Replace Implant System的临床应用及评价

目的 :评价ReplaceImplantSystem的临床效果。方法 :用ReplaceImplantSystem进行延期或即刻种植。采用埋入式二次手术方式 ,对72例患者植入90枚种植体 ,金属烤瓷冠修复 ,临床随访观察3年。结果 :种植体成功率100% ,种植体周齿槽骨水平吸收<0.2mm/年 ,烤瓷冠崩瓷4颗 ,固定螺丝钉松动1颗 ,种植体周围龈炎11颗。结论 :ReplaceImplantSystem适用于常见的牙列缺损的延期或即刻种植。

Xive Implant System的临床应用评价

目的:评价XiveImplantSystem的临床效果。方法:应用XiveImplantSystem对失牙区进行即刻或延期种植,部分采用埋入或二次手术方式,部分采用一次手术直接安装愈合基台,对62例患者植入100枚种植体,金属烤瓷冠及8例后牙区因颌龈距过低而采用铸造冠修复。临床随访观察三年六个月。结果:种植体成功率100%,种植体周牙槽骨吸收<0.2mm/年,种植体周围炎2枚,固定螺丝松动2枚。结论:XiveImplantSystem适用于牙列缺损及缺失的延期或即刻修复。

Low Cost Osseointegrated Implant System for Developing Countries

Objective: Osseointegrated hearing implants have been readily available and extensively used in developed countries for over twenty years. Despite a great need for this technology, use of these implants in developing countries has been limited due to the prohibitive cost of the surgical implant system as well as the implant devices themselves. To address this problem we have developed a drill and implant system that mimics the currently available instrumentation using materials that are readily available at a fraction of the cost. Study Design: Proof of Concept. Methods: The construction of the drill and implant system will be described. Testing of the system so that it adhered to Cochlear’sTM Bone anchored hearing aid system specifications including the drill speed and torque settings were measured. Temperature readings were also recorded during procedures performed on human cadaveric temporal bones. Results: The speed of the drill with the guide drill and countersink drill bits ranged from 1400 revolutions per minute (rpm) to 2300 rpm’s. The temperature change of the room temperature temporal bones varied from 0 degrees to +0.2 degrees Fahrenheit during the drilling process with both drill bits. All five implants were stable in the cadaver bone after being checked for initial stability. Conclusion: This low cost implant system may make the BAHA technology more easily available to developing countries pending future studies with animal models.

Systemic modulation of skeletal mineralization by magnesium implant promoting fracture healing: Radiological exploration enhanced with PCA-based machine learning in a rat femoral model

The clinical application of magnesium(Mg)and its alloys for bone fractures has been well supported by in vitro and in vivo trials.However,there were studies indicating negative effects of high dose Mg intake and sustained local release of Mg ions on bone metabolism or repair,which should not be ignored when developing Mg-based implants.Thus,it remains necessary to assess the biological effects of Mg implants in animal models relevant to clinical treatment modalities.The primary purpose of this study was to validate the beneficial effects of intramedullary Mg implants on the healing outcome of femoral fractures in a modified rat model.In addition,the mineralization parameters at multiple anatomical sites were evaluated,to investigate their association with healing outcome and potential clinical applications.Compared to the control group without Mg implantation,postoperative imaging at week 12 demonstrated better healing outcomes in the Mg group,with more stable unions in 3D analysis and high-mineralized bridging in 2D evaluation.The bone tissue mineral density(TMD)was higher in the Mg group at the non-operated femur and lumbar vertebra,while no differences between groups were identified regarding the bone tissue volume(TV),TMD and bone mineral content(BMC)in humerus.In the surgical femur,the Mg group presented higher TMD,but lower TV and BMC in the distal metaphyseal region,as well as reduced BMC at the osteotomy site.Principal component analysis(PCA)-based machine learning revealed that by selecting clinically relevant parameters,radiological markers could be constructed for differentiation of healing outcomes,with better performance than 2D scoring.The study provides insights and preclinical evidence for the rational investigation of bioactive materials,the identification of potential adverse effects,and the promotion of diagnostic capabilities for fracture healing.

