Implant and method for forming implant

Abstract

To provide a lightweight implant that reduces the effects of ptosis in a patient and reduces adverse reactions by the patient to the implant.SOLUTION: An embodiment of the present specification relates to an implant for insertion into a patient. The implant comprises a plurality of unit cells configured to form a three-dimensional lattice structure, and the three-dimensional structure comprises a resting volume of the implant. The plurality of unit cells are configured to form a porous network structure of the three-dimensional structure, and the three-dimensional structure is a reversibly compressible three-dimensional structure, a bulk porosity of the three-dimensional structure (101) in the implant being at least 50%.SELECTED DRAWING: Figure 14B

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a joint venture with European Patent Application No. 19195332.2 filed on September 4, 2019 at the European Patent Office. No. 6,399,433, filed on Oct. 13, 2003, the entire contents of which are incorporated herein by reference for all purposes.

[0002] The embodiments disclosed herein relate to the field of implants, and in particular to soft tissue implants that are inserted into a patient. The present invention relates to an implant suitable for tissue reconstruction, a method for forming the implant, and a method for tissue reconstruction and and / or the use of said implant for tissue augmentation. [Background technology]

[0003] Breast augmentation and reconstructive mammaplasty have been performed for decades and are a very common procedure performed worldwide. While overall patient satisfaction is high, common long-term effects include These include breast tissue atrophy, accelerated ptosis (e.g., sagging) and collapse of the inframammary fold. There is evidence that these events are due to the continuous load and compressive forces induced by breast implants. For example, mechanical challenges that exceed the elastic capacity of breast tissue components can eventually lead to irreversible Conventional silicone implants are filled with an incompressible liquid. This can introduce heavy loads that can cause tissue stretching. and silicone implants can rupture, causing health problems and leading to additional surgery. Implants may also include space-occupying structures that can be filled with fluid. In Patent Document 1 and Non-Patent Document 1, a three-dimensional scaffold structure with voids is described, all of which are spatially occupied. The authors disclose an implant filled with a space-occupying structure that is a three-dimensional scaffold structure. Removably attached and configured to prevent tissue infiltration and / or individual cell infiltration. After implant placement (e.g. 6 to 8 weeks after implant placement), The occupying structure is removed from the remaining part of the implant and from the implant site in a second surgery. . [Prior art documents] [Patent documents]

[0004] [Patent Document 1] International Publication No. 2016 / 038083 [Non-patent literature]

[0005] [Non-Patent Document 1] Chhaya et al. Transformation of Breast Reconstruction via Additive Biomanufacturing. Sci. Rep. 6, 28030; doi: 10.1038 / srep28030 (2016) Summary of the Invention

[0006] Various embodiments may reduce the effects of ptosis in a patient and improve patient compliance with the implant. The present invention relates to providing a lightweight implant that reduces adverse reactions caused by the injection of

[0007] The embodiments disclosed herein relate to an implant for insertion into a patient. The implant comprises a plurality of unit cells configured to form a three-dimensional lattice structure, The original structure comprises the rest volume of the implant. The unit cells are arranged in a three-dimensional porous network. The three-dimensional structure is configured to form a tissue, and the three-dimensional structure is a reversibly compressible three-dimensional structure, The bulk porosity of the three-dimensional structure (101) in the implant is at least 50%.

[0008] Various embodiments relate to a further implant for insertion into a patient. The present invention relates to a porous three-dimensional scaffold structure including an array of unit cells, the unit cells being arranged in a three-dimensional a plurality of unit cells in the three-dimensional structure, the unit cells being configured to form a porous network of the structure; The average pore size is at least 0.5 mm.

[0009] Various embodiments relate to a further implant for insertion into a patient. The scaffold structure includes a plurality of hollow micropores extending between a first outer surface region and a second outer surface region of the three-dimensional porous scaffold structure. The porous scaffold structure includes a three-dimensional porous scaffold structure having a groove, the porous scaffold structure including a surface degradable polymer material. The first outer surface area is configured to face the chest wall of a patient receiving the implant, and the second outer surface area is configured to face the chest wall of a patient receiving the implant. The shape of the area represents the shape of the breast constructed by the implant, and the multiple hollow grooves represent the shape of the implant. The implant is configured to align with Cooper's ligament of a patient receiving the implant.

[0010] Various embodiments relate to a method of forming an implant, the method comprising: A three-dimensional (3D) printed structure is then printed in layers to define a stationary volume for the component. each printed layer includes a lattice array of two-dimensional unit cells, and the three-dimensional printed structure includes a three-dimensional The original printed structure has a porosity such that it is compressible to at least 80% of its rest volume.

[0011] Finally, the present invention also relates to a method for tissue reconstruction or augmentation, which method comprises the steps of any of the methods disclosed herein. The method includes the step of implanting the implant into the body of a subject.

[0012] The foregoing and other features of the present disclosure are set forth in the following description and appended claims, taken in conjunction with the accompanying drawings. The scope of the present disclosure will become more fully apparent from the accompanying drawings, which illustrate only some embodiments according to the present disclosure. It is understood that the present disclosure is illustrative and therefore should not be considered as limiting its scope. In order that the advantages of the present disclosure may be more readily ascertained, the present disclosure is further illustrated by way of the accompanying drawings, in which: It is explained specifically and in detail. [Brief description of the drawings]

[0013] [Figure 1A] FIG. 1 shows an implant with space-occupying structures as described in International Patent Application WO 2005 / 023366. [Figure 1B] FIG. 1 illustrates an implant of the present invention for insertion into a patient. [Figure 1C] FIG. 1 illustrates a reversibly compressible spring-like unit cell and a reversibly compressible implant of the present invention. [Figure 1D] FIG. 1 illustrates a reversibly compressible spring-like unit cell and a reversibly compressible implant of the present invention. [Figure 2A] FIG. 2 is a perspective side view of an implant for insertion into a patient. [Figure 2B] FIG. 1 is a cross-sectional side view of the implant showing the upper and lower pole pieces of the implant. [Figure 2C] FIG. 2 is a top view (plan view) of a first exterior surface region of the implant. [Figure 2D] FIG. 1 is a top view of two sublayers that may be intersected to form a unit cell. [Figure 2E] FIG. 2 is a cross-sectional longitudinal side view of the implant. [Figure 2F] FIG. 13 is a perspective side view of a lower pole portion of a second exterior surface region of the implant. [Figure 2G] FIG. 2 is a perspective top view (plan view) of a second exterior surface region of the implant. [Figure 3A] FIG. 1 is a perspective side view of an implant having multiple surface fillers. [Figure 3B] 1A-1D are perspective side and top views of an implant with surface-filling posts. [Figure 4A] FIG. 2 is a perspective longitudinal side view of the implant. [Figure 4B] FIG. 2 is a perspective top view of the implant. [Diagram 5] FIG. 1 is a perspective top view of an implant of the present invention. [Figure 6A] FIG. 1 is a graph showing the c-value, which represents the flexibility of the implant. [Figure 6B] FIG. 1 illustrates forces acting on an implant. [Figure 6C] (i)-(iii) indicate implant compressibility and overestimation of implant volume. [Figure 6D] (i)-(iii) show the effect of skin tension on the shape of the implant after insertion into the patient. [Figure 6E] FIG. 1 is a perspective view of an implant disclosed herein having the form of a hip implant. [Figure 7A] FIG. 1 shows the implant after insertion into a patient. [Figure 7B] 1 shows the anatomy of a patient's breast as constructed by the implants. [Figure 7C] 1 shows a depiction of the forces acting on the breast. [Figure 7D] 1 shows histological photographs of regenerated breast tissue. [Figure 7E] FIG. 13 illustrates the force of Cooper's ligament acting on one filament of the implant. [Figure 7F] FIG. 1 illustrates internal forces acting on breast tissue. [Figure 8] 1 shows a flow chart of a method for forming an implant. [Figure 9A] FIG. 1 shows a schematic bottom view of the implant used in the animal studies described herein, with the dimensions of the implant shown. [Figure 9B] FIG. 1 shows a schematic side view of the implant used in the animal studies described herein, also showing the dimensions of the implant. [Figure 9C]9A and 9B depict magnetic resonance imaging (MRI) images of minipigs in treatment group 3 as described herein, with the implants depicted in FIG. 9C being inserted. The MRI image in FIG. 9C was taken two weeks after the insertion of the implants. [Figure 9D] FIG. 9C shows an MRI image of the same minipig, taken 4 weeks after implantation. [Figure 10A] FIG. 4 is a reproduction of the histological image of FIG. 4 of Non-Patent Document 1 showing areas of chronic inflammation characterized by lymphatic structures following implantation of an implant / scaffold in a miniature pig as described in Chhaya et al. and Patent Document 1. [Figure 10B] 4 of Non-Patent Document 1 showing tissue components infiltrated into the pores of the implant of the present invention used in the animal study described herein. FIG 10B shows that there was no sign of chronic inflammation after implantation of the implant / scaffold of the present invention in miniature pigs as described herein. [Figure 11A] 1 shows a schematic diagram of a soft tissue reconstruction implant for reconstruction of a breast or breast area of ​​a patient's body. [Figure 11B] 1 shows a schematic diagram of a soft tissue reconstruction implant for reconstruction of a breast or breast area of ​​a patient's body. [Figure 11C] 1 shows a schematic diagram of a soft tissue reconstruction implant for reconstruction of a breast or breast area of ​​a patient's body. [Figure 11D] 1 shows a schematic diagram of a soft tissue reconstruction implant for reconstruction of a breast or breast area of ​​a patient's body. [Figure 11E] 1 shows a schematic diagram of a soft tissue reconstruction implant for reconstruction of a breast or breast area of ​​a patient's body. [Figure 12A] 1 shows a schematic diagram of a soft tissue reconstruction implant for reconstruction of the buccal area (or cheek) of a patient's body. [Figure 12B] 1 shows a schematic diagram of a soft tissue reconstruction implant for reconstruction of the buccal area (or cheek) of a patient's body. [Figure 12C] 1 shows a schematic diagram of a soft tissue reconstruction implant for reconstruction of the buccal area (or cheek) of a patient's body. [Figure 13A] 1 shows a schematic diagram of a soft tissue reconstruction implant for the reconstruction of the testicular region of a patient's body. [Figure 13B] 1 shows a schematic diagram of a soft tissue reconstruction implant for the reconstruction of the testicular region of a patient's body. [Figure 14A] 1B-10B show the implant in more detail. [Figure 14B] 1B-10B show the implant in more detail. [Figure 14C] 1B-10B show the implant in more detail. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] The following detailed description shows by way of illustration specific embodiments in which the claimed subject matter may be practiced. Reference is made to the accompanying drawings, which illustrate embodiments that may enable those skilled in the art to practice the subject matter. The various embodiments, although different, are not necessarily mutually exclusive. For example, it is understood that the particular The features, structures, or characteristics may be modified in other ways without departing from the spirit and scope of the claimed subject matter. In the present specification, the term "one embodiment" may be used. References to "one embodiment" or "an embodiment" are to At least one particular feature, structure, or characteristic described in connection with the embodiment is intended to be included herein. Therefore, the term "one embodiment" or "one embodiment" is used to refer to any one of the above-mentioned embodiments. Use of the phrase "in the form" does not necessarily refer to the same embodiment. The location or arrangement of particular elements within an embodiment may be varied without departing from the spirit and scope of the claimed subject matter. It is understood that the present invention can be modified within a wide range of scope. The following detailed description is therefore not to be construed as limiting. and the scope of the subject matter is to be construed as including the full scope to which the appended claims are entitled. The scope of the present invention is defined solely by the appended claims, together with equivalents, appropriately interpreted. In this specification, like numerals refer to the same or similar elements or features throughout the several views. The elements depicted in the specification do not necessarily correspond to each other, but rather each element may be The elements may be expanded or contracted to more easily understand them in the context of the specification. .

[0015] As used herein, the terms "over," "to," and "between" are used interchangeably. The terms "on" and "on" refer to the relative position of one layer with respect to another. A layer that is "over" or "on" another layer is a layer that is It may be in direct contact with the layer of, or may have one or more intervening layers. An interlayer may be in direct contact with the layer in question or may have one or more intervening layers. It may have the following characteristics.

[0016] FIG. 1B shows a diagram of an implant 100 of the present invention for insertion into a patient.

[0017] The implant 100 comprises a plurality of units configured to form a three-dimensional lattice structure 101. The three-dimensional structure 101 comprises the cell 102. The three-dimensional structure 101 comprises the rest volume of the implant 100. a number of unit cells 102 configured to form a porous network of a three-dimensional structure 101; The three-dimensional structure 101 is a reversibly compressible three-dimensional structure 101 .

[0018] The three-dimensional lattice structure 101 can be a mesh-like structure. For example, the implant 100 The unit cells may include a plurality of lines configured to form a mesh-like structure. Each unit cell 102 in 102 may form an individual unit cell 102 and / or may be a regular and / or The lines can be formed from a single layer of material (e.g., forming walls surrounding individual unit cells). A mesh-like three-dimensional lattice structure 101 can be formed and / or provided. Each unit cell 102 formed from the dotted lines is configured to include a pore having a pore diameter, or The crossing lines can be arranged so that the crossing lines are aligned in a unit cell 10. For example, the intersecting lines may define or define a plurality of pores in the three-dimensional structure 1. The shape (e.g., shape, dimensions) of the individual unit cells 102 (e.g., each unit cell 102) in The plurality of unit cells 102 can form or define a three-dimensional structure. The porous network may be configured to form a porous network of structure 101. It may refer to (and / or include) the pores of the plurality of unit cells 102 within the dimensional structure 101. (It may be something like that.)

[0019] The unit cell 102 can be the smallest and most basic unit of the three-dimensional lattice structure 101. The intersections of the multiple lines form repeating unit cells 101 that form a three-dimensional lattice structure 101. For example, the unit cells 102 can be configured to form a three-dimensional lattice structure 1 At least (equal to or greater than) 80% (or for example at least 90%, or at least 95%) of the total number of cases. The child structure 101 is made up of a number of adjacent lattice structures 101 that are connected to each other throughout the lattice structure 101. It may include (e.g., directly adjacent) unit cells.

