WO2023056347A1 - Échafaudage, dispositifs et procédés associés pour l'implantation osseuse - Google Patents
Échafaudage, dispositifs et procédés associés pour l'implantation osseuse Download PDFInfo
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- WO2023056347A1 WO2023056347A1 PCT/US2022/077245 US2022077245W WO2023056347A1 WO 2023056347 A1 WO2023056347 A1 WO 2023056347A1 US 2022077245 W US2022077245 W US 2022077245W WO 2023056347 A1 WO2023056347 A1 WO 2023056347A1
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Definitions
- This disclosure relates to a scaffold material that resembles natural bone, medical devices made from this scaffold material, and related methods for bone implantation.
- LIF lumbar interbody fusion
- MIS minimally invasive surgical
- FBSS failed back surgery syndrome
- revision spine surgery also suffers from poor success rates. Secondary revision cases have a success rate of 30%, third surgeries are 15%, and a fourth surgical intervention is 5%.
- revision adult spinal deformity patients who endured two or more previous demonstrate more coronal and sagittal imbalance and worse functional status.
- Other potential complications for LIF are dural tears, neurological injuries, pseudoarthrosis, infection, and wound healing issues.
- the present disclosure provides a scaffold for growing bone, comprising a randomized porosity pattern typical of native trabecular bone.
- the scaffold comprises rounded, square, and rectangular shapes and variegated patterns which align with native vertebral bone structure.
- the scaffold comprises one or more structural cues chosen from porosity, pore size, grain size, and surface topography.
- the one or more structural cues enhance at least one of multipotent mesenchymal stem cell (MSC) differentiation, osteoblast growth, extracellular matrix (ECM) deposition, and new bone formation.
- MSC multipotent mesenchymal stem cell
- ECM extracellular matrix
- new bone formation is after MSC differentiation, osteoblast growth, ECM deposition, or combinations thereof.
- the scaffold is configured to house one or more biologic agents
- the present disclosure also provides a medical device comprising a scaffold disclosed herein.
- the medical device is a pedicle screw.
- the pedicle screw reduces or does not exhibit screw loosening, screw backout, rod breakage, lowered bone mineral density.
- the pedicle screw focuses bone growth throughout a shaft to minimize shear stresses on a distal tip and spreads micromotion throughout the screw to encourage bony ingrowth.
- the pedicle screw comprises at least one trephine to harvest bone internally within the screw.
- the pedicle screw comprises a fluted tip.
- the pedicle screw is configured as a polyaxial tulip.
- the pedicle screw further comprises a tulip, such as a polyaxial tulip.
- the pedicle screw is configured in arcuate cross-section patterns varied from the proximal end to distal tip for placement into an internal cavity of a vertebral body such that upon coaxial rotation of the device autograft is harvested within the screw’s scaffold.
- the pedicle screw further comprises at least one autologous product sprayed on or injected through the screw.
- the pedicle screw is configured in a double ball angulation.
- the pedicle screw is configured into a low profile.
- the pedicle screw further comprises a locking cap with reverse angle threads.
- the pedicle screw is cannulated. In certain embodiments, the pedicle screw is non-cannulated.
- the present disclosure provides a pedicle screw comprising a cap, saddle, shaft having a core comprising a scaffold disclosed herein, and a tulip.
- FIG. 1 is a top view of a diagram showing a pedicle screw implanted through a pedicle into the vertebral body of a vertebra.
- FIG. 2 shows a side plan view of an embodiment of a pedicle screw 3D-printed in titanium.
- FIG. 3 shows a top plan view of the pedicle screw of FIG. 2.
- FIG. 4 shows a bottom plan view of the pedicle screw of FIG. 2.
- FIG. 5 shows a side plan view of an embodiment of a pedicle screw 3D-printed with scaffold disclosed herein.
- FIG. 6 shows a top plan view of the pedicle screw of FIG. 5.
- FIG. 7 shows a bottom plan view of the pedicle screw of FIG. 5.
- FIG. 8 shows a side plan view of another embodiment of a pedicle screw 3D-printed with scaffold disclosed herein.
- FIG. 9 shows a top plan view of the pedicle screw of FIG. 8.
- FIG. 10 shows a bottom plan view of the pedicle screw of FIG. 8.
- FIG. 11 shows a side plan view of an embodiment of a porous pedicle screw.
- FIG. 12 shows an exploded view of the porous pedicle screw of FIG. 11 with a tulip and pins.
- FIG. 13 shows a top plan view of the cap of the porous pedicle screw of FIG. 11.
- FIG. 14 shows a side plan view of the cap of the porous pedicle screw of FIG. 11.
- FIG. 15 shows a perspective view of the saddle of porous pedicle screw of FIG. 11.
- FIG. 16 shows a perspective view of the tulip of FIG. 12.
- the present disclosure provides a scaffold for growing bone, comprising a randomized porosity pattern typical of a native trabecular bone.
- the disclosed scaffolds, screws, and methods can prevent common failures in spinal fusion surgery.
- Additive manufacturing has been combined with regenerative therapies.
- Topography of 3D printed porous patterns has higher adhesion of stem cells to titanium.
- Mesenchymal and hematopoietic stem cells have therapeutic effects on bone. Combining these two modalities improves bone integrations and pullout strength over prior pedicle screws, thereby reducing the likelihood of revision lumbar fusion.
- the porous scaffold disclosed herein corresponds to the native bone and is shaped like a traditional pedicle screw.
- Porous 3D printed scaffolds promote osseointegration, fusion, and fixation within a bone.
- the open skeleton with a scaffold is similar to that of native bone. This similarity allows physicians to make patient-specific choices using other agents to promote bone formation and/or stabilize the device.
- Triangular- shaped porosity sequences have been used in the prior art. Rounded, square/rectangular shapes and variegated patterns more closely align with native vertebral bone structure.
- the scaffold’s structure reduces the likelihood of revision of the medical device from which it is made, for example, screw loosening, screw backout, rod breakage, and lower bone mineral density.
- the disclosed scaffold and devices integrate orthopedic products with regenerative medicine to prevent the risks of delayed bone fusion to implanted devices.
- the scaffold comprises one or more structural cues chosen from porosity, pore size, grain size, and surface topography.
