Breaking the Saturation of Sensitivity for Ultrawide Range Flexible Pressure Sensors by Soft-Strain Effect.

The flexible pressure sensors with a broad pressure range and unsaturated sensitivity are highly desired in practical applications. However, pressure sensors by piezoresistive effect are always limited by the compressibility of sensing layers, resulting in a theoretically decreasing sensitivity of less than 100%. Here, a unique strategy is proposed that utilizes the strain effect, simultaneously achieving a trade-off between a wider pressure detection range and unsaturated sensitivity. Ascribed to the strain effect of sensing layers induced by interlaced microdomes, the sensors possess an increased sensitivity (5.22-70 MPa-1) over an ultrawide pressure range (45 Pa-4.1 MPa), a high-pressure resolution (5 Pa), fast response/recovery time (30/45 ms), and a robust response under a high-pressure loading of 3.5 MPa for more than 5000 cycles. These superior sensing performances allow the sensor to monitor large pressure. The flexible pressure sensor array can assist doctors in restoring the neutral mechanical axis, tracking knee flexion angles, and extracting gait features. Moreover, the flexible sensing array can be integrated into the joint motion surveillance system to map the balance medial-lateral contact forces on the metal compartments in real time, demonstrating the potential for further development into precise medical human-machine interfaces during total knee replacement surgery.

The Promotion of Mechanical Properties by Bone Ingrowth in Additive-Manufactured Titanium Scaffolds.

Although the initial mechanical properties of additive-manufactured (AM) metal scaffolds have been thoroughly studied and have become a cornerstone in the design of porous orthopaedic implants, the potential promotion of the mechanical properties of the scaffolds by bone ingrowth has barely been studied. In this study, the promotion of bone ingrowth on the mechanical properties of AM titanium alloy scaffolds was investigated through in vivo experiments and numerical simulation. On one hand, the osseointegration characteristics of scaffolds with architectures of body-centred cubic (BCC) and diamond were compared through animal experiments in which the mechanical properties of both scaffolds were not enhanced by the four-week implantation. On the other hand, the influences of the type and morphology of bone tissue in the BCC scaffolds on its mechanical properties were investigated by the finite element model of osseointegrated scaffolds, which was calibrated by the results of biomechanical testing. Significant promotion of the mechanical properties of AM metal scaffolds was only found when cortical bone filled the pores in the scaffolds. This paper provides a numerical prediction method to investigate the effect of bone ingrowth on the mechanical properties of AM porous implants, which might be valuable for the design of porous implants.

Additive manufactured polyether-ether-ketone implants for orthopaedic applications: a narrative review.

Polyether-ether-ketone (PEEK) is believed to be the next-generation biomedical material for orthopaedic implants that may replace metal materials because of its good biocompatibility, appropriate mechanical properties and radiolucency. Currently, some PEEK implants have been used successfully for many years. However, there is no customised PEEK orthopaedic implant made by additive manufacturing licensed for the market, although clinical trials have been increasingly reported. In this review article, design criteria, including geometric matching, functional restoration, strength safety, early fixation, long-term stability and manufacturing capability, are summarised, focusing on the clinical requirements. An integrated framework of design and manufacturing processes to create customised PEEK implants is presented, and several typical clinical applications such as cranioplasty patches, rib prostheses, mandibular prostheses, scapula prostheses and femoral prostheses are described. The main technical challenge faced by PEEK orthopaedic implants lies in the poor bonding with bone and soft tissue due to its biological inertness, which may be solved by adding bioactive fillers and manufacturing porous architecture. The lack of technical standards is also one of the major factors preventing additive-manufactured customised PEEK orthopaedic implants from clinical translation, and it is good to see that the abundance of standards in the field of additive-manufactured medical devices is helping them enter the clinical market.

Additively-manufactured PEEK/HA porous scaffolds with highly-controllable mechanical properties and excellent biocompatibility.

