OBJECTIVE:To provide reference for the further standardization of biological products injection for treatment in-structions. METHODS:32 biological products injection for treatment instructions collected from Ma’anshan Center for Disease Control and Prevention and Ma’anshan Central Hospital during Jan. to Jun. in 2015. The information of marked item was summa-rized and analyzed. RESULTS & CONCLUSIONS:Among 32 biological products injection for treatment instructions, the mark rates of drug names,main ingredients,character,indications,specification,usage and dosage,package,term of validity,opera-tive norm,license number,manufacturing enterprise and other items all reached 100%. Although the mark rates of ADR,contrain-dication,precaution,drug use of pregnant women and nursing mothers,drug interactions,pharmacokinetics,drug use of the elder-ly,storage and other items were relatively high,but some items lacked the specific description of the content. The mark rates of drug use of children,drug overdose,toxicology,warnings,clinical trial were 56.25%,62.50%,59.38%,37.50% and 18.75%. Some biological products injection for treatment instructions are not revised timely and not complete in content and non-standard in writing,which can not meet the needs that clinical pharmacists and patients get enough drug safety information from instructions. Manufacturing enterprise is suggested to label the content of package inserts completely,verify and supplement related content, standardize and improve the instructions.

Accurate measurements of voltage and current from electrosurgery are the basis of development of electrosurgery with feedback function. We, therefore, developed a parameter measurement system based on PC, with high voltage and current from electrosurgery being sensed with transformers, amplified, filtered, transformed into single-ended signals, and then into RMS signals. The root mean square (RMS) signals were transformed into digital signals through DAQ card and the data was processed in PC with Labview. The process included sampling, displaying and storage. The experiment results indicated that the measurement system could measure the output parameters from electrosurgery steadily and correctly so that the development of the system has been successful. It can be the basis of development of embedded parameters measurement system and can provide accurate feedback information for intellectual electrosurgery.
Electrosurgery ; instrumentation ; Equipment Design

BACKGROUND:With the development of medical instruments, more and more traditional surgical operations are replaced by minimal y invasive surgeries. In minimal y invasive surgery, cutting and sealing tissue is a conventional procedure;however, due to the limitation of space and vision, the ordinary methods are not suitable for minimal y invasive surgery. OBJECTIVE:To develop high frequency electrosurgical generator that has a constant power output and ability for tissue cutting and closing. METHODS:In order to improve the efficiency of tissue cutting and sealing in surgical, a kind of high-frequency energy generator was developed for tissue cutting and sealing. The instrument consisted of switching power supply with adjustable amplitude, high-frequency power amplifier, impedance monitor and microcontrol er. The energy converter composed of switching power supply and high-frequency power amplifier converted the 220 V, 50 Hz utility powers to a kind of high-frequency energy with 450 kHz and applied on tissues. Impedance monitor would real-timely detect the electrical parameter impacting on tissue that was provide the amount of feedback to microcontrol er in order to complete constant power control and bioimpedance determination by the control er. RESULTS AND CONCLUSION:The experimental results indicated that the instrument could rapidly and stably provide high-frequency energy, and could detect the biological impedance in real-time, achieve constant power output through feedback control, and could cut and close the biological tissue efficiently.

