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.

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.

Recent advances and innovations in the design and fabrication of wearable flexible biosensors and human health monitoring systems based on conjugated polymers

Wearable biosensors have received great interest as patient-friendly diagnostic technologies because of their high flexibility and conformability.The growing research and utilization of novel materials in designing wearable biosensors have accelerated the development of point-of-care sensing platforms and implantable biomedical devices in human health care.Among numerous potential materials,conjugated polymers(CPs)are emerging as ideal choices for constructing high-performance wearable biosensors because of their outstanding conductive and mechanical properties.Recently,CPs have been extensively incorporated into various wearable biosensors to monitor a range of target biomolecules.However,fabricating highly reliable CP-based wearable biosensors for practical applications remains a significant challenge,necessitating novel developmental strategies for enhancing the viability of such biosensors.Accordingly,this review aims to provide consolidated scientific evidence by summarizing and evaluating recent studies focused on designing and fabricating CP-based wearable biosensors,thereby facilitating future research.Emphasizing the superior properties and benefits of CPs,this review aims to clarify their potential applicability within this field.Furthermore,the fundamentals and main components of CP-based wearable biosensors and their sensing mechanisms are discussed in detail.The recent advancements in CP nanostructures and hybridizations for improved sensing performance,along with recent innovations in next-generation wearable biosensors are highlighted.CPbased wearable biosensors have been—and will continue to be—an ideal platform for developing effective and user-friendly diagnostic technologies for human health monitoring.

Deep brain implantable microelectrode arrays for detection and functional localization of the subthalamic nucleus in rats with Parkinson’s disease

The subthalamic nucleus(STN)is considered the best target for deep brain stimulation treatments of Parkinson’s disease(PD).It is difficult to localize the STN due to its small size and deep location.Multichannel microelectrode arrays(MEAs)can rapidly and precisely locate the STN,which is important for precise stimulation.In this paper,16-channel MEAs modified with multiwalled carbon nanotube/poly(3,4-ethylenedioxythiophene):poly(styrene sulfonate)(MWCNT/PEDOT:PSS)nanocomposites were designed and fabricated,and the accurate and rapid identification of the STN in PD rats was performed using detection sites distributed at different brain depths.These results showed that nuclei in 6-hydroxydopamine hydrobromide(6-OHDA)-lesioned brains discharged more intensely than those in unlesioned brains.In addition,the MEA simultaneously acquired neural signals from both the STN and the upper or lower boundary nuclei of the STN.Moreover,higher values of spike firing rate,spike amplitude,local field potential(LFP)power,and beta oscillations were detected in the STN of the 6-OHDA-lesioned brain,and may therefore be biomarkers of STN localization.Compared with the STNs of unlesioned brains,the power spectral density of spikes and LFPs synchronously decreased in the delta band and increased in the beta band of 6-OHDA-lesioned brains.This may be a cause of sleep and motor disorders associated with PD.Overall,this work describes a new cellular-level localization and detection method and provides a tool for future studies of deep brain nuclei.

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.

Recent advances of implantable systems and devices in cancer therapy and sensing

Malignant tumors have the capability to metastasize and colonize,meaning that they can spread to other organs and tissues,distributing metastatic focus and are hard to target.Although significant advances have been made in cancer treatment,it remains one of the leading causes of death around the globe.In recent years,new-emerging implantable systems and devices have been developed to tackle the challenge of metastatic tumors.In this review,implantable systems for suppressing tumors and preventing tumor recurrence are reported.In particular,we emphasize the responsive drug delivery systems and the external field assisted catalytic therapy for tumor treatment,as well as implantable biosensors for tumor microenvironment monitoring.We also conclude the open challenges and future perspectives of implantable systems and devices for cancer therapy and sensing.

Antitachycardia pacing programming in implantable cardioverter defibrillator:A systematic review

Implantable cardioverter defibrillator(ICD) programminginvolves several parameters. In recent years antitachycardia pacing(ATP) has gained an increasing importance in the treatment of ventricular arrhythmias, whether slow or fast. It reduces the number of unnecessary and inappropriate shocks and improves both patient's quality of life and device longevity. There is no clear indication regarding the type of ATP to be used, except for the treatment of fast ventricular tachycardias(188 bpm-250 bpm) where it has been shown a greater efficacy and safety of burst compared to ramp; 8 impulses in each sequence of ATP appears to be the best programming option in this setting. Beyond ATP use, excellent clinical results were obtained with programming standardization following these principles: extended detection time in ventricular fibrillation(VF) zone; supraventricular discrimination criteria up to 200 bpm; first shock in VF zone at the maximum energy in order to reduce the risk of multiple shocks. The MADIT-RIT trial and some observational registries have also recently demonstrated that programming with a widespread use of ATP, higher cut-off rates or delayed intervention reduces the number of inappropriate and unnecessary therapies and improves the survival of patients during mid-term follow-up.

