Surgical Innovation最新文献

Introduction: Testing the fluorescence emission of the vascular circulation status of the indocyanine green (ICG) fluorescence contrast agent to validate the system performance is crucial. Hence, the development of an ICG phantom is imperative, and this study proposes a method for manufacturing an ICG phantom.

Method: The ICG with an initial concentration was subjected to 0.2 cc sampling through syringe(x), and an ICG (0.2 cc) is diluted with silicon (S_i) latex lubber (10 mL) during the manufactured the phantom. The brightest fluorescence expression state is 30 μM, and if it exceeded 50 μM, fluorescence fading occurred and changed to a dark color.

Results: The liquid (ICG) of the concentration range is 0.003 mM to 0.24 mM, and the maximum fluorescence expression range is 0.005 to 0.006 mM when the phantom is irradiated using a 780-nm (800 mW) LED. In addition, the fluorescence emission is reduced to 0.24 mM, and the fluorescence expression concentration is 10 μM, 30 μM, and 50 μM, respectively. The decreasing of the fluorescence emission is beginning to 50 μM.

Conclusions: In this study, the proposed phantom with ICG fluorescence emission using latex lubber is proposed. In this works, the proposed phantom is improved the performance for ICG fluorescence emission. In the manufactured phantom, the phantom is used for gelatin, and the advance of phantom has easy manufacturing and long-life fluorescence emission (semipermanent) due to incorrodible material (latex lubber). To experimental results of a phantom, the ICG fluorescent contrast medium (0.055 mM) is same to 30 μM. Then, the 0.055 mM and 30 μM have high resolution and fluorescence emission status. Thus, the results are in good agreement.

Background: Clinical trials represent a significant risk in the commercialization of surgical technologies. There is incentive for companies to mitigate their regulatory risk by targeting 510K over Premarket Approval (PMA) pathways in order to limit the scope, complexity and cost of clinical trials. As such, not all companies will publish clinical data in the scientific literature.

Purpose: We set out to investigate the relationship between scientific publication by surgical device companies and the impact it has on company valuation. We hypothesize that publishing in the scientific literature correlates with success of the surgical device companies as measured by funding.

Research design: We first obtained a list of surgical device startup companies and their financial deals using the Pitchbook database. Those companies were then cross referenced with the FDA database and the Dimensions database for product registrations and peer reviewed publications, respectively. Analysis was then performed using these query results.

Study sample and data collection: We obtained a list of US surgical device startups financing deals closed between 2010 and 2020 from the Pitchbook database. We queried the Pitchbook for deal dates from January 1, 2010 to January 1, 2020 for deal types spanning early stage investment to IPO. Deals were limited to those conducted in the United States and to the surgical device industry. We queried the FDA database for product registration information associated with each of the companies involved in the deals. We tabulated the number of journal articles associated with surgical device companies using the Dimensions Search API as well as a manual confirmation.

Results: Five hundred thirty five (535) deals from 222 companies were found in Pitchbook that met our criteria. Querying the FDA database resulted in 578 registrations associated with these companies. Publications per company ranged widely.

Conclusions: Companies that are able to generate a more numerous publications had correspondingly higher valuations during funding rounds. A subset of outstanding companies were analyzed and at least four factors affect: direct value of publications, indirect valve of publications, survivorship bias, and adoption share; each of which will be discussed in this manuscript.

Introduction: Many indwelling drainage tubes after surgery. Due to the characteristics of the implanted end in the body and the tube fixed in the body, once the force is pulled, it is easy to cause extubation events, and the incidence of unplanned extubation is at a high level. And considerable distress to patients.

Methods: We designed a magnetically controlled separable pipe joint device, which can realize the pipe's automatic separation and protection function in a critical state, and protect the patient's pipe from being pulled out when the pipe is affected by an external force. And realize the automatic closing function and automatic alarm function of the broken end after the pipeline is separated, to minimize the occurrence of unplanned extubation.

Results: The magnetically-controlled separable pipe joint was initially applied to the clinic. Compared with the traditional drainage tube, the incidence of unplanned extubation time can be effectively reduced, and the safety, portability, and maneuverability have been greatly guaranteed.

Conclusion: The magnetron detachable pipe joint device provides a new idea for selecting clinical drainage tubes by improving the defects of traditional drainage tubes. It can effectively prevent the occurrence of unplanned extubation.

Background: To evaluate the efficacy of the preoperative ultrasonographic sliding sign in predicting intra-abdominal adhesions.

Methods: This was a single-center, double-blinded, prospective observational study undertaken from March and September 2021 on 110 patients with a history of previous abdominal surgery. All patients who were scheduled for laparoscopy underwent slide test in 5 zones of abdomen: right lower quadrant, left lower quadrant, previous operation site, vesicouterine pouch, and rectovaginal pouch. Adhesions were assessed by the same gynecologic surgeon using ultrasonography before the surgery and by gynecological surgeons during surgery, and by a third gynecologic surgeon to compare the preoperative slide test findings and laparoscopic findings after the surgery.