Establishment of quantitative evaluation system for cochlear implant effectiveness for hearing-impaired children

Introduction:Cochlear implant is currently the most widely proven interventions for auditory rehabilitation for children with severe sensorineural hearing impairment.However,there are obvious limitations in these current evaluation methods.This study aims to develop an evaluation system for quantitatively evaluating the effectiveness of cochlear implants for hearing-impaired children.Methods:A correspondence questionnaire was developed based on an initial indicator system that was developed based on the literature focused on the evaluation of cochlear implant outcomes in children.Twenty-five experts in otology,clinical audiology,rehabilitation audiology,and mental health from nine provinces in China were consulted.The degree of authority and coordination of experts and the indicators and weights of the quantitative evaluation system were analyzed.Seventy-eight children aged 3–11 years after cochlear implantation were recruited from two centers in Hubei province to evaluate the reliability and validity of the quantitative evaluation system.Results:The opinions of experts converged after the second round of correspondence,and the coordination and authority of the expert consensus were met.The recall rate of the questionnaire was 100%for both rounds.Five secondary indicators,including auditory ability,verbal ability,behavioral assessment,learning capabilities,and quality of life,and 13 tertiary indicators were reserved for the evaluation of cochlear implant effectiveness.The weight of each indicator was calculated.The Cronbach’sαcoefficient of the quantitative evaluation system based on the standardized items was 0.930,and the three extracted common factors could explain 78.86%of the total variance.Conclusions:An expert consensus-based evaluation system that can quantitatively evaluate the effectiveness of cochlear implants in children has been developed with good reliability and validity.

Effects of systematic cardiac rehabilitation training in elderly patients with unstable angina following cardiac stent implantation

BACKGROUND Coronary stent implantation is usually used to treat unstable angina to alleviate stenosis or occlusion,promoting blood flow restoration and alleviating symptoms such as myocardial ischemia.And postoperative cardiac rehabilitation is essential for enhancing recovery and prognosis.Nevertheless,conventional rehabilitation lacks specificity,particularly for elderly patients with multiple comorbidities and poor compliance,rendering it less effective.AIM To investigate the effects of systematic cardiac rehabilitation training in elderly patients with unstable angina following coronary stenting intervention.METHODS A retrospective enrollment was conducted comprising fifty-four elderly patients with unstable angina pectoris who underwent systematic cardiac rehabilitation training after receiving coronary intervention as the rehabilitation group,while fifty-three elderly patients who received basic nursing and rehabilitation guidance measures after coronary intervention were assigned to the control group.Differences in Seattle Angina Questionnaire scores,survival quality(SF-36)scores,cardiopulmonary exercise function assessment index,echocardiographic cardiac function index,and adverse cardiovascular events were compared between the two groups.RESULTS After intervention,the rehabilitation group observed greater VO2 Max,maximum metabolic equivalent,eft ventricular ejection fraction,left ventricular end-diastolic diameter and smaller left ventricular end-systolic diameter.And the rehabilitation group observed greater scores of physical activity limitation,stable angina pectoris,treatment satisfaction,and SF-36 score.The incidence of adverse cardiovascular events in the two groups,showed no significant difference.CONCLUSION Systematic cardiac rehabilitation following coronary stenting in elderly patients with unstable angina pectoris can enhance cardiac function recovery,consequently enhancing both quality of life and cardiopulmonary exercise tolerance.

Effect of Implanted Chip System on Blood Pressure Regulation in Rabbits

Objective: To evaluate the efficiency of an implanted chip system on blood pressure regulation. Methods: The mean arterial pressure (MAP) and heart rate (HR) were recorded in anesthetized rabbits. Based on the set point theory, an implanted chip system was designed to regulate the blood pressure by stimulating the aortic depressor nerve (ADN) according to the feedback of blood pressure. The blood pressure regulation induced by the implanted chip system was carried out twice (lasted for 15 min and 60 min respectively) and the change of MAP and HR during the regulation was compared with the control. Results: There was a significant decrease of MAP during the first regulation ([-32.0 ± 6.6] mmHg) and second regulation ([-27.4 ± 6.2] mmHg) compared with the control (P<0.01). The HR was also significantly decreased during regulation compared with the control. Both MAP and HR returned to the baseline immediately without rebound after the regulation ceased. Conclusion: The implanted chip system can regulate the blood pressure successfully and keep the blood pressure in a lower constant level without adaptation.

