Implants and methods of forming implants

Abstract

Embodiments herein relate to a three-dimensional implant for tissue reconstruction or tissue augmentation inserted into a patient. The implant includes a plurality of strands forming a three-dimensional structure, the three-dimensional structure including a plurality of hollow channels. Each hollow channel includes a plurality of sidewalls. The sidewalls include a plurality of strand segments and a plurality of gaps arranged in an alternating pattern of gaps, such that a gap is formed between adjacent strand segments of the sidewalls. The gaps include a gap length (gl) and a resting gap height (gh). The plurality of gaps are reversibly expanding gaps. The adjacent strand segments include a deflection capacity (delta) based on an object to be received by the reversibly expanding gaps. A radius (R) of the plurality of strands and the gap length (gl) of the reversibly expanding gaps are based on a yield strength (sigma yield ), an elastic modulus (E), and the deflection capacity delta of the adjacent strand segments forming the reversibly expanding gaps.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to European patent application 20186961.7 filed with the European Patent Office on 21 July 2020, the entire contents of which are incorporated herein for all purposes. Technical Field

[0003] The embodiments described herein relate to the field of implants, and more specifically, to implants inserted into a patient's body, and methods for forming implants. Background Technology

[0004] In surgeries worldwide, implants are placed into patients. Depending on the intended use of the implant, it must meet specific criteria. These criteria relate to the implant's geometry and / or mechanical stability. In some cases, such as when the implant is used in reconstructive surgery, it must be handled by the surgeon before, during, and / or after insertion. An implant is required that meets the patient's geometric and mechanical requirements and is easily manipulated and / or controlled by the surgeon performing the procedure. Summary of the Invention

[0005] Various embodiments relate to providing an implant that can be flexibly customized to meet the standards required for the reconstruction of parts of a patient's body, and also enhances and improves the operability and maneuverability of the implant for the surgeon performing the procedure.

[0006] The embodiments described herein relate to a three-dimensional implant inserted into a patient's body. The implant includes multiple strands forming a three-dimensional structure. The three-dimensional structure includes multiple hollow channels. Each hollow channel includes multiple sidewalls. The sidewalls include alternating strand segments and multiple gaps, such that gaps are formed between adjacent strand segments of the sidewalls. The gaps include a gap length (gl) and a stationary gap height (gh). The multiple gaps are reversibly expanding gaps. The height of the gap increases as an object is received by the gap, and decreases as the object is removed from the gap. The multiple strands are made of materials with a yield strength (σ). yield The material is formed based on the yield strength (σ) and elastic modulus (E) of the multiple strands. The radius (R) of the strands and the gap length (gl) of the reversible expansion gap are based on the yield strength (σ) of the material. yield ), elastic modulus (E) and deflection capacity δ of the adjacent strands forming the reversible expansion gap.

[0007] Various embodiments relate to an implant for guiding a needle through the implant to perform an implantation procedure.

[0008] Various embodiments relate to a method for forming a three-dimensional implant. The method includes forming a plurality of strands to form a three-dimensional structure. The plurality of strands are made of materials having a yield strength (σ). yield The material is formed with a yield strength (σ) and an elastic modulus (E). The three-dimensional structure includes multiple hollow channels. Each hollow channel includes multiple sidewalls, wherein the sidewalls include multiple gaps and multiple continuous strand segments of the multiple strands. The multiple strand segments and the multiple gaps are arranged alternately, such that gaps are formed between adjacent strand segments of the sidewalls. The gaps include a gap length (gl) and a stationary gap height (gh). The multiple gaps are reversibly expanding gaps. The height of the reversibly expanding gap increases as an object is received by the gap, and the height of the gap decreases as the object is removed from the gap. The radius (R) of the multiple strands and the gap length (gl) of the reversibly expanding gap are based on the yield strength (σ) of the material. yield ), elastic modulus (E) and deflection capacity δ of the adjacent strands forming the reversible expansion gap.

[0009] Various embodiments relate to a three-dimensional implant for tissue reconstruction or enhancement inserted into a patient's body. The implant includes multiple planar layers. A first set of sublayers includes multiple strands oriented along a first direction. A second set of sublayers includes multiple strands oriented along a second direction. Sublayers in the first set and sublayers in the second set are arranged alternately in a third direction. The multiple layers form a three-dimensional structure including multiple hollow channels extending in the third direction, wherein the implant is compressible at least in the third direction. Each hollow channel includes a first sidewall and a second sidewall, the first sidewall extending in the third direction and including alternately arranged multiple strand segments oriented along the first direction and multiple gaps, the second sidewall extending in the third direction and including alternately arranged multiple strand segments oriented along the second direction and multiple gaps. At least one of the first and second sidewalls of the hollow channel is a wavy sidewall. The multiple strand segments of the wavy sidewall belong to different layers of the implant. Adjacent strand segments of the wavy sidewall are separated by gaps. The adjacent strands are laterally offset relative to each other to form a pattern of multiple peaks and multiple troughs in the wavy sidewalls.

[0010] Finally, the present invention relates to a method for tissue reconstruction or tissue enhancement, wherein the method includes implanting an implant as defined herein into the body of a subject. Attached Figure Description

[0011] The foregoing and other features of this disclosure will become more apparent when read in conjunction with the accompanying drawings. It should be understood that the drawings depict only a few embodiments according to this disclosure and should not be construed as limiting its scope. The advantages of this disclosure can be more readily identified by using the accompanying drawings, which will describe the disclosure in more specific and detailed manner, wherein:

[0012] Figure 1A and 1B The perspective and cross-sectional side views of the three-dimensional implant 100 inserted into the patient's body are shown respectively;

[0013] Figure 1C The gap of the implant between two adjacent strands of the sidewall is shown;

[0014] Figure 1D and 1E The first and second sublayers of the implant are shown respectively;

[0015] Figure 1F A diagram of a beam with two simple supports that deflect.

[0016] Figure 1G The diagram illustrates the deflection of adjacent strands in response to needle insertion.

[0017] Figure 1H The arrangement of adjacent strands with zero lateral offset is shown;

[0018] Figure 1I The arrangement of adjacent strands with a lateral offset greater than zero is shown;

[0019] Figure 2A and 2B The perspective and cross-sectional side views of another implant inserted into the patient's body are shown respectively;

[0020] Figure 3A A perspective view of an implant suitable for use as a breast implant is shown;

[0021] Figure 3B and 3C The illustration shows a perspective side view and a perspective top view of the implant, which includes multiple outlines and surface filler lines.

[0022] Figure 3D A perspective view of the implant is shown;

[0023] Figure 4A An implant without a reversibly expandable gap is shown;

[0024] Figure 4B An image shows a cannula for fat injection inserted with an implant having a reversible expansion gap;

[0025] Figure 4C An example of a possible insertion region for multiple injection tests is shown;

[0026] Figure 4D The stress-strain curves of strands made of different materials are shown;

[0027] Figure 5A The implant is shown after a simulated fat injection surgery;

[0028] Figures 5B to 5D Images of the implants after fat injection are shown respectively;

[0029] Figure 6 A flowchart of a method 600 for forming an implant is shown;

[0030] Figures 7A to 7G An implant with at least one wavy sidewall is shown. Detailed Implementation

[0031] In the following detailed description, reference is made to the accompanying drawings, which illustrate by way of illustration specific embodiments in which the claimed subject matter can be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the subject matter. It should be understood that although the various embodiments differ, they are not necessarily mutually exclusive. For example, a particular feature, structure, or characteristic described herein in connection with one embodiment may be implemented in other embodiments without departing from the spirit and scope of the claimed subject matter. References to “one embodiment” or “an embodiment” in this specification mean that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one implementation contained in this description. Therefore, the use of the phrase “one embodiment” or “in one embodiment” does not necessarily refer to the same embodiment. Furthermore, it should be understood that the position or arrangement of various elements in each disclosed embodiment may be modified without departing from the spirit and scope of the claimed subject matter. Therefore, the following detailed description should not be considered limiting, and the scope of the subject matter is defined only by the appended claims as properly interpreted, and by their full scope and equivalents. In the drawings, the same reference numerals indicate the same or similar elements or functions throughout multiple views, and the elements depicted therein are not necessarily proportional to each other, but may be enlarged or reduced in size to facilitate understanding of the elements in the context of this specification.

[0032] As used herein, the terms “above,” “beside,” and “above” indicate the relative position of a layer with respect to other layers. A layer located “above” or “above” another layer may be in direct contact with that other layer or may have one or more intermediate layers. A layer located “between” layers may be in direct contact with those layers or may have one or more intermediate layers. As used herein, the phrases “A, B, and / or C” may refer to “A,” “B,” “C,” “A and B,” “B and C,” “A and C,” and “A and B and C.”

[0033] Figure 1A and 1B Perspective and cross-sectional side views of the implant 100 inserted into the patient's body are shown, respectively.

[0034] like Figure 1A As shown, the implant 100 includes multiple strands 101 forming a three-dimensional structure 102. The three-dimensional structure 102 includes multiple hollow channels 103. Each hollow channel 103 includes multiple sidewalls 104. The sidewalls 104 include multiple strand segments 105 arranged alternately and multiple gaps 106 (e.g., ...). Figure 1B As shown), gaps 106 are formed between adjacent strands 105 of the sidewall 104. The multiple gaps 106 are reversibly expanding gaps.

[0035] Typically, the hollow passage 103 can be formed by at least three sidewalls that are adjacent to each other (or, for example, intersect each other), such that the hollow space is surrounded by the sidewalls. Figure 1A In the example, multiple hollow channels 103 are shown, each channel having a square cross-section. Each hollow channel 103 with a square cross-section may have four intersecting sidewalls 104.

[0036] Figure 1B A cross-sectional side view of the implant 100, taken through line A-A', is shown. This side view shows multiple strands (also called filaments) 101 of the three-dimensional structure 102, wherein the multiple (parallel) strands 101 form the sidewalls 104, 104A of two adjacent (e.g., directly adjacent) channels 103, 103A of the three-dimensional structure 102. Figure 1BAs shown, taking hollow channel 103A as an example, hollow channel 103A may include a first sidewall 104A (shown as a sidewall parallel to the page) formed by multiple parallel strands 101. Hollow channel 103A may also include a second sidewall 104B (shown as strands entering and / or leaving the page), a third sidewall 104C (shown as strands entering and / or leaving the page), and a fourth sidewall (not shown). The third sidewall 104C may be a facing sidewall opposite to the second sidewall 104B. The second sidewall 104B and the third sidewall 104C may be adjacent to the first sidewall 104A and the fourth sidewall. The fourth sidewall may be a facing sidewall opposite to the first sidewall 104A. Where the sidewalls intersect, their strands may cross each other in an alternating manner.