[0020] Implant 101 static volume (cm 3 ) before inserting the implant 101 into the patient The static volume of the implant 101 can be the volume of the implant 101 at rest. The volume of the implant 101 when only one outer surface of the implant 101 is subjected to an external force is defined as For example, the implant 101 may be attached to a carrier surface (e.g., a desk surface, or For example, the first outer surface of the implant is capable of contacting the carrier surface and a second (opposite-facing) outer surface that is not subjected to compression forces That is, the static volume of the implant 101 may be a volume acting on the surface of the implant. The volume of the implant 101 without any opposing compressive forces. When a compressive force (physical or mechanical) acts on one or more outer surfaces of the implant 10 1 is at least 80% (or for example at least 70%, or for example at least at least 60%, or for example at least 50%, or for example at least 30%, or for example It may be compressible by at least 20%, or for example by at least 10%. Compressible to at least 80% means that the implant can reach 80% or less of its rest volume. (due to the compressive force). The rest volume of the implant 101 is, for example, Calculate based on the construction volume (desired or required volume) of the breast constructed by 01. After insertion into the patient, the implant 101 can be used to determine the volume of the breast. or configured to be compressible into at least a build volume so as to reach It is possible.

[0021] Each of the unit cells 102 in the plurality of unit cells 102 may be a spring-like unit cell. The spring-like unit cell can expand to at least 80% (or for example at least at least 70%, or for example at least 60%, or for example at least 50%, or for example at least Compressible by at least 30%, or such as at least 20%, or such as at least 10% As used herein, compressible to at least 80% means The spring-like unit cell can be reversibly compressed to less than 80% of its original volume. By being reversibly compressible, each unit cell 102 can be compressed. Recover or return to its original (rest) volume after the contraction force is released. rn) (even at the same ambient pressure and temperature). The unit cell expands to a fraction of its original volume after the compressive force acting on the implant 100 is released. at least 80% (or for example at least 90%, or for example at least 95%, or for example The present invention can be configured to return at least 98%, or up to 100%, for example. As used in the fine print, at least 80% return means returning to 80% or more of its original volume. This refers to the fact that it is possible to

[0022] 1C and 1D show a reversibly compressible spring-like unit cell 102 and a reversibly compressible A diagram of an implant 100 is shown.

[0023] The three-dimensional structure 101 comprises a plurality of reversibly compressible unit cells 102. The spring-like implant 100 provides shape stability. The spring-like implant 100 can be configured to move when a force 103 is applied to the implant. and the implant 100 can deform when or after the force is released. The ability of the implant 100 to return to its shape depends on the tissue and To avoid occlusion of the pleural cavity and / or any extra force acting on the thoracic cavity that may damage the lungs. The implant 100 may be a soft tissue reconstruction implant ( For example implants suitable for and / or for soft tissue reconstruction.

[0024] As shown in FIG. 1C, the reversibly compressible structure of the implant 100 and the reversibly compressible The unit cell 102 can be configured to accommodate a force acting along a certain direction (e.g., an opposing compressive force along the z-axis). 103) in a different direction, such as a vertical direction 104 (e.g., along the x-direction). can be done.

[0025] As shown in FIG. 1D, when the compressive force 103 is released (indicated by the change in the direction of the arrow of 103), The energy stored during this process is proportional to the force applied when the The implant acts in two directions (indicated by the change in the direction of the arrow at 104). This helps the shape of the foam spring back and return to its original shape (e.g., original volume). At least 80% of the total.

[0026] Each spring-like unit cell 102 is axially movable in at least one Cartesian direction and / or can be losslessly compressible in the three Cartesian directions. shows that the unit cell 102 is compressible in the z-direction, but the spring-like unit The cells 102 may be arranged in three Cartesian directions and / or in any direction in three-dimensional space. It will be appreciated that the image may be losslessly compressible.

[0027] 2A-2G show different views of an implant 200 of the present invention being inserted into a patient. The plant 200 may be one or more of the implants 100 described in connection with FIGS. 1B-1D or All of the features may be included, as well as various other features.

[0028] 2A shows a perspective side view of implant 200. The three-dimensional structure of implant 200. 101 may include an array of layers 126. The array of layers 126 may extend in the z direction (e.g., vertical direction ) a plurality of outer layers 126 (e.g., parallel to the xy plane) disposed successively to each other. For example, the implant 200 may include a tertiary The scaffold structure 101 may be formed by successive printing layers 126 to form a three-dimensional (3D) printed scaffold structure 101. Arrow 117 indicates the printing direction (e.g., in the z-direction) of the successive arrangement of successive layers 126. Each outer layer 126 of the array of 126 is a two-dimensional lattice arrangement of a plurality of two-dimensional unit cells 102. The continuous arrangement (by printing) of overlapping layers 126 may include a second outer surface. The edges (or peripheries) of the layers 126 define the shape and / or geometry of the region 106. This can lead to the formation of a three-dimensional structure 101.

[0029] The three-dimensional structure 101 of the implant 200 has a first outer surface region 105 and a second (different and / or The implant 200 may include an outer surface region 106 (facing the opposite side). It is understood that the term "outermost surface," "outermost layer," and / or "outermost contour" refers to (or may refer to) the outermost surface, outermost layer, and / or outermost contour of The outermost surface and the outermost contour may be formed from one or more layers or lines. The outer surface region may be the outermost layers of the implant 200 (e.g., a single outermost layer, or, e.g., multiple layers). The outer surface region may refer to (or may be) the outermost layer of the implant 10. 0 may refer to the outward facing surface.

[0030] The first exterior surface region 105 of the implant 200 may include or have a first surface curvature. The first exterior surface region 105 of the implant 200 is the largest planar surface (or For example, the first outer surface region 105 may be the It may be the flattest surface and / or the surface having the least (or smallest) amount of curvature. As shown in FIG. 2C, the first outer surface region 105 of the implant 200 is a two-dimensional (xy) dimension. Alternatively or optionally, the first outer surface region 1 may be parallel to the root plane. The best fit plane for 05 can be a plane parallel to the two-dimensional (xy) Cartesian plane. .

[0031] The second exterior surface region 106 of the implant 200 includes 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 region 106 of the implant 200 is a periphery 1 of the first outer surface region 105. 07 (e.g., the outer periphery) of the first outer surface region 105 of the implant 200. For example, the second outer surface region 106 of the implant 200 may be in contact with the first outer surface region 106. The peripheral portion 107 of the first outer surface region 105 is in contact with the second outer surface region 105. There may be a shared edge (or boundary) between the regions 106 .

[0032] The second outer surface area 106 is shaped to represent the shape of the patient's breast that will be constructed with the implant 200. For example, the second outer surface region 106 may have an upper The pole portion 109 may include a lower pole portion 111. The upper pole portion 109 may include an impingement portion 120. The upper part of the breast may have a shape constructed by the plant 200. The upper part of the breast may have a shape constructed by the plant 200. It may be the area of ​​the breast from the nipple area of ​​the patient upwards towards the patient's head. The recess 111 may have the shape of the lower part of the breast that is to be constructed by the implant 200. The lower breast may be the area of ​​the breast from the patient's nipple area downward toward the patient's legs. The upper pole portion 109 and the lower pole portion 111 are formed at the tip region 1 of the second outer surface region 106. 12. The second outer surface region 106 of the implant The location (or position) of the apical region 112 in the breast is determined by the location (or position) of the breast formed by the implant 200. It may be based on (and / or match) the location (or position) of the nipple / areola of the tuft.

[0033] FIG. 2B shows a cross-sectional side view of implant 200. 1, upper pole piece 109 and lower pole piece 111 are shown.

[0034] In the cross-sectional side view, the first outer surface region 105 is aligned along a Cartesian x-axis (e.g., from -x to +x). The first outer surface region 105 can be considered as a straight line extending along (e.g., parallel to) the For example, the slope of the second outer surface region 106 may be equal to 0. The (surface) curvature of the pole portion 109 and the (surface) curvature of the lower pole portion 111 are Alternatively, the (surface) curvature of the second outer surface region 106 may be greater than that of the first outer surface region 106. The curvature of the upper pole portion 109 can be equal to or smaller than the curvature Da of the first outer surface region. The contour and shape of the upper pole portion 109 and the lower pole portion 111 of the outer surface region 106 are 200 can be adjusted based on the desired size and shape.

[0035] The curvature and / or contour of the upper pole portion 109 and the lower pole portion 111 define a second outer surface region 10 At least one of the projections, heights, and widths (symbolized by squares) of each of the six multiple sections The plurality of sections may be based on the adjustment of a plurality of points in the second outer surface region 106. Each section can be defined based on the second outer surface region 106 (e.g., p1 to p7). The distance between the points and the number of points can be selectively adjusted. It can be adjusted.

[0036] The Cartesian z-axis lies at (e.g., directly at) the apex region 112 of the second outer surface region 105. (e.g., at x=0). The upper pole portion 109 of the second outer surface region 106 is The lower pole portion 111 of the second outer surface region 106 is in the +x region. Generally, the sections of the upper pole piece 109 have a positive inclination with respect to the x-axis and z-axis. A point p4 (e.g., the center point of the apex region 112) that defines the apex region 112 can be expressed as follows: The section of the upper pole piece 109 close to the apex region 112 (e.g., For example, a section near point 4 may have a small slope, for example a slope close to 0. The sections p3 to p4 may have a smaller slope than the sections p2 to p3, and the sections p2 to p3 may The lower pole portion 111 may have a smaller inclination than the section p1-p2. The section can have a negative slope with respect to the x-axis and the z-axis. A section of the pole portion 111 (e.g., near point 4) has a small inclination, e.g., a inclination close to 0 For example, the section p4-p5 may have a smaller slope than the section p5-p6. Depending on the desired shape or configuration of the implant 200, the subsections of the lower pole portion 111 may be can have a positive slope (e.g., the subdivision between divisions p6 and p7). Thus, The curvature of the lower pole portion 111 of the second outer surface region 106 is equal to the curvature of the upper pole portion 111 of the second outer surface region 106. It can be made to appear larger than the curvature of 109.

[0037] FIG. 2C shows a top view (plan view) of the first exterior surface region 105 of the implant 200.

[0038] In a top view, the first outer surface region 105 can have a circular or elliptical shape. The surface region 105 may include (or may refer to) a first layer 126 of an array of layers. As shown in FIG. 2C, each outer layer 126 can include an array of two-dimensional unit cells 102. The two-dimensional unit cell 102 is a rhomboid (or diamond or rhombus) unit cell. It is possible.

[0039] FIG. 2D illustrates the top surfaces of two sublayers 136A, 136B that may be intersected to form a unit cell. The figure is shown.

[0040] Each outer layer 126 of the unit cell includes a first sublayer 13 that includes lines 128 oriented in a first direction. 6A (or a first group of sublayers) and a line 129 oriented in a second direction different from the first direction. A second sublayer 136B (or a second group of sublayers) may be included. Each sublayer line may include an opening in the sublayer. It can be part of a continuous sublayer line that bends continuously from the start point S to the end point E of the sublayer. For example, the line 128 of the first sublayer 136A extends from a starting point S to an end point E of the sublayer 136A. It may be part of a line 138 of a continuous, meandering sublayer. The line 129 of the layer 136B is a continuous, meandering line from a starting point S to an end point E of the sublayer 136B. The intersecting lines that form the unit cell are straight lines. or alternatively, the intersection lines can be sine lines and the unit cell can be "free" The lines 128, 136 in each of the sublayers 136A, 136B may have the shape of a "pattern". 29 can be parallel to each other (e.g., sharpness between lines within a sublayer or between lines optimal for sine lines). (The angle can be within + / - 5°.) A plurality of lines 128 in the first sublayer and a plurality of lines 129 in the second sublayer The lines 129 intersect or intersect to form a two-dimensional lattice arrangement of two-dimensional unit cells of the outer layer 126. The two-dimensional unit cells of each layer 126 of the stacked layer sequence can intersect at the intersection region. The fibers 102 may form a three-dimensional lattice structure 101.

[0041] As shown in FIG. 2C, each unit cell 102 of the outer layer 126 has a pore size of 10 mm. 136A, 136B, including the intersecting lines 128, 129 extending from adjacent sublayers 136A, 136B. For example, two adjacent layers of the first sublayer 136A may be formed of The adjacent (and parallel) lines 128 are two adjacent (and parallel) lines of the second (adjacent) sublayer. 129. The area of ​​the unit cell enclosed by the intersection lines is a rhomboid (or In some embodiments, the unit cell may have a shape of a diamond or a rhombus. The minimum angle j between two intersecting lines of the rule is 5° to 90° (or for example 10° to 80°, or for example For example, the angle can be set to 30° to 60°.

[0042] Each two-dimensional unit cell 102 can have a pore size that defines the dimension of the unit cell 102. The pore size w of the unit cell 102 of the layer can be determined by, for example, the distance between two lines (e.g. The smallest dimension of a pore (or width).

[0043] The three-dimensional structure 101 of the implant 200 is made up of a number of unit cells having a range of different pore sizes. As shown in FIG. 2C, the first layer 126 can be made up of a first outer surface region. The pore size of the unit cell 102 can be the outermost layer of the pores in the first unit cell 105. The surface pore size of the surface pores (openings) in one outer surface region of the implant. The minimum (minimum) of the plurality of unit cells in the first outer surface region 105 of 200 The surface pore size w is at least (e.g., equal to or smaller than (e.g. at least 6 mm, or e.g. at least 8 mm) At least 80 of the unit cells 102 in (or of) the first outer surface region 105 may be % (or for example at least 70%, or for example at least 80%) of the surface pore size is at least 2 mm (or e.g. at least 0.75 mm, or e.g. at least 1 mm) It is possible.

[0044] The size of the openings (e.g., surface pore size) on the surface of the implant 200 may vary depending on the implant. The first outer surface region 10 of the three-dimensional structure can be changed depending on the position in the component 200. The (average) surface pore size of the openings in (or of) the second outer surface area of ​​the three-dimensional structure 101 At least (e.g., equal to or greater than) the (average) surface pore size of the openings in region 106. 10% (or e.g. at least 25%, or e.g. at least 30%, or e.g. For example, the first outer surface region may be at least 35% larger. The (average) surface pore size at 105 is the average surface pore size at the lower pole portion 111 of the second outer surface region 106. The (average) surface pore size of the upper pole portion (109) can be larger than that of the upper pole portion (109). The (average) surface pore size may be larger than the (average) surface pore size.

