Ultrasonic Surgical Instruments Research Articles

Acoustic black hole ultrasonic scalpel

Ultrasonic scalpels (USs), as the preferred energy instruments, are facing a growing need to exhibit enhanced performance with the diversification of modern surgical challenges. Hence, we proposed an acoustic black hole ultrasonic scalpel (ABHUS) in longitudinal-bending coupled vibration for efficient surgical cutting. By incorporating an acoustic black hole profile, the local bending wave velocity is reduced and the amplitude is amplified cumulatively, thus creating a high-energy region near the blade tip to enhance the cutting performance of the ABHUS. The precise physical analysis model is established for systematic design of the ABHUS and quick estimation of its frequency characteristics. The vibration simulation and experiments demonstrate that compared with the conventional ultrasonic scalpel (CUS), the output amplitude of the ABHUS significantly increases, particularly a 425% increase in bending vibration displacement. The in-vitro cutting experiment confirms that ABHUS exhibits superior cutting performance. Our design presents vast possibilities and potential for the development of high-performance ultrasonic surgical instruments, serving as an innovative supplement with extraordinary significance for application of acoustic black holes.

Training Model for Brain Tumor Removal (Model TOM Meningioma)

With the development of stereotactic radiotherapy, opportunities to perform craniotomies for brain tumors under a microscope are decreasing, making it difficult to learn surgical techniques in clinical practice. For safety and ethical reasons, it is useful to create a brain tumor training model for hands-on practice. We created a sphenoidal ridge meningioma model with the following parameters: (1) the location of the tumor should be distinguishable using neuronavigation, (2) the feeding artery should allow for confirmation and hemostasis, (3) the tumor and brain should be properly adherent and dissectable, and (4) the tumor can be decompressed and removed using an ultrasonic surgical device. We created the model out of polyvinyl alcohol and produced a mold using a 3-dimensional printer. Thirteen young neurosurgeons used these models, and a questionnaire survey was conducted. It was possible to train neurosurgeons for tumor removal using this model. The results of the questionnaire showed that the model, usefulness of the clinical application, and willingness to participate again were highly rated. This model was created to practice procedures with realty and designed to be visualized by navigation systems, to be removed with ultrasonic surgical instruments, and to be dissected using microinstruments. This model is useful to learn surgical techniques and strategies and to test and develop new surgical equipment. Training using a brain tumor model should be good off-the-job training for young neurosurgeons.

Comparison of Harmonic scalpel and monopolar cautery for capsulectomy at the second stage of expander/implant breast reconstruction.

BackgroundCapsular contracture is a common complication of two-stage expander/implant breast reconstruction. To minimize the risk of this complication, capsulectomy is performed using monopolar cautery or ultrasonic surgical instrumentation, the latter of which can be conducted with a Harmonic scalpel. To date, there is disagreement regarding which of the two methods is superior. The purpose of this study was to compare postoperative outcomes between a group of patients who underwent surgery using a Harmonic scalpel and another group treated with monopolar cautery.MethodsA retrospective chart review was conducted of patients who underwent capsulectomy as part of two-stage breast reconstruction between January 2018 and February 2019 and who received at least 1 month of follow-up after surgery. Operative time and postoperative outcomes, including drainage duration, were analyzed.ResultsIn total, 36 female patients underwent capsulectomy. The monopolar group consisted of 18 patients and 22 breasts, while the Harmonic scalpel group consisted of 18 patients and 21 breasts. There was no statistically significant difference in demographics between the two groups. The Harmonic scalpel group had a significantly shorter mean drainage duration (6.65 days vs. 7.36 days) and a smaller mean total drainage volume (334.69 mL vs. 433.54 mL) than the monopolar cautery group (P<0.05). No statistically significant difference was observed with regard to seroma or hematoma formation.ConclusionsThe Harmonic scalpel approach for capsulectomy reduced the total drainage volume and drainage duration compared to the monopolar cautery approach. Therefore, this approach could serve as a good alternative to electrocautery.

