle or ellipse. For example, the first group of contour lines 119 may be composed of 2 contour lines to 20 contour lines. The contour lines of the first group of contour lines 119 may be formed continuously (successively) in the direction from the first outer surface area 105 toward the vertex area 112 (such as in the z-axis direction). Optionally, the thickness or height h of the first group of contour lines (measured in the vertical z-axis direction) may range from 1mm to 20mm (or, for example, 2mm to 10mm, or, for example, 1.5mm to 5mm).

[0106] The multiple lines of the three-dimensional structure 101 forming implant 200 may also include a second group of contour lines 121. Different from the first group of contour lines 119 forming a complete profile around the periphery 107 of the first outer surface area, each contour line of the second group of contour lines 121 may form a semi-profile around the second outer surface area. The semi-profile of the second group of contour lines 121 may only partially (as 30% to 80%, or for example 40% to 70%, or for example 50% to 70%) extend around the periphery of the layer. For example, the second group of contour lines 121 may be arranged at (or for example around) the upper end portion 109 of the second outer surface area 106, and the lower end portion 111 of the second outer surface area 106 may not have (may not have) contour lines. The second group of contour lines 121 may be arranged successively relative to each other between the first outer surface area and the vertex area. Optionally, the second group of contour lines 121 need not be formed at the periphery of each transverse layer, but may be formed at the periphery of every other layer or at the periphery of every other layer group.

[0107] Optionally, the surface pore size of the openings at the surface of the upper portion 109 may be determined by the vertical spacing between consecutive (directly adjacent) contours of the second set of contours 121. For example, the vertical spacing between consecutive contours of the second set of contours may range from 0.5 mm at the upper interface region 114 to (or, for example, increase to) 5 mm at the vertex region 112 of the second outer surface region 106. With respect to the direction of increasing pore size, the direction of increase is indicated by arrow 113. Optionally, the vertical spacing between consecutive contours of the second set of contours may increase from 0.5 mm to 4 mm (or, for example, from 0.5 mm to 2 mm).

[0108] The three-dimensional structure 101 of implant 200 can be formed by surface degradable polymer. Surface degradable polymer material can be a polymer material that is degraded mainly by surface degradation mechanism (contrary to main body degradation). For example, surface degradation means the decomposition of the outer surface of polymer material (contrary to the inside of polymer material). The decomposition rate of the outer surface of polymer material can be at least 2 times (or for example at least 5 times, or for example at least 10 times, or for example at least 100 times) of the decomposition rate of the inside of polymer material. Main body degradation means that the outer surface and the inside of the material are degraded or decomposed at the same rate and at the same time (such as the ratio of the external decomposition rate to the internal decomposition rate is less than 1.2). Surface degradable polymer can be such as biodegradable polymer. The multiple lines (or all lines) can include or be produced from or made from biodegradable materials. Biodegradable materials can be materials such as those described in international patent application WO 2016 / 038083. In an illustrative example, the biodegradable material may be selected from polycaprolactone, poly(1,3-trimethylene carbonate), polylactic acid, polyglycolide, poly(ester amide), poly(ethylene glycol) / poly(butylene terephthalate), poly(glycerol sebacate), poly(1,8-octanediol-citric acid copolymer), poly(1,10-decanediol-D,L-lactic acid copolymer), poly(citric acid glycol), poly(glycolide-caprolactone copolymer), poly(1,3-trimethylene carbonate-lactide copolymer), poly(1,3-trimethylene carbonate-caprolactone copolymer), or a copolymer of at least two of these materials. Optionally, the biodegradable material may be polycaprolactone. Optionally, the biodegradable material may be a copolymer of polycaprolactone and polytrimethylene carbonate or polylactic acid. Alternatively, the plurality of threads may include a non-degradable material such as nylon.

[0109] Figure 5 A perspective top view of implant 200 is shown. Implant 200 may include a combination of Figures 1B to 4B One or more or all of the features described above, and various other features.

[0110] In some embodiments, the implant 200 is an implant for insertion into a patient's body. The implant comprises a porous three-dimensional scaffold structure comprising an arrangement of unit cells 102, wherein the overall porosity of the implant is at least 80%.

[0111] In some specific embodiments, the implant 200 comprises a porous three-dimensional scaffold structure 101 comprising an arrangement of unit cells 102. A plurality of unit cells 102 are arranged to form a porous network of the three-dimensional scaffold structure 101. The average pore size of the plurality of unit cells 102 of the three-dimensional structure 101 is at least about 0.5 mm (or, for example, at least about 0.75 mm, or, for example, at least about 0.8 mm, or, for example, at least about 1 mm, or, for example, at least about 1.5 mm, or, for example, at least about 2 mm, or, for example, at least about 5 mm).

[0112] In some embodiments, implant 200 comprises a three-dimensional porous scaffold structure 101, which includes a plurality of hollow channels 118 extending between a first outer surface region (not shown in the top view) and a second outer surface region 106 of the three-dimensional porous scaffold 101. The porous scaffold structure 101 comprises a surface-degradable polymer material. The first outer surface region is configured to face the chest wall of a patient receiving the implant. The geometry of the second outer surface region represents the geometry of a breast to be constructed using implant 200. The plurality of hollow channels 118 are configured to align with the Cooper's ligaments of a patient receiving the implant.

[0113] The implant 200 includes a porous three-dimensional scaffold structure 101, which includes an arrangement structure composed of unit cells 102. The diagram shows the implant 200, which includes, for example, a plurality of lines, contour lines 119, and a surface filling portion 122. The implant 200 may include a porous three-dimensional scaffold, which includes an arrangement structure composed of unit cells. A plurality of unit cells 102 are arranged to form a porous network of a three-dimensional structure. The pore size of the plurality of unit cells 102 of the three-dimensional structure may be at least 0.5 mm.

[0114] The plurality of lines (eg, intersection lines, contour lines, surface fill lines) may include a degradable (eg, surface degradable) polymer material.

[0115] The mechanical challenges of daily activities may exceed the elastic capacity of breast tissue and ultimately result in irreversible tissue stretch that is proportional to the mass introduced. Contrary to long-standing dogma, the weight of the implant, rather than its volume, may serve as the basis for future tissue damage and deformation. For example, the elastic tissue of the breast can be represented by a spring with a constant K. In a static upright posture, the weight of the implant can displace the breast downward with a force proportional to the weight of the implant, as described by the following formula: F = m x g, where F is the force, m is the mass, and g is the standard gravity constant. The stretching of the tissue can be linear (within the elastic limit of the tissue), and therefore, the displacement of the tissue can increase in direct relation to the weight of the implant. The displacement is described as Δx = F / K, where Δx is the displacement, F is the applied force, and K is the spring constant. Conventional heavier implants can result in increased force and therefore stretching of the breast compared to lighter implants. Implant 200, being a lightweight implant, may reduce deformation and reduce the extent of breast tissue damage, which may reduce subsequent re-operations, further improving patient safety and satisfaction.

[0116] In order to alleviate the problem of weight affecting the shape of the result, the implant 200 may include a low-density scaffold so that for the same volume, the weight of the implant 200 can be reduced, and therefore, the force acting on the breast can be reduced. The weight (mass) of the scaffold can be described by the following formula:

[0117] m=ρ*V

[0118] Where m is the mass of the support, ρ is the density of the support, and V is the volume of the support.

[0119] The implant 200 may include a low density scaffold and a highly porous scaffold. The bulk (or overall) porosity of the implant of the present invention may be described by the following formula:

[0120]

[0121] Where V V is the volume of the void space, and V T is the total volume of the scaffold.

[0122] Therefore, the volume of the bracket can be expressed as:

[0123] V=V T -V V .

[0124] The bulk (or overall) porosity of the implant (scaffold) may be at least 80%, or at least 85%, or at least 90%, or at least 95%. The material density p of the implant 200 may be 0.1 gr / cm 3 Up to 2gr / cm 3 In the range (or for example in the range of 0.1 gr / cm3 Up to 1gr / cm 3 In the range of 0.1 gr / cm 3 Up to 0.5gr / cm 3 The material density can be determined by dividing the mass of the implant 200 by the idle volume of the implant prior to insertion into the patient. In comparison, the material density of polysiloxane / silicone is 0.98 gr / cm 3 , and the material density of the salt solution is 1.005gr / cm 3 Thus, the mass of implant 200 is at most 0.1 times its volume in milliliters, and at most 0.1 times that of a conventional non-porous silicone / saline solution implant whose mass is in grams and whose mass is approximately the same as its volume in milliliters. For example, a 250 ml volume implant 200 weighs 25 g, while a 250 ml volume conventional silicone / silicone implant weighs 240 g, and a 250 ml volume saline solution implant weighs 250 g. One or more or all of these features result in an implant having a lightweight scaffold, wherein the mass can be reduced by 90% compared to conventional implants.

[0125] Fig. 6A A graphical illustration 600 is shown representing a c-value representation of the softness of the implant 200. The graphical illustration shows a graph of force (N) 131 versus strain value ε (%) 132 at various levels of compression applied to the implant 200.