Polyetheretherketone (PEEK) was widely applied into fabricating of orthopaedic implants, benefitting its excellent biocompatibility and similar mechanical properties to native bones. However, the inertness of PEEK hinders its integration with the surrounding bone tissue. Here PEEK scaffolds with a series of hydroxyapatite (HA) contents in gradient were manufactured via fused filament fabrication (FFF) 3D printing techniques. The influence of the pore size, HA content and printing direction on the mechanical properties of the PEEK/HA scaffolds was systematically evaluated. By adjusting the pore size and HA contents, the elastic modulus of the PEEK/HA scaffolds can be widely tuned in the range of 624.7-50.6 MPa, similar to the variation range of natural cancellous bone. Meanwhile, the scaffolds exhibited higher Young's modulus and lower compressive strength along Z printing direction. The mapping relationship among geometric parameters, HA content, printing direction and mechanical properties was established, which gave more accurate predictions and controllability of the modulus and strength of scaffolds. The PEEK/HA scaffolds with the micro-structured surface could promote cell attachment and mineralization in vitro. Therefore, the FFF-printed PEEK/HA composites scaffolds can be a good candidate for bone grafting and tissue engineering.

Effects of Raster Angle and Material Components on Mechanical Properties of Polyether-Ether-Ketone/Calcium Silicate Scaffolds.

Polyetheretherketone (PEEK) was widely used in the fabrication of bone substitutes for its excellent chemical resistance, thermal stability and mechanical properties that were similar to those of natural bone tissue. However, the biological inertness restricted the osseointegration with surrounding bone tissue. In this study, calcium silicate (CS) was introduced to improve the bioactivity of PEEK. The PEEK/CS composites scaffolds with CS contents in gradient were fabricated with different raster angles via fused filament fabrication (FFF). With the CS content ranging from 0 to 40% wt, the crystallinity degree (from 16% to 30%) and surface roughness (from 0.13 ± 0.04 to 0.48 ± 0.062 µm) of PEEK/CS scaffolds was enhanced. Mechanical testing showed that the compressive modulus of the PEEK/CS scaffolds could be tuned in the range of 23.3-541.5 MPa. Under the same printing raster angle, the compressive strength reached the maximum with CS content of 20% wt. The deformation process and failure modes could be adjusted by changing the raster angle. Furthermore, the mapping relationships among the modulus, strength, raster angle and CS content were derived, providing guidance for the selection of printing parameters and the control of mechanical properties.

Topological design and biomechanical evaluation for 3D printed multi-segment artificial vertebral implants.

Customized spinal implants fabricated by additive manufacturing have been increasingly used clinically to restore the physiological functions. However, the mechanisms and methods about the design for the spinal implants are not clear, especially for the reconstruction of multi-segment vertebral. This study aims to develop a novel multi-objective optimization methodology based on various normal spinal activities, to design the artificial vertebral implant (AVI) with lightweight, high-strength and high-stability. The biomechanical performance for two types of AVI was analyzed and compared under different loading conditions by finite element method. These implants were manufactured via selective laser melting technology and evaluated via compressive testing. Results showed the maximum Mises stress of the optimized implant under various load cases were about 41.5% of that of the trussed implant, and below fatigue strength of 3D printed titanium materials. The optimized implant was about 2 times to trussed implant in term of the maximum compression load and compression stiffness to per unit mass, which indicated the optimized implant can meet the safety requirement. Finally, the optimized implant has been used in clinical practice and good short-term clinical outcomes were achieved. Therefore, the novel developed method provides a favorable guarantee for the design of 3D printed multi-segment artificial vertebral implants.

Biomechanical characterization of vertebral body replacement in situ: Effects of different fixation strategies.