DEVELOPMENT OF INDICATION SYSTEM OF MOBILE ULTRASONIC SURGICAL INSTRUMENT

Prevalence of gunshot wounds in modern world is associated with criminalization of society, terrorist threats, increase of a number of local military conflicts and civil unrest. Search and development of methods for reducing blood loss, accelerating the healing of postoperative wounds and scars resorption is an important goal of modern surgery, the solution of which is facilitated by the use of ultrasound. The use of ultrasonic surgery in military medicine and the use of piezoelectric elements as the source of ultrasound are perspective. Primary surgical treatment of wounds is the main method of preventing the development of severe infectious complications of gunshot wounds. When using an ultrasonic surgical instrument, an urgent task is to disinfect it before and after the operation. The purpose of this work is to develop an indication system for a mobile ultrasonic surgical instrument. A monochrome OLED display is used to indicate the state and interaction with the user in a mobile ultrasonic surgical instrument. STM32 series microcontroller is used to work with the display. The indication system provides a display of the current value of power, time and battery charge. The following settings menu items are available: frequency, power, sterilization, clock, information. The power value is presented in percent as a scale from 0% to 100%. The sterilization time setting menu provides a maximum sterilization time of 99 minutes and 59 seconds. The handle of the surgical instrument has all basic control elements for ease of use and simplicity. Proposed surgical instrument is mobile and can be used in extreme conditions. It does not require the use of a power cord. Li-ion batteries are used to ensure the mobility of the instrument. This work was made within the framework of a state budgetary research topic “Development of mobile highly effective ultrasonic surgical instrument for military and civil medicine”.

Dielectric and piezoelectric properties of (0.10-x) Pb (Mn1/3Nb2/3)O3 -x Pb(Ni1/3Nb2/3)O3-0.91Pb(Zr1/2Ti1/2)O3 ceramics with high Qm

In this paper, for developing the piezoelectric ceramics suitable for ultrasonic surgical instruments application, (0.10-x) Pb (Mn1/3Nb2/3)O3 -x Pb(Ni1/3Nb2/3)O3-0.91Pb(Zr1/2Ti1/2)O3 (x=0. 0.015, 0.03, 0.045, 0.06, 0.075) ceramics were manufactured and then their physical characteristics were systematically analyzed. When Pb(Ni1/3Nb2/3)O3 and sintered temperature were is 0 mol%, 940°C, respectively, the excellent electrical properties (d33=236 pC/N, εr=731.9, kp=0.5839, Qm=1982) were obtained for ultrasonic surgical instruments and actuators.

РОЗРОБКА СИСТЕМИ ЗНЕЗАРАЖЕННЯ УЛЬТРАЗВУКОВОГО ХІРУРГІЧНОГО ІНСТРУМЕНТУ

Prevalence of gunshot wounds in modern world is associated with criminalization of society, terrorist threats, increase of a number of local military conflicts and civil unrest. Search and devel-opment of methods for reducing blood loss, accelerating the healing of postoperative wounds and scars resorption is an important goal of modern surgery, the solution of which is facilitated by the use of ultrasound. The use of ultrasonic surgery in military medicine and the use of piezoelectric elements as the source of ultrasound are perspective.Primary surgical treatment of wounds is the main method of preventing the development of se-vere infectious complications of gunshot wounds. When using an ultrasonic surgical instrument, an urgent task is to disinfect it before and after the operation. The purpose of this work consists in the development of disinfection method for destruction of pathogen of infection on the cutting part of ultrasonic surgical instrument. In the paper a diagram is worked out and the design of tension transformer is conducted for ultraviolet emitters, the dock-station is constructed for a mobile ultrasonic surgical instrument for its loading and the process of desinfection. The model of ultrasonic surgical instrument and disinfection method for destruction of pathogen of infection on the cutting part of ultrasonic surgical instruments are developed. The worked out surgical instrument is mobile and autonomous, that is provided by the use of Li-ion accumulators, reliable and has considerable tenure of employment of active elements from piezoceramics, comfortable in exploitation and simple in a management due to the use of ergonomic handle.

