Implant and method of forming an implant

Abstract

The present embodiments relate to a three dimensional implant for tissue reconstruction or augmentation for insertion into a patient.SOLUTION: The implant includes a plurality of strands forming a three dimensional structure with a plurality of hollow channels. Each hollow channel comprises a plurality of sidewalls. The sidewall comprises a plurality of strand segments and a plurality of gaps alternately arranged such that a gap is formed between adjacent strand segments. The plurality of gaps are reversibly expandable gaps. The adjacent strand segments define a deflection capability (δ) based on an object received in the reversibly expandable gap. The radius (R) of the strand segments and the gap length (gl) of the reversibly-expandable gap are based on the yield strength (σ yield), the elastic modulus (E) of the material, and the deflection capability δ of the adjacent strand segments.SELECTED DRAWING: Figure 3A

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application is based on European Patent Application No. 201869 filed with the European Patent Office on July 21, 2020. No. 61.7, the entire contents of which are incorporated herein for all purposes. can be.

[0002] The embodiments described herein relate to the field of implants, and in particular to implants for insertion into a patient. The present invention relates to an implant for the treatment of a vascular disease, and a method for forming the implant. [Background technology]

[0003] Surgeries to insert implants into patients are performed all over the world. Depending on the intended use of the implant, the implant may be required to meet certain standards. Such criteria may relate to the implant geometry and / or the mechanical stability of the implant. In cases where implants are used in reconstructive surgery, The implant must not be handled by the surgeon before, during, and / or after insertion into the It may be necessary to design a device that meets the geometric and mechanical criteria required by the patient and It is desirable to have an implant that can be easily handled and / or manipulated by the surgeon performing the implant procedure. It can be enjoyed. Summary of the Invention

[0004] Various embodiments are flexible and adjustable to meet the patient's body part reconstruction needs. and the implant can be easily handled and operated by the surgeon. The present invention relates to an implant that can enhance and improve operability.

[0005] The embodiments described herein relate to a three-dimensional implant for insertion into a patient. The implant contains multiple strands that form a three-dimensional structure. The structure includes a plurality of hollow channels. Each hollow channel has a plurality of si The sidewall has a sidewall. A gap is formed between the adjacent strand segments. The gear has a plurality of strand segments and a plurality of gaps arranged alternately. The gap consists of a gap length (gl) and a static gap height (gh). The gap is a reversibly expandable gap. The height of the gap is determined by the gap The gap height increases with the amount of material that can be accommodated by the gap. The yield strength (σ yield ) and bullets The strands are made of a material with a coefficient of elasticity (E). The gap length (gl) of the reversibly expandable gap is related to the yield strength (σ yield ), materials The elastic modulus (E) and the adjacent strands forming a reversibly expandable gap It is based on the deflection capacity δ of the segment.

[0006] Various embodiments may be used to guide a needle through an implant for an implant procedure. The present invention relates to an implant for use in

[0007] Various embodiments relate to methods for forming three-dimensional implants. The method includes forming a plurality of strands to form a three-dimensional structure. The land is the yield strength (σ yield ) and a modulus of elasticity (E) The three-dimensional structure includes multiple hollow channels. Each hollow channel has multiple sizes. The sidewall has a plurality of gaps and a plurality of consecutive strands. and a strand segment connected to the plurality of strand segments. A gap is formed between adjacent strand segments in the sidewall. The gaps are arranged alternately so that the gap length (gl) and the static The gaps are reversibly expandable gaps. The height of the reversibly expandable gap depends on the object that can be accommodated in the gap. The gap height increases as the object is removed from the gap. The radius of the strand (R) and the gap length of the reversibly expandable gap (gl) are , yield strength (σ yield ), the elastic modulus of the material (E), and the reversibly expandable gear The deflection capacity δ of adjacent strand segments forming a loop is used as the basis.

[0008] Various embodiments provide a three-dimensional implant for tissue reconstruction or tissue augmentation for insertion into a patient. Regarding the implant: The implant comprises multiple planar layers. The first sublayers include a plurality of strands oriented in a first direction. The first sublayer comprises a plurality of strands oriented in a second direction. The sublayers of the Breyer group and the sublayers of the second sublayer group are in the third direction. The layers are arranged alternately in a third direction. and forming a three-dimensional structure comprising the implant, the implant being compressible along at least a third direction. Each hollow channel extends in the third direction and is arranged alternately in the first direction. A first sidewall consisting of a plurality of oriented strand segments and a plurality of gaps. and a plurality of alternatingly arranged, oriented in the second direction, extending in a third direction. a second sidewall comprising strand segments and a plurality of gaps; At least one of the first sidewall and the second sidewall of the hollow channel The contoured sidewall has multiple strands. The segments belong to different layers of the implant. Adjacent strand segments in a chain are separated by a gap. Adjacent strand segments are formed by multiple peaks (pe) in the contoured sidewall. lateral orientation relative to each other to create a pattern of ak and multiple troughs. It has offsets.

[0009] Finally, the present invention also relates to a method of tissue reconstruction or tissue augmentation, which method comprises the steps of: The present invention includes implanting an implant, as defined herein, into the body of a subject.

[0010] The foregoing and other features of the present disclosure are set forth in the following description and accompanying drawings, taken in conjunction with the accompanying drawings. The present disclosure will be more fully apparent from the following claims. Only a few embodiments are shown and therefore should not be considered limiting in scope. It is understood that the present disclosure is not limited to the following specific embodiments, and that the present disclosure is not intended to be limiting. This is explained more specifically and in more detail through the use of planes. [Brief explanation of the drawings]

[0011] [Figure 1A] FIG. 1A shows a perspective view of a three-dimensional implant 100 for insertion into a patient. [Figure 1B] FIG. 1B shows a side cross-sectional view of a three-dimensional implant 100 for insertion into a patient. [Figure 1C] FIG. 1C shows a gap in the implant between two adjacent strand segments in the sidewall. [Figure 1D] FIG. 1D shows the first sublayer of the implant. [Figure 1E] FIG. 1E shows the second sublayer of the implant. [Figure 1F] FIG. 1F shows a beam with two simple supports undergoing deflection. [Figure 1G] FIG. 1G illustrates the deflection of adjacent strand segments upon needle insertion. [Figure 1H] FIG. 1H shows the arrangement of adjacent strand segments when the lateral offset is zero. [Figure 1I] FIG. 1I shows the arrangement of adjacent strand segments when the lateral offset is greater than zero. [Figure 2A] FIG. 2A shows a perspective view of a further implant for insertion into a patient. [Figure 2B] FIG. 2B shows a cross-sectional side view of a further implant for insertion into a patient. [Figure 3A] FIG. 3A shows a perspective view of an implant suitable for use as a breast implant. [Figure 3B] FIG. 3B shows a perspective side view of an implant including multiple contouring strands and surface filler strands. [Figure 3C]FIG. 3C shows a perspective top view of an implant including multiple contouring strands and surface filler strands. [Figure 3D] FIG. 3D shows a perspective view of the implant. [Figure 4A] FIG. 4A shows a reversibly expandable gapless implant. [Figure 4B] FIG. 4B shows an image of inserting a cannula for fat injection into an implant having a reversibly expandable gap. [Figure 4C] Figure 4C shows an example of an insertable region for a multi-injection study. [Figure 4D] FIG. 4D shows the stress-strain curves of strands of different materials. [Figure 5A] FIG. 5A shows the implant after a fat injection sham surgery. [Figure 5B] FIG. 5B shows an image of the implant after fat injection. [Figure 5C] FIG. 5C shows an image of the implant after fat injection. [Figure 5D] FIG. 5D shows an image of the implant after fat injection. [Figure 6] FIG. 6 shows a flow chart of a method 600 for forming an implant. [Figure 7A] FIG. 7A shows an implant having at least one contoured sidewall. [Figure 7B] FIG. 7B shows an implant having at least one contoured sidewall. [Figure 7C] FIG. 7C shows an implant having at least one contoured sidewall. [Figure 7D] FIG. 7D shows an implant having at least one contoured sidewall. [Figure 7E] FIG. 7E shows an implant having at least one contoured sidewall. [Figure 7F]FIG. 7F shows an implant having at least one contoured sidewall. [Figure 7G] FIG. 7G shows an implant having at least one contoured sidewall. DETAILED DESCRIPTION OF THE INVENTION

[0012] 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 show: The various embodiments, although different, are not necessarily mutually exclusive. For example, it should be understood that the particular No feature, structure, or characteristic may be modified without departing from the spirit and scope of the claimed subject matter. , may be implemented in other embodiments. Reference to an embodiment implies that a particular feature, structure, or characteristic described in connection with an embodiment is not necessarily a feature, structure, or characteristic that is not specifically described herein. It means that the invention is included in at least one embodiment that is included within the scope of the invention. Use of the phrases "in an embodiment" or "in an embodiment" does not necessarily refer to the same embodiment. Furthermore, the location or arrangement of individual elements within each disclosed embodiment is not intended to be limiting. It will be understood that changes may be made without departing from the spirit and scope of the claimed subject matter. Therefore, the following detailed description should not be taken in a limiting sense, but The scope is the same as that of the appended claims, properly interpreted, along with the full range of equivalents to which the appended claims are entitled. In the drawings, like numerals refer to the same elements throughout the several views. The elements depicted therein are not necessarily to scale relative to each other. are not identical, rather the individual elements are expanded or otherwise modified for easier understanding in the context of this specification. indicates that it may be reduced.

[0013] As used herein, the terms "over," "to," "between," and "on" refer to It can refer to the relative position of one layer in relation to another. or "on" means that one or more layers are in direct contact with other layers. A layer "between" layers may be in direct contact with the layers, or There may be one or more intervening layers. As used herein, "A, B and / or C" The phrases "A," "B," "C," "A and B," "B and C," "A and It can mean "A and B and C" and "A and B and C."

[0014] 1A and 1B are perspective and side cross-sectional views of an implant 100 for insertion into a patient. The respective views are shown.

[0015] As shown in FIG. 1A, the implant 100 comprises a plurality of struts forming a three-dimensional structure 102. The three-dimensional structure 102 includes a plurality of hollow channels 103. Each hollow channel 103 has a plurality of side walls 104. The sidewall 104 has a groove between adjacent strand segments 105. A plurality of strand segments 10 are interleaved to form a gap 106. 5 and a plurality of gaps 106 (shown in FIG. 1B). is the reversibly expandable gap.

[0016] Generally, the hollow channel 103 is formed such that the hollow space is surrounded by sidewalls. At least three sidewalls that are continuous with one another (or, for example, cross one another) In the example of FIG. 1A, multiple hollow channels, each having a square cross section, can be formed. One (or each) hollow channel 103 has a square cross section. may have four intersecting sidewalls 104.

[0017] FIG. 1B shows a cross-sectional side view of implant 100 along line A-A'. Shown are multiple strands (also called filaments) 101 of the parent structure 102. However, the multiple (parallel) strands 101 are connected to two adjacent ( For example, the sidewalls 104, 104A of the (directly adjacent) channels 103, 103A. As shown in FIG. 1B, taking the hollow channel 103A as an example, The first sidewall 104 is formed from a plurality of parallel strands 101. A (shown as a sidewall parallel to the plane of the paper). A is the second sidewall 104B (strands entering and / or exiting the page). the third sidewall 104C (shown as a hole in and / or out of the plane of the paper); The wire further includes a fourth sidewall (not shown) and a fourth sidewall (shown as strands extending from the wire). The third sidewall 104C faces the second sidewall 104B. The second sidewall 104B and the third sidewall Both the first sidewall 104A and the fourth sidewall 104C are The fourth side wall may be continuous with the first side wall 104A. Where the sidewalls intersect, the strands may be alternately intersecting.