[0126] The c value can be expressed as follows:

[0127]

[0128] F 20％ The force value when the compression rate is 20%, in N,

[0129] F 10％ is the force value when the compression rate is 10%, in N.

[0130] ε 10％ is the strain value when the compression rate is 10%,

[0131] ε 20％ It is the strain value when the compression rate is 20%.

[0132] like Fig. 6AAs shown, implant 200 may have a lower c value (i.e., the implant is softer) than other implants (implants without multiple spring-like unit cells of implant 200). For example, the c value representing the softness of implant 200 may be in the range of 20N to 200N (such as in the range of 20N to 150N, or for example in the range of 20N to 90N, or for example in the range of 30N to 90N, or for example in the range of 50N to 90N). The c value in the range of 20N to 90N is a good range for balancing mechanical integrity and patient comfort. The softness of the implant can be controlled to prevent deformation caused by skin tension during wound healing. For example, if the implant is too soft (such as a c value of less than 20N), implant 200 may be more easily deformed.

[0133] Figure 6B Schematic diagram showing the forces acting on implant 200.

[0134] After insertion (or implantation) into the patient's body, the implant 200 may be in direct contact with the skin and breast tissue. The combined effects of the tension of the skin 151, 152, the weight of the breast tissue overlapping the implant, and daily activities 153 (such as when a woman sleeps on her belly) may cause a compressive force 154 to act in the direction of the ridge height of the implant 200, resulting in deformation of the implant.

[0135] Figure 6C (i-iii) show the compressibility of implant 200 and the overestimation of the volume of implant 200.

[0136] Figure 6C (i) shows that the implant 200 may have an idle volume or initial shape prior to insertion into the patient.

[0137] Figure 6C (ii) An overestimation 154 of the volume of the implant 200 showing that it exceeds the build volume. Because the implant 200 may be a collapsible 3D printed structure, the constant compressive forces acting on the implant due to skin pull and tissue weight may result in permanent volume loss before stability is achieved. To ensure that the desired volume matches the actual augmented / reconstructed breast volume, the volume of the implant may be overestimated (relative to the idle volume) to account for the initial compression caused by the effects of skin pull and tissue weight. For example, the overestimation 154 of the volume may be 20% to 30% of the projected volume / elevation volume (build volume) 155 of the implant.

[0138] Figure 6C (iii) shows the volume of the implant 200 after insertion into the patient's body, where the volume of the implant matches the original required volume (built volume) due to the skin tension.

[0139] Fig.6D (i) to (iii) show the effect of skin tension on the shape of implant 200 after insertion into a patient.

[0140] Fig.6D (i) shows that implant 200 may have an idle volume or initial shape prior to insertion into a patient.

[0141] Fig.6D (ii) Shows the effect of skin tension on implant 200. To reduce the effect of skin tension on the scaffold protuberance height / projection, implant 200 has been constructed so that when tension occurs, the upper end side 109 can be compressed (or squeezed) first (in direction 157), resulting in a smooth transition between the chest wall and the nipple, and the lower end side can provide a natural breast ptosis effect (in direction 156). These two features are beneficial in giving the scaffold its built volume and the desired aesthetic and natural shape.

[0142] Fig.6D (iii) shows the implant 200 after being inserted into the patient's body. The implant 200 can recover a portion of its original volume, to at least 80% (or, for example, at least 95%) of its original volume, after being compressed during the insertion of the implant 200 into the patient's body. Therefore, the implant 200 can obtain the desired build volume and shape (such as an ideal natural shape) under the skin with the upper end side 109 compressed and the lower end side 111 drooping.

[0143] Fig. 7A The diagram shows implant 200 after insertion into a patient.

[0144] The implant 200 can be configured such that the first outer surface region 105 of the implant 200 is arranged facing the chest wall 141 of the patient 200 receiving the implant. Optionally, the implant 200 can be arranged such that the first outer surface region 105 faces the pectoral muscle 143 (e.g., the implant can be arranged on top of the pectoral muscle). The apex region 112 of the second outer surface region 106 of the implant can be located at the nipple / areola of the breast to be constructed using the implant 200 (or, for example, directly opposite the nipple / areola, or, for example, directly below the nipple / areola). The first outer surface region 105 (having an average maximum surface pore size) can be configured to face the patient's vascular source. Body fluids or blood vessels from the patient can penetrate the porous network of the implant 200 along the direction guided by the channel 118 in the implant 200. Alternatively, the implant 200 can be arranged below the pectoral muscle 143. For example, the first outer surface region 105 of the implant may be configured to face the patient's chest wall 141 , and muscles may be arranged on the second outer surface region 106 .

[0145] Figure 7BThe anatomy of a patient's breast is shown as to what is to be created using implant 200 (eg, breast augmentation, or eg, breast reduction, or eg, breast restoration).

[0146] After the implant 200 is inserted into the patient, the scaffold (e.g., three-dimensional structure) can be resorbed and regenerated tissue can be left behind. The regenerated tissue is fibrovascular tissue, which can weigh similarly to silicone implants and healthy tissue. The constant force generated by the weight of the tissue can cause irreversible tissue stretching. Therefore, the number of channels and the channel inclination can be selected to reduce tissue stretching.

[0147] Figure 7C The display represents the forces acting on the breast. The breast can be designed as a semi-elliptical bundle of length L. The mass of the breast generates a force aligned with gravity (W_Breast). F represents the reaction force acting in the muscle (F_Pectoralis Fascia) and rib (F_Ribs) areas, which helps the system maintain the shape of the breast.

[0148] Nevertheless, the force acting in tension and against gravity (F_Cooper) plays an important role (e.g., the most important role) in providing support and maintaining shape. In young, healthy breast tissue, this effect is produced by bundles of fibers called suspensory or Cooper's ligaments, which arise from the pectoral fascia and firmly connect the breast to the overlying skin that passes through and around the breast tissue. When using a traditional silicon implant, it may weigh about the same as regenerated healthy tissue, but there is no such system to attach it to the pectoral fascia.

[0149] In order to facilitate the tissue to maintain its shape and not be affected by the weight, the regenerated tissue can be reinforced in the following manner without considering any other materials (the introduction of other materials may cause safety issues): that is, by placing the material of the implant 200 so that the ligament (channel) is along the direction of the tension required to support the structure. When the material degrades in the body, the area of ​​the tissue directly surrounding the scaffold fibers is composed of regular dense connective tissue aligned / arranged along the surface of the ribs, which is the same as the composition of tendons and ligaments. Therefore, the scaffold can be anchored to the surrounding tissue and at the same time have a self-made structure (such as a template scaffold structure) that provides stability to the shape over time. Therefore, although the implant 200 is mainly described herein for breast implants, this implant is also suitable for other parts of the body, such as the chest, the buttocks area (also called buttocks), the lower leg, the face area such as the cheek (or zygomatic area), or the genital area such as the testicular area, just to name a few exemplary body parts. Therefore, the implant of the present invention can take any suitable form, which depends only on the tissue to be reconstructed or augmented. The implant may be, for example, in the form of a buttock implant as described in U.S. Pat. No. 10,004,585 (a perspective view of a buttock implant in the form described in U.S. Pat. No. 10,004,585 is shown in FIG. Fig. 6E), chest (see Figures 11A to 11E Breast implants shown to reconstruct the pectoral or chest area of ​​a patient's body), the zygomatic or cheek area (see Figures 12A to 12C , which shows a schematic diagram of a soft tissue reconstruction implant used to reconstruct the zygomatic region (or cheek)), or the testicular region (see Figures 13A to 13B , which shows a schematic diagram of a soft tissue reconstruction implant used to reconstruct the testicular area of ​​a patient's body).

[0150] Fig.7D Histological images showing regenerated breast tissue.

[0151] After insertion into the patient, the tissue regenerated within the channel 118 of the implant 200 may be loose in nature and may have a high degree of vascularisation and randomness in terms of collagen fiber arrangement (parts (i) and (ii)). However, the area of ​​tissue directly surrounding the scaffold fibers is regular dense connective tissue, which has the same composition as tendons and ligaments and is aligned along the surface of the ribs (parts (iii) and (iv)). Therefore, by using 3D printing technology to form the channel 118 of the implant 200, it is possible to control the growth location of the stiffest area of ​​the tissue.

[0152] During daily activities of healthy tissue (such as standing, running, jumping, and walking), the Cooper's ligament 144 can withstand the greatest forces and is anatomically considered to be a structural framework that can maintain the breast to be built. The multiple hollow channels 118 can be configured to align with the Cooper's ligament 144 of the patient receiving the implant 200, so that after the implant 200 is inserted into the patient's body, body fluids or blood vessels can penetrate the pores of the implant 200 (such as the hollow channels) to form tissue fibers aligned along the hollow channels, which mimics the alignment of the patient's Cooper's ligament 144 before the insertion of the implant 200. The channels 118 can be oriented in such a way that once the regenerated tissue is fully embedded in the surrounding tissue, the denser tissue will align like the Cooper's ligament (such as from the muscle 143 to the nipple 142) and apply tension to serve as support for the new tissue ( Fig. 7A ), which contributes to and improves the structural stability of the implant 200.

