hard tissue implant

专利摘要:
HARD TISSUE IMPLANTATION. Hard tissue implants are provided that include a massive implant, a face, abutments and slots. Abutments are for implantation into hard tissue. The cracks will be occupied by the hard tissue. The hard tissue implant has a Young's modulus of elasticity of at least 10 GPa, has a ratio of (i) the sum of the crack volumes to (ii) the sum of the abutment volumes and the crack volumes of 0.40 :1 to 0.90:1, does not comprise any part that is hollow, and does not comprise any part, other than the pillars, extending to or beyond the distal ends of any of the pillars. Methods of making and using the hard tissue implants are also provided.
公开号:BR112014010164B1
申请号:R112014010164-7
申请日:2012-10-24
公开日:2021-05-18
发明作者:George J. Picha；Dawn Thompson
申请人:Gary A. Zwick；
IPC主号:

专利说明:

CROSS REFERENCE
[0001] This application claims the benefit of U.S. Non-Provisional Application No. 13/317,719, filed October 26, 2011, the disclosure of which is incorporated in its entirety herein for reference purposes. TECHNICAL FIELD
[0002] The present disclosure relates generally to a hard tissue implant, and more particularly to a hard tissue implant including a massive implant, a face, abutments and slots. BACKGROUND OF THE INVENTION
[0003] Conventional hard tissue implants include implants designed to promote hard tissue intragrowth based on the formation of a tissue/implant interface in which the implant forms a continuous phase and the tissue forms a discontinuous phase, for example, based on the implant having a concave and/or porous surface on which hard tissue can grow, and designed to have added surface modifications, eg, added modifications based on sintering.
[0004] For example, Van Kampen et al., Pat. No. 4,608,052 discloses an implant for use in the human body having an integral attachment surface adapted to allow for intragrowth of living tissue. The implant surface is defined by a multiplicity of adjacent, generally concave surface parts having crisscross, generally aligned edges which define an internal connecting surface part and by a multiplicity of spaced abutments projecting from the internal clamping surface. Van Kampen also discloses that the implants were provided with porous surfaces, as described in U.S. Patent Nos. 3,605,123, 3,808,606 and 3,855,638.
[0005] Furthermore, for example, JD Bobyn et al, 150 Clinical Orthopedics & Related Research 263 (1980), reveal that a pore size range of approximately 50 to 400 µm provided an optimal or maximum clamping force (17 MPa ) in the shortest time period (8 weeks) with respect to cobalt-based alloy implants with porous powder-formed surfaces. Specifically, the implants were fabricated based on cylindrical rods of cobalt-based alloy coating fused with cobalt-based alloy powder in four particle size ranges. Particle size ranges were as follows: 25 to 45 µm; 45 to 150 µm; 150 to 300 µm; and 300 to 840 µm. The corresponding pore size ranges of the particles were as follows: 20 to 50 µm; 50 to 200 µm; 200 to 400 µm; and 400 and 800 µm, respectively. The particles were then bonded to the rods based on sintering. All implants are manufactured to have a maximum diameter of 4.5 mm and a length of 9.0 mm. The implants were surgically inserted into the holes in femurs of dogs, allowing bone intragrowth to occur. After varying periods of time (4, 8 or 12 weeks), the maximum force required to dislodge the implants was determined. Implants with a pore size smaller than 50 µm produced relatively low clamping forces at all times, while implants with a pore size larger than 400 µm exhibited relatively high dispersion with respect to clamping forces, thus indicating that a pore size range of approximately 50 to 400 µm provided optimal or maximum clamping force.
[0006] Conventional hard tissue implants also include implants with surface texturing, for example burrs or abutments, to make it difficult to remove the implants from the hard tissue or to mechanically anchor more effectively at an earlier date or affix to adjacent hard tissue .
[0007] For example, Amrich et al., Pat. U.S. No. 7,018,418 disclose implants with a textured surface with micro-recesses so that the outer surface protrudes over the micro-recesses. In one embodiment, unidirectional burrs are produced on the surface that can be inserted into bone or tissue. The directional orientation of burrs is intended to make it difficult to remove the bone or tissue.
[0008] In addition, for example, Picha, Pat. U.S. No. 7,556,648 discloses a spinal implant, i.e., an implant for use in fusing and stabilizing adjacent spinal vertebrae, including a hollow, generally tubular casing having an outer side surface, a front end and a rear end. The outer surface includes a plurality of pillars arranged in a non-helical arrangement. Each abutment has a height of 100 to 4,500 μm and a lateral dimension at its widest point of 100 to 4,500 μm. The outer surface also has a plurality of holes therethrough to allow bone intragrowth therethrough.
[0009] Unfortunately, hard tissue interfaces and hard tissue implants in which the hard tissue is in a discontinuous phase can be susceptible to imbalance of the normal stresses exerted on the bone, resulting in resorption of the affected hard tissue, eg resorption bone, with time. Furthermore, the addition of surface texturing to sintered implants can result in surface texturing taking up an excessive volume of hard tissue/matched implant interfaces, leaving insufficient space for the hard tissue. In addition, spinal implants are designed to perform, under conditions relevant to the spine, i.e., compression, rotary shear and vertical shear, with compression being essentially constant, rotary shear being intermittent, and vertical shear being rare in instead of conditions relevant to other hard tissues, such as long bones, maxillary bones, mandibular bones and membranous bones, that is, load-bearing conditions, including compression and tension, varying along the hard tissue and over time, and intermittent rotary and vertical shear. Therefore, there is a need for hard tissue implants of general applicability that address these issues and offer improvements. The device disclosed here is such an implant. SUMMARY
[0010] A hard tissue implant is provided which includes a massive implant, a face, abutments and slots. The face is an outer surface of the massive implant. Abutments are for implantation into hard tissue. The abutments are distributed on the face, over an area of at least 80 mm2, and extend distally therefrom. Each abutment is integral to the massive implant, has a distal end, a cross-sectional area of (200 μm x 200 μm) to (10,000 μm x 10,000 μm), i.e. 4.0 x 104μm2a 1.0 x 108 μm2, and has an abutment height of 100 to 10,000 µm. The cracks will be occupied by the hard tissue. Cracks are defined by the pillars. Each crack has a width of 100 to 10,000 µm, as measured along the shortest distance between adjacent pillars. The hard tissue implant has a Young's modulus of elasticity of at least 10 GPa, and has a ratio of (i) the sum of the crack volumes to (ii) the sum of the abutment volumes and the crack volumes of 0.40 :1 to 0.90:1. The hard tissue implant does not include any portion that is hollow, and does not include any portion (other than the abutments) extending to or beyond the distal ends of any of the abutments.
[0011] Also provided is a method for producing a hard tissue implant that, after implantation in a hard tissue, provides immediate load transfer and prevents the imbalance of normal stresses exerted on the bone. The hard tissue implant includes a massive implant, a face, abutments and slots. The face is an outer surface of the massive implant. Abutments are for implantation into hard tissue. The abutments are distributed on the face, over an area of at least 80 mm2, and extend distally therefrom. Each abutment is integral to the massive implant, has a distal end, a cross-sectional area of (200 μm x 200 μm) to (10,000 μm x 10,000 μm), i.e. 4.0 x 104μm2a 1.0 x 108 μm2, and has a height of 100 to 10,000 µm. The cracks will be occupied by the hard tissue. Cracks are defined by the pillars. Each crack has a width of 100 to 10,000 µm, as measured along the shortest distance between adjacent pillars. The hard tissue implant has a Young's modulus of elasticity of at least 10 GPa, and has a ratio of (i) the sum of the crack volumes to (ii) the sum of the abutment volumes and the crack volumes of 0.40 :1 to 0.90:1. The hard tissue implant does not include any portion that is hollow, and does not include any portion (other than the abutments) extending to or beyond the distal ends of any of the abutments. The method includes designing the hard tissue implant so that the ratio of (i) the product (a) of the modulus of elasticity of the hard tissue implant and (b) the sum of the abutment volumes to (ii) the product (a) the modulus of elasticity of the hard tissue and (b) the sum of the crack volumes is from 0.80:1 to 3.8:1. The method also includes producing the hard tissue implant.
[0012] Also provided is a method of using a hard tissue implant in the hard tissue of an individual in need thereof. The hard tissue implant includes a massive implant, a face, abutments and slots. The face is an outer surface of the massive implant. Abutments are for implantation into hard tissue. The abutments are distributed on the face, over an area of at least 80 mm2, and extend distally from it. Each abutment is integral to the massive implant, has a distal end, a cross-sectional area of (200 μm x 200 μm) to (10,000 μm x 10,000 μm), i.e. 4.0 x 104μm2a 1.0 x 108 μm2, and has a height of 100 to 10,000 µm. The cracks will be occupied by the hard tissue. Cracks are defined by the pillars. Each crack has a width of 100 to 10,000 µm, as measured along the shortest distance between adjacent pillars. The hard tissue implant has a Young's modulus of elasticity of at least 10 GPa, and has a ratio of (i) the sum of the crack volumes to (ii) the sum of the abutment volumes and the crack volumes of 0.40 :1 to 0.90:1. The hard tissue implant does not include any portion that is hollow, and does not include any portion (other than the abutments) extending to or beyond the distal ends of any of the abutments. The method includes selecting the hard tissue implant so that the ratio of (i) the product (a) the modulus of elasticity of the hard tissue implant and (b) the sum of abutment volumes for (ii) the product (a) of the modulus of elasticity of the hard tissue and (b) the sum of the crack volume is from 0.80:1 to 3.8:1. The method also includes implanting the hard tissue implant into the hard tissue. BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
[0014] These and other features, aspects and advantages of the present disclosure are better understood when the following detailed description is read with reference to the accompanying drawings, in which:
[0015] FIG. 1 is a schematic perspective view of a hard tissue implant;
[0016] FIG. 2 is another schematic perspective view of a hard tissue implant;
[0017] FIG. 3 is a schematic top plan view of a hard tissue implant;
[0018] FIG. 4 is a schematic side elevation view of a hard tissue implant;
[0019] FIG. 5A is a schematic perspective view of an abutment of a hard tissue implant;
[0020] FIG. 5B is a schematic cross-sectional view of an abutment of a hard tissue implant;
[0021] FIGS. 6A-E are schematic top plan views of a hard tissue implant in which the circumference of the cross-sectional area of the pillars has (A) a square shape, (B) a rectangular shape, (C) a zigzag shape, (D) a circular shape and (E) an oval shape;
[0022] FIG. 7 is a schematic perspective view of part of a hard tissue implant;
[0023] FIGS. 8A-E are graphs of compressive results in canines, expressed as load (N) versus extension (mm), for canine femoral implants corresponding to (A) a control implant, (B) implant 1, (C) implant 2, ( D) implant 3, and (E) implant 4;
[0024] FIG. 9 is a graph of mean final load (N) at failure for the control implant and implants 1 to 4; and
[0025] FIGS. 10A-D are histological micrographs at 4X magnification of (a) implant 1 (PEEL, 100 μm slit width) face 25 μm H&E dye, (B) implant 2 (PEEK, 200 μm slit width) face 25 μm trichrome dye, (C) implant 3 (PEEK, slit width 400 μm) face 25 μm trichrome dye, and (D) implant 4 (titanium, slit 400 μm) 25 μm trichrome dye. DETAILED DESCRIPTION
[0026] Hereinafter, we will describe the present disclosure in more detail with reference to the accompanying drawings, in which exemplary embodiments of the invention are illustrated. Wherever possible, the same reference numerals are used throughout the drawings to refer to the same or similar parts. However, the present invention may be embodied in many different forms and is not intended to be limited to the embodiments presented herein. These embodiments are presented so that this disclosure will be both thorough and complete, and will fully convey the scope of the invention to those skilled in the art.
[0027] As shown in the figures, illustrative hard tissue implants are provided. Hard tissue implants offer advantages, including, for example, that hard tissue implants can promote hard tissue remodeling and growth at the implant site and that the interface of hard tissue implants and hard tissue can resist leakage / substantial elongation and load before failure. Without intending to be limited to theory, it is believed that these advantages are based on the properties of hard tissue implants and the interface resulting from their implantation. Specifically, hard tissue implants can provide immediate load transfer after implantation and prevent the imbalance of normal stresses placed on the bone over time, thus promoting hard tissue remodeling and growth at the implantation site. For example, with the provision of immediate load transfer, implant abutments can be pressed deep into hard tissue, allowing for enhanced load transfer, potentially eliminating implant micro-movement and migration over time, accommodating torque and /or eliminating the need for adhesives such as cement or grout to retain the implant in place. Furthermore, the interface can have a continuous phase corresponding to the hard tissue and a discontinuous phase corresponding to the hard tissue implant. Hard tissue can also constitute at least 40% of the interface volume, and the Young's modulus product of the hard tissue and the tissue volume and the Young's modulus product of the implant and the volume of the implant posts can be well matched. Thus, the interface has mechanical properties similar to those of the massive hard tissue adjacent to the interface. The result is that the interface after implantation of a hard tissue implant into a hard tissue is surprisingly durable and resilient to load. In addition, hard tissue implants can promote rich vascularization of the hard tissue at the interface, enhancing wound healing, providing nutritional support, accelerating healing, remodeling and hard tissue integration, and limiting the potential for tissue infection. hard. Rapid or immediate integration of hard tissue into the space between the abutments of the hard tissue implant, for example, by immediate impregnation of the implant into the surrounding tissue without the need for subsequent hard tissue intragrowth, can also prevent harmful cellular reactions at the interface, such as such as the formation of fibrous tissue, seroma or thrombosis.