[0018] Some (or all) of the channel 103, such as the sidewall 104A of the hollow channel 103A, The (or each) sidewall 104 is made up of a plurality of continuous (vertical) tubular members arranged in succession in the z direction. Each strand segment 105A may include a plurality of strand segments 105B. The longer continuous strands form part of the sidewall 104 or channel 103 of the Optionally, the hollow channel 10 A plurality of continuous strand segments 105A forming the sidewall 104A of the 3A. Each sidewall 104A may have a plurality of gaps. The hollow channel 103A may further include a plurality of gaps 106A and A plurality of strand segments 105A are formed adjacent (e.g., between (e.g., directly adjacent) strand segments 105A (e.g., sidewalls 104A (e.g., one) gap 10 6A may be arranged adjacent (e.g. directly adjacent) (or, for example, consecutive) strand segments are separated by gaps 106A. That's fine.

[0019] FIG. 1C shows a (single) sidewall of the hollow channel 103A of the implant 100. The gap 1 between two adjacent strand segments 105A in the roll 104A Indicates 06A.

[0020] The gap 106A may also be referred to as a slit and / or a space, and is a gap between two adjacent The blank space between the lengths of adjacent strand segments 105A is Gap 106A forms the periphery of gap 106A (e.g., gap 1 06A, or for example, surrounding the gap 106A.) Two pairs of crossing strands The first pair of strands of the first sidewall 104A may be defined by 101. The strand segments 105A (parallel to the y-direction) may be opposing strands, and and / or may be substantially parallel to one another as desired. The members 105B and 105C are formed on the second sidewall 104B and the third sidewall 104C. The strands of the cable 104C may be opposed and may be substantially parallel to one another. Gap 106A may be an area bounded by two pairs of intersecting strands. The first pair of strand segments 105A forming the gap 106A are hollow channels Adjacent strand segments in the same (first) sidewall 104A of 103A The second pair of strand segments may be 105A. 104B and the opposing strands of the third sidewall 104C.

[0021] The gap 106A may have a baseline gap height gh, The baseline (or static) gap may be defined by the in-gap height gh. The tip height gh is the distance between two adjacent strands 1 when the implant 100 is at rest. Additionally or alternatively, the base The line gap height gh is the midpoint region of the gap 106A (e.g., The height of the gap 106A at the midpoint region of the strand segment 105A was Additionally or alternatively, the baseline gap height may be determined by the implant's resting position. The average (mean) gap height of the implant gap is 80% or more when Furthermore, the gap 106A may be set to a maximum value (maximum or maximum value) of the gap 106A. The gap length may have a baseline gap length gl, which is the gest dimension. Furthermore, the baseline gap length gl may be and between the two nearest edges of the second strand 105C (FIG. 1C), or alternatively, From the center of the first strand 105B to the center of the second strand 105C (FIG. 1G) which is the length of the strand segment between the second pair of strands 105B, 105C The strands of the second pair may be connected to the strands of the first pair where the two pairs intersect. The second pair of strands may be fused to the segment, and the second pair of strands may be fused to the segment at both ends of the gap length gl. A simple support for the first pair of strand segments may be formed.

[0022] The two pairs of intersecting strands 101 may be fused or bonded at the intersection region. Additionally, or if desired, opposing strand segments 105A may be aligned with baseline gears. The gap height gh is equal to or less than the average strand diameter d. When the gap height is expanded (e.g., The shape of the gap 106 is changed or modified (by inserting a needle into the gap) If necessary, the intersecting strand segments 105A, 105B, The area enclosed by the two pairs of 105C may remain unchanged. Or, if desired, the area enclosed by two pairs of intersecting strands 101 is originally 110% or more (or e.g. 120% or more, or e.g. 150% or more) of the enclosed area above, or for example 200% or more, or for example 120% to 250%, or for example 120 % to 200%).

[0023] FIG. 1C also illustrates the spring-like structure of reversibly expandable gaps 106 (such as gap 106A). The gap 106A is drawn to the opposing strand segment 105A. When tension (indicated by opposing arrows 113, 114) is applied, the gap height gh increases. Furthermore, the opposing strand segments 105A of the gap 106A are each The strand segment 105A in the gap 106A may be subjected to a pair of tensile forces. When a tensile force is applied, the gap 106A expands relative to the baseline gap height gh. For example, the reversibly expandable gap 106 may be configured to 110% or more of the baseline gap height gh and / or the average strand diameter d or for example 120% or more, or for example 150% or more, or for example 200% or more, or is, for example, 110% to 250%, or, for example, 120% to 250%, or, for example, 120% The reversibly expandable gap 106A may be expandable to a gap width of 100 mm or less. After the tension (113, 114) is removed from the strand 105A of the loop 106A (the same recovering or returning to its original (resting) gap height (even at ambient pressure and temperature) For example, the reversibly expandable gap 106 acts on the strand 105A. After the applied tension is removed, the original gap height gh and / or average strand straightness Less than 110% (or for example less than 105%, or for example 100%, or for example configured to recover or return to 80% to 115%, or, for example, 90% to 110%) Good too.

[0024] If necessary, the baseline gap length gl is twice the baseline gap height gh or more (e.g., 5 times or more, or e.g., 10 times or more). , the baseline gap height gh is between 0.05 mm and 5 mm (or e.g. 0.1 It may be between 0.5 mm and 2 mm, or for example between 0.5 mm and 1.5 mm). Optionally, the average thickness of the plurality of strands 101 is between 0.05 mm and 5 mm (or for example between 0.1 mm and 2 mm, or for example between 0.5 mm and 1.5 mm) If necessary, the baseline gap length gl may be adjusted to the diameter d of the strand 101. (or thickness) is more than twice (or more than, say, five times, or more than, say, ten times) larger For example, the baseline gap length gl may be less than 25 mm (or, for example, 0.5 mm). Optionally, the baseline gap height gh may be , 40% to 100% of the average (mean) strand diameter d of the implant strand 101 (Or, for example, 40% to 80%, or, for example, 40% to 60%). The second sidewall 104B and the third sidewall 104C each have a , only one strand segment 105B, 105C is shown, but the second side a plurality of strands in each of the wall 104B and the third sidewall 104C; is disposed between the first pair of strand segments 105A of the first sidewall 104A. In this case, the baseline gap height gh may be It may depend on the total thickness of the pair of strands in the z-direction, e.g., the baseline The gap height gh is 40% to 100% of the total thickness in the z-direction of the second pair of strands. (or may be, for example, 40% to 80%, or, for example, 40% to 60%).

[0025] As shown in FIG. 1B, each hollow channel 103, 103A is formed by a first plurality of continuous streams. a land segment 105A and a first plurality of reversibly expandable gaps 106; The hollow channel 103A may include at least a first sidewall 104A containing A second plurality of continuous strand segments and a second plurality of reversibly expandable gaps. The second sidewall 104B may further include a second sidewall 104B including a second sidewall. The first sidewall 104B may be continuous with the first sidewall 104A. The strand segment 105A and the second plurality of consecutive strands The strand segment 105B is a hollow channel 1 a first end 137 of the longitudinal axis of the hollow channel 103A and a second end 138 of the longitudinal axis of the hollow channel 103A. The ends 138 may be arranged alternately in the direction between them.

[0026] The two side walls 104, 104A of the adjacent channels 103, 103A are further The sidewalls 104B may be separated (or divided) by a sidewall 104B. Wall 104B is made up of a plurality of strands (shown in FIG. 1B as entering the page). The strands of the further sidewall 104B may be 4A, 104A, and 101 may intersect with the strands 101 forming the hollow channels. The channels of 103 may be located adjacent to each other (e.g., directly adjacent). The adjacent channels 103A and 103B may share a common sidewall 104B. good.

[0027] The implant 100 may have different sizes depending on the purpose of the implant. In the x-direction, the implant can be up to 30 cm (or between 1 cm and 30 cm, for example). In the y direction, the thickness of the substrate may be between 10 cm and 15 cm, or between 10 cm and 15 cm. Therefore, implants may be up to 30cm (or between 1cm and 30cm, or e.g. In the z-direction, the implant may have a dimension of 10 cm to 15 cm. The maximum length is 30 cm (or for example between 1 cm and 30 cm, or for example between 10 cm and 1 The dimensions may be between 1.5 cm and 5 cm.

[0028] The plurality of strands 101 of the three-dimensional structure 102 of the implant 100 A volume of material may be constructed (or made up). The material volume occupied by the implant should be 5% to 70% (or e.g., 50%) of the total static implant volume. % to 70%, or for example 50% to 60%). , the implant gap 106 is 30% to 95% (or For example, 30% to 50%, or for example, 40% to 50% may be constituted (or included) The material volume of the three-dimensional structure 102 of the implant may include multiple sub-substrates of the implant. The side wall 104 may comprise (or include) 80% to 100% of the material volume. The material of the implant 100 that is not formed by the plurality of sidewalls 104 The remainder of the volume may be contributions from, for example, contour lines and / or surface filler lines Optionally, the strand segments 105 of the sidewall 104 may be Less than 90% (or for example less than 50%, or for example 50% to 70%, or For example, 50% to 60% of the total thickness may be composed (or made up) of the sidewall. The remainder of 104 is occupied by a gap 106. At least 80% (or for example, at least 100%) of all sidewalls 104 At least 95%, or for example 100%, of the gaps 106 may be reversibly expandable. Additionally, or if desired, at least some of all gaps 106 of the implant 100 may be At least 50% (or e.g., at least 60%, or e.g., at least 70%) It is a reversibly expandable gap.

[0029] As shown in FIG. 1A, the implant 100 is a mesh-like structure or scaffold. A three-dimensional structure 102 may be formed (or fabricated) which may be a structure. For example, a plurality of strands 101 (or lines) form a mesh-like three-dimensional structure 102. The three-dimensional structure 102 may be configured to define the rest volume of the implant 100. The rest volume (cm) of the implant 100 may be determined (or may have a value).3 )teeth, prior to inserting the implant 100 into the patient to build and / or reconstruct soft tissue. The rest volume of the implant 100 may be the volume of the implant 100 in a rest state. The implant 100 in a resting state may be the volume of the implant 100. The implant 100 rests on a carrier surface (e.g., a table surface, or e.g., a board). One of the implants 100 is in contact with the patient's body. The implant may be in a state where only one outer surface (for example, outer surface 108) is subjected to an external force. For example, the resting implant 100 may be configured such that the first outer surface 108 of the implant is The second (opposing) outer surface 109 may be in contact with the surface and may be resistant to any tensile and It may also mean that the material is not subject to any compressive force. The rest volume of the implant 100 is determined by the opposing compressive or tensile forces acting on the implant surface. The volume of the implant 100 in its unloaded state may be the static volume of the implant 100. The volume is based on the build volume (desired or required volume) of the implant 100 to be inserted into the patient. For example, if desired, implant 100 may be inserted into a patient. After insertion, the implant 100 constitutes or reaches the build volume. Additionally, the sintered body may be configured to be compressible to less than its build volume.

[0030] The strands 101 may be wires or strings of material. 101 (or line, or filament) may have a length and cross-sectional diameter d The diameter of the strand 101 can be determined by the minimum cross-sectional dimension of the strand 101. Optionally, the length of the strand 101 may be the average dimension of the strand 101. It may be larger than the diameter of the wire 101 (e.g., at least 5 times larger, or, for example, at least (for example, at least 10 times larger, or for example, at least 20 times larger). Depending on the application, it may be, for example, between 300 μm and 350 μm.

[0031] The term hollow channel 103 refers to a cavity surrounded by sidewalls of the channel. At least 70% (or e.g. at least 80%, or e.g. at least 90% of the total mass is filled with strand segments or strands of other material. It may refer to an empty or unoccupied channel. For example, a hollow channel 103 is not necessarily limited to a channel that is not completely (100%) filled. That's fine.