[0037] One (or each) sidewall 104 of channel 103, such as sidewall 104A of hollow channel 103A, may include a plurality of continuous strand segments 105A arranged continuously along the z-direction (vertical direction). Each strand segment 105A may be part (or segment) of a longer continuous strand 101 forming part of another sidewall 104 or channel 103. Optionally, the plurality of continuous strand segments 105A forming sidewall 104A of hollow channel 103A may be substantially parallel to each other. Each sidewall 104A may also include a plurality of gaps 106A. The plurality of gaps 106A and the plurality of strand segments 105A of hollow channel 103A may be arranged alternately such that (e.g., one) gap 106A may be located between adjacent (e.g., directly continuous) strand segments 105A of sidewall 104A (e.g., between two continuous strand segments 105A of sidewall 104A). Adjacent (e.g., directly adjacent, or consecutive) line segments can be separated by a gap of 106A.

[0038] Figure 1C The gap 106A between two adjacent strand segments 105A of the (one, single) sidewall 104A of the hollow channel 103A of the implant 300 is shown.

[0039] Gap 106A may also be referred to as a slit and / or spacing, and refers to the blank space between the lengths of two adjacent strand segments 105A. Gap 106A may be defined by two pairs of intersecting strands 101 forming the perimeter of gap 106A (e.g., bordering gap 106A, or, for example, surrounding gap 106A). The first pair of strand segments 105A (parallel to the y-direction) of the first sidewall 104A may be opposing facing strand segments and / or may optionally be substantially parallel to each other. The second pair of strand segments 105B, 105C may be opposing facing strands of the second sidewall 104B and the third sidewall 104C, and may be substantially parallel to each other. Gap 106A may be a region surrounded by two pairs of intersecting strands. The first pair of strand segments 105A forming gap 106A may be adjacent strand segments 105A of the same (first) sidewall 104A of the hollow channel 103A. The second pair of line segments can be the opposite line segments of the second sidewall 104B and the third sidewall 104C.

[0040] The gap 106A may have or may be defined by a baseline gap height h. The baseline (or stationary) gap height gh may be the minimum (or minimum) height between two adjacent strand segments 105A when the implant 100 is stationary. Additionally or alternatively, the baseline gap height gh may be the height of the gap 106A at the midpoint region of the gap 106A (e.g., the midpoint region of the strand segments 105A of the gap 106A). Additionally or alternatively, the baseline gap height may be the average (mean) gap height of more than 80% of the implant gaps when the implant is stationary. Furthermore, the gap 106A may have or may be defined by a baseline gap length gl, which is the maximum (or highest) dimension of the gap 106A. Furthermore, the baseline gap length gl may be the length of the strand segment between the second pair of strands 105B, 105C, for example, the length of the strand segment between the two nearest edges of the first strand 105B and the second strand 105C. Figure 1C ), or, the length of the line segment from the center of the first line 105B to the center of the second line 105C ( Figure 1G The second pair of strands can be fused to the first pair of strands at the intersection of the two pairs of strands, and the second pair of strands can form simple support for the first pair of strands at the opposite ends of the gap length gl.

[0041] The two pairs of intersecting strands 101 may be fused or joined at the intersection area. Additionally or alternatively, the opposing facing strand segments 105A may have some sag or bend, such that the baseline gap height gh is equal to or less than the average strand diameter d. The shape of the gap 106 may be changed or modified when the gap height is increased (e.g., by inserting a needle into the gap). Optionally, the area enclosed by the two pairs of intersecting strand segments 105A, 105B, 105C may remain unchanged. Alternatively or alternatively, the area enclosed by the two pairs of intersecting strands 101 may be increased to more than 110% of the original enclosed area (or, for example, more than 120%, or more than 150%, or more than 200%, or, for example, between 120% and 250%, or, for example, between 120% and 200%).

[0042] Figure 1C The spring-like feature of the reversible expanding gap 106 (e.g., gap 106A) is also shown. If tension (indicated by opposing arrows 113, 114) is applied to the opposing facing strand segments 105A of gap 106A, the gap height gh increases. Furthermore, each of the opposing facing strand segments 105A of gap 106A can be subjected to opposite tension. When tension is applied to the strand segments 105A of gap 106A, gap 106A can be configured to expand relative to the baseline gap height gh. For example, the reversible expanding gap 106 can expand to more than 110% (or, for example, more than 120%, or, for example, more than 150%, or, for example, more than 200%, or, for example, between 110% and 250%, or, for example, between 120% and 250%, or, for example, between 120% and 200%) of the baseline gap height gh and / or the average strand diameter d. After the tension (113, 114) is removed from the strand segment 105A of the gap 106A (even under the same ambient pressure and temperature), the reversible expansion gap 106A can recover or return to its original (static) gap height. For example, after the tension applied to the strand segment 105A is removed, the reversible expansion gap 106 can be configured to recover or return to less than 110% (or, for example, less than 105%, or, for example, less than 100%, or, for example, between 80% and 115%, or, for example, between 90% and 110%) of its original gap height gh and / or average strand diameter d.

[0043] Optionally, the baseline gap length gl can be more than twice the baseline gap height gh (or, for example, more than five times, or, for example, more than ten times). Optionally, the baseline gap height gh can be 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). Optionally, the average thickness of the multiple strands 101 can be 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). Optionally, the baseline gap length gl can be more than twice the diameter d (or, for example, more than five times, or, for example, more than ten times) the diameter (or thickness) of the strands 101. For example, the baseline gap length gl can be less than 25 mm (or, for example, between 0.5 mm and 25 mm). Optionally, the baseline gap height gh can be between 40% and 100% (or, for example, between 40% and 80%, or, for example, between 40% and 60%) of the average (mean) diameter d of the implant's sutures 101. It is understood that, although... Figure 1C Only one corresponding strand segment 105B, 105C of each of the second sidewall 104B and the third sidewall 104C is shown, but more than one strand of each of the second sidewall 104B and the third sidewall 104C may be arranged between the first pair of strand segments 105A of the first sidewall 104A. In this case, the baseline gap height gh may depend on the total thickness of the second pair of strands in the z-direction. For example, the baseline gap height gh may be between 40% and 100% (or, for example, between 40% and 80%, or, for example, between 40% and 60%) of the total thickness of the second pair of strands in the z-direction.

[0044] like Figure 1B As shown, each hollow channel 103, 103A may include at least a first sidewall 104A, which includes a first plurality of continuous strand segments 105A and a first plurality of reversible expansion gaps 106. The hollow channel 103A may also include a second sidewall 104B, which includes a second plurality of continuous strand segments and a second plurality of reversible expansion gaps. The second sidewall 104B may be adjacent to the first sidewall 104A. Strand segments 105A in the first plurality of continuous strand segments 105A and strand segments 105B in the second plurality of continuous strand segments 105B may be alternately arranged along one direction between a first end 137 and a second end 138 of the longitudinal axis of the hollow channel 103A.

[0045] The two sidewalls 104 and 104A of adjacent channels 103 and 103A can be separated (or divided) by another sidewall 104B. The other sidewall 104B may include multiple strands (such as...). Figure 1B(As shown, you will be directed to the next page). The strands of the other sidewall 104B may intersect with the strands 101 that form sidewalls 104A, 104A. The channels in the plurality of hollow channels 103 may be arranged adjacent to each other (e.g., directly adjacent). Adjacent channels 103A, 103B may share a common sidewall 104B.

[0046] Depending on the purpose of the implant, the implant 100 can have different sizes. In the x-direction, the implant can have a size up to 30 cm (or, for example, between 1 cm and 30 cm, or, for example, between 10 cm and 15 cm). In the y-direction, the implant can have a size up to 30 cm (or, for example, between 1 cm and 30 cm, or, for example, between 10 cm and 15 cm). In the x-direction, the implant can have a size up to 30 cm (or, for example, between 1 cm and 30 cm, or, for example, between 10 cm and 15 cm).

[0047] The multiple strands 101 of the three-dimensional structure 102 of the implant 100 can form (or may constitute) the material volume of the implant. The material volume occupied by the multiple strands 101 can be between 5% and 70% (or, for example, between 50% and 70%, or, for example, between 50% and 60%) of the total static implant volume. Additionally or optionally, the gap 106 of the implant can form (or may include) 30% to 95% (or, for example, between 30% and 50%, or, for example, between 40% and 50%) of the total static implant volume. In the material volume of the three-dimensional structure 102 of the implant, the multiple sidewalls 104 of the implant can form (or may include) 80% to 100% of the material volume. The remaining material volume of the implant 100 not formed by the multiple sidewalls 104 can be, for example, contour lines and / or surface fill lines. Optionally, the strand segments 105 of the sidewall 104 may constitute (or form) less than 90% of the sidewall 104 (or, for example, less than 50%, or, for example, between 50% and 70%, or, for example, between 50% and 60%), while the remainder of the sidewall 104 is occupied by the gap 106. Optionally, at least 80% (or, for example, at least 95% or, for example, 100%) of all the sidewalls 104 may include reversibly expandable gaps 106. Additionally or optionally, at least 50% (or, for example, at least 60%, or, for example, at least 70%) of all the gaps 106 of the implant 100 are reversibly expandable gaps.

[0048] like Figure 1A As shown, the implant 100 can form (or may be) a three-dimensional structure 102, which can be a mesh structure or a scaffold structure. For example, multiple strands 101 (or lines) can be configured to form a mesh-like three-dimensional structure 102. The three-dimensional structure 102 can define (or may have) the static volume of the implant 100. The static volume of the implant 100 (cm²) 3The rest volume of implant 100 can be the volume of implant 100 before it is inserted into the patient to construct and / or reconstruct soft tissue. The rest volume of implant 100 can be the volume of implant 100 when it is at rest. The resting implant 100 can be the implant state when only one outer surface (e.g., outer surface 108) of implant 100 is subjected to external forces, such as when implant 100 is placed (in contact with or fixed to a carrier surface) on a carrier surface (e.g., a workbench surface, or a board). For example, a resting implant 100 can mean that the first outer surface 108 of the implant is in contact with the carrier surface, and the second (opposite facing) outer surface 109 is not subject to any tension and / or compressive forces. In other words, the rest volume of implant 100 can be the volume of implant 100 when no reverse compressive or tensile forces are acting on the implant surface. The rest volume of implant 100 can be derived based on the constructed volume (desired or required volume) of implant 100 to be inserted into the patient. For example, alternatively, the implant 100 may be configured to be compressible to a volume smaller than the construction volume, such that the implant 101 includes or reaches the construction volume after being inserted into the patient's body.

[0049] The multiple strands 101 can be multiple wires or rope-like materials. The strands 101 (or wires or filaments) can have a length and a cross-sectional diameter d. The diameter of the strands 101 can be the average size of the strands 101, such as the minimum cross-sectional size of the strands 101. Optionally, the length of the strands 101 can be larger than the diameter of the strands 101 (e.g., at least 5 times larger, or at least 10 times larger, or at least 20 times larger). For example, the strand diameter can optionally be between 300µm and 350µm.

[0050] The term hollow channel 103 can refer to a channel in which at least 70% (or, for example, at least 80%, or, for example, at least 90%) of the channel volume surrounded by the sidewalls of the channel is not filled or occupied by any material such as strand segments or strands. For example, hollow channel 103 is not necessarily limited to a completely (100%) unfilled channel.