Design and evaluation of a novel sub-scaffold dental implant system based on the osteoinduction of micro-nano bioactive glass

Alveolar ridge atrophy brings great challenges for endosteal implantation due to the lack of adequate vertical bone mass to hold the implants.To overcome this limitation,we developed a novel dental implant design:sub-scaffold dental implant system(SDIS),which is composed of a metal implant and a micro-nano bioactive glass scaffold.This implant system can be directly implanted under mucous membranes without adding any biomolecules or destroying the alveolar ridge.To evaluate the performance of the novel implant system in vivo,SDISs were implanted into the subepicranial aponeurosis space of Sprague–Dawley rats.After 6 weeks,the SDIS and surrounding tissues were collected and analysed by micro-CT,scanning electron microscopy and histology.Our results showed that SDISs implanted into the sub-epicranial aponeurosis had integrated with the skull without any mobility and could stably support a denture.Moreover,this design achieved alveolar ridge augmentation,as active osteogenesis could be observed outside the cortical bone.Considering that the microenvironment of the sub-epicranial aponeurosis space is similar to that of the alveolar ridge,SDISs have great potential for clinical applications in the treatment of atrophic alveolar ridges.The study was approved by the Animal Care Committee of Guangdong Pharmaceutical University(approval No.2017370).

Impact of osteoporosis in dental implants:A systematic review

AIM: To assess the failure and bone-to-implant contact rate of dental implants placed on osteoporotic subjects. METHODS: Extensive examination strategies were created to classify studies for this systematic review. MEDLINE(via Pub Med) and EMBASE database were examined for studies in English up to and including May 2014. The examination presented a combination of the MeS H words described as follow: "osteoporosis" or "osteopenia" or "estrogen deficiency" AND "implant" or "dental implant" or "osseointegration". Assessment of clinical and/or histological peri-implant conditions in osteoporosis subjects treated with titanium dental implants. The examination included a combination of the MeS H terms described as follow: "osteoporosis" or "osteopenia" or "estrogen deficiency" AND "implant" or "dental implant" or "osseointegration".RESULTS: Of 943 potentially eligible articles, 12 were included in the study. A total of 133 subjects with osteoporosis, 73 subjects diagnosed with osteopenia and 708 healthy subjects were assessed in this systematic review. In these subjects were installed 367, 205, 2981 dental implants in osteoporotic, osteopenic and healthy subjects, respectively. The failure rate of dental implant was 10.9% in osteoporotic subjects, 8.29% in osteopenic and 11.43% in healthy ones. Bone-to-implant contact obtained from retrieved implants ranged between 49.96% to 47.84%, for osteoporosis and non-osteoporotic subjects. CONCLUSION: Osteoporotic subjects presented higher rates of implant loss, however, there is a lower evidence to strengthen or refute the hypothesis that osteoporosis may have detrimental effects on bone healing. Consequently, final conclusions regarding the effect of osteoporosis in dental implant therapy cannot be made at this time. There are no randomized clinical trial accessible for evaluation and the retrospectivenature of the evaluated studies shall be taken in account when interpreting this study.

New skin closure system facilitates wound healing after cardiovascular implantable electronic device surgery

The manuscript describes the efficacy of a new skin closure system(Zip Line?) for wound closure after pacemaker/implantable cardioverter defibrillator surgery. The system is particularly useful when wound healingis difficult with traditional methods and in patients at high risk for surgical site infections(SSIs). This skin closure option is easy and quick to apply and remove, and produces excellent cosmetic results. Although it is associated with a minimal expense upcharge, the benefits, including the potential for decrease in SSI, make it attractive and worth considering for skin closure in device patients, particularly those at increased risk of complications.