[0028] As used herein, the term "hard tissue implant" refers to an implant suitable for implantation into a hard tissue. Examples of hard tissue implants include rods, plates, screws, pins, and bone anchoring devices. Examples of hard tissue implants also include a tibial implant, a femoral implant, a shoulder implant, a small joint implant, a cranial implant, a cervical implant, and a metatarsal implant. Examples of hard tissue implants also include a dental implant. Examples of hard tissue implants also include cartilaginous implants. Examples of hard tissue suitable for implantation of hard tissue implants include bone, cartilage, calcified cartilage, non-calcified cartilage and tissue that has become mineralized. Examples of hard tissue also include long bones, maxillary bones, mandibular bones and membranous bones. Examples of hard tissue also include the tibia, femur, shoulder, small joints, skull and metatarsal. Examples of hard tissue also include the spine.
[0029] As used herein, the term "abutment" refers to a projection that extends distally from a face of a hard tissue implant, that is, that is not in physical contact with any other pillars or other parts of the implant besides the face, and which serves for implantation in a hard tissue. Since an abutment is not in direct physical contact with any other abutments or other parts of the implant other than the face, when implanted into hard tissue, no abutment forms a discontinuous phase within the resulting interface of the hard tissue and the hard tissue implant. An abutment may have a cross-sectional area, that is, an area of a cross-section taken in relation to a vertical axis along which the abutment extends distally from the face of the implant of, for example, (i) ( 200 μm x 200 μm) to (10,000 μm x 10,000 μm), i.e. 4.0 x 104 μm2a 1.0 x 108 μm2, (ii) (200 μm x 200 μm) to (2000 μm x 2,000 μm), i.e. 4, 0 x 104μm2a 4.0 x 106μm2, (iii) (250 μm x 250 μm) to (1,000 μm x 1,000 μm), that is, 6.3 x 104μm2a 1.0 x 106μm2, (iv) (300 μm x 300 μm) to (500 μm x 500 μm), that is, 9 x 104μm2a 2.5 x 105μm2, (v) (350 μm x 350 μm) to (450 μm x 450 μm), that is, 1.2 x 105μm2a 2.0 x 105μm2or (vi) (395μm x 395μm) to (405μm x 405μm), ie, 1.6 x 105μm2. Of course, the expression of cross-sectional areas of columns as squares of linear dimensions, i.e. (200 µm x 200 µm), here and throughout this application, is for convenience only and is not intended to limit any columns thus described to square shapes , square cross-sections or square cross-sections. An abutment can have abutment height, ie the height of the abutment from the face of the hard tissue implant to the distal end of the abutment, for example, 100 to 10,000 μm, 100 to 5,000 μm, 200 to 2,500 μm , 300 to 1000 μm, 400 to 600 μm, 450 to 550 μm, 490 to 510 μm, or 500 μm. A column can have a volume, ie a product of the column cross-sectional area and column height, for example, from (i) (200 μm x 200 μm x 100 μm) to (10,000 μm x 10,000 μm x 10,000 μm), that is, 4.0 x 106μm3a 1.0 x 1012μm3, (ii) (200μm x 200μm x 100μm) to (2000μm x 2000μm x 5,000μm), i.e. 4.0 x 106μm3a 2.0 x 1010μm3, (iii) (250 μm x 250 μm x 200 μm) to (1,000 μm x 1,000 μm x 2,500 μm), that is, 1.3 x 107μm3a 2.5 x 109μm3, (iv) (300 μm x 300 μm x 300 μm) to (500 μm x 500 μm x 1000 μm), that is, 2.7 x 107μm3a 2.5 x 108μm3, (v) (350 μm x 350 μm x 400 μm) to (450 μm x 450 μm x 600 μm), that is, 4.9 x 107μm3a 1.2 x 108μm3, or (vi) (395 μm x 395 μm x 490 μm) to (405 μm x 405 μm x 510 μm), that is, 7 ,7 x 107μm3a 8.4 x 107μm3. A pillar can have, as seen from a top view, a square shape, a rectangular shape, a zigzag shape, a circular shape or an oval shape, respectively, or, alternatively, it can have other polygonal shapes, curvilinear or variable.
[0030] As used here, the term “crack” refers to the spaces between the pillars. Thus, the pillars define the cracks. Cracks can have a slit height as defined by the abutments of, for example, 100 to 10,000 μm, 100 to 5,000 μm, 200 to 2,500 μm, 300 to 1,000 μm, 400 to 600 μm, 450 to 550 μm or 500 μm. Cracks can have a slit width, as measured along the shortest distance between adjacent pillars, of, for example, 100 to 10,000 µm, 100 to 7,500 µm, 100 to 3,000 µm, 150 to 1000 µm, 175 to 450 µm, 190 to 410 µm, 190 to 210 µm or 390 to 410 µm. The cracks have a volume corresponding to the volume of space between the pillars.
[0031] As used herein, the term "pore" refers to an empty space less than 1,000 μm in size, that is, having a diameter less than 1,000 μm, on or below a surface, for example, the surface of a hard tissue implant. Pores can occur in a material naturally, for example, based on a natural porosity of the material, or they can be introduced, for example, by chemical or physical treatment. Pores can be continuous with respect to one another, based on being interconnected to each other below a surface, or pores can be discontinuous, based on not being interconnected to each other below a surface. The pores can be large enough to allow the migration and proliferation of osteoblasts and mesenchymal cells. Thus, for example, a porous surface is a surface that includes voids of less than 1000 µm in size on the surface, whereas a non-porous surface is a surface that does not include such void space.
[0032] As used herein, the term "hollow", when used with reference to a part of a hard tissue implant, means that the part includes, below a surface thereof, at least an empty space, eg, cavity , hole or similar, of more than 5,000 μm in size, ie having a diameter greater than 5,000 μm. Therefore, a part that is not hollow does not include any such empty space.
[0033] As used herein, the term "interface resulting from implantation of hard tissue implant into hard tissue", or, more simply, "interface", refers to the product of implantation, in which the implant abutments Hard tissue implants are implanted into a hard tissue, and the hard tissue implant slots are occupied, partially or completely, by the hard tissue. The interface includes the abutments, the hard tissue that occupies the hard tissue implant slots, any unoccupied space remaining in the slots, any hard tissue that occupies any additional space between the implant face and a plane defined by the distal ends of the abutments , and any hard tissue that occupies any pores on the face of the pillars. Therefore, the interface boundaries are the hard tissue implant face, the inner surfaces of any pores in the face, and the massive tissue surrounding the interface. In another illustrative embodiment, for example, immediately after pressing the hard tissue implant into the hard tissue and/or after remodeling and hard tissue growth to fill the entire space between the hard tissue implant and the hard tissue, the abutments are implanted in the hard tissue, and the slits are completely occupied by the hard tissue. In another illustrative embodiment, for example, after implanting the hard tissue implant partially into the hard tissue and/or prior to hard tissue remodeling and growth to fill the entire space between the hard tissue implant and the hard tissue, the abutments are implanted partially in the hard tissue, and the cracks are partially occupied by the hard tissue.
[0034] As used herein, the term "continuous", when used, for example, in reference to the hard tissue of an interface, means that the hard tissue forms a single continuous phase, extending across and along the interface to each interface boundary. As used herein, the term "discontinuous", when used, for example, in reference to the hard tissue implant of an interface, means that the hard tissue implant does not form such a continuous single phase. Hard Tissue Implant
[0035] Considering the aspects and an illustrative hard tissue implant in more detail, FIG. 1 provides a schematic perspective view illustration of an example hard tissue implant 100 in perspective view for illustrative purposes. As described in more detail below, the hard tissue implant 100 can be made of a material with a Young's modulus of elasticity, i.e., a tensile modulus of elasticity of at least 10 GP, as measured at 21°C, including, by example, (1) implantable grade polyetherketone, eg carbon fiber reinforced implantable grade polyetherketone, which has a Young's modulus of elasticity of at least 18 GPa, (ii) titanium, which has a modulus of elasticity Young's modulus of approximately 110 GPa, (iii) stainless steel, which has a Young's modulus of elasticity of approximately 200 GPa, (iv) cobalt-chromium alloy, which has a Young's modulus of elasticity greater than 200 GPa, or ( vi) titanium alloy, which has a Young's modulus of elasticity of approximately 105-120 GPa, all as measured at 21oC. The hard tissue implant 100 can also be made from hard tissue obtained from a human or animal, for example, an autologous hard tissue, an allogeneic hard tissue, a xenogenic hard tissue, human cartilage, animal cartilage, a human bone , an animal bone, or a cadaver bone. Such hard tissues obtained from a human or animal may have a Young's modulus of elasticity of, for example, 10 to 18 GPa. Such hard tissues obtained from a human or animal may also be treated, prior to implantation, to decrease or eliminate the ability of hard tissue to elicit an immune response in an individual after implantation in the individual. The hard tissue implant can also be made from more than one of the materials and/or hard tissue mentioned above. Therefore, the hard tissue implant 100 has a Young's modulus of elasticity of at least 10 GPa, for example, 18 to 230 GPa, 18 to 25 GPa, 100 to 110 GPa, 190 to 210 GPa, 200 to 230 GPa, 105 to 120 GPa, or 10 to 18 GPa.
[0036] As shown in FIG. 1, the hard tissue implant 100 includes a massive implant 110, a face 120, abutments 140, and slots 150.
[0037] Considering the massive implant 110 in more detail, as shown in FIG. 1, the massive implant 110 forms the core of the hard tissue implant 100 and may have a three-dimensional rectangular prism shape, although cuboid, cylindrical, pyramidal, conical, and other three-dimensional shapes can be used in additional examples. The massive implant 110 may be made from one or more of the rigid materials or tissues noted above with respect to the implant 100, for example, a material such as implantable grade polyetherketone, titanium, stainless steel, cobalt-chromium alloy or alloy of titanium, or, for example, a hard tissue obtained from a human or animal, such as an autologous hard tissue, an allogeneic hard tissue, a xenogenic hard tissue, human cartilage, animal cartilage, a human bone, an animal bone or a corpse bone.
[0038] The massive 110 implant can be porous or non-porous. For example, massive implant 110 can include one or more surfaces that are porous and/or can be made of one or more materials that are porous. Such porous surfaces may include pores with diameters of, for example, 1 to 900 µm, 100 to 800 µm or 200 to 600 µm. In addition, for example, massive implant 110 can include only surfaces that are non-porous and/or can be made of one or more materials that are non-porous.
[0039] Now considering face 120 in more detail, as shown in FIG. 1, face 120 of hard tissue implant 100 is an outer surface of massive implant 110, having a total area 160. As shown in FIG. 1, face 120 may be flat, that is, have a flat contour. Alternatively, as shown in FIG. 2, face 120 may be cylindrical, that is, have a cylindrical outline. As additional alternatives, face 120 can have other angular, curvilinear, and/or irregular contours. As shown in FIG. 3, face 120 may have a peripheral rectangular shape as seen from a top view, although other polygonal, curved, or other shapes may be used in additional examples. As shown in FIGS. 1 and 2, the face may be defined by an edge 130. For example, as shown in FIG. 1, edge 130 may be a single continuous edge defining face 120. Furthermore, for example, as shown in FIG. 2, edge 130 may be two edges that are discontinuous with respect to one another that together define face 120. In addition, for example, edge 130 may be three or more edges that are discontinuous with respect to one another that together define face 120. As shown in FIGS. 1 and 2, edge 130 and posts 140 closest to edge 130 may define a peripheral edge 122 of face 120. Also as illustrated in FIGS. 1 and 2, edge 130 may define an intersection between face 120 and one or more adjacent faces 124 of hard tissue implant 100. As illustrated, face 120 and one or more adjacent faces 124 may intersect at edge 130 at a right angle, although face 120 and one or more adjacent faces 124 may also intersect at other angles, for example, acute angles, obtuse angles or variable angles. As also illustrated, edge 130 may be sharp, although other rounded, angular, smooth, and/or irregular edges may be used in other examples. Face 120 can be porous, for example, including pores with diameters of, for example, 1 to 900 µm, 100 to 800 µm or 200 to 600 µm, or face 120 can be non-porous. The massive implant 110 may include more than one face 120, for example two, three, four, five or more faces 120.
[0040] Now considering the posts 140 in more detail, the posts 140 are for implantation in a hard tissue. Hard tissue can be selected, for example, from the group consisting of bone, cartilage, calcified cartilage, non-calcified cartilage, and tissue that has become mineralized. Hard tissue can also be selected, for example, from the group consisting of long bone, maxillary bone, mandibular bone, and membranous bone. Hard tissue can also be selected, for example, from the group consisting of tibia, femur, shoulders, small joints, skull and metatarsal. Hard tissue can also be, for example, pimples.
[0041] As shown in FIG. 3, posts 140 are distributed on face 120 of hard tissue implant 100, over an area 170 of face 120 of at least 80 mm2. For example, abutments 140 can be distributed in a regular pattern 310 on face 120 of hard tissue implant 100, over area 170 of face 120. In this regard, abutments 140 can be distributed in uniform rows along a horizontal axis 320 and a vertical axis 330 of face 120, and can be distributed along a given row evenly with respect to the distances between the centers 142 of the pillars 140 in the row. In addition, for example, columns 140 can also be distributed in other regular patterns, for example, columns 140 can be distributed in rows that are uniform with respect to the horizontal axis 320 but not the vertical axis 330, or vice versa, the pillars 140 in a row can be offset from pillars 140 in adjacent rows, pillars 140 can be arranged in a spiral pattern, etc. Furthermore, for example, the posts 140 can be distributed on the face 120 of the hard tissue implant 100 in irregular patterns or randomly. For example, abutments 140 can be distributed on face 120 of the hard tissue implant 100 so that the abutments 140 are grouped more densely in one area of face 120 and less densely in another area of face 120. Furthermore, to a massive implant 110 including more than one face 120 along which the abutments 140 are distributed, the abutments 140 can be distributed differently on the various faces 120, for example in different regular patterns 310, in different irregular patterns and/or grouped in different densities.