[0051] The three-dimensional structure 102 may include layers of multiple basic planes (e.g., parallel to the xy plane) arranged or stacked continuously with each other in the z-direction 107 (e.g., vertical direction). Optionally, each planar layer may include multiple strands 101 arranged in a two-dimensional lattice to form a unit cell. The various layers of the implant 100 may be arranged continuously (stacked and / or one layer on top of another) such that the unit cells of the continuous layers (formed on top of each other) can form multiple hollow channels 103. Each channel 103 may be formed by (or may include) a column of unit cells from the continuously stacked layers. For example, in Figures 1A to 1CIn the illustrated implant 100, the implant 100 may include multiple layers of square unit cells arranged above each other to form a hollow channel 103 with a square cross-section. Optionally, the unit cells may be regularly repeated in a manner that comprises more than 50% (or, for example, more than 80%, or, for example, more than 90%, or, for example, more than 95%) of the rest volume of the three-dimensional lattice structure 102. Thus, the lattice structure 102 may include multiple adjacent (e.g., directly adjacent) unit cells that are connected to each other throughout the lattice structure 102. The unit cell may be the smallest and most basic unit of the three-dimensional lattice structure 102.

[0052] Optionally, each planar layer of the unit cell may include a first sublayer (or a first group of sublayers) comprising strands oriented along a first direction, and an adjacent second sublayer (or a second group of sublayers) comprising curves oriented along a second direction different from the first direction.

[0053] Figure 1D The first sublayer of the implant 100 is shown, the first sublayer 115 including strands 101 oriented along a first direction (e.g., the y direction). Figure 1E A second sublayer 116 of implant 100 is shown, and the first sublayer 116 includes strands 101 oriented along a second direction (e.g., the x-direction). Optionally, the strands 101 within each respective sublayer may be parallel to each other (e.g., the acute angle between strands within a sublayer, or the acute angle between strands most suitable for sinusoidal strands, may be within + / - 5°). Multiple strands 101 of the first sublayer 115 and multiple strands 101 of the second sublayer 116 may intersect at intersection points or intersection regions to form a two-dimensional lattice arrangement of layers. Optionally, the strands 101 of each sublayer 115, 116 (or, for example, within) may be part of a continuous strand that curves continuously from the start point S of the sublayer to the end point E of the sublayer. For example, optionally, the strands of the first sublayer 115 may be part of a continuous sublayer strand that curves continuously from the start point S of the first sublayer to the end point E. Optionally, the strands of the second sublayer 116 may be part of a continuous sublayer strand that curves continuously from the start point S of the second sublayer to the end point E. The continuous strands of the sublayer can have multiple straight portions oriented along a first direction. The multiple straight portions of the sublayer can be connected by curved portions. The curved portions can be formed at least partially on the boundaries or perimeters of the layers and can form sidewalls of surface-fill lines or channels at the surface of the implant. Each sublayer can have its own boundary or perimeter where curved portions (or surface-fill lines) are formed. Optionally, the strands can be straight strands, or they can be sinusoidal zigzag strands, wherein the unit cell can have a "free-form" shape.

[0054] The first sublayer 115 and the second sublayer 116 can be arranged such that their respective strands 101 intersect to form a two-dimensional lattice arrangement of unit cells. The intersecting strands 101 of the first sublayer 115 and the second sublayer 116 can be arranged such that each unit cell formed by the intersecting strands may include, or may be referred to as, a hole with an aperture. The intersecting strands may form or define the geometry (e.g., shape, size, aperture) of a single unit cell. Each two-dimensional unit cell may have an aperture that defines the unit cell size. The aperture of a two-dimensional unit cell can be described based on its diameter, width, and / or aperture area. For example, the aperture w of a unit cell of a layer may be referred to as the diameter or width of the hollow channel 103 (e.g., ...). Figure 1A (As shown). Optionally, the average pore size of the plurality of unit cells of the three-dimensional structure 102 may be 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, 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 70%, or, for example, at least 80%) of the pore area of ​​the surface pores of the three-dimensional structure 101 may be at least 0.75 mm. 2 (or, for example, at least 1mm) 2 or, for example, at least 3mm 2 The surface aperture area can be the region enclosed by intersecting strands that define the surface aperture.

[0055] Multiple two-dimensional unit cells can be polygonal unit cells, triangular unit cells, rhombic unit cells, elongated rhombic unit cells, square unit cells, ellipsoidal unit cells, sinusoidal unit cells, and / or hexagonal unit cells. It is understood that the implant 100 may optionally include unit cells that predominantly have one of these shapes (e.g., more than 50%, or more than 60%, or more than 70%, or more than 80%) throughout the entire volume of the implant 100, or alternatively, the implant 100 may include unit cells having a variety of different shapes. The sidewalls 104 of the hollow channel 103 may be formed by multiple strands 101 that are substantially parallel to the xy plane, vertically stacked along the z-direction (third direction), and substantially oriented in the same direction. The sidewalls 104 of the hollow channel 103 may be arranged such that the cross-sectional shape of the hollow channel 103 is one of the following groups of shapes: polygonal, triangular, rhombic, elongated rhombic, square, ellipsoidal, sinusoidal, and hexagonal.

[0056] Compared to the aperture, the gap 106 of the implant 100 may indicate (or may be) the minimum spacing between any adjacent strands forming the hollow channel 103. For example, the gap 106 may have a minimum area (e.g., minimum gap area) surrounded by the strands of the implant, compared to the aperture area of ​​the unit cell. Optionally, the gap area of ​​the gap 106 (which may be the area surrounded by two pairs of opposing strands defining the gap 106) may be less than 50% of the aperture area (or, for example, less than 40%, or, for example, less than 30%).

[0057] Each hollow channel 103 may extend along a longitudinal axis. The longitudinal axis may be a line including the midpoint of the sidewall of the hollow channel 103. For example, the hollow channel 103 may extend between a first outer surface region 108 and a second outer surface region 109 of the three-dimensional structure 102. For example, channels 103 in a plurality of hollow channels 103 (e.g., optionally, each channel, or, for example, one or more channels 103) may be configured to extend from the first outer surface region 108 toward the second outer surface region 109. The precise location and / or tilt angle of the plurality of hollow channels 103 may be configured according to the patient's needs. Optionally, the plurality of hollow channels 103 may be parallel to each other (e.g., the acute angle between the sidewalls of adjacent channels may be within + / - 5°). Optionally, the plurality of hollow channels 103 may converge toward a converging region (or point), wherein the converging region is located outside the first outer surface region 108 or the second outer surface region 109. Optionally, the hollow channel 103 may include a zigzag channel, an inclined channel, and / or a conical channel. Optionally, the hollow channel 103 may be a channel inclined relative to the first outer surface region 108. For example, in the cells forming a cell column, the cells of the second layer may have a lateral offset (in the x or y direction) relative to the adjacent cells of the first layer. The lateral offset value between the first and second cells may be between 0% and 50% of the cell's aperture (or, for example, between 0% and 20%, or, for example, between 5% and 10%). Optionally, within the same column, the cells of each layer may have the same lateral offset relative to the cells of the directly preceding layer. Optionally, at least 80% (or, for example, at least 70%, or, for example, at least 50%) of the cells in the same column (forming the same channel) may have the same aperture and the same aperture shape. Alternatively, in the case of a tapered channel, the cells forming the same channel may have different apertures (e.g., the aperture of the cells may decrease or increase toward one of the outer surface regions).

[0058] The multiple strands 101 can be configured such that the gap 106A can reversibly expand when the implant is at rest and / or even when the implant 100 is under compression. When a (physical or mechanical) compressive force is applied to more than one outer surface of the implant 101, the implant 101 can be compressed to less than 80% of its rest volume (or, for example, less than 70%, or, for example, less than 60%, or, for example, less than 50%, or, for example, less than 30%, or, for example, between 30% and 95%, or, for example, between 45% and 80%, or, for example, between 45% and 70%, or, for example, between 80% and 95%).

[0059] The expandability of the implant gap can be explained by analogy to the deflection of a beam. The implant gap can be expandable, meaning that the strands can deflect and / or bend in response to one or more forces applied to them without breaking, thus increasing the gap height between two adjacent strand segments. The bending stress σ of a beam (or strand segment) that undergoes simple bending in response to an applied external force can be expressed as…

[0060]

[0061] like Figure 1F As shown, this type of beam is simply supported at both ends. When an external force or moment is applied to the beam, the bending moment is the reaction force induced in the beam. 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 beam's cross-section. The maximum bending moment M caused by a load applied at the center between the supports can be described or defined by the following equation.

[0062] (2):

[0063] L is the length of the beam, and F is the force applied to the beam. Maximum bending stress σ max It can be expressed by the following equation

[0064] (1):

[0065] M can be the maximum bending moment, c max It is the maximum distance from the neutral axis. I is the moment of inertia of the beam's cross section. The deflection δ of the central load on a beam with two simple supports can be described by the following equation:

[0066] (3):

[0067] 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. When considering implant 100, the deflection capability δ of the implant strands may lead to gap widening. Deflection capability may reflect or may be the desired deflection capability of the strands and / or the desired expansion capability of the gap height (e.g., how much the gap is expected to expand).

[0068] Figure 1G It shows Figure 1C An illustration of the implant shown. (See diagram.) Figure 1G As shown, inserting the needle 155 into the gap can apply one or more forces 113, 114 to the implant. The diameter nd of the needle can be greater than the baseline gap height gh. The gap length can be represented by gl, which can be the length of the strand segment between the center of the first strand 105B and the center of the second strand 105C. The first strand and the second strand 105C can serve as simple support for adjacent strand segments 101 of the gap.

[0069] The insertion of the needle causes a deflection δ in each of the two consecutive strand segments 105a. Each strand segment 105a can be behaved like a beam with two simple supports 105B and 105c subjected to bending stress. The deflection of adjacent strand segments 105a caused by the insertion of the needle can be represented by dashed lines. The deflection can be expressed by the following equation.

[0070]

[0071] The maximum bending stress that the strand of wire may be subjected to (e.g., through the insertion needle 155) is

[0072] (4):

[0073] R is the radius of the strand (e.g., d = 2 × R).

[0074] Using equations (3) and (4),

[0075] (5):

[0076] Maximum stress σ can be obtained max The equation:

[0077] (6):

[0078] Elastic deformation can be governed by a rule such that σ max The value does not exceed σ yield That is, the yield strength of the wire material. Therefore

[0079] (7):1

[0080] The deflection capability δ can be expressed by the following equation.

[0081] (8):

[0082] The reversible expansion gap 106 can expand to between 110% and 250% of the baseline gap height gh. This can occur if the needle diameter nd is between 110% and 250% of the baseline gap height gh. These parameters can be expressed by the following equation.