[0153] Fig. 7E Shows the Cooper's ligament forces acting on a ligament (or, for example, a channel with absorbed tissue).

[0154] By examining the forces of daily activities and the tensile strength of the ligament, the number of channels 118 of the implant 200 and the inclination angle of the channels 118 of the implant 200 can be determined.

[0155] Assuming that during jumping (in an extreme case), the breast mass m = 1 kg and the angle α = 60°, the force (F 库柏 ) can be in the range of 50N to 60N. After each strand / bundle is absorbed into the hollow channel 118, the area of ​​dense tissue can be roughly similar to that of a ligament. For example, the surface area of ​​a ligament (channel) with a diameter of 200 μm of the implant 200 is 314×10 -10 m 2 .

[0156] The force acting on a single dense connective tissue ligament can be calculated using the following formula:

[0157] Force = Strength (σ) x Area

[0158] The strength can be the tensile strength of the ligament and the tissue area that replaces the ligament. The tensile strength of the ligament is reported to be 40 MPa.

[0159] The maximum force borne by a single ligament can be expressed as:

[0160] F 韧带 =40×10 6 ×314×10 -10 =1.2N

[0161] In the worst case (in a jump, with a fiber diameter of 200 μm, m = 1 kg, and α = 60°), the total number of ligaments that might be needed to generate a force of 60 N is:

[0162]

[0163] For healthy breast tissue, the tilt angle α may range from 45° to 60°. Therefore, the theoretical maximum and minimum values ​​of α used by the ligaments in the three-dimensional structure can be calculated.

[0164] Figure 7F Diagram showing the internal forces acting on breast tissue when running, jumping, walking, and standing.

[0165] d2 represents the effective radius of curvature of the breast; d1 represents the center of gravity of the breast (assuming it is reasonably a semicircle); α is the dorsal insertion angle of the breast; and O is the reference point of the base of the breast.

[0166] The forces for standing, walking, running, and jumping can be expressed as follows:

[0167]

[0168] m is the breast mass and W(W 乳房 ) is the force generated by the weight of the breast.

[0169] To obtain the value of force, m can range from 0.5kg to 1kg; and α ranges from 45° to 60°. To calculate the maximum internal force of breast tissue, the acceleration is assumed to be the maximum value reported in the literature.

[0170] The acceleration can be expressed as follows:

[0171]

[0172] g=9.81m / s 2 .

[0173] The force can be calculated as follows:

[0174]

[0175] In the following examples, an extreme case is assumed, such as a small volume implant (100 ml) with 65 ligaments, a breast weight of 1 kg and no bra is worn when jumping. Maintaining balance is important to ensure that the breast maintains its shape and prevents sagging. Balance can be expressed as:

[0176] (W+ma y )×d1=(F C cosα)×d2

[0177] And α is calculated as follows:

[0178]

[0179] Where W = 9.8N, m = 1kg, a y =6×g, g=9.81m / s 2 ,and

[0180] Assuming all ligaments are in tension, the maximum force that can be applied is:

[0181] F TOT =F 韧带 × Number of ligaments = 1.2N × 65 = 78N

[0182] For example, the maximum value of α can be calculated as:

[0183]

[0184] Assume that only half of the ligament is in tension. The maximum force that can be applied is:

[0185] F TOT =F 韧带 x Number of ligaments = 1.2N x 30 = 36N

[0186] For example, the maximum value of α can be calculated as:

[0187]

[0188] Therefore, the acute inclination angle k between the hollow channel side walls of the multiple hollow channels representing the first outer surface area and a reference axis (such as the x-axis) may be in the range of 3° to 87°, or in the range of 3° to 54° (or for example in the range of 10° to 50°, or for example in the range of 25° to 45°).

[0189] After the tissue is injected into the scaffold, the implant 200 can allow tissue regeneration and maintain the vitality of the adipose tissue, which requires nutrition. The four main blood sources in the breast are the internal mammary artery, the lateral thoracic artery, the anterior intercostal artery, and the thoracoacromial artery. Therefore, the porous network and / or scaffold structure of the implant 200 composed of unit cells 102 can provide space for blood vessels to penetrate and fill the scaffold, especially at the interface between the scaffold and the main blood source. Nevertheless, for the implant 200, it is important to leave appropriate space throughout the scaffold so that blood vessels can enter from any point. However, highly porous implants can cause discomfort to the patient. For example, the higher the porosity of the implant, the higher the surface roughness and the greater discomfort to the patient. The implant 200 provides space for material exchange (potentially harmful substances that may be trapped in the scaffold can escape, and substances that help tissue regeneration can enter the scaffold), and also takes into account the comfort of the patient (for example, by reducing tissue irritation and / or inflammation). Implant 200 addresses issues of patient comfort (through space filler portions and contours) and stent security by providing a smooth interface between the stent and tissue despite the stent's porosity.

[0190] To support vascularization of the stent, it is contemplated that implant 200 may have a highly porous stent with the largest pore size at the location of the stent facing the primary blood supply (eg, Fig. 7A In order to strike a compromise between surface roughness and providing space for blood vessels to infiltrate and distribute throughout the stent, having multiple porosities (e.g., two or more different porosities and / or pore size ranges) may be considered ( Figures 2A to 2E). For example, the upper surface porosity and / or pore size range may be lower than the overall porosity value, but may face an area of ​​tissue with only a small blood supply. For example, the overall porosity and / or pore size range may be higher than the surface value and may provide space for all blood vessels to colonize the entire scaffold. Because there is the possibility of controlling fiber cohesion, the channels of the implant can be aligned towards the main supplying blood vessels, with the channels having the largest pore size at the interface between the scaffold and the muscle and the smallest pore size at the interface between the scaffold and the nipple / breast tissue. For example, the pore size at the bottom is 8mm, the pore size at the top is 2mm, and the projection / ridge height of the channel on the underside of the implant is in the range of 6mm to 2mm.

[0191] Because of the possibility of controlled fiber cohesion, implant 200 may include a full profile at the bottom to ensure implant stability, and a semi-profile in the remainder of the scaffold to ensure that porosity is maintained on the lower end of the scaffold ( Figures 4A to 4B ). The use of a semi-contour can make the surface smooth and comfortable for the patient, but at the same time maintain a certain porosity to allow material exchange and vascular penetration. In some examples, the implant 200 can include an upper surface with a porosity of about 83% and a pore size in the range of 0 to 6 mm on the upper surface. The overall porosity can be 95% and the main pore size can be in the range of 0 to 8 mm.

[0192] Unlike implant 200, conventional silicone implants may be filled with an incompressible fluid. However, over time, silicone implants may rupture, leading to health problems and possibly requiring additional surgery.

[0193] The implant 200 can be formed by 3D printing to control the fiber (channel) cohesion and produce a structure that can be reversibly compressed, thereby creating an implant 200 that is comfortable for the patient. The implant 200 can be configured to provide shape stability while retaining the softness of the implant. The implant 200 can ensure that the shape of the implant conforms to the desired shape and ensure that the final shape of the breast after insertion into the patient can be ideal and natural.

[0194] Implant 200 utilizes a spring-like system ( Figures 1C to 1D ) provides shape stability to the stent, a spring-like system that deforms when a force is applied and recovers said shape when the force is released, thereby avoiding pore blockage and avoiding any additional force applied to the chest cavity, which may cause tissue damage or in the worst case, lung damage. The reversibly compressible structure can transmit / transfer forces acting in one direction to a perpendicular direction ( Figure 1C Once the force is released, the energy stored in the process will act in the opposite direction ( Figure 1D), which helps the shape to rebound and recover its shape within 8 hours.

[0195] The shape stability and softness of the implant are important to ensure patient comfort. The implant 200 may have anisotropic mechanical properties, which may include a combination of spring-like unit cells and channels aligned with the nipple area. Due to the spring-like unit cells, the implant 200 may be soft in the lateral direction to ensure a natural feel. In addition, due to the combination of the spring-like unit cells and the orientation of the channels (along the printing direction), the implant 200 may still be soft but strong enough to maintain shape under the weight of tissue and other forces.

[0196] To ensure shape stability and desired softness of the implant 200, the anisotropic mechanical properties may include a combination of spring-like unit cell action and alignment of the channels with the direction of the applied primary force. To ensure that the volume of the scaffold in vivo is the same as the desired volume, the implant 200 may be formed by considering the forces acting on the scaffold after insertion into the patient, and a predetermined percentage of extra volume (or extra size) may be considered during the manufacturing process. To provide a natural effect, depending on the desired shape and the forces acting on the breast, it may be anticipated that the external shape may be adjusted to achieve the desired effect after the force is applied.

[0197] Figure 8 A flow chart is shown of a method 800 for forming an implant of the present invention.

[0198] The method 800 includes sequentially printing layers 830 to form a three-dimensional (3D) printed structure. The 3D printed structure defines a free volume of an implant to be formed. Each printed layer includes a grid arrangement of two-dimensional unit cells. The 3D printed structure has a porosity such that (or wherein) the 3D printed structure can be compressed to at least 80% of its free volume.