[0045] A rhomboid (or diamond) unit cell 102 is shown in FIG. 2C, but may optionally be It is understood that the plurality of two-dimensional unit cells 102 can be polygonal unit cells. For example, multiple two-dimensional unit cells can be a triangular unit cell, a diamond-shaped unit cell, a rhomboid unit cell, unit cell, rectangular unit cell, parallelogram unit cell and / or hexagonal unit cell. The implant 200 may be modified in various ways, such as by mixing unit cells. It is understood that the overall volume may contain one or more unit cells. The plant 200 is comprised of primarily diamond-shaped unit cells (e.g., more than 50%, or For example, more than 60%, or for example more than 70%, or for example more than 80% of the unit cells are Alternatively, the two-dimensional Instead of a unit cell, the unit cell 102 in the plurality of unit cells 102 is a plurality of planar filaments. It may include (or may be) a three-dimensional unit cell having a set. Each planar facet of the original unit cell defines a pore and / or a pore size of the three-dimensional unit cell 102. Generally speaking, each three-dimensional unit cell 102 has at least four pores. For example, a three-dimensional unit cell of a tetrahedron can include the four triangles of the tetrahedron unit cell. The shaped surface may include at least four openings (or pores). For example, , a hexagonal three-dimensional unit cell has 6 The opening (pore) may include one or more openings (pores).

[0046] The average thickness of the wires is 0.1mm to 5mm (or for example 0.1mm to 2mm, or for example Therefore, the thickness of the first direction can be set to 0.5 mm to 1.5 mm. Each sublayer 136A having lines oriented in a second (different) direction is a sublayer 136B having lines oriented in a second (different) direction. 36B, adjacent (or consecutive) lines having lines oriented in the (same) first direction. ) sublayer 136A. Thus, each sublayer oriented in the first direction Layer 136A is 0.1 mm to 5 mm (or for example 0.1 mm to 2 mm, or for example 0.5 By separating them by a distance of 1.5 mm from each other, adjacent ones oriented in the same first direction Similarly, the second direction can be separated from the adjacent (or contiguous) sublayer 136A. Each sublayer 136B to be oriented may have a thickness of 0.1 mm to 5 mm (or for example 0.1 mm to 2 mm, or in the same second direction by separating them by a distance of, for example, 0.5 mm to 1.5 mm. It can be separated from the adjacent (or successive) sublayer 136B to which it is oriented. This can result in an arrangement of roughly spaced layers and sublayers, with respect to each other. Allows free movement of individual wires (e.g. by compression, extension, translation).

[0047] FIG. 2E shows a longitudinal section (side view) of the first outer surface region 105 of the implant 200. The cross-sectional side view shows a (two-dimensional) unit cell of the continuous layer as a first exterior region 105 of the three-dimensional structure 101. The arrangement of layers may be configured to form a plurality of hollow grooves 118 extending between the second exterior surface regions 106. This cross-sectional side view illustrates how individual layers in implant 200 can be constructed. 1 shows a plurality of hollow grooves 118 formed by an arrangement of two-dimensional unit cells of successive layers within the

[0048] At least one groove 118 of the plurality of hollow grooves extends from the first outer surface region 105 to the second outer surface region 106 at an apex. 102 and / or the lower pole portion 111 of the second exterior surface region 106. Additionally or alternatively, one or more further grooves of the plurality of hollow grooves may be configured as follows: 118 is a portion extending from the upper pole portion 109 of the second outer surface region 106 to the tip region of the second outer surface region 106 112 and / or the lower pole piece 111. Optionally, the hollow grooves may be parallel to one another (e.g., the gap between the sidewalls of adjacent grooves may be 100 mm). (Acute angles may be within + / - 5°). Alternatively, the plurality of hollow grooves may be formed in a first position of the three-dimensional structure. Towards a convergent region (or point) located outside the first outer surface region 105 or the second outer surface region 106 For example, the convergence point may be located on the apical region 112 of the implant 200. It can be placed.

[0049] The plurality of hollow grooves 118 are inclined relative to the first outer surface region 105 of the implant 200. Between the sidewall of the hollow groove 118 and a reference axis (e.g., the x-axis) representing the first outer surface area The acute inclination angle k may be less than 90°, or may be less than 60°, for example. The reference axis may be based on a best fit plane or line of the first exterior surface region 105. The plurality of hollow grooves 118 may include 5 to 1000 hollow grooves (or, for example, 5 to 60 grooves, or, for example, 8 Each of the inclined grooves may be arranged so as to overlap each other. The unit cells may be formed from pillars of unit cells by successive layers 126 deposited on the In the unit cells forming the unit cell pillars, the unit cells of the second layer are adjacent The unit cell of the first layer may have an outer offset (in the x-direction) relative to the unit cell of the first layer. .

[0050] The sidewalls of the pillars of the unit cell are vertically deposited in the z direction and are made up of multiple layers oriented in the same direction. The outer lines (which lie substantially parallel to the xy plane) can be formed to form side walls. The lines that form the individual unit cells of the unit cell pillar. For example, a diamond-shaped The unit cell pillars can be formed by vertical stacking of diamond-shaped unit cells; The lines or walls surrounding (and defining) the individual unit cells of layer 126 are the boundaries between successive unit cells of successive layers. The pillars of the unit cell can therefore be aligned with the lines or walls that surround (and define) the unit cell. The walls of each unit cell in the can form at least a portion of a side wall of a pillar of the unit cell. The individual unit cells in the unit cell column are arranged such that, within the same column, the unit cells of each successive layer are (Direct) Alignment with an outer offset relative to the unit cell of the previous layer. The outer offset between the first and second unit cells is 0.01 times the pore size of the unit cells. % to 50% (or for example 0% to 20%, or for example 5% to 10%). Optionally, within the same pillar, the unit cell of each layer is aligned in the same direction relative to the unit cell of the immediately preceding layer. Optionally, two columns in the same column (forming the same groove) may have the same outer offset. At least (e.g., equal to or greater than) 80% (or, e.g., at least At least 70%, or for example at least 50%) may have the same pore size and the same pore shape. Alternatively, in the case of tapered grooves, the unit cells forming the same groove may have different pore sizes. (e.g., the pore size of the unit cell may decrease or increase toward one portion of the outer surface region. The surface porosity and different surface pore sizes are shown in Figures 2F and 2G. is.

[0051] FIG. 2F shows a perspective side view of the lower pole piece 111 of the second exterior surface region.

[0052] As shown in FIG. 2F and FIG. 2A, the surface of the lower pole portion 111 of the second outer surface region 106 The surface pore diameter w extends from the lower pole boundary region 115 of the second outer surface region 106 toward the apex region 112. It can be increased (gradually, or e.g., stepwise, or e.g., layer by layer) over time. The lower pole boundary region 115 is a region where the lower pole portion 111 of the second outer surface region 106 is in contact with the first outer surface region 106 . 05 and a portion of the periphery 107 of the three-dimensional structure 101. The surface pore size of the lower pole portion 111 of the second outer surface region 106 is, for example, 0.15 mm or 2 mm at the pole boundary region 115 to the apex region of the second outer surface region 106 6mm max, 8mm max, 9mm max, or 10mm max towards area 112 The direction of increase is indicated by arrow 116. Optionally, the surface pores The diameter is from 3 mm to 7 mm (or for example from 3 mm to 6 mm, or for example from 4 mm to 8 mm (as in the implants used in the experimental examples of this application). Cut.

[0053] FIG. 2G shows a perspective top view of the second exterior surface region 106 of the implant 200.

[0054] As shown in FIG. 2G, the tip region 112 is disposed between the upper pole piece 109 and the lower pole piece 111. As shown in FIG. 2G (and FIG. 2A), Additionally or optionally, the (average) surface pore size in the first outer surface region 105 is The (average) surface pore size of the second outer surface region 109 may be larger than the (average) surface pore size of the second outer surface region 109. The surface pore size at the upper pole portion 109 of the second outer surface region 106 is Increases (gradually, or e.g., stepwise, or e.g., The direction of increase is indicated by arrow 113. The boundary region 114 is formed by the upper pole portion 109 of the second outer surface region 106 being spaced apart from the periphery of the first outer surface region 105. 107. For example, the surface pore size at the upper pole portion 109 of the second outer surface region 106 is 0.5 mm at the upper pole boundary region 114 of the region 106 to the maximum at the apex region 112 Optionally, the surface pore size can be increased from 0.5mm to 4mm. (or e.g. 0.5mm to 2mm, or e.g. 0.8mm to 2mm, or e.g. The surface hole in the upper pole piece 109 can be increased (for example, from 1 mm to 2 mm). The gap diameter is determined by the contour line (FIGS. 4A and 4B) located at the upper pole portion 109 of the second outer surface region 106. This can be achieved (or relied upon) by spacing the (It is possible to do so.)

[0055] The average surface pore diameter w of the surface pores in (or within) the apical region is 2 mm to 6 mm (or For example, it may be in the range of 2 mm to 4 mm, or for example, 2 mm to 3 mm.

[0056] Generally speaking, at least 50% (or for example at least 70%) of the three-dimensional structure 101 or for example at least 80% of the surface pores have a surface pore size of at least 0.5 mm (or for example at least The three-dimensional structure may be at least 0.75 mm, or for example at least 1 mm. The average surface pore size of 101 is at least 0.5 mm (or for example at least 0.75 mm The average surface pore size may be at least 1 mm. Add the pore size of the total number of openings on the outermost surface of 01 to get the pore size of the outermost surface of the three-dimensional structure. The surface pores in the three-dimensional structure 101 can be calculated by dividing the surface pores by the total number of openings. At least 50% (or for example at least 70%, or for example at least 80%) of the gap The surface pore area must be at least 0.75 mm 2 (or e.g. at least 1 mm 2 , or example For example, at least 3 mm 2 The surface pore area can be defined as the area of ​​the surface pore. It may be the area enclosed by the intersecting lines.

[0057] Optionally, the pore sizes of the unit cells 102 within a layer can vary from one another. In the case of par grooves, or confluence grooves, the unit cells within the layer have the same shape but different pore sizes. Therefore, the pore size of the unit cells at different locations of the implant 200 can be can be different from one another. For example, the unit cells 10 within the bulk of the implant 200 The pore size (bulk pore size) of the second unit cell 102 varies depending on the location of the unit cell 102 within the implant 200. They can be changed into each other.

[0058] FIG. 3A illustrates a perspective side three-dimensional view of an implant 200 having a plurality of surface fillers 122. This figure shows a side view of the lower pole portion 111 of the implant 200. The plant 200 may incorporate one or more or all of the features described in connection with FIGS. 1B-2G, as well as various Other features may be included.

[0059] The surface filler 122 fills the openings (surface pores) at the outermost surface of the three-dimensional structure 101. Each surface infill 122 may be formed by one or more openings on the outermost surface of the three-dimensional structure 101. One or more fill lines 124 configured to at least partially fill the mouth (surface void) The one or more fill lines 124 of the surface fill portion 122 may include an outer surface area of ​​the three-dimensional structure. The surface pores 123 in the region are connected (or the spaces between them are at least partially filled) to a group of intersecting lines. The surface pores may be at least partially filled. The fill line is 50% to 99% (or, for example, 55% to 95%, or, for example, 8% to 10%) of the surface area of ​​the pore. For example, the surface area of ​​the pores 123A is filled with 0% to 95% of the surface area of ​​the pores 123A. A larger proportion of pores 123B are filled, but both pores 123A and 123B are filled to a lesser extent. Optionally, the three-dimensional structure 101 may be considered to be at least partially filled. At least 20% (or for example at least 30%, or for example At least 40%) can be at least partially filled by the surface filling portion 122. Optionally, a surface filler 122 may be formed (or disposed) on the second exterior surface region. while the first outer surface region can be free of surface filler 122 (e.g., All surface pores in the outer surface area may be open).

[0060] FIG. 3B shows a perspective side and top view of an implant 200 with surface-filling posts 125. This figure illustrates the surface porosity of the implant 200.

[0061] Optionally, the second outer surface region may have filled (closed) and unfilled (open) surface pores. The ratio of surface porosity to surface porosity can be 1:2. In this way, the implant can be The surface porosity of the plant 200 can be defined. It can be (or may be) expressed as the void ratio or percentage (e.g., a measure of open space) of the outermost surface of The surface porosity of the implant 200 can be determined by the outermost surface (e.g., the porosity of the 3D structure 101). Total voids (m2) in the outermost surface (total surface area of ​​unfilled openings) 2 ) by implantation The total surface area (m 2 ) can be defined by dividing The surface porosity of the second exterior region is less than the bulk porosity of the three-dimensional structure of the implant. The surface porosity of the second outer surface region may be less than the surface porosity of the first outer surface region. (For example, 0.8 times, or for example, 0.5 times, or for example, 0.2 times, or for example, 0.1 times) 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 bulk porosity of the three-dimensional structure 101 of the implant 200 can be at least 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 For example, the bulk porosity of the implant may be at least 90%. The bulk porosity of the implant before it is inserted into the patient can be between 80% and 99%. 200 of the void ratio or percentage (e.g., a measure of void space) can be expressed (or taken as) The bulk porosity of the implant 200 is the total void space within the implant (m 3 )of The total volume (m 3 ) by dividing can be done.

[0062] The compressibility of the three-dimensional structure 101 in the implant is determined by the bulk porosity and and / or based on (or e.g. proportional to) the total void. For example, cubic The base structure 101 has a minimum compressed volume V based on (or, for example, proportional to) the cavity of the implant. C For example, the third dimension can be compressed to V C =V T -V V Compressible to And V C is the volume of the compressed implant, and V V is the volume of the void, and V T is the total static volume of the scaffold. That is, the implant is based on (proportional to) the volume of the void. It can be compressed by a volume equal to or smaller than the mass of the object.

[0063] A spring-like implant will return to its original shape after the compressive force acting on the implant is removed. At least 80% (e.g., 80% or more) (or, e.g., at least 90%, or, e.g., at least 95%, or for example at least 98%, or for example up to 100%) It can be configured as follows.

[0064] The amount of restitution of a spring-like implant is based on the amount of compression acting on the implant. For example, the implant may have a compressive strength of less than 30% in at least one direction. After the force is removed, the scaffold 101 can be compressed to 80% or more of its original size. Alternatively, the implant can be repositioned to a maximum of 80%. After the force is removed, the scaffold 101 can be compressed to a size of 85% or more of the initial projection. It can return to 90% or more.