[0083]

[0084] and

[0085] (9):

[0086] E and σ yieldThe material properties of the strand material of implant 100 are as follows. The radius R of the strand and the length gl of the strand segment between the two supports 105B and 105C are the geometric characteristics of the strand of implant 100. Equation (10) can be obtained based on equation (7).

[0087] (10):

[0088] Figure 1H The zx section is shown Figure 1G The illustration shows the adjacent strand 105A. In some examples, the lateral offset of a strand segment 105A relative to its adjacent strand segment 105A in a subsequent layer is zero along the xy plane (or horizontal to the xy plane) (offset = 0). In these cases, the baseline gap height gh can simply be equal to the average strand diameter d or 2R.

[0089] Or, such as Figure 1I As shown, it is possible that the lateral offset of a line segment 105A relative to its adjacent line segment 105A in a subsequent layer is greater than zero along or horizontally to the xy plane. In these cases, the gap height gh can be expressed as (11):

[0090] lt can be referred to as the layer thickness. The dimension 2×lt can be the distance between the midpoint of the first strand segment 105A and the midpoint of the second adjacent strand segment 105B, measured in the z-direction. The dimension 2×lt can be the offset in the z-direction, while the lateral offset can be the offset in the x or y direction. The lateral offset value between adjacent strand segments can be between 0% and 99% of the gap length gl (or, for example, between 0% and 50%, or, for example, between 0% and 10%).

[0091] Figure 2A and 2B Perspective and cross-sectional side views of the implant 200 inserted into the patient's body are shown, respectively. The implant 200 may include a combination of... Figures 1A to 1E One or more of the features described. Implant 200 may have different dimensions than implant 100, such as a different gap height to gap length ratio. For example, the baseline gap height gh may be similar to the baseline gap length gl (e.g., between 95% and 100% of the baseline gap length).

[0092] Implants 100 and 200 can be any type of implant suitable for insertion into a patient, who can be a living being (e.g., a human or animal). Implants 100 and 200 can be scaffolds for bone tissue or implants for any soft tissue portion of a human or animal body. Implants can be breast or chest implants (the latter can be used to treat chest deformities such as pectus excavatum), or implants for other parts of the body, such as the buttocks (also known as the hip), lower leg, part of the face (e.g., the cheek), or testicular implants. It is noted herein that pectus excavatum deformities such as pectus excavatum can affect both men and women, and therefore pectus excavatum in both male and female subjects can be treated with the implants of the present invention. Based on the foregoing, the implants of the present invention can take any suitable form, depending only on the tissue to be reconstructed or enhanced. Implants can, for example, take the form of a gluteal muscle implant as described in U.S. Patent 10,004,585. Depending on the type of implant required, the geometry of implants 100 and 200 (e.g., the size and / or shape of the implant) can be customized to meet the required standards for the implant.

[0093] Figure 3A A perspective view of an implant 300 suitable for use as a breast implant is shown. The implant 300 may include a combination of... Figures 1A to 2B The description refers to one or more or all of the features of the implant. Although implant 300 is described in relation to breast implants, such implants may also be used in other parts of the body, such as the chest, buttocks, lower legs, or parts of the face, such as the cheek (see above).

[0094] like Figure 3A As shown, the implant 300 includes multiple strands 101 forming a three-dimensional structure 302. The three-dimensional structure 302 includes multiple hollow channels 103. Each hollow channel 103 includes multiple sidewalls 104. The sidewalls 104 include multiple strand segments 105 arranged alternately and multiple gaps 106, such that the gaps 106 are formed between adjacent strand segments 105 of the sidewalls 104. The multiple gaps 106 are reversibly expandable gaps.

[0095] The three-dimensional structure 302 of the implant 300 may include a first outer surface region 308 and a second (different and / or opposite facing) outer surface region 309. It is understood that the outer surface regions may indicate (or may be) the outermost surface, outermost layer, and / or outermost contour of the implant 300. The outermost surface and outermost contour may be formed by one or more layers or lines. The outer surface regions may indicate (or may be) the outermost group of layers of the implant 300 (e.g., a single outermost layer, or, for example, multiple outermost layers). The outer surface regions may indicate the outward-facing surfaces of the implant 300.

[0096] The first outer surface region 308 of the implant 300 may include or have a first surface curvature. The first outer surface region 308 of the implant 300 may be the largest planar (or, for example, the flattest) surface of the implant 300. For example, the first outer surface region 308 may be the flattest surface of the implant and / or a surface with the smallest (or least) amount of curvature. Figure 3A As shown, the first outer surface region 308 of the implant 300 can be substantially parallel to a two-dimensional (xy) Cartesian plane. Alternatively or optionally, the best-fit plane of the first outer surface region 308 can be parallel to a two-dimensional (xy) Cartesian plane.

[0097] The second outer surface region 309 may have a geometry (e.g., shape, curvature, size) representing the geometry of the patient's breast constructed by the implant 300. The second outer surface region 309 of the implant 300 may include or may have a second surface curvature different from the first surface curvature. The second surface curvature may be greater than the first surface curvature. The second outer surface region 309 of the implant 300 may be adjacent to (e.g., abutting) the first outer surface region 308 of the implant 300 at its perimeter 317 (e.g., periphery). For example, the second outer surface region 309 of the implant 300 may abut the first outer surface region 308, wherein the perimeter 317 of the first outer surface region 308 may be a shared edge (or interface) between the first outer surface region 308 and the second outer surface region 106. Additionally or optionally, the second outer surface region 309 may include a vertex region 318 located at the second outer surface region 309. The location (or site) of the apex region 318 at the second outer surface region 318 of the implant can be based on the location (or site) of the nipple / areola of the breast constructed by the implant 300 (and / or may coincide with the location or site of the nipple / areola of that breast).

[0098] Optionally, the acute angle between one or more sidewalls and a reference axis (e.g., the x-axis) representing the first outer surface region can be less than 90 degrees (or, for example, less than 60 degrees). The reference axis can be based on a plane or line that best fits the first outer surface region 108. Optionally or alternatively, the acute angle between one or more sidewalls 104s and the reference axis can be approximately 90 degrees (e.g., as shown in the figure). Figures 1A to 2B As shown, the channel can be a vertical channel. The multiple hollow channels 103 can consist of 5 to 1000 hollow channels (or, for example, 5 to 60 channels, or, for example, 8 to 20 channels).

[0099] The three-dimensional structure 302 of the implant 300 can be a reversibly compressible three-dimensional structure 302. For example, the individual cells of the implant 300 can be spring-shaped cells. A spring-shaped cell can be compressed to at least 80% (or, for example, at least 70%, or at least 60%, or at least 50%, or at least 30%) of its original volume. By being reversibly compressible, each cell can recover or return to its original (rest) volume after the compressive force is removed (even under the same ambient pressure and temperature). A reversibly compressible spring-shaped cell can be configured to recover to 80% to 100% (or, for example, 95% to 100%, or at least 98% to 100%) of its original volume after the compressive force applied to the implant 300 is removed.

[0100] The softness of implant 300 can be represented by the c-value. The c-value can be expressed by the following formula.

[0101]

[0102] F 20% It is the force (in N) when compressed by 20%, F 10% It is the force (in N) when compressed by 10%, ε 10% It is the strain value when compressed by 10%, ε 20% It is the strain value when compressed by 20%. For example, the c value, which represents the softness of implant 300, can be between 20N and 190N (or, for example, between 20N and 150N, or, for example, between 30N and 100N, or, for example, between 30N and 40N).

[0103] The material density ρ of implant 300 can be as low as 0.1 gr / cm³. 3 Up to 2 gr / cm 3 Between (or for example 0.1 gr / cm) 3 Up to 1gr / cm 3 Between, or for example, 0.1 gr / cm 3 Up to 0.5 gr / cm 3 (Between). Material density can be determined by dividing the weight of the implant (300) by its resting volume before insertion into the patient. In comparison, the material density of silicone is 0.98 gr / cm³. 3 The density of the salt water is 1.005 gr / cm³. 3Therefore, the weight of implant 300 can be 10% to 20% (or, for example, 10% to 15%) of its volume (in milliliters), and 10% to 20% (or, for example, 10% to 15%) of a conventional non-porous silicone / saline implant (whose weight in grams is approximately the same as its volume in milliliters). For example, implant 300 with a volume of 250 ml can weigh 25 g, while a conventional silicone implant with a volume of 250 ml can weigh 240 g, and a saline implant with a volume of 250 ml can weigh 250 g. One or more of these characteristics result in an implant with a lightweight scaffold, where a 90% weight reduction can be achieved compared to conventional implants.

[0104] The multiple strands 101 of the implant 300 may be formed of a polymeric material, such as a surface-degradable polymer. The surface-degradable polymeric material may include or may be a polymeric material that degrades primarily through surface degradation mechanisms (rather than bulk degradation). The multiple strands 101 may include or may be formed or made of a biodegradable material. The biodegradable material may be selected from polycaprolactone, poly(1,3-trimethylene carbonate), polylactic acid, polyglycolide, poly(esteramide), poly(ethylene glycol) / poly(butylene terephthalate), poly(glycerol sebacate), poly(1,8-octanediol-citric acid), poly(1,10-decanediol-D,L-lactic acid), poly(citric acid glycol ester), poly(glycolide-co-caprolactone), 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. Alternatively, the biodegradable material may be a copolymer of polycaprolactone and polytrimethyl carbonate or polylactic acid. Optionally, the strands 101 may include a non-degradable material, such as nylon. The thickness (or diameter) of the strands 101 may be selected to make the strands flexible. For example, a bulk PCL may have an elastic modulus (E) of 216 MPa, a tensile strength of 10 MPa, and a breaking stress of 26.5 MPa.

[0105] Equation (10): It can be used in the design of the implants described in this article. The selection can be based on the material properties of the material used to form the implant (such as Young's modulus and yield strength) and the deflection capacity δ required according to surgical requirements (such as the size of the needle used by the surgeon).

[0106] For example, the material used to form the implant 300 may have an elastic modulus of 270 MPa and a yield strength of 12.5 MPa. The diameter of the needle used can be 2mm.

[0107] You can select implant-related geometric characteristics such as lateral offset, layer thickness, radius, and gap length. For example, the lateral offset can be 1 mm, the layer thickness lt can be 0.2 mm, the radius R can be 0.175 mm, and the gap length gl can be 6 mm.

[0108] Using equation (11): It can calculate or determine the value of the gap height, where = 0.709.

[0109] Using equation (8): It is possible to calculate or determine the value of the deflection capability, where

[0110] = =0.6452

[0111] Using equation (10), we can calculate The maximum limit, where = .

[0112] = =0.004861, which is less than the maximum limit. = .

[0113] Additionally or optionally, the implant 300 may also include multiple contour lines 319 disposed on an outer surface region (e.g., a second outer surface region 309) of the implant 300.

[0114] Figure 3B and 3C The illustration shows a perspective side view and a perspective top view of the implant 300, which also includes multiple contour lines 319 and surface fill lines 322.

