Validation of a high-fidelity training model for fetoscopic spina bifida surgery.

Open fetal surgery for spina bifida (SB) is safe and effective yet invasive. The growing interest in fetoscopic SB repair (fSB-repair) prompts the need for appropriate training. We aimed to develop and validate a high-fidelity training model for fSB-repair. fSB-repair was simulated in the abdominal cavity and on the stomach of adult rabbits. Laparoscopic fetal surgeons served either as novices (n = 2) or experts (n = 3) based on their experience. Technical performance was evaluated using competency Cumulative Sum (CUSUM) analysis and the group splitting method. Main outcome measure for CUSUM competency was a composite binary outcome for surgical success, i.e. watertight repair, operation time ≤ 180 min and Objective-Structured-Assessment-of-Technical-Skills (OSATS) score ≥ 18/25. Construct validity was first confirmed since competency levels of novices and experts during their six first cases using both methods were significantly different. Criterion validity was also established as 33 consecutive procedures were needed for novices to reach competency using learning curve CUSUM, which is a number comparable to that of clinical fSB-repair. Finally, we surveyed expert fetal surgeons worldwide to assess face and content validity. Respondents (26/49; 53%) confirmed it with ≥ 71% of scores for overall realism ≥ 4/7 and usefulness ≥ 3/5. We propose to use our high-fidelity model to determine and shorten the learning curve of laparoscopic fetal surgeons and retain operative skills.

Handheld Active Add-On Control Unit for a Cable-Driven Flexible Endoscope.

The instruments currently used by surgeons for in utero treatment of the twin-to-twin transfusion syndrome (TTTS) are rigid or semi-rigid. Their poor dexterity makes this surgical intervention risky and the surgeon's work very complex. This paper proposes the design, assembly and quantitative evaluation of an add-on system intended to be placed on a commercialized cable-driven flexible endoscope. The add-on system is lightweight and easily exchangeable thanks to the McKibben muscle actuators embedded in its system. The combination of the flexible endoscope and the new add-on unit results in an easy controllable flexible instrument with great potential use in TTTS treatment, and especially for regions that are hard to reach with conventional instruments. The fetoscope has a precision of 7.4% over its entire bending range and allows to decrease the maximum planar force on the body wall of 6.15% compared to the original endoscope. The add-on control system also allows a more stable and precise actuation of the endoscope flexible tip.

A mixed-reality surgical trainer with comprehensive sensing for fetal laser minimally invasive surgery.

PURPOSE: Smaller incisions and reduced surgical trauma made minimally invasive surgery (MIS) grow in popularity even though long training is required to master the instrument manipulation constraints. While numerous training systems have been developed in the past, very few of them tackled fetal surgery and more specifically the treatment of twin-twin transfusion syndrome (TTTS). To address this lack of training resources, this paper presents a novel mixed-reality surgical trainer equipped with comprehensive sensing for TTTS procedures. The proposed trainer combines the benefits of box trainer technology and virtual reality systems. Face and content validation studies are presented and a use-case highlights the benefits of having embedded sensors. METHODS: Face and content validity of the developed setup was assessed by asking surgeons from the field of fetal MIS to accomplish specific tasks on the trainer. A small use-case investigates whether the trainer sensors are able to distinguish between an easy and difficult scenario. RESULTS: The trainer was deemed sufficiently realistic and its proposed tasks relevant for practicing the required motor skills. The use-case demonstrated that the motion and force sensing capabilities of the trainer were able to analyze surgical skill. CONCLUSION: The developed trainer for fetal laser surgery was validated by surgeons from a specialized center in fetal medicine. Further similar investigations in other centers are of interest, as well as quality improvements which will allow to increase the difficulty of the trainer. The comprehensive sensing appeared to be capable of objectively assessing skill.

From a Disposable Ureteroscope to an Active Lightweight Fetoscope-Characterization and Usability Evaluation.

The twin-to-twin transfusion syndrome is a severe fetal anomaly appearing in up to 15% of identical twin pregnancies. This anomaly occurs when twins share blood vessels from a common placenta. The complication leads to an unbalanced blood transfusion between both fetuses. A current surgical treatment consists in coagulating the shared vessels using a fetoscope with an embedded laser. Such treatment is very delicate and constraining due to limited vision and size of the insertion area. The rigidity and lack of controllability of the current used instruments add an additional difficulty and limit the choice in insertion site. This letter proposes an improved flexible fetoscope, offering an enhanced laser controllability and higher versatility regarding the location of the insertion site. A better approach angle can therefore be realized. Also, tissue damage may be further reduced. This single-handed controllable active fetoscope is obtained after adaptation of a LithoVue (Boston Scientific, Natick, MA, USA), a commercially available passive flexible ureteroscope. The LithoVue is fitted with a unique lightweight add-on actuation module foreseen of an artificial muscle and a dedicated control system. Experiments in a mixed reality trainer suggested that the proposed fetoscope is compact, ergonomic, and intuitive in use, allowing an adequate control of the flexible end.

Haptic Guidance Based on All-Optical Ultrasound Distance Sensing for Safer Minimally Invasive Fetal Surgery.

By intervening during the early stage of gestation, fetal surgeons aim to correct or minimize the effects of congenital disorders. As compared to postnatal treatment of these disorders, such early interventions can often actually save the life of the fetus and also improve the quality of life of the newborn. However, fetal surgery is considered one of the most challenging disciplines within Minimally Invasive Surgery (MIS), owing to factors such as the fragility of the anatomic features, poor visibility, limited manoeuvrability, and extreme requirements in terms of instrument handling with precise positioning. This work is centered on a fetal laser surgery procedure treating placental disorders. It proposes the use of haptic guidance to enhance the overall safety of this procedure and to simplify instrument handling. A method is described that provides effective guidance by installing a forbidden region virtual fixture over the placenta, thereby safeguarding adequate clearance between the instrument tip and the placenta. With a novel application of all-optical ultrasound distance sensing in which transmission and reception are performed with fibre optics, this method can be used with a sole reliance on intraoperatively acquired data. The added value of the guidance approach, in terms of safety and performance, is demonstrated in a series of experiments with a robotic platform.