[0042] As shown in FIGS. 1 and 3, posts 140 may be distributed on face 120 of hard tissue implant 100 so that none of posts 140 is located on an edge 130, i.e. face 120 may have a peripheral edge 122 that is not occupied by any posts 140, resulting in the area 170 of face 120 over which posts 140 are distributed being less than the total area 160 of face 120. In other illustrative embodiments, posts 140 may be distributed over face 120 of the tissue implant hard,100 so that at least some of the posts 140 are located on an edge 130, for example the area 170 of the face 120 over which the posts 140 are distributed may be equal to the total area 160 of the face 120.
[0043] As shown in FIG. 4, posts 140 extend distally from face 120 of hard tissue implant 100. For example, posts 140 may extend distally along a vertical axis 410 of face 120 of hard tissue implant 100. As illustrated, posts 140 can extend in a uniform direction, that is, all posts 140 extend distally at the same angle to face 120 and in the same direction. In addition, for example, some abutments 140 may extend distally at a different angle and/or in a different direction than other abutments 140, eg for a hard tissue implant 100 for which face 120 is not flat . As also illustrated, pillars 140 may be perpendicular to face 120, for example, extending perpendicularly from face 120. In addition, for example, pillars 140 may extend from face 120 at other angles and /or at varying angles.
[0044] As illustrated in FIG. 1, each abutment 140 is integral to the massive implant 110, that is, the abutments 140 and the massive implant 110 are made of the same starting material, rather than, for example, the abutments 140 being a complement to the massive implant 110. As well as the massive implant 110, the abutment 140 can be porous, for example, including pores with diameters of, for example, 1 to 900 µm, 100 to 800 µm or 200 to 600 µm, or the abutment 140 can be non-porous.
[0045] As shown in FIG. 4, each post 140 has a distal end 430, corresponding to the most distal part of post 140 relative to face 120 of hard tissue implant 100. As also illustrated, each post 140 may have distal edges 432, corresponding to edges defining the end. distal edges 430 of each pillar 140. Each pillar 140 may also have side edges 434, corresponding to the edges of the sides of each pillar 140. As further illustrated, the distal edges 432 and/or the side edges 434 can be sharpened, although other edges rounded, angular, smooth and/or irregular can be used in additional examples.
[0046] With respect to the dimensions of the pillars 140, as shown in FIGS. 5A and 5B, each pillar 140 has a cross-sectional area 510, i.e. an area of a cross-section taken with respect to the vertical axis 410 along which the pillar 140 extends distally from the face 120 of, for example, ( i) (200 μm x 200 μm) to (10,000 μm x 10,000 μm), i.e. 4.0 x 104 μm2a 1.0 x 108 μm2, (ii) (200 μm x 200 μm) to (2000 μm x 2,000 μm), this is 4.0 x 104μm2a 4.0 x 106μm2, (iii) (250μm x 250μm) to (1,000μm x 1,000μm), that is, 6.3 x 104μm2a 1.0 x 106μm2, (iv) (300 μm x 300 μm) to (500 μm x 500 μm), that is, 9 x 104μm2a 2.5 x 105μm2, (v) (350 μm x 350 μm) to (450 μm x 450 μm), that is, 1, 2 x 105μm2a 2.0 x 105μm2or (vi) (395μm x 395μm) to (405μm x 405μm), ie, 1.6 x 105μm2. As illustrated in FIGS. 4 and 5B, each abutment 140 has an abutment height 420, i.e. the height of abutment 140 from the face 120 of the hard tissue implant 100 to the distal end 430 of the abutment 140, for example, from 100 to 10,000 µm , 100 to 5,000 μm, 200 to 2,500 μm, 300 to 1,000 μm, 400 to 600 μm, 450 to 550 μm, 490 to 510 μm, or 500 μm. As shown in FIG. 5A, each column 140 has a volume 520, that is, the product of the column cross-sectional area and column height, for example, from (i) (200 μm x 200 μm x 100 μm) to (10,000 μm x 10,000 μm x 10,000 μm), i.e. 4.0 x 106μm3a 1.0 x 1012μm3, (ii) (200 μm x 200 μm x 100 μm) to (2000 μm x 2,000 μm x 5,000 μm), i.e. 4.0 x 106 μm3a 2.0 x 1010 μm3, (iii) (250 μm x 250 μm x 200 μm) to (1,000 μm x 1,000 μm x 2,500 μm), that is, 1.3 x 107μm3a 2.5 x 109μm3, (iv) (300 μm x 300 μm x 300 μm) to (500 μm x 500 μm x 1000 μm), that is, 2.7 x 107μm3a 2.5 x 108μm3, (v) (350 μm x 350 μm x 400 μm) to (450 μm x 450 μm x 600 μm), that is, 4.9 x 107μm3a 1.2 x 108μm3, or (vi) (395 μm x 395 μm x 490 μm) to (405 μm x 405 μm x 510 μm) , that is, 7.7 x 107μm3a 8.4 x 107μm3. As shown in FIG. 1, all pillars 140 may, for example, have identical dimensions, for example, pillar cross-sections 410, pillar heights 420 identical, and therefore identical individual volumes. Alternatively, one or more pillars 140 may have dimensions that differ from those of pillars 140, such that the individual volumes of the one or more pillars 140 differ from the other pillars 140.
[0047] Turning to FIGS. 6A-6E, corresponding to a top plan view of the hard tissue implants 100 having abutments 140 of various shapes, the abutments 140 may have, as seen from a top view, a square shape 610, a rectangular shape 620, a zigzag shape 630, a circular shape 640 or an oval shape 650, respectively, or alternatively may have other polygonal, curvilinear or variable shapes. For example, in some embodiments, all pillars 140 may have the same shape, for example, a square shape 610, a rectangular shape 620, a zigzag shape 630, a circular shape 640, or an oval shape 650, as seen. for a top view. Furthermore, for example, in some embodiments, not all pillars 140 have the same shape seen from a top view.
[0048] Now considering the slits 150 in more detail, the slits 150 must be occupied by the hard tissue. For example, when implanting the hard tissue implant 100 into a hard tissue, the hard tissue can immediately occupy all or part of the space corresponding to the slots 150. This can be done, for example, by pressing the hard tissue implant 100 in the hard tissue. Furthermore, as the hard tissue, after implantation, does not immediately occupy all the space corresponding to the slits 150, the hard tissues can consequently occupy all or part of the space corresponding to the slits 150 based on remodeling and/or growth of hard tissue over time.
[0049] As shown in FIGS. 1, 3 and 4, the posts 140 define the slots 150 therebetween, i.e. the slots 150 are the spaces between the posts 140. Therefore, as shown in FIG. 4, the slits 150 have a slit height 440 as defined by the posts 140 of, for example, 100 to 10,000 μm, 100 to 5,000 μm, 200 to 2,500 μm, 300 to 1,000 μm, 400 to 600 μm, 450 to 550 μm or 500 µm. As shown in FIGS. 6A-E, slits 150 have a slit width of 152 as measured along the shortest distance between adjacent columns 140 of, for example, 100 to 10,000 µm, 100 to 7,500 μm, 100 to 3,000 μm, 150 to 1,000 µm, 175 to 450 µm, 190 to 410 µm, 190 to 210 µm or 390 to 410 µm. As shown in FIG. 7, the slots 150 have a volume 710 corresponding to the volume of the space between the pillars 140.
[0050] The hard tissue implant 100 has a ratio of (i) the sum of the volumes 710 of the slots 150 to (ii) the sum of the volumes 520 of the abutments 140 and the volumes 710 of the slots 150 of, for example, 0, 40:1 to 0.90:1, 0.51:1 to 0.90:1, 0.51:1 to 0.60:1, or 0.70:1 to 0.76:1. Without intending to be bound by theory, it is believed that this ratio determines the approximate percentages of hard tissue and hard tissue implant 100 that will occupy the interface after implantation of the hard tissue implant implant 100, for example, that, after pressing implant 100 into hard tissue, or after hard tissue remodeling and growth following implantation, that hard tissue will occupy all or essentially all of the space corresponding to slots 150 of hard tissue implant 100.
[0051] More specifically, as shown in FIG. 7, the interface includes (i) the pillars 140, (ii) the slots 150 of the hard tissue implant 100, which have a volume 710 and which, at or after implantation, becomes occupied by the hard tissue, (iii) any additional space between face 120 of implant 100 and a plane 720 defined by distal ends 430 of abutments 140, for example, the space between peripheral edge 122 of face 120 that is not occupied by abutments 140 and plane 720 , which has a volume 730, and which is also made up of hard tissue, and (iv) any pores 740 on face 120 or pillars 140 which, depending on size, can also become occupied by hard tissue.
[0052] Thus, for example, a ratio (i) of the sum of the volumes 710 of the slots 150 to (ii) the sum of the volumes 520 of the columns 140 and the volumes 710 of the slots 150 of 0.40:1 would result, after the implantation of a hard tissue implant 100 and the subsequent remodeling and growth of the hard tissue, where the implant 100 includes an edge 130 and for which posts 140 are located at edge 130, in an interface that includes, in volume, 40 % hard tissue and 60% hard tissue implant,100, and more particularly 60% of abutments 140 of the hard tissue implant 100. Similarly, a ratio (i) of the sum of the 710 volumes of the slots 150 to (ii) the sum of the volumes 520 of the pillars 140 and the volumes 710 of the slots 150 of 0.40:1 would result, after implantation of a hard tissue implant 100 and the subsequent remodeling and growth of the hard tissue, in which the implant 100 includes an edge 130 and for which pillars 140 are located on edge 130, in an interface that includes, in volume, 40% more hard tissue and 60% less hard tissue implant,100, with the percentage of hard tissue increasing, and the percentage of hard tissue implant 100 decreasing, with an increasing distance between the more peripheral pillars 140 and slots 150 and edge 130 of the hard tissue implant 100. As another example, ratios 0.51:1, 0.60:1, 0.70:1, 0.76:1 and 0.90:1 would result at interfaces that include, by volume, 51% hard tissue and 49% hard tissue implant 100, 60% hard tissue and 40% hard tissue implant 100, 70% hard tissue and 30% hard tissue implant 100, 76% hard tissue and 24% hard tissue implant 100, and 90% hard tissue and 10% hard tissue implant, respectively, for a hard tissue implant 100 in which the implant 100 includes an edge 130 and for which abutments 140 are located at edge 130. Furthermore, the percentage of hard tissue would increase, and the percentage of implant hard tissue 100 would decrease, with increasing distance. between the more peripheral abutments 140 and the slits 140 and edge 130 of the hard tissue implant 100. It is further believed that by achieving an interface that is at least 40% hard tissue but has a sufficient amount of the hard tissue implant 100 to support and prevent the implant 100 from migrating, that the interface will exhibit properties similar to those of massive hard tissue adjacent to the interface, eg, high resilience to load.
[0053] As shown in FIG. 1, the hard tissue implant 100 does not include any portion that is hollow. By this it is understood that neither the massive implant 110, nor any of the abutments 140, nor any other physical part (referring to additional physical components, not the slots 150) of the hard tissue implant 100 include, below a surface of the themselves, any empty space, eg cavity, hole, or the like, with a dimension greater than 5,000 μm, ie with a diameter greater than 5,000 μm.
[0054] As also illustrated in FIG. 1, the hard tissue implant 100 also does not include any non-abutment portion extending to or beyond the distal ends 430 of any of the abutments 140. It is understood by this that, with respect to any face 120 of the implant, hard tissue 100 from which the abutments 140 extend distally, no other physical part of the hard tissue implant 100 (referring to additional physical components, not the slots 150) extends to or beyond the distal ends 430 of the abutments 140. In other words, the abutments 140 of the hard tissue implant 100 are not recessed or submerged relative to any other part of the hard tissue implant 100.
[0055] Without intending to be bound by theory, it is believed that by making the hard tissue implant 100 do not include any part that is hollow and does not include any part other than a pillar extending to or beyond of the distal ends 430 of any of the abutments140, that the interface resulting from the implantation of the hard tissue implant 100 into the hard tissue will result in an interface that is continuous with the hard tissue and discontinuous with the hard tissue implant 100. it is also noted that such an interface will exhibit properties similar to those of massive hard tissue adjacent to the interface, for example, high load resilience.
[0056] Considering the exemplary embodiments of the hard tissue implant 100 in more detail, in an illustrative embodiment, the modulus of elasticity of the hard tissue implant 100 is 18 to 25 GPa and the ratio (i) of the sum of the 710 volumes of the slots 150 for (ii) the sum of the volumes 520 of the columns 140 and the volumes 710 of the slots 150 is from 0.51:1 to 0.60:1. In another illustrative embodiment, the modulus of elasticity of the hard tissue implant 100 is from 100 to 110 GPa and the ratio of (i) the sum of the volumes 710 of the slots 150 to (ii) the sum of the volumes 520 of the pillars 140 and the volumes 710 of slots 150 is from 0.70:1 to 0.76:1. In another illustrative embodiment, the hard tissue implant 100 is made of implantable grade polyetheretherketone, the cross-sectional area 510 of each abutment 140 is from (350 µm x 350 µm) to (450 µm x 450 µm), the abutment height 420 of each column 140 is from 400 to 600 μm, the slit width 152 of each slit 150 is from 190 to 210 μm, and the ratio of (i) the sum of the volumes 710 of the slits 150 to (ii) the sum of the volumes 520 of pillars 140 and volumes 710 of slots 150 is from 0.85:1 to 1.6:1. In another illustrative embodiment, the hard tissue implant 100 is made of implantable grade polyetheretherketone, the cross-sectional area 510 of each abutment 140 is from (395 µm x 395 µm) to (405 µm x 405 µm), the abutment height 420 of each column 140 is from 490 to 510 µm, the slit width 152 of each slit 150 is from 190 to 210 µm, and the ratio of (i) the sum of the volumes 710 of the slits 150 to (ii) the sum of the volumes 520 of pillars 140 and volumes 710 of slots 150 is from 0.92:1 to 1.4:1. In another illustrative embodiment, the hard tissue implant 100 is made of titanium, the cross-sectional area 510 of each abutment 140 is from (350 µm x 350 µm) to (450 µm x 450 µm), the abutment height 420 of each abutment 140 is from 400 to 600 μm, the slit width 152 of each slit 150 is from 390 to 410 μm, and the ratio of (i) the sum of the 710 volumes of the slits 150 to (ii) the sum of the 520 volumes of the columns 140 and of the volumes 710 of the slots 150 is from 2.2:1 to 3.7:1. In another illustrative embodiment, the hard tissue implant 100 is made of titanium, the cross-sectional area 510 of each abutment 140 is from (395 µm x 395 µm) to (405 µm x 405 µm), the abutment height 420 of each abutment 140 is from 490 to 510 μm, the slit width 152 of each slit 150 is from 390 to 410 μm, and the ratio of (i) the sum of the 710 volumes of the slits 150 to (ii) the sum of the 520 volumes of the columns 140 and of the volumes 710 of slots 150 is from 2.4:1 to 3.5:1. Methods of Production of Hard Tissue Implants
