OBJECTIVE: To study the mechanical properties related to the typical functional failure modes of non-absorbable suture anchor in clinical use, and to support product design, development and verification. METHODS: By retrieving the database of relevant adverse events, the typical functional failure modes of non-absorbable suture anchor were summarized, and the influencing factors of functional failure were further analyzed by studying the mechanical properties related to functional failure. The publicly available test data was retrieved for verification and provided reference for the researchers. RESULTS: The typical functional failure modes of non-absorbable suture anchor include anchor failure, suture failure, fix loosening, inserter failure, which are related to the mechanical properties of products, such as screw-in torque and break torque of screw-in anchors, insertion force of knock-in anchors, suture strength, pull-out force before and after system fatigue test and elongation of sutures after fatigue test. CONCLUSIONS Enterprises should pay attention to improving the mechanical performance level of products through material, structural design and the suture weaving process to ensure the safety and effectiveness of products.
Suture Anchors ; Suture Techniques ; Sutures ; Absorbable Implants ; Biomechanical Phenomena ; Materials Testing

BACKGROUND: There are few data comparing clinical outcomes of complex percutaneous coronary intervention (CPCI) when using biodegradable polymer drug-eluting stents (BP-DES) or second-generation durable polymer drug-eluting stents (DP-DES). The purpose of this study was to investigate the safety and efficacy of BP-DES and compare that with DP-DES in patients with and without CPCI during a 5-year follow-up. METHODS: Patients who exclusively underwent BP-DES or DP-DES implantation in 2013 at Fuwai Hospital were consecutively enrolled and stratified into two categories based on CPCI presence or absence. CPCI included at least one of the following features: unprotected left main lesion, ≥2 lesions treated, ≥2 stents implanted, total stent length >40 mm, moderate-to-severe calcified lesion, chronic total occlusion, or bifurcated target lesion. The primary endpoint was major adverse cardiac events (MACE) including all-cause death, recurrent myocardial infarction, and total coronary revascularization (target lesion revascularization, target vessel revascularization [TVR], and non-TVR) during the 5-year follow-up. The secondary endpoint was total coronary revascularization. RESULTS: Among the 7712 patients included, 4882 (63.3%) underwent CPCI. Compared with non-CPCI patients, CPCI patients had higher 2- and 5-year incidences of MACE and total coronary revascularization. Following multivariable adjustment including stent type, CPCI was an independent predictor of MACE (adjusted hazard ratio [aHR]: 1.151; 95% confidence interval [CI]: 1.017-1.303, P  = 0.026) and total coronary revascularization (aHR: 1.199; 95% CI: 1.037-1.388, P  = 0.014) at 5 years. The results were consistent at the 2-year endpoints. In patients with CPCI, BP-DES use was associated with significantly higher MACE rates at 5 years (aHR: 1.256; 95% CI: 1.078-1.462, P  = 0.003) and total coronary revascularization (aHR: 1.257; 95% CI: 1.052-1.502, P  = 0.012) compared with that of DP-DES, but there was a similar risk at 2 years. However, BP-DES had comparable safety and efficacy profiles including MACE and total coronary revascularization compared with DP-DES in patients with non-CPCI at 2 and 5 years. CONCLUSIONS Patients underwent CPCI remained at a higher risk of mid- to long-term adverse events regardless of the stent type. The effect of BP-DES compared with DP-DES on outcomes was similar in CPCI and non-CPCI patients at 2 years but had inconsistent effects at the 5-year clinical endpoints.
Humans ; Drug-Eluting Stents/adverse effects* ; Myocardial Infarction/complications* ; Polymers/therapeutic use* ; Treatment Outcome ; Coronary Artery Disease/complications* ; Percutaneous Coronary Intervention/adverse effects* ; Absorbable Implants ; Prosthesis Design

The composite material PLGA compounded with β-tricalcium phosphate (β-TCP) was prepared by melt blending method, and the absorbable interface screw was prepared by injection molding process. Prepare PBS buffer that simulates human body, conduct in vitro degradation experiments on interface screws according to relevant national and industry standards, then test and characterize interface screws at different time points for degradation of intrinsic viscosity, average molecular weight distribution, mass loss, mechanical properties and thermal properties. According to the degradation performance-time curve, determine the time node at which the interface screw loses the mechanical properties. In this paper, the in vitro degradation behavior of interfacial screws prepared from PLGA and β-TCP composites was studied in detail, providing a reference and basis for the degradation behavior of absorbable products prepared from PLGA and β-TCP composites.
Humans ; Polyesters ; Materials Testing ; Calcium Phosphates ; Absorbable Implants