[0032] The three-dimensional structures 102 are arranged on top of each other in the z-direction 107 (e.g., vertical direction). a plurality of substantially planar layers (e.g., in the xy plane) arranged or stacked in series Optionally, each planar layer may include two dimensions of the unit cell. The implant 100 may include a plurality of strands 101 forming a lattice arrangement. The layers are formed by a unit cell of successive layers (formed on top of each other) that contains multiple hollow chambers. 103. ) may be arranged in successive layers stacked on top of each other. may be formed from (or may include) a column of unit cells from For example, in the implant 100 shown in FIGS. 1A to 1C, the implant 100 is A plurality of hollow channels 103 arranged on top of each other to form a hollow channel 103 having a rectangular cross section. Optionally, the unit cell may comprise a primarily square-shaped unit cell of a layer of , 50% or more (or, for example, 80% or more, or, for example, It may be repeated regularly over a period of time (for example, 90% or more, or, for example, 95% or more). Thus, the lattice structure 102 is made up of a plurality of adjacent lattice structures connected to one another throughout the lattice structure 102. The unit cells may include adjacent (e.g., directly adjacent) unit cells. It may be the smallest and most basic unit of 02.

[0033] Optionally, each planar layer of the unit cell has strands oriented in a first direction. A first sublayer (or a group of first sublayers) including a first direction and a second direction different from the first direction. An adjacent second sublayer (or second sublayer) containing strands oriented in two directions Breyer group).

[0034] FIG. 1D shows the first sublayer of the implant 100. 5 includes strands 101 oriented in a first direction (e.g., the y-direction). 1 shows a second sublayer 116 of the implant 100, the second sublayer 116 being a The strands 101 are oriented in two directions (e.g., the x direction). The strands 101 within each sublayer may be parallel to each other (e.g., The acute angle between strands in the ear, or the optimal acute angle between strands for sinusoidal strands, is , may be within ±5°). 101 and the plurality of strands 101 of the second sublayer 116 at intersections or intersection regions. , forming a two-dimensional lattice array of sublayers. The strands 101 of (or within) the ears 115, 116 are sublayers. It was part of a continuous strand that meandered continuously from the start point S of the sublayer to the end point E of the sublayer. For example, if desired, the strands of the first sublayer 115 may be One of the continuous sublayer strands that meanders continuously from the start point S of the brayer to the end point E. Optionally, the strands of the second sublayer 116 may be One of the continuous sublayer strands that meanders continuously from the start point S of the brayer to the end point E. The continuous strands of the sublayer may be a plurality of perpendicular strands oriented in a first direction. The straight portions of the sublayer may be connected by serpentine portions. The meandering portion may be formed at least in part at the boundary or periphery of the layer. Often, the surface of the implant is also affected by the surface filler lines or sidewalls of the channels. Each sublayer may have a meandering portion (or surface filler line) formed therein. Optionally, the strands may have their own boundaries or perimeters. The strands may be straight or, alternatively, the strands may be sinusoidally zig-zag. g) may be strands, where the unit cell has a "free-form" shape It may be possible.

[0035] The first sublayer 115 and the second sublayer 116 are The strands 101 may be arranged to intersect and form a two-dimensional lattice array of unit cells. The intersecting strands 115 and 116 of the first sublayer 115 and the second sublayer 116 O1 is configured such that each unit cell formed from the intersecting strands can contain a pore having a pore diameter. The intersecting strips may be arranged as shown, or as holes having a diameter. The bonds form or define the geometry (e.g., shape, dimensions, pore size) of the individual unit cells. Each two-dimensional unit cell can have a pore size that defines the dimension of the unit cell. The pore size of a two-dimensional unit cell can be described in terms of its diameter, width, and / or pore area. For example, the pore diameter w of the unit cell of a certain layer may be set to be equal to the pore diameter of the hollow channel 103 (see FIG. 1A). The diameter or width of the three-dimensional structure 102 may be referred to as the diameter or width of the three-dimensional structure 102 (as shown). The average pore size of the plurality of unit cells is at least 0.5 mm (or, for example, at least 0.75 mm, or for example at least 0.8 mm, or for example at least 1 mm, or for example For example, at least 1.5 mm, or for example, at least 2 mm, or for example, at least 5 mm At least 25% (or for example at least 100%) of the surface pores of the three-dimensional structure 102 may be At least 70%, or for example at least 80%, of the pore area is at least 0.75 mm 2 (or e.g. at least 1mm 2 , or for example at least 3 mm 2 ) may be The surface pore area is the area enclosed by the intersecting strands that define the surface pore. good.

[0036] The various two-dimensional unit cells are polygonal, triangular, and diamond-shaped. shaped unit cell, rhombic shaped unit cell, square shaped unit cell, elliptical shaped, sinusoidal shaped, and / or Alternatively, the implant 100 may have a hexagonal unit cell. Throughout the volume of the plant 100, one of these shapes is predominant (e.g., 50% or more). or above, or for example 60% or more, or for example 70% or more, or for example 80% or more Alternatively, implant 100 may include unit cells having a variety of different shapes. It can be understood that the unit cell may include a sidewall 103 of the hollow channel 103. 04 lies substantially parallel to the xy plane and stacks perpendicularly in the z direction (third direction) The wire is formed from a plurality of strands 101 that are aligned in substantially the same direction. The sidewalls 104 of the hollow channel 103 may be formed in a shape similar to the cross-sectional shape of the hollow channel 103. Shapes include polygonal, triangular, diamond, rhombus, square, elliptical, sinusoidal and hexagonal The shapes may be arranged to take any one of a group of shapes.

[0037] Compared to the holes, the gaps 106 of the implant 100 form hollow channels 103. It may (or may not) refer to the minimum spacing between any adjacent strands. For example, the gap 106 is smaller than the implant's striations compared to the unit cell pore area. The bond may have a minimum area enclosed by the bond (eg, a minimum gap area). If necessary, the gap area of ​​the gap 106 (two pairs of opposing electrodes defining the gap 106) The area enclosed by the strands (which may be less than 50% of the pore area) (or e.g. For example, it may be less than 40%, or for example less than 30%.

[0038] Each hollow channel 103 may extend along the longitudinal axis of the hollow channel 103. The longitudinal axis may be a line containing the midpoint of the sidewall of the hollow channel 103. The hollow channel 103 may be formed between, for example, a first outer surface region 108 and a second outer surface region 109 of the three-dimensional structure 102. The channel 103 (e.g., For example, if desired, each channel, or for example one or more channels 103, may include a first outer The second outer surface region 109 may be configured to extend from the surface region 108. The exact position and / or angle of inclination of the hollow channel 103 can be configured according to the patient's needs. If necessary, the plurality of hollow channels 103 may be arranged parallel to each other. (For example, the acute angle between the sidewalls of adjacent channels should be within ±5°.) Alternatively, the plurality of hollow channels 103 may be oriented toward a convergence region (or convergence point). The converging region may be the first outer surface region 108 or the second outer surface region 109. If necessary, the hollow channel 103 may be a zigzag channel, an inclined channel, or the like. Optionally, the hollow portion may include a hollow and / or tapered channel. The channel 103 may be an inclined channel relative to the first outer surface region 108. For example, among the unit cells forming a column of unit cells, the unit cells of the second layer are adjacent The lateral offset (in the x or y direction) is The lateral offset between the first unit cell and the second unit cell may be The threshold value is between 0% and 50% (or e.g., between 0% and 20%, or e.g., between 5%) of the pore diameter of the unit cell. Optionally, within the same column, the unit cell of each layer can be Each unit cell may have the same lateral offset relative to the unit cell of the previous layer. If necessary, at least 80% (or more) of the unit cells in the same column (forming the same channel) or for example at least 70%, or for example at least 50%) of the same pore size and the same Alternatively, in the case of a tapered channel, the same channel may be formed. The unit cells may have different pore sizes (e.g., the pore sizes of the unit cells may be different in one of the outer surface regions). (It may decrease or increase towards the

[0039] The plurality of strands 101 may be configured to be in contact with the implant when the implant is at rest and / or when the implant is in contact with the implant. The gap 106A is reversibly expandable even when the plant 100 is compressed. The implant 100 may be configured to have multiple outer surfaces (physical or mechanical) When subjected to compressive forces, the implant 100 will expand to less than 80% of its rest volume (or even less than 100%). For example, less than 70%, or for example, less than 60%, or for example, less than 50%, or for example, less than 30% Less than, or for example 30% to 95%, or for example 45% to 80%, or for example 45% It can be compressed up to 70%, or for example 80% to 95%.

[0040] The gap expansion of the implant can be explained with reference to the deflection of the beam. The gap of the plant is expandable, which allows one or more In response to the force, the gap height between two adjacent strand segments increases. In addition, the strands are able to flex and / or bend without breaking. This means that the beam (or strand segment) simply bends in response to an applied external force. The bending stress σ of the tensile strength can be expressed as follows:

number

[0041] As shown in Figure 1F, such a beam is simply supported at both ends and the bending moment is applied to the beam. is the reaction that occurs in a beam when a force or moment is applied. σ is the bending stress M is the bending moment, C is the distance from the neutral axis, and I is the moment of inertia of the cross section of the beam. The maximum bending moment M caused by a load applied at the center between the supports is It can be described or defined by the following formula:

number

[0042] where L is the length of the beam and F is the force acting on the beam. Maximum bending stress σ max is expressed as follows: It is possible.

number

[0043] M is the maximum bending moment, and C max is the maximum distance from the neutral axis. I is the cross section of the beam. The moment of inertia of the surface is given by the deflection δ of a central load on a beam with two simple supports. , which is expressed by the following equation:

number

[0044] where L is the length of the beam, F is the applied force, E is Young's modulus, and I is the moment of inertia of the beam. Considering implant 100, the deflection capacity δ of the strands of the implant is determined by the gap The deflection capacity may be increased by adjusting the desired deflection capacity of the strand and / or is the desired expansion of the gap height (e.g., how far the gap is expected to expand) It may reflect the above or may be itself.

[0045] FIG. 1G shows an illustration of the implant shown in FIG. 1C. Insertion of the needle 155 into the tip may exert one or more forces 113, 114 on the implant. The needle may have a diameter nd greater than the baseline gap height gh. The gap length is the distance between the center of the first strand 105B and the center of the second strand 105C. The length of the strand segment between the first and second cores can be represented by gl. The first strand and the second strand 105C are adjacent strand segments of the gap. It can serve as a simple support for the component 105.

[0046] The needle insertion causes a deflection δ in each of two consecutive strand segments 105A. Each strand segment 105A is subjected to bending stresses and has two simple supports. It can behave like a beam with 105B and 105C. The deflection of the adjacent strand segment 105A that is rubbed against the strand segment 105A can be represented by a dotted line. The deflection can be expressed by the following formula:

number

[0047] The maximum bending stress of the strand, which may be subjected to forces such as by the insertion of needle 155, is: The formula is as follows:

number

[0048] R may be the radius of the strand (e.g., d=2×R).

[0049] Using equations (3) and (4),

number

[0050] and the maximum stress σ max The following formula is obtained.

number

[0051] For elastic deformation, σ max The value of σ is the yield strength of the strand material. yiel d Therefore, we can apply the rule that

number

[0052] The deflection capacity δ can be expressed by the following formula:

number

[0053] The reversibly expandable gap 106 is 110% to 2% of the baseline gap height gh. It may be expandable up to 50%. This is because the needle diameter nd is the baseline gap height This can occur when the temperature is between 110% and 250% of gh. These parameters are It can be expressed by the following formula.

number

[0054] and,

number

[0055] E and σ yield are the material properties of the strand material of the implant 100. The radius R of the strand and the strand spacing between the two supports 105B and 105C are The segment length, gl, is a geometric characteristic of the strand of the implant 100. Equation (10) can be obtained based on equation (7).

number

[0056] FIG. 1H is an explanatory diagram showing the adjacent strands 105A of FIG. 1G in a zx cross section. In some instances, the adjacent strand segment 105A in the next layer The lateral offset of one strand segment 105A relative to the other is along the xy plane. (or horizontally) equals 0 (offset = 0). In these cases, the baseline gap The strand height gh may simply be equal to the average strand diameter d or 2R.