Piezotome Rhinoplasty Reduces Postsurgical Morbidity and Enhances Patient Satisfaction: A Multidisciplinary Clinical Study

Experimental and clinical studies in various fields of oral and maxillofacial surgery suggest the use of piezotomes to reduce postsurgical morbidity and enhance healing. The aim of the study was to investigate if rhinoplasty surgery with piezotomes might decrease postsurgical morbidity and increase overall patient satisfaction when compared with rhinoplasty with traditional instruments and protocols. In this prospective clinical study, patients in a cosmetic surgery department, ear-nose-throat (ENT) department, and the department for maxillofacial surgery, scheduled for cosmetic reductive rhinoplasty, underwent rhinoplasty with traditional instruments or an ultrasonic surgical device called a "piezotome." Before rhinoplasty, all patients were evaluated by the Rhinoplasty Outcome Evaluation (ROE) questionnaire. Staging for ecchymosis/edema and for pain was performed on the seventh day after surgery, and at 6months after surgery, patients were again evaluated by the ROE score. Female and male patients aged between 24 and 57years were included; patients had to be free of functional impairments of nasal breathing. Data were anonymized and evaluated with SPSS software (version 22.0; IBM, Armonk, NY) (1-way analysis of variance, Games-Howell post hoc test for primary and secondary outcome evaluation, Levene test of equal variances, t test, and Pearson correlation of primary and secondary outcome evaluation). Eighty-four patients were fully documented by ecchymosis/edema staging, pain staging, and ROE; of these, 51 women and 12 men underwent cosmetic rhinoplasty in a department of plastic and reconstructive surgery; an ENT department; or a department for maxillofacial surgery. A piezotome rhinoplasty was performed in 16 female and 5 male patients. Statistical evaluation verified that there were no significant differences between the three surgical disciplines when a rhinoplasty was performed with traditional instruments (P > .7), but showed that the use of ultrasonic surgical instruments significantly improved immediate postsurgical morbidity in terms of ecchymosis/edema and pain (P < .05), as well as ROE score after 6months (P < .05). Correlation of ecchymosis/edema and pain with ROE score showed a significant difference (P ≤ .01) in favor of the piezotome. The use of ultrasonic surgical devices in reductive rhinoplasty decreases postsurgical morbidity and increases overall patient satisfaction significantly. The results of this study suggest piezotomes to be the surgical instrument of choice not only for oral surgical procedures, but also for cosmetic surgery on facial bones.

An Automated Algorithm for Measurement of Surgical Tip Excursion in Ultrasonic Vibration Using the Spatial 2-Dimensional Fourier Transform in an Optical Image

The International Electrotechnical Commission (IEC) has defined a standard IEC 61847 (First Edition, 1998) for characterization of ultrasonic surgical systems. This standard prescribes several methods for measurement of primary tip vibration excursion. The first method described in the standard uses an optical microscope and relies on the motion blur of a vibrating object as it is imaged at low frame rates (e.g. 30 Hz) of conventional video equipment. This is a widely used method, that predates the standard, in ultrasonic surgical instrument design, and it is one of the key parameters that surgeons who use these devices are aware of. It is relatively easily measured using a microscope system. Although this method is widespread, the accuracy of this method is highly dependent on multiple factors such as operator training, microscope lighting and modulation of surgical tip motion. It is also a manual and time consuming measurement such that a continuous measurement that describes dynamics at the scale of micro-seconds becomes impossible. Here we describe an algorithm to automate this measurement so that it can be done at high speed without operator training, reducing human error and operator variation. The algorithm derives from techniques used in motion blur estimation and reduction in the image processing literature. A 2 dimensional spatial Fourier transform is computed from the microscope image of an ultrasonically vibrating tip. A peak detection algorithm is used along with pre-processing to reduce noise. Separation of peaks in the Fourier domain is used to estimate tip excursion. We present data that shows an error of about 1% between manual and automated methods, when measurements are in the range of 300 microns and about 20% when the measurements are in the range of 30 microns.

Ultrasonic dissection versus conventional electrocautery during gastrectomy for gastric cancer: A meta-analysis of randomized controlled trials

ObjectiveUse of ultrasonic surgical instrument is gaining popularity for dissection and coagulation in open surgery. However, there is still no consensus on the efficacy and safety of its use compared with conventional surgical technique in open gastrectomy for gastric cancer. The aim of this meta-analysis was to evaluate the role and surgical outcomes of ultrasonic dissection (UD) compared with conventional electrocautery (EC). MethodsA systematic literature search was performed to identify all studies comparing UD and EC in gastric cancer surgery. Intraoperative and postoperative outcomes were compared using weighted mean differences (WMDs) and odds ratios (ORs). ResultsFive studies were included in this meta-analysis, comprising 489 patients. Meta-analysis results showed that compared with EC, UD was associated with significantly shorter operation time (P = 0.03), less intraoperative blood loss (P = 0.002), lower morbidity (P = 0.02), and reduced postoperative hospital stay (P = 0.03). However, there was no significant difference between the two surgical techniques with regards to postoperative abdominal drainage (P = 0.17), and total cost in hospital (P = 0.59). ConclusionsCompared to EC, the use of UD during open gastrectomy can provide several improved outcomes for operation time, intraoperative blood loss, overall morbidity, and postoperative hospital stay. It appears that UD can be used instead of conventional EC in open gastric cancer surgery, although more larger trials with long follow-up should be performed.