[0199] The method 800 may optionally include determining 810 a build volume of the implant prior to sequentially printing each layer. The method 800 may further include determining 820 an idle volume of the implant based on the build volume of the implant. For example, the idle volume of the implant to be printed may be an overestimate of the build volume of the implant / the idle volume may be greater than the build volume.

[0200] In method 800, sequentially printing 830 the layers may include printing a first layer to form a first outer surface region of the 3D printed structure, and printing successive layers on top of the first layer according to a printing direction. The printing direction (e.g., z-axis direction) may be a direction perpendicular to the plane of the first layer. Edge regions of the consecutively, sequentially printed layers may form a second outer surface region of the 3D printed structure adjacent to the first outer surface region. The second outer surface region may define a geometry of a breast to be constructed using the implant, and an area between the first outer surface region and the second outer surface region may define an idle volume of the implant prior to implantation into a patient.

[0201] The consecutive layers may be arranged relative to each other so that the unit cells of each layer may form a plurality of hollow channels of the 3D printed structure. The plurality of hollow channels may extend between a first outer surface region and a second outer surface region of the three-dimensional structure (e.g., in a direction from the first outer surface region toward the second outer surface region).

[0202] Optionally, the layers may be printed sequentially to form a plurality of three-dimensional unit cells (eg, tetrahedral unit cells) of a 3D structure. Optionally, the two-dimensional unit cells of a layer may be viewed as faces (or planes) of a three-dimensional unit cell.

[0203] After forming the sequentially printed layers, method 800 may further include forming 840 a plurality of surface filling portions. Forming the surface filling portions may include forming one or more filling lines to at least partially fill one or more openings (surface pores) at the outermost surface of the three-dimensional structure.

[0204] Method 800 may further include forming 850 a plurality of contour lines after sequentially printing each layer. Forming a plurality of contour lines may include forming a first group of contour lines around the periphery of the first outer surface area and / or forming a second group of contour lines. Unlike the first group of contour lines forming a complete contour around the periphery of the first outer surface area, each contour line of the second group of contour lines may form a half contour around the second outer surface area.

[0205] It is understood that the features described herein with respect to various specific embodiments may be combined with each other. Method 800 may include: Figures 1B to 7F One or more or all of the features described in relation thereto.

[0206] Experimental Example 1: Long-term implantation study of the implant of the present invention in combination with autologous fat graft (AFG) in large animals (Elegaard Göttingen minipigs)

[0207] The absorbable implants (scaffolds) described herein, made using 3D printed medical grade polycaprolactone in accordance with ISO 11137 (sterilization), 13485 (quality systems), 11607 (packaging), and 14644-1 (cleanroom) standards, were used in the study to evaluate the safety of the finished implants, including:

[0208] 1. Evaluation of long-term immune response.

[0209] 2. Evaluation of long-term AFG maintenance.

[0210] 3. Device (implant) performance.

[0211] 4. Device handling during surgery.

[0212] Elegaard Göttingen miniature pigs purchased from Elegaard, Dalmose, Denmark were used in this study. Due to the small size of the animals, a 100 cm 3 Bracket. The bracket has the following dimensions (see also Fig.9A and 9B ):

[0213] Height: 84mm.

[0214] Width: 91mm.

[0215] · Bump height / projection: 31.5mm.

[0216] • Pore size at the bottom and at the top of the implant: 4 mm (bottom), 8 mm (top), meaning the average pore size is greater than 4 mm.

[0217] The miniature pigs used in this study are 1 / 1.5 times the size of an average human female. Taking into account the difference in size, the equivalent size of the stent in an average human female is:

[0218] Height: 126mm.

[0219] Width: 136.5mm.

[0220] · Bump height: 47.25mm.

[0221] • Pore size at the bottom and at the top of the implant: 4 mm (bottom), 8 mm (top), meaning the average pore size is greater than 4 mm.

[0222] Therefore, the selected implant (scaffold) size in miniature pigs corresponds to a volume of 300 cm 3The implant is intended to be placed in a female of average size. However, it should be noted that the implant used in this animal study is also intended for use in human patients, i.e., female patients of smaller than average size.

[0223] The study included a total of 32 animals randomized into three time point groups (6-week pilot study, 12-month and 24-month main studies).

[0224] 12 month time point → 16 animals.

[0225] 24 month time point → 16 animals (n=32 treatments).

[0226] The following four treatment groups were selected in this study.

[0227] 1. Group 1 was a negative control group, in which only the implant of the present invention (ie, no AFG) was implanted.

[0228] 2. In group 2, after implantation of the implant (stent) of the present invention, AFG (50 cm 3 ) added to the scaffold volume.

[0229] 3. In group 3, after implantation of the implant of the present invention, autologous fat injection (50 cm 3 ).

[0230] 4. Group 4 was the positive control group, in which only AFG was performed, which was equivalent to the standard AFG procedure in humans as much as possible.

[0231] Magnetic resonance imaging (MRI) was used to assess tissue penetration into the implants of the present invention. Fig. 9C Two weeks after implantation in miniature pigs in treatment group 3, some tissue had infiltrated the implants. Fig.9D It was shown that at 4 weeks after implantation, complete and rapid tissue penetration into the minipig implant occurred. In this context, it should be noted that complete tissue penetration was only observed after 24 weeks using implants as described in WO 2016 / 038083 and Chhaya et al. (2016, supra). Thus, the implants of the present invention result in faster tissue penetration, providing a significant advantage over known implants.

[0232] In this study, it was found that compared to, for example, WO 2016 / 038083 and Chhaya et al. (2016, supra), the implant (scaffold) design has the following other functional differences.

[0233] Pore ​​Size and Porosity:

[0234] All open documents related to soft tissue engineering, including WO 2016 / 038083 and Chhaya et al. (2016, supra), describe a scaffold with an average pore size of less than or equal to 1 mm. On the contrary, in order to regenerate a large tissue volume (>50 ml) in a clinically relevant environment, the present invention finds that a large pore (>1 mm) is required to allow blood vessels to effectively penetrate into the central region of the implant. The pore size of the implant of the present invention used in this study is 8 mm at the bottom and 4 mm at the top (apex), so this demand can be met, so that blood vessels can effectively penetrate into the central region of the implant.

[0235] Mechanical properties

[0236] Studies such as Chhaya et al. (2016, supra) aimed at regenerating large amounts of soft tissue describe the use of small pore sizes (<0.5 mm) combined with a rigid porous architecture. The rigid architecture was found to cause irritation within the tissue. This irritation issue was shown to cause mild chronic inflammation within the pores of the device, as shown in Figure 4 of Chhaya et al. (2016, supra) (reproduced here as Fig. 10A ) – Characterized by invasion of tissues by lymphoid structures.

[0237] On the contrary, if Fig. 10B As shown, the highly porous and spring-like compressible implants produced with the design features specified in the present application do not cause any irritation or chronic inflammation. Therefore, the ability of the implant of the present invention to avoid inflammation after implantation due to these mechanical properties, together with the very rapid tissue penetration ability and the light weight of the implant, make the implant of the present invention an ideal candidate for tissue restoration and expansion.

[0238] Figures 11A to 11E Several diagrams of soft tissue reconstruction implants 300 are shown for use in reconstructing the pectoralis muscle or pectoralis region of a patient's body, such as in the case of congenital pectus excavatum. Implant 300 may include a combination of Figures 1B to 10B One or more or all of the features described above, and various other features.

[0239] Fig.11A and 11B An individual bottom view of a pectoral implant 300 is shown. The pectoral implant may include a first outer surface region 105, which may be the largest plane (or, for example, a flat surface) of the implant. Continuous layers of unit cells may form a plurality of hollow channels extending between the first outer surface region 105 and the second outer surface region 106 of the three-dimensional structure 101 of the pectoral implant 300.

[0240] Fig. 11C and 11DA perspective side view and a top view are shown of a pectoral implant 300. The contour and shape of the second outer surface region 106 can be based on the desired size and shape of the pectoral implant 300.

[0241] Fig.11E A cross-sectional side view of a pectoral implant is shown showing a plurality of hollow channels extending between a first outer surface region 105 and a second outer surface region 106 of a three-dimensional structure 101 of a pectoral implant 300 .

[0242] Experimental Example 2: Breast Implant Phase 1 Trial

[0243] The soft tissue reconstruction implant described herein (such as the pectoral implant 300) is an absorbable soft tissue reconstruction scaffold used to reconstruct the pectoral muscles or pectoral region of a patient's body, such as in the case of congenital pectus excavatum. The impact of the surgery was reported at: https: / / www.abc.net.au / news / 2020-07-21 / world-first-3d-chest-scaffold-funnel-chest-queensland / 12477704).