Flatfoot could be divided into flexible flatfoot and rigid flatfoot. Flatfoot with symptoms is called symptomatic flatfoot, surgical treatment is required if conservative treatment is not effective. Subtalar arthroereisis is a minimally invasive procedure which has been used for many years with good results in flexible flatfoot, however, still has many controversial points. Controversial points focus on indications and contraindications, optimal age, subtalar arthroereisis alone or not, efficacy and safety of absorbable material implants, and implant removal. The paper reviewed and summarized the use and controversies of subtalar arthroereisis in symptomatic flatfoot as follows:the best indication for subtalar arthroereisis was pediatric flexible flatfoot syndrome and aged from 10 to 12 years old was optimal age for treatment;tarsal coalitions with flatfoot and adult flatfoot were relative indications. Stiff flatfoot, joint laxity, and subtalar arthritis were contraindications;obesity and neurogenic flexible flatfoot were relative contraindications. The correction ability of subtalar arthroereisis alone was limited, and it's combined with other procedures depending on patient's situation. The safety and efficacy of absorbable material implants had been reported. Routine removal of the implant was not necessary, the main reason of which was tarsal sinus pain.
Adult ; Humans ; Child ; Flatfoot/surgery* ; Orthopedic Procedures/methods* ; Absorbable Implants ; Subtalar Joint/surgery* ; Heel/surgery* ; Pain/surgery*

Objective: To evaluate the 4-year clinical outcomes of patients following Firesorb bioresorbable scaffold (BRS) implantation. Methods: The study reported the 4-year follow-up results of the FUTURE I study. FUTURE I was a prospective, single-center, open-label, first-in-man study which evaluated the feasibility, preliminary safety, and efficacy of Firesorb stent in the treatment of coronary artery stenosis. A total of 45 patients with single de novo lesions in native coronary arteries ,who hospitalized in Fuwai Hospital from January to March 2016 were enrolled. After successfully stent implantation these patients were randomized in a 2∶1 ratio into cohort 1 (n=30) or cohort 2 (n=15). The patients in cohort 1 underwent angiographic, IVUS or OCT examination at 6 months and 2 years; and cohort 2 underwent angiographic, IVUS or OCT at 1 and 3 years. All patients underwent clinical follow-up at 1, 6 months and 1 year and annually thereafter up to 5 years. The primary endpoint was target lesion failure (TLF, including cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization). Secondary endpoints included patient-oriented composite endpoint (PoCE, defined as composite of all death, all miocardial infarction, or any revascularization). Results: A total of 45 patients were enrolled and implanted with Firesorb BRS, including 35 males (77.8%), and the age was (54.4±9.3) years. At 4 years, 10 patients in cohort 1 were reexamined by coronary angiography and OCT examination. Among them, 2 patients' stents were completely degraded and absorbed. Compared with the OCT images of the other 8 patients in cohort 2 at 3 years, the degree of stent degradation was increased, and no stent adherence was found. The 4-year clinical follow-up rate was 100%. In 4-year clinical following up, 2 patients suffered PoCE (4.4%): 1 patient underwent non-target vessel revascularization the day after index procedure and target vessel revascularization (Non-target lesion revascularization) at 2-year imaging follow-up; the other patient underwent target lesion revascularization during imaging follow-up at 4 years but not due to ischemic driven. There was no scaffold thrombosis or TLF events through 4 years. Conclusions: Four years after the implantation, complete degradation and absorption of the Firsorb stent are evidenced in some patients. Firesorb stent is feasible and effective in the treatment of patients with non-complex coronary lesions.
Absorbable Implants ; Cardiovascular Agents ; Coronary Artery Disease/surgery* ; Drug-Eluting Stents ; Humans ; Male ; Middle Aged ; Percutaneous Coronary Intervention ; Prospective Studies ; Sirolimus ; Treatment Outcome