Comparison of Surface Morphology and Healing in Rat Calvaria Bone Defects between Ultrasonic Surgical Method and Rotary Cutting Method

The aim of this study was to investigate the influence of ultrasonic surgical method (piezoelectric surgery) on invasions of bone structure in early stages and the subsequent healing process of bone defects of rat calvaria as compared with that of rotary cutting using an appropriate rotation speed. Thirteen-week-old male Sprague-Dawley rats were used in this study. Bone defects were prepared in rat calvaria using either an ultrasonic surgical instrument with an ultrasonic insert tip (Ui) or a handpiece with a round bur (Rb) as a rotary cutting instrument (control). Morphological evaluations of the cutting surfaces in the bone defects were assessed by scanning electron microscope (SEM) and confocal laser microscope (CLM) observation. The degree of invasions of the bone structure in the early stages after bone defects were made was assessed by the ratio of empty osteocyte lacunae relative to the total number of osteocytes. The process of bone healing was analyzed by histological observation, immunohistochemical staining with proliferating cell nuclear antigen (PCNA) and osteocalcin (OC), and ratio of PCNA-positive cells. Many fine, parallel streaky cutting traces were observed in the Ui groove surfaces, whereas the Rb groove surfaces were flat and no parallel cutting traces were observed. The arithmetic average roughness of the Ui group (10.06 ± 1.96 µm) was significantly higher than that of the Rb group (2.52 ± 0.16 µm) (p < 0.05). During the entire observation period, no differences in histological observation and immunohistochemical staining were observed between the Ui and Rb groups. No significant differences were recognized in the ratio of empty lacunae and PCNA-positive cells between the Ui and Rb groups. In the present study, there were no appreciable differences in the invasions of bone structure in the early stages and the subsequent healing process of the bone defects of rat calvaria between ultrasonic surgical method and rotary cutting method.

Thermal Measurements of Resonant Ultrasonic Surgical Horn

Temperatures at the distal end of the tip in ultrasonic surgical instruments are of interest because this is the applied part to a patient. It is difficult to directly measure these temperatures using contacting temperature sensors due to high vibration levels. Non-contact infrared (IR) thermography could be an important tool to experimentally determine the tip temperature. However, the low emissivity and polished cylindrical geometry of the tips complicate accurate IR thermography. In this study, we use Cr2O3 high emissivity paint to coat the tip for increased accuracy in IR measurements. Temperature measurements are consistent with heat generation models based on mechanical quality factor of about 5000 for the titanium tip material. It was found that no heat is generated at the tip distal end where strain is low. Air cooling by aspiration is effective at keeping tip distal end temperatures at near ambient levels even with heat transfer by conduction from warmer parts of the tip.

치과용 초음파 골수술기 설계 및 평가

A piezoelectric ultrasonic bone surgical instrument, usually used to remove the tartar out of teeth or to cut the dentine of the tooth, is a recently popular instrument for dental treatment due to its several merits such as small size, low-electric power and precision control of surgical operation. It has typically two parts of a tip and vibration system which is also composed of head, piezoelectric elements and tail-mass. In order to improve the performance of the instrument, it is important to standardize the size of the vibration system without tip for high performance. In this study, a Finite Element Analysis (FEA) was utilized to optimize the structure of ultrasonic instrument in vibration system. Consequently, this study revealed that influence of several tips on property were minimized and it showed good property at the frequency range of 22~32 kHz.