[0057] Methods will now be described for producing a hard tissue implant that, after implantation in a hard tissue, provides immediate load transfer and prevents the imbalance of normal stresses exerted on the bone. As described above with reference to FIGs. 1-7, hard tissue implant 100 includes a massive implant 110, a face 120, abutments 140, and slots 150. Face 120 is an outer surface of the massive implant 110. Abutments 140 are for implantation into a hard tissue. Abutments 140 are distributed on face 120 of hard tissue implant 100 over an area of at least 80 mm2. Abutments 140 extend distally from face 120 of the hard tissue implant 100. Each abutment 140 is integral to the massive implant 110, has a distal end 430, a cross-sectional area 510 from (200 µm x 200 µm) to (10,000 µm) μm x 10,000 μm), ie 4.0 x 104μm2a 1.0 x 108μm2, and has a 420 abutment height of 100 to 10,000 μm. Slots 150 will be occupied by the hard tissue. Slits 150 are defined by abutments 140. Each slit 150 has a width 152 of 100 to 10,000 µm as measured along the shortest distance between adjacent abutments 140. Hard tissue implant 100 has a Young's Modulus of Elasticity of Fur minus 10 GPa, and has a ratio of (i) the sum of the 710 volumes of the 150 slots to (ii) the sum of the 520 volumes of the 140 columns and the 710 volumes of the 150 slots of 0.40:1 to 0.90:1 . The hard tissue implant 100 does not include any portion that is hollow, and does not include any portion (other than the abutments) extending to or beyond the distal ends 430 of any of the abutments 140.
[0058] The method may include a step of designing the hard tissue implant 100 so that the ratio of (i) the product of (a) the modulus of elasticity of the hard tissue implant 100 and (b) the sum of the volumes 520 of the pillars 140, for (ii) the product (a) of the elastic modulus of the hard tissue and (b) the sum of the volumes 710 of the slits 150 is, for example, from 0.80:1 to 3.8:1, 0 .90:1 to 3.6:1, 0.85:1 to 1.6:1, 0.92:1 to 1.4:1, 2.2:1 to 3.7:1 or 2.4 :1 to 3.5:1. Without intending to be bound by theory, it is believed that by designing the hard tissue implant 100 in this way, the interface resulting from the implantation of the hard tissue implant 100 will have a Young's modulus of elasticity similar to that of the massive hard tissue adjacent to the interface, and again will exhibit properties similar to those of massive hard tissue adjacent to the interface, e.g., high load resilience. This step can be carried out, for example, by determining the aspects of the hard tissue implant 100 in view of the particular hard tissue that will be the object of implantation. Aspects to be determined include the material from which the hard tissue implant 100 will be made, the dimensions of the massive implant 100 of the hard tissue implant 100, the area 170 of the face 120 of the hard tissue implant 100 along which abutments 140 will be distributed, and the number, distribution, size and direction of extension of the pillars 140.
[0059] Hard tissue can be selected, for example, from the group consisting of bone, cartilage, calcified cartilage, non-calcified cartilage and tissue that has become mineralized. Hard tissue can also be selected, for example, from the group consisting of long bone, maxillary bone, mandibular bone, and membranous bone. Hard tissue can also be selected, for example, from the group consisting of the tibia, femur, shoulders, small joints, skull and metatarsus. Hard tissue can also be, for example, pimples.
[0060] The hard tissue implant 100 can be made, for example, of a material selected from the group consisting of implantable grade polyetheretherketone, titanium, stainless steel, cobalt-chromium alloy, and titanium alloy. The hard tissue implant 100 can also be made, for example, of hard tissue obtained from a human or animal selected from the group consisting of an autologous hard tissue, an allogeneic hard tissue, a xenogenic hard tissue, human cartilage, cartilage animal, a human bone, an animal bone and a cadaver bone.
[0061] The Young's modulus of elasticity of the hard tissue into which the hard tissue implant 100 will be implanted can be taken into account. Young's modulus of elasticity of hard tissue can be determined, for example, based on previously determined values for hard tissue of this type or based on direct measurement. For example, it has been reported in the technique that wet human femoral bone produces values for Young's modulus of elasticity, as determined by mechanical testing, as follows: Elong 17 GPa, Etransv 11.5, and Etransv 11.5. See, for example, Elastic anisotropy of bone, http://silver.neep.wisc.edu/~lakes/BME315N3.pdf (last accessed December 8, 2010) (quoting Reilly, DT & Burstein, AH, The Elastic and Ultimate Properties of Compact Bone Tissue, 8 J. Biomechanics 393-405 (1975)). It has also been reported in the technique that wet bovine femoral bone produces values for Young's modulus of elasticity, as determined by ultrasound, as follows: Elong 22 GPa, Etransv 15, and Etransv 12. See, for example, Elastic anisotropy of bone (quoting Van Buskirk, WC & Ashman, RB, The Elastic Moduli of Bone, in Mechanical Properties of Bone, ASME-ASCE Joint Applied Mechanics, Fluids Engineering and Bioengineering Conference, Boulder, CO, 1981). It was also reported in the technique that the stiffness of compact bone tissue varies with the type of bone, for example, Young's modulus of peroneal bone and tibial bone are about 18% larger and 8% larger, respectively, than the modulus. of elasticity of the femoral bone. See, for example, Elastic anisotropy of bone.
[0062] In addition, the hard tissue implant 100 may include the various illustrative embodiments as disclosed above.
[0063] Thus, for example, the hard tissue implant 100 can be designed for implantation, for example, in a femur. The hard tissue implant 100 can be made, for example, of implantable grade polyetheretherketone, which has a Young's modulus of elasticity of 18 GPa. The hard tissue implant 100 can be designed such that the massive implant 110 has it. a three-dimensional rectangular prism shape with a length of 12 mm, a width of 8 mm and a height of 3 mm. The area 170 of the face 120 over which the posts 140 are distributed can be designed, for example, to be 11.2 mm x 7.6 mm, ie 85 mm2, and to have a flat contour. The hard tissue implant 100 can include, for example, abutments 140 distributed in a regular pattern of 19 columns along the length of the massive implant 110 and 13 rows across the width of the massive implant 110, for a total of 247 abutments 140. Pillars 140 can be designed to have, for example, a square shape as seen in a top view, each pillar 140 having a length of 400 µm, a width of 400 µm and a height of 500 µm. Posts 140 can also extend perpendicularly from face 120.
[0064] From the foregoing, it will also be appreciated that this project would result in a sum of (i) the volumes 520 of the columns 140 and (ii) the volumes 710 of the slots 150 being equal to the product (i) of the area 170 of the face 120 along which the columns 140 are distributed and (ii) the column height 420 of the columns 140, the product in this case being (1.12 x 104 μm x 7.6 x 103 μm x 500 μm), ie , 4.26 x 1010μm3.
[0065] It will also be appreciated that this design would result in each column 140 having a cross-sectional area 510 of (400 µm x 400 µm), ie, 1.6 x 105 µm2. It will also be appreciated that the sum of the volumes 520 of the columns 140 could be determined from the product of (i) the number of columns 140 on face 120, (ii) the cross-sectional area 510 of each column 140 and (iii) the column height 420 of each pillar 140, the product, in this case, being (19 x 13 x 400 μm x 400 μm x 500 μm), that is, 1.98 x 1010μm3.
[0066] It will also be appreciated that this design would result in slit widths 150, as measured over the shortest distance between adjacent posts 140, of 200 µm. It will also be appreciated that the sum of the volumes 710 of the slits 150 could also be determined from the difference between (i) the product of (a) the area 170 of the face 120 over which the columns 140 are distributed and (b) that of the column height 420 of columns 140 and (ii) the sum of the volumes 520 of columns 140, the difference in this case being (4.26 x 1010μm3-1.98 x 1010μm3), that is, 2.28 x 1010 μm3 .
[0067] From the foregoing, it will also be appreciated that the ratio (i) of the sum of the volumes 710 of the slots 150 to (ii) the sum of the volumes 520 of the columns 140 and the volumes 710 of the slots 150 can also be determined , the ratio, in this case, being (2.28 x 1010μm3): (4.26 x 1010μm3), that is, 0.54:1.
[0068] As can be seen from the above values, for the implantation of a hard tissue implant 100 made of implantable grade polyetheretherketone having a Young's modulus of elasticity of 18 GPa and having the dimensions noted above, into human femoral bone moist, which, as noted above, has values for the Young's modulus of elasticity of Elong 17 GPaaix, Etransv 11.5 and Etransv 11.5, the ratio (i) of the product (a) of the tissue implant's modulus of elasticity. - of the hard 100 and (b) the sum of the volumes 520 of the columns 140, that is, (18 x 1.98 x 1010 μm3), or 3.56 x 1011μm3, for (ii) the product (a) of the modulus of elasticity of the hard tissue and (b) the sum of the 710 volumes of the 150 slits, that is, (17 x 2.28 x 1010μm3) for (11.5 x 2.28 x 1010μm3), or 3.88 x 1011μm3a 2, 62 x 1011μm3, is from 0.92:1 to 1.4:1.
[0069] As another example, the hard tissue implant 100 can be designed for implantation, for example, into a femur. The hard tissue implant 100 can be made, for example, of titanium, which has a Young's modulus of elasticity of 107 GPa. The hard tissue implant 100 can be designed such that the massive implant 110 thereof has a shape of three-dimensional rectangular prism with a length of 12 mm, a width of 8 mm and a height of 3 mm. The area 170 of face 120 over which the posts 140 are distributed can be designed, for example, to be 11.6 mm x 7.6 mm, ie 85 mm2, and to have a flat contour. The hard tissue implant 100 can include, for example, posts 140 distributed in a regular pattern of 15 columns along the length of the massive implant 110 and 10 rows across the width of the massive implant 110, for a total of 150 posts 140. Pillars 140 can be designed to have, for example, a square shape as seen in a top view, each pillar 140 having a length of 400 µm, a width of 400 µm and a height of 500 µm. Pillars 140 can again extend perpendicularly from face 120.
[0070] From the foregoing, it will also be appreciated that this project would result in a sum of (i) the volumes 520 of the columns 140 and (ii) the volumes 710 of the slots 150 being equal to the product (i) of the area 170 of the face 120 along which the columns 140 are distributed and (ii) the column height 420 of the columns 140, the product in this case being (1.16 x 104μm x 7.6 x 103μm x 500 μm), that is, 4 .41 1010μm3.
[0071] It will also be appreciated that this design would result in each pillar 140 having a 510 cross-sectional area of (400 µm x 400 µm), ie, 1.6 x 105 µm2. It will also be appreciated that the sum of the volumes 520 of the pillars 310 could be determined from the product of (i) the number of pillars 140 according to the regular pattern 310 of distribution of the pillars 140, (ii) the cross-sectional area 510 of each pillar 140 and (iii) the height of pillar 420 of each pillar 140, the product in this case being (15 x 10 x 400 μm x 400 μm x 500 μm), that is, 1.20 x 1010μm3.
[0072] It will also be appreciated that this design would also result in slit widths 150, as measured over the shortest distance between adjacent posts 140, of 400 µm. Therefore, it will also be appreciated that the sum of the volumes 710 of the slots 150 could also be determined from the difference between (i) the product (a) of the area 170 of the face 120 over which the columns 140 are distributed and (b) ) the height of column 420 of columns 140 and (ii) the sum of the volumes 520 of columns 140, the difference, in this case, being (4.41 x 1010μm3-1.20 x 1010 μm3), that is, 3, 21 x 1010μm3.
[0073] From the foregoing, it will also be appreciated that the ratio (i) of the sum of the volumes 710 of the slots 150 to (ii) the sum of the volumes 520 of the columns 140 and the volumes 710 of the slots 150 can also be determined , the ratio, in this case, being (3.21 x 1010μm3):(4.41 1010μm3), that is, 0.73:1.
[0074] As can be seen from the above values, for the implantation of a hard tissue implant 100 made of implantable grade polyetheretherketone having a Young's modulus of elasticity of 18 GPa and having the dimensions noted above, into human femoral bone moist, which, as noted above, has values for the Young's modulus of elasticity of Elong 17 GPaaix, Etransv 11.5 and Etransv 11.5, the ratio (i) of the product (a) of the tissue implant's modulus of elasticity hard 100 and (b) the sum of the volumes 520 of the columns 140, that is, (18 x 1.20 x 1010 μm3), or 1.28 x 1012 μm3, for (ii) the product (a) of the modulus of elasticity of the hard tissue and (b) the sum of the volumes 710 of the slits 150, that is, (17 x 3.21 x 1010μm3) to (11.5 x 3.21 x 1010μm3), or 5.45 x 1011μm3a 3.69 x 1011μm3, is from 2.4:1 to 3.5:1.
[0075] Additional alternatives for the step of designing the hard tissue implant 100 so that the ratio of (i) the product of (a) the modulus of elasticity of the hard tissue implant 100 and (b) the sum of the volumes 520 of the abutments 140 for (ii) the product (a) of the modulus of elasticity of the hard tissue and (b) the sum of the volumes 710 of the slits 150 is, for example, from 0.80:1 to 3.8:1, 0.90 :1 to 3.6:1, 0.85:1 to 1.6:1, 0.92:1 to 1.4:1, 2.2:1 to 3.7:1, or 2.4: 1 to 3.5:1, may include, for example, using different materials to produce the hard tissue implant 100, selecting different dimensions of the massive implant 110 from the hard tissue implant 100, selecting a different area 170 of the face 120 of the hard tissue implant 100 along which the abutments 140 will be distributed, and/or the selection of different numbers, distributions, sizes and directions of extension of the abutments 140. For example, for the design of an implant. hard tissue 100 made of hard tissue, Young's modulus of elasticity relatively low hard tissue could be taken into account, so that the hard tissue implant 100 can be designed to produce an interface, when implanting a hard tissue, for which the ratio (i) of the sum of the crack volumes for (ii) the sum of the volumes of the pillars and the volumes of the gaps is approximately 0.50:1 and the ratio (i) of the product (a) of the modulus of elasticity of the hard tissue implant 100 and (b) the sum of the volumes 520 of the pillars 140 for (ii) the product (a) of the modulus of elasticity of the hard tissue and (b) the sum of the volumes 710 of the slits 150 is approximately 1:1. In addition, for example, for the design of a hard tissue implant 100 for implantation in relatively old hard tissue, for example, of an elderly person, a relative decrease in Young's modulus of elasticity associated with the older age of a hard tissue can be taken into account when designing the hard tissue implant 100.