[0057] Alternatively, as shown in FIG. 1I, the xy plane may be parallel to or parallel to the xy plane. flat, one for its adjacent strand segment 105A in the next layer It is possible for the lateral offset of strand segment 105A to be greater than zero. In such a case, the gap height gh can be expressed as:

number

[0058] lt is sometimes called the layer thickness. The dimension 2 × lt is the thickness of the first strand segment. between the midpoint of the first adjacent strand segment 105A and the midpoint of the second adjacent strand segment 105A. The dimension 2 × lt is the offset in the z direction. , whereas the lateral offset may be an offset in the x or y direction. The lateral offset between adjacent strand segments is 0% to 10% of the gap length g. It may be 99% (or for example 0% to 50%, or for example 0% to 10%).

[0059] 2A and 2B are perspective and side cross-sectional views of an implant 200 for insertion into a patient. 1A-1E. The implant 200 has the features described in connection with FIGS. 1A-1E. The implant 200 may include one, more, or all of the following: having different dimensions compared to implant 100, such as a different height / gap length ratio; For example, the baseline gap height gh can be calculated by multiplying the baseline gap length gl by It may be the same (for example, it may be 95% to 100% of the baseline gap length). stomach).

[0060] The implant 100, 200 is a living body (e.g., a human body or, e.g., an animal body). The implant 10 may be any type of implant suitable for insertion into a patient. 0,200 may be a skeleton for bone tissue or any part of the human or animal body. The implant may be a soft tissue implant. The implant may be a breast or pectoral implant. (the latter may be used for the treatment of pectoral muscle deformities such as pectus excavatum), or other parts of the body, such as the buttocks (also known as the buttocks), calves, parts of the face such as the cheeks, In this context, pectoral muscle deformities such as pectus excavatum are considered to be a sign of male may affect both men and women, and therefore funnel both male and female subjects It should be noted that both breasts can be treated with the implant of the present invention. Therefore, the implant of the present invention can be used in any manner depending only on the tissue to be reconstructed or augmented. The implant may take any suitable form, for example, as described in U.S. Pat. The implant may have the form of a gluteal implant as described in US Pat. No. 4,585. Depending on the type of implant being used, the geometry of the implant 100, 200 (e.g. , size and / or shape of the implant) meet the required standards for the implant. The time can be adjusted to

[0061] FIG. 3A shows a perspective view of an implant 300 suitable for use as a breast implant. The implant 300 has the features of the implant described in connection with FIGS. 1A-2B. The implant 300 may include one or more or all of the following: Although implants are described, such implants may be placed in the breast, buttocks, or abdomen. It is also effective on other parts of the body, such as the back, back, or parts of the face, such as the cheeks (see above). see).

[0062] As shown in FIG. 3A, the implant 300 comprises a plurality of struts forming a three-dimensional structure 302. The three-dimensional structure 302 includes a plurality of hollow channels 103. Each hollow channel 103 has a plurality of side walls 104. The strand 104 has a gap between adjacent strand segments 105 of the sidewall 104. The strand segments 105 and 106 are arranged alternately to form a plurality of strand segments 105 and 106. The plurality of gaps 106 are reversibly expandable gaps. It is a top.

[0063] The three-dimensional structure 302 of the implant 300 comprises a first outer surface region 308 and a second (different) outer surface region 309. and / or an opposing outer surface region 309. Refers to the outermost surface, outermost layer, and / or outermost contour of the plant 300 (or so It can be understood that the outermost surface and the outermost contour may be defined by one or more rays. The outer surface region may be formed from a wire or a wire. It can refer to a group (e.g., a single outermost layer, or, e.g., multiple outermost layers). The outer surface region faces the exterior of the implant 300. You may also point to the face.

[0064] The first outer surface region 308 of the implant 300 may include a first surface curvature or The first outer surface region 308 of the implant 300 may include It may be the largest planar (or e.g. flattest) surface at 0. For example, The outer surface area 308 of the implant is the flattest surface and / or the smallest (or As shown in FIG. 3A, the implant 300 may have a surface with a minimal amount of curvature. The first outer surface region 308 is substantially parallel to a two-dimensional (xy) Cartesian plane. Alternatively, or if desired, the best fit plane of the first exterior surface region 308 may be: It may be parallel to a two-dimensional (xy) Cartesian plane.

[0065] The second outer surface area 309 defines the shape of the patient's breast that will be created by the implant 300. The implant 300 may have a geometric shape (e.g., shape, curvature, size) that represents the implant. The second outer surface region 309 may include 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 exterior surface region 309 of the implant 300 is located around the periphery 317 (e.g., a first outer surface region 308 of the implant 300 at a portion of the first outer surface region 308, e.g., the outer periphery of the first outer surface region 308. For example, the second outer surface region 309 of the implant 300 may be 8, and the periphery 317 of the first outer surface region 308 may be in contact with the second outer surface region 308. There may also be a shared edge (or interface) between the outer surface region 309 of the In accordance with the second outer surface region 309, the second outer surface region 309 may include a vertex region 318. The location (or position) of the apex region 318 on the second outer surface region 309 of the implant ) at the nipple / areola location (or position) of the breast constructed by the implant 300 may be based on (and / or coincide with)

[0066] Optionally, one or more sidewalls and a reference axis (e.g., The inclination angle of the acute angle between the x-axis and the x-axis is less than 90° (or less than 60°, for example). The reference axis may be based on a plane or a best fit line of the first exterior surface region 108. Optionally, or alternatively, one or more sidewalls 104 may be aligned with the reference axis. The acute angle between the two may be approximately 90° (for example, as shown in Figures 1A-2B). The channels may be vertical channels. 0 hollow channels (or e.g., 5-60 channels, or e.g., 8-20 channels) It may be composed of a plurality of channels.

[0067] The three-dimensional structure 302 of the implant 300 is a reversibly compressible three-dimensional structure 302. For example, the individual unit cells of the implant 300 may be spring-like unit cells. The spring-like unit cell may expand to at least 80% (or e.g., at least) of its original volume. At most 70%, or for example at least 60%, or for example at least 50%, or for example For example, it may be compressible by at least 30%. Therefore, each unit cell will remain in its original shape after the compressive force is removed (even at the same ambient pressure and temperature). It is possible for the reversibly compressible spring-like unit to recover or return to its original (rest) volume. The implant 300 is then compressed to about 80% of its original volume after the compressive force applied to the implant 300 is removed. 0% to 100% (or e.g. 95% to 100%, or e.g. 98% to 100%) It may be configured to recover.

[0068] The softness of the implant 300 can be expressed by the c value, which can be expressed by the following formula: It is possible.

number

[0069] F 20% is the force value (N) at 20% compression, F 10% is compressed by 10% is the force value (N) at10% is the strain value at 10% compression, and ε 20% is the strain value at 20% compression. The value is, for example, 20N to 190N (or, for example, 20N to 150N, or, for example, 30N 100N, or for example 30N to 40N).

[0070] The material density ρ of the implant 300 is 0.1 gr / cm 3 ~2gr / cm 3 (or e.g. For example, 0.1 gr / cm 3 ~1gr / cm 3 , or for example 0.1gr / cm 3 ~0.5g r / cm 3 ) The material density may be used to balance the weight of the implant 300 against the insertion into the patient. This can be determined by dividing by the rest volume of the previous implant. The density of the material in the ricone is 0.98gr / cm 3 and the material density of saline is 1 .005gr / cm 3 Therefore, the weight of the implant 300 is milliliters. may be 10% to 20% (or e.g., 10% to 15%) of its volumetric value of the unit; and , a conventional non-porous silicone / saline implant (whose weight in grams is 10% to 20% (or e.g. 10% to 15%) of the volume in milliliters ) As an example, an implant 300 having a volume of 250 ml may be g, whereas a conventional silicone implant with a volume of 250 ml. A saline implant weighing 240 g and having a volume of 250 ml is One, several, or all of these characteristics give it a lightweight skeleton. This results in an implant that is 90% lighter than conventional implants. It is possible.

[0071] The plurality of strands 101 of the implant 300 may be made of a polymer, such as a surface degradable polymer. Surface degradable polymeric materials may be formed from materials that degrade primarily through bulk degradation. It may include polymeric materials that degrade via a surface degradation mechanism, or The plurality of strands 101 may comprise a polymer material. It may be formed or made from a biodegradable material. The materials are polycaprolactone, poly(1,3-trimethylene carbonate), and polylactide. , polyglycolide, poly(ester amide), poly(ethylene glycol) / poly(butyl ether) Poly(ethylene terephthalate), Poly(glycerol sebacate), Poly(1,8-octanedioic acid) Poly(1,10-decanediol-co-citric acid), poly(1,10-decanediol-co-D,L-lactic acid), poly( Citrate diol), poly(glycolide-co-caprolactone), poly(1,3-trimethylsilyl) Poly(1,3-trimethylene carbonate-co-lactide), Poly(1,3-trimethylene carbonate-co- caprolactone), and copolymers of at least two of these materials. Optionally, the biodegradable material may be polycaprolactone. Optionally, the biodegradable material may be a mixture of polycaprolactone and poly-trimethylene carbonate. Alternatively, the copolymer may be a copolymer of either a carboxylate or a polylactide. The strands 101 may comprise a non-degradable material such as nylon. The thickness (or diameter) of the strands may be selected so that the strands are flexible. PCL, for example, has an elastic modulus (E) of 216 MPa, a tensile strength of 10 MPa, and a It may have a breaking stress of 0.5 MPa.

[0072] Equation (10) above can be applied to the design of the implants described herein. R / gl 2 The material properties (Young's modulus and yield strength, etc.) of the material used to form the implant are The desired deflection capacity based on surgical requirements, such as the size of the needle the surgeon will be using. The selection can be based on δ.

[0073] For example, the material used to form the implant 300 may have an elastic modulus of 270 MPa. coefficient, and a yield strength σ of 12.5 MPa yield The needle used may have may have a diameter of 2 mm.

[0074] Implant-related parameters such as lateral offset, layer thickness, radius, and gap length For example, a lateral offset of 1 mm may be chosen to The layer thickness lt may be 0.2 mm and the radius R may be 0.175 mm. The gap length gl may be 6 mm.

[0075] Using equation (11) above, the value of the gap height can be calculated or determined, where

number

[0076] Using equation (8) above, the value of the deflection capacity can be calculated or determined, where:

number

[0077] Using the above formula (10), R / gl 2 Calculating the upper limit of

number

[0078] Additionally or optionally, the implant 300 may include an outer surface area of ​​the implant 300. and a plurality of contouring strands 319 disposed in the second outer surface region 309 (e.g., in the second outer surface region 309). It may also be included in the above.

[0079] 3B and 3C show a plurality of contouring strands 319 and surface fillers. 3A-3C show perspective side and top views of an implant 300 further including strands 322. vinegar.