[0244] Currently, there are three main surgical options for breast mound reconstruction after mastectomy or for congenital defects such as pectus excavatum. Reconstruction with silicone implants involves several disadvantages, including capsular contracture. In addition, silicone implants can rupture, dislodge, deform, and develop chronic seromas, or hematomas. Free tissue transfers (such as latissimus dorsi, pedicled transverserectus abdominis myocutaneous, or deep inferior epigastric perforator flap surgery) usually require 8 to 9 hours and are associated with a prolonged hospital stay and a prolonged recovery period. The main complication of these is that clots sometimes form in the veins used to drain blood from the flap or in the arteries used to supply blood to the flap. Both conditions can lead to necrosis of the flap tissue. Finally, autologous fat transfer or fat injection methods produce poor clinical results for large-volume reconstruction (greater than 100cc) due to tissue resorption and necrosis that reduce the graft volume by 40% to 60%. There are two other methods for excavated pectus defects: Nuss surgery and vacuum cage. The key step of the Nuss surgery is the introduction of a curved rod to lift the sternum. Complications of this operation include such as long-term pain, secondary surgery (in which the curved rod needs to be removed several years later), possible damage to the heart and lungs during the operation, and misplacement of the curved rod. Another solution is the vacuum cage, which lifts the sternum with a suction cup without surgical intervention, which has poor clinical results for severe cases of excavated pectus and cannot be used in patients with heart disease.

[0245] The trials conducted by the chest implants described herein were conducted by plastic surgeons and reconstructive surgeons for surgery on congenitally deformed pectus excavatum. Pectus excavatum (pectus excavatum syndrome) is a chest deformation characterized by a depression in the middle or lateral side of the sternum. Pectus excavatum syndrome can occur in 1% to 2% of the population and is the most common congenital thoracic vertebral deformity. The surgery for implanting the implant into the patient is designed to be a minimally invasive surgery that does not contact any bones and is less painful to recover from than other treatments, and wherein an absorbable scaffold is used, which provides simplicity compared to other techniques using polysiloxane / silicone / silicone. The patient had pectus excavatum deformity and was born with lymphatic disease affecting the chest wall and upper limbs, and limb hypertrophy. This symptom is called Klippel-Trenaunay syndrome. An old scar of 6 cm previously used to insert a tissue expander was used to approach the front of the sternum. This necessarily includes releasing the sternocostal head of the ipsilateral pectoralis major muscle, as is conventional in breast expansion surgery. Once a space / pocket is created for the implant to accommodate, the implant is inserted. Fat grafts are then harvested from the patient's thigh and abdomen. The fat is prepared using the standard Coleman fat transfer technique and then injected directly into the implant using a standard fat injection cannula. An important part of the procedure is the injection of the patient's own fat into the scaffold at the time of implant insertion or a few weeks later. This stimulates regeneration of the highly porous scaffold and a significant amount (such as greater than 70%, or such as greater than 80%, or such as greater than 90%) of the patient's own tissue. The wound is then closed in a standard two-layer manner. No surgical drainage is required. A light compression dressing is used as is routine for breast implant surgery. Significant differences can be observed when using the camouflaged 3D printed scaffold to mask deformities such as pectus excavatum. The patient has undergone 17 surgeries for his pectus excavatum deformity, which affects his heart and lung function. The surgery can mask the deformity without damaging his organs. In addition, the material of the implant allows the implant to completely disappear after a period of time.

[0246] The implants described herein are implanted by minimally invasive surgery. The absorbable (e.g., fully absorbable) porous scaffold has highly specialized topological and design features and can be used as a platform for injected adipose tissue obtained using standard liposuction surgery. The absorbable polymer supports the regeneration of natural breast tissue after implantation. The tissue can be regenerated from the patient's own fat without the need to cultivate stem cells or animal-derived products. The implant is absorbed over a period of time (e.g., two years) and provides a stable platform for the injected adipose tissue to mature, adapt to its environment, and stabilize. Other implants may not have this degree of compressibility or flexibility, and / or are not designed to disappear. For example, silicone implants need to be replaced due to complications such as capsular contracture, and silicone implants are not lifelong devices. For example, in a sense, patients with silicone implants will need up to three revision surgeries throughout their lifetime. The implants described herein avoid these revision procedures by providing a porous network in which the patient's own tissue can regenerate after the implant is implanted into the surgical site. Furthermore, the reversible compressibility and spring-like properties of the implant allow the stent to be folded and / or compressed such that only very small incisions are required, which minimizes disruption to the patient's body and / or surgical scars or wounds.

[0247] Other illustrative examples of the soft tissue reconstruction implant of the present invention

[0248] Figures 12A to 12C A schematic diagram of a soft tissue reconstruction implant 400 for use in reconstructing the zygomatic region (or cheek) of a patient's body is shown. The implant 400 may include a combination of Figures 1B to 11E One or more or all of the features described above, and various other features.

[0249] Fig. 12A and 12B A perspective top view of a zygomatic implant 400 is shown. Fig. 12C A side view of a zygomatic implant 400 is shown. The zygomatic implant may include a plurality of hollow channels extending between a first outer surface region 105 and a second outer surface region 106 of a three-dimensional structure 101 of the zygomatic implant 400. The zygomatic implant may also include a contour line 421 that forms a complete contour and / or a partial contour around the perimeter of the first outer surface region 105 and the second outer surface region 106. The zygomatic implant may optionally include an apex region 112. The distance between the apex region 112 of the second outer surface region 105 and the first outer surface region 105 may be the maximum height between any location of the second outer surface region 105 and the first outer surface region 105.

[0250] The spring-like, reversibly compressible implant allows the zygomatic implant to mimic the softness and reversible compressibility of the patient's cheek (eg, the consistency of human fat and tissue).

[0251] Figures 13A to 13B A perspective side view and a top view are shown, respectively, of a soft tissue reconstruction implant 500 for reconstruction of a testicular region of a patient's body. The implant 500 may include a combination of Figures 1B to 12C One or more or all of the features described above, and various other features.

[0252] The testicular implant 500 may optionally be spherical and / or oval. The testicular implant may include a plurality of hollow channels extending between the first outer surface region 105 and the second outer surface region 106 of the three-dimensional structure 101 of the testicular implant 500. Optionally, the hollow channels may be zigzag or sinusoidal channels. The implant 500 may also include a contour line 521 that forms a complete and / or partial contour around the perimeter of the first outer surface region 105 and the second outer surface region 106. Optionally, the testicular implant 500 may include a vertex region 112 at the second outer surface region 106.

[0253] Testicular implants may be performed during testicular surgery or cosmetic surgery. Testicular implant 500 may have a desired testicular size (e.g., normal human-sized testicles) and may be implanted in a patient where one or both testicles are not present. Testicular implant 500 may have features that allow it to fit within the scrotum after implantation in the scrotum. A pair of testicular implants 500 may be used to establish or restore symmetry in the testicles, such as in cases where the original testicular sizes of the patient differ greatly from each other.

[0254] Similar to saline breast implants, existing testicular implants can be filled with saline solution and therefore have similar problems / challenges as saline breast implants. After implantation, saline testicular implants may experience hardening of the capsule around the implant. In addition, infection, implant migration within the body, and scarring from the incision are all possible. The reversibly compressible testicular implant 500 allows the surgical scar to be as small as possible, thereby shortening recovery time. Therefore, the testicular implant surgery can be performed as an outpatient procedure and anesthesia can be reduced.

[0255] Each implant described herein may be a reversibly compressible implant similar to a spring, which can be restored or recovered to its original (idle) volume after removing the compressive force (without changing the ambient pressure and temperature). The spring-like implant can be compressed to at least (such as less than or equal to) 80% (or, for example, at least 70%, or, for example, at least 60%, or, for example, at least 50%, or, for example, at least 30%) of its original volume. The spring-like implant can be configured to recover to at least 80% (such as equal to or greater than 80%) (or, for example, at least 90% or, for example, at least 95%, or, for example, at least 98%, or, for example, up to 100%) of its original volume after removing the compressive force applied to the implant. The surface filling line 122 and the contour lines 119, 121, 421 also provide user comfort, which can prevent irritation. Therefore, a spring-like and smooth implant for insertion into a patient's body can be provided without the need for an external covering (such as in the case of a saline solution implant). The implant can be biodegradable. Optionally, after implantation, the implant may be injected with fat to soften the implanted area, depending on the desired softness of the implanted area. Alternatively, fat injection may not be performed during the implantation process. Tissue infiltrates the inserted implant, and after a few weeks, the implant may biodegrade.

[0256] Figures 14A to 14C Display Combination Figures 1B to 10B More details of the implant 100, 200, which may be a soft tissue reconstruction implant for reconstructing the breast region of a patient's body. The soft tissue reconstruction implant 100, 200 may be a reversibly compressible implant similar to a spring.

[0257] The implant 100, 200 includes a plurality of unit cells 102 arranged to form a spring-like three-dimensional grid structure 101, which includes the idle volume of the implant. The plurality of unit cells 102 are arranged to form a porous network of a three-dimensional structure. The overall porosity of the three-dimensional structure 101 of the implant is at least 50%, or at least 60%, or at least 70%.

[0258] Each unit cell 102 may be a reversibly compressible spring-like unit cell, wherein the reversibly compressible spring-like unit cell can be compressed to at least (e.g., equal to or less than) 10% or 20% of its original volume, and can recover to at least (e.g., equal to or greater than) 80% of its original volume.

[0259] The surface porosity of the second outer surface region 106 may be less than the overall porosity of the three-dimensional structure of the implant 100, 200. The material density of the implant may be 0.1 gr / cm 3 Up to 2gr / cm 3 within the range.