[0076] The method may also include a step of producing the hard tissue implant 100 according to the design. Methods for producing a hard tissue implant 100 as disclosed herein include laser cutting, injection molding and other conventional manufacturing methods that are well known in the art. Methods of Using Hard Tissue Implants
Methods of using a hard tissue implant 100 in a hard tissue of an individual in need thereof will now be described. As described above with reference to FIGs. 1-7, hard tissue implant 100 includes a massive implant 110, a face 120, abutments 140, and slots 150. Face 120 is an outer surface of the massive implant 110. Abutments 140 are for implantation into a hard tissue. Abutments 140 are distributed on face 120 of hard tissue implant 100 over an area of at least 80 mm2. Abutments 140 extend distally from face 120 of the hard tissue implant 100. Each abutment 140 is integral to the massive implant 110, has a distal end 430, a cross-sectional area 510 from (200 µm x 200 µm) to (10,000 µm) µm x 10,000 µm), i.e. 4.0 x 104 µm2a 1.0 x 108 µm2, and has a 420 abutment height of 100 to 10,000 µm. Slots 150 will be occupied by the hard tissue. Slits 150 are defined by abutments 140. Each slit 150 has a width 152 of 100 to 10,000 µm as measured along the shortest distance between adjacent abutments 140. Hard tissue implant 100 has a Young's Modulus of Elasticity of Fur minus 10 GPa, and has a ratio of (i) the sum of the 710 volumes of the 150 slots to (ii) the sum of the 520 volumes of the 140 columns and the 710 volumes of the 150 slots of 0.40:1 to 0.90:1 . The hard tissue implant 100 does not include any portion that is hollow, and does not include any portion (other than the abutments) extending to or beyond the distal ends 430 of any of the abutments 140.
[0078] The method includes a step of selecting the hard tissue implant 100 so that the ratio of (i) the product of (a) the modulus of elasticity of the hard tissue implant 100 and (b) the sum of the volumes 520 of the abutments 140, for (ii) the product (a) of the modulus of elasticity of the hard tissue and (b) the sum of the volumes 710 of the slits 150 is, for example, from 0.80:1 to 3.8:1, 0, 90:1 to 3.6:1, 0.85:1 to 1.6:1, 0.92:1 to 1.4:1, 2.2:1 to 3.7:1 or 2.4: 1 to 3.5:1.
[0079] The method also includes a step of implanting the hard tissue implant 100 into the hard tissue. The implant can be carried out, for example, without rotation or twisting of the hard tissue implant 100. The implant can also be carried out, for example, without the use of adhesives, for example, cement or grout. The implant can also be performed, for example, without the use of screws or coating mechanisms..
[0080] The implant may include, for example, pressing the hard tissue implant 100 into the hard tissue, thereby providing immediate load transfer and preventing imbalance of the normal stresses exerted on the bone. The pressing can take place, for example, by direct compression, mechanical compression or threading. Such pressing may include pressing posts 140 of hard tissue implant 100 into hard tissue so that posts 140 penetrate hard tissue, partially or completely. For example, the hard tissue implant 100 can be pressed into the hard tissue so that the abutments 140 penetrate the hard tissue to a depth of, for example, 1 to 10,000 μm, 100 to 5,000 μm, 200 to 2,500 μm, 300 to 1000 μm, 400 to 600 μm, 450 to 550 μm, 490 to 510 μm or 500 μm. In addition, for example, the pillars 140 can be pressed into the hard tissue so that the pillars 140 penetrate the hard tissue to a depth, relative to the pillar height 420 of the pillars 140, of, for example, 25%, 50%, 75% and 100% of the pillar height 420 of the pillars 140.
[0081] The implant may also include, for example, pressing the hard tissue implant 100 into the hard tissue, so that the posts 140 are oriented perpendicular to the axis of primary tension and compression of the hard tissue and penetrate into the hard tissue, thereby providing immediate load transfer and preventing the imbalance of normal stresses exerted on the bone. The term "primary hard tissue tension and compression axis", as used herein, means the main axis of hard tissue along which tension and compression forces are transmitted during normal function and use of hard tissue, for example , the long axis of a bone, such as the tibia or femur. Without intending to be limited to theory, it is believed, having the abutments 140 oriented perpendicularly to the axis of tension and primary compression of the hard tissue, and also causing the abutments 140 to penetrate the hard tissue during the implant, which immediately after the implant, the hard tissue implant 100 will experience immediate load transfer with respect to hard tissue tension and compression, and that this will prevent imbalance of normal hard tissue stresses at the interface of the hard tissue implant 100 and the hard tissue.
[0082] Also, for example, the implant may also include pressing the hard tissue implant 100 into the hard tissue, so that the posts 140 are oriented at an acute angle to the direction of pressing and penetrate the hard tissue, thereby providing immediate load transfer and preventing the imbalance of normal stresses exerted on the bone. It is understood by the pillars 140 being oriented at an acute angle with respect to the direction of pressing that the pillars 140 are inclined forward to at least some extent, that is, they are at an angle of less than 90°, with respect to the direction. of the trajectory by which the implant 100 is pressed into the hard tissue. It is understood, by being oriented at an acute angle, that a plurality of pillars, for example, at least 10%, at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 90% or 100% are oriented at an acute angle, for example at angles ranging from 1° to 89°, 10° to 80°, 20° to 70° , 30° to 60°, 40° to 50°, 1° to 10°, 11° to 20°, 21° to 30°, 31° to 40°, 41° to 50°, 51° to 60°, 61 ° to 70°, 71° to 80°, 81° to 89°, 15°, 30°, 45°, 60° or 75°, in relation to the direction of pressing. Without intending to be limited to theory, it is believed, having the abutments 140 oriented at an acute angle to the direction of pressing, and also causing the abutments 140 to penetrate the hard tissue during implantation, that, again , immediately after implant, the hard tissue implant 100 will experience immediate load transfer with respect to the tension and compression of the hard tissue, thereby providing immediate load transfer between the hard tissue implant 100 and the hard tissue, and that will prevent imbalance of normal hard tissue stresses at the hard tissue and hard tissue implant interface.
[0083] In addition, for example, the implant may include pressing the hard tissue implant 100 into a cavity that has been wedged into the hard tissue so that the posts 140 penetrate the hard tissue, thereby providing immediate load transfer and preventing the imbalance of normal stresses exerted on the bone. For example, the cavity can be coined to dimensions wider than the massive implant 110, but narrower than the massive implant 110 including the posts 140, so that pressing the hard tissue implant 100 into the cavity results in the posts 140 of the hard tissue implant 100 contacting and penetrating the hard tissue during pressing. Also, for example, the cavity that has been stamped into the hard tissue can be tapered from the hard tissue surface inwards, i.e. wider in the hard tissue surface and narrower with greater depth in the hard tissue, so that the pressing of the hard tissue implant 100 into the well results in the abutments 140 of the hard tissue implant 100 contacting and penetrating the hard tissue only after the implant 100 has been pressed to some depth in the well. In addition, for example, the hard tissue implant 100 can be tapered so that a tapered cavity and a tapered hard tissue implant 100 have a complementary fit, for example, so that the pressing of the hard tissue implant 100 into the cavity results in the abutments 140 of the hard tissue implant 100 contacting and penetrating the hard tissue only after the implant 100 has been pressed to a certain depth into the cavity in each complementary engagement area between the tapered cavity and the tapered hard tissue implant 100. Without intending to be bound by theory, it is believed that by pressing the hard tissue implant 100 into a cavity that has been wedged into the hard tissue so that the posts 140 penetrate the hard tissue during the implant, that, again, immediately after implantation, the hard tissue implant 100 will experience immediate load transfer in relation to the tension and compression of the hard tissue, and that this will prevent desiccation. freedom from normal hard tissue stresses at the interface of the hard tissue implant 100 and the hard tissue.
[0084] Conventional approaches to implant hard tissue implant 100, press hard tissue implant 100 into hard tissue, orient hard tissue implant 100 or pillars 140 thereof, and press hard tissue implant 100 into a cavity that was minted in hard tissue are known in the art and can be used in the methods disclosed herein.
[0085] Hard tissue can be selected, for example, from the group consisting of bone, cartilage, calcified cartilage, non-calcified cartilage and tissue that has become mineralized. Hard tissue can also be selected, for example, from the group consisting of long bone, maxillary bone, mandibular bone, and membranous bone. Hard tissue can also be selected, for example, from the group consisting of the tibia, femur, shoulders, small joints, skull and metatarsus. Hard tissue can also be, for example, pimples.
[0086] The hard tissue implant 100 can be made, for example, of a material selected from the group consisting of implantable grade polyetheretherketone, titanium, stainless steel, cobalt-chromium alloy, and titanium alloy. The hard tissue implant 100 can also be made, for example, of hard tissue obtained from a human or animal selected from the group consisting of an autologous hard tissue, an allogeneic hard tissue, a xenogenic hard tissue, human cartilage, cartilage animal, a human bone, an animal bone and a cadaver bone.
[0087] The method can be applied to illustrative embodiments of the hard tissue implant 100 as disclosed above. The ratio of (i) the sum of the volumes 710 of the slots 150 to (ii) the sum of the volumes 520 of the posts 140 and the volumes 710 of the slots 150 can be determined essentially as described above in connection with the design of the hard tissue implant 100. The ratio (i) of the product (a) of the modulus of elasticity of the implant of hard tissue 100 and (b) of the sum of the volumes 520 of the pillars 140, to (ii) of the product (a) of the modulus of elasticity of the hard tissue and (b) the sum of the volumes 710 of the slits 150 can also be determined essentially as described above with respect to the design of the hard tissue implant 100.
[0088] The implant may include, for example, pressing the hard tissue implant 100 into the hard tissue, thereby providing immediate load transfer and preventing imbalance of the normal stresses exerted on the bone. Methods for pressing a hard tissue implant 100 into a hard tissue are also known in the art.
[0089] Additional aspects of the present disclosure will be understood in conjunction with one or more of the following examples, which are presented by way of illustration. EXAMPLE 1
[0090] Hard tissue implants: Four types of hard tissue implants with abutments, here designated as implant 1, implant 2, implant 3 and implant 4, and a smooth control implant were designed and produced.
[0091] Specifically, implants 1 to 3 were made of implantable grade polyetheretherketone ("PEEK"), having a Young's modulus of elasticity of approximately 18 GPa. Implant 4 was made of titanium, having a modulus of Young's elasticity of approximately 107 GPa. All implants 1 to 4 were constructed to have a generally rectangular prism shape, with a length of 12mm, a width of 8mm and a depth of 4mm. All massive implants of implants 1 to 4 were produced with a length of 12 mm, a width of 8 mm and a depth of 3 mm. Therefore, each of the massive implants of implants 1 to 4 had two faces with a length of 12 mm and a width of 8 mm. Each of the two faces was defined by a sharp edge.
[0092] The abutments were distributed in a regular pattern on the two faces of each massive implant from implants 1 to 4, as follows.
[0093] For implant 1 (PEEK), the abutments were distributed on each of the two faces in 23 columns along the length of the massive implant and 15 rows along the width of the massive implant, corresponding to 345 abutments per face. The pillars were located 300 µm from the edge. The abutments were integrated into the massive implant. Each of the pillars had a length of 400 µm and a width of 400 µm, and therefore a square shape as seen from a top view and a cross-sectional area of 1.6 x 105 µm2. Each of the pillars had a height of 500 µm. According to this distribution, the crack width was 100 µm as measured along the shortest distance between adjacent pillars, and the gap height was 500 µm.
[0094] For implant 2 (PEEK), the abutments were distributed on each of the two sides in 19 columns along the length of the massive implant and 13 rows along the width of the massive implant, corresponding to 247 abutments per face. The pillars were located 200 μm from the edge with a length of 12 mm, and 400 μm from the edge with a length of 8 mm. The abutments were integrated into the massive implant. Each of the pillars had a length of 400 µm and a width of 400 µm, and therefore a square shape as seen from a top view and a cross-sectional area of 1.6 x 105 µm2. Each of the pillars had a height of 500 µm. According to this distribution, the slit width was 200 µm as measured along the shortest distance between adjacent pillars, and the slit height was 500 µm.
[0095] For implants 3 (PEEK) and 4 (titanium), the abutments were distributed on each of the two sides in 15 columns along the length of the massive implant and 10 rows along the width of the massive implant, corresponding to 150 pillars per face. The pillars were located 200 µm from the edge. The abutments were integrated into the massive implant. Each of the pillars had a length of 400 µm and a width of 400 µm, and therefore a square shape as seen from a top view and a cross-sectional area of 1.6 x 105 µm2. Each of the pillars had a height of 500 µm. According to this distribution, the slit width was 400 µm as measured along the shortest distance between adjacent pillars, and the slit height was 500 µm.
[0096] The dimensions of the abutments and slots, with respect to one of the two faces of each of the implants 1 to 4, and various ratios thereof, calculated essentially as described above, are illustrated in TABLES 1 to 3.