[0080] As shown in FIGS. 3B and 3C, the multiple strands forming implant 300 are , may include a plurality of contouring strands 319 and surface filler strands 322 Each contouring strand 319 forms a semi-contour around the second outer surface region 309. The semi-contour of the contouring strand 319 is partially (e.g., 30% to 80%, or, e.g., 40% to 70%, or, e.g., 50% to 70%) ) may extend. A plurality of contouring strands 319 may extend from the first exterior surface region 308 to the apex region. The plurality of contoured stripes may be arranged consecutively (e.g., consecutively) between the regions 318. The strands 319 may further comprise adjacent contouring strands 319 each having a reversibly expandable gap. For example, the reversibly expandable contours may be arranged to be separated by a gap 106. The forming gap 106 is formed between adjacent strand segments of the plurality of contour forming strands 319. It may be formed between the

[0081] As shown in FIG. 3D, the implant 300 is formed on the outermost surface of the three-dimensional structure 302. It may further include surface filler strands 322. If desired, multiple surface fillers may be used. The strands 322 are arranged in a second outer surface region into columns 323 (or strips). Each surface filler column 323 may be arranged in a plurality of surface filler strips. The land 322 and a plurality of reversibly expandable surface gaps may be included. The expandable surface gap is between adjacent surface filler strands 322 of the column 323. The surface filler column 323 may be disposed adjacent to the open column 324. The open columns may include surface columns that do not include surface filler portions. (or surface columns). Multiple surface filler columns, if desired. 323 and a plurality of open columns 324 are formed on an outer surface area (e.g., second outer surface area 309 ) may be arranged alternately. If necessary, multiple surface filler columns 323 and , and the plurality of open columns 324 may be arranged in a cross shape in the outer surface area.

[0082] A plurality of hollow channels 103 extend through the bulk of the implant 300. Adjacent strand segments may be separated by a reversibly expandable gap. This may be done.

[0083] The implant 300 can be inserted into the area of ​​a breast patient. After the insertion of the 300, fat injection may be required. The reason is that the tissue that "regenerates" inside the implant is harder than natural breast tissue. Therefore, the final state is as soft as natural breast tissue. To achieve this, a suitable proportion of fat is collected, for example by liposuction, and then inserted into the skin using a specific cannula. (or a needle) can be used to inject the implant 300. The reversibly expandable gap 106 of 0 allows for the elimination of problems in the injection procedure (e.g., the construction being retracted several times). Note that this may perforate and damage the strands, affecting the overall structural integrity of the implant 300. This can avoid the risk of

[0084] The implant 300 is configured to guide a needle through the implant for the implant procedure. The implant 300 may be an implant for use in implanting a three-dimensional structure. 302 is configured to receive an elongated object (such as a needle for fat injection) within its bulk. The elongated object may be a baseline gap of the implant gap 106. The diameter of the elongated object may be greater than the height gh. For example, the diameter of the elongated object may be greater than the height gh. The gap height of the base line was 110% to 250% of the gap height gh of the base line. Additionally, the elongated object may be at least twice (or 5 times, or 10 times longer. Thus, the height of the gap 106 increases with the object being received, and the object When removed from the gap 106, the height of the gap 106 is reduced. Such needles or cannulas may be at least 0.8 mm (or at least 2 mm, or for example at least 4 mm, or for example 0.8 mm to 4 mm; Or, for example, a diameter of 0.8 mm to 3 mm and a length of at least 2 cm. All gaps in the implant 300 having a baseline gap height of less than 1 mm More than 80% (or, say, more than 90%, or, say, all) of the caps are reversibly expandable The gap may be a small gap.

[0085] FIG. 4A shows implants 100, 200, and 300 having reversibly expandable gaps. Shown is an implant without a

[0086] Implants 100, 200, 300 with reversibly expandable gaps 106 In contrast, the implant in Figure 4A requires the surgeon to insert the fat injection needle into the exact location. For example, after inserting an implant into a patient, the surgeon The mouths must be visually located. These largest openings define the ends of the channels. The area of ​​the pore diameter may be at least two times larger than the area of ​​the gap. The surgeon then guides the needle precisely into the hole and along the length of the channel (e.g., The surgeon must insert the end of the channel into the eye. If you cannot see it visually or you implant the needle at an angle that is not aligned with the channel length, When inserting the needle into the port or into the sidewall of the channel, Injection of the implant may damage the strands and / or This may damage the three-dimensional structure of the object.

[0087] FIG. 4B is an image diagram showing the insertion of a cannula for fat injection into the implant 300. In the case of the implant 300, the surgeon can select any part of the implant (e.g., any surface) It is possible to blindly insert a needle into the implant 300. The implant 300 having the gap 106 allows the second outer surface area of ​​the implant to 309, wherein the needle can be inserted into the breast implant from any direction; and / or Alternatively, a needle may be inserted through any sidewall 104 within the bulk of the implant 300. The needle can be first inserted from the insertion area of ​​the implant 300 to the implant 3 The insertion area may be inserted through the bulk internal structure of the implant. The needle may be a hollow tube having several (e.g., multiple) hollow tubes. simultaneously crossing and / or simultaneously entering the channel 103 and several (e.g., multiple In other words, the needle may be inserted through a plurality of hollow The needles may be inserted simultaneously through the channels 103. The needles are then withdrawn in multiple steps. The implant 300 can be extracted in a stepwise manner. Afterwards, fat can be injected through the needle into the implant. The injection is repeated until the needle is completely withdrawn from the implant. This process, starting from , may be performed iteratively from multiple random insertion regions. The number of times this process is performed (e.g., at least 20 times, or, e.g., at least 30 times) , or e.g., at least 60 times) may be determined based on the number of injections required and / or the fat injection required. May be volume-based. May require frequent needle insertions during surgery. Implant 300 requires the surgeon to visually locate each channel and opening before inserting the needle. Instead, blind insertion can be performed, speeding up the surgical process. Additionally, the implant 300 allows for multiple side cannulae. This allows the wall 104 and the channel 103 to be penetrated simultaneously. It can also speed up the surgical process. Additionally, the gap 106 allows for the advancement of the cannula. The implant 300 can be accommodated so that neither the implant 300 nor the cannula can be damaged. Therefore, the inserted implant 300 does not create a reversibly expandable gap. The implant 300 has improved structural integrity compared to the unloaded implant 300.

[0088] Figure 4C shows an insertable endothelial cell for multi-injection testing. An example of a suitable area is shown below. A specific number of injections (e.g., 60 injections) can be administered over three broad injection sites. For example, 20 times over each region can be divided into (431, 432, 433). An injection (e.g., needle insertion) may be performed on the first outer surface region 30 of the implant. The needle may be inserted at any angle relative to the needle tip. For example, the needle may be inserted at a flat It may be inserted flat or at an angle or tilt relative to the first exterior surface region 308. It may be inserted with

[0089] The plurality of strands 101 are configured to be in contact with the implant when the implant is at rest and when the implant is Even when 300 is compressed (e.g., while implant 300 is inside the body) Alternatively, the gap 106 of the implant 300 may be configured to be reversibly expandable. During compression, the implant should be kept at less than 90% (or for example, less than 70%) of its rest volume. or for example less than 60%, or for example less than 50%, or for example less than 30% The height of the gap 106 may be determined by the gap 106. Acceptable objects may include the baseline gap height gh and / or the average stratification. A value greater than 110% (or for example, 150%) of the band diameter d, or Values ​​greater than 200%, or for example, 120% to 250%, or for example, 120% to The reversibly expandable gap 106 may be increased by up to 200%. By removing the gap 106, its original gap height and / or average striation At least 110% (or for example at least 105%, or for example 10 0%, or for example 80% to 115%, or for example 90% to 110%) It may be configured to reduce (or decrease)

[0090] To accommodate each needle insertion, the plurality of strands 101 may include at least two (or e.g., two or more, or for example three or more, or for example five or more) continuous hollow channels The reversibly expandable gap 106 is formed by the gap of at least two consecutive hollow channels. The objects are arranged to be simultaneously expandable by the objects simultaneously accepted by the The plurality of strands 101 may be formed by at least two (or more, e.g., different sidewalls (e.g., two or more, or three or more, or five or more) 104, the reversibly expandable gap 106 is at least two (or more, e.g., , or e.g., three or more, or e.g., five or more) different sidewall gaps Therefore, it may be arranged so that it can be simultaneously expanded by the objects that can be accommodated at the same time. The expansion of the gap 106 increases the overall rest volume (or build volume) of the implant 300. ) can occur without increasing or changing the gap. The implant 300 may be configured to expand while the overall volume of the implant 300 remains constant or even under compression. It may be configured as follows.

[0091] The surgeon inserting the needle penetrates the bulk of the implant without damaging the structure. For example, the filaments surrounding the gap should be able to bend and stretch. It will not break even if it is twisted or moved out of the way. To insert the needle through the clamp, use a force of 50N or less (e.g., 2N to 50N, or e.g., For example, a force of 1 N to 20 N, or 5 N to 10 N, may be applied. When subjected to a force of 0 N, the filament reversibly deforms (lengthens or stretches) The needle is then allowed to pass through the gap. At this point of extension, the filament does not break. The material itself can be selected so that

[0092] Figure 4D shows the results of the experiments using stainless steel, polylactic acid plastic (PLA), and polycaprolactone (PCL). Figure 1 shows stress-strain curves for strands made of different materials, such as

[0093] The breaking point of the stainless steel strand is 32% strain under a stress of 720 MPa. When a PLA strand is subjected to a stress of 40 MPa, it breaks at a strain of 5%. The strain at break of the PCL strand is 460% (under stresses of less than 50 MPa). It is about 15 times stronger than stainless steel strands and about 70 times stronger than PLA strands. PCL can accept large deformations due to its high breaking strain, which is the initial length This means that it will stretch at least four times.

[0094] The material forming the multiple strands should have a stress-strain curve with a strain at break. The fracture point is determined as a fracture point where the crack is greater than 30% and the stress at the fracture point is less than 250 MPa. may be selected to have

[0095] The implant strand material exhibits stress-strain behavior similar to that of PCL. , the break point on the stress-strain diagram is more than 30% (or more than 100%, for example) For example, more than 200%, or more than 300%, or more than 400%. The applied stress is less than 50 MPa or between 10 MPa and 250 MPa (or for example 10 M Pa to 100 MPa, or for example between 10 MPa and 50 MPa, or for example between 10 30 MPa). The break point is greater than 30% (or for example, more than 100%, or for example, more than 200%, or for example 300% or more, or for example 400% or more), and the corresponding stress is , less than 50 MPa (or for example between 10 MPa and 250 MPa, or for example 10 MPa between 10 and 100 MPa, or for example between 10 and 50 MPa, or for example between 10 and 30 MPa).

[0096] For example, the distance between two adjacent strands is between 0.56 mm and 1.84 mm. When the needle diameter is 2 mm, the PCL reaches the breaking point during the needle penetration into the wall. On the other hand, PLA and stainless steel can be easily deformed without any damage. It cannot withstand deformation and reaches the breaking point during needle penetration.

[0097] FIG. 5A shows an implant such as implant 300 after a simulated surgery. During the simulated surgery, The implants 300 were inserted into the pigs. Fat was injected from the appropriate location. Upon removal, the three-dimensional skeletal structure of the implant 300 was Despite the fact that 02 is filled with fat and the blind (random) injection , indicating that the fat was evenly distributed.

[0098] 5B, 5C, and 5D show images of implant 300 after blind injection. FIG. 5C shows that the fat is evenly distributed over the implant 300. The black represents fat and the red represents air. The dimensions and / or mechanical properties of the skeleton before fat injection Mechanical tests (e.g., tensile, compressive, and shear tests) were performed to assess changes in A tensile test (by friction) was carried out for 11,112 cycles at a frequency of 0.4 Hz. Dimensions (width, projections and height), softness (c value), and shear strength of the skeleton (Fmax) It was confirmed that the implant was still within its specifications. The tensile strength of the Runt 300 was not compromised. The softness index after the test (which is the completeness of the skeleton) When comparing the results of the pre-test (which is a good indicator of the efficacy of the drug) with the results of the pre-test, only a decrease of about 10% was detected. Therefore, the scaffolds had reasonable and expected losses in mechanical properties. , skeletal integrity was not affected.

[0099] FIG. 6 shows a flow chart of a method 600 for forming an implant of the present invention.