BACKGROUND AND OBJECTIVE: Artificial vertebral implant with a lateral or posterior screw-rod fixation system are usually employed in lumbar reconstruction surgery to rebuild the lumbar spine after partial resection due to a tumor or trauma. However, few studies have investigated the effect of the various fixation systems on the biomechanics of the reconstructed lumbar system. This study aims to evaluate the influence of different surgical fixation strategies on the biomechanical performance of a reconstructed lumbar spine system in terms of the strength and long-term stability. METHODS: Two typical lumbar spine reconstruction case models that correspond to lateral or posterior fixation systems were built based on the clinical data. Finite element analyses were performed, and comparisons were made between the two models based on the predicted stress distribution of the reconstructed lumbar spine model, bone-growth area of the endplate, and the range of motion under various normal daily activities. RESULTS: The load from the upper vertebral body was found to be effectively transmitted onto the lower vertebral body by a vertebral implant with the lateral fixation system; this was favorable for bone growth after surgery. However, significantly high stresses were concentrated around the interaction region between the screws and bone, owing to the uneven lateral fixation structure; this may increase the risk of bone fractures and screw loosening in the long term. For the posterior fixation case, stably posterior fixation structure was favorable to maintain stability for the reconstructed lumbar spine. However, the load was mainly transmitted via the fixation rod rather than the vertebral implant, owing to the stress shielding effect. Therefore, the predicted strain on the endplate were insufficient for bone ingrowth under most of the spinal activates, which could cause bone loss and prosthesis loosening. CONCLUSIONS: In this study, the comparisons of the reconstructed lumbar spine system with lateral and posterior fixation strategies were conducted. The Pros and Cons of these two fixation strategies was deeply discussed and the associated clinical issues were provided. The results of this study will have a clear impact in understanding the biomechanics of the lumbar spine with different fixation strategies and providing necessary instructions to the design and application of the lumbar spinal fixation system.

A general multi-objective topology optimization methodology developed for customized design of pelvic prostheses.

In this study, a multi-objective topology optimization method has been formulated and carried out for various resection types, with minimization of a weighted sum of the compliance (maximized stiffness) under six routine activities of daily life as the objective function and volume reduction as a constraint. Unique prosthetic geometries with low weight and remarkable strength closely matching the pelvic bone shape were obtained. The strength of the optimized implants was investigated through finite element analysis and it has been found that the initial geometries of the optimized implants could withstand the static loading conditions of various routine activities having less stress concentration areas. A 3D printed patient-specific topology optimized hemi-pelvic prosthesis has been designed based on the proposed method and implanted successfully in a patient with pelvic sarcoma. Therefore, pelvic prostheses can be designed and then manufactured via additive manufacturing technologies with the minimum material in less time and having robust mechanical fixation responses. Conclusively, the topology optimization method used for the design of pelvic prostheses improves the biomechanical performance of the implants with reduced weight and higher stiffness than the traditional implants. Including the topology optimization procedure in the phase of designing patient-specific pelvic implants is therefore, highly recommended.

Application of 3D-printed PEEK scapula prosthesis in the treatment of scapular benign fibrous histiocytoma: A case report.

BACKGROUND: Bone benign fibrous histiocytoma (BFH) is an invasive primary bone tumor. When the local excision is not complete, the risk of recurrence is high, and hence, one-piece resection is necessary. The major challenge for clinicians is to reconstruct the bone after resection of the tumor. The present study investigated the efficacy of 3-dimensional (3D) printing technique in the treatment of benign fibrous histiocytoma of the scapula. METHODS: The patient with benign fibrous histiocytoma of scapular bone was treated with PEEK (polyetheretherketone) prosthesis replacement using the 3D printing technique. X-ray and computed tomography (CT) scans evaluated the relationship between the position of the prosthesis and that of the shoulder joint. Also, the constant score of the shoulder joint was calculated. RESULTS: The anteroposterior radiograph showed that the position of the left scapula prosthesis is satisfactory and that of the shoulder joint is normal. Three months after the operation, the X-ray examination indicated the lack of flexibility and shift, as well as, dislocation and disjunction of PEEK prosthesis. The constant score of the left shoulder function was 68 points. Active shoulder joint activity: 120° on the lift, 90° on abduction, 50° on the external rotation, and 70° on internal rotation. CONCLUSIONS: The application of 3D-printed PEEK scapula prosthesis with total shoulder replacement offers the possibility of accurate reconstruction, improves the operability of surgery, shortens the operation time, and allows early functional recovery of the patients.