[0097] The ratios (i) of the product (a) of the modulus of elasticity of the hard tissue implant and (b) the sum of the volumes of the pillars for (ii) the product (a) of the modulus of elasticity of the hard tissue and ( b) the sum of the slit volumes, for each of the implants 1 to 4, in relation to the human femur, calculated essentially as described above, are illustrated in TABLE 4.
*The ratio corresponds to the ratio (i) of the product (a) of the modulus of elasticity of the hard tissue implant and (b) of the volume of the abutments to (ii) the product (a) of the modulus of elasticity of the hard tissue and (b) ) the sum of the crack volumes.
[0098] The smooth control implant was made of PEEK, with dimensions of 12 mm x 8 mm x 3 mm, and had no abutment surfaces. EXAMPLE 2
[0099] Mechanical and histological test of hard tissue implants: The mechanical and histological properties of implants 1 to 4 and the control implant, as described in Example 1, and the tissue-implant interfaces thereof, were tested in an animal model. Specifically, 5 large adult male dogs were selected. Surgery regulated and approved by the IACCUC was performed. One of each of the implants 1 to 4 and the control implant were implanted in each femur of each dog, with the implant being carried out in the posterior shaft of the femoral shaft, the implants being implanted in a single line along the long axis of the femur , the order of the implants being determined at random, and the implants being oriented so that the 12 mm axes of the implants were parallel to the long axis of the femur, and the 8 mm axes of the implants were orthogonal to the surface of the femur , that is, the implants were implanted in such a way that the two compilation faces of each of the implants 1 to 4 were in contact with the femur. The implant was performed by pressing each implant into the femur. Six weeks after implantation, dogs were euthanized and implants were collected. For each of implants 1 to 4 and the control implant, six specimens were mechanically tested and two specimens were analyzed with respect to histology.
[00100] The mechanical test was carried out as follows. Each sample was tested using a compression method based on the use of a compression head and a plunger. Preparation of the collected implants included cutting the bone into separate test sections and removing the medullary tissue to lessen the extra strength. The implant surface was normally aligned to the compression head. The plunger was a 3 x 10 mm piece of metal. A compression rate of 1 mm/min was used. The upper limit of load for the load cell was 1000 N. The load (N) versus extension (mm) and the load (N) to failure were measured for each sample.
[00101] The results for load extension are shown in FIGS. 8A-E. As can be seen from FIGS. 8C-E, implants 2, 3 and 4, corresponding to PEEK, PEEK and titanium implants, respectively, having slit widths of 200 μm, 400 μm and 400 μm, respectively, underwent substantial leakage/elongation before the failure. In fact, two samples of implant 4 withstood the upper limit of the 1000 N load for the load cell. In contrast, as seen in FIGS. 8A and 8B, the control implant, which was devoid of abutments, and implant 1, corresponding to a PEEK implant having a slit width of 100 µm, did not undergo substantial flow/elongation prior to failure. The results suggest that slit widths of 200 to 400 µm allow the implants to undergo substantial flow/elongation prior to failure.
[00102] The results for load-to-failure are shown in FIG. 9. As can be seen, implant 4, corresponding to a titanium implant with a width of 400 μm, had the highest load to the average failure, > 816 N (taking into account that two of the samples withstood the upper limit of 1000 No. of load for the load cell). Implant 2, corresponding to a PEEK implant with a slit width of 200 μm, had the highest load until the next failure, 742 N. Implant 3, corresponding to a PEEK implant with a slit width of 400 μm, had the higher load until the next failure, 700 N. Implant 1, corresponding to a PEEK implant with a slot width of 100 μm, and the control implant, corresponding to a PEEK implant without abutments, had substantially lower loads to failure , of 286 N and 46 N, respectively. The results suggest that slit widths of 200 to 400 µm allow implants to withstand a relatively high load before failure. Furthermore, considering these results in view of the data in TABLE 3, the results also suggest that hard tissue implants have a ratio of the sum of the crack volumes to the sum of the abutment volumes and the crack volumes of 0.51: 0 to 0.90:1, eg implants 2, 3 and 4, can withstand relatively high loads before failure. Furthermore, considering these results in view of the data in TABLE 4, the results suggest that hard tissue implants additionally have a ratio (i) of the product of the modulus of elasticity of the hard tissue implant and the sum of the volumes of the abutments to (ii ) the product of the hard tissue's modulus of elasticity and the sum of the crack volumes between about 0.80:1 to 3.8:1, for example, implants 2 and 4, can withstand even higher loads before failure.
[00103] Histological analyzes were performed using hematoxylin and eosin stain and trichrome stain. Illustrative results are shown in FIGS. 10A-D, corresponding to histological micrographs at a 4X magnification of (a) implant 1 (PEEL, 100 μm slit width) face 25 μm H&E dye, (B) implant 2 (PEEK, 200 μm slit width) face 25 μm trichrome dye, (C) implant 3 (PEEK, slit width 400 μm) face 25 μm trichrome dye, and (D) implant 4 (titanium, slit 400 μm) 25 μm trichrome dye. Results for the histological analysis indicate that all implants 1 to 4, having slit widths of 100 μm, 200 μm, 400 μm and 400 μm, respectively, presented bone intragrowth in their slits. The intragrowth for implant 1 was different from implants 2 to 4, but nevertheless occurred. Implants 2 to 4, but not implant 1, also showed rich vascularity in their clefts. No significant inflammatory response was observed with any of implants 1 to 4. The results indicate that the failure of implant 1 to undergo substantial leakage/elongation before failure and the lower load to failure for implant 1 relative to implants 2, 3, and 4 are not due to an absence of bone swell, but rather suggest that limiting bone volume at the interface may lead implants to fail to undergo substantial leakage/elongation prior to failure and to have relatively low loads to failure. EXAMPLE 3
[00104] Prognostic example relating to hip and other prostheses: Hard tissue implant, including a massive implant, a face, abutments and slits, as described above, can be used in the hip prosthesis to allow for initial ambulation, or potentially , immediate ambulation, avoiding the need for grout or cement, and for intimate and immediate integration of the bone with the implant at the interface. The hard tissue implant and hard tissue interface is expected to respond to mechanical stress more like natural hard tissue than a corresponding interface formed with a conventional implant, with possible benefits including the elimination of imbalance of normal stresses exerted on the bone. The implant can be, for example, a non-metallic polymer implanted in a joint articulated surface. Similarly, the hard tissue implant can be used in shoulder prosthesis, wrist or finger joint prosthesis, ankle prosthesis, knee prosthesis and cartilage inserts. EXAMPLE 4
[00105] Prognostic example regarding metatarsal wedge implants: the hard tissue implant, including a massive implant, one face, abutments and slots, as described above, can be used in metatarsal wedge implants. In pediatrics, there are patients for whom an implant wedge needs to be implanted in order to realign and redirect the metatarsal and tarsal elements. Conventional wedge devices tend to be improperly secured due to poor integration and load transfer. Hard tissue implants, as described above, can allow for fixation with the potential of eliminating screws and other fixation mechanisms, and can reduce the potential for migration and non-union of the implant. EXAMPLE 5
[00106] Prognostic example relating to screws: Hard tissue implant, including a massive implant, a face, abutments and slots, as described above, can be formed as a screw including abutments in threads or in a helical face of the screw. Such a screw can be useful for spinal surgery, plate fixation, or ligament repair, eg knee anterior cruciate ligament repair, with the fixation end of the screw, including the pillars, being implanted into the hard tissue to allow for transfer of optimal load. Such a screw can also be useful for insertion and tension anchorage. EXAMPLE 6
[00107] Prognostic example relating to dental implants: The hard tissue implant, including a massive implant, a face, abutments and slots, as described above, can also be used as a dental implant. Conventional mechanisms for fixation of dental implants with smooth surfaces or conventional surface morphologies in maxillary and mandibular bones are inadequate, based on poor load transfer with respect to compression and vertical shear of the bone to dental implants and poor matching of the Young's modulus of elasticity between dental implants and bone. The hard tissue implant as described above can provide improved load transfer based on implantation of the hard tissue implant in the form of a dental implant, or (i) such that the implant abutments are oriented perpendicular to the primary compression axis of the maxillary or mandibular bone and penetrate the jaw bone, or (ii) pressing the implant into the maxillary or mandibular bone so that the implant abutments are oriented at an acute angle to the direction of pressing and penetrate the bone. The hard tissue implant, as described above, will also provide improved correlation of the Young's modulus of elasticity between the implant and the hard tissue at the interface. The resulting interface can be expected to be durable, resistant to the imbalance of normal stresses placed on bone, and resilient to load. EXAMPLE 7
[00108] Prognostic example relating to minimally invasive surgery: Hard tissue implant, including a massive implant, a face, abutments and slits, as described above, can also be used in minimally invasive surgery. Current approaches to reconstructive surgery include minimally invasive surgery requiring the addition or removal of only a minor or superficial portion of a hard tissue component from a joint, finger, wrist, elbow, shoulder, knee, or (potentially) hip. Consequently, a new interface needs to be created and inserted into the corresponding hard tissue. The hard tissue implant, as described above, can be designed for initial impregnation and load-bearing, based on satisfactory surface integration through load-bearing, with the result that no extensive use of screws or fixation mechanisms at the time of implant. EXAMPLE 8
[00109] Prognostic example relating to hard tissue implants made from hard tissue: The hard tissue implant, including a massive implant, a face, abutments and slots as described above, can also be used as a hard implant. For example, a hard tissue, such as bone, e.g., human bone, animal bone or cadaver bone, can be machined to form the implant as described above. The implant can then be implanted into an individual, eg a human or animal, who needs it, eg a cancer patient from whom a tumor has been removed and into which a large segment of bone can be inserted. Machining the bone to form the implant can allow for ambulation, integration and interfacial integration compared to a conventional implant. Also, for example, a hard tissue, such as cartilage, can be machined to form the implant, as described above. The implant can then be implanted into another hard tissue, eg bone, to overlay the other hard tissue. Implants machined from hard tissue can be used to replace part or all of the articulated surfaces of the hard tissue into which they are implanted, leaving most of the hard tissue in place, thereby minimizing the extension of the implant.
[00110] It will be apparent to those skilled in the art that various modifications and variations can be made without departing from the spirit and scope of the claimed invention.