[0100] The method 600 includes a step 620 of forming a plurality of strands to form a three-dimensional structure. The multiple strands have a yield strength (σ yield ) and elastic modulus (E) The three-dimensional structure contains multiple hollow channels. Each hollow channel is The sidewalls have a plurality of gaps and a plurality of slots. and a plurality of consecutive strand segments of the strand. The segments and gaps are gaps between adjacent strand segments of the sidewall. The gaps are arranged alternately so that gaps are formed. The gaps are determined by the gap length (gl) and static The gaps are configured as reversibly expandable gaps. Adjacent strand segments of a reversibly expandable gap are adjacent strands. The gap is used to obtain an increased gap height between strand segments. The gap has a deflection capacity (δ) corresponding to the object being inserted. In response to the object being moved, the gap moves back towards the rest gap height. The radius (R) and the gap length (gl) of each of the gaps are determined by the yield strength and and elastic modulus.

[0101] Step 620 of forming the plurality of strands includes sequentially printing a plurality of layers. The layers may comprise a lattice arrangement of two-dimensional unit cells. Aligned unit cells of successive layers of layers form hollow channels The implant may be positioned to form a three-dimensional (3D) printed skeletal structure. To achieve this, layers are sequentially built up (or three layers are built up, e.g., by fused deposition modeling). The printing may be performed by a method in which the sequential arrangement of successive layers is in the direction of printing. This may be done layer by layer in the printing direction (e.g., z direction) as they are formed. By sequentially arranging layers on top of each other (by printing), the edges (or or surroundings) define the shape and / or geometry of the implant to be formed; Alternatively, multiple strands can be selectively ablated by laser irradiation, resulting in the formation of a three-dimensional structure. It may be formed by any three-dimensional printing method, such as selective laser sintering (SLS). Dimensional structures can be produced using printing processes based on movement in three or more dimensions, e.g., five-dimensional (5D) printing processes. The encapsulated encapsulant may be formed by a printing process, or a six-dimensional (6D) printing process.

[0102] Method 600 may optionally include (e.g., before step 620 of forming the plurality of strands) 6) determining at least one of the following parameters: The parameters to be set are the number of hollow channels in the three-dimensional structure to be formed, The number of layers in the structure and the dimensions of the unit cell formed may also be important. The parameters to be determined are the gap length gl between adjacent strands in the layer, and is the gap height gh of the gap between adjacent strands in the sidewall of the channel. Further, the determined parameters may include a diameter d of the plurality of strands to be formed. It may include.

[0103] The step 610 of determining the parameters is accommodated by the reversibly expandable gap. Based on the object being measured, the deflection capacity (δ) of the reversibly expandable gap is determined. The step 610 of determining the parameters may include determining the material of the plurality of strands to be formed. The method may further include determining a property, the material property being the yield strength (σ yield ) and Young's modulus (E). The step 610 of determining the parameters The radius (R) and gap length of each strand segment The step 610 of determining the parameters may further include determining (gl). the number of hollow channels in the three-dimensional structure to be formed, the number of layers in the three-dimensional structure to be formed, and and / or may further comprise determining the dimensions of the unit cell.

[0104] Determine the parameters so that a 3D structure containing a reversibly expandable gap is formed. After the R / gl 2 ≦σ yield / 1 The parameters may be determined so that 2Eδ is the three-dimensional structure that is formed. The number of hollow channels determined, the number of layers determined, the dimensions of the unit cell determined, The determined gap length g between adjacent strands in the sidewall of the channel The determined gap height gh between adjacent strands, the determined perpendicularity of the strands The parameters formed by the method 600 may include at least one of the following: The three-dimensional structure is the same as that of the implants 100, 200, and 110 described in relation to FIGS. 1A to 5C. 300 may be any three-dimensional structure.

[0105] 7A-7G show an oscillating (e.g., undulating, or, for example, zigzag, or sinusoidal) 7A-7C show examples of implants 700A-700F including channels with wavy sidewalls. Implants 700A-700F have one of the features already described in connection with FIGS. 1A-6. For example, implants 700A-700F may include any one or more of the implants 700A-700F. 1A-6, including the reversibly expandable gap described in connection with the implants of FIG. That's fine.

[0106] Figure 7A shows a three-dimensional soft tissue implant 700A for insertion into a patient. The component 700A includes a plurality of strands 101 that form a three-dimensional structure. The structure includes a plurality of hollow channels 103. Each hollow channel 103 has a plurality of intersecting Each sidewall 134 has alternating It comprises a plurality of strand segments 105 and a plurality of gaps 106. At least one sidewall 134 of the roller 103 is undulating (e.g., vibrating). (zigzag and / or sinusoidal sidewalls). The first contoured sidewall 134 is connected to the first contoured sidewall 135. and a second contoured sidewall 134 facing away from the contoured sidewall 134. good.

[0107] The hollow channel 103 having at least one contoured sidewall is A (e.g., zigzag and / or sinusoidal) channel can be called a Each zigzag (or sinusoidal) channel 103 has a first end 137 (proximal The channel zigzags between the first end 138 (distal end) of the channel 103 and the second end 138 (distal end) of the channel 103. At least two opposing sidewalls of the channel are disposed relative to one another so that For example, the zigzag channel 103 may be a first zigzag channel. a side wall 134 and a second zigzag side wall opposite the first zigzag side wall; Each zigzag sidewall 13 of the zigzag channel may have a wall 134. The wire 4 may comprise a plurality of strands 101 arranged successively in the z-direction. The lands 101 may be substantially parallel to each other and perpendicular to the z direction. The continuously disposed strands 101 of the zag sidewall 134 are laterally spaced relative to one another. and along the sidewall 134, the peak 135 and the The undulating sidewalls may be arranged to form a pattern of troughs 136. The multiple strand segments of a cord belong to different layers of the implant. Adjacent strand segments of the sidewall are spaced apart by gaps (e.g., a reversibly expandable gap (as described in any one of claims 1 to 4), and The undulating sidewalls are designed to form a pattern of multiple peaks and multiple troughs. have a lateral offset relative to each other.

[0108] Each hollow channel is formed by at least three sidewalls that are continuous with one another. The peaks and troughs of the contoured sidewall are caused by multiple stripes on the sidewall. The strand segments are formed by the lateral offset between adjacent strand segments. The peak and trough are located between the first distal end of the channel and the second distal end of the channel. They are arranged alternately.

[0109] The undulating portion (e.g., zigzag or sinusoidal portion) is located at the first end of the channel 103. 137 to the second end 138 of the channel 103 (and / or and a second end 138 of the channel 103, It can be understood as a region with multiple peaks (maxima) 135 and troughs (minima) 136. These peaks 135 and troughs 136 may be formed by passing through the sidewall. It can be seen from a vertical cross section (e.g., through the z direction). It may be perpendicular to the land direction and may be a cross section through the channel length and / or a cross section through the channel length. It may be a parallel cross section.

[0110] The peak 135 (and / or trough 136) is formed when the angle θ (e.g., θt or θp) a first plurality of continuous strands 745 in the zigzag sidewall 134; and a second plurality of consecutive strands 746 immediately adjacent thereto. The sidewall 134 may be formed from strands of zigzag sidewalls 134. 745 and directly in the trough of the undulating portion. The angle may be formed between adjacent second plurality of consecutive strands 746. and the angle θp is such that the second plurality of consecutive strands are spaced apart at the peak of the undulating portion. The second plurality of continuous strands are formed between the first and second adjacent strands. The undulating portion may be an angle where θt and / or θp are less than 180°. In contrast, straight sidewalls may be present along the entire channel length. Along the axis, θ may be 180°.

[0111] The undulating portion of the channel 103 has at least one θt that is less than 180° and Optionally, the zigzag channel 103 may include an undulating angle of θp. The portion of the peaks that are present are 1 to 1000 (or e.g., 2 to 50, or e.g., 2 to 25) and and a trough.

[0112] FIG. 7A shows an example of an implant 700A. Includes a 2D perspective cross-sectional view (top image) and a 2D cross-sectional view (bottom image). OA includes at least one contoured sidewall portion, and the contoured portion is jig- This is the zag part.

[0113] In the example of FIG. 7A, the first zigzag sidewall portion 134 and the second zigzag sidewall portion 135 are The geometries of the wall portions 134 are mutually dependent (or interdependent), ignoring manufacturing variations. or, for example, identical, or, for example, similar to each other). The use of the term refers to the first zigzag sidewall portion 134 and the second zigzag sidewall portion 135. The wall portions 134 (and / or zigzag longitudinal axes 742A) are of the same characteristics as each other. and / or the first zigzag side The first zigzag sidewall 134 and the second zigzag sidewall and 80% or more ( or for example over 90% or, for example, over 95% or, for example, over 100%), It may be understood to mean that they may have the same or similar geometric shapes or features. One such feature is the number of peaks 135 and troughs 136 along the channel length. Another such feature may be the vertical height between a peak and an immediately adjacent trough. It may be a peak-to-trough height. The feature was the peak-to-peak width between immediately successive peaks. Another such feature is the trough-to-trough width (tr It may be a rough-to-trough width.

[0114] For example, a first zigzag sidewall 134 and an opposite second zigzag sidewall The peaks 135 and troughs 136 may have a similar pattern. For example, the θt and θp arrangement of the first sidewall portion 134 is The θt and θp arrangements may be the same as those of the θt and θp arrangements of the tubular portion 134. The first zigzag sidewall portion 134 and the second zigzag sidewall portion The peaks 135 and troughs 136 of 134 form a first zigzag pattern along the length of the channel. between the sidewall portion 134 and the second zigzag sidewall portion 134 (minimum The channels may be arranged relative to one another so that they have a constant (maximum or minimum) diameter. Between the first zigzag sidewall and the second zigzag sidewall along the length of the The (minimum or minimum) diameter may have a deviation of less than 10%. The longitudinal axis 742A is aligned with the first zigzag sidewall 134 and the second zigzag sidewall 135. at least one (e.g., both) of the sidewalls 134. It may have a geometric shape.

[0115] The first zigzag sidewall portion 134 and the second zigzag sidewall portion 1 34 is a first zigzag sidewall portion 134 and a second zigzag sidewall At least 80% (or, for example, at least a small portion) of the channel length in at least one of the portions 134 at least 90%, or for example at least 95%, or for example 100%) For example, the first zigzag sidewall 134 may have a continuous stripe shape (or may be the same). The relative lateral offset (x direction) between the strands is of the channel length in at least one of the first zigzag sidewall portion and the second zigzag sidewall portion. Ignoring manufacturing variations along at least 80% of the second zigzag sidewall 1 Even if the relative lateral offset (x-direction) between 34 consecutive strands is the same good.

[0116] The longitudinal axis may include multiple midpoints along the channel length of the channel 103 or The plurality of midpoints may be defined by a first plurality of midpoints along the channel length. Within the (minimum or minimum) diameter dmin between the sidewall and the second sidewall The first zigzag sidewall and the second zigzag sidewall may be formed as a single point. The peaks 135 and troughs 136 are aligned such that the zigzag longitudinal axis 742A is aligned with the first The first end and the second end of the channel may be disposed relative to each other so as to extend between the first end and the second end of the channel. The zigzag longitudinal axis 742A is connected to the first zigzag sidewall and the second zigzag sidewall. It may have a pattern similar to that of the wall.

[0117] FIG. 7B shows an example of a further implant 700B. 0B includes a 3D oblique cross-sectional view (top image) and a 2D cross-sectional view (bottom image). Implant 700B may be similar to implant 700A, and implant 700B may be similar to implant 700B. However, implant 70 may include one or more or all of the features of A. 0B, the second sidewall portion 134 is oriented with respect to the longitudinal axis 742B. It may be a mirror image of the second sidewall portion 134 .