Efficacy and economic analysis of Ex- PRESS implantation versus trabeculectomy in uncontrolled glaucoma： a systematic review and Meta-analysis

AIM：To systematically review the current evidence based on the efficacy and cost of Ex-PRESS implantation and trabeculectomy（Trab）for uncontrolled glaucoma.·METHODS：Clinical trials were identified by electronic databases（Pub Med,EMBASE,ISI Web of science and Cochrane library）,and data,such as intraocular pressure（IOP）,the complete and qualified success rate,the postoperative complications and the cost,were exacted from these relevant studies.Weighted mean difference（WMD）,odds ratio（OR）and 95%confidence intervals（CIs）were calculated and were pooled using a randomeffects model.·RESULTS：Eleven relevant publications and two abstracts met the inclusion criteria.The efficacy of ExPRESS was similar to that of Trab in the percentage of IOP reduction（IOPR%）at 1,2y（WMD：-2.01;95%CI：-7.92-3.90;=0.50 and WMD：2.89;95%CI：-8.05-13.83;=0.60,respectively）.Ex-PRESS possessed a significant higher complete and qualified success rate（OR：1.59;95%CI：1.07-2.35;=0.02 and OR：1.74;95%CI：1.06-2.86;=0.03,respectively）.Moreover,Ex-PRESS exerted a significantly lower frequency of hypotony and hyphema than Trab（OR：0.39;95%CI：0.21-0.72;=0.003 and OR：0.27;95%CI：0.10-0.69;=0.003,respectively）.However,there was no consistent result on the cost between the two groups according to the previous three studies.·C ONCLUSION：Both Trab and Ex-PRESS have equivalent efficacy in lowering IOP,yet Ex-PRESS had a lower risk of hypotony and hyphema than Trab.Nevertheless,whether the cost of Ex-PRESS was less than that of Trab should be further investigated to ensure evidence-based conclusion in the long run.

An Implanted Closed-loop Chip System for Heart Rate Control:System Design and Effects in Conscious Rats

Objective： To evaluate the efficiency of an implanted chip system for the control of heart rate （HR）. Methods： The HR was recorded in six conscious Sprague-Dawley （SD） rats. An implanted chip system was designed to regulate the HR by stimulating the right cervical vagus nerve according to the feedback of real time HR. Each rat was subjected to 30-min regulation and 30-min recovery. The change of HR during the regulation period was compared with the control. The ECG was recorded during the experiment for 24 h. Results： The ECG signals were successfully recorded during the experiment. The HR was significantly decreased during the period of regulation compared with control （-79.3 ± 34.5, P 〈 0.01, n = 6） and then recovered to normal after regulation. Conclusion： The described implanted chip system can regulate the HR to a designated set point.

Optics‑guided Robotic System for Dental Implant Surgery

At present,dental implant surgery mainly relies on the clinical experience of the doctor and the assistance of preoperative medical imaging.However,there are some problems in dental implant surgery,such as narrow space,sight obstruction,inaccurate positioning,and high requirements of doctors’proficiency.Therefore,a dental implant robot system(DIRS)guided by optical navigation is developed in this study,with an x-shaped tool and an irregular pentagonal tracer are designed for spatial registration and needle tip positioning strategy respectively.The coordinate system of each unit in DIRS is unified through system calibration,spatial registration,and needle tip positioning strategy.Then the surgical path is planned on the computed tomography(CT)images in the navigation software before operation.The automatic positioning method and the auxiliary positioning method can be used in the operation to achieve accurate positioning and assist doctors to complete the operation.The errors of spatial registration,needle tip positioning strategy,and the overall accuracy of the system were evaluated respectively,and the results showed that they all met the needs of clinical surgery.This study preliminarily verified the feasibility of the precise positioning method for dental surgery robots and provided certain ideas for subsequent related research.

Long-term clinical performance of flapless implant surgery compared to the conventional approach with flap elevation:A systematic review and meta-analysis