A 16-channel high-voltage reconfigurable and flexible-controlled implantable wireless closed-loop system for SCI repair

An adaptive closed-loop system for spinal cord injury(SCI) repair is designed. It integrates stimulation and recording on 16 pairs of electrodes. Two switches(SAS3 T16/SAS1 T16 X2) fabricated in high-voltage 0.8 μm process with online re-configurable function are proposed. These two switches are combined with commercial off-the-shelf(COTS) electronics to implement the closed-loop implantable system in compact module. The system includes amplifier for recording neural signals, high-voltage stimulator, power transmission device, central processing module and flexible implantable electrodes. Two customized switches route any electrode to amplifier or stimulator, and nerve stimulation and signal recording are performed through lead wire-driven channels. The entire system is able to operate at up to 28 V, and is a biocompatible package with a volume of 42 mm×35 mm×8 mm. This system solves several problems encountered in implantable devices: low flexibility, negative influence of stimulus artifacts on neural detection and low integration of electrodes.

Advances in Wireless,Batteryless,Implantable Electronics for Real‑Time,Continuous Physiological Monitoring

This review summarizes recent progress in developing wireless,batteryless,fully implantable biomedical devices for real-time continuous physiological signal monitoring,focusing on advancing human health care.Design considerations,such as biological constraints,energy sourcing,and wireless communication,are discussed in achieving the desired performance of the devices and enhanced interface with human tissues.In addition,we review the recent achievements in materials used for developing implantable systems,emphasizing their importance in achieving multi-functionalities,biocompatibility,and hemocompatibility.The wireless,batteryless devices offer minimally invasive device insertion to the body,enabling portable health monitoring and advanced disease diagnosis.Lastly,we summarize the most recent practical applications of advanced implantable devices for human health care,highlighting their potential for immediate commercialization and clinical uses.

Implantable Electrochemical Microsensors for In Vivo Monitoring of Animal Physiological Information

In vivo monitoring of animal physiological information plays a crucial role in promptly alerting humans to potential diseases in animals and aiding in the exploration of mechanisms underlying human diseases.Currently,implantable electrochemical microsensors have emerged as a prominent area of research.These microsensors not only fulfill the technical requirements for monitoring animal physiological information but also offer an ideal platform for integration.They have been extensively studied for their ability to monitor animal physiological information in a minimally invasive manner,characterized by their bloodless,painless features,and exceptional performance.The development of implantable electrochemical microsensors for in vivo monitoring of animal physiological information has witnessed significant scientific and technological advancements through dedicated efforts.This review commenced with a comprehensive discussion of the construction of microsensors,including the materials utilized and the methods employed for fabrication.Following this,we proceeded to explore the various implantation technologies employed for electrochemical microsensors.In addition,a comprehensive overview was provided of the various applications of implantable electrochemical microsensors,specifically in the monitoring of diseases and the investigation of disease mechanisms.Lastly,a concise conclusion was conducted on the recent advancements and significant obstacles pertaining to the practical implementation of implantable electrochemical microsensors.

Early clinical outcome with lens position adjustment following implantable collamer lens surgery

AIM:To observe early clinical outcome with lens position adjustment following the implantable collamer lens(ICL)surgery.METHODS:Sixty patients were selected for this retrospective study.One eye from each patient received Toric ICL for astigmatism correction,and the other received non-astigmatic ICL surgery using horizontal position.Patients with higher postoperative arch height were selected,and their non-astigmatic eye clinical outcome were observed after ICL surgery at 1wk,1,and 3mo.The clinical measurements included uncorrected visual acuity(UCVA),intraocular pressure(IOP),refractive state,corneal endothelium cell count,and arch height.Three months later,the ICL in each patient’s non-astigmatic eye was adjusted to the vertical from the horizontal position.The results were compared before and 1wk,1,and 3mo after adjustment.RESULTS:UCVA and IOP were significantly reduced 1wk after position adjustment compared to 1wk after ICL implantation(P<0.05).The patients demonstrated significantly reduced arch height and corneal endothelium cell count 1wk,1,and 3mo after adjusting position compared to 1wk,1,and 3mo after ICL implantation(P<0.05).However,there was no significant difference in refraction between 1wk,1,and 3mo after ICL implantation and position adjustment(P>0.05).CONCLUSION:Early positioning adjustment postphakic ICL implantation can benefit patients with adjusted arch height or higher IOP.Despite the good clinical effects,the doctors should pay attention to the potential for adverse effects on UCVA and corneal endothelium cells following early position adjustment after posterior chamber phakic ICL implantation.

Clinical prediction of insufficient vaults after implantable collamer lens implantation

AIM:To determine the factors related to preoperative ocular characters that are predictive of insufficient vault(<250μm)after implantable collamer lens(ICL V4c;STAAR Surgical)implantation.METHODS:The participants underwent ICL surgery and were divided into the low(<250μm)and normal(250-1000μm)vault groups based on the postoperative vault at 3mo.The preoperative biometric parameters and clinical outcomes were compared between the two groups.The relationship between the 3-month vault values and preoperative ocular parameters were evaluated by Generalized estimating equations.RESULTS:Sixteen(23 eyes)and 36 patients(63 eyes)were in the low and normal vault groups,respectively.All implantation procedures were uneventful with no cataract formation in the early postoperative period.The sulcusto-sulcus lens rise(STSL)and iris ciliary angle(ICA)were correlated with vault at 3mo after surgery.Every 0.1 mm increase in STSL was associated with 38.9μm decrease in the postoperative 3-month vault.A rise of 1 degree in ICA is associated with a reduction of 4μm in vault.CONCLUSION:Eyes with a narrow ciliary sulcus are associated with a higher rate of low vault after ICL implantation,suggesting a need for adjustments to the ICL size in these patients.Evaluating the characteristics of the ciliary sulcus contributes valuable information to predict low vault after surgery.