[0065] Additionally, the implants 100, 200 may be configured to move in one or more axial directions (e.g., two directions, such as x-y directions). reversible compression in one or three axes (e.g. x, y, z) simultaneously Thus, the implant can be displaceable in one or more axial directions (e.g., height). , width, length and / or projection) of its original size (or 70% or less, or for example 60% or less, or for example 50% or less, or for example 30% or less, or The implant may be compressible, for example by 20% or less, or for example by 10% or less. The object is to be resized to at least 80% (e.g. 90%) of its original size in each of the first, second, or third axes. or more, or for example 95% or more, or for example 98% or more, or for example 100%) It can be configured as follows.

[0066] Optionally, the plurality of surface infilling portions may include a plurality of surface infilling posts 125 in the second exterior region 106. The surface filling pillars 125 can be configured to form a pillar (or strip). The surface filler may include a plurality of surface fillers that fill adjacent surface voids (e.g., openings). The filler pillar can be disposed adjacent to the open pillar 135. The open pillar 135 has a surface filler portion. Optionally, the surface of the pillar may include porosity. The surface filling pillars 125 and the plurality of open pillars 135 are disposed in the outer surface region (e.g., in the second outer surface region). Optionally, the plurality of surface-filling pillars and the plurality of open pillars may be arranged in an alternating fashion. They may be arranged in a cross shape in the outer surface area.

[0067] The surface filling pillar 125 disposed in the lower pole portion of the second outer surface region is In some embodiments, the top openings of some of the grooves of the 00 may be at least partially covered or closed. The surface filling posts 125 disposed in the upper pole portion of the second outer surface region are The sidewall of the cavity may include (or form part of) the sidewall of the cavity.

[0068] 4A and 4B show a longitudinal side view and a top view, respectively, of implant 200. The device 200 may incorporate one or more or all of the features described in connection with FIGS. 1B-3B, as well as various other features. It may include features.

[0069] As shown in FIGS. 4A and 4B, a plurality of tubular members 102 that form a three-dimensional structure 101 of the implant 200 are The line may include a plurality of contour lines. A first group of contour lines 119 in the plurality of lines may include: Around the periphery 107 of the first outer surface region 105 (or for example, at least one The first group of contour lines 119 may be arranged around the first outer periphery 107 of the upper layer. Enough (e.g., at least 90%, or, e.g., less than 100%) around the periphery 107 of the surface region 105 can be arranged to be, for example, at least 95%, or at least 99%, or 100%. For example, a closed circle or a closed ellipse is formed. The first group 119 of contour lines can consist of, for example, from 2 to 20 contour lines. The contour lines in the first group 119 of contour lines can be formed continuously (successively) in the direction from the first outer surface region 105 towards the tip region 112 (for example, in the z direction). Optionally, the thickness or height h (measured perpendicularly, in the z direction) of the first group of contour lines can be in the range of 1 mm to 20 mm (or 2 mm to 10 mm, or for example 1.5 mm to 5 mm). mm to 5 mm). mm to 5 mm). mm to 5 mm).

[0070] The plurality of lines forming the three-dimensional structure 101 of the implant 200 can further include a second group 121 of contour lines. Different from the first group 119 of contour lines that form a complete contour around the periphery 107 of the first outer surface region, each contour line of the second group 121 of contour lines can form a semi-contour around the second outer surface region. The semi-contour of the second group 121 of contour lines can extend only partially (for example, 30% to 80%, or for example 40% to 70%, or for example 50% to 70%) around the periphery of the layer. For example, the second group 121 of contour lines can be arranged at (or around, for example) the upper pole portion 109 of the second outer surface region 106, and there can be no (can be made to have no) contour lines at the lower pole portion 111 of the second outer surface region 106. The second group 121 of contour lines can be arranged continuously with respect to each other between the first outer surface region and the tip region. Optionally, the second group 121 of contour lines does not have to be formed at the periphery of all the outer layers, nor does it have to be formed in all the alternating layers, or in all the alternating groups of layers. 70%) around the periphery of the layer. For example, the second group 121 of contour lines can be arranged at (or around, for example) the upper pole portion 109 of the second outer surface region 106, and there can be no (can be made to have no) contour lines at the lower pole portion 111 of the second outer surface region 106. 70%) around the periphery of the layer. For example, the second group 121 of contour lines can be arranged at (or around, for example) the upper pole portion 109 of the second outer surface region 106, and there can be no (can be made to have no) contour lines at the lower pole portion 111 of the second outer surface region 106. 06's upper pole portion 109 (or around, for example), and there can be no contour lines at the lower pole portion 111 of the second outer surface region 106 (can be made to have no). 06's upper pole portion 109 (or around, for example), and there can be no contour lines at the lower pole portion 111 of the second outer surface region 106 (can be made to have no). 06's upper pole portion 109 (or around, for example), and there can be no contour lines at the lower pole portion 111 of the second outer surface region 106 (can be made to have no). The second group 121 of contour lines can be arranged continuously with respect to each other between the first outer surface region and the tip region. Optionally, the second group 121 of contour lines does not have to be formed at the periphery of all the outer layers, nor does it have to be formed in all the alternating layers, or in all the alternating groups of layers. The second group 121 of contour lines can be arranged continuously with respect to each other between the first outer surface region and the tip region. Optionally, the second group 121 of contour lines does not have to be formed at the periphery of all the outer layers, nor does it have to be formed in all the alternating layers, or in all the alternating groups of layers. The second group 121 of contour lines can be arranged continuously with respect to each other between the first outer surface region and the tip region. Optionally, the second group 121 of contour lines does not have to be formed at the periphery of all the outer layers, nor does it have to be formed in all the alternating layers, or in all the alternating groups of layers.

[0071] Optionally, the surface pore size of the opening in the surface of the upper pole piece 109 is a second group of contour lines. It is defined by the vertical space between 121 consecutive (directly adjacent) contours. For example, The vertical space between successive contours of the second group of contours is 0.05 mm in the upper pole boundary region 114. 0.5 mm to a maximum of 5 mm at the apex region 112 of the second exterior region 106 (or for example, increase). The direction of increase is indicated by arrow 11, as is the direction of increase in pore size. 3. Optionally, the vertical space between successive contours of the second group of contours is 0.5 The increase can be from 0.5 mm to 4 mm (or for example from 0.5 mm to 2 mm).

[0072] The three-dimensional structure 101 of the implant 200 can be formed from a surface degradable polymer. Surface degradable polymeric materials are those that degrade primarily via a surface decomposition mechanism as opposed to bulk decomposition. For example, surface decomposition can refer to the internal decomposition of a polymer material. This refers to the collapse of the outer surface of a polymeric material, as opposed to the collapse of the outer surface of a polymeric material. At least two times (or for example at least five times, or for example at least a little) the internal disintegration of the polymeric material. The rate of reaction can be at least 10 times, or for example at least 100 times. Decomposition is the process where the outer surface and the inner part of a material are decomposed at the same time and at the same rate (e.g. the rate of outer surface decomposition and the rate of inner decomposition). Decomposition or disintegration occurs when the rate of degradation is less than 1.2. Surface degradable polymers are, for example, For example, the wires may be made of a biodegradable polymer. It may include, be formed from, or consist of a degradable material. The biodegradable material can be, for example, the material described in US Pat. Illustrative examples of biodegradable materials include polycaprolactone, poly(1,3-trimethylenediaminetetraacetate), and poly(1,3-trimethylenediaminetetraacetate). Poly(ester amide), poly( Poly(ethylene glycol) / poly(butylene terephthalate), poly(glycerol sebacate) Poly(1,8-octanediol-co-citric acid), Poly(1,10-decanediol-co-citric acid), Poly(glycolide-co-D,L-lactic acid), Poly(diol citrate), Poly(glycolide-co- Prolactone), Poly(1,3-trimethylene carbonate-co-lactide), Poly(1 , 3-trimethylene carbonate-co-caprolactone), or at least one of these materials. Optionally, the biodegradable material may be selected from a copolymer of the two. Optionally, the biodegradable material can be polycaprolactone and poly(titanium dioxide). It can be a copolymer with either ethylene carbonate or polylactide. Alternatively, the lines may comprise a non-degradable material, such as nylon.

[0073] FIG. 5 shows a perspective top view of the implant 200. The implant 200 is similar to the implant 200 shown in FIGS. It may include one or more or all of the features described in relation to B, as well as various other features. .

[0074] In some embodiments, the implant 200 is an implant for insertion into a patient. The implant comprises a porous three-dimensional scaffold structure comprising an array of unit cells 102, The bulk porosity of the implant is at least 80%.

[0075] In some embodiments, the implant 200 comprises an array of unit cells 102. The three-dimensional scaffold structure 101 includes a porous three-dimensional scaffold structure. A plurality of unit cells 102 are arranged in the three-dimensional scaffold structure 101. The three-dimensional structure 101 is configured to form a porous network of a plurality of unit cells. The average pore size of the filter 102 is at least about 0.5 mm (or, for example, at least about 0.75 mm). m, or such as at least about 0.8 mm, or such as at least about 1 mm, or such as At least about 1.5 mm, or such as at least about 2 mm, or such as at least about 5 mm ).

[0076] In some embodiments, the implant 200 comprises a first portion of the three-dimensional porous scaffold 101. A plurality of hollow grooves 104 extending between the outer surface region (not shown in the top view) and the second outer surface region 106. The three-dimensional porous scaffold structure 101 includes a surface degradable polymer. The first exterior surface region is configured to face the chest wall of a patient receiving the implant. The shape of the second outer surface region represents the shape of the breast to be constructed by the implant 200. The plurality of hollow grooves 118 are adapted to be aligned with the Cooper's ligament of the patient receiving the implant. It is composed of.

[0077] The implant 200 comprises a porous three-dimensional scaffold structure 101 comprising an array of unit cells 102. The figure includes, for example, an implant including a number of lines, contours 119 and surface fills 122. 2 shows an implant 200. The implant 200 is a porous three-dimensional structure comprising an array of unit cells. The plurality of unit cells 102 form a three-dimensional porous network. The pore size of the plurality of unit cells 102 in the three-dimensional structure is at least It can be 0.5 mm.

[0078] Multiple lines (e.g., intersection lines, contour lines, surface fill lines) are degradable (e.g., surface degradable) poly The composition may include a mer material.

[0079] The mechanical challenges of daily activities can exceed the elastic capacity of breast tissue, resulting in the introduction of This can ultimately lead to irreversible tissue stretching in direct proportion to the amount of Contrary to widespread belief, implant weight, rather than volume, is the basis for future tissue defects and deformities. For example, the elastic tissue of the breast can be represented by a spring with a constant K. When the implant is stationary in a standing position, the weight of the implant exerts the following force: F = m × g. where F is force, m is mass, and g is the standard gravitational constant. The implant can be displaced downwards on the breast with a force proportional to its weight. It is possible (within the elastic limits of the tissue) that the tissue displacement is therefore positive relative to the weight of the implant. The displacement is described by Δx=F / K, where Δx is the displacement and F is the force acting on the where K is the force applied to the implant and K is the spring constant. This can result in increased force compared to conventional implants, which can lead to a consequential stretching of the breast. Certain implants 200 can reduce the extent of deformity and loss of breast tissue, This can reduce subsequent reoperations, further improving patient safety and satisfaction. To make.

[0080] To reduce the weight issue that affects the shape of the result, the implant 200 is made of a low density scaffold. , and the weight of the implant 200 can be reduced for the same volume. As a result, the force acting on the breast can be reduced as well. Weight of the scaffold can be explained by the following formula:

number

[0081] The implant 200 can include a low density scaffold and a highly porous scaffold. The bulk (or overall) porosity of the implant can be described by the following equation:

number

[0082] Therefore, the volume of the scaffold is expressed as:

number

[0083] FIG. 6A shows a graph 600 of a representation of the c-value, which represents the flexibility of the implant 200. The graph of FIG. 1 shows the force (N) acting on the implant 200 at various levels of compression. A chart of the strain vs. strain value ε (%) 132 is shown.

[0084] The c value is expressed by the following formula:

number

[0085] As shown in FIG. 6A, the implant 200 includes a plurality of spring-like members. The implant may have a lower c value than other implants that do not have a unit cell (i.e., The c value, which represents the flexibility of the implant 200, is, for example, 20 N. ~200N (for example, 20N~150N, or for example, 20N~90N, or for example, 30N~ 90N, or for example, 50N to 90N. The c value of 20N to 90N can be This is a good area to balance mechanical integrity and patient comfort. The softness can be adjusted to prevent deformation due to skin tension during the wound healing process. For example, if the implant is too soft (e.g., has a c value less than 20 N), The plant 200 may become more malleable.

[0086] FIG. 6B shows a diagram of the forces acting on the implant 200.

[0087] After insertion into the patient, the implant 200 is in direct contact with the skin and breast tissue. The tension of the skin 151, 152, the weight of the breast tissue overlying the implant, The combined effect of 153 and daily activities (e.g., women sleeping on their stomachs) This creates a compressive force 154 acting in the direction of the projection of the implant 200, resulting in the implant This leads to deformation.

[0088] FIG. 6C (i-iii) shows the compressibility of the implant 200 and the volume of the implant 200. Indicates an overestimation.

[0089] FIG. 6C(i) shows the implant 200 having a rest volume or initial shape prior to insertion into a patient. This shows that it is possible to

[0090] FIG. 6C(ii) shows an overestimation 154 of the volume of the implant 200 over the build volume. The implant 200 can be a folded 3D printed structure, so that the implant The effect of constant compressive force exerted by skin tension and tissue weight on the tissue is persistent before reaching a plateau. This may result in a substantial volume loss. To ensure that the initial collapse due to the effects of skin tension and tissue weight is taken into account, To achieve this, the implant volume can be overestimated (relative to the static volume). For example, the overestimation of the volume154 is 20% to 15% of the implant protrusion volume (construction volume)155. It can be 30%.

[0091] FIG. 6C(iii) shows the volume of the implant 200 after insertion into a patient, and the skin tension In effect, the volume of the implant corresponds to the original required volume (build-up volume).

[0092] 6D(i)-(iii) show the skin in the form of implant 200 after insertion into a patient. Show the effects of tension.

[0093] FIG. 6D(i) shows the implant 200 having a rest volume or initial shape prior to insertion into a patient. This shows that it is possible.