- Porosity and pore size cue signal mechanical strength, cell settlement, and cell migrations.
- Grain size cures signal protein absorption, cell adhesion, cell proliferation, and cell adhesion.
- Surface topography cures signal- specific surface area, cell adhesion, and a material-tissue interface.
- Other scaffold features include pH and wall thickness.
- the one or more structural cues enhance at least one of multipotent mesenchymal stem cell (MSC) differentiation, osteoblast growth, extracellular matrix (ECM) deposition, and new bone formation.
- the new bone formation occurs after MSC differentiation, osteoblast growth, ECM deposition, or combinations thereof.
- Bones can generally be divided into cancellous bone and cortical bone.
- “Cancellous bone,” also called “trabecular bone” or “spongy bone,” is a light, porous bone enclosing numerous large spaces that give a honeycombed or spongy appearance.
- the bone matrix, or framework is organized into a three-dimensional latticework of bony processes, called trabeculae, arranged along stress lines. The spaces between are often filled with marrow and blood vessels.
- trabeculae of a cancellous bone can look like septa. But, they are topologically distinct in three dimensions, with trabeculae roughly rod or pillar-shaped and septa sheet-like.
- Cancellous bone makes up about 20% of the human skeleton, providing structural support and flexibility without compact bone. It is found in most areas of bone not subject to great mechanical stress. It makes up much of the enlarged ends (epiphyses) of the long bones and is the major component of the ribs, the shoulder blades, the flat bones of the skull, and a variety of short, flat bones elsewhere in the skeleton.
- High porosity makes trabecular bone compliant. Large variations in architecture lead to high heterogeneity.
- the modulus and strength vary inversely with porosity and highly depend on the porosity structure.
- the porosity percent of cancellous bone is between 75% and 95%.
- the density is between 0.2 and 0.8 g/cm 3 . Porosity can reduce the strength of the bone but also reduce its weight.
- the porosity and its structure affect the strength of the material.
- the microstructure of trabecular bone is typically oriented.
- the “grain” of porosity is aligned where mechanical stiffness and strength are the greatest.
- Young’s modulus for trabecular bone, including vertebral bone is between 800 and 14,000 Mpa. Its strength of failure is 1 to 100 MPa.
- Cortical bone or “compact bone” is much denser than cancellous bone. It forms the hard exterior (cortex) of bones. The cortical bone gives bone its smooth, white, and solid appearance. It accounts for about 80% of the total bone mass of an adult human skeleton. Cancellous bone is usually surrounded by a shell of compact bone, which provides greater strength and rigidity. The open structure of cancellous bone enables it to dampen sudden stresses, as in load transmission through the joints. Varying proportions of space to bone are found in different bones according to the need for strength or flexibility. Cancellous bone also has a relatively high level of metabolic activity.
- “Wolff’s law” refers to the bone in a healthy person or animal adapting to the loads under which it is placed. For example, if loading on a particular bone increases, it will remodel itself over time to become stronger to resist that loading. Vertebrae
- Each vertebra is an irregular bone with a complex structure composed of bone and some hyaline cartilage in the vertebrate spinal column. The proportions vary according to the segment of the backbone and vertebrate species.
- the basic configuration of vertebrae varies.
- the large part is the body, and the central part is the centrum.
- the upper and lower surfaces of the vertebra body give attachment to the intervertebral discs.
- the posterior part forms a vertebral arch in eleven parts, consisting of two pedicles, two laminae, and seven processes.
- the laminae give attachment to the ligamenta flava (ligaments of the spine).
- the body of the vertebra and the vertebral arch form the vertebral foramen, the larger, central opening that accommodates the spinal canal, which encloses and protects the spinal cord.
- Pedicles and laminae form the vertebral arch.
- Two pedicles extend from the sides of the vertebral body to join the body to the arch.
- the pedicles are short thick processes that extend, one from each side, posteriorly, from the junctions of the posterolateral surfaces of the centrum, on its upper surface.
- a broad plate called a “lamina”
- lamina projects backward and medialward to join and complete the vertebral arch and form the posterior border of the vertebral foramen, which completes the triangle of the vertebral foramen.
- the upper surfaces of the laminae are rough to give attachment to the ligamenta flava.
- ligaments connect the laminae of the adjacent vertebra along the length of the spine from the level of the second cervical vertebra.
- vertebral notches Above and below the pedicles are shallow depressions called vertebral notches (superior and inferior). When the vertebrae articulate, the notches align with those on adjacent vertebrae, forming the intervertebral foramina openings.
- the foramina allow spinal nerves and associated blood vessels to enter and exit each vertebra.
- the articulating vertebrae provide a strong pillar of support for the body.
- the present disclosure provides a device formed from a scaffold disclosed herein.
- the device is cannulated and fenestrated with the scaffold.
- the device comprises a threaded distal region, an optionally threaded central region, and an optionally threaded proximal region, depending on the compressive forces.
- the device is chosen from pedicle screw, cannulated pedicle screw, fenestrated pedicle screw, large-headed screw, small-headed screw, headless screw, trauma hip fracture device, glenoid cage, screws for a glenoid cage, trauma plate, tibial stem, femoral stem, hammertoe implant, nail fusion system, Charcot foot deformity correction, radial head fracture device, high tibial osteotomy, deformity correction, corpectomy cage, oncological correction, anchor, dental implant, maxillofacial implant, and sports medicine anchor.
- the screw is configured with features that facilitate bone to grow through the structure of the screw from opposing sides allowing the bone to connect through the screw.
- the structure is narrow, such as through the screw thread, thereby permitting rapid through growth.
- the structure is deeper, such as through the minor diameter, thus bonding stronger.
- the feature is a void in the screw or porous or structured to promote bone growth.
- the structure collects autografts within the channels inside the device.
- the feature is impregnated with one or more polymers.
- the device is configured to enhance the stabilization and fixation of bone screws within the bone and improve bone mineral density.
- the device includes a spinal implant configured for engagement with cortical bone and cancellous bone within the vertebra.
- the device is configured to resist and/or prevent toggling on a bone screw when the bone screw is engaged with dense cortical bone and a less dense cancellous bone resulting from a load on the bone screw.
- the device is configured to resist and/or prevent loosening of the bone screw from the cortical bone and, in some instances, pull it out from the vertebra.