[0260] The present invention is further characterized by the following items.

[0261] Item 1: An implant for insertion into a patient's body. The implant comprises a plurality of unit cells, the plurality of unit cells are arranged to form a three-dimensional grid structure, the three-dimensional structure has an idle volume of the implant, wherein the plurality of unit cells are arranged to form a porous network of the three-dimensional structure, and wherein the three-dimensional structure is a reversibly compressible three-dimensional structure.

[0262] Item 2: The implant of Item 1, wherein a single unit cell of the plurality of unit cells comprises a reversibly compressible unit cell.

[0263] Item 3: An implant as in Item 1 or 2, wherein the unit cell of the plurality of unit cells is a three-dimensional unit cell.

[0264] Item 4: An implant as in any one of Items 2 to 3, wherein the reversibly compressible unit cell can be compressed to at least 50%, or at least 60%, or at least 70%, or at least 80% of its original volume, and can recover at least 80% of its original volume.

[0265] Item 5: The implant of any one of items 1 to 4, wherein the idle volume of the implant is based on a build volume of a breast to be built using the implant, wherein the implant is configured to be reversibly compressible to at least the build volume.

[0266] Item 6: The implant of any one of items 1 to 5, wherein each unit cell comprises an intersection line composed of a plurality of lines, wherein the intersection lines of the unit cells are configured to form pores of the plurality of unit cells.

[0267] Item 7: The implant of any one of Items 1 to 6, wherein the intersection lines of the unit cells define the pore size of the unit cells.

[0268] Item 8: The subject matter of any one of Items 1 to 7, wherein the average pore size of the plurality of unit cells of the three-dimensional structure is at least 0.5 mm.

[0269] Item 9: The implant of any one of Items 1 to 8, wherein at least 50% of the unit cells of the plurality of unit cells of the three-dimensional structure have a pore size of at least 0.5 mm.

[0270] Item 10: The implant of any one of Items 1 to 9, wherein the three-dimensional structure comprises:

[0271] a first outer surface region of the implant comprising a first surface curvature; and

[0272] a second outer surface region of the implant comprising a second surface curvature,

[0273] wherein the second outer surface region of the implant is adjacent to the first outer surface region of the implant at a periphery of the first outer surface region, and

[0274] The geometry of the second outer surface area represents the geometry of a breast to be constructed using the implant.

[0275] Item 11: The implant of Item 10, wherein the second outer surface region comprises:

[0276] an upper portion having the upper geometry of the breast to be constructed with the implant, and

[0277] a lower portion having the lower geometry of the breast to be constructed with the implant,

[0278] The upper end portion and the lower end portion meet at a vertex region of the second outer surface region of the three-dimensional structure.

[0279] Item 12: The implant of Item 11, wherein the first outer surface region comprises a surface of the implant having the smallest curvature,

[0280] wherein the curvature of the upper end portion of the second outer surface region is greater than the curvature of the first outer surface region, and

[0281] The curvature of the lower end portion of the second outer surface region is greater than or equal to the curvature of the upper end portion of the second outer surface region.

[0282] Item 13: The implant of any one of Items 1 to 13, wherein the average pore size of the openings at the first outer surface region of the three-dimensional structure is at least 25% larger than the average pore size of the openings at the second outer surface region of the three-dimensional structure.

[0283] Item 14: The implant of any one of items 10 to 13, wherein the average pore size of the openings at the first outer surface region of the implant is at least 2 mm.

[0284] Item 15: An implant as in any one of Items 11 to 14, wherein the pore size at the upper end portion of the second outer surface region increases from 0.5 mm at the upper end interface region to 5 mm at the apex region of the second outer surface region,

[0285] The upper interface region is an interface region of a three-dimensional structure in which an upper portion of the second outer surface region meets a portion of a periphery of the first outer surface region.

[0286] Item 16: An implant as in any one of items 11 to 15, wherein the pore size at the lower end portion of the second outer surface region increases from 0.15 mm or 2 mm at the lower end interface region to up to 6 mm, or up to 8 mm, or up to 9 mm, or up to 10 mm toward the apex region of the second outer surface region,

[0287] The lower end interface region is an interface region of a three-dimensional structure in which a lower end portion of the second outer surface region meets a portion of a periphery of the first outer surface region.

[0288] Item 17: An implant as in any one of Items 10 to 16, wherein the surface porosity of the second outer surface region is less than the overall porosity of the three-dimensional structure of the implant.

[0289] Item 18: An implant as described in any one of Items 1 to 17, wherein the overall porosity of the three-dimensional structure of the implant is at least 50%, or at least 60%, or at least 70%, or at least 80%.

[0290] Item 19: An implant as in Item 18, wherein the overall porosity of the implant is in the range of 50% to 99%, or in the range of at least 60% to 99%, or in the range of at least 70% to 99%, or in the range of at least 80% to 99%.

[0291] Item 20: The implant according to any one of items 1 to 19, wherein the material density of the implant is 0.1 gr / cm 3 Up to 2gr / cm 3 within the range.

[0292] Item 21: An implant as in any one of Items 1 to 20, wherein the plurality of unit cells comprises a plurality of three-dimensional unit cells, wherein the three-dimensional unit cells are tetrahedral unit cells.

[0293] Item 22: An implant according to any one of items 1 to 20, wherein the three-dimensional structure comprises a layer arrangement structure comprising a plurality of lateral layers stacked one on top of the other,

[0294] Each transverse layer of the layer arrangement structure includes a grid arrangement structure, and the grid arrangement structure includes a plurality of two-dimensional unit cells.

[0295] Item 23: The implant of Item 22, wherein the plurality of two-dimensional unit cells are at least one of triangular unit cells, diamond unit cells, rhombus unit cells, rectangular unit cells, and hexagonal unit cells.

[0296] Item 24: The implant of item 22 or 23, wherein the three-dimensional structure comprises a first outer surface region, the first outer surface region comprising a first layer of the layer arrangement structure, and

[0297] wherein the two-dimensional unit cells of the successive layers of the layer arrangement structure form a plurality of hollow channels extending between the first outer surface region and the second outer surface region of the three-dimensional structure,

[0298] The second outer surface area is adjacent to the first outer surface area at a periphery of the first outer surface area.

[0299] Item 25: An implant as in Item 24, wherein the plurality of hollow channels are parallel to each other.

[0300] Item 26: The implant of item 24 or 25, wherein the first outer surface region is configured to face a chest wall of a patient receiving the implant, and wherein the plurality of hollow channels are configured to align with Cooper's ligament of the patient receiving the implant.

[0301] Item 27: An implant as in any one of Items 24 to 26, wherein the plurality of hollow channels are inclined relative to a first outer surface region of the implant, wherein an acute inclination angle between the plurality of hollow channels and a reference axis representing the first outer surface region is less than 60 degrees.

[0302] Item 28: The implant of any one of items 24 to 27, wherein the plurality of hollow channels are configured to converge toward a convergence region, wherein the convergence region is located outside the first outer surface region or outside the second outer surface region of the three-dimensional structure.

[0303] Item 29: The implant of any one of Items 24 to 28, wherein the second outer surface region comprises:

[0304] an upper portion comprising the geometry of the upper part of the breast to be constructed with the implant, and

[0305] a lower portion comprising the geometry of the lower part of the breast to be constructed with the implant,

[0306] wherein the upper end portion and the lower end portion meet at a vertex region of the second outer surface region,

[0307] One or more channels of the plurality of hollow channels are configured to extend from the first outer surface region toward at least one of an apex region of the second outer surface region and a lower end portion of the second outer surface region.

[0308] Item 30: The implant of Item 29, wherein one or more other channels of the plurality of hollow channels are configured to extend from an upper end portion of the second outer surface region toward at least one of an apex region and a lower end portion of the second outer surface region.

[0309] Item 31: The implant of any one of Items 1 to 30, wherein a first set of contour lines in the plurality of lines are arranged around a periphery of a first outer surface region of the implant.

[0310] Item 32: The implant of Item 31, wherein the plurality of lines comprises a second set of contour lines,

[0311] wherein each contour line of the second set of contour lines forms a semi-contour around a second outer surface area of ​​the implant,

[0312] The second set of contour lines are arranged sequentially relative to each other between the first outer surface region and the vertex region of the second outer surface region.

[0313] Item 33: The implant of Item 32, wherein the second set of contour lines are arranged at an upper portion of the second outer surface region, and wherein a lower portion of the second outer surface region is free of contour lines.

[0314] Item 34: The implant of Item 22, comprising a plurality of surface filling portions, wherein the surface filling portions comprise one or more filling lines that at least partially fill openings at an outer surface region of the three-dimensional structure.

[0315] Item 35: The implant of Item 34, wherein the one or more filling lines of the surface filling portion are configured to connect a set of intersecting lines defining unit cells located at an outermost surface of the three-dimensional structure.