[0115] like Figure 3B and 3C As shown, the multiple strands forming the implant 300 may include multiple contour lines 319 and surface filler lines 322. Each contour line 319 may form a semi-contour surrounding the second outer surface region 319. The semi-contour of the contour line 319 may extend only partially (e.g., between 30% and 80%, or between 40% and 70%, or between 50% and 70%) around the perimeter of the layer. The multiple contour lines 319 may be arranged coherently (e.g., continuously) between the first outer surface region 308 and the vertex region 318. The multiple contour lines 319 may also be arranged such that adjacent contour lines 319 are separated by a reversible expansion gap 106. For example, the reversible expansion gap 106 may be formed between adjacent strand segments of the multiple contour lines 319.

[0116] like Figure 3D As shown, the implant 300 may further include surface filler lines 322 formed on the outermost surface of the three-dimensional structure 302. Optionally, multiple surface filler lines 322 may be arranged in columns 323 (or strips) on the second outer surface region. Each surface filler column 323 may include multiple surface filler strands 322 and multiple reversible expandable surface gaps. Each reversible expandable surface gap may be formed between adjacent surface filler lines 322 of the column 323. Surface filler columns 323 may be arranged adjacent to open columns 324. Open columns may include (or may be) surface columns without surface filler portions. Optionally, multiple surface filler columns 323 and multiple open columns 324 may be arranged alternately on the outer surface region (e.g., the second outer surface region 309). Optionally, multiple surface filler columns 323 and multiple open columns 324 may be arranged in a cross-shaped manner on the outer surface region.

[0117] Multiple hollow channels 103 can extend through the body of the implant 300. Adjacent strands can be separated by reversibly expanding gaps.

[0118] Implant 300 can be inserted into the patient's breast region. After implant 300 is inserted, fat injection may be necessary. Fat injection is required because the regenerated tissue within the implant is observed to be firmer than natural breast tissue. Therefore, to achieve a final result as soft as natural breast tissue, an appropriate percentage of fat can be collected, for example through liposuction, and injected into implant 300 using a specific cannula (or needle). Due to the reversible expansion gap 106 of implant 100, problematic aspects of the injection process (e.g., multiple punctures of structures, damage to sutures, and injections affecting the overall structural integrity of implant 300) can be avoided.

[0119] Implant 300 can be an implant used to guide a needle through the implant for implantation surgery. Implant 300 can be configured to receive an elongated object (such as a needle for fat injection) into the body of the three-dimensional structure 102. The diameter of the elongated object can be greater than the baseline gap height gh of the implant gap 106. For example, the diameter of the elongated object can be 110% to 250% of the baseline gap height gh of the implant gap 106. Furthermore, the length of the elongated object can be at least two times (or five times, or ten times) greater than the width of the hollow channel. Multiple strands can be configured such that the height of the gap 106 increases as the object is received by the gap, and the height of the gap 106 decreases as the object is removed from the gap 106. Such a needle or cannula can have a diameter of at least 0.8 mm (or, for example, at least 2 mm, or, for example, at least 4 mm, or, for example, between 0.8 mm and 4 mm, or, for example, between 0.8 mm and 3 mm) and a length of at least 2 cm. More than 80% (or, for example, more than 90%, or, for example, all) of all gaps in implants 300 with a baseline gap height of less than 1 mm can be reversibly expandable gaps.

[0120] Figure 4A Implants without the reversible expansion gap of implants 100, 200, and 300 are shown.

[0121] Unlike implants 100, 200, and 300, which have a reversible expansion gap 106, Figure 4A Implants require surgeons to insert fat injection needles at precise locations. For example, after inserting the implant into the patient, the surgeon must visually locate the largest opening of the implant. These largest openings may be channel holes defining the ends of the channel, with the aperture area at the channel ends being at least twice the area of ​​the gap. The surgeon must then precisely insert the needle into the hole and along the length of the channel (e.g., along the longitudinal axis of the channel). If the surgeon cannot visually locate the ends of the channel, inserts the needle into the implant at an angle not along the length of the channel, or inserts the needle into the sidewall of the channel, needle injection may damage the sutures of the implant and / or damage the three-dimensional structure of the implant.

[0122] Figure 4BAn image of a cannula for fat injection inserted into implant 300 is shown. For implant 300, the surgeon can blindly insert a needle into implant 300 from anywhere on the implant (e.g., any surface). Due to the reversible expansion gap 106 of implant 300, the needle can be inserted into the breast implant from any direction at the second outer surface region 309 of the implant, and / or the needle can be inserted through any sidewall 104 within the body of implant 300. The needle can initially be inserted through the internal structure of the implant 300 from the insertion region. The insertion region can be a randomly selected region of the implant. The needle can be inserted in such a manner that it simultaneously passes through and / or enters several (e.g., multiple) hollow channels 103 and through several (e.g., multiple) sidewalls. In other words, the needle can be inserted simultaneously through multiple hollow channels 103. The needle can then be withdrawn from implant 300 in a progressive manner over multiple withdrawal steps. After each withdrawal step, the fat in the needle can be injected into the implant. The alternating process of needle removal and fat injection can be repeated until the needle is completely removed from the implant. This process, beginning with blind injection, can be repeated from multiple random insertion areas. The number of times this process is performed (e.g., at least 20, or at least 30, or at least 60) can be based on the required number of injections and / or the required amount of fat injected. Needle insertion is frequently required during the procedure. Implant 300 can expedite the procedure because the surgeon no longer needs to visually locate each channel and opening before inserting the needle, but can instead perform blind insertion. Furthermore, implant 300 allows the cannula to simultaneously penetrate multiple sidewalls 104 and channels 103. This also expedites the procedure. Moreover, since the gap 106 is capable of accommodating the cannula's entry, neither implant 300 nor the cannula is damaged. Therefore, the inserted implant has improved structural integrity compared to implant 300 without reversibly expandable gaps.

[0123] Figure 4C Examples of possible insertion regions for multiple injection tests are shown. A number of injections (e.g., 60 injections) can be distributed across three broad injection sites (431, 432, 433). For example, 20 injections can be performed on each region. Injections (e.g., needle insertion) can be performed such that the needle can be inserted at any angle relative to the first outer surface region 308 of the implant. For example, the needle can be inserted into a flat plane or at an angle of inclination or deviation relative to the first outer surface region 308.

[0124] The multiple strands 101 can be configured such that the gap 106 of the implant 300 can reversibly expand when the implant is in a static state, or even when the implant 300 is in a compressed state (e.g., even when the implant 300 is located in the body). The implant in a compressed state can be an implant that has been compressed to less than 90% of its original volume (or, for example, less than 70%, or less than 60%, or less than 50%, or less than 30%). As the object is received by the gap 106, the height of the gap 106 can be increased to more than 110% of the baseline gap height gh and / or the average strand diameter d (or, for example, more than 150%, or more than 200%, or, for example, between 120% and 250%, or, for example, between 120% and 200%). As the object is removed from the gap 106, the reversibly expanding gap 106 can be configured to recover or restore (or reduce) to at least 110% (or, for example, at least 105%, or, for example, at least 100%, or, for example, between 80% and 115%, or, for example, between 90% and 110%) of its original gap height gh and / or average strand diameter d.

[0125] To accommodate each needle insertion, the multiple strands 101 can be arranged such that the reversibly expanding gaps 106 of at least two (or, for example, more than two, or, for example, more than three, or, for example, more than five) consecutive hollow channels can simultaneously expand as the object is received by the gaps in at least two consecutive hollow channels. The multiple strands 101 can be arranged such that the reversibly expanding gaps 106 of at least two (or, for example, more than two, or, for example, more than three, or, for example, more than five) different sidewalls 104 of the implant 300 can simultaneously expand as the object is received by the gaps in at least two (or, for example, more than two, or, for example, more than three, or, for example, more than five) different sidewalls 104. Expansion of the gaps 106 can occur even without increasing or changing the total resting volume (or structural volume) of the implant 300. In other words, the reversibly expanding gaps can be configured to expand while the total volume of the implant 300 remains constant or even under compression.

[0126] The surgeon inserting the needle should be able to penetrate the body of the implant without damaging its structure. For example, the filament surrounding the gap may bend, stretch, or deviate from its path without breaking. Furthermore, the surgeon can apply a force not exceeding 50 N (or, for example, between 2 N and 50 N, or between 5 N and 20 N, or between 5 N and 10 N) to insert the needle into the gap. For example, when subjected to a force of 10 N from the injection needle, the filament may reversibly deform (elongate, stretch, or move) to allow the needle to pass through the gap. The material itself can be chosen so that the filament does not break at this point of elongation.

[0127] Figure 4DStress-strain curves of strands from different materials, including stainless steel, polylactic acid (PLA), and polycaprolactone (PCL), are shown.

[0128] Under a stress of 720 MPa, the fracture point of stainless steel strands can be at 32% strain. When subjected to a stress of 40 MPa, the fracture point of PLA strands can be at 5% strain. The fracture strain value of PCL strands is 460% (under stresses less than 50 MPa), approximately 15 times greater than that of stainless steel strands and approximately 70 times greater than that of PLA strands. Due to its high fracture strain, PCL accepts large deformations, meaning it can extend at least four times its initial length.

[0129] The material used to form the multiple strands can be selected such that it has a fracture point on the stress-strain diagram, wherein the strain at the fracture point is greater than 30% and the stress at the fracture point is less than 250 MPa.

[0130] The material of the implanted wire strands can exhibit stress-strain behavior similar to that of PCL. For example, the breakage point on the stress-strain diagram can be higher than 30% (or, for example, higher than 100%, or higher than 200%, or higher than 300%, or higher than 400%), and the stress can be lower than 50 MPa, or between 10 MPa and 250 MPa (or, for example, between 10 MPa and 100 MPa, or between 10 MPa and 50 MPa, or between 10 mmPa and 30 MPa). Alternatively, the breakage point of one of the multiple wire strands can be greater than 30% (or, for example, greater than 100%, or higher than 200%, or higher than 300%, or higher than 400%), and the corresponding stress can be lower than 50 MPa (or, for example, between 10 MPa and 250 MPa, or between 10 MPa and 100 MPa, or between 10 mmPa and 50 MPa, or between 10 MPa and 30 MPa).

[0131] For example, if the distance between two adjacent strands varies between 0.56 mm and 1.84 mm, and the needle diameter is 2 mm, PCL may easily deform without reaching its breakage point during the needle's penetration of the wall. In contrast, PLA and stainless steel do not undergo such deformation; they reach their breakage point during needle penetration.

[0132] Figure 5A An implant, such as implant 300 after a simulated surgery, is shown. During the simulated surgery, implant 300 is inserted into a pig. Fat is blindly injected (from random locations) into implant 300. After removal, the three-dimensional scaffold structure 302 of implant 300 is shown to be filled with fat, and the fat is evenly distributed despite the blind (random) injection.