Objective:To study the changes of food characters in early swallowing recovery in patients with different laryngeal function preservation surgery.Methods:Collected patients with laryngeal cancer hypopharyngeal cancer who underwent laryngeal function preservation surgery in Lihuili Hospital of Ningbo Medical Center from January 2019 to March 2020. By fiberoptic endoscopic evaluation of swallowing (FEES) combined with Penetration and Aspiration Scale (PAS), prospectively observed the aspiration and invasion of solid, paste, fluid and other food in the early stage of trial feeding in patients with laryngeal hypopharyngeal cancer undergoing open laryngeal function preservation.Results:Among the 69 patients, 21 had vertical partial laryngectomy and 19 had partial pharyngeal partial laryngectomy. 15 days after the operation, 2 groups of patients after solid and paste food adaptability scored (1.14±0.36), (1.29±0.56) and (2.53±2.04), (2.84±2.31) points, Friedman Mtest for comparison difference had statistical significance ( Mvalues were 23.463 and 22.227, P<0.01); the liquid food for adaptability scored (2.10±1.09), (4.42±2.24) points, the pairwise comparison of liquid, solid and paste showed statistically significant differences ( tvalues were-0.976 to 1.105, P<0.05). The pairwise comparison of the adaptability of the two groups on 20 days after surgery showed no statistically significant difference ( P>0.05).Throat on the cricoid cartilage resection-ring hyoid epiglottis anastomosis (SLCP-CHEP) was 17 cases, laryngeal glottis level partial resection was 12 cases; postoperative 15 days the adaptability on the behavior of three kinds of food grade 2 groups of patients (4.65±1.90), (5.59±1.46), (6.53±1.13) points and (6.67±1.07), (4.50±2.07), (6.92±0.79) points, respectively; Minspection differences were statistically significant ( Mvalues were 29.525, 22.136, P<0.01).The pairwise comparison of solid and paste food in the two groups 20 days after the operation showed no statistically significant difference ( P>0.05), while the difference of liquid and paste was statistically significant ( tvalues were-1.375 to-0.853, P<0.05). Conclusion:In the early recovery of patients undergoing laryngeal function preservation surgery, the vertical group and the partial pharyngeal partial laryngectomy group has better adaptability to solid and paste food. The horizontal group has better adaptability to paste, the CHEP group has better adaptability to solid, and the four groups has the worst adaptability to convection, the recovery time of convective mass between the CHEP group and the horizontal group was longer. To understand the adaptability of patients with different surgical methods to food traits at the early stage of trial feeding can help to implement targeted rehabilitation programs, carry out progressive diet training, and reduce the complications of misinvasion, aspiration, aspiration pneumonia and other complications in the recovery cycle.

OBJECTIVE: To evaluate the usefulness of monitoring transcranial electrically stimulated motor evoked potential (MEP) and its impact on postoperative motor function after surgical clipping of intracranial aneurysms. METHODS: A total of 69 aneurysm patients were monitored for MEP during surgery. The postoperative and preoperative neurological function variation and the correlation between them were compared. RESULTS: MEP deteriorated in 9/68 patients, 6 of the deteriorated MEP returned to normal within 1-40 min, and no new motor deficit emerged. 3 of MEP failed to return to the baseline, which were consistent with postoperative motor function deficit. CONCLUSION Changes in MEP could serve as early indication of the cerebral ischemia, predicting postoperative motor function and providing a guide to a safe time for temporary clipping. FNMEP monitoring is a safe and reliable tool for the integrity of facial nerve pathway in giant aneurysm surgery.
Adolescent ; Adult ; Evoked Potentials, Motor ; physiology ; Female ; Forecasting ; Humans ; Intracranial Aneurysm ; physiopathology ; surgery ; Male ; Middle Aged ; Motor Neurons ; physiology ; Neurosurgical Procedures ; instrumentation ; methods ; Postoperative Period ; Surgical Instruments ; Young Adult

Objective To investigate the suitable treatment of post operative anastomotic recurrence after anterior resection of rectal cancer and analyze the relationship between different kinds of therapy with prognosis. Methods The clinical data of 41 cases of local recurrent rectal cancer after anterior resection admitted in our hospital from 1999 to 2009 were analyzed retrospectively. The median survival time and survival rate were calculated by Life Tables method. The influence of different kinds of treatment to prognosis was evaluated by Kaplan-Meier method and the variability was analyzed by Log-rank method. P <0.01 means statistical significance. Results Thirty-three (80.5 %) of 41 patients were recurrent in the first 3 years and the median survival time was 23 months. Seventeen (41.5 %) of 41 patients underwent radical R0 resection. The median survival time of radical resection patients and non-radical resection ones were 49 months and 18 months, respectively, and the difference was significant (χ2=12.245, P=0.000). Thirty-one patients with radiotherapy and/or chemotherapy showed a statistically longer median survival time than the other 10 patients without these adjuvant treatment (39 months and 9 months, respectively) (χ2=17.533, P =0.000). Conclusion Most post operative anastomotic recurrent of rectal cancer cases occurs in the first 3 years after primary surgery. Radical resection, radiotherapy and chemotherapy can improve the prognosis.