[0094] FIG. 6D(ii) shows the effect of skin tension on the implant 200. To reduce the effect of skin tension on the skin, the upper pole side 109 is first It is compressed (or crushed) in the direction 157 to provide a smooth transition between the chest wall and the nipple. The lower pole side is implanted to provide a natural breast sagging effect (in the direction 156). Both of these features are important in determining the construction volume and aesthetics required for the scaffold. This serves to provide the scaffold with a natural shape.

[0095] FIG. 6D(iii) shows the implant 200 after insertion into a patient. 0 is at least 80% of its original volume after compression during insertion of the implant 200 into the patient. % (or for example at least 95%) of the original volume. Thus, The implant 200 has a compressed upper pole side 109 and a sagging lower pole side 110. 1. It is possible to obtain the desired construction volume and shape (e.g., the ideal natural shape) under the skin. do.

[0096] FIG. 7A shows a view of the implant 200 after insertion into a patient.

[0097] The first outer surface region 105 of the implant 200 is in contact with the chest wall 1 of the patient receiving the implant 200. The implant 200 can be configured to face the 41. Optionally, the implant 200 may be positioned such that the first outer surface region 105 faces the pectoral muscle 143. The implant can be placed over the pectoral muscle. The apical region 112 of the second outer surface region 106 of the implant is constructed with the implant 200. Located at (e.g. directly facing or e.g. directly below) the nipple / areola of the breast being treated The first outer surface region 105, which has the largest average surface pore size, can be The implant 2 can be configured to face the vascular source. The porous network of the implant 200 in a direction guided by the direction of the grooves 118 in the implant 200. Alternatively, the implant 200 can be placed underneath the pectoral muscle 143. For example, the first exterior surface region 105 of the implant may be positioned adjacent to the patient's chest wall 14. 1 and the muscle can be disposed on the second exterior region 106. Cut.

[0098] FIG. 7B illustrates a patient's breast (e.g., breast augmentation, or e.g., Breast reduction, or for example breast revision, anatomical structures.

[0099] After the implant 200 is inserted into the patient, the scaffold (e.g., the three-dimensional structure) is allowed to resorb. The regenerated tissue is a fibrovascular tissue, and the regenerated tissue can be left intact. The silicone implant may have a similar weight to healthy tissue. Thus, a certain force acting on the tissue can cause irreversible tissue stretching. The number of grooves and the slope of the grooves can be selected to reduce tissue stretching.

[0100] FIG. 7C shows a representation of the forces acting on the breast. The breast is modeled as a semi-ellipsoidal beam of length L. The mass of the breast creates a force that is aligned with gravity (W_breast). F is the muscle This represents the reaction forces acting in the flesh (F_pectoral fascia) and rib (F_rib) areas of the breast. Helps the system maintain its shape.

[0101] However, the key roles (e.g. the most important roles) in providing support and maintaining form , exerted by a force (F_Cooper) acting in tension against gravity. In healthy breast tissue, this effect originates from the pectoral fascia and passes through the periphery of the breast tissue. Fibrous strands called suspensory ligaments or Cooper's ligaments that firmly attach the breast to the underlying skin When using conventional silicone implants, the weight is transferred to the regenerative tissue. and is almost similar to healthy tissue, but there is no system of attachment to the pectoral fascia. stomach.

[0102] It is necessary to support the structure so that the tissue can maintain its shape and not be affected by weight. Implant 2 in a manner that orients the filaments (grooves) in the direction of the required tensile force. 00 material without considering any additional materials that may create safety issues. The material can reinforce regenerated tissue. The material decomposes in the body while forming a scaffolding fiber. The immediately surrounding tissue area consists of tightly packed regular connective tissue aligned along the surface of the strut. This is the same structure as tendons and ligaments. Therefore, the scaffold can be fixed to the surrounding tissue and It is now possible to have a self-made structure (e.g., a mold scaffold structure) for the shape to be stable over time. Therefore, the implant 200 is a breast implant. To name just a few exemplary body regions, such implants are described below. The area can be covered with other parts of the body such as the chest, buttocks (also known as the buttocks), calves, cheeks (or It is effective even on parts of the face, such as the cheeks, or on genital areas, such as the testicular region. The implant of the present invention can be simply any optimal tissue corresponding to the tissue to be reconstructed or augmented. The implant can be of any of various shapes, for example, as described in U.S. Pat. No. 1,004,585. The buttock implant as described in the specification (as described in U.S. Pat. No. 10,004,585) A perspective view of a buttock implant having such a configuration is shown in FIG. 6E), chest (patient See the breast implant shown in Figures 11A-11E for reconstruction of the chest or chest area of ​​the body. ), cheek or buccal area (soft tissue reconstruction implant for reconstruction of the buccal area (or buccal area) of a patient's body 12A-12C, which show schematic diagrams of the endoscopic reconstruction of the testicular region of the patient's body), or the testicular region (see FIG. 12A-12C, which shows schematic diagrams of the endoscopic reconstruction of the testicular region of the patient's body), 13A-13B, which show schematic diagrams of a soft tissue reconstruction implant for It is possible.

[0103] FIG. 7D shows a histological photograph of the regenerated breast tissue.

[0104] The tissue that regenerates within the grooves 118 of the implant 200 after insertion into the patient is autogenous in nature. It has a high degree of vascularization and randomness with respect to the arrangement of collagen fibers. However, the structure may be directly surrounding the scaffold fiber (panels (i) and (ii)). The fibrous regions are regular connective tissues, with the same structure as tendons and ligaments, aligned along the surface of the struts. (Panels (iii) and (iv)). Thus, the groove 118 of the implant 200 By using 3D printing technology to form where the stiffest areas of tissue will grow It is possible to adjust

[0105] During everyday activities (e.g., standing, running, jumping, and walking) in healthy tissue, The force of the Cooper's ligament, which is considered anatomically as the structural framework that holds the constructed breast, is The plurality of hollow grooves 118 may be supported by the implant 200. The implant can be configured to align with the patient's Cooper's ligament 144, thereby providing an impact resistance to the patient. After insertion of the implant 200, body fluids or blood vessels enter the pores (e.g., hollow grooves) of the implant 200. The tissue infiltrates into the hollow groove to form long, aligned tissue fibers, and the .... The arrangement of the patient's Cooper's ligament 144 can be mimicked. The regenerated tissue can be sufficiently integrated into the surrounding tissue. The embedded, denser tissue is aligned with Cooper's ligament (e.g., muscle 143 to nipple 144). 42), new tissue that provides and improves the structural stability of the implant 200 (FIG. 7A) The hollow grooves 118 can be oriented to exert a tensile force that acts as a support for the

[0106] FIG. 7E shows the force of Cooper's ligament acting on one filament (or, for example, absorbed one groove with tissue removed).

[0107] The number of grooves 118 of the implant 200 and the inclination angle of the grooves 118 of the implant 200 are determined by the following factors: The forces due to the activity and the tensile strength of the ligaments can be determined by testing.

[0108] Assuming that the mass of the breast m = 1 kg and the jump angle α = 60° (extreme case) , the force that Cooper's ligament can withstand (F クーパー ) may be 50N to 60N. After absorption of the threads into the retina, the areas of dense tissue are roughly similar to the filaments. For example, the filaments (grooves) of the implant 200 have a diameter of 200 μm and a diameter of 314× 10 -10 m 2 has a surface area of

[0109] The force acting on a single dense connective tissue filament is

number

[0110] The maximum force exerted by a single filament is:

number

[0111] In the worst case (fiber diameter 200 μm, m = 1 kg and α = 60° when jumping), a force of 60 N The occurrence may require the following total number of filaments:

number

[0112] In healthy breast tissue, the tilt angle α can be in the range of 45° to 60°. Therefore, we calculate the theoretical maximum and minimum values ​​of α that can be used for the filaments inside the three-dimensional structure. It is possible.

[0113] FIG. 7F is a diagram showing the internal forces acting on breast tissue during running, jumping, walking, and standing. show.

[0114] d 2 represents the effective radius of curvature of the breast, and d 1 is the weight of the breast (reasonably assumed to be a semicircle) represents the heart, α is the dorsal insertion angle of the breast, and O is the reference point at the base of the breast.

[0115] The forces exerted when standing, walking, running, and jumping are expressed as follows:

[0116] [Table 1]

[0117] m is the mass of the breast, and W(W 乳房 ) is the force generated by the weight of the breast.

[0118] To calculate the force, m is in the range of 0.5kg to 1kg.

number

[0119] The acceleration can be considered as follows:

[0120] [Table 2]

[0121] The force can be calculated as follows:

[0122] [Table 3]

[0123] In the following example, a small amount of implant (100 ml) with, for example, 65 filaments ) and the extreme weight of the breasts hanging down during a jump without a bra is 1 kg. This is a case scenario in which the breasts need to maintain their shape and balance to prevent sagging. It is important that this balance is maintained.

number

number

number

[0124] Assuming all filaments are working in tension, the maximum force that can be applied is would be as follows:

number

[0125] For example, the maximum value of α can therefore be calculated as follows:

number

[0126] Assume that only half the filaments are in tension. The maximum force that can act is It becomes like this.

number

[0127] For example, the minimum value of α can therefore be calculated as follows:

number

[0128] Therefore, a reference axis (e.g., The acute inclination angle k between the x-axis and the x-axis is 3° to 87°, or 3° to 54° (or for example 10° to 50°). °, or for example in the range of 25° to 45°).

[0129] The implant 200 enables tissue regeneration and allows fat tissue to survive once injected into the scaffold. The four main blood sources to the breast are the internal thoracic artery, the external thoracic artery, the anterior thoracic artery, and the posterior thoracic artery. The intercostal artery and the thoracic acromion artery. The structure and / or porous network therefore provides a barrier to the formation of blood vessels, particularly at the interface between the scaffold and the major blood sources. This allows for space for blood vessels to infiltrate and live in the scaffold. It is important to have adequate space throughout the entire field so that blood vessels can reach it from all points. However, highly porous implants can cause discomfort to the patient. For example, more porous implants have a higher surface roughness and may be more susceptible to injury to patients. The implant 200 provides space for the exchange of material (within the scaffolding). The scaffold is designed to trap potentially harmful substances that may be trapped by the tissue and to trap materials that may aid in tissue regeneration. and taking into account the patient's comfort (e.g. tissue stimulation and / or (by reducing infection). The implant 200, despite its porous scaffold, Addresses patient comfort and scaffold safety by providing a smooth interface between scaffold and tissue (through space-filling and contour lines).

[0130] To aid in vascularization of the scaffold, the implant 200 is provided with a major blood supply. 7A) and have the highest pore size of the scaffolds that have high porosity. It is possible to compromise the surface roughness to allow blood vessels to infiltrate and distribute throughout the entire scaffold. To provide space for distribution, different porosities (e.g., two or more different porosities and / or or pore area) can be considered (Figures 2A-2E). For example, the upper surface porosity and and / or the pore size range can be smaller than the bulk porosity value, but with minor blood It may be facing the tissue region in which the fluid supply is located. For example, bulk porosity and / or The pore size range can be higher than the surface value, so that all blood vessels can migrate throughout the scaffold. The possibility of adjusting fiber deposition allows for a better interface between the scaffold and muscle. and smallest at the interface between the scaffold and nipple / breast tissue. The implant grooves should be aligned toward the major blood supply so that the pore size is For example, the hole diameter at the bottom is 8 mm and the hole diameter at the top is 2 mm. The protrusion of the groove on the underside of the plant ranges from 6 mm to 2 mm.

[0131] The adjustable fiber deposition allows the implant 200 to ensure implant stability. This can include a full contour at the bottom to maintain clearance in the lower pole of the scaffold. A semi-contour may be included in the remaining portion of the scaffold to provide support (FIGS. 4A-4B). Contours are used to smooth surfaces and make the patient comfortable, but at the same time, to facilitate material exchange and blood flow. Maintain a constant porosity required to allow vascular infiltration. In the present invention, the implant 200 includes an upper pole surface having a porosity of approximately 83%. The pore size on the surface of the upper pole can be set to 0 mm to 6 mm. Bulk porosity can be 95% and the bulk pore size can be 0mm to 8mm.

[0132] Unlike implant 200, conventional silicone implants are filled with an incompressible liquid. However, over time silicone implants can rupture and cause health problems. This can potentially lead to additional surgery.

[0133] Adjust the fiber (groove) deposition to create a reversibly compressible structure, which is comfortable for the patient To create the implant 200, the implant 200 is formed using 3D printing. The implant 200 is shape stable while retaining the flexibility of the implant. The implant 200 can be configured to provide Meets demands and ensures that the final shape of the breast after insertion into the patient is ideal and natural It is possible.

[0134] The implant 200 is a flexible material that deforms when a force is applied and returns to its original shape when it is released. The use of such a system provides morphological stability to the scaffold (Figures 1C-1D) and allows tissue or It acts on the pulmonary obstruction and thoracic cavity, which in severe cases can cause damage to the lungs. Avoid any extraneous force. The reversibly compressible structure avoids the force acting along one direction. When the force is released, the accumulated force during this process is released (Fig. 1C). Energy acts in the opposite direction (Figure 1D), helping the shape spring back in less than 8 hours. Return that shape.

[0135] The shape stability and flexibility of the implant are important to ensure patient comfort. The planar material 200 can have anisotropic mechanical properties, which are due to the spring-like unit cells and the The spring-like unit cells can include a combination of grooves aligned toward the neck region. The implant 200 is softer laterally to ensure a natural feel. It is also strong enough to maintain its shape under the weight of the tissue and other forces, but The combination of the spring-like unit cells and the groove orientation allows the implant 20 to move along the printing direction. 0 can still be softened.

[0136] Anisotropic mechanical properties to ensure shape stability and desired flexibility of the implant 200 The effect of the spring-like unit cells is a combination of both the effect of the grooves aligned in the direction of the major force. The implant 200 may be configured to accommodate a variety of body sizes, including any size that requires a large amount of scaffolding in the body. It is important to take into account the forces acting on the scaffold after insertion into the patient to ensure that the load is the same as the load. and the additional volume (or additional size) of a certain percentage can be taken into consideration during manufacturing. It can be used to achieve a natural looking result and to shape and shape the breasts. Depending on the force, the contour adjustments are considered in advance so that the desired result is obtained after applying the force. This can be taken into consideration.

[0137] FIG. 8 shows a flow chart of a method 800 of forming an implant of the present invention.

