Kyoto, Japan
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PubMed | Ehime Implant Clinic, Sagawa Printing Co., Kyushu University, Osaka Yakin Kogyo Co. and 3 more.
Type: Journal Article | Journal: Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery | Year: 2015

Development of new custom-made devices to reconstruct alveolar bone for implantation, and comparison with conventional methods were the goals of this study.Using a computer-aided design technique, three-dimensional images were constructed. From these data, custom-made devices were produced by a selective laser melting method with pure titanium. Clinical trials also have been conducted with 26 participants who needed bone reconstruction before implantation; they were divided into 2 groups with 13 patients each. The first group uses custom-made devices; the other uses commercial titanium meshes that need to bend during operation. Some clinical aspects are evaluated after the trial.The custom-made devices can be produced closely by following the data precisely. Devices are fit for bone defect site. Moreover, the operation time of the custom-made group (75.4 11.6 min) was significantly shorter than that of the conventional group (111.9 17.8 min) (p < 0.01). Mucosal rupture occurs, without significant difference (p = 0.27), in a patient in the custom-made without severe infection (7.7%), and 3 in conventional (23.1%), respectively. The retaining screw is significantly fewer in the custom-made group than commercial mesh group (p < 0.01).These results indicate that our novel protocol could be simple and safe for providing powerful support for guided bone regeneration.


Patent
Chubu University, Advanced Medix Inc. and Sagawa Printing Co. | Date: 2010-01-29

Bone repair materials are disclosed, from which ions are hardly eluted in living body and which are superior in apatite-forming ability and resistance to apatite peeling and have a scratch resistance high enough for practical use. The material comprises a substrate made of titanium or titanium alloys, and a surface layer, made substantially of titanium oxide, along the surface of the substrate. The substrate has on the surface thereof irregularities of from 1 nm to 10 m in average in both width and depth. The layer has a zeta potential of +4.5 mV or more under an aqueous solution environment of pH 6 to 8, and a critical scratch resistance of 35 mN or more when vibration 100 m in amplitude is added to a stylus with a spring constant of 200 g/mm on the surface layer and the stylus is moved at a rate of 10 mm/sec under a load increasing at a rate of 100 mN/min.


Patent
Chubu University, Advanced Medix Inc. and Sagawa Printing Co. | Date: 2011-12-07

Bone repair materials are disclosed, from which ions are hardly eluted in living body and which are superior in apatite-forming ability and resistance to apatite peeling and have a scratch resistance high enough for practical use. The material comprises a substrate made of titanium or titanium alloys, and a surface layer, made substantially of titanium oxide, along the surface of the substrate. The substrate has on the surface thereof irregularities of from 1 nm to 10 m in average in both width and depth. The layer has a zeta potential of +4.5 mV or more under an aqueous solution environment of pH 6 to 8, and a critical scratch resistance of 35 mN or more when vibration 100 m in amplitude is added to a stylus with a spring constant of 200 g/mm on the surface layer and the stylus is moved at a rate of 10 mm/sec under a load increasing at a rate of 100 mN/min.


Taniguchi N.,Kyoto University | Fujibayashi S.,Kyoto University | Takemoto M.,Kyoto University | Sasaki K.,Sagawa Printing Co. | And 5 more authors.
Materials Science and Engineering C | Year: 2016

Selective laser melting (SLM) is an additive manufacturing technique with the ability to produce metallic scaffolds with accurately controlled pore size, porosity, and interconnectivity for orthopedic applications. However, the optimal pore structure of porous titanium manufactured by SLM remains unclear. In this study, we evaluated the effect of pore size with constant porosity on in vivo bone ingrowth in rabbits into porous titanium implants manufactured by SLM. Three porous titanium implants (with an intended porosity of 65% and pore sizes of 300, 600, and 900 μm, designated the P300, P600, and P900 implants, respectively) were manufactured by SLM. A diamond lattice was adapted as the basic structure. Their porous structures were evaluated and verified using microfocus X-ray computed tomography. Their bone-implant fixation ability was evaluated by their implantation as porous-surfaced titanium plates into the cortical bone of the rabbit tibia. Bone ingrowth was evaluated by their implantation as cylindrical porous titanium implants into the cancellous bone of the rabbit femur for 2, 4, and 8 weeks. The average pore sizes of the P300, P600, and P900 implants were 309, 632, and 956 μm, respectively. The P600 implant demonstrated a significantly higher fixation ability at 2 weeks than the other implants. After 4 weeks, all models had sufficiently high fixation ability in a detaching test. Bone ingrowth into the P300 implant was lower than into the other implants at 4 weeks. Because of its appropriate mechanical strength, high fixation ability, and rapid bone ingrowth, our results indicate that the pore structure of the P600 implant is a suitable porous structure for orthopedic implants manufactured by SLM. © 2015 Elsevier B.V.