[0133] Figure 5B , 5C Images of the implant 300 after blind injection are shown in 5D and 5D respectively. Figure 5C The fat is shown to be uniformly distributed within implant 300. White represents fat, and black represents air. Mechanical tests (e.g., tensile, compression, and shear tests) were performed prior to fat injection to assess changes in the stent's dimensions and / or mechanical properties. After 11,112 tensile tests (by friction) at a frequency of 0.4 Hz, the stent's shear strength (Fmax), dimensions (width, projection, and height), and flexibility (c-value) remained within the implant's specifications. In other words, the tensile strength of implant 300 was not compromised. Comparing the post-test flexibility index (a good indicator of stent integrity) to the pre-test results, only approximately 10% degradation was detected. Therefore, despite a reasonable and expected loss of mechanical properties, the stent's integrity was not affected.

[0134] Figure 6 A flowchart of a method 600 for forming the implant of the present invention is shown.

[0135] Method 600 involves forming more than 620 strands to create a three-dimensional structure. The strands are composed of materials with a yield strength (σ... yield The material is formed based on the yield strength and elastic modulus (E). This three-dimensional structure comprises multiple hollow channels. Each hollow channel includes multiple sidewalls. The sidewalls include multiple gaps and multiple continuous strand segments of multiple strands. The multiple strand segments and multiple gaps are arranged alternately such that gaps are formed between adjacent strand segments of the sidewalls, wherein each gap includes a gap length (gl) and a resting gap height (gh). The multiple gaps are reversibly expanding gaps. Adjacent strand segments of a reversibly expanding gap include a deflection capability (δ) in response to an object being received by the gap, thereby gaining an increased gap height between adjacent strand segments. In response to the object being removed from the gap, the gap returns to its resting gap height. The radius (R) of the multiple strands and the corresponding gap length (gl) of the multiple gaps are based on the yield strength and elastic modulus of the material.

[0136] Forming more than 620 strands can include sequentially printing multiple layers, where each layer comprises a lattice arrangement of two-dimensional unit cells. The multiple layers can be arranged such that aligned unit cells of consecutive layers form hollow channels in multiple channels. An implant can be formed by sequentially forming (or, for example, by 3D printing modeled via fused deposition modeling) layers to form a three-dimensional (3D) printed scaffold structure. Printing can be performed layer-by-layer in the printing direction (e.g., in the z-direction), thus forming a sequential arrangement of consecutive layers in the printing direction. The sequential arrangement of layers over each other (by printing) can result in the formation of a three-dimensional structure where the edges (or boundaries) of the multiple layers define the shape and / or geometry of the implant to be formed. Alternatively, the multiple strands can be formed using any three-dimensional printing method, such as selective laser sintering (SLS). Optionally, the three-dimensional structure can be formed using a printing process based on motion in more than three dimensions, such as a five-dimensional (5D) printing process or a six-dimensional (6D) printing process.

[0137] Optionally, method 600 may further include determining at least one of the following parameters (e.g., before forming the 620+ strands). The parameters to be determined may be 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 the size of the unit cell to be formed. Furthermore, the parameters to be determined may be the gap length gl between adjacent strands within a layer, and the gap height gh between adjacent strands within the channel sidewalls. Additionally, the parameters to be determined may include the diameter d of the multiple strands to be formed.

[0138] Determining the 610 parameters may include determining the deflection capability (δ) of the reversible expansion gap based on the object to be received by the reversible expansion gap. Determining the 610 parameters may also include determining the material properties of the multiple strands to be formed, wherein the material properties include the material's yield strength (σ). yield The determination of the 610 parameters may also include determining the radius (R) and gap length (gl) of the corresponding strands in the multiple strands to be formed. The determination of the 610 parameters may also include determining 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 / or the size of the unit cell.

[0139] After determining the parameters, multiple strands can be formed, thereby creating a three-dimensional structure including reversible expanding gaps. For example, parameters can be determined such that... The resulting three-dimensional structure may include at least one of the following parameters: the determined number of hollow channels, the determined number of layers, the determined cell size, the determined gap length gl between adjacent strands within a layer, the determined gap height gh between adjacent strands within the channel sidewalls, and the determined diameter of the multiple strands. The three-dimensional structure formed by method 600 may be a combination of... Figures 1A to 5CThe three-dimensional structure of any implant 100, 200, 300 is described.

[0140] Figures 7A to 7G Examples of implants 700A to 700F are shown, which include channels with oscillating (e.g., wavy, or, for example, zigzag or sinusoidal) sidewalls. Implants 700A to 700F may include those already bonded Figures 1A to 6 The description includes one or more of the features. For example, implants 700A to 700F may include a combination of... Figures 1A to 6 The implant describes a reversible expansion gap.

[0141] Figure 7A A three-dimensional soft tissue implant 700A is shown, inserted into a patient's body. The implant 700A includes multiple strands 101 forming a three-dimensional structure. This three-dimensional structure includes multiple hollow channels 103. Each hollow channel 103 includes multiple intersecting sidewalls 134. Each sidewall 134 includes multiple alternately arranged strand segments 105 and multiple gaps 106. At least one sidewall 134 of the hollow channel 103 is wavy (e.g., oscillating, zigzag, and / or sinusoidal sidewalls). Optionally, each hollow channel 103 may include a first wavy sidewall 134 and a second wavy sidewall 134 opposite to the first wavy sidewall 134.

[0142] A hollow channel 103 having at least one wavy sidewall can be referred to as a wavy (e.g., Z-shaped and / or sinusoidal) channel. One (or each) Z-shaped (or sinusoidal) channel 103 may have at least two opposing sidewalls arranged relative to each other such that the channel extends in a tortuous manner between a first end 137 (proximal end) of the channel and a second end 138 (distal end) of the channel 103. For example, a Z-shaped channel 103 may have a first Z-shaped sidewall 134 and a second Z-shaped sidewall 134 opposite to the first Z-shaped sidewall. Each Z-shaped sidewall 134 of the Z-shaped channel may include a plurality of strands 101 arranged sequentially along the z-direction. The plurality of strands 101 may be substantially parallel to each other and perpendicular to the z-direction. The sequentially arranged strands 101 of the Z-shaped sidewall 134 may be arranged with a lateral offset relative to each other, thereby forming a pattern of crests 135 and troughs 136 along the sidewall 134. The multiple strands of the wavy sidewall belong to different layers of the implant. Adjacent strands of the wavy sidewall are spaced apart (e.g., Figures 1 to 1). Figure 6 The reversible expansion gaps shown in any of the figures are separated and laterally offset from each other to form a pattern of multiple peaks and troughs on the wavy sidewalls.

[0143] Each hollow channel is formed by at least three adjacent sidewalls. The crests and troughs of the wavy sidewalls are formed by the lateral offset between adjacent strands of multiple strands in the sidewalls. The crests and troughs are alternately arranged between the first and second distal ends of the channel.

[0144] The wavy portion (e.g., a zigzag or sinusoidal portion) can be understood as a portion having multiple peaks (maximum values) 135 and troughs (minimum values) 136, which are arranged alternately from the first end 137 of the channel 103 to the second end 138 of the channel 103 (and / or between the first end 137 and the second end 138 of the channel 103). These peaks 135 and troughs 136 can be viewed from a vertical section passing through the sidewall (e.g., through the z-direction). This vertical section can be perpendicular to the strand direction and can be a cross-section passing through and / or parallel to the length of the channel.

[0145] Crests 135 (and / or troughs 136) can be formed by multiple strands of a zigzag sidewall 134, arranged such that an angle θ (e.g., θt or θp) is formed between a first plurality of continuous strands 745 and a directly adjacent second plurality of continuous strands 746 of the zigzag sidewall 134. Angle θt is the angle between the first plurality of continuous strands 745 and the directly adjacent second plurality of continuous strands 746 formed at the trough of the wavy portion, and angle θp is the angle between the second plurality of continuous strands 745 and the directly adjacent (third) second plurality of continuous strands formed at the crest of the wavy portion. The wavy portion can be a portion where θt and / or θp are less than 180°. In contrast, a straight sidewall can be a sidewall with θ equal to 180° along the entire channel length.

[0146] The wavy portion of channel 103 may include at least one angle θt and / or θp less than 180°. Optionally, the wavy portion of the zigzag channel 103 may include 1 to 1000 (or, for example, 2 to 50, or, for example, 2 to 25) crests and troughs.

[0147] Figure 7A An example of implant 700A is shown. Figure 7A The images include a three-dimensional perspective cross-section (top image) and a two-dimensional cross-section (bottom image) of the implant 700A. The implant 700A includes at least one wavy sidewall portion, wherein the wavy portion is a Z-shaped portion.

[0148] exist Figure 7AIn the example, the geometries of the first Z-shaped sidewall portion 134 and the second Z-shaped sidewall portion 134 may be related to each other (or, for example, identical, or, for example, similar), ignoring manufacturing differences. The term "similar" can be understood to mean that the first Z-shaped sidewall portion 134 and the second Z-shaped sidewall portion 134 (and / or the Z-shaped longitudinal axis 742A) may have one or more or all of the same features, and / or the first Z-shaped sidewall and the second Z-shaped sidewall may have the same or similar geometries or features exceeding 80% (or, for example, more than 90%, or, for example, more than 95%, or, for example, more than 100%) of the channel length of at least one of the first Z-shaped sidewall and the second Z-shaped sidewall 134. One such feature may be the number of crests 135 and troughs 136 along the channel length. Another such feature may be the peak-to-trough height, which may be the vertical height between a crest and a directly adjacent trough. Another such feature may be the peak-to-peak width between two directly consecutive crests. Another such feature could be the valley-valley width between directly continuous troughs.

[0149] For example, the first Z-shaped sidewall 134 and the opposing second Z-shaped sidewall 134 may have similar patterns of crests 135 and troughs 136. For example, the arrangement of θt and θp of the first sidewall portion 134 may be the same as the arrangement of θt and θp of the second sidewall portion 134. Additionally or alternatively, the crests 135 and troughs 136 of the first Z-shaped sidewall portion 134 and the second Z-shaped sidewall portion 134 may be arranged relative to each other such that the (minimum or smallest) diameter between the first Z-shaped sidewall portion 134 and the second Z-shaped sidewall portion 134 along the channel length is constant. For example, the (minimum or smallest) diameter between the first Z-shaped sidewall and the second Z-shaped sidewall along the channel length may have a deviation of less than 10%. Furthermore, the Z-shaped longitudinal axis 742A may have a similar (or identical) geometry to at least one of the first Z-shaped sidewall 134 and the second Z-shaped sidewall 134 (e.g., all two sidewalls).

[0150] The first Z-shaped sidewall portion 134 and the second Z-shaped sidewall portion 134 may be similar (or identical) along at least 80% (or, for example, at least 90%, or, for example, at least 95%, or, for example, 100%) of the channel length of at least one of the first Z-shaped sidewall portions 134. For example, the relative lateral offset (x-direction) between the continuous strands of the first Z-shaped sidewall 134 may be the same as the relative lateral offset (x-direction) between the continuous strands of the second Z-shaped sidewall 134, ignoring differences arising from the manufacturing along at least 80% of the channel length of at least one of the first Z-shaped sidewall portions and the second Z-shaped sidewall portion.