[0138] The method 800 includes a step of successively printing layers to form a three-dimensional (3D) printed structure. 30. The three-dimensional printed structure defines the rest volume of the implant to be formed. Each printed layer The three-dimensional printed structure may have porosity, For (or here) a three-dimensional printed structure is compressible to at least 80% of its rest volume. .

[0139] The method 800 includes a step 8 of determining a build volume of the implant prior to successive printing of layers. 10. The method 800 may include determining an implant based on a build volume of the implant. The method may further include determining 820 a static volume of the printout. The rest volume of the implant measured may be an overestimate of the build-up volume of the implant. do.

[0140] In the method 800, the step of successively printing layers 830 includes printing a first exterior surface area of ​​the 3D printed structure. printing a first layer to form a region; and applying a successive layer on the first layer according to the printing direction. The printing direction (e.g., z direction) may be in the plane of the first layer. The continuous edge region of the continuous printed layer may be in a direction perpendicular to the first outer surface region. A second exterior region of the 3D printed structure can be formed adjacent the ink jet head region. The second exterior region can be formed by The shape of the breast to be constructed by the plant can be defined, and a first outer surface area and a second outer surface area can be defined. The area between the regions can define the rest volume of the implant prior to implantation in a patient.

[0141] Successive layers can be positioned relative to one another so that the unit cells of the layers are A plurality of hollow grooves can be formed. The plurality of hollow grooves can be formed by connecting the first outer surface region of the three-dimensional structure and the second outer surface region of the three-dimensional structure. It can extend between two outer surface regions (e.g., from a first outer surface region to a second outer surface region). direction).

[0142] Optionally, the 3D structure may be formed into a plurality of three-dimensional unit cells (e.g., tetrahedral unit cells). Optionally, the two-dimensional unit cell of the layer can be a three-dimensional unit cell. can be considered as facets (or planes) of

[0143] After forming the successive printed layer, the method 800 includes a step 84 of forming a plurality of surface infills. The formation of the surface filling portion may further include one or more of the following on the outermost surface of the three-dimensional structure: Forming one or more fill lines to at least partially fill the upper opening (surface void) The steps may include:

[0144] The method 800 further includes a step 850 of forming a plurality of contour lines after the successive printing of the layers. The formation of the plurality of contour lines may include a first group of contour lines around a periphery of the first outer surface region. and / or forming a second set of contour lines around the periphery of the first outer surface region. Unlike the first group of contour lines that form a complete contour around the part, each loop in the second group of contour lines The contour may form a semi-contour around the second exterior surface region.

[0145] The features described with respect to the various embodiments of this specification may be combined with each other. Method 800 can be understood to include one or more of the methods previously described with respect to FIGS. 1B-7F. It may include all or some of the above features.

[0146] Experimental Example 1: Autologous fat transplantation in a large animal (Ellegaard-Göttingen minipig) model (A Long-term implantation study using the implant of the present invention in combination with FG ISO11137 (sterilization), 13485 (quality system), 11607 (packaging) 14644-1 (Cleanroom) standards. 3D printed absorbable polycaprolactone scaffolds for medical applications is used to evaluate the safety of the finished implant, which is Including below. 1. Long-term evaluation of immune responses 2. Long-term evaluation of AFG persistence 3. Device (implant) performance 4. Device operability during surgical procedures

[0147] Ellegard Göttingen Mini available from Ellegard GmbH, Dalmoset, Denmark Pigs were selected for this study. 3 scaffolding was used for small sized animals. The scaffold had the following dimensions (see also Figures 9A and 9B): Height: 84mm ·Width: 91mm ·Protrusion: 31.5mm Pore ​​size at the base and top of the implant: 4mm (base), 8mm (top), This means that the average pore size is greater than 4 mm.

[0148] The size of the minipigs used in this study is about 1.5 times smaller than the average human female. Taking into account size differences, the equivalent dimensions of the scaffold for an average human female would be: . Height: 126mm ·Width: 136.5mm ·Protrusion: 47.25mm Pore ​​size at the base and top of the implant: 4mm (base), 8mm (top), This means that the average pore size is greater than 4 mm.

[0149] Therefore, the implant (scaffold) size selected in minipigs should be chosen based on the average body size. Size of human female attached to 300cm 3 However, The implants used in this animal study are smaller than those found in human patients, i.e., average body size. It should be noted that it is intended that the treatment be used in female patients as well.

[0150] This clinical trial included three time point groups (a 6-week pilot study, a 12-month study, and a 2-month study). A total of 32 animals randomized to the study (4-month main study) were included. 12 month time point → 16 animals 24 month time point → 16 animals (n=32 treatments)

[0151] Four treatment groups were selected for this study: 1. Group 1 is a negative control in which only the implant of the present invention is implanted. Group (i.e. no AFG). 2. In group 2, the volume of the scaffold increased immediately after implantation of the implant (scaffold) of the present invention. AFG (50cm 3 ) is carried out. 3. In group 3, autologous fat injection (5 0cm 3 ) is executed. 4. Group 4 is a positive control in which only AFG is performed and viable As far as possible, it corresponds to the standard AFG procedure performed in humans.

[0152] The tissue infiltration of the implants of the present invention was evaluated by magnetic resonance imaging (MRI). C. Implant-related changes in minipigs in treatment group 3 2 weeks after implantation. Figure 9D shows partial tissue invasion into the implant in the minipig, whereas Figure 9E shows complete and rapid invasion into the implant in the minipig. This indicates that rapid tissue infiltration occurs already 4 weeks after implantation. In this regard, in the implants described in Patent Document 1 and Non-Patent Document 1, However, complete tissue invasion was observed only after 24 weeks. The plant provides faster tissue infiltration, which is a significant improvement over known implants. Provides benefits.

[0153] For example, implant (scaffold) designs as described in Patent Document 1 and Non-Patent Document 1 In comparison, the following additional functional differences were found in the present study:

[0154] Pore ​​size and porosity All published literature related to soft tissue engineering, including Patent Document 1 and Non-Patent Document 1, has been In contrast, in clinically relevant settings, To regenerate large volumes of tissue (>50 ml), blood vessels must be able to reach the central area of ​​the implant. Large pores (>1 mm) are required to allow efficient infiltration of the neoplasia. Found in the present invention. 8mm gap at the bottom and 4mm gap at the top (apex) The implants of the present invention used in this study, which have a diameter of 1.5 mm, meet this need and Thus allowing efficient infiltration of neovascularization into the central region of the implant.

[0155] mechanical properties In studies such as Non-Patent Document 1, which aims to regenerate large volumes of soft tissue, The use of a combination of small pore size (<0.5 mm) and rigid porous structure was described. It has been shown that stiff structures can cause inflammation in tissues. This inflammation problem is caused by The lymphatic structure is characterized by invasion of lymphatic structures. As shown in Fig. 1A (replicate 0A), mild chronic inflammation was observed within the pores of the device. It has been shown to occur.

[0156] In contrast, as shown in FIG. 10B, by using the design features specified in this application, The resulting highly porous, spring-like compressible implants did not cause inflammation or chronic inflammation. These mechanical properties, combined with the very rapid tissue infiltration and light weight of the implant, were therefore The ability of the implant of the present invention to avoid inflammation after implantation is due to the quality of the implant. This makes them ideal candidates for tissue restoration and augmentation.

[0157] 11A-11E show a reconstruction of the chest or chest region of a patient's body, such as in the case of congenital pectus excavatum. Shows several views of a soft tissue reconstruction implant 300 for including one or all of the features described in connection with FIGS. 1B - 10B, and various other features can be.

[0158] FIGS. 11A and 11B show bottom views of a chest implant 300 respectively. The chest implant can include a first outer surface region 105 that can be the largest planar (or for example, flattest) surface of the implant. A continuous layer of unit cells can extend between a first outer surface region 105 and a second outer surface region 106 in a three - dimensional structure 101 of the chest implant 300 to form a plurality of hollow grooves.

[0159] FIGS. 11C and 11D show perspective side and top views of the chest implant 300. The contour and shape of the second outer surface region 106 can be based on the desired size and shape of the chest implant 300.

[0160] FIG. 11E shows a cross - sectional side view of the chest implant showing a plurality of hollow grooves extending between a first outer surface region 105 and a second outer surface region 106 in a three - dimensional structure 101 of the chest implant 300.

[0161] Experimental Example 2: Clinical Phase 1 of Chest Implant Soft tissue reconstruction implants as described herein (such as the chest implant 300) are absorbable soft tissue reconstruction scaffolds and are used to reconstruct the chest or thoracic region of a patient's body, such as in the case of congenital pectus excavatum. The impact of the surgery is at https: / / www.abc.net.au / news / 2020 - 0 ​​​​​​Reported in 7-21 / world-first-3d-chest-scaffold-funnel-chest-queensland / 12477704 is doing.

[0162] Currently, the main treatment is breast reconstruction following mastectomy or for congenital defects such as pectus excavatum. There are two surgical options: reconstruction using silicone implants, which can prevent capsular contracture and In addition, silicone implants are associated with several disadvantages, including potential rupture, displacement, and It also depends on the deformity, chronic seroma, or hematoma. Latissimus dorsi, transverse pedicle rectus abdominis myocutaneous flap, or deep subcutaneous flap. Free tissue transfer procedures such as abdominal artery perforator flaps often take 8 to 9 hours and require hospital stays of 10 to 20 minutes. The main complication is the increased risk of blood drainage from the flap. Sometimes, a thrombus may form in the vein that supplies the flap, or in the artery that supplies the flap. Both cases can result in necrosis of the flap tissue. Finally, autologous fat grafting or lipofilling The rings are large-volume, with a 40%-60% reduction in implant volume due to tissue resorption and necrosis. Reconstruction (over 100cc) results in poor clinical results. There are two other methods, the Nas method and the Vacuum Bell. The key step is to introduce a curved bar that lifts the sternum. Problems include chronic pain, needing to have the rod removed after a few years, and pain during surgery. This includes potentially damaging the heart and lungs, as well as placing the rod in the wrong position. The solution is the vacuum bell, which uses suction cups to lift the sternum without surgical intervention. Some cases of pectus excavatum have a poor clinical outcome and are associated with cardiac involvement. It cannot be used in the following cases.

[0163] Clinical trials using the chest implants described herein have been performed on congenital pectus excavatum. Performed by plastic and reconstructive surgeons. Pectus excavatum (pectus excavatum syndrome) is a condition characterized by a central or lateral A chest deformity characterized by a sunken sternum. Pectus excavatum syndrome affects 1% to 2% of the population. It is the most common congenital thoracic deformity that can occur in the patient's body. The procedure to insert the catheter does not touch the bone and is less painful than other procedural approaches. Designed as a minimally invasive procedure with predictable recovery, the use of a resorbable scaffold is in silico This technique offers simplicity compared to other techniques that use a trochanter. He was born with lymphatic obstruction affecting the chest wall and upper limbs, and with enlarged limbs. This combination is known as the Klippel-Trenauret syndrome. A 6cm old scar was used to approximate the anterior aspect of the sternum. This entailed removal of the sternocostal portion of the ipsilateral pectoralis major muscle as is routinely performed in surgery. A cavity for the implant was created and the implant was inserted. Fat was harvested from the patient's thighs and abdomen using standard Coleman fat transfer techniques. The fat was then injected directly into the implant using a standard fat injection needle. The key is to inject the patient's own fat into the scaffold at the time of implant insertion or several weeks later. This allows for a significant amount of the patient's own tissue (e.g., more than 70%, or, e.g., more than 80%) to be retained. The regeneration of the highly porous scaffold with a porosity of 100% or more (e.g., 90% or more) is then stimulated. The opening was closed in a standard two-layer fashion. No surgical drains were required. Breast implant surgery Light compression therapy was applied, as is routinely done in the United States. Therefore, a significant difference was observed when using a sham 3D printed scaffold. She has already had 17 surgeries for a chest deformity that is affecting her heart and lung function. The surgery managed to mask the deformity without damaging her organs. The plant's materials allow the implant to disappear completely after some time.

[0164] Implants as described herein were implanted by minimally invasive methods. Resorbable (e.g. fully absorbable) porous scaffolds have very specific topologies and design features. This demonstrates that the endothelial graft serves as a base for the injection of adipose tissue harvested using standard liposuction surgery. The absorbable polymer helps regenerate natural breast tissue after implantation. Regenerating tissue from the patient's own body fat without the need for alveoli or products of animal origin The implant will be absorbed over a period of time (e.g. 2 years) and the injected fat will be absorbed. It provides a stable foundation for an organization to mature, adapt and stabilize in its environment. The pads may not be compressible or malleable and / or may not be designed to dissipate. For example, silicone implants may need to be replaced due to complications such as capsular contracture. Silicone implants are not lifelong devices. Patients with runts will require up to three revision procedures at some point in their lives. The implants described herein are adapted to adhere to the patient's own tissue after implantation at the surgical site. By providing a porous network that can regenerate tissue, these revision procedures can be avoided. Furthermore, the incompressibility and spring-like properties of the implant prevent the folding and / or compression of the scaffold. This allows for only very small incisions to be made, minimizing injury to the patient's body and / or the risk of injury to the hand. Minimize surgical scars or scars.

[0165] Further Examples of Use of the Soft Tissue Reconstruction Implant of the Present Invention 12A-12C show a soft tissue reconstruction implant for reconstruction of the cheek (or cheeks) of a patient's body. 1B-11E. The present invention may include one or more or all of the features described above, as well as various other features.

[0166] 12A and 12B show perspective top views of a cheek implant 400. FIG. 2 shows a side view of the cheek implant 400. The cheek implant is a three-dimensional structure of the cheek implant 400. A plurality of hollow grooves extending between the first outer surface region 105 and the second outer surface region 106 of the structure 101. The cheek implant may include a periphery of the first outer surface region 105 and a second outer surface region 106. 06. The invention may further include a contour line 421 forming a complete and / or partial contour around the The cheek implant can optionally include an apex region 112. The second outer surface region The distance between the apex region 112 of the first outer surface region 105 and the second outer surface region 105 is It may be the maximum height between any portion of the exterior surface region 105.

[0167] The spring-like, reversibly compressible implant allows the cheek implant to conform to the flexibility of the patient's cheek. This allows for mimicking compressibility (such as the consistency of human fat and tissue).