Takemoto M.,Kyoto University | Fujibayashi S.,Kyoto University | Ota E.,Shiga Medical Center for Children | Otsuki B.,Kyoto University | And 9 more authors.
European Spine Journal | Year: 2016

Purpose: Image-based navigational patient-specific templates (PSTs) for pedicle screw (PS) placement have been described. With recent advances in three-dimensional computer-aided designs and additive manufacturing technology, various PST designs have been reported, although the template designs were not optimized. We have developed a novel PST design that reduces the contact area without sacrificing stability. It avoids susceptibility to intervening soft tissue, template geometric inaccuracy, and difficulty during template fitting. Methods: Fourteen candidate locations on the posterior aspect of the vertebra were evaluated. Among them, locations that had high reproducibility on computed tomography (CT) images and facilitated accurate PS placement were selected for the final PST design. An additive manufacturing machine (EOSINT M270) fabricated the PSTs using commercially pure titanium powder. For the clinical study, 36 scoliosis patients and 4 patients with ossification of the posterior longitudinal ligament (OPLL) were treated with thoracic PSs using our newly developed PSTs. We intraoperatively and postoperatively evaluated the accuracy of the PS hole created by the PST. Results: Based on the segmentation reproducibility and stability analyses, we selected seven small, round contact points for our PST: bilateral superior and inferior points on the transverse process base, bilateral inferior points on the laminar, and a superior point on the spinous process. Clinically, the success rates of PS placement using this PST design were 98.6 % (414/420) for scoliosis patients and 100 % (46/46) for OPLL patients. Conclusion: This study provides a useful design concept for the development and introduction of patient-specific navigational templates for placing PSs. © 2015, Springer-Verlag Berlin Heidelberg.


Otawa N.,Kyushu University | Sumida T.,Kyushu University | Kitagaki H.,Osaka Yakin Kogyo Co. | Sasaki K.,Sagawa Printing Co. | And 6 more authors.
Journal of Cranio-Maxillofacial Surgery | Year: 2015

Objective The purpose of this study was to verify the modeling accuracy of various products, and to produce custom-made devices for bone augmentation in individual patients requiring implantation. Materials and methods Two-(2D) and three-dimensional (3D) specimens and custom-made devices that were designed as membranes for guided bone regeneration (GBR) were produced using a computer-aided design (CAD) and rapid prototyping (RP) method. The CAD design was produced using a 3D printing machine and selective laser melting (SLM) with pure titanium (Ti) powder. The modeling accuracy was evaluated with regard to: the dimensional accuracy of the 2D and 3D specimens; the accuracy of pore structure of the 2D specimens; the accuracy of porosity of the 3D specimens; and the error between CAD design and the scanned real product by overlapped images. Results The accuracy of the 2D and 3D specimens indicated precise results in various parameters, which were tolerant in ISO 2768-1. The error of overlapped images between the CAD and scanned data indicated that accuracy was sufficient for GBR. In integrating area of all devices, the maximum and average error were 292 and 139 μm, respectively. Conclusions High modeling accuracy can be achieved in various products using the CAD/RP-SLM method. These results suggest the possibility of clinical applications. © 2015 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.