[0316] Item 36: The implant of Item 35, wherein the three-dimensional structure comprises:

[0317] a first group of unit cells at an outermost surface of the three-dimensional structure, the first group of unit cells comprising surface-filling portions occupying openings of the first group of unit cells, and

[0318] A second group of unit cells at an outermost surface of the three-dimensional structure, the second group of unit cells having no surface-filling portion.

[0319] Item 37: The implant of any one of Items 34 to 36, wherein at least 20% of the unit cells of the plurality of unit cells at the outermost surface of the three-dimensional structure are at least partially filled with a surface-filling portion.

[0320] Item 38: The implant of Item 37, wherein a plurality of surface filling rows and a plurality of opening rows are alternately arranged in the outer surface area,

[0321] wherein the openings of the surface-filling columns at the outermost surface of the three-dimensional structure are at least partially filled with the surface-filling portion, and

[0322] The openings of the opening row at the outermost surface of the three-dimensional structure have no surface filling portion.

[0323] Item 39: An implant as in Item 38, wherein the surface fill column comprises channel side walls of a plurality of hollow channels.

[0324] Item 40: An implant as described in any one of Items 1 to 39, wherein the c value representing the softness of the implant is in the range of 20N to 200N.

[0325] Item 41: An implant as in any one of items 6 to 40, wherein the plurality of threads comprise a surface degradable polymer material.

[0326] Item 42: An implant as in any one of Items 6 to 40, wherein the plurality of threads comprise a non-degradable material.

[0327] Item 43: An implant as in any one of Items 24 to 42, wherein the plurality of hollow channels comprises 5 to 1000 hollow channels.

[0328] Item 44: An implant for insertion into a patient's body, the implant comprising:

[0329] A porous three-dimensional scaffold structure comprising an arrangement of unit cells, wherein the overall porosity of the implant is at least 50%, or at least 60%, or at least 70%.

[0330] Item 45: The implant of Item 44, wherein the overall porosity of the implant is in the range of 75% to 99%.

[0331] Item 46: The implant of any one of Items 44 to 45, wherein the surface porosity of the implant is in the range of 30% to 80%.

[0332] Item 47: The implant of any one of Items 44 to 46, wherein the surface porosity of the implant is in the range of 40% to 70%.

[0333] Item 48: The implant of any one of Items 44 to 47, wherein the surface porosity of the implant is in the range of 50% to 60%.

[0334] Item 49: An implant according to any one of items 44 to 48, wherein the material density of the implant is 0.1 gr / cm 3 Up to 2gr / cm 3 within the range.

[0335] Item 50: The implant of any one of items 44 to 48, wherein a single unit cell of the plurality of unit cells is a spring-like unit cell, wherein the spring-like unit cell is reversibly compressible.

[0336] Item 51: The implant of any one of Items 45 to 51, wherein the three-dimensional structure comprises:

[0337] a first outer surface region of the implant comprising a first surface curvature; and

[0338] a second outer surface region of the implant comprising a second surface curvature,

[0339] wherein the second outer surface region of the implant adjoins the first outer surface region of the implant at a periphery of the first outer surface region, and

[0340] The geometry of the second outer surface area represents the geometry of a breast to be constructed using the implant.

[0341] Item 52: The implant of Item 51, wherein the second outer surface region comprises:

[0342] an upper portion comprising the geometry of the upper part of the breast to be constructed with the implant, and

[0343] a lower portion comprising the geometry of the lower part of the breast to be constructed with the implant,

[0344] The upper end portion and the lower end portion meet at a vertex region of the second outer surface region of the three-dimensional structure.

[0345] Item 53: An implant as in Item 51 or 52, wherein the surface porosity of the second outer surface region is less than the surface porosity of the first outer surface region.

[0346] Item 54: An implant for insertion into a patient's body. The implant comprises:

[0347] A porous three-dimensional scaffold structure comprising an arrangement structure composed of unit cells,

[0348] where multiple unit cells are arranged to form a porous network with a three-dimensional structure,

[0349] The average pore size of the plurality of unit cells of the three-dimensional structure is at least 0.5 mm.

[0350] Item 55: The implant of Item 54, wherein the average pore size of the plurality of unit cells of the three-dimensional structure is at least 3 mm.

[0351] Item 56: The implant of Item 54 or 55, wherein at least 50% of the unit cells of the plurality of unit cells of the three-dimensional structure have a pore size of at least 0.5 mm.

[0352] Item 57: The implant of any one of Items 54 to 56, wherein the three-dimensional structure comprises:

[0353] a first outer surface region of the implant comprising a first surface curvature; and

[0354] a second outer surface region of the implant comprising a second surface curvature,

[0355] wherein the second outer surface region of the implant adjoins the first outer surface region of the implant at a periphery of the first outer surface region, and

[0356] The geometry of the second outer surface area represents the geometry of a breast to be constructed using the implant.

[0357] Item 58: The implant of Item 57, wherein the second outer surface region comprises:

[0358] an upper portion comprising the geometry of the upper part of the breast to be constructed with the implant, and

[0359] a lower portion comprising the geometry of the lower part of the breast to be constructed with the implant,

[0360] The upper end portion and the lower end portion merge at a vertex region of the second outer surface region of the three-dimensional structure.

[0361] Item 59: The implant of any one of Items 55 to 58, wherein an average pore size at a first outer surface region of the three-dimensional structure is at least 25% larger than an average pore size at a second outer surface region of the three-dimensional structure.

[0362] Item 60: The implant of item 58 or 59, wherein the average pore size at the first outer surface region of the implant is at least 8 mm.

[0363] Item 61: An implant as in any one of Items 55 to 58, wherein the pore size at the upper end portion of the second outer surface region increases from 0.5 mm at the upper end interface region to 5 mm at the apex region of the second outer surface region,

[0364] The upper interface region is an interface region of a three-dimensional structure in which an upper end portion of the second outer surface region intersects a portion of a periphery of the first outer surface region.

[0365] Item 62: An implant as in any one of items 58 to 61, wherein the pore size at the lower end portion of the second outer surface region increases from 2 mm at the lower end interface region to up to 6 mm towards the apex region of the second outer surface region,

[0366] The lower end interface region is an interface region of a three-dimensional structure in which a lower end portion of the second outer surface region meets a portion of a periphery of the first outer surface region.

[0367] Item 63: An implant as in any one of items 54 to 62, wherein the pore size of the openings at the second outer surface region of the implant increases from 0.5 mm at the upper end interface region to 2 mm at the apex region of the second outer surface region.

[0368] Item 64: The implant of any one of items 54 to 63, wherein the pore size of the openings at the second outer surface region of the implant increases from 2 mm at the lower end interface region to up to 6 mm toward the apex region.

[0369] Item 65: An implant for insertion into a patient's body. The implant comprises:

[0370] a three-dimensional porous scaffold comprising a plurality of hollow channels extending between a first outer surface region and a second outer surface region of the three-dimensional porous scaffold,

[0371] The porous scaffold comprises a surface degradable polymer material.

[0372] wherein the first outer surface area is configured to face a chest wall of a patient receiving the implant,

[0373] wherein the geometry of the second outer surface area represents the geometry of a breast to be created using the implant, and

[0374] The plurality of hollow channels are configured to align with the Cooper's ligament of a patient receiving the implant.

[0375] Item 66: The implant of Item 65, wherein the three-dimensional porous scaffold comprises a plurality of transverse layers stacked in sequence, wherein each transverse layer of the layer arrangement structure comprises a grid arrangement structure, wherein the grid arrangement structure comprises a plurality of two-dimensional unit cells,

[0376] The two-dimensional unit cells of the plurality of transverse layers of successive layers / sequentially arranged layers are arranged to form a plurality of hollow channels extending between a first outer surface region and a second outer surface region of the three-dimensional porous scaffold.

[0377] Item 67: The implant of item 65 or 66, wherein the second outer surface region is adjacent to the first outer surface region at a periphery of the first outer surface region.

[0378] Item 68: The subject matter of any one of Items 65 to 67, wherein the plurality of hollow channels are inclined relative to a first outer surface region of the implant, wherein an acute inclination angle between the plurality of hollow channels and a reference axis representing the first outer surface region is less than 60 degrees.

[0379] Item 69: The subject matter of any one of Items 65 to 68, wherein the plurality of hollow channels are configured to converge toward a convergence region, wherein the convergence region is located outside of a first outer surface region of the three-dimensional structure or outside of a second outer surface region of the three-dimensional structure.

[0380] Item 70: The subject matter of any one of Items 63 to 67, wherein the second outer surface region comprises:

[0381] an upper portion comprising the geometry of the upper part of the breast to be constructed with the implant, and

[0382] a lower portion comprising the geometry of the lower part of the breast to be constructed with the implant, wherein the upper portion and the lower portion meet at the apex region of the second outer surface region,

[0383] One or more channels of the plurality of hollow channels are configured to extend from the first outer surface region toward at least one of an apex region of the second outer surface region and a lower end portion of the second outer surface region.

[0384] Item 71: The implant of item 70, wherein one or more other channels of the plurality of hollow channels are configured to extend from an upper end portion of the second outer surface region toward at least one of an apex region and a lower end portion of the second outer surface region.