- the device is configured to facilitate bone through-growth to improve bone attachment to the bone screw.
- the bone screw is anchored in the bone, thereby reducing pullout.
- the bone screw is designed to spread micromotion and reduce shearing to strengthen bone mineral density.
- the device includes a bone screw having bone through-growth through the shaft of the screw to reduce toggle and potential failure of the screw.
- the bone screw includes features that allow the bone to grow through the structure of the bone screw from opposing sides allowing bone to connect through those bone screw structures.
- the bone screw includes features that may be narrow, such as through the bone screw thread, which would allow for rapid through-growth.
- the bone screw includes features that may be deeper, such as through the minor diameter, which would provide a larger volume of bone through-growth.
- the bone screw includes features that may be a void or cavity through opposite sides of the bone screw and/or a void or cavity that enters and exits from the same or adjoining surfaces.
- the void or cavity may contain a scaffold for the bone to attach or a porous structure on the surface of the void.
- the bone screw includes features or structures that may be disposed along a shaft portion of the bone screw. In some embodiments, the bone screw includes features or structures that may be disposed continuously along a surface of the bone screw, such as, for example, along a distal end. In some embodiments, the bone screw includes features or structures that may be disposed discontinuously along a portion of the bone screw. In some embodiments, the bone screw includes features or structures that may include a scaffold or polymers.
- the device comprises a spinal implant having a hybrid configuration that combines a manufacturing method, such as, for example, one or more prior manufacturing features and materials, and a manufacturing method, such as, for example, one or more additive manufacturing features and materials.
- additive manufacturing includes 3-D printing.
- additive manufacturing includes fused deposition modeling, selective laser sintering, direct metal laser sintering, selective laser melting, electron beam melting, layered object manufacturing, and stereolithography.
- additive manufacturing comprises one or more chosen from rapid prototyping, desktop, direct, digital, instant, and on-demand manufacturing.
- the device comprises a spinal implant manufactured by a fully additive process and grown or otherwise printed.
- the devices comprises one or more chosen from demineralized bone matrix (DBM), pre-packed DBM, pre-packed synthetic DBM, unpacked DBM, and magnesium-infused titanium.
- DBM demineralized bone matrix
- pre-packed DBM pre-packed synthetic DBM
- unpacked DBM unpacked DBM
- magnesium-infused titanium magnesium-infused titanium
- the device comprises a spinal implant, such as, for example, a bone screw manufactured by combining traditional manufacturing methods and additive manufacturing methods.
- the bone screw is manufactured by applying additive manufacturing material where the bone screw can benefit from the materials and properties of additive manufacturing.
- traditional materials are used where the benefits, such as physical properties and cost, are superior to those resulting from additive manufacturing features and materials.
- the device treats a spinal disorder chosen from degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis, other curvature abnormalities, kyphosis, tumor, and fractures.
- Treating” or “treatment” of a disease or condition refers to performing a procedure that may include administering one or more drugs to a patient, employing implantable devices, and/or employing instruments that treat the disease, such as microdiscectomy instruments to remove portions bulging or herniated discs, and/or bone spurs, to alleviate signs or symptoms of the disease or condition. Treating or treatment does not require complete alleviation of signs or symptoms, does not require a cure, and specifically includes procedures that have a marginal effect on the patient. For example, treatment can include inhibiting the disease, e.g., arresting its development, or relieving the disease, e.g., causing regression.
- prevention refers to alleviation before signs or symptoms of a disease or condition appear. Thus, prevention includes preventing the disease from occurring in a patient who may be predisposed to the disease but has not yet been diagnosed as having it.
- tissue includes soft tissue, ligaments, tendons, cartilage, and/or bone.
- the tissue is cancellous bone, cortical bone, or corticocancellous bone.
- devices are used with other osteal and bone-related applications, including diagnostics and therapeutics.
- devices are alternatively employed in surgical treatment with a patient in a prone or supine position and/or employ various surgical approaches to the spine, including anterior, posterior, posterior mid-line, lateral, posterolateral, and/or anterolateral approaches, and in other body regions such as maxillofacial and extremities.
- the devices may also be alternatively employed with procedures for treating the lumbar, cervical, thoracic, sacral, and pelvic regions of a spinal column.
- the devices may also be used on animals, bone models, and other non-living substrates, for example, in training, testing, and demonstration.
- the device is a custom medical device. In certain embodiments, the device is adapted for sports medicine.
- the device is temperature-sensing. In certain embodiments, the device is pH-balancing.
- the devices are fabricated having a porosity with a porogen that is spheroidal, cuboidal, rectangular, elongated, tubular, fibrous, disc-shaped, plateletshaped, polygonal, or a mixture thereof.
- the porosity is based on a plurality of macropores, micropores, nanopores structures, and/or a combination thereof.
- the device is fabricated from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics, bone material, and composites thereof.
- the device comprises one or more chosen from a metal, ceramic, rubber, hydrogel, rigid polymer, fabric, bone material, and composites thereof.
- the device comprises a metal chosen from stainless steel alloys, aluminum, commercially pure titanium, titanium alloys, Grade 5 titanium, superelastic titanium alloys, magnesium-infused titanium, cobalt-chrome alloys, superelastic metallic alloys such as nitinol, super elastoplastic metals such as Gum Metal®.
- the device comprises a ceramic and composites thereof, such as calcium phosphate (e.g., SkeliteTM).
- the device comprises a rubber chosen from poly aryletherketone (PAEK), polyetheretherketone (PEEK), poly etherketoneketone (PEKK), polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO4 rubber, polyethylene terephthalate (PET), silicone, polyurethane, silicone-polyurethane copolymer, and polyolefin rubber.
- PAEK poly aryletherketone
- PEEK polyetheretherketone
- PEKK poly etherketoneketone
- PEK polyetherketone
- carbon-PEEK composites PEEK-BaSO4 rubber
- PET polyethylene terephthalate
- silicone polyurethane
- silicone-polyurethane copolymer silicone-polyurethane copolymer
- polyolefin rubber polyolefin rubber.
- the device comprises a hydrogel.
- the device comprises fabric.