Evaluation of endoscopic harmonic diverticulostomy

The purpose of this study is to review a consecutive series of patients with Zenker's diverticulum who were treated with endoscopic diverticulostomy using either the endoscopic stapler (ENDO GIA 30 Autosuture; Covidien, Dublin, Ireland) or Harmonic Ultrasonic Surgical Instrumentation (Ethicon Endo-Surgery, Cincinnati, OH) to evaluate the safety and optimal application of Harmonic technology to the treatment of patients with Zenker's diverticulum. This is a retrospective review at a tertiary academic hospital with institutional review board approval. All patients undergoing endoscopic repair of Zenker's diverticulum between April 1, 2009 and December 1, 2010 at a single institution were studied. A total of 65 endoscopic diverticulostomies were performed: 24 Harmonic assisted, 41 stapler assisted. Average diverticulum size was 3.46 cm. There were two complications with staple-assisted (pharyngeal leak and recurrence) and six complications with Harmonic-assisted diverticulostomies (two pharyngeal leaks, two chest pains, one recurrence, and one subcutaneous emphysema). There was a statistically significant difference in the complication rates between the staple-assisted (4.88%) and Harmonic-assisted (25%) cohorts (P = .04). There were no complications with diverticula <2 cm. Endoscopic Harmonic esophagodiverticulostomy has been reported for the treatment of Zenker's diverticula. However, our data demonstrate a significantly higher complication rate with use of the Harmonic technology compared to the staple-assisted method (P = .04). Additional evaluations are warranted to validate these findings and before Harmonic diverticulostomy can be recommended as treatment for the majority of cases.

Evaluation of Safety of Endoscopic Harmonic Diverticulostomy

Objective: Review a series of patients with Zenker diverticulum who were treated with endoscopic diverticulostomy using Harmonic Ultrasonic Surgical Instrumentation (Ethicon Endosurgery, Cincinnati, Ohio) in order to evaluate the safety and optimal application of this technology to the treatment of patients with this disorder. Method: Retrospective chart review of patients undergoing endoscopic surgical correction of Zenker diverticulum with Harmonic Ace curved shears between July 1, 2009 and November 1, 2010. Presenting symptoms, size of diverticulum, operative times, length of hospital stay, outcomes, and complications were reviewed. Results: A total of 60 endoscopic diverticulostomies were performed, and 24 were Harmonic-assisted. Eight required hospital stays, with their average stay being 2.13 days (0.7 days for all Harmonic patients). There were 6 complications with Harmonic treatments (25%). Two patients had chest pain with negative work-ups. Two patients had subcutaneous air. One had a documented salivary leak. One patient had diverticulum recurrence. No patients had hemorrhage, mediastinitis, or death. The average diverticulum size was 3.24 cm, and there were no complications with diverticula less than 2 cm. There were two complications with the staple technique (6.45%). Conclusion: Endoscopic staple diverticulostomy is a proven safe treatment for Zenker diverticulum with few limitations. Harmonic instrumentation may be effective with diverticula less than 2 cm. However, based on observed complication rates, additional evaluations are warranted before endoscopic Harmonic diverticulostomy can be recommended as treatment for the majority of cases.

Cutting characteristics of ultrasonic surgical instruments

Ultrasonic surgical devices are becoming increasingly popular and work is required to understand the performance of the cutting tips. This experimental study looks to investigate the way in which ultrasonic bone cutting tools oscillate and how this oscillation is modified when contacted against bone surfaces with varying loads. The defects produced in instrumented bone surfaces were measured and related to the tip motion. An ultrasonic cutting probe was scanned, unloaded, using a scanning laser vibrometer to determine its free oscillation pattern and amplitude. This probe tip was then contacted against bone under various loads to assess the modification in oscillation characteristics. Cuts were performed over a period of 10 s. The cut bone surfaces were assessed using laser profilometry to determine defect depths. The average vibration displacement amplitude at the probe tip, under load, was <12 μm in the longitudinal direction and was greatest for the cortical cutting mode. Elliptical probe motion was successfully mapped out under the range of loads tested. Defect depths of up to 0.36 mm were detected and were greatest when the tip was in contact with the bone with a load of 100 g. This work showed that the nature of the surface being cut may significantly alter the mode shape and magnitude of the probe oscillation. The maximum depth of cut with minimum restraining of tip motion was achieved at 100 g contact load.