[0168] 13A-13B show a soft tissue reconstruction implant 50 for reconstruction of the testicular region of a patient's body. 1B to 12C are perspective side and top views, respectively, of the implant 500. The present invention may include one or more or all of the features described in connection with, as well as various other features.

[0169] Testicular implant 500 can be optionally spherical and / or ovoid. The implant comprises a first outer surface region 105 of the three-dimensional structure 101 of the testicular implant 500. and the second exterior surface region 106. The grooves can be zigzag or sinusoidal grooves. The implant 500 has a first outer surface. forming a complete and / or partial contour around the periphery of region 105 and second exterior region 106; The testicular implant 500 may further include a contour line 521. An apex region 112 in the outer surface region 106 may be included.

[0170] Testicular implants can be performed in testicular surgery or cosmetic cases. The testicle 500 is of a desired size (e.g., the size of an average human testicle). It can be implanted in patients when one or both testicles are absent. After implantation in the scrotum, the plant 500 allows the testicular implant to fit within the scrotum. A set of testicular implants 500 may be sized to accommodate the patient's testicular mass. To create or restore symmetry between testes when they are significantly different in size It can be used.

[0171] Similar to saline breast implants, current testicular implants are filled with saline. can be used without any need for saline implants, posing similar challenges to those posed by saline implants. After implantation, saline testicular implants showed no significant changes in the surrounding area. In addition, there is a risk of infection, migration of the implant within the body, and dissection. The reversibly compressible testicular implant 500 reduces the risk of scarring from surgery. can be made as small as possible, which allows the recovery time to be reduced. Testicular implant surgery can be performed as an outpatient procedure, reducing the need for anesthesia. can.

[0172] Each of the implants described herein is a spring-like, reversibly compressible implant. The implant can be reconstructed after the compression force is released (such as by changing the ambient pressure and temperature). (recover or return to its original (rest) volume) The spring-like implant should expand to at least (e.g., equal to or greater than) its original volume. 80% (or for example at least 70%, or for example at least 60%, or for example For example, the material may be compressible by at least 50%, or for example by at least 30%. The implant of this type regains its original volume after the compressive force acting on the implant is released. At least 80% (e.g., 80% or more) (or, e.g., at least 90%, or, e.g., at least at least 95%, or for example at least 98%, or for example up to 100%) The surface filling line 122 and the contour lines 119, 121, and 421 can also be constructed as follows: It provides comfort to the user and prevents inflammation. Therefore, the outer covering (saline implant The spring-like, smooth implant is easy to insert into the patient without the need for a special device (such as a The implant may be biodegradable. Optionally, after implantation, Depending on how soft the buried region is desired, the buried region may be softened. To improve the appearance of the implant, fat can be injected into it. It is also possible to not perform fat injections. The tissue will infiltrate the inserted implant and will last for several weeks. The implant then biodegrades.

[0173] 14A-14C show more detailed views of implant 1 as described in connection with FIGS. 1B-10B. 00, 200 as soft tissue reconstruction implants for reconstruction of the breast region of a patient's body. The soft tissue reconstruction implants 100, 200 may be configured with a spring-like, reversibly compressible It can be an implant.

[0174] The implants 100, 200 are configured to form a spring-like three-dimensional lattice structure 101. The three-dimensional structure includes a plurality of unit cells 102 that are spaced apart from one another, the unit cells comprising the rest volume of the implant. The unit cells 102 are configured to form a three-dimensional porous network. The bulk porosity of the three-dimensional structure 101 in the implant is at least 50%, or Both are 60% or at least 70%.

[0175] The individual unit cells 102 can be reversibly compressible spring-like unit cells, A reversibly compressible spring-like unit cell must expand to at least (e.g., equal to or less than) its original volume. It is compressible to at least (e.g. equal to or less than) 10% or 20% of its original volume. (greater than that) back to 80%.

[0176] The surface porosity of the second exterior surface region 106 is preferably in the form of a three-dimensional structure in the implant 100, 200. The bulk porosity of the implant may be less than 0.1 gr / cm3 ~2gr / cm 3 It can be said that:

[0177] The present invention is further characterized by the following:

[0178] Item 1: An implant for insertion into a patient. The implant has a three-dimensional lattice structure. a plurality of unit cells configured to form a three-dimensional structure, the three-dimensional structure being a static structure of the implant; a plurality of unit cells configured to form a three-dimensional porous network having a volume; , the three-dimensional structure is a reversibly compressible three-dimensional structure.

[0179] Item 2: Each unit cell in the plurality of unit cells includes a unit cell that is reversibly compressible. 2. The implant according to item 1.

[0180] Item 3: The unit cell in the plurality of unit cells is a three-dimensional unit cell. The implant described.

[0181] Item 4: A reversibly compressible unit cell shall compress to at least 50% of its original volume, or less. Compressible to at least 60%, or at least 70%, or at least 80%, and 4. The implant according to any of items 2 or 3, which returns to at least 80% of its original volume.

[0182] Item 5: The static volume of the implant is based on the constructed volume of the breast constructed by the implant. The implant is configured to be reversibly compressible to at least a build volume. 5. The implant according to any one of items 1 to 4.

[0183] Item 6: Each unit cell includes a plurality of lines of intersection, and the intersection of the unit cell is the unit cell of 6. The implant according to any one of items 1 to 5, configured to form a plurality of pores.

[0184] Item 7: The intersection line of the unit cell defines the pore size of the unit cell. Implants listed.

[0185] Item 8: The average pore size of the unit cells in the three-dimensional structure is at least 0.5 mm. The subject matter of any of Examples 1 to 7.

[0186] Item 9: The pore size of at least 50% of the unit cells in the three-dimensional structure is at least 9. The implant according to any one of items 1 to 8, which is 0.5 mm.

[0187] Item 10: The three-dimensional structure is a first outer surface region of the implant having a first surface curvature; a second outer surface region of the implant having a second surface curvature; The second outer surface region of the implant is disposed around the periphery of the first outer surface region of the implant. adjacent to the surface area, The shape of the second outer surface region represents the shape of the breast to be constructed by the implant, items 1 to 9 2. The implant according to claim 1 .

[0188] Item 11: The second outer surface region is an upper pole portion having a shape of an upper portion of a breast to be constructed by the implant; a lower pole portion having a shape of a lower portion of the breast to be constructed by the implant; The upper pole portion and the lower pole portion meet at an apex region of the second outer surface region of the three-dimensional structure. 11. The implant according to item 10.

[0189] Item 12: the first outer surface region comprises a surface of least curvature on the implant; the curvature of the upper pole portion of the second exterior surface region is greater than the curvature of the first exterior surface region; and the curvature of the lower pole portion of the second outer surface region is greater than or equal to the curvature of the upper pole portion of the second outer surface region; Item 12. The implant according to item 11.

[0190] Item 13: The average pore size of the openings in the first outer surface region of the three-dimensional structure is At least 25% larger than the average pore size of the openings in the two outer surface regions, any one of items 1 to 13 2. The implant according to claim 1 .

[0191] Item 14: The average pore size of the openings in the first outer surface region of the implant is at least 2 mm. 14. The implant according to any one of items 10 to 13, wherein

[0192] Item 15: The pore size of the upper pole part of the second outer surface region is 0. 5 mm to a maximum of 5 mm in the apical region of the second outer surface region, The upper pole boundary region is a region in which the upper pole portion of the second outer surface region is adjacent to a portion of the periphery of the first outer surface region. 15. The implant according to any one of items 11 to 14, which is a boundary region of intersecting three-dimensional structures.

[0193] Item 16: The pore size of the lower pole portion of the second outer surface region is 0.15 at the lower pole boundary. mm or 2 mm to a maximum of 6 mm or a maximum of 8 mm toward the apical region of the second outer surface region; increases up to 9mm or up to 10mm, The lower pole boundary region is a region in which the lower pole portion of the second outer surface region is integrated with a portion of the periphery of the first outer surface region. 16. The implant according to any one of items 11 to 15, which is a boundary region of intersecting three-dimensional structures.

[0194] Item 17: The surface porosity of the second outer surface region is the bulk porosity of the three-dimensional structure of the implant. 17. The implant according to any one of items 10 to 16, wherein the porosity is less than 10%.

[0195] Item 18: The bulk 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% of items 1 to 17 2. The implant according to claim 1 .

[0196] Item 19: The bulk porosity of the implant is 50%, or at least 60%, or less. 19. The implant according to claim 18, wherein the β-amylase activity is at least 70%, or at least between 80% and 99%. nt.

[0197] Item 20: The implant material density is 0.1gr / cm 3 ~2gr / cm 3 The item 20. The implant according to any one of 1 to 19.

[0198] Item 21: The plurality of unit cells includes a plurality of three-dimensional unit cells, the three-dimensional unit cells being tetrahedral. 21. The implant according to any of items 1 to 20, which is a unit cell.

[0199] Item 22: The three-dimensional structure includes an arrangement of layers including a plurality of outer layers arranged successively with respect to each other. fruit, Each outer layer of the layer array includes a lattice array including a plurality of two-dimensional unit cells. The implant according to any one of the above.

[0200] Item 23: Several two-dimensional unit cells are available: a triangular unit cell, a diamond-shaped unit cell, at least one of a rhomboid unit cell, a tetragonal unit cell, and a hexagonal unit cell; 23. The implant according to item 22.

[0201] Item 24: The three-dimensional structure comprises a first exterior region including a first layer of the arrangement of layers; A two-dimensional unit cell of successive layers of the array of layers is formed between a first exterior region and a second exterior region of the three-dimensional structure. forming a plurality of hollow grooves extending in the The second outer surface region is adjacent to the first outer surface region at the periphery of the first outer surface region. 23. An implant according to any one of claims 23 to 23.

[0202] Item 25: The implant according to Item 24, wherein the hollow grooves are parallel to one another.

[0203] Item 26: the first outer surface region is configured to face a chest wall of a patient receiving the implant; The plurality of hollow grooves are configured to align with Cooper's ligaments of a patient receiving the implant. 26. An implant according to any of items 24 or 25.

[0204] Item 27: The plurality of hollow grooves are inclined with respect to the first outer surface region of the implant, and the plurality of hollow grooves are inclined with respect to the first outer surface region of the implant. The acute inclination angle between the hollow groove and the reference axis representing the first outer surface region is less than 60°. 27. An implant according to any one of 26.

[0205] Item 28: The plurality of hollow grooves are configured to converge toward a convergence region, and the convergence region is a three-dimensional Any of items 24 to 27 located outside the first outer surface region or the second outer surface region in the three-dimensional structure 2. The implant according to claim 1 .

[0206] Item 29: The second outer surface area has the shape of the upper part of the breast to be constructed by the implant. An upper pole portion; a lower pole portion having a shape of a lower portion of the breast to be constructed by the implant; the upper pole portion and the lower pole portion meet at a tip region of the second outer surface region; At least one of the plurality of hollow grooves extends from the first outer surface region to an apex region of the second outer surface region and Item 24 to be configured to extend toward at least one of the lower pole portions of the region. 29. An implant according to any one of 28.

[0207] Item 30: One or more further grooves of the plurality of hollow grooves extend from the upper pole portion of the second outer surface region to the first The tip region of the two outer surface regions and the lower pole portion are configured to extend toward at least one of the tip region and the lower pole portion. 30. The implant according to item 29,

[0208] Item 31: A first group of contour lines in the plurality of lines is a periphery of a first outer surface region of the implant. 31. The implant according to any of items 1 to 30, which is placed around

[0209] Item 32: the plurality of lines includes a second group of contour lines; Each contour line in the second group of contour lines forms a semi-contour around a second outer surface region of the implant. Completed, The second group of contour lines are continuous with respect to one another between the apex region of the first outer surface region and the apex region of the second outer surface region. 32. The implant according to item 31, which is placed in

[0210] Item 33: A second group of contour lines is disposed at the upper pole portion of the second outer surface region, 33. The implant according to item 32, wherein the lower pole portion of the face region is free of contour lines.

[0211] Item 34. A method for manufacturing a three-dimensional structure comprising the steps of: 23. The method according to claim 22, further comprising: Implants listed.

[0212] Item 35: One or more fill lines of the surface infill section form a unit cell on the outermost surface of the three-dimensional structure. 35. The implant of item 34, configured to connect to a group of defining intersecting lines.

[0213] Item 36: The three-dimensional structure is A single unit cell at an outermost surface of the three-dimensional structure with a surface infill that closes the openings of the first group of unit cells. a first group of position cells; a second group of unit cells at an outermost surface of the three-dimensional structure that is free of surface infills. 35. An implant as described in claim 35.

[0214] Item 37: At least 20% of the unit cells on the outermost surface of the three-dimensional structure are surface 37. The impeller according to any one of items 34 to 36, which is at least partially filled with a filling part. Runt.

[0215] Item 38: The surface filling pillars and the open pillars are alternately arranged in the outer surface region; The openings of the surface filling pillars at the outermost surface of the three-dimensional structure are at least partially filled with the surface filling. Partially filled, and The openings of the open columns at the outermost surface of the three-dimensional structure are free of surface filling, as described in item 37 Implants.

[0216] Item 39: The implant according to item 38, wherein the surface filling pillars include side walls of the grooves in the plurality of hollow grooves. plant.

[0217] Item 40: The c value, which indicates the flexibility of the implant, is 20N to 200N. Items 1 to 39 2. The implant according to claim 1 .

[0218] Item 41: The method according to any one of Items 6 to 40, wherein the plurality of wires includes a surface degradable polymer material. Implants.

[0219] Item 42: The implant according to any one of items 6 to 40, wherein the plurality of wires comprises a non-degradable material. nt.

[0220] Item 43: Any of items 24 to 42, wherein the plurality of hollow grooves comprises 5 to 1000 hollow grooves. The implant according to claim 1.

[0221] Item 44: An implant for insertion into a patient, the implant comprising: The implant has a porous three-dimensional scaffold structure containing an array of unit cells, and the bulk porosity of the implant is low. at least 50%, or at least 60%, or at least 70%.

[0222] Item 45: The implant according to Item 44, wherein the bulk porosity of the implant is 75% to 99%. Plant.

[0223] Item 46: The surface porosity of the implant is 30% to 80%. The implant according to any one of the preceding claims.

[0224] Item 47: The surface porosity of the implant is 40% to 70%. The implant according to any one of the preceding claims.

[0225] Item 48: The surface porosity of the implant is 50% to 60%. The implant according to any one of the preceding claims.