BACKGROUND The conventional implant approach involves flap elevation,which may result in increased soft tissue and bone loss and postoperative morbidity.The flapless surgical technique,aided by three-dimensional medical imaging equipment,is regarded as a possible alternative to the conventional approach to alleviate the above issues.Several studies have been performed regarding the role of flapless implant surgery.However,the results are inconsistent and there is no robust synthesis of long-term evidence to better inform surgeons regarding which type of surgical technique is more beneficial to the long-term prognosis of patients in need of implant insertion.AIM To compare the long-term clinical performance after flapless implant surgery to that after the conventional approach with flap elevation.METHODS PubMed,EMBASE,Cochrane Central Register of Controlled Trials,and grey literature databases were searched from inception to 23 September 2019.Randomised controlled trials (RCTs) and cohort studies comparing the long-term clinical performance after flapless implant surgery to that after the conventional approach over a follow-up of three years or more were induded.Meta-analyses were conducted to estimate the odds ratios (ORs) or mean differences (MDs) and their 95 To confidence intervals (CIs) between the long-term implant survival rate,marginal bone loss,and complication rate of the flapless and conventional groups.Subgroup analyses were carried out to account for the possible effects of the guided or free-hand method during flapless surgery.RESULTS Ten articles,including four RCTs and six cohort studies,satisfied the eligibility criteria and nine of them were inclded in the meta-analysis.There was no significant difference between the long-term implant survival rate [OR=1.30,95%CI (0.37,4.54),P=0.68],marginal bone loss [MD=0.01,95%CI (-0.42,0.44),P=0.97],and complication rate [OR=1.44,95%CI (0.77,2.68),P=0.25] after flapless implant surgery and the conventional approach.Moreover,subgroup analyses revealed that there was no statistically significant difference between the implant survival rate [guided:OR=1.52,95%CI (0.19,12.35),P=0.70];free-hand:n=1,could not be estimated),marginal bone loss [guided:MD=0.22,95%CI (-0.14,0.59),P=0.23;free-hand:MD=-0.27,95%CI (-1.10,0.57),P=0.53],or complication rate [guided:OR=1.16,95%CI (0.52,2.63),P=0.71;free-hand:OR=1.75,95%CI(0.66,4.63),P=0.26] in the flapless and conventional groups either with use of the surgical guide or by the free-hand method.CONCLUSION The flapless surgery and conventional approach had comparable clinical performance over three years or more.The guided or free-hand technique does not significantly affect the long-term outcomes of flapless surgery.

A Systematic Approach for Making 3D-Printed Patient-Specific Implants for Craniomaxillofacial Reconstruction

Craniomaxillofacial reconstruction implants,which are extensively used in head and neck surgery,are conventionally made in standardized forms.During surgery,the implant must be bended manually to match the anatomy of the individual bones.The bending process is time-consuming,especially for inexperienced surgeons.Moreover,repetitive bending may induce undesirable internal stress concentration,resulting in fatigue under masticatory loading in v iv o and causing various complications such as implant fracture,screw loosening,and bone resorption.There have been reports on the use of patient-specific 3D-printed implants for craniomaxillofacial reconstruction,although few reports have considered implant quality.In this paper,we present a systematic approach for making 3D-printed patientspecific surgical implants for craniomaxillofacial reconstruction.The approach consists of three parts:First,an easy-to-use design module is developed using Solidworks®software,which helps surgeons to design the implants and the axillary fixtures for surgery.Design engineers can then carry out the detailed design and use finite-element modeling(FEM)to optimize the design.Second,the fabrication process is carried out in three steps:0 testing the quality of the powder;(2)setting up the appropriate process parameters and running the 3D printing process;and (3)conducting post-processing treatments(i.e.,heat and surface treatments)to ensure the quality and performance of the implant.Third,the operation begins after the final checking of the implant and sterilization.After the surgery,postoperative rehabilitation follow-up can be carried out using our patient tracking software.Following this systematic approach,we have successfully conducted a total of 41 surgical cases.3D-printed patient-specific implants have a number of advantages;in particular,their use reduces surgery time and shortens patient recovery time.Moreover,the presented approach helps to ensure implant quality.

The Computer Simulation System for Range Distribution of various Implantat

In this paper, the integrated software system named PRDII(Project Range Distribution of Ion Implantation), which is based on the transport theory and Monte Carlo method and is developed by ourselves for range distribution of ion implantation, is introduced. The system generally possess versatility., efficiency and practicality. As for versatility, the system can build and utilize the parameter bank of various ions and material bank of various parts, can calculate the range distributions of implanted ions in the target for various conditions, such as for different incident ions, for different compositions and shapes of targets, for different energies.. doses and angles of incidence; As for efficiency, the computations are accelerated greatly by using some numerical simulating formulae instead of numerical iterative solutions in key procedure and using fixed fly path instead of random fly path; As for practicality, the preassumptions of the simulation are more close to the reality and the simulating results are more accurate in that the sputtering and the dynamic changes of target composition during penetration are considered and the advanced Monte Carlo method is used. Compared to other similar software, such as famous TRIM[1] and SASAMAL[2], it is more beautiful for interface, more convenient for operation, It can call, compute.. compare.. comment, copy and print all curves needed, and the simulating results consist with the experiments very well.