- the device comprises a rigid polymer chosen from polyphenylene,
- the device comprises bone material chosen from autograft, allograft, xenograft, or transgenic cortical and/or corticocancellous bone.
- the device comprises tissue growth or differentiation factors.
- the device comprises resorbable materials, such as composites of metals and calcium-based ceramics, composites of PEEK and calcium-based ceramics, composites of PEEK with resorbable polymers, totally resorbable materials, such as calcium-based ceramics, for example, calcium phosphate, tri-calcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymers, such as polyketide, polyglycolide, polytyrosine carbonate, polycaprolactone, and other combinations.
- resorbable materials such as composites of metals and calcium-based ceramics, composites of PEEK and calcium-based ceramics, composites of PEEK with resorbable polymers, totally resorbable materials, such as calcium
- the device comprises a rubber chosen from poly aryletherketone (PAEK), polyetheretherketone (PEEK), poly etherketoneketone (PEKK), polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO4 rubber, polyethylene terephthalate (PET), silicone, polyurethane, silicone-polyurethane copolymer, polyolefin rubber, synthetic collagen, and collagen matrix.
- the device comprises synthetic collagen.
- the device comprises collagen matrix.
- the device comprises magnesium, vitamins, and minerals.
- “Vitamin” refers to an organic molecule (or a set of molecules closely related chemically, i.e. vitamers) that is an essential micronutrient that an organism needs in small quantities for the proper functioning of its metabolism.
- vitamin A as all-trans-retinol, all-trans-retinyl-esters, as well as all-//Y/n.s-bela-carolene and other provitamin A carotenoids
- vitamin Bi thiamine
- vitamin B 2 riboflavin
- vitamin B3 niacin
- vitamin B5 pantothenic acid
- vitamin Be pyridoxine
- vitamin B7 biotin
- vitamin B9 folic acid or folate
- vitamin B12 cobalamins
- vitamin C ascorbic acid
- vitamin D calciferols
- vitamin E tocopherols and tocotrienols
- vitamin K phytoquinone and menaquinones
- a “mineral” refers to a chemical element required as an essential nutrient by organisms to perform functions necessary for life, including potassium, chlorine, sodium, calcium, phosphorous, magnesium, iron, zinc, manganese, copper, iodine, chromium, molybdenum, selenium, and cobalt.
- the device comprises a metal chosen from iron, stainless steel alloys, aluminum, commercially pure titanium, titanium alloys, Grade 5 titanium, superelastic titanium alloys, magnesium-infused titanium, cobalt-chrome alloys, superelastic metallic alloys such as nitinol, super elastoplastic metals such as Gum Metal®.
- the device comprises titanium.
- the device comprises iron.
- the device is manufactured or 3D-printed from materials such as titanium, titanium alloy, cobalt chrome, carbon fiber, magnesium infused titanium, iron, or stainless steel.
- the device is manufactured from a shape memory alloy or shape memory polymer, allowing the device to conform to an anatomical shape of the patient’s body.
- the device comprises magnesium-infused titanium. In certain embodiments, the device comprises an angiotensin receptor blocker coating. In certain embodiments, the device comprises a type-1 cartilage collagen coating. In certain embodiments, the device is infused with an antibiotic.
- the device is employed to treat an affected section of vertebrae.
- a medical practitioner obtains access to a surgical site, including the vertebrae, in any appropriate manner, such as through incision and retraction of tissues.
- the device comprises a bone screw to augment a surgical treatment.
- the device can be pre-assembled for delivery to a surgical site or assembled in situ. In certain embodiments, the device is entirely or partially revised, removed, or replaced.
- the device is used with surgical methods or techniques, including, but not limited to, open surgery, mini-open surgery, minimally invasive surgery (MIS), and percutaneous surgical implantation, whereby the vertebra is accessed through a mini-incision or a sleeve provides a protected passageway to the area.
- a surgical treatment such as a corpectomy or discectomy, can be performed to treat a disease or disorder.
- the surface of the devices comprises a non-solid configuration, such as a lattice.
- the non-solid configuration comprises a porous structure or a trabecular configuration.
- the non-solid configuration is configured to provide one or a plurality of pathways to aid bone growth within and through from one surface to an opposite surface of the device.
- the lattice comprises one or more portions, layers, or substrates. In some embodiments, one or more portions, layers, or substrates of the lattice are disposed side by side, offset, staggered, stepped, tapered, end to end, spaced apart, in series, or parallel. In some embodiments, the lattice defines a thickness, which may be uniform, undulating, tapered, increasing, decreasing, variable, offset, stepped, arcuate, angled, and/or staggered. In some embodiments, one or more lattice layers are disposed in a side-by-side, parallel orientation within a wall. In certain embodiments, the lattice comprises one or more layers of a material matrix.
- the lattice comprises a plurality of nodes and openings disposed in rows and columns or randomly. In some embodiments, the plurality of nodes and openings are disposed in series. In some embodiments, the plurality of nodes and openings are disposed in parallel.
- the lattice forms a rasp-like configuration.
- the lattice is configured to engage tissue.
- the engagement of the lattice is to cut, shave, shear, incise or disrupt the tissue.
- the lattice comprises a configuration chosen from cylindrical, round, oval, oblong, triangular, polygonal having planar or arcuate side portions, irregular, uniform, non- uniform, consistent, variable, horseshoe shape, U-shape, or kidney bean shape.
- the lattice is rough, textured, porous, semi-porous, dimpled, knurled, toothed, grooved, or polished, for example, to engage and cut the tissue.
- the lattice forms a tunnel configured to guide, drive, or direct the cut tissue into an opening, such as fusing the device to the tissue. Screw
- the device is a screw.
- the screw is chosen from a posted screw, a pedicle screw, a bolt, a bone screw for a lateral plate, an interbody screw, a uniaxial screw, a fixed angle screw, a multi-axial screw, a side-loading screw, a sagittal adjusting screw, a transverse sagittal adjusting screw, an awl tip, a dual rod multi-axial screw, midline lumbar fusion screw, and/or a sacral bone screw.
- the device is a bone screw.
- the device is a pedicle screw. Referring to FIG. 1, a pedicle screw is shown implanted through a pedicle into the vertebral body of a vertebra.
- the pedicle screw has a cage with polymers held within the cannulated and/or fenestrated portion of the screw.