[0151] The longitudinal axis may include or may be defined by a plurality of midpoints along the length of the channel 103. These midpoints may be the midpoints of a (minimum or lowest) diameter dmin between a first sidewall and a second sidewall along the length of the channel. The crests 135 and troughs 136 of the first and second Z-shaped sidewalls may be arranged relative to each other such that the Z-shaped longitudinal axis 742A extends between a first end and a second end of the channel. The Z-shaped longitudinal axis 742A may have a pattern similar to that of the first and second Z-shaped sidewalls.

[0152] Figure 7B An example of another implant, 700B, is shown. Figure 7B Includes a three-dimensional perspective cross-section (top image) and a two-dimensional cross-section (bottom image) of implant 700B. Implant 700B may be similar to implant 700A and includes one or more or all of the features of implant 700A. However, in the case of implant 700B, the second sidewall portion 134 may be a mirror image of the first and second sidewall portions 134 about the longitudinal axis 742B.

[0153] Figure 7C An example of another implant, 700C, is shown. Figure 7C Includes a three-dimensional perspective cross-section (top image) and a two-dimensional cross-section (bottom image) of implant 700C. Implant 700C may be similar to implant 700A and includes one or more or all of the features of implant 700A. However, in the case of implant 700C, the wavy portion of channel 103 is sinusoidal rather than zigzag.

[0154] In the sinusoidal sidewall portion, the tangents along the first plurality of continuous strands 745 can be varying tangents (e.g., gradually changing, e.g., gradually decreasing), and the tangents along the second plurality of continuous strands 746 can also be varying tangents (e.g., gradually changing, e.g., gradually increasing). In the Z-shaped sidewall portion, the tangents along the first plurality of continuous strands 745 can be constant tangents (e.g., fixed tangent value, e.g., positive tangent), and the tangents along the second plurality of continuous strands 746 can also be constant tangents (e.g., fixed tangent value, e.g., negative tangent).

[0155] Figure 7D An example of another implant, the 700D, is shown. Figure 7D Includes a three-dimensional perspective cross-section (top image) and a two-dimensional cross-section (bottom image) of implant 700D. Implant 700D may be similar to implant 700C and includes one or more or all of the features of implant 700C. However, in the case of implant 700D, the second sidewall portion 134 may be a mirror image of the first and second sidewall portions 134 about the longitudinal axis 742D.

[0156] Figure 7E An example of another implant, the 700E, is shown. Figure 7E Includes a three-dimensional perspective cross-section (top image) and a two-dimensional cross-section (bottom image) of implant 700E. Implant 700E may be similar to implants 700A to 700D and may include one or more or all of the features of these implants.

[0157] As illustrated in implant 700E, the wavy portion may include a zigzag portion, wherein the angles θ (e.g., θt or θp) of the wavy portions may differ (or vary) from one another within the wavy portions of the sidewall 134. Changing the angle θ may alter the softness of the implant. For example, an implant portion with a smaller θ may be softer than an implant portion with a larger θ. Additionally or optionally, features such as peak-to-valley height hpt, peak-to-peak width wpp, and / or valley-to-valley width wtt may vary (differentiate) from one another within the wavy portions of the sidewall 134.

[0158] Understandable. Figures 7A to 7G The features can be combined with each other to form an implant with the desired softness and elasticity.

[0159] One (or each) wavy sidewall may include at least one of a zigzag portion and a sinusoidal portion. Optionally, the zigzag (or sinusoidal) portion may extend over the entire length of channel 103 (or may include the entire length of channel 103). Alternatively, the zigzag (or sinusoidal) portion may extend over a selected portion (e.g., a proportion, section, or segment) of the entire length of channel 103 (or may include a selected portion of the entire length of channel 103). In some examples, one or more or all of these parameters (angles θt, θp, hpt, wpp, wtt) may remain constant (e.g., the same) throughout the entire wavy portion (or within the entire wavy portion). In other examples, these parameters may vary throughout the entire wavy portion (or within the entire wavy portion). In some examples, the wavy portion may include the entire (e.g., the whole) length of sidewall 134. In some examples, the wavy portion may include 10% to 90% (or, for example, 20% to 80%, or, for example, 30% to 70%) of the entire sidewall 134. For example, the sidewall may include wavy portions and straight portions. In some examples, the sidewall 134 may include any number of zigzag portions, sinusoidal portions, straight portions, and / or combinations thereof.

[0160] The sidewalls 134 of channel 103 (e.g., the sidewalls surrounding channel 103) may be similar to each other (identical, or, for example, completely identical). Alternatively or optionally, they may be related to each other (e.g., mirror images of each other). Alternatively or optionally, they may be different from each other. In some examples, all sidewalls of the implant may be sinusoidal sidewalls. In other examples, all sidewalls of the implant may be zigzag sidewalls. In some examples, the sidewalls of the implant may be a mixture of zigzag and sinusoidal sidewalls.

[0161] Figure 7F An example of another implant, the 700F, is shown. Figure 7F Includes a three-dimensional perspective cross-section (top image) and a two-dimensional cross-section (bottom image) of implant 700F. Implant 700F may be similar to implants 700A through 700E and may include one or more or all of the features of these implants.

[0162] like Figure 7F As shown, the implant 700F may include a tilted Z-shaped (sine-shaped) channel, while Figures 7A to 7E The channel extends parallel to the z-direction.

[0163] In the inclined channel, the acute angle k between the longitudinal axis 742E and the reference axis (e.g., the x-axis or y-axis) representing the first outer surface region can be less than 90 degrees, or for example less than 60 degrees.

[0164] Figure 7G Another example of a 700G implant is shown. Figure 7G Includes a three-dimensional perspective cross-section (top image) and a two-dimensional cross-section (bottom image) of implant 700G. Implant 700G may be similar to implants 700A to 700F and may include one or more or all of the features of these implants.

[0165] Figure 7G The sidewalls of a fractal Z-shaped portion (e.g., a Z-shaped portion within a Z-shaped portion) are shown. In other words, the first plurality of continuous strands 745 may include Z-shaped portions instead of forming a smooth surface. Additionally or alternatively, the second plurality of continuous strands 746 may include Z-shaped portions instead of forming a smooth surface or line.

[0166] exist Figures 7A to 7G In the implant, the vertical height between peaks and adjacent troughs (peak-to-trough height hpt), and the peak-to-peak width (wpp) (and / or trough-to-trough width (wtt)) between directly continuous peaks can be 1% to 99% (or, for example, 1% to 50%, 1% to 20%, or 1% to 5%) of the maximum size of the implant. The maximum size of the implant can be the maximum size of the implant in the x, y, or z direction.

[0167] Understandable, regarding Figures 1A to 7G The features described in the various embodiments can be combined with each other. Further features of the invention are as follows.

[0168] Item 1: A three-dimensional implant inserted into the patient's body. The implant comprises multiple strands forming a three-dimensional structure. This three-dimensional structure includes multiple hollow channels. Each hollow channel includes multiple sidewalls. Each sidewall comprises alternating strand segments and multiple gaps, such that the gaps are formed between adjacent strand segments of the sidewall. The multiple gaps are reversibly expandable gaps.

[0169] Item 2: The implant according to Item 1, wherein the reversibly expandable gap can expand to more than 110% of the baseline gap height.

[0170] Item 3: The implant according to Item 1 or Item 2, wherein the reversibly expandable gap is expandable relative to the baseline gap height, wherein the baseline gap height is the minimum height of the gap when the implant is at rest.

[0171] Item 4: An implant according to any one of items 1 to 3, wherein the reversibly expandable gap is expandable relative to the baseline gap height.

[0172] Item 5: An implant according to any one of items 1 to 4, wherein the reversibly expandable gap is expandable relative to the baseline gap height, wherein the baseline gap height of the gap is between 0.1 mm and 2 mm.

[0173] Item 6: An implant according to any one of items 1 to 5, wherein the reversibly expandable gap is expandable relative to the baseline gap height, wherein the length of the baseline gap is at least twice the length of the baseline gap height.

[0174] Item 7: An implant according to any one of items 1 to 6, wherein the plurality of strands are configured such that when the implant is in a stationary state and when the implant is in a compressed state, the gap among the plurality of gaps is reversibly expanded.

[0175] Item 8: An implant according to any one of items 1 to 7, wherein the implant is reversibly compressible to less than 80% of its rest volume.

[0176] The rest volume is the volume of the implant when it is not subjected to tension or compressive forces.

[0177] Item 9: An implant according to any one of items 1 to 8, wherein the implant is configured to receive an elongated object into the body of a three-dimensional structure.

[0178] Item 10: The implant according to Item 9, wherein the diameter of the elongated object is greater than the baseline gap height of the reversible expansion gap, and wherein the length of the elongated object is greater than twice the width of the hollow channel.

[0179] Item 11: An implant according to any one of items 1 to 10, wherein the plurality of strands are configured such that the height of the gap increases as an object is received by the gap, and wherein the height of the gap decreases as the object is removed from the gap.

[0180] The diameter of the object is greater than the baseline gap height.

[0181] Item 12: The implant according to Item 11, wherein the height of the gap is the minimum dimension of the gap measured at the midpoint of the gap.

[0182] Item 13: The implant according to Item 11 or Item 12, wherein the height of the gap increases to more than 110% of the baseline gap height as the object is received by the gap, and wherein the height of the gap decreases to less than 105% of the baseline gap height as the object is removed from the gap.

[0183] Item 14: An implant according to any one of items 11 to 13, wherein a plurality of strands are arranged such that the reversible expansion gaps of at least two different sidewalls are simultaneously expandable as the object is simultaneously received by the gaps of at least two sidewalls.

[0184] Item 15: An implant according to any one of items 11 to 14, wherein a plurality of strands are arranged such that the reversible expansion gap of at least two consecutive hollow channels is simultaneously expandable as the object is simultaneously received by the gap of at least two consecutive hollow channels.

[0185] Item 16: An implant according to any one of items 9 to 15, wherein the object is a needle.

[0186] Item 17: The implant according to Item 16, wherein the needle has a diameter of at least 1 mm and a length of at least 2 cm.

[0187] Item 18: The implant according to Item 1, wherein each hollow channel extends along the longitudinal axis of the hollow channel, wherein multiple strand segments are arranged continuously in one direction between a first end and a second end of the longitudinal axis.

[0188] Item 19: An implant according to any one of items 1 to 18, wherein the multiple continuous strands forming the sidewall of the hollow channel are substantially parallel to each other.

[0189] Item 20: An implant according to any one of items 1 to 19, wherein each hollow channel includes at least a first sidewall and a second sidewall, the first sidewall including a first plurality of continuous strand segments and a first plurality of reversible expansion gaps, the second sidewall including a second plurality of continuous strand segments and a second plurality of reversible expansion gaps, wherein the second sidewall is adjacent to the first sidewall, wherein the strand segments of the first plurality of continuous strand segments and the strand segments of the second plurality of continuous strand segments are alternately arranged in one direction between a first end and a second end of the longitudinal axis.