Ultrasonic and Nonultrasonic Instrumentation

To compare the efficacy and safety of ultrasonic surgical instrumentation with nonultrasonic traditional surgical techniques in various types of surgery. Electronic searches of MEDLINE, Current Contents, and the Cochrane Library were performed for the period of 1990 to June 1, 2005, using relevant search terms. A manual check of all references in accepted studies was also performed. Only comparative studies (including randomized and nonrandomized control trials) of ultrasonic surgical instrumentation with nonultrasonic instrumentation were accepted. Procedures of interest included the following: colorectal surgery, gynecologic surgery, head and neck surgery, solid organ surgery, vessel harvesting, cholecystectomy, hemorrhoidectomy, mastectomy, and Nissen fundoplication. Two investigators reviewed each study: the first investigator extracted all relevant data, and consensus of each extraction was performed by a second investigator to verify the data. Data were then entered into a database and quality checked for accuracy. Fifty-one primary studies that examined 4902 patients were included in this systematic review, of which 24 were randomized trials and 27 were nonrandomized studies. Comparative meta-analyses for blood loss, surgery time, and hospital length of stay were performed using a random-effects model and stratified by surgery type. Heterogeneity was tested using Q statistics. Statistical significance was defined as P < .05. Meta-analysis of outcomes comparing ultrasonic with conventional nonultrasonic surgical instrumentation demonstrates significant improvement of several perioperative outcomes in procedure-specific settings when ultrasonic instrumentation is used.

249: The Use of a Vessel-sealant Device (LigaSure) Compared with Ultrasonic Surgical Instrumentation (Harmonic Ace) in Radical Hysterectomy for Cervical Cancer

To evaluate surgical outcomes in women undergoing laparoscopic radical hysterectomy for cervical cancer using a vessel-sealant device (LigaSure Atlas, Valleylab, Boulder, Colorado, USA) compared with an ultrasonic surgical device (Harmonic ACE, Ethicon Endo-Surgery, Cincinnati, Ohio).

Piezoelectric bone surgery in otosclerosis

Conclusion. This test of the Piezosurgery® medical device for osteoplasty of the external auditory duct posterior wall and stapedotomy highlighted the advantages of this device. The device's accuracy and selectivity render it superior to conventionally rotating instruments in otologic surgery. The precise nature of the instrument allows exact, clean, and smooth cut geometries during surgery, without any visible injury to the adjacent soft tissue. Objective. The aim of this work was to test the Piezosurgery® device as a new and alternative method to conventional bone tissue management in otologic surgery and in particular in stapedotomy and the external auditory duct posterior wall. Materials and methods. The Piezosurgery® medical device is a piezoelectric ultrasonic bone-cutting surgical instrument designed to perform sharp cutting actions. The equipment consists of two piezoelectric hand-pieces and two insets that are connected to a main unit, which supplies power and has holders for the hand-piece and irrigation fluids. Piezosurgery uses low frequency ultrasonic waves (24.7–29.5 kHz), the applied power can be modulated between 2.8 and 16 W, and the machine is programmed in accordance with the density of the bone cut. The micro-vibrations that are created in the piezoelectric hand-piece cause the inserts to vibrate linearly between 60 and 210 µm and allow a selective cut of mineralized tissues without trauma to soft tissues. The interoperative irrigation cools down the bone surface and make the operating site blood-free. Twenty patients affected by otosclerosis underwent treatment utilizing the device. Results. In all the patients treated, the characteristics of the ultrasonic frequencies allowed rapid and easy intraoperative management, without any visible injury to the adjacent soft tissue. No side effects were detected.

超音波手術器を使用して摘出手術を行った犬の髄膜腫の2症例

超音波手術器を使用して摘出手術を行った犬の髄膜腫の2症例

Multifunctional curved blade for use with an ultrasonic surgical instrument

The present invention relates, in general, to ultrasonic surgical clamping instruments and, more particularly, to a multi-functional curved shears blade for an ultrasonic surgical clamping instrument (120). Disclosed is an ultrasonic surgical instrument that combines end effector geometry to best affect the multiple functions of a shears type configuration. The shape of the blade is characterized by a radius cut to form a curved, and potentially tapered geometry. This cut creates a curved surface including a concave surface (53), and a convex surface (57). The convex surface transitions into a short, straight, flat surface. The length of this straight portion affects, in part, the acoustic balancing of the transverse motion induced by the curved shape. Relative to straight blade tips, the tip curvature of the present design provides improved visibility of the transection site and improved access to targeted tissues.