- the internal core of the screw is a trephine to collect and harvest autograft upon and/or during insertion of the screw.
- post-implantation options prevent revision surgery through polymer injection through the screw.
- the pedicle screw does not exhibit screw loosening, screw backout, rod breakage, or lowered bone mineral density.
- the pedicle screw has reduced one or more screw loosening, screw backout, rod breakage, and lowered bone mineral density.
- the disclosed screws focus on bone growth throughout the shaft to minimize shear stresses on the distal tip and spread micromotion evenly throughout the screw to encourage bony ingrowth.
- the scaffold of pedicle screw provides options for simple to complex bone mineral densities and immunocompromised patients.
- the scaffold is impregnated with one or more biologies, antibiotics, demineralized bone matrices, nanotechnology, or regenerative medicine therapies.
- the structure of the pedicle screw 300,400,500 is specifically designed to help bone in-growth through the pedicle screw 300,400,500 by using the scaffold 280, similar to native trabecular bone in the vertebral body.
- the core 260 aids autograft harvesting during the insertion process to push autograft into built-in channels within the core 260 of the pedicle screw 300,400,500.
- the walls surrounding the pores harvest the autograft and act as trephines.
- This structure also aided the pedicle screw’s 300,400,500 structural integrity, resisted bone mineral density loss, and reduced micromotion.
- the pedicle screws 200,300,400,500 disclosed herein overcome the many failures of the prior art pedicle screws.
- the pedicle screw lacks a windshield wiper effect.
- the pedicle screw resists backout.
- the pedicle screw does not exhibit excessive micromotion.
- the pedicle screw has a low frequency of low- virulent microorganisms detected by sonication, for example, due to individual screw sterilization and packaging.
- the head and shaft of the pedicle screw resist failure.
- the pedicle screw is adapted for each type of bone quality. In certain embodiments, the pedicle screw has adequate thread depth.
- the pedicle screw withstands insertion torque, particularly at the head-to-screw coupling. In certain embodiments, the fatigue lifespan of the pedicle screw does not decrease when the screw is fully inserted. In certain embodiments, the pedicle screw has good instrumentation. In certain embodiments, the pedicle screw achieves angulation for rod acceptance. In certain embodiments, the pedicle screw does not have cyclic loading based on physiological conditions during walking. In certain embodiments, the pedicle screw does not fail in long- segment posterior cervical fusion, not requiring concomitant C6 or T1 buttress pedicles. In certain embodiments, the pedicle screw distributes stress. In certain embodiments, the pedicle screw does not immunocompromise the patient. In certain embodiments, the pedicle screw does not comprise PEEK. In certain embodiments, the pedicle screw does not have tulip or locking cap stresses.
- the distal tip 220 of the pedicle screw 200,300,400,500 has a surface configuration chosen from angled, irregular, uniform, non-uniform, offset, staggered, tapered, arcuate, undulating, mesh, porous, semi-porous, dimpled, pointed, textured, or combinations thereof.
- the distal tip 220 includes a nail configuration, barbs, expanding elements, raised elements, ribs, and/or spikes to provide a fabrication platform for forming a portion thereon via additive manufacturing.
- the distal tip 220 has a cross-section configuration chosen from oval, oblong triangular, square, polygonal, irregular, uniform, non-uniform, offset, staggered, tapered, or combinations thereof.
- the pedicle screw 200,300,400,500 comprises a thread 230 that extends between the proximal end 210 and distal tip 220.
- the thread 230 comprises an external thread form.
- the thread form comprises a leading edge 231 having a leading surface 235 and a trailing edge 232 having a trailing surface 236.
- the leading surface 235 defines a first opening 251.
- the trailing surface 236 defines a second opening 252.
- the first and second openings 251,252 are axially aligned.
- the first and second openings 251,252 are disposed circumferentially about the thread form.
- the leading surface 235 and/or the trailing surface 236 comprises at least one tissue gathering member.
- the tissue gathering member comprises a cutting edge.
- the cutting edge is configured to be rasp-like.
- the cutting edge is configured to engage tissue, for example, to cut, shave, shear, incise, or disrupt the tissue.
- the cutting edge is configured to be cylindrical, round, oval, oblong, triangular, polygonal, having planar or arcuate side portions, irregular, uniform, non-uniform, consistent, variable, horseshoe shape, U-shape, or kidney bean shape.
- the cutting edge is rough, textured, porous, semi-porous, dimpled, knurled, toothed, grooved, or polished to engage and cut the tissue.
- the cutting edge forms a tunnel configured to guide, drive, or direct the cut tissue into the void, such as fusing the screw with the tissue.
- manipulating the pedicle screw 200,300,400,500 by rotation or translation causes the cutting edge 271 of the screw to cut and guide the tissue or bone into the core 260, thereby promoting bone growth and fusion to the pedicle screw 200,300,400,500.
- the tissue is embedded into the core 260 to promote bone growth and fusion to the pedicle screw 200,300,400,500.
- the lattice is disposed within the core 260 to form a scaffold 280 for bone growth.
- the thread 230 is configured as fine, closely spaced, or shallow to engage with the tissue. In some embodiments, the thread 230 comprises an increased pitch and an equal lead between thread turns. In some embodiments, the thread 230 comprises a smaller pitch or more thread turns per the axial distance to fixate stronger fixation with the tissue or resist loosening from the tissue. In some embodiments, the thread 230 is configured to be continuous along a portion. In some embodiments, the thread 230 is configured to be intermittent, staggered, or discontinuous. In certain embodiments, the thread 230 comprises a single thread turn. In certain embodiments, the thread comprises a plurality of discrete threads.
- the thread 230 comprises a penetrating element, for example, chosen from a nail configuration, barb, expanding element, raised elements, rib, or spike.
- the thread 230 is configured as self-tapping or intermittent at the distal tip 220.
- the distal tip 220 is rounded.
- the distal tip 220 is self-drilling.
- the distal tip 220 comprises a solid outer surface.
- the screw is a 3D-printed porous pedicle screw. Its porosity mimics native vertebral bone to attach and keep stem cells, growth factors, and other proteins within the structure of the pedicle screw and encourage bone growth through the screw, stabilizing the overall construct.