Objective To investigate the hepatic hemodynamic characteristics of cirrhotic patients with splenectomy using iodine map of dual-source computed tomography(DSCT).Methods Twenty-four cirrhotic patients with splenectomy were selected as a study group,41 cirrhotic patients without splenectomy as a cirrhosis group and other 32 patients with normal liver as a control group.The iodine concentration(IC)in hepatic arterial and venous phases was measured on the iodine map,and the arterial iodine fraction(AIF)and portal venous iodine concentration(PVIC)were calculated.Receiver operating characteristic(ROC)curves were plotted and the area under the curve(AUC)was recorded to evaluate the diagnostic efficacy of each parameter using the DeLong test.Results IC in arterial phase and AIF were significantly higher,and IC in venous phase and PVIC were significantly lower in study group(P<0.05).The AUC values of the four parameters between study group and cirrhosis group were 0.735,0.992,0.943,and 0.994,respectively.Conclusion DSCT iodine map is helpful for clinical quantitative assessment of hepatic hemodynamic characteristics in cirrhotic patients with splenectomy,and the PVIC has optimal independent diagnostic performance.

Objective To analyze the influence regularities of different sizes on thermal stress field of bipolar high-frequency electric knife. Methods Based on the ANSYS software, the electric-thermal coupling simulation analysis was performed for thermal stress field of bipolar high-frequency electric knife during working. The effects of 3 different insulation layer thicknesses (0-5, 1-0, 1-5 mm), electrode thicknesses (0-5, 1-0, 1-5 mm) and coating thicknesses (3, 6, 9 μm) on thermal stress field of bipolar high-frequency electric knife were studied. Results If thickness of the insulation layer was larger, deformation of the myocardial tissues would be smaller due to thermal stress, that is, the thickness of the insulation layer was inversely proportional to thermal deformation of the myocardial tissue during working process of the high-frequency electric knife. For the 3 electrode thicknesses, 1-0 mm was a better choice. And for the 3 coating thicknesses, 6 μm was a better choice. Conclusions The component sizes for the high-frequency electric knife have an important influence on thermal stress field, and the result can provide guidance for design of the high-frequency electric knife.

Objective To develop a novel electric stapler, so as to improve the automation, convenience and precision of minimally invasive surgery. Methods The clamping, firing and turning mechanism of the new electric stapler was innovatively designed to realize the electric drive of minimally invasive surgical anastomosis on the basis of traditional mechanical stapler. The motion process of electric clamping, firing and double-screw turning mechanism was analyzed in detail, and the equations for motion function of three mechanisms were solved, providing a theoretical basis for the intelligent control algorithm of electric stapler. Results The electric clamping and firing process was simulated using ADAMS software to verify the equation of motion. The prototype of the new electric stapler was made, and the anastomosis experiment and blasting pressure experiment of the in vitro small intestine tissues were carried out. The range of anastomotic blasting pressure was between 3.7 kPa and 11.67 kPa, meeting the basic requirements in clinic. Conclusions The structure of the new electric stapler can meet the requirements of electric pressing and firing in minimally invasive surgery, contributing to achieve tissue anastomosis more conveniently, quickly and effectively.

Objective The ileum of porcine intestines with radiofrequency (RF) energy was fused through a novel linkage-type pressure controlled electrode, so as to verify feasibility and security of intestinal reconstruction in the RF energy tissue fusion technology. Methods Fresh porcine intestines were fixed on negative electrode in the order of ‘mucosa-serosa’, and then different compressive pressures （497，796，995，1 194，1 492 kPa）and RF energy were applied to the tissues through positive electrode of pressure cone to complete intestinal anastomosis. Biomechanical properties of the fused area were studied by tensile strength and bursting pressure test, and the thermal diffusion and tissue microstructure also studied. ResultsThe anastomotic tensile strength and bursting pressure could reach （8.73±1.11） N and （8.29±0.41） kPa, respectively, when the energy output power, pressure and welding time were 160 W, 995 kPa and 13 s, respectively, and an intact microstructure with little free collagen in the fused area could be observed. Conclusions The technology of RF energy-based tissue fusion could accomplish fast and stable intestinal tract reconstruction, showing great potential in clinical application. It is of great significance to shorten the operation time, simplify the operation process and improve the operation quality.