[0190] Item 21: An implant according to any one of items 1 to 20, wherein the channels in a plurality of hollow channels are arranged adjacent to each other, and wherein adjacent channels share a common sidewall.

[0191] Item 22: An implant according to any one of items 1 to 21, wherein a plurality of sidewalls of the hollow channel are arranged such that the cross-section of the hollow channel is one of the following shapes: polygonal, triangular, rhomboid, elongated rhomboid, square, ellipsoidal, sinusoidal and hexagonal.

[0192] Item 23: An implant according to any one of items 1 to 22, wherein more than 80% of all of the plurality of sidewalls includes a reversibly expandable gap.

[0193] Item 24: An implant according to any one of items 1 to 23, wherein more than 50% of all gaps in the plurality of sidewalls are reversibly expandable gaps.

[0194] Item 25: An implant according to any one of items 1 to 24, wherein the break point of one of the strands is defined by a strain greater than 30% and a corresponding stress less than 250 MPa.

[0195] Item 26: An implant according to any one of items 1 to 25, wherein the plurality of strands comprises a polymer material.

[0196] Item 27: The implant according to Item 26, wherein the flexible polymer material comprises at least one material from the group consisting of polycaprolactone, poly(1,3-trimethylene carbonate), polylactic acid, polyglycolic acid, poly(esteramide), poly(ethylene glycol) / poly(butylene terephthalate), poly(glycerol sebacate), poly(1,8-octanediol-citric acid), poly(1,10-decanediol-D,L-lactic acid), poly(citric acid glycol ester), poly(glycolic acid-co-caprolactone), poly(1,3-trimethylene carbonate-co-lactide), poly(1,3-trimethylene carbonate-c-caprolactone), and copolymers of at least two of these materials.

[0197] Item 28: An implant according to any one of items 1 to 27, wherein the thickness of the strands of the plurality of strands is between 0.05 mm and 2 mm.

[0198] Item 29: An implant according to any one of items 1 to 28, wherein the plurality of strands include a material volume, wherein the material volume is between 5% and 50% of the total implant volume of the implant.

[0199] Item 30: The implant according to Item 29, wherein the plurality of sidewalls comprise more than 80% of the material volume of a three-dimensional structure.

[0200] Item 31: An implant according to any one of items 1 to 30, wherein the implant comprises a plurality of stranded wire layers stacked on top of each other, the plurality of stranded wire layers forming a unit cell arrangement of a three-dimensional structure.

[0201] Item 32: The implant according to any one of items 1 to 31 further includes one or more contour lines disposed on the outer surface region of the implant, wherein the multiple contour lines are arranged such that a plurality of reversibly expanding contour gaps are formed between adjacent strands of the multiple contour lines.

[0202] Item 33: An implant according to any one of items 1 to 32, used to guide a needle through the implant for implantation surgery.

[0203] Item 34: A method for forming an implant. The method includes forming a plurality of strands to form a three-dimensional structure. The three-dimensional structure includes a plurality of hollow channels. Each hollow channel includes a plurality of sidewalls. The sidewalls include a plurality of gaps and a plurality of continuous strand segments of the plurality of strands. The strand segments and the gaps are arranged alternately such that gaps are formed between adjacent strand segments of the sidewalls. The gaps are reversibly expandable gaps.

[0204] Item 35: The method according to Item 34, wherein forming multiple strands comprises sequentially printing multiple layers, wherein each layer comprises a lattice arrangement of two-dimensional unit cells, wherein the multiple layers are arranged such that aligned unit cells of consecutive layers among the multiple layers form hollow channels among multiple channels.

[0205] Item 36: The method according to Item 34 or Item 35 further comprises: determining at least one of the following: 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; the size of the unit cell; and forming the plurality of strands such that a three-dimensional structure including a reversibly expanding gap is formed, wherein the three-dimensional structure includes the determined number of hollow channels, the determined number of layers, and the determined size of the unit cell.

[0206] Item 37: The method according to any one of items 34 to 36, wherein the reversible expansion gap can be expanded to more than 110% of the baseline gap height.

[0207] Item 38: The method according to any one of items 34 to 37, wherein the reversibly expandable gap is expandable relative to the baseline gap height, wherein the baseline gap height is the minimum height of the gap when the implant is stationary.

[0208] Item 39: A three-dimensional soft tissue implant for insertion into a patient. The implant comprises multiple strands forming a three-dimensional structure including multiple hollow channels. Each hollow channel includes multiple sidewalls. Each sidewall includes multiple strand segments arranged alternately and multiple gaps. At least one sidewall of the hollow channel is a wavy sidewall.

[0209] Item 40: The implant according to Item 39, wherein the wavy sidewall includes at least one of a Z-shaped portion and a sinusoidal portion.

[0210] Item 41: The implant according to Item 39 or Item 40, wherein each hollow channel includes a first wavy sidewall and a second wavy sidewall.

[0211] Item 42: A method for tissue reconstruction or tissue enhancement, the method comprising implanting an implant as defined in any one of items 1 to 33 or an implant as defined in any one of items 39 to 41 into a subject, the implant being manufactured by a method as defined in any one of items 34 to 38.

[0212] Item 43: The method described in Item 42, wherein the method includes reconstructing body parts.

[0213] Item 44: The method described in Item 43, wherein the body part is selected from the breast, chest, buttocks, calves and part of the face.

[0214] Item 45: According to the method described in Item 44, a portion of the face is the cheek.

[0215] Item 46; the method described in Item 44, wherein the subject has pectus excavatum.

[0216] Item 47: The method according to any one of items 42 to 44, wherein the method includes breast reconstruction.

[0217] Item 48: The method described in Item 47, wherein breast reconstruction is performed after a breast mass excision or mastectomy.

[0218] Since embodiments of the invention have been described in such detail, it should be understood that the invention as defined by the appended claims is not limited to the specific details set forth in the foregoing description, as many obvious variations are possible without departing from its spirit or scope.

Claims

1. A three-dimensional implant (100, 200, 300) inserted into a patient for tissue reconstruction or enhancement, said implant comprising: Multiple strands (101) form a three-dimensional structure (102), wherein the three-dimensional structure (102) includes multiple hollow channels (103). Each hollow channel (103) includes multiple sidewalls (104). The sidewall (104) includes multiple alternating strands (105) and multiple gaps (106), such that the gaps (106) are formed between adjacent strands (105) of the sidewall, wherein each gap includes a gap length gl and a stationary gap height gh. Wherein, the plurality of gaps (106) are reversibly expanding gaps, wherein the height of the reversibly expanding gap increases as an object (155) is received by the gap, the object causing a deflection δ in each of the adjacent strands, and wherein the height of the gap decreases as the object is removed from the gap. Among them, the multiple strands (101) are made of materials with a yield strength σ yield The material is formed with an elastic modulus E, wherein each strand (101) has a length and a cross-sectional diameter, and the ratio of the radius R of the strand segment (101) to the square of the gap length gl of the reversible expansion gap is based on the yield strength σ of the material. yield The elastic modulus E of the material and the deflection capability δ of the adjacent strands (105) of the gap (106), wherein the deflection capability δ is the deflection of the adjacent strands caused when the object is inserted into the gap; The ratio of the radius R of the plurality of strands (101) to the square of the gap length gl of the reversible expansion gap (106) is given by the expression It is indicated that δ represents the deflection capability of the strand segment of the gap.

2. The implant according to claim 1, wherein, The ratio of the radius R of the strand segment (101) to the square of the gap length gl of the reversible expansion gap (106) is proportional to the yield strength σ of the material. yield It is proportional to the ratio of the product of the elastic modulus E and the deflection capability δ of the strand segment (105) of the gap (106).

3. The implant according to claim 1 or 2, wherein, The deflection capability δ of the strand segment of the reversible expansion gap (106) is between 0.05 and 0.75 times the gap height gh.

4. The implant according to claim 1 or 2, wherein, The reversible expansion gap (106) is expandable relative to the static gap height, wherein the static gap height is the minimum or minimum height between adjacent strands when the implant is stationary.

5. The implant according to claim 1 or 2, wherein, The channels in the plurality of hollow channels (103) are arranged adjacent to each other, and the adjacent channels share a common sidewall.

6. The implant according to claim 1 or 2, wherein, More than 80% of all the sidewalls (104) of the plurality of sidewalls include the reversible expansion gap (106).

7. The implant according to claim 1 or 2, wherein, More than 50% of all the gaps in the plurality of sidewalls (104) are reversibly expanding gaps (106).

8. The implant according to claim 1 or 2, wherein, The material used to form the multiple strands has a fracture point on the stress-strain diagram, wherein the strain at the fracture point is greater than 30%, and the stress at the fracture point is less than 250 MPa.

9. The implant according to claim 1 or 2, wherein, The multiple strands (101) include a material volume, wherein the material volume is between 5% and 50% of the total implant volume of the implant.

10. The implant according to claim 1 or 2, further comprising one or more contour lines (319) disposed on the outer surface region of the implant, and in, The one or more contour lines (319) are arranged such that the reversible expansion gap is formed between adjacent strands of the one or more contour lines.

11. The implant according to claim 1 or 2, wherein, The plurality of hollow channels (103) include at least one of a sinusoidal channel and a Z-shaped channel.

12. The implant according to claim 1 or 2, for guiding a needle through the implant to perform an implantation procedure.

13. A method for forming a three-dimensional implant, the method comprising: Multiple strands (620) are formed to create a three-dimensional structure, wherein the multiple strands are composed of strands with a yield strength σ. yield And the material with elastic modulus E is formed, The three-dimensional structure includes multiple hollow channels, each hollow channel including multiple sidewalls, each sidewall including multiple gaps and multiple continuous strand segments of the multiple strands. The multiple strands and the multiple gaps are arranged alternately, such that the gaps are formed between adjacent strands on the sidewall. Each gap includes a gap length *gl* and a stationary gap height *gh*. Wherein, the plurality of gaps are reversibly expanding gaps, wherein the height of the reversibly expanding gap increases as an object is received by the gap, the object causing a deflection δ in each of the adjacent strands, and wherein the height of the gap decreases as the object is removed from the gap. Each strand (101) has a length and a cross-sectional diameter, wherein the cross-sectional diameter of the plurality of strands is selected such that the radius R of the plurality of strands and the gap length gl of the reversible expansion gap are based on the yield strength σ of the material. yield The elastic modulus E and the deflection capability δ of the adjacent strands forming the reversible expansion gap, wherein the deflection capability δ is the deflection of the adjacent strands caused when the object is inserted into the gap.

14. The method of claim 13, further comprising: The deflection capability δ of the reversible expansion gap is determined based on the object to be received by the reversible expansion gap; Determine the material properties of the multiple strands to be formed, wherein the material properties include the yield strength σ of the material. yield And Young's modulus E; as well as Determine the radius R and gap length gl of the corresponding strands among the multiple strands to be formed.

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