[0385] Item 72: The implant of any one of items 1 to 71, wherein the overall porosity of the implant is at least 50%, or at least 60%, or at least 70%, or at least 80%, wherein the overall porosity is described by the following formula:

[0386]

[0387] Where V V is the volume of the void space, and V T is the total volume of the scaffold.

[0388] Item 73: A method for forming an implant, wherein the method comprises:

[0389] The layers are sequentially printed to form a three-dimensional (3D) printed scaffold structure that defines the unused volume of the implant to be formed,

[0390] Each printing layer includes a grid arrangement structure composed of two-dimensional unit cells.

[0391] Wherein the 3D printed structure has an overall porosity that enables the 3D printed structure to be compressed to at least 80% of its idle volume.

[0392] Item 74: The method of Item 73, wherein an average pore size of the plurality of unit cells of the three-dimensional structure is at least 0.5 mm.

[0393] Item 75: The method of item 73 or 74, wherein

[0394] The layers are printed sequentially, including:

[0395] printing a first layer to form a first outer surface region of the 3D support structure, and

[0396] Successive layers are printed on the first layer according to the printing direction, and edge regions of the consecutive layers form a second outer surface region of the 3D support structure adjacent to the first outer surface region.

[0397] Item 76: A method as described in any one of Items 73 to 75, wherein

[0398] The unit cells of the layers of the three-dimensional (3D) scaffold structure form a plurality of hollow channels extending between a first outer surface region and a second outer surface region of the three-dimensional structure.

[0399] Item 77: A method as described in any one of Items 73 to 76, wherein

[0400] The layers are printed sequentially to form a plurality of three-dimensional unit cells of a three-dimensional (3D) printed scaffold structure.

[0401] Item 78: A method for forming an implant, the method comprising:

[0402] The layers (830) are sequentially printed to form a three-dimensional (3D) printed structure, the 3D printed structure defining the idle volume of the implant to be formed,

[0403] Each printed layer includes a grid arrangement structure composed of two-dimensional unit cells.

[0404] The three-dimensional printed structure has an overall porosity that enables the three-dimensional printed structure to be compressed to at least 80% of its idle volume.

[0405] Item 79: A method for tissue reconstruction or tissue expansion, the method comprising: implanting an implant defined in any one of Items 1 to 72 or an implant manufactured using a method defined in any one of Items 73 to 78 into a subject's body.

[0406] Item 80: A method as in Item 79, wherein the method comprises reconstruction of a body part.

[0407] Item 81: The method of Item 80, wherein the body part is selected from the group consisting of the buttocks region, the lower leg, and a portion of the face, chest, and genital area.

[0408] Item 82: The method of Item 81, wherein the part of the face is a cheek.

[0409] Item 83: A method as described in any one of Items 80 to 82, wherein the method comprises chest reconstruction or breast reconstruction.

[0410] Item 84: The method of Item 83, wherein breast reconstruction is performed after lumpectomy or mastectomy.

[0411] Item 85: A method as in Item 83, wherein the chest reconstruction comprises reconstructing the pectoral muscles or chest area of ​​the patient's body.

[0412] Item 86: A method as in Item 85, wherein the chest reconstruction comprises treating congenital pectus excavatum.

[0413] Having thus described the particular embodiments of the present invention in detail, it should be understood that the present invention as defined by the appended claims is not limited to the specific details set forth in the foregoing description, since many obvious variations are possible without departing from the spirit or scope thereof.

Claims

1. A soft tissue reconstruction implant (100, 200, 300, 400, 500) for insertion into a patient's body, the implant comprising: A plurality of repeated unit cells (102), the plurality of unit cells are connected to each other to form a three-dimensional grid structure (101), the unit cell (102) is a basic unit of the three-dimensional grid structure, wherein the three-dimensional grid structure has an idle volume of an implant, wherein the plurality of unit cells (102) are arranged to form a porous network of the three-dimensional grid structure, wherein the three-dimensional grid structure (101) is a reversibly compressible three-dimensional grid structure, wherein the overall porosity of the three-dimensional grid structure (101) of the implant is at least 50%; a plurality of surface filling portions arranged to form a plurality of surface filling columns (125) located at the outer surface region; and A plurality of opening columns are located at the outer surface area, the plurality of opening columns being free of surface filling portions.

2. The implant according to claim 1, wherein A single unit cell (102) of the plurality of unit cells is a reversibly compressible unit cell like a spring, wherein the three-dimensional grid structure can be compressed to at least 80% of its idle volume.

3. The implant according to claim 1 or 2, comprising layers composed of the unit cells arranged one above the other, in, The edge regions of the layers of the three-dimensional grid structure form an outer surface region of the implant, wherein the outer surface region assumes the geometry of the patient's body part to be constructed by the implant.

4. The implant according to claim 1, wherein The average pore size of the openings at the first outer surface region (105) of the three-dimensional grid structure (101) is at least 25% larger than the average pore size of the openings at the second outer surface region (106) of the three-dimensional grid structure (101).

5. The implant according to claim 1, wherein The three-dimensional grid structure (101) comprises: a first outer surface region (105) of the implant having a first surface curvature; and a second outer surface region (106) of the implant having a second surface curvature, wherein the second outer surface region (106) of the implant is adjacent to the first outer surface region (105) of the implant at a periphery (107) of the first outer surface region (105), and Therein, the geometry of the second outer surface area (106) represents the geometry of the breast area, the zygomatic area, the buttocks area or the genital area to be constructed by the implant.

6. The implant according to claim 5, wherein The second outer surface region (106) comprises: an upper portion (109) having the geometry of the upper part of the breast to be constructed by the implant; and a lower portion (111) having the geometry of the lower part of the breast to be constructed by the implant, The upper end portion (109) and the lower end portion (111) merge at a vertex region (112) of the second outer surface region (106) of the three-dimensional grid structure (101).

7. The implant according to claim 6, wherein The pore size of the openings at the second outer surface region (106) of the implant increases from 0.5 mm at the upper end interface region (114) to 2 mm or 5 mm at the apex region of the second outer surface region, and from 10 mm, or 8 mm, or 6 mm at the lower end interface region (115) to 0.5 mm toward the apex region (112).

8. The implant according to claim 6, wherein The pore size of the openings at the second outer surface region (106) of the implant increases from 0.5 mm at the upper end interface region (114) to 2 mm or 5 mm at the apex region of the second outer surface region, and increases from 0.5 mm at the lower end interface region (115) to up to 6 mm, or up to 8 mm, or up to 10 mm toward the apex region (112).

9. An implant according to any one of claims 4 to 8, wherein The surface porosity of the second outer surface region is less than the overall porosity of the three-dimensional lattice structure of the implant.

10. The implant according to any one of claims 1 to 2 and 4 to 8, wherein The material density of the implant is 0.1 gr / cm 3 Up to 2gr / cm 3 within the range.

11. An implant according to any one of claims 1 to 2 and 4 to 8, wherein The three-dimensional grid structure (101) comprises: A first outer surface region (105) comprising a first layer (126) of a layer arrangement consisting of a plurality of layers (126), Each layer (126) of the layer arrangement structure includes a grid arrangement structure comprising a plurality of two-dimensional unit cells (102), wherein the two-dimensional unit cells of the layers arranged sequentially in the layer arrangement structure form a plurality of hollow channels (118) extending between a first outer surface region (105) and a second outer surface region (106) of the three-dimensional grid structure.

12. An implant according to any one of claims 4 to 8, comprising a first set of contour lines (119) of a plurality of lines and a second set of contour lines (121) of the plurality of lines, the first set of contour lines forming a complete contour around the periphery of the first outer surface area of ​​the implant, in, Each contour line of the second set of contour lines (121) forms a semi-contour surrounding a second outer surface area of ​​the implant, The second group of contour lines (121) are arranged sequentially relative to each other between the first outer surface region (105) and the vertex region (112) of the second outer surface region (106).

13. An implant according to any one of claims 1 to 2 and 4 to 8, wherein The surface filling portion (122) includes one or more filling lines (124) configured to at least partially fill openings located at an outer surface region of the three-dimensional grid structure.

14. An implant according to any one of claims 1 to 2 and 4 to 8, wherein The c value representing the softness of the implant is in the range of 20N to 200N, wherein the c value is represented by the following formula: Among them, F 20％ is the force value when the compression rate is 20%, in N. where F 10％ is the force value when the compression rate is 10%, in N. where ε 10 % is the strain value when the compression rate is 10%, and where ε 20 % is the strain value when the compression rate is 20%.

15. A method for forming a soft tissue reconstruction implant, the method comprising: printing the layers sequentially to form a three-dimensional printed grid structure comprising a plurality of repeated unit cells, the unit cells being the basic units of the three-dimensional printed grid structure, the three-dimensional printed grid structure defining an idle volume of the implant to be formed, Each printed layer includes a grid arrangement structure composed of two-dimensional unit cells. wherein the 3D printed mesh structure has an overall porosity of at least 50%, such that the 3D printed mesh structure is reversibly compressible, wherein the plurality of surface filling portions are arranged to form a plurality of surface filling columns located at the outer surface region; and A plurality of opening columns located at the outer surface area are free of surface filling portions.

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