Objective: To assess the efficacy of a bioabsorbable steroid-eluting sinus stent in improving surgical outcomes when placed in the frontal sinus ostium (FSO) following full endoscopic sinus surgery (ESS) in patients with whole group chronic rhinosinusitis with nasal polyps (CRSwNP). Methods: Patients with whole group CRSwNP who had similar lesions on bilateral sinus between September 2019 and March 2020 in Department of Otorhinolaryngology Head and Neck Surgery, Shanghai Changhai Hospital were chosen. Patients with CRSwNP who underwent extended ESS were randomly assigned to receive a steroid-eluting sinus stent in one FSO whereas the contralateral side received surgery alone. Endoscopic evaluations recorded at 30, 90 days postoperative were graded by an independent assessment panel to assess the need for interventions in the FSO. Semi-quantitative data with CT and endoscopic score were performed by rank sum test. The need for postoperative intervention and the patency rate of FSO were analyzed using the McNemar test. Results: Thirty-one patients with whole group CRSwNP met all eligible criteria, including 17 males and 14 females, with the age of (44.5±11.8) years(x¯±s). Stents were successfully placed in one FSO of all patients. At 30 days post-ESS, the assessment panel reported that steroid-eluting stents reduced the need for postoperative interventions by 41.0% (χ²=5.314,P=0.021), the need for oral steroid interventions by 40.0% (χ²=4.133,P=0.042) and the need for surgical interventions by 74.8% (χ²=4.292,P=0.038) compared to control sinuses with no stents. Clinical surgeons also reported greater diameter of FSO compared to control sinuses at 30 days post-ESS (74.2% vs 48.4%, χ²=4.351, P=0.037). These results at 90 days post-ESS were consistent with those at 30 days post-ESS. Conclusion: Bioabsorbable steroid-eluting sinus stents in the FSO can reduce polyp formation, adhesion, and the need for postoperative interventions in FSO of CRSwNP patients and improve the early postoperative outcomes.
Absorbable Implants ; Adult ; China ; Chronic Disease ; Endoscopy ; Female ; Frontal Sinus/surgery* ; Humans ; Male ; Middle Aged ; Nasal Polyps/complications* ; Paranasal Sinuses ; Rhinitis/complications* ; Stents ; Steroids ; Treatment Outcome

Biodegradable vascular stents have better biocompatibility than drug-eluting stents. The blood vessels are rebuilt and degraded after normal physiological functions are restored. Due to it will not stay in the body for a long time and the patients don't need taking anti-rejection drugs all the time, it becomes the focus of attention in the treatment of coronary heart disease. This article introduced the development history of biodegradable stents and reviewed the research status of several different materials of vascular stents (animals or humans)
Absorbable Implants ; Animals ; Drug-Eluting Stents ; Humans ; Stents

Absorbable Implants ; Consensus ; Coronary Angiography ; Coronary Artery Disease ; Coronary Vessels ; Drug-Eluting Stents ; Everolimus ; Percutaneous Coronary Intervention ; Treatment Outcome

OBJECTIVE: To evaluate early clinical effects of bioabsorbable suture anchors for the treatment of Bankart lesion. METHODS: Total 23 patients with the Bankart lesion were treated with arthroscopic repair using bioabsorbable suture anchors from January 2010 to June 2017. There were 20 males and 3 females, with an average age of (23.4±3.9) years old (ranged, 19 to 34 years old). Fourteen patients had injuries on the right shoulder joint and 9 patients had the injuries on the left side. The mechanism of primary dislocation included 17 cases of training, 5 cases of sports injury and 1 case of falling down. The mean interval time from injury to surgery was(10.9±5.8) months (ranged, 3 to 36 months). The Bankart lesion was repaired by bio-cortical suture anchors. The Rowes rating system for Bankart repair was used to evaluate therapeutic effects. RESULTS: All 23 patients were followed up, with a mean duration of(24.5±3.7) months(ranged, 18 to 39 months). At the latest follow up, there was no recurrent dislocation occurred, and all patients had returned to sports and work. The Rowes rating system for Bankart repair was 53.91±11.67 pre-operationally and 91.74±12.30 post operationally, respectively ( CONCLUSION Applying bio-cortical bone suture anchors for the Bankart lesion is a reliable, efficient and cost effective treatment, which is also suitable for the revision of the Bankart lesion.
Absorbable Implants ; Adult ; Arthroscopy ; Bankart Lesions ; Female ; Humans ; Joint Instability ; Male ; Range of Motion, Articular ; Recurrence ; Shoulder Dislocation/surgery* ; Shoulder Joint ; Suture Anchors ; Treatment Outcome ; Young Adult

The study reconstructed vascular model by the realistic Optical Coherence Tomography (OCT) data to investigate the influence of the local hemodynamics caused by different thickness and width of bioresorbable vascular scaffold (BRS) implantation in Left Anterior Descending (LAD) artery. The study explored the relationship between the stent structure and thrombus, and the result can provide a valuable reference for the optimal design of BRS.
Absorbable Implants ; Coronary Vessels ; Hemodynamics ; Humans ; Prosthesis Design ; Stents ; Tomography, Optical Coherence ; Treatment Outcome