[0118] FIG. 7C shows an example of a further implant 700C. Includes a 3D oblique cross-sectional view (top image) and a 2D cross-sectional view (bottom image) of the implant. Implant 700C may be similar to implant 700A, and may be similar to implant 700B. However, implant 70 may include one or more or all of the features of A. In the case of 0C, the undulating portion of the channel 103 is sinusoidal rather than zigzag.

[0119] In the sinusoidal sidewall portion, along the first plurality of continuous strands 745 The tangent may be a varying tangent (e.g., gradually varying, e.g., gradually decreasing); The tangents along the second plurality of continuous strands 746 may also be varying tangents (e.g., gradually In the zigzag sidewall portion, Thus, the tangents along the first plurality of continuous strands 745 are constant tangents (e.g., fixed tangents). line value, e.g., a positive tangent), and along the second plurality of continuous strands 746 The tangent obtained may also be a constant tangent (eg, a fixed tangent value, eg, a negative tangent).

[0120] FIG. 7D shows an example of a further implant 700D. Includes 0D 3D perspective section (top image) and 2D section (bottom image). 700D may be similar to implant 700C and may be a variant of implant 700C. However, implant 700D may include one, more, or all of the features. In this case, the second sidewall portion 134 is oriented such that the first and second The sidewall portion 134 may be a mirror image of the sidewall portion 134.

[0121] FIG. 7E shows an example of a further implant 700E. Includes 0E 3D perspective section (top image) and 2D section (bottom image). 700E may be similar to implants 700A-700D, and implant It may include one or more or all of the features of.

[0122] As shown in the case of implant 700E, the undulating portion includes a zigzag portion. The angle θ (for example, θt or θp) of the undulating portion may be set to the sidewall 134. The angle θ may be different (or varied) from one another within the undulating portion. The softness of the implant may be changed by increasing the θ. The thinner portions of the implant may be softer than the portions of the implant with a larger θ. Additionally, or as needed, the peak-to-trough height hpt, peak-to-peak width wpp, and and / or trough-trough width wtt, etc., may be determined by the contours of the sidewall 134. Within each part, they may vary (be different from each other).

[0123] The features of Figures 7A to 7G can be combined with each other to create an ink with desired softness and elasticity. It will be appreciated that a plant may be formed.

[0124] One (or each) contoured sidewall may have a minimum of zigzag and sinusoidal sections. Optionally, the zigzag (or sinusoidal) portion may include at least one 103 (or may include the entire length of the channel 103). Alternatively, the zigzag (or sinusoidal) portion may be selected from the entire length of the channel 103. It may extend over a selected portion (e.g., a proportion, or a subportion, or a segment) (or may include selected portions). In some examples, these parameters (angle θt , θp, hpt, wpp, wtt) over the entire undulating area In other examples, , these parameters are,over the entire undulating part (or within the undulating part), In some instances, the contoured portion may extend over the entire sidewall 134 (e.g., In some instances, the contoured portion may include a length (e.g., the entire length) of the sidewall. 10% to 90% (or for example 20% to 80%, or for example 30% to For example, the sidewall may include a contoured portion and a straight portion. In some examples, the sidewalls 134 may have zigzag portions, sinusoidal portions, and and straight segments may include any number and / or combination of straight segments.

[0125] The sidewalls 134 of the channel 103 (e.g., the sidewalls surrounding the channel 103) The elements may be similar (the same, or for example identical) to one another. If desired, they may be dependent on each other (eg, mirror images of each other). Alternatively, or if desired, they may be different from one another. Alternatively, all of the sidewalls of the implant may be sinusoidal sidewalls. In this example, even if all the sidewalls of the implant are zigzag sidewalls, In some instances, the sidewalls of the implant may be zigzag sidewalls or It may also be a mixture with a sinusoidal sidewall.

[0126] FIG. 7F shows an example of a further implant 700F. Includes a 3D perspective cross-section (top image) and a 2D cross-section (bottom image) of the implant. Implant 700F may be similar to implants 700A to 700E and may be It may include one or more or all of the characteristics of a runt.

[0127] While Figures 7A to 7E show channels extending parallel to the z-direction, Figure 7F shows Thus, implant 700F may include angled zigzag (sinusoidal) channels.

[0128] For an angled channel, the longitudinal axis 742E and a reference axis representing the first outer surface area (e.g., , x-axis or y-axis) and the inclination angle k of the acute angle between is less than 90°, or, for example, 60° It may be less than.

[0129] FIG. 7G shows an example of a further implant 700G. Includes a 3D oblique cross-sectional view (top image) and a 2D cross-sectional view (bottom image) of 0G. Implant 700G may be similar to implants 700A to 700F. It may include one or more or all of the features of.

[0130] Figure 7G shows a fractal zigzag (e.g., a zigzag within a zigzag). ) in other words, a first plurality of continuous strands 745 Instead of forming a smooth surface, the surface may include zigzag portions. Optionally, the second plurality of continuous strands 746 may be arranged to form a smooth surface or line. Alternatively, it may include a zigzag portion.

[0131] In the implants of FIGS. 7A to 7G, the distance between the peak and the adjacent trough , the vertical height of the peak-to-trough height hpt and between directly successive peaks, The peak-to-peak width wpp (and / or trough-to-trough width wtt) of the implant 1% to 99% (or e.g. 1% to 50%, or e.g. 1% to 20%) of the maximum dimension, The maximum dimension of the implant may be in the x-direction, y-direction or may be the maximum dimension of the implant in the z direction.

[0132] The features described with respect to the various embodiments of FIGS. 1A to 7G may be combined with each other. It will be understood that the present invention is further characterized by the following items.

[0133] Item 1: Three-dimensional implant for insertion into the patient. The implant forms a three-dimensional structure. The three-dimensional structure contains multiple hollow channels. Each hollow channel has a plurality of sidewalls. the strand segments are alternately arranged so that gaps are formed between adjacent strand segments of the strand, The strand segments and gaps are reversible. This is a gap that can be expanded.

[0134] Item 2: Reversibly expandable gap greater than 110% of baseline gap height 10. The implant according to item 1, which is highly expandable.

[0135] Item 3: Reversibly expandable gap expands relative to baseline gap height and the baseline gap height is the maximum gap height when the implant is at rest. 3. The implant according to item 1 or 2, which is of small height.

[0136] Item 4: Reversibly expandable gap expands relative to baseline gap height 4. The implant according to any one of items 1 to 3,

[0137] Item 5: Reversibly expandable gap expands relative to baseline gap height and the baseline gap height of the gap is between 0.1 mm and 2 mm. An implant according to any one of items 1 to 4.

[0138] Item 6: Reversibly expandable gap expands relative to baseline gap height and the baseline gap length is at least 2 times larger.

[0139] Item 7: Multiple strands are used when the implant is at rest and when the implant is When the gap is compressed, the gap between the gaps is reversibly expandable. 7. The implant according to any one of items 1 to 6, comprising:

[0140] Item 8: The implant is reversibly compressible to less than 80% of its rest volume. 8. The implant according to any one of items 1 to 7. wherein the rest volume is the volume at which the implant It is the volume of the implant when it is free from tension and compression forces.

[0141] Item 9: The implant is constructed to receive an elongated object within the bulk of its three-dimensional structure. 9. The implant according to any one of items 1 to 8, wherein the implant is formed of a fibrous material.

[0142] Item 10: Baseline gap height of a reversibly expandable gap of an elongated object and the elongated object has a length greater than twice the width of the hollow channel. 10. The implant according to item 9, comprising:

[0143] Item 11: Multiple strands are held in the gap by an object that is received by the gap. As the gap height increases, the gap height decreases as the object is removed from the gap. 11. The implant according to any one of items 1 to 10, wherein the implant is configured to reduce wherein the object has a diameter greater than the baseline gap height of the gap. .

[0144] Item 12: Gap height is the smallest dimension of the gap, measured at the midpoint of the gap. Item 12. The implant according to item 11.

[0145] Item 13: The height of the gap depends on the object that is received by the gap. Increased beyond 110% of the line gap height and the gap height is such that the object is no longer in the gap. Item 11: Or the implant according to 12.

[0146] Item 14: At least two different sidewall reversibly expandable gaps, An object that can be accommodated simultaneously by at least two different sidewall gaps The multiple strands are arranged so that they can be simultaneously expanded. 13. An implant according to any one of claims 13.

[0147] Item 15: A reversibly expandable gap of at least two consecutive hollow channels, At least two consecutive hollow channel gaps simultaneously accept the object. The multiple strands are arranged so that they can be simultaneously extended by An implant according to any one of items 11 to 14.

[0148] Item 16: The implant according to any one of items 9 to 15, wherein the object is a needle.

[0149] Item 17: The needle has a diameter of at least 1 mm and a length of at least 2 cm; 17. The implant according to item 16.

[0150] Item 18: Each hollow channel extends along the longitudinal axis of the hollow channel and includes a plurality of strips. The band segments are connected in a direction between a first end of the longitudinal axis and a second end of the longitudinal axis. 2. The implant according to item 1, wherein the implant is positioned adjacent to the graft.

[0151] Item 19: A plurality of continuous strand segments forming the sidewalls of a hollow channel. 19. The implant according to any one of items 1 to 18, wherein the vertices are substantially parallel to each other. .

[0152] Item 20: Each hollow channel includes a first plurality of continuous strand segments and a first a first sidewall including a plurality of reversibly expandable gaps, and a second sidewall including a plurality of continuous a second plurality of reversibly expandable gaps and a second plurality of strand segments extending from the second plurality of reversibly expandable gaps; a second sidewall and a second sidewall connected to the first sidewall. a strand segment that is contiguous and is a first plurality of contiguous strand segments; The strand segments of the second plurality of consecutive strand segments are aligned along the longitudinal axis. Items 1 to 3 are arranged alternately in a direction between the first end and the second end of the longitudinal axis. 19. An implant according to any one of claims 19 to 20.

[0153] Item 21: The channels of the plurality of hollow channels are arranged adjacent to each other, and 21. The method according to any one of items 1 to 20, wherein the channels share a common sidewall. Implant.

[0154] Item 22: The plurality of side walls of the hollow channel are formed such that the cross-sectional shape of the hollow channel is polygonal. From the group of shapes: triangle, diamond, rhombus, square, oval, sinusoidal and hexagonal The shape of the conductor is one of the following: Implants.

[0155] Item 23: 80% or more of all sidewalls of multiple sidewalls are reversibly expandable. 23. The implant according to any one of items 1 to 22, comprising an expandable gap.

[0156] Item 24: At least 50% of all gaps in multiple sidewalls are reversibly expandable 24. The implant according to any one of items 1 to 23, wherein the gap is a gap.

[0157] Item 25: Strand breakage in multiple strands at strains greater than 30% and a corresponding stress of less than 250 MPa. The implant described in 1.

[0158] Item 26: Any one of Items 1 to 25, wherein the plurality of strands are made of a polymer material. The implant described.

[0159] Item 27: The flexible polymer material is from the group of flexible polymer materials consisting of: 27. The implant according to item 26, comprising at least one material: polycaprolactone, poly Poly(1,3-trimethylene carbonate), polylactide, polyglycolide, poly(es teramide), poly(ethylene glycol) / poly(butylene terephthalate), poly( Glycerol sebacate), poly(1,8-octanediol-co-citric acid), poly( 1,10-decanediol-co-D,L-lactic acid), poly(citric acid diol), poly(glycol) Poly(1,3-trimethylene carbonate-co-caprolactone), Poly(1,3-trimethylene carbonate-co-caprolactone) and these A copolymer of at least two materials.

[0160] Item 28: The strand thickness of the multiple strands is between 0.05 mm and 2 mm; 28. The implant according to any one of items 1 to 27.

[0161] Item 29: Multiple strands make up the material volume, and the material volume is the total implant volume. 29. The implant according to any one of items 1 to 28, which is 5% to 50% of the implant volume.