Results: Seventy-three (66.4%) patients underwent laparoscopic surgery, and 37 (33.6%) patients underwent laparotomy. The mean age of patients was 46.9 ± 1.0 years. Sensitivity, specificity, and positive and negative predictive values of preoperative ultrasonography in predicting adhesions were 89.5%, 91.7%, 97.5%, and 71.0%, respectively. The accuracy of the slide test was calculated as 90.0%. It was found that as the total number of cesarean sections increased the estimates of vesicouterine adhesions and actual adhesions increased (P = .008). Also, the prediction of intra-abdominal adhesions and actual adhesions significantly increased as the total number of surgical operations increased (P = .002).

Conclusions: Intra-abdominal adhesions can be detected with the slide test, which is a non-invasive and well-tolerated procedure. Slide test can guide the physician before the elective operation in patients with previous abdominal surgery and may assist in counseling patients.

Background: Antonio Scarpa (1752-1832) is generally remembered for his discoveries in the field of anatomy, but he also provided some important contributions to the history of surgery.

Methods: We analyzed main treatises written by Scarpa, highlighting how he contributed to the development of modern surgery.

Results: Scarpa made great innovations in three branches of surgery: abdominal surgery (hernia), orthopedics (clubfoot) and vascular surgery (aneurism). Furthermore, he contributed to the birth of modern ophthalmology.

Need: This study developed a nano-filter to reduce the concentration of hazardous substances in surgical smoke.

Methodology and device description: The nano-filter consists of nanomaterials and hydrophilic materials. Smoke was collected before and after using the new nano-filter during the surgery.

Preliminary results: The concentration of PM_2.5 and PAHs produced by the monopolar device was the highest (P < .05). The concentration of PM_2.5 and PAHs after using a nano-filter was less than the non-filter group (P < .05).

Current status: Surgical smoke generated by monopolar and bipolar devices pose a potential cancer risk to health staff in the operational room. The concentration of PM and PAHs were reduced and the cancer risk was not obvious by using the nano-filter.

Background/need: Pleural empyemas carry a high morbidity and mortality. Some can be managed with medical treatment but most require some form of surgery with the goals to remove the infected material from the pleural space and to help re-expand the collapsed lung. Keyhole surgery by Video Assisted Thoracoscopy Surgery (VATS) is rapidly becoming a common approach to deal with early stage empyemas to avoid larger, more painful thoracotomies that hinder recovery. However, the ability to achieve those aforementioned goals is often hindered by VATS surgery due to the instruments available.

Methodology and device description: We have developed a simple instrument called the "VATS Pleural Debrider" to achieve those goals in empyema surgery that can be used in keyhole surgery.

Preliminary results: We have used this device in over 90 patients with no peri-operative mortality and a low re-operation rate.

Current status: Used in routine urgent/emergency pleural empyema surgery across 2 cardiothoracic surgery centres.

Need: Electrical stimulation (ES) is a promising therapy for multisegmental gastrointestinal (GI) motility disorders such as gastroparesis with slow-transit constipation or chronic intestinal pseudo-obstruction. Wireless communicating GI devices for smart sensing and ES-based motility modulation will soon be available. Before placement, a potential benefit for each GI segment must be intraoperatively assessed.

Technical solution: A minimally invasive multisegmental electromyography (EMG) analysis with ES of the GI tract is required.

Proof of concept: Two porcine experiments were performed with a laparoscopic setup. Multiple hook-needle electrodes were subserosally applied in the stomach, duodenum, jejunum, ileum, and colon. EMG signals were acquired for computer-assisted motility analysis. Gastric ES, duodenal ES, jejunal ES, ileal ES, and colonic ES were applied.

Next steps: Further technological and rapid regulatory solutions are desired to initialize a clinical trial of the next generation devices in the near future.

Conclusion: We demonstrate a laparoscopic strategy with EMG analysis and ES of multiple GI segments. Thus, GI function may be evaluated before theranostic devices are placed. Extended GI resection or organ transplantation may be delayed or even avoided in affected patients.

Need: Counting surgical sharps in surgeries mitigates the risk of retained surgical items in patients. Current procedures rely on manual counts throughout and at the end of each surgery. The manual count is lengthy, burdensome, and carries the risk of injuries.

Technical solution: This paper presents the design and early evaluation of a technology aid to automatize the sharps' counting process; it is composed of a shell holding a set of optical sensors that count needles that pass through the shell's top slot.

Proof of concept: The device was tested with needles originating from 20 surgeries. Users surveyed reported a decrease in counting time and perceived injury risk. The average count error was 4.4%, indicating the need to continue advancing the technology.

Next steps: The counting technology needs to be refined to increase accuracy, and a user guide for the equipment must be prepared. Thereafter, a new set of trials must be performed.

Conclusion: Our work provides a detailed requirements list for developing a technology aid to improve the needle count process and investigates one possible technological route to address this problem.