From oral formulations to drug-eluting implants:using 3D and 4D printing to develop drug delivery systems and personalized medicine

Since the start of the Precision Medicine Initiative by the United States of America in 2015,interest in personalized medicine has grown extensively.In short,personalized medicine is a term that describes medical treatment that is tuned to the individual.One possible way to realize personalized medicine is 3D printing.When using materials that can be tuned upon stimulation,4D printing is established.In recent years,many studies have been exploring a new field that combines 3D and 4D printing with therapeutics.This has resulted in many concepts of pharmaceutical devices and formulations that can be printed and,possibly,tailored to an individual.Moreover,the first 3D printed drug,Spritam®,has already found its way to the clinic.This review gives an overview of various 3D and 4D printing techniques and their applications in the pharmaceutical field as drug delivery systems and personalized medicine.

Preclinical in vivo research of magnesium-based implants for fracture treatment: A systematic review of animal model selection and study design

Background:Degradable magnesium implants are promising for clinical fracture treatment,providing less stress-shielding mechanical support and superior bone-strengthening benefits to traditional materials.The quality of preclinical research is essential for developing Mg implants;however,there are considerable variations in the model selection and study design in published studies,posing challenges for safe and effective clinical translation of lab discoveries.Objective:The purpose of this systematic review is to investigate the current progress on in vivo research of Mg implants for fracture treatment,focusing on model selection,Mg materials,implant design,methodological and analyzing techniques,aiming to provide comprehensive guidance for future preclinical research.Materials and methods:Pub Med and Embase online databases were searched to identify researches investigating Mg implants in animal models of fracture from 1960 to December 2019,using a combination of keywords:magnesium and fracture.Eligible studies were included without language restriction.Data extraction was conducted for qualitative analysis.Meta-analysis was not performed due to extensive heterogeneities among studies.Results:Twenty studies published from 2014 to 2019 were included.Publication information,animal model,methodological quality,implants preparation,and evaluation techniques were extracted.The methodological assessment revealed low to high risk of bias among studies.Both rodent and non-rodent species were selected,and the anatomical sites for inducing fractures included both cranial-facial and limb bones.Pure Mg and alloys with or without surface modification were evaluated,covering implant designs of both intra-medullary and extra-medullary fixation.Radiological and histological evaluations were commonly conducted.Conclusions:Published in vivo evidence confirmed the role of Mg-based implants in promoting fracture healing.However,considering heterogeneity in animal selection,implant preparation,and evaluation methods,there still lacks a standardized reference model.By analyzing the information extracted from included studies,the systematic review may facilitate planning and conducting preclinical research with translational perspective.

Wireless communication and wireless power transfer system for implantable medical device

Traditional magnetically coupled resonant wireless power transfer technology uses fixed distances between coils for research,to prevent fluctuations in the receiving voltage,and lead to reduce transmission efficiency.This paper proposes a closed-loop control wireless communication wireless power transfer system with a wearable four-coil structure to stabilize the receiving voltage fluctuation caused by changes in the displacement between the coils.Test results show that the system can provide stable receiving voltage,no matter how the distance between the transmitting coil and the receiving coil is changed.When the transmission distance is 20 mm,the power transfer efficiency of the system can reach 18.5%under the open-loop state,and the stimulus parameters such as the stimulation period and pulse width can be adjusted in real time through the personal computer terminal.

Improvement of Systemic Symptoms after Dental Implant Removal

Dental implants have spread worldwide in dentistry. The risks and complications reported are limited to local issues. However, in this case, a patient complained of systemic symptoms after dental implantation. This case report aims to demonstrate that systemic symptoms such as lumbago, shoulder stiffness, neck pain, hip joint pain, and facial pain improved after the removal of well-osseointegrated titanium implants. The results suggest that harmful electromagnetic waves received by implants affect body conditions;however, to date, the underlying mechanisms have not been identified. Therefore, further research is required.