- the built-in trephines collect autograft and regenerative cells within the porous matrix.
- the disclosed topography attracts bone-forming stem cells within and around the device, reducing overall construct macromotion.
- this device enables surgeons to meet patient-specific needs, such as, but not limited to, spraying/injecting regenerative products to stimulate the bone-forming osteogenic cascade, proactively injecting the screw scaffold with antibiotics for diabetic prone infections, and the option to inject bone cement to further stabilize the construct in severely osteoporotic bone.
- the screw reduces revision rates, improves bone mineral density, and/or addresses patient- specific needs during spine fusions.
- bone mineral density improves, constructs are stabilized, and the likelihood of revision is reduced.
- the screw is a 3D-printed titanium porous pedicle screw with a porous pattern throughout the screw similar to native bone.
- the function of the porous pattern is to attach to the surrounding bone, keeping osteogenic stem cells in place and collecting autograft bone within its porous structure.
- An advantage of the porous structure is the ability to inject polymers and regenerative therapies through the screw.
- stem cell therapies are injected through the screw implant. In such embodiments, failure likelihood is reduced.
- the surgeon can inject or spray the screw with autologous concentrated stem cells.
- autologous concentrated stem cells collect an autograft/stem cell mixture internally using its built-in trephines.
- the osteogenic stem cells then bind with the concentrated blood stem cells and signal the process of mutation and replication, forming more osteogenic cells within the screw, followed by a healing cascade of bone directed within and around the screw.
- the combination of (a) osteoconductive (bone grows on the surface), (b) osteoinductive (recruiter of cells for bone healing), and (c) osteogenic (development and formation of bone) healing cascade of the stem cells improve bone mineral density and support superior bone integration and pullout strength.
- the patient is diabetic and prone to infection.
- the surgeon can inject a mixture comprising a calcium sulfate product and antibiotics through the screw before or after insertion or on the screw within the pedicle to provide antibiotic delivery in the area.
- the antibiotics are delivered for between two and six weeks. As such, the likelihood of revision due to infection is reduced.
- manufacturing comprises machining, such as subtractive, deformative, or transformative manufacturing.
- manufacturing includes cutting, grinding, rolling, forming, molding, casting, forging, extruding, whirling, grinding, cold working, or combinations thereof.
- manufacturing includes a portion of the device formed by a medical machining process.
- CNC computer numerical control
- Swiss machining devices CNC turning with living tooling, wire EDM 4th axis, and combinations thereof.
- the manufacturing for fabricating a portion of the devices includes a finishing process, such as laser marking, tumble blasting, bead blasting, micro blasting, powder blasting, or combinations thereof.
- the device is fabricated per instructions from a computer and processor based on the digital rendering and/or data of a selected configuration via additive manufacturing.
- additive manufacturing comprises 3-D printing.
- additive manufacturing is chosen from fused deposition modeling, selective laser sintering, direct metal laser sintering, selective laser melting, electron beam melting, layered object manufacturing, stereolithography, and combinations thereof.
- additive manufacturing comprises rapid prototyping, desktop manufacturing, direct manufacturing, direct digital manufacturing, digital fabrication, instant manufacturing, on-demand manufacturing, or combinations thereof.
- a portion of the device is manufactured by additive manufacturing and then mechanically attached to a surface of the device, for example, by welding, threading, adhesives, or staking.
- the device is configured based on imaging from patient anatomy. Suitable imaging techniques include, but are not limited to, X-ray, fluoroscopy, computed tomography (CT), magnetic resonance imaging (MRI), surgical navigation, bone density (DEXA), or acquirable 2-D or 3-D images of patient anatomy. Selected configuration parameters for the device are collected, calculated, or determined. Examples of configuration parameters include, but are not limited to, patient anatomy imaging, surgical treatment, historical patient data, statistical data, treatment algorithms, implant material, implant dimensions, porosity, and manufacturing method. In some embodiments, the configuration parameters comprise implant material and device porosity based on patient anatomy and surgical treatment. In some embodiments, porosity is selected. In some embodiments, the configuration parameter of the device is patient specific. In some embodiments, the configuration parameter of the device is based on a generic configuration and is not patient specific.
- a digital rendering or data of a device is generated for display from a graphical user interface or storage on a database attached to a computer and a processor.
- the computer display via a monitor saves, digitally manipulates, or prints a hard copy of the digital rendering or data.
- the device is designed virtually with a CAD/CAM program on a computer display.
- the processor executes code stored in a computer-readable memory medium to execute one or more computer instructions, for example, transmitting instructions to an additive manufacturing device.
- the database or computer-readable medium comprises RAM, ROM, EPROM, magnetic, optical, digital, electromagnetic, flash drive, semiconductor technology, or combinations thereof.
- the processor instructs motors to control the movement and rotation of device components.
- Regenerative medicine refers to a branch of translational research in tissue engineering and molecular biology, which deals with replacing, engineering, or regenerating human cells, tissues, or organs to restore or establish normal function. This field holds the promise of engineering damaged tissues and organs by stimulating the repair mechanisms within the patient’s body to functionally heal previously irreparable tissues or organs. For example, during bone regeneration, new bone formation is primarily affected by physicochemical cues in the surrounding microenvironment. Tissue cells reside in a complex scaffold physiological microenvironment.
- regenerative medicine is incorporated with the scaffolds or devices disclosed herein. Autogenous graft incorporation occurs in five stages: inflammation, vascularization, osteoinduction, osteoconduction, and remodeling.
- Inflammation lasts for about 7 to 14 days.
- Initial insult to the local blood supply and decortications results in hematoma around the bone graft, in which inflammatory cells invade.
- the fibroblast- like cells in the inflammatory tissue transform into the fibrovascular stroma.
- Perioperative anti-inflammatory medications decrease fusion rates because of the inflammatory process.
- vascular buds appear in the fibrovascular stroma, resembling scar tissue formation during vascularization.
- Primary membranous bone forms near the decorticated bone.
- minimal cartilage and endochondral ossification occur.
- reparation comprises increased vascularization, necrotic tissue resorption, osteoblasts, and chondroblasts differentiation.
- stem cells differentiate into osteoblasts.
- New bone extends towards the central zone of the fusion mass. The cortical portion of the graft continues to resorb.