Pattanayak D.K.,Chubu University | Fukuda A.,Kyoto University | Matsushita T.,Chubu University | Takemoto M.,Kyoto University | And 5 more authors.
Acta Biomaterialia | Year: 2011

Selective laser melting (SLM) is a useful technique for preparing three-dimensional porous bodies with complicated internal structures directly from titanium (Ti) powders without any intermediate processing steps, with the products being expected to be useful as a bone substitute. In this study the necessary SLM processing conditions to obtain a dense product, such as the laser power, scanning speed, and hatching pattern, were investigated using a Ti powder of less than 45 μm particle size. The results show that a fully dense plate thinner than 1.8 mm was obtained when the laser power to scanning speed ratio was greater than 0.5 and the hatch spacing was less than the laser diameter, with a 30 μm thick powder layer. Porous Ti metals with structures analogous to human cancellous bone were fabricated and the compressive strength measured. The compressive strength was in the range 35-120 MPa when the porosity was in the range 75-55%. Porous Ti metals fabricated by SLM were heat-treated at 1300 °C for 1 h in an argon gas atmosphere to smooth the surface. Such prepared specimens were subjected to NaOH, HCl, and heat treatment to provide bioactivity. Field emission scanning electron micrographs showed that fine networks of titanium oxide were formed over the whole surface of the porous body. These treated porous bodies formed bone-like apatite on their surfaces in a simulated body fluid within 3 days. In vivo studies showed that new bone penetrated into the pores and directly bonded to the walls within 12 weeks after implantation into the femur of Japanese white rabbits. The percentage bone affinity indices of the chemical- and heat-treated porous bodies were significantly higher than that of untreated implants. © 2010 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.


Fukuda A.,Kyoto University | Takemoto M.,Kyoto University | Saito T.,Kyoto University | Fujibayashi S.,Kyoto University | And 7 more authors.
Acta Biomaterialia | Year: 2011

Many studies have shown that certain biomaterials with specific porous structures can induce bone formation in non-osseous sites without the need for osteoinductive biomolecules, however, the mechanisms responsible for this phenomenon (intrinsic osteoinduction of biomaterials) remain unclear. In particular, to our knowledge the type of pore structure suitable for osteoinduction has not been reported in detail. In the present study we investigated the effects of interconnective pore size on osteoinductivity and the bone formation processes during osteoinduction. Selective laser melting was employed to fabricate porous Ti implants (diameter 3.3 mm, length 15 mm) with a channel structure comprising four longitudinal square channels, representing pores, of different diagonal widths, 500, 600, 900, and 1200 μm (termed p500, p600, p900, and p1200, respectively). These were then subjected to chemical and heat treatments to induce bioactivity. Significant osteoinduction was observed in p500 and p600, with the highest observed osteoinduction occurring at 5 mm from the end of the implants. A distance of 5 mm probably provides a favorable balance between blood circulation and fluid movement. Thus, the simple architecture of the implants allowed effective investigation of the influence of the interconnective pore size on osteoinduction, as well as the relationship between bone quantity and its location for different pore sizes. © 2011 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.


PubMed | Red Cross, Sagawa Printing Co., Kyoto University, Osaka Medical College and 3 more.
Type: Journal Article | Journal: European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society | Year: 2016

Image-based navigational patient-specific templates (PSTs) for pedicle screw (PS) placement have been described. With recent advances in three-dimensional computer-aided designs and additive manufacturing technology, various PST designs have been reported, although the template designs were not optimized. We have developed a novel PST design that reduces the contact area without sacrificing stability. It avoids susceptibility to intervening soft tissue, template geometric inaccuracy, and difficulty during template fitting.Fourteen candidate locations on the posterior aspect of the vertebra were evaluated. Among them, locations that had high reproducibility on computed tomography (CT) images and facilitated accurate PS placement were selected for the final PST design. An additive manufacturing machine (EOSINT M270) fabricated the PSTs using commercially pure titanium powder. For the clinical study, 36 scoliosis patients and 4 patients with ossification of the posterior longitudinal ligament (OPLL) were treated with thoracic PSs using our newly developed PSTs. We intraoperatively and postoperatively evaluated the accuracy of the PS hole created by the PST.Based on the segmentation reproducibility and stability analyses, we selected seven small, round contact points for our PST: bilateral superior and inferior points on the transverse process base, bilateral inferior points on the laminar, and a superior point on the spinous process. Clinically, the success rates of PS placement using this PST design were 98.6% (414/420) for scoliosis patients and 100% (46/46) for OPLL patients.This study provides a useful design concept for the development and introduction of patient-specific navigational templates for placing PSs.

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