权利要求:
Claims (9)
[0001]
1. Hard tissue implant (100), CHARACTERIZED by comprising: (a) a massive implant (110); (b) a face (120) being an outer surface of the massive implant (110); (c) abutments (140) for implantation into hard tissue, the abutments (140) being distributed on the face (120), over an area (170) of at least 80 mm2, and extending distally from of it, and each abutment (140) being integral to the massive implant (110), having a distal end (430), with a cross-sectional area (510) of 200 x 200 to 10,000 x 10,000 μm2, and having a height (420) from 100 to 10,000 µm; and (d) slits (150) to be occupied by the hard tissue, the slits (150) being defined by the posts (140) and each slit (150) having a width (152) of 100 to 10,000 µm as measured over the distance shorter between adjacent pillars (140); wherein: the hard tissue implant (100) has a Young's modulus of elasticity of at least 10 GPa, has a ratio of (i) the sum of the volumes (710) of the slits (150) to (ii) the sum of the volumes (520) of pillars (140) and volumes (710) of cracks (150) from 0.40:1 to 0.90:1, does not comprise any part that is hollow, and does not comprise any part other than pillars, extending to or beyond the distal ends (430) of any one of the pillars (140); the pillars (140), as seen from the top view, are square in shape; and the posts (140) have distal edges (432) and side edges (434), both the distal edges (432) and the side edges (434) being sharpened.
[0002]
2. Hard tissue implant (100) according to claim 1, CHARACTERIZED by the fact that the hard tissue implant (100) is made of a material selected from the group consisting of implantable grade polyetheretherketone, titanium , stainless steel, cobalt-chromium alloy, and titanium alloy.
[0003]
3. Hard tissue implant (100), according to claim 1, CHARACTERIZED by the fact that the cross-sectional area (510) of each pillar (140) is (250 x 250) μm2a (1,000 x 1,000) μm2.
[0004]
4. Hard tissue implant (100), according to claim 1, CHARACTERIZED by the fact that the height (420) of each pillar (140) is from 200 to 2,500 μm.
[0005]
5. Hard tissue implant (100), according to claim 1, CHARACTERIZED by the fact that the modulus of elasticity of the hard tissue implant (100) is from 18 to 25 GPa and the ratio (i) of the sum of the volumes (710) of the slots (150) to (ii) the sum of the volumes (520) of the columns (140) and the volumes (710) of the slots (150) is from 0.51:1 to 0.60:1.
[0006]
6. Hard tissue implant (100), according to claim 1, CHARACTERIZED by the fact that the modulus of elasticity of the hard tissue implant (100) is from 100 to 110 GPa and the ratio of (i) the sum of the volumes (710) of the cracks (150) for (ii) the sum of the volumes (520) of the columns (140) and the volumes (710) of the cracks (150) is from 0.72:1 to 0.76:1.
[0007]
7. Hard tissue implant (100), according to claim 1, CHARACTERIZED by the fact that the hard tissue implant (100) can provide immediate load transfer after being implanted and prevent the imbalance of normal stresses exerted on the bone with the time.
[0008]
8. Hard tissue implant (100), according to claim 1, CHARACTERIZED by the fact that the massive implant (110) is non-porous and the pillars (140) are non-porous.
[0009]
9. Hard tissue implant (100), according to claim 1, CHARACTERIZED by the fact that the hard tissue implant (100) can provide immediate load transfer after being implanted and prevent the imbalance of normal stresses exerted on the bone with over time, the massive implant (110) is non-porous and the abutments (140) are non-porous.