- Osteoconduction is characterized by ingrowth into the host bone and creeping substitution. Osteoblasts create new bone while osteoclasts simultaneously resorb graft bone. A central zone of the endochondral interface is observed at the center of fusion mass, uniting the lower and upper halves of fusion. Pluripotent cells in this central zone differentiate into cartilaginous tissue with less vascularization.
- bone marrow aspirate with allograft is more cost-effective than recombinant human bone morphogenetic protein-2 (rhBMP).
- rhBMP human bone morphogenetic protein-2
- bone marrow- derived cell-enriched allografts compare to autografts in bone grafting and spinal fusion procedures.
- BMA increases the regenerative potential of corticocancellous allogeneic bone grafts. When treating unicameral bone cysts, healing rates were high (98.7 %) for bone marrow with demineralized bone matrix injection.
- the pedicle screw 200 was 3D-printed in titanium.
- the pedicle screw 200 comprised a thread 230 disposed around a shaft 240 that extends between the proximal end 210 and distal tip 220.
- the thread 230 comprised an external thread form with a leading edge 231 having a leading surface 235 and a trailing edge 232 having a trailing surface 236.
- the leading surface 235 defined a first opening 251.
- the trailing surface 236 defined a second opening 252.
- the first and second openings 251,252 were axially aligned.
- the pedicle screw 200 had a core 260 extending through the center of the pedicle screw 200 from the proximal end 210 to the distal tip 220.
- the distal tip 220 comprised two cutting members 270, each having a cutting edge 271
- a pedicle screw 300 was 3D-printed in titanium with a scaffold 280 disclosed herein.
- the pedicle screw 300 comprised a thread 230 disposed around a shaft 240 that extends between the proximal end 210 and distal tip 220.
- the shaft 240 comprises two regions of scaffold 280 exposed to the outer surface of the pedicle screw 300.
- the thread 230 comprised an external thread form with a leading edge 231 having a leading surface 235 and a trailing edge 232 having a trailing surface 236.
- the leading surface 235 defined a first opening 251.
- the trailing surface 236 defined a second opening 252.
- the first and second openings 251,252 were axially aligned.
- the pedicle screw 300 had a core 260 filled with scaffold 280 extending through the center of the pedicle screw 300 from the proximal end 210 to the distal tip 220.
- the distal tip 220 comprised three cutting members 270, each having a cutting edge 271.
- FIGS. 8-10 another embodiment of a pedicle screw 400 was 3D-printed in titanium with scaffold 280 disclosed herein.
- the pedicle screw 400 comprised a thread 230 disposed around a shaft 240 that extends between the proximal end 210 and distal tip 220.
- the shaft 240 comprises regions of scaffold 280 exposed to the outer surface of the pedicle screw 400 between the middle seven turns of the thread 230.
- the thread 230 comprised an external thread form with a leading edge 231 having a leading surface 235 and a trailing edge 232 having a trailing surface 236.
- the leading surface 235 defined a first opening 251.
- the trailing surface 236 defined a second opening 252.
- the first and second openings 251,252 were axially aligned.
- the pedicle screw 400 had a core 260 filled with scaffold 280 extending through the center of the pedicle screw 400 from the proximal end 210 to the distal tip 220.
- the distal tip 220 comprised three cutting members 270, each having a cutting edge 271.
- FIGS. 11-16 another embodiment of a pedicle screw 500 was 3D- printed in metal with scaffold 280 disclosed herein.
- the pedicle screw 500 comprises a cap 510, saddle 520, and shaft 540, and, when present, a tulip 590 and a pair of pins 595.
- the cap 510 is configured to couple to the saddle 520 via cap threads 513 operatively disposed in saddle grooves 523.
- the saddle 520 is configured to couple to the shaft 540.
- the distal tip 220 of the shaft 540 can be disposed through the bottom opening 592 of the tulip 590 and held into place with pins 595 disposed through the side openings 596 of the tulip 590.
- the pedicle screw 500 comprises a thread 230 disposed around a shaft 240 that extends between the proximal end 210 and distal tip 220.
- the shaft 240 comprises regions of scaffold 280 exposed to the outer surface of the pedicle screw 500 between the middle thirteen turns of the thread 230.
- the thread 230 comprises an external thread form with a leading edge having a leading surface and a trailing edge having a trailing surface.
- the pedicle screw 500 had a core filled with scaffold 280 extending through the center of the pedicle screw 500 from the proximal end 210 to the distal tip 220.
- the distal tip 220 comprised cutting members 270.
- the cap 510 comprises a cap body 514 having a cap thread 513 disposed in a spiral around the outer surface of the cap body 514 between the cap top 511 and the cap bottom 512.
- the saddle 520 comprises a saddle body 524 having a saddle top 521, a saddle bottom 522, and at least one saddle groove 523 disposed on the interior surface of the saddle body 524.
- the at least one saddle groove 523 is configured to receive and operatively couple the cap threads 513.
- the saddle bottom 522 is configured to receive and operatively couple the proximal end 210 of the shaft 540.
- the tulip 590 comprises a tulip body 594 having a top opening 591, bottom opening 592, at least one pair of tulip grooves 593 disposed on the interior surface of the tulip body 594, a pair of side openings 596 between the at least one pair of tulip groove 593 and the bottom opening 592.
- the at least one pair of tulip grooves 593 are configured to receive and operatively couple the threads 230 of the shaft 540 when the distal tip 220 of the shaft 540 passes through the bottom opening 592 of the tulip 590.
- a pair of pins 595 can be operatively coupled to the tulip 590 through the pair of side openings 596.
- the pores of the scaffold 280 promoted boney in-growth through the screw.
- Other materials fabricating the pedicle screw included pre-packed demineralized bone matrix (DBM), pre-packed synthetic DBM, unpacked DBM, and magnesium-infused titanium. Built-in channels captured autograft during insertion.
- the screw had double ball angulation and a low profile.
- the screw comprised a locking cap with reverse-angle threads.
- the screw can be cannulated or non-cannulated.
- the screws were between 35 mm and 65 mm long and between 4.5 mm and 8.5 mm in diameter.
- the rod acceptance was 5.5 mm.
- the device was tested in cobalt chrome and met American Society for Testing and Materials (ASTM) standards 543, 1798, and 1717.