[0226] Item 49: The density of the implant material is 0.1gr / cm 3 ~2gr / cm 3 The term An implant according to any one of items 44 to 48.

[0227] Item 50: Each unit cell in the plurality of unit cells is a spring-like unit cell, 49. The implant according to any one of items 44 to 48, wherein the unit cell is reversibly compressible. to.

[0228] Item 51: The three-dimensional structure is a first outer surface region of the implant having a first surface curvature; a second outer surface region of the implant having a second surface curvature; The second outer surface region of the implant is disposed around the periphery of the first outer surface region of the implant. adjacent to the surface area, The shape of the second outer surface region represents the shape of the breast to be constructed by the implant, 51. An implant according to any one of claims 51 to 51.

[0229] Item 52: The second outer surface region is an upper pole portion having a shape of an upper portion of a breast to be constructed by the implant; a lower pole portion having a shape of a lower portion of the breast to be constructed by the implant; The upper pole portion and the lower pole portion meet at an apex region of the second outer surface region of the three-dimensional structure. Item 52. The implant according to item 51.

[0230] Item 53: The surface porosity of the second outer surface region is smaller than the surface porosity of the first outer surface region. 1 or 52. An implant according to any one of claims 1 or 52.

[0231] Item 54: An implant for insertion into a patient, the implant comprising: a porous three-dimensional scaffold structure including an array of unit cells; the plurality of unit cells are configured to form a three-dimensional porous network; The average pore size of the unit cells in the three-dimensional structure is at least 0.5 mm. plant.

[0232] Item 55: The average pore size of the unit cells in the three-dimensional structure is at least 3 mm. 55. The implant according to item 54.

[0233] Item 56: The pore size of at least 50% of the unit cells in the three-dimensional structure is at least 56. The implant according to any of items 54 or 55, wherein the thickness of the implant is at least 0.5 mm.

[0234] Item 57: Three-dimensional structure a first outer surface region of the implant having a first surface curvature; a second outer surface region of the implant having a second surface curvature; The second outer surface region of the implant is disposed around the periphery of the first outer surface region of the implant. adjacent to the surface area, and The shape of the second outer surface region represents the shape of the breast to be constructed by the implant, 56. An implant according to any one of claims 56 to 57.

[0235] Item 58: The second outer surface area is an upper pole portion having a shape of an upper portion of a breast to be constructed by the implant; a lower pole portion having a shape of a lower portion of the breast to be constructed by the implant; The upper pole portion and the lower pole portion meet at an apex region of the second outer surface region of the three-dimensional structure. Item 58. The implant according to item 57.

[0236] Item 59: The average pore size in the first outer surface region of the three-dimensional structure is greater than the average pore size in the second outer surface region of the three-dimensional structure. 59. The method according to any one of items 55 to 58, wherein the average pore size in the region is at least 25% larger than the average pore size in the region. Implant.

[0237] Item 60: The average pore size in the first outer surface region of the implant is at least 8 mm 60. An implant according to any of items 58 or 59.

[0238] Item 61: The pore size of the upper pole portion of the second outer surface region is 0. 5 mm in the apical region of the second outer surface region to 5 mm in the apical region of the second outer surface region; The upper pole boundary region is a boundary region of the three-dimensional structure, and the upper pole portion of the second outer surface region is a first 59. An implant according to any one of items 55 to 58, intersecting a portion of the periphery of one outer surface region.

[0239] Item 62: The pore diameter of the lower pole part of the second outer surface area is 2m m towards the apical region of the second outer surface region up to a maximum of 6 mm; The lower pole boundary region is a boundary region of the three-dimensional structure, and the lower pole portion of the second outer surface region is a first 62. An implant according to any one of items 58 to 61, intersecting a portion of the periphery of one outer surface region.

[0240] Item 63: The pore size of the opening in the second outer surface region of the implant is Item 5. The thickness of the outer surface of the second outer region increases from 0.5 mm in the apical region to 2 mm in the apical region of the second outer region. 4. An implant according to any one of claims 4 to 62.

[0241] Item 64: The pore size of the opening in the second outer surface region of the implant is The thickness increases from 2 mm in the apical region to a maximum of 6 mm toward the apical region. 2. The implant according to claim 1 .

[0242] Item 65: An implant for insertion into a patient, the implant comprising: A three-dimensional porous scaffold comprising a plurality of hollow channels extending between a first outer surface region and a second outer surface region. Equipped with a dimensional porous scaffold, The porous scaffold comprises a surface degradable polymeric material; the first exterior surface region is configured to face a chest wall of a patient receiving the implant; The shape of the second outer surface region represents the shape of the breast to be constructed by the implant; and The plurality of hollow grooves are configured to align with Cooper's ligaments of a patient receiving the implant. r, implant.

[0243] Item 66: The three-dimensional porous scaffold comprises a plurality of outer layers arranged successively with respect to each other, each outer layer of the array includes a lattice arrangement of a plurality of two-dimensional unit cells; The two-dimensional unit cell in the successive layers of the plurality of outer layers is a first exterior surface region of the three-dimensional porous scaffold. Item 66. As described in item 65, configured to form a plurality of hollow grooves extending between the second outer surface regions. Implants.

[0244] Item 67: The second outer surface region is adjacent to the first outer surface region at the periphery of the first outer surface region; 67. An implant according to any of items 65 or 66.

[0245] Item 68: The plurality of hollow grooves are inclined with respect to the first outer surface region of the implant, Item 65. The acute inclination angle between the reference axis representing the number of hollow grooves and the first outer surface area is less than 60°. The subject matter described in any one of claims 1 to 67.

[0246] Item 69: The plurality of hollow grooves are configured to converge toward a convergent region, the convergent region being 65 to 68, which is located outside the first outer surface region or the second outer surface region in the three-dimensional structure. The subject matter described herein.

[0247] Item 70: The second outer surface area has the shape of the upper part of the breast to be constructed by the implant. An upper pole portion; a lower pole portion having a shape of a lower portion of a breast to be constructed by the implant; the upper pole portion and the lower pole portion meet at an apex region of the second outer surface region; At least one of the plurality of hollow grooves extends from the first outer surface region to an apex region of the second outer surface region and Item 63 to 64 are configured to extend toward at least one of the lower pole portions of the region. 67. The subject matter described in any one of claims 67.

[0248] Item 71: One or more further grooves of the plurality of hollow grooves extend from the upper pole portion of the second outer surface region to the first The tip region of the two outer surface regions and the lower pole portion are configured to extend toward at least one of the tip region and the lower pole portion. 71. The implant according to item 70,

[0249] Item 72: The bulk porosity of the implant is at least 50%, or at least 60%; or at least 70%, or at least 80%, and the total porosity is expressed by the formula: It is stated,

number

[0250] Item 73: A method for forming an implant, the method comprising: To form a three-dimensional (3D) printed structure that defines the rest volume of the implant to be formed. printing successive layers on the Each printed layer comprises a lattice array of two-dimensional unit cells; The three-dimensional printed structure is compressible to at least 80% of its original volume. The method has a bulk porosity of.

[0251] Item 74: The average pore size of the unit cells in the three-dimensional structure is at least 0.5 mm. Item 74. The method according to Item 73.

[0252] Item 75: The step of successively printing layers includes: printing a first layer to form a first exterior region of a 3D scaffold structure; and printing successive layers on the first layer according to a printing direction, forming a 3D scaffold structure. The edge region of the continuous layer forming the second outer surface region is adjacent to the first outer surface region, item 73 or 7 5. A method according to any one of claims 4 to 4.

[0253] Item 76: A unit cell of a layer of a 3D scaffold structure is a first outer surface region and a second outer surface region of the three-dimensional structure. 76. The method according to any one of items 73 to 75, wherein a plurality of hollow grooves extending between the first and second surfaces are formed.

[0254] Item 77: Layers form multiple three-dimensional unit cells in three-dimensional (3D) printed scaffold structures 77. The method according to any one of items 73 to 76, wherein the printing is performed continuously in the manner described above.

[0255] Item 78: A method for forming an implant, the method comprising: To form a three-dimensional (3D) printed structure that defines the rest volume of the implant to be formed. printing (830) successive layers on the Each printed layer comprises a lattice array of two-dimensional unit cells; The three-dimensional printed structure is compressible to at least 80% of its original volume. The method has a bulk porosity of.

[0256] Item 79: A method for tissue reconstruction or tissue augmentation, the method comprising any one of items 1 to 72. Implants manufactured by the method specified in any one of items 73 to 78 into the body of a subject.

[0257] Item 80: The method according to item 79, comprising reconstruction of a body part.

[0258] Item 81: The body parts consist of the buttocks area, calves, and parts of the face, chest, or genital area. 81. The method of claim 80, wherein the compound is selected from the group consisting of:

[0259] Item 82: The method according to Item 81, wherein the part of the face is a cheek.

[0260] Item 83: The method according to any of items 80 to 82, comprising chest reconstruction or breast reconstruction.

[0261] Item 84: Breast reconstruction is performed after lumpectomy or mastectomy. The method described.

[0262] Item 85: The method according to item 83, wherein the chest reconstruction includes reconstruction of the chest or chest area of ​​the patient's body. method.

[0263] Item 86: The method of item 85, wherein the chest reconstruction includes treatment of congenital pectus excavatum.

[0264] Although detailed embodiments of the present invention have been described, the scope of the present invention is defined by the appended claims. The present invention can be easily modified in many ways without departing from the spirit or scope of the present invention. It will be understood that the present invention is not limited to the specific details set forth above.

Claims

1. A soft tissue reconstruction implant (100, 200) for insertion into a patient, the implant comprising: Runt is The device comprises a plurality of unit cells (102) configured to form a three-dimensional lattice structure (101). the three-dimensional structure comprises a rest volume of the implant; The plurality of unit cells (102) are configured to form the three-dimensional porous network. The three-dimensional structure (101) is a reversibly compressible three-dimensional structure, and the imp The bulk porosity of the three-dimensional structure (101) in the plant is at least 50%. Plant.

2. Each unit cell (102) in the plurality of unit cells is a reversibly compressible spring-like The implant of claim 1 , wherein the unit cell is

3. The unit cells in the three-dimensional structure have an average pore size of at least 0.5 mm.

3. The implant according to claim 1 or 2.

4. The average pore size of the openings in the first outer surface region (105) of the three-dimensional structure (101) is the average pore size of the openings in the second outer surface region (106) of the three-dimensional structure (101) being smaller than the average pore size of the openings in the second outer surface region (106) of the three-dimensional structure (101).

4. An implant according to any one of claims 1 to 3, which is at least 25% larger.

5. The three-dimensional structure (101) is a first outer surface region (105) of said implant having a first surface curvature; a second outer surface region (106) of the implant having a second surface curvature; The second outer surface area (106) of the implant is peripheral to the first outer surface area (105). adjacent to the first outer surface region (105) of said implant at (107); The shape of the second outer surface area (106) corresponds to the shape of the breast to be created by the implant. The implant according to any one of claims 1 to 4, which represents

6. The second outer surface region (106) is An upper pole portion (109) having the shape of the upper part of the breast to be constructed by said implant. and, A lower pole part (111) having the shape of the lower part of the breast to be constructed by said implant. And, The upper pole piece (109) and the lower pole piece (111) are 6. The method according to claim 5, wherein the first outer surface region (106) of the first outer surface region (106) of the first outer surface region (106) of the second ... second outer surface region (106) of the first outer surface region (106) of the second outer surface region The implant described.

7. The pore size of the opening in the second outer surface region (106) of the implant is 0.5 mm in the boundary region (114) to 2 mm in the apex region of the second outer surface region or 5 mm at the lower pole boundary region (115), and 10 mm or 8 mm at the lower pole boundary region (116). or increasing from 6 mm to a maximum of 0.5 mm towards the apex region (112). The implant according to claim 1.

8. The pore size of the opening in the second outer surface region (106) of the implant is 0.5 mm in the boundary region (114) to 2 mm in the apex region of the second outer surface region or 5 mm at the lower pole boundary region (115) to the apical region. 6 mm, or 8 mm, or 10 mm toward the region (112) 7. The implant of claim 6 .

9. The surface porosity of the second exterior surface region is in proportion to the bulk porosity of the three-dimensional structure of the implant. An implant according to any one of claims 4 to 8, which is less than porous.

10. The material density of the implant is 0.1 gr / cm ３ ~2gr / cm ３ Claims 1 to 5 10. An implant according to any one of claims 9.

11. The three-dimensional structure (101) is a first exterior region (105) comprising a first layer (126) of an array of layers (126); Each layer (126) of the layer array includes a lattice array comprising a plurality of two-dimensional unit cells (102). and a two-dimensional unit cell of successive layers of the array of layers is a first exterior surface region (105) of said three-dimensional structure. The second outer surface region (106) is provided with a plurality of hollow grooves (118) extending therebetween.

11. An implant according to any one of claims 10.

12. A contour of a plurality of lines disposed around a perimeter of a first outer surface region of the implant. a first group (119) and a second group (121) of contour lines in the plurality of lines; Each of the second group of contour lines (121) is arranged around a second outer surface region of the implant. Forming a semi-contour of The second group of contour lines (121) correspond to the first outer surface region (105) of the implant. are disposed consecutively relative to one another between the apex regions (112) of the second outer surface region (106). The implant according to any one of claims 1 to 11.

13. Further comprising a plurality of surface fillers (122); The surface filler (122) at least partially fills the openings in the outer surface area of ​​the three-dimensional structure. The method according to any one of claims 1 to 12, further comprising one or more fill lines (124) configured for automatic filling.

2. An implant according to any one of claims 1 to 11.

14. The c value representing the flexibility of the implant is 20N to 200N; The c value is represented by the following formula: [0010] F ２０％ is the force value in N at 20% compression, F １０％ is the force value in N at 10% compression, ε １０％ is the strain value at 10% compression, and ε ２０％ is a strain value at 20% compression, Implants listed.

15. 1. A method (800) of forming a soft tissue reconstruction implant, the method comprising: forming a three-dimensional (3D) printed structure that defines a rest volume of the implant to be formed; printing (830) successive layers such that Each printed layer comprises a lattice array of two-dimensional unit cells; The three dimensional printed structure is at least one of a plurality of layers, such that the three dimensional printed structure is reversibly compressible. The method of claim 1, wherein the bulk porosity is at least 50%.

Images