类似技术:

---

公开号 | 公开日 | 专利标题

---

BR112014010164B1|2021-05-18|hard tissue implant

---

US11045231B2|2021-06-29|Methods for delivery of screws for joint fusion

---

US20130030529A1|2013-01-31|Implant interface system and method

---

US20110313532A1|2011-12-22|Bone implant interface system and method

---

US7361369B2|2008-04-22|Implant with structure allowing injection of polymer for attaching implant to tissue

---

TW200304368A|2003-10-01|Surgical implant

---

WO2011063250A1|2011-05-26|Implantable devices for subchondral treatment of joint pain

---

Ono et al.2000|Evaluation of a high density polyethylene fixing system for hydroxyapatite ceramic implants

---

RU136335U1|2014-01-10|SURFACE ROOF ENDOPROTHESIS

---

WO2018165403A1|2018-09-13|Hard-tissue stem implant comprising a bulk stem implant, a face, pillars for contacting a cancellous portion of a hard tissue, and slots, wherein the pillars are prearranged to match an underlying structure of the cancellous portion

---

WO2021050712A1|2021-03-18|Implant for attaching a tendon or a ligament to a hard tissue

---

US11213398B2|2022-01-04|Hard-tissue implant comprising a bulk implant, a face, pillars, slots, and at least one support member

---

AU2020344620B2|2022-02-17|Implant comprising first and second sets of pillars for attaching a tendon or ligament to a hard tissue

---

AU2020344620B8|2022-03-03|Implant comprising first and second sets of pillars for attaching a tendon or ligament to a hard tissue

---

CN102178983A|2011-09-14|HA fiber-enhanced PEEK backbone fusion device

---

US20210068961A1|2021-03-11|Hard-tissue implant comprising a shaft, a surface, pillars for contacting a hard tissue, slots to be occupied by the hard tissue, and a thread disposed helically along the shaft

---

RU98910U1|2010-11-10|SURFACE ROOF ENDOPROTHESIS

同族专利:

---

公开号 | 公开日

---

BR112014010164A2|2017-04-25|

---

EP2757999A1|2014-07-30|

---

US9579206B2|2017-02-28|

---

US20170119530A1|2017-05-04|

---

US20160213475A1|2016-07-28|

---

US20130110255A1|2013-05-02|

---

CA2853479A1|2013-05-02|

---

WO2013063069A1|2013-05-02|

---

US20140277559A1|2014-09-18|

---

US8771354B2|2014-07-08|

---

US10154908B2|2018-12-18|

---

JP2014534860A|2014-12-25|

---

EP2757999A4|2015-05-27|

---

JP6336393B6|2018-08-15|

---

US9333081B2|2016-05-10|

---

JP6336393B2|2018-06-06|

---

CA2853479C|2016-08-23|

引用文献:

---

公开号 | 申请日 | 公开日 | 申请人 | 专利标题

---

---

BE493526A|1949-04-25|

---

US3605123A|1969-04-29|1971-09-20|Melpar Inc|Bone implant|

---

CA962806A|1970-06-04|1975-02-18|Ontario Research Foundation|Surgical prosthetic device|

---

US3808606A|1972-02-22|1974-05-07|R Tronzo|Bone implant with porous exterior surface|

---

US4237559A|1979-05-11|1980-12-09|General Electric Company|Bone implant embodying a composite high and low density fired ceramic construction|

---

DE3322803A1|1983-06-24|1985-01-10|Orthoplant Vertriebs-GmbH, 2800 Bremen|Cement-free implantable prosthesis having a grid profile|

---

US4608052A|1984-04-25|1986-08-26|Minnesota Mining And Manufacturing Company|Implant with attachment surface|

---

GB8524823D0|1985-10-08|1985-11-13|Finsbury Instr Ltd|Orthopaedic implants|

---

US4778469A|1986-11-04|1988-10-18|Pfizer Hospital Products Group Inc.|Method of forming tissue ingrowth surface on surgical implants|

---

US4865603A|1988-02-04|1989-09-12|Joint Medical Products Corporation|Metallic prosthetic devices having micro-textured outer surfaces|

---

US7534254B1|1988-06-13|2009-05-19|Warsaw Orthopedic, Inc.|Threaded frusto-conical interbody spinal fusion implants|

---

US5236453A|1990-03-09|1993-08-17|Picha George J|Mammary implant and method for reducing capsule contracture|

---

DE4133877C1|1991-10-12|1993-05-19|S + G Implants Gmbh, 2400 Luebeck, De|

---

US5207709A|1991-11-13|1993-05-04|Picha George J|Implant with textured surface|

---

US5263953A|1991-12-31|1993-11-23|Spine-Tech, Inc.|Apparatus and system for fusing bone joints|

---

US5545226A|1992-05-29|1996-08-13|Porex Technologies Corp.|Implants for cranioplasty|

---

US20010039454A1|1993-11-02|2001-11-08|John Ricci|Orthopedic implants having ordered microgeometric surface patterns|

---

US5876457A|1997-05-20|1999-03-02|George J. Picha|Spinal implant|

---

US6106558A|1997-09-15|2000-08-22|Applied Medical Research, Inc.|Neuro decompression device|

---

ES2217796T3|1998-08-03|2004-11-01|Synthes Ag Chur|INTERVERTEBRAL GRAFT SEPARATOR.|

---

US7115143B1|1999-12-08|2006-10-03|Sdgi Holdings, Inc.|Orthopedic implant surface configuration|

---

KR100371308B1|2000-08-28|2003-02-07|구자교|a prosthetic implant for spinal interbody fusion and a inserting apparatus thereof|

---

US7018418B2|2001-01-25|2006-03-28|Tecomet, Inc.|Textured surface having undercut micro recesses in a surface|

---

PT2055267E|2001-05-01|2013-07-15|Amedica Corp|Radiolucent bone graft|

---

US6569201B2|2001-09-28|2003-05-27|Depuy Acromed, Inc.|Hybrid composite interbody fusion device|

---

US7192447B2|2002-12-19|2007-03-20|Synthes |Intervertebral implant|

---

US7205051B2|2003-09-30|2007-04-17|Depuy Products, Inc.|Medical implant or medical implant part|

---

KR20070004656A|2004-01-30|2007-01-09|오스테오테크, 인코포레이티드|Stacking implants for spinal fusion|

---

US7723395B2|2004-04-29|2010-05-25|Kensey Nash Corporation|Compressed porous materials suitable for implant|

---

US7250550B2|2004-10-22|2007-07-31|Wright Medical Technology, Inc.|Synthetic bone substitute material|

---

US20070168037A1|2006-01-13|2007-07-19|Posnick Jeffrey C|Orthopedic implant|

---

US7833204B2|2007-05-14|2010-11-16|Applied Medical Research|Intramedullary access or infusion devices|

---

WO2009022911A2|2007-08-16|2009-02-19|Cam Implants B.V.|Prosthesis comprising an anti-micromotion bone-interfacing surface and method for the manufacture thereof|

---

US20090069904A1|2007-09-12|2009-03-12|Applied Medical Research|Biomaterial including micropores|

---

JP5266069B2|2008-02-07|2013-08-21|昭和医科工業株式会社|cage|

---

WO2009108789A1|2008-02-29|2009-09-03|Vot, Llc|Tibial prosthesis|

---

US20110213467A1|2009-01-20|2011-09-01|Zimmer, Inc.|Orthopaedic implant with woven ingrowth material|

---

US20100256758A1|2009-04-02|2010-10-07|Synvasive Technology, Inc.|Monolithic orthopedic implant with an articular finished surface|

---

DK2253291T3|2009-05-19|2016-06-13|Nat Univ Ireland Galway|The bone implants with a structure overfladeforankrende|

---

EP2579819A4|2010-06-08|2013-12-11|Smith & Nephew Inc|Implant components and methods|

---

CN103068343B|2010-07-23|2016-08-03|普里韦勒普-施皮内股份公司|Surgery implant and relevant kit utility|

---

US9132021B2|2011-10-07|2015-09-15|Pioneer Surgical Technology, Inc.|Intervertebral implant|

---

US8771354B2|2011-10-26|2014-07-08|George J. Picha|Hard-tissue implant|

---

US9237950B2|2012-02-02|2016-01-19|Biomet Manufacturing, Llc|Implant with patient-specific porous structure|

---

US8843229B2|2012-07-20|2014-09-23|Biomet Manufacturing, Llc|Metallic structures having porous regions from imaged bone at pre-defined anatomic locations|

---

FR3019032A1|2014-03-27|2015-10-02|Ps Ii|FEMORAL IMPLANT COMPRISING A RECEPTION PORTION WITH ANCHORING PICOTS AND TOTAL KNEE PROSTHESIS COMPRISING SUCH A FEMORAL IMPLANT|

---

US20170224497A1|2014-07-31|2017-08-10|Ossis Limited|Improved Implant Surface|GB0918484D0|2009-10-22|2009-12-09|Depuy Int Ltd|A medical implant device|

---

EP2755604A4|2011-09-15|2015-02-18|Amedica Corp|Coated implants and related methods|

---

US8771354B2|2011-10-26|2014-07-08|George J. Picha|Hard-tissue implant|

---

US9526640B2|2013-08-18|2016-12-27|Boston Scientific Scimed, Inc.|Anti-migration micropatterned stent coating|

---

CN106456344B|2014-04-02|2018-12-04|波士顿科学国际有限公司|The interior mirror support covered using adhesion elements|

---

AU2014321170B2|2014-08-26|2017-07-06|Wright Medical Technology, Inc|Intramedullary support with porous metal splines|

---

DE102015103965A1|2015-03-17|2016-09-22|Leibniz-Institut Für Neue Materialien Gemeinnützige Gmbh|Composite Pillarstrukturen|

---

US10856992B2|2016-04-27|2020-12-08|AOD Holdings, LLC|Implant device including tapered protrusions and method for inserting the same into bone|

---

DE102016113956A1|2016-07-28|2018-02-01|Leibniz-Institut Für Neue Materialien Gemeinnützige Gmbh|Device with a structured coating|

---

WO2018165403A1|2017-03-10|2018-09-13|Applied Medical Research, Inc.|Hard-tissue stem implant comprising a bulk stem implant, a face, pillars for contacting a cancellous portion of a hard tissue, and slots, wherein the pillars are prearranged to match an underlying structure of the cancellous portion|

---

US20200323646A1|2017-03-10|2020-10-15|Gary A. Zwick, Trustee Of The Everest Trust Uta April 20, 2017|Spinal interbody cage comprising a bulk interbody cage, a top face, a bottom face, pillars, and slots|

---

US11213398B2|2017-03-10|2022-01-04|Gary A. Zwick|Hard-tissue implant comprising a bulk implant, a face, pillars, slots, and at least one support member|

---

USD841799S1|2017-05-23|2019-02-26|AquaCast Liner LLC|Extended liner|

---

USD840026S1|2017-05-23|2019-02-05|AquaCast Liner LLC|Padded liner|

---

EP3773348A4|2018-04-10|2022-01-19|Gary A Zwick Trustee Of The Everest Trust Uta April 20 2017|Spinal interbody cage comprising top and bottom faces with mesh structures, pillars and slots|

---

CN110141400B|2019-05-10|2021-06-15|温州医科大学附属第二医院、温州医科大学附属育英儿童医院|Cartilage repair support|

---

US11123173B2|2019-09-11|2021-09-21|Gary A. Zwick|Implant comprising first and second sets of pillars for attaching a tendon or a ligament to a hard tissue|

法律状态:
2018-07-17| B08E| Application fees: payment of additional fee required [chapter 8.5 patent gazette]|

---

2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

---

2019-01-22| B25A| Requested transfer of rights approved|Owner name: GARY A. ZWICK (US) |

---

2019-03-26| B08H| Application fees: decision cancelled [chapter 8.8 patent gazette]|Free format text: ANULADA A PUBLICACAO CODIGO 8.5 NA RPI NO 2480 DE 17/07/2018 POR TER SIDO INDEVIDA. UMA VEZ QUE A COMPLEMENTACAO DA 5A ANUIDADE NAO SE FAZ NECESSARIA, POIS O DEPOSITANTE E PESSOA FISICA E A ANUIDADE FOI PAGA COM VALOR MAIOR. |

---

2019-11-05| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

---

2020-10-20| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application [chapter 6.1 patent gazette]|

---

2021-03-23| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

---

2021-05-18| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 24/10/2012, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

---

申请号 | 申请日 | 专利标题

---

US13/317,719|2011-10-26|

---

US13/317,719|US8771354B2|2011-10-26|2011-10-26|Hard-tissue implant|

---

PCT/US2012/061627|WO2013063069A1|2011-10-26|2012-10-24|Hard tissue implant|

---