- ASTM American Society for Testing and Materials
- ASTM standard 543 evaluates plastic materials for resistance to chemical reagents, including cast, hot-molded, cold-molded, laminated resinous products, and sheet materials. Three procedures are presented, two under practice A (Immersion Test) and one under practice B (Mechanical Stress and Reagent Exposure under Standardized Conditions of Applied Strain). These practices report changes in weight, dimensions, appearance, color, strength, and other mechanical properties. Standard reagents are specified to establish results on a comparable basis without precluding other chemical reagents pertinent to specific chemical resistance requirements. Provisions are made for various exposure times, stress conditions, and exposure to reagents at elevated temperatures. The type of conditioning (immersion or wet patch/wipe method) depends upon the material's end-use.
- ASTM standard 1798 covers the measurement of uniaxial static, fatigue strength, and resistance to loosening the component interconnection mechanisms of spinal arthrodesis implants. This test method provides a means of mechanically characterizing different designs of spinal implant interconnections. The various components and interconnections may be combined for static and fatigue testing of the spinal implant construct. This test method does not address the analysis of spinal implant constructs or subconstructs or define levels of performance of spinal implants.
- ASTM standard 1717 covers the materials and methods for the static and fatigue testing of spinal implant assemblies in a vertebrectomy model.
- the test materials for combinations of spinal implant components can be specific, depending on the spinal location and intended application method to the spine. These test methods provide a basis for the mechanical comparison among past, present, and future spinal implant assemblies. They allow comparison of spinal implant constructs with different intended spinal locations and application methods to the spine. These test methods are not intended to define levels of performance. Instead, these test methods set out guidelines for load types and methods of applying loads, measuring displacements, determining the yield load, and evaluating the stiffness and strength of the spinal implant assembly. Methods for three static load types and one fatigue test are defined for the comparative evaluation of spinal implant assemblies.
- the pedicle screw 200,300,400,500 is individually packaged in a double TyvekTM peel tray.
- the pedicle screw 200,300,400,500 is injected or sprayed with a material, such as BMA concentrate, calcium phosphate, biologic, and/or antibiotics.
- a material such as BMA concentrate, calcium phosphate, biologic, and/or antibiotics.
- the filled or coated screw rested for 10-15 minutes before insertion for the material to absorb.
- the first specific aim is to determine whether the porous pedicle screw promotes bone integration and pullout strength compared to the gold- standard pedicle screw/rod constructs in a posterior lumbar interbody fusion sheep model.
- the topography of 3D printed porous patterns has higher adhesion of stem cells to titanium.
- mesenchymal and hematopoietic stem cells have therapeutic effects on bone.
- the bone mineral densities (BMD) of 84 vertebral bodies (Li-Le) will be measured from six sheep one week preoperatively and postoperatively at 24 and 36 weeks. Each subject will receive two separate lumbar interbody fusions (LIF) at the L2-L3 and L4-L5 joints. Li and Le will be naive controls to compare changes with and without hardware.
- lumbar spine sections (L1-L5) will be freshly dissected to a single functional spinal unit (FSU) (i.e., L4-L5) for post-sacrifice assessments.
- FSU functional spinal unit
- High- resolution biplanar digital radiographs and photos will be taken at sacrifice following fine dissection in the sagittal and coronal planes.
- Non-destructive range of motion (ROM) biomechanics will be measured on all samples, including ROM biomechanics under pure moment loading in flexion-extension, lateral bending, and axial rotation to 6.0 N-m, yielding range of motion (Degrees), construct stiffness (Deg. I N-m), and neutral zone (Deg.).
- Other tests will include micro-computed tomography (MicroCT) of each FSU and associated pedicle screws, quantitative assessment of the posterior lumbar fusion (PLF) region (bone volume and bone density), qualitative assessment of bone ingrowth around pedicle screws, pedicle screw histology, organ histology, and static histomorphometry of screw regions of interest (ROIs), including the percentage of the bone area within ROI, percentage of fibrous tissue within ROI, percentage of void space with ROI, percentage of the screw within ROI, and percentage of bone on-growth to the device.
- MicroCT micro-computed tomography
- PPF posterior lumbar fusion
- ROIs screw regions of interest
- Slides will be delivered to a certified pathologist for histopathology analysis.
- the pathologist will be initially blinded to the treatment parameters of each site. Then, when applicable, the sections will be analyzed and graded per cell type and responses following the grading scheme in Table 3. After scoring all the slides for data post-processing, the pathologist will be unblinded so they can compare data to the control samples.
- the histopathology report will include, but will not be limited to, a summary of methods and materials, tabulated and qualitative data through the last time point and conclusions, low-power images, and representative photomicrographs to illustrate the findings.
- An unpaired t-test with an alpha (a) value of 0.05 will be performed to determine statistical significance for biomechanical and histomorphometric outcome parameters. Then, the data will be compared with similar retrospective studies.
- porous pedicle screws have a topography and porous pattern for promoting stem cell adhesion.
- Human mesenchymal stem cells have the strongest adhesive affinity for titanium surfaces with porosities between 50% and 70%, a more robust and dense internal cellular migration pattern, and high cell viability. Therefore, the porous pattern and topography of porous pedicle screws should have a similar adhesion to stem cells.
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- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Molecular Biology (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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- Oral & Maxillofacial Surgery (AREA)
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Abstract
La divulgation concerne un échafaudage pour la croissance osseuse, comprenant un motif de porosité aléatoire typique de l'os trabéculaire natif. La présente divulgation concerne également un dispositif médical comprenant un échafaudage divulgué. Dans des modes de réalisation particuliers, le dispositif médical est une vis pédiculaire. L'échafaudage peut comprendre des formes arrondies, carrées et rectangulaires et des motifs panachés qui s'alignent avec la structure osseuse vertébrale native. L'échafaudage peut comprendre un ou plusieurs repères structurels choisis parmi la porosité, la taille des pores, la taille des grains et la topographie de surface, le ou les repères structurels améliorant au moins l'une de la différenciation de cellules souches mésenchymateuses multipotentes (CSM), de la croissance des ostéoblastes, du dépôt de la matrice extracellulaire (MEC) et de la nouvelle ostéogenèse.
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