[0162] Item 30: The plurality of sidewalls constitutes 80% or more of the material volume of the three-dimensional structure. Item 29. The implant according to item 29.

[0163] Item 31: The implant comprises multiple layers of strands arranged on top of each other. ,Multiple layers of strands form an array of unit cells of a three-dimensional structure, Items 1-3 10. The implant according to any one of claims 1 to 9.

[0164] Item 32: One or more contouring strands disposed on the outer surface region of the implant and a plurality of contouring strands, each of the plurality of contouring strands being spaced apart from one another by a distance of about 100 mm. A plurality of reversibly expandable contoured gaps are formed between the land segments. 32. The implant according to any one of items 1 to 31, wherein the implant is disposed on the

[0165] Item 33: For implant surgery, a needle is used to guide the needle through the implant. 33. The implant according to any one of items 1 to 32.

[0166] Item 34: A method for forming an implant. This method comprises forming a plurality of implants to form a three-dimensional structure. The three-dimensional structure includes a plurality of hollow channels. Each hollow channel has a plurality of sidewalls. and a plurality of consecutive strand segments of the plurality of strands. The number of strand segments and the number of gaps are the adjacent strands of the sidewall. The segments are arranged alternately so that gaps are formed between them. , a reversibly expandable gap.

[0167] Item 35: Forming multiple strands means printing multiple layers sequentially. a layer comprising a lattice arrangement of two-dimensional unit cells, and a plurality of successive layers The aligned unit cells of the plurality of layers are arranged to form a hollow channel of the plurality of channels. Item 35. The method according to item 34, wherein

[0168] Item 36: Number of hollow channels in the three-dimensional structure to be formed, the three-dimensional structure to be formed determining at least one of the number of layers and the dimensions of the unit cell; Multiple strands are formed to form a three-dimensional structure containing a reversibly expandable gap. and forming a three-dimensional structure having a determined number of hollow channels, a determined number of 36. The method according to item 34 or 35, comprising: a layer of the material; and the dimensions of the unit cell being determined. Law.

[0169] Item 37: Reversibly expandable gap is greater than 110% of baseline gap height. The method according to any one of items 34 to 36, which is also highly scalable.

[0170] Item 38: The reversibly expandable gap is expandable relative to the baseline gap height. The baseline gap height is the gap height when the implant is at rest. 38. The method according to any one of items 34 to 37, wherein the minimum height is

[0171] Item 39: A three-dimensional soft tissue implant for insertion into a patient. The implant comprises a plurality of It contains multiple strands that form a three-dimensional structure containing hollow channels. Each sidewall has a plurality of sidewalls. At least one of the hollow channels has a plurality of strand segments and a plurality of gaps. One sidewall is a contoured sidewall.

[0172] Item 40: The undulating sidewall has at least one zigzag portion and one sine wave portion. Item 39. The implant according to item 39, comprising one of:

[0173] Item 41: Each hollow channel has a first contoured sidewall and a second contoured sidewall. 41. The implant according to item 39 or 40, comprising a sidewall.

[0174] Item 42: A method for tissue reconstruction or tissue augmentation, comprising any one of items 34 to 38. Any of items 1 to 33 or any of items 39 to 41 manufactured by the method and implanting the implant as defined in any one of claims 1 to 4 into the body of a subject.

[0175] Item 43: The method of item 42, including reconstruction of a body part.

[0176] Item 44: Body parts are selected from the group consisting of breasts, chest, buttocks, calves, and parts of the face. Item 44. The method according to item 43, wherein the

[0177] Item 45: The method according to Item 44, wherein the part of the face is the cheek.

[0178] Item 46: The method of Item 44, wherein the subject has pectus excavatum.

[0179] Item 47: The method according to any one of items 42 to 44, including breast reconstruction.

[0180] Item 48: Breast reconstruction is performed after lumpectomy or mastectomy, Item 47 The method described below.

[0181] Although the embodiments of the present invention have been described in detail, the scope of the present invention is defined by the appended claims. The defined invention is susceptible to many obvious modifications without departing from its spirit or scope. It should be understood that the present invention should not be limited to the specific details set forth in the above description. Let's do it.

Claims

1. A three-dimensional implant (100) for tissue reconstruction or tissue augmentation, for insertion into a patient. 200, 300), The implant comprises a plurality of strands (101) forming a three-dimensional structure (102). Preparation, The three-dimensional structure (102) comprises a plurality of hollow channels (103), Each of the hollow channels (103) comprises a plurality of sidewalls (104); The sidewall (104) has adjacent strand centers in the sidewall. The segments (105) are alternately arranged so that gaps (106) are formed between them. a plurality of strand segments (105) and a plurality of gaps (106); The gap is composed of a gap length (gl) and a static gap height (gh), the plurality of gaps (106) are reversibly expandable gaps; The height of the reversibly expandable gap is determined by the size of the object to be accommodated by the gap. Increased by (155) The height of the reversibly expandable gap is adjusted to allow the object to be removed from the gap. It decreases by being The plurality of strands (101) have a yield strength (σ ｙｉｅｌｄ ) and elastic modulus (E) formed from a material having The radius (R) and the reversibly expandable gap (1 06) gap length (gl) is the yield strength (σ ｙｉｅｌｄ ), the elastic modulus of the material ( E), and the adjacent strips forming the reversibly expandable gap (106). The impact is characterized by the deflection capacity (δ) of the strand segment (105). Runt.

2. 10. The implant of claim 1, The number of gaps is determined by the square of the gap length (gl) of the reversibly expandable gap. The ratio of the radius (R) of the strand (101) to the yield strength (σ ｙｉｅｌｄ ) , the elastic modulus (E) of the material, and the strand segment length of the gap (106). The implant is characterized in that the deflection capacity (δ) of the implant (105) is based on the deflection capacity (δ).

3. 3. The implant according to claim 1 or 2, The above-mentioned gap length (gl) of the reversibly expandable gap (106) is multiplied by the square of the gap length (gl). The ratio of the radii (R) of the strands (101) is equal to the yield strength (σ) of the material. ｙ ｉｅｌｄ ) and the elastic modulus (E) and the gap (106) of the strand segment ( 105) and the deflection capacity (δ) of the implant.

4. 4. The implant according to claim 1, The above-mentioned gap length (gl) of the reversibly expandable gap (106) is multiplied by the square of the gap length (gl). The ratio of the radii (R) of the strands (101) is expressed by the following formula, and δ is the radius of the strands (101) An implant characterized by a deflection capacity of the strand segments of the implant. [Equation 1]

5. 5. The implant according to claim 1, The flexibility of the strand segments of the reversibly expandable gap (106) The force (δ) is between 0.05 and 0.75 times the static gap height (gh) of the gap. An implant characterized by being located between

6. 6. The implant according to claim 1, The reversibly expandable gap (106) is expandable relative to the baseline gap height. It is Noh, The baseline gap height is the gap height when the implant is at rest. An implant characterized by its height.

7. 7. The implant according to claim 1, the channels of the plurality of hollow channels (103) are arranged adjacent to each other; An implant characterized in that adjacent channels share a common sidewall.

8. 8. The implant according to claim 1, 80% or more of all the sidewalls (104) of the plurality of sidewalls An implant comprising the reversibly expandable gap (106).

9. 9. The implant according to any one of claims 1 to 8, At least 50% of all gaps in the plurality of sidewalls (104) are reversibly expanded. An implant characterized by a possible gap (106).

10. 10. The implant according to any one of claims 1 to 9, The material for forming the plurality of strands has a breaking point on a stress-strain diagram. death, The strain at the breaking point is greater than 30% and the stress at the breaking point is 250 MPa. An implant characterized in that it is less than.

11. 11. The implant according to any one of claims 1 to 10, The plurality of strands (101) comprises a volume of material; The material volume is 5% to 50% of the total implant volume of the implant. The implant features:

12. 12. The implant according to any one of claims 1 to 11, One or more contouring strands (31) disposed on the outer surface region of the implant. 9) further comprising: The plurality of contouring strands (319) are arranged such that adjacent strands of the plurality of contouring strands are spaced apart from each other. Multiple reversibly expandable contouring gaps are formed between the strand segments. The implant is characterized in that it is arranged so as to

13. 13. The implant according to any one of claims 1 to 12, The plurality of hollow channels (103) may include at least one sinusoidal channel and one zigzag channel. An implant characterized by comprising at least one of the following:

14. 14. The implant according to any one of claims 1 to 13, For use in guiding a needle through said implant for implant surgery. An implant characterized by:

15. 1. A method for forming a three-dimensional implant, comprising: The method further comprises forming a plurality of strands (620) to form a three-dimensional structure. ), The strands have a yield strength (σ ｙｉｅｌｄ ) and elastic modulus (E) It is formed from the three-dimensional structure includes a plurality of hollow channels; Each hollow channel comprises a plurality of sidewalls; The sidewall has a plurality of gaps and a plurality of continuous strands of the plurality of strands. It has a land segment, The plurality of strand segments and the plurality of gaps are provided in the sidewall. The strand segments are alternately arranged so that gaps are formed between adjacent strand segments. 、 The gap is composed of a gap length (gl) and a static gap height (gh), the plurality of gaps are reversibly expandable gaps; The height of the reversibly expandable gap is determined by the size of the object to be accommodated by the gap. Increased by things, The height of the reversibly expandable gap is adjusted to allow the object to be removed from the gap. It decreases by being The radius (R) of the plurality of strands and the gap length ( g) is the yield strength (σ ｙｉｅｌｄ ), the elastic modulus (E) of the material, and The deflection capacity of the adjacent strand segments ( δ) based on the formation of a three-dimensional implant.

16. 16. The method for forming a three-dimensional implant according to claim 15, Based on the object accommodated by the reversibly expandable gap, determining the deflection capacity (δ) of the expandable gap; The yield strength (σ) of the material of the strands to be formed ｙｉｅｌｄ )oh determining material properties including Young's modulus (E); of each of the plurality of strand segments to be formed. determining a radius (R) and a gap length (gl); The method for forming a three-dimensional implant further comprises:

17. A three-dimensional implant (100) for tissue reconstruction or tissue augmentation, for insertion into a patient. 200, 300), The implant has a first set of sublayers (115) each having a plurality of layers oriented in a first direction. and a second set of sublayers (116) having strands of The first sublayer group (115) and the second sublayer group (115) have strands. and the sublayers of the group of sublayers (116) are alternately arranged in a third direction. A plurality of planar layers having a plurality of hollow channels (103) extending in the third direction. the plurality of layers forming a three-dimensional structure including the implant is compressible along at least the third direction; Each hollow channel (103) A plurality of alternatingly arranged, first direction-oriented, and third direction-extending electrodes. A first sub-segment (105A) consisting of a plurality of strand segments (105A) and a plurality of gaps (106A). side walls (104A) and upper walls (104B) extending in the third direction and arranged alternately. A plurality of strand segments (105B) oriented in the second direction and a plurality of gaps ( and a second sidewall (104B) consisting of a first sidewall (106B), The first sidewall (104A) and the second sidewall (104B) of the hollow channel At least one of the walls (104B) is a contoured sidewall; The plurality of strand segments of the contoured sidewall (104A, 104B) The implants (105A, 105B) belong to different layers in the implant. 、 Adjacent strand centers in the contoured sidewalls (104A, 104B) The segments (105A, 105B) are separated by a gap (106), The adjacent strand segments (105A, 105B) are A plurality of peaks (135) and a plurality of troughs (136) in the walls (104A, 104B) 36) have a lateral offset relative to each other to create a pattern An implant characterized by:

18. 18. The implant of claim 17, The undulating sidewalls (104A, 104B) have zigzag and sinusoidal portions.

10. An implant comprising at least one of the following portions:

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