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.

Rhegmatogenous retinal detachment in highly myopic eyes with implantable collamer lens

AIM:To investigate the clinical characteristics,treatment methods and outcomes of rhegmatogenous retinal detachment(RRD)in highly myopic eyes with implantable collamer lens(ICL).METHODS:High myopia patients who received treatment for nontraumatic RRD after ICL implantation surgery at the Retinal Department of Zhongshan Ophthalmic Center from Jan 2018 to Dec 2022 were reviewed.Comprehensive ophthalmologic examinations including visual acuity measurement and digital fundus photography were performed in each patient.RESULTS:A total of nine RRD eyes from nine patients who received V4c-ICL implantation were included.The mean time from ICL implantation surgery to the diagnosis of RRD was 32.44±22.56mo(range,1-60mo).At the initial visit for RRD,giant retinal tear(GRT),horseshoe tear,simple round hole,and horseshoe tear combined with round hole were detected in 3,3,2,and 1 eye(s),respectively,with maculaoff in eyes.Eight patients received surgical treatment,and one patient was treated by retinal laser photocoagulation alone.The ICL was preserved in 7 eyes.At the last followup,the mean best corrected visual acuity(BCVA)improved significantly from 1.76±1.06 logMAR at presentation to 0.81±1.01 logMAR(P=0.035),and no case of recurrent retinal detachment was found.CONCLUSION:The morphological presentation of retinal breaks is diverse in this study.The ICL can be preserved in most cases during the course of retinal detachment repair surgery in our data,companied with acceptable visual and anatomical outcomes.

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.

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。

Self-Powered Implantable Skin-Like Glucometer for Real-Time Detection of Blood Glucose Level In Vivo

Implantable bioelectronics for analyzing physiological biomarkers has recently been recognized as a promising technique in medical treatment or diagnostics. In this study, we developed a self-powered implantable skinlike glucometer for real-time detection of blood glucose level in vivo. Based on the piezo-enzymatic-reaction coupling effect of GOx@ZnO nanowire, the device under an applied deformation can actively output piezoelectric signal containing the glucose-detecting information. No external electricity power source or battery is needed for this device, and the outputting piezoelectric voltage acts as both the biosensing signal and electricity power. A practical application of the skin-like glucometer implanted in mouse body for detecting blood glucose level has been simply demonstrated. These results provide a new technique path for diabetes prophylaxis and treatment.

Chinese expert consensus and practice guideline of totally implantable access port for digestive tract carcinomas

Totally implantable access port is a fully implantable drug delivery system that is implanted subcutaneously and can be retained for a long time.Advantages of ports include a simple nursing process,low risk of infection and embolism,and high patient comfort.In order to promote the standardized application of ports in the treatment of digestive tract tumors and reduce port-related complications,the Chinese Research Hospital Association Digestive Tumor Committee,the Chinese Association of Upper Gastrointestinal Surgeons,the Chinese Gastric Cancer Association,and the Gastrointestinal Surgical Group of Chinese Surgical Society Affiliated to Chinese Medical Association have organized multidisciplinary expert discussions at the General Hospital of the People’s Liberation Army and nationwide expert letter reviews and on-site seminars,and formulated an expert consensus of the operation guidelines.

Design of Floating Mass Type Piezoelectric Actuator for Implantable Middle Ear Hearing Devices

To overcome some of the problems inherent in conventional heating aids such as low gain at high fi＇equencies due to acoustic feedback, discomfort in occlusion of the extemal ear canal and so on, implantable middle ear hearing devices （IMEHDs） have been developed over the past two decades. For such kinds of IMEHDs, this paper presents the design of a floating mass piezoelectric actuator using a PMN-30%PT stack as a new type of vibrator. The proposed piezoelectric actuator consists of only three components of a piezoelectric stack, a metal case and a clamp. For the purpose of aiding the design of this actuator, a coupling biomechanics model of human middle ear and the piezoelectric actuator was constructed. This model was built based on a complete set of computerized tomography section images of a healthy volunteer＇s left ear by reverse engineering technology. The validity of this model was confirmed by comparing the motion of the tympanic membrane and stapes footplate obtained by this model with published experimental measurements on human temporal bones. It is shown that the designed actuator can be implanted on the incus long process by a simple surgical operation, and the stapes footplate displacement by its excitation at 10.5 V root-mean-square（RMS） voltage was equivalent to that from acoustic stimulation at 100 dB sound pressure level（SPL）, which is adequate stimulation to the ossicular chain. The corresponding power consumption is 0.04 mW per volt of excitation at 1 kHz, which is low enough for the transducer